Syllabus.

FLEMMING, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, v. FLORIDA CITRUS EXCHANGE ET AL.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT.

No. 27. Argued November 17, 1958.-Decided December 15, 1958. Under § 406 (b) of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration in 1939 certified as "harmless and suitable for use in food" a coal-tar color which has been used for many years in coloring oranges. After new tests in 1951-1953 had shown that the color had toxic effects on animals, and after public notice and hearings, the Secretary of Health, Education, and Welfare in 1955 ordered the color removed from the certified list. Under §§ 301 and 402 (c) of the Act, this had the effect of making it unlawful to ship in interstate commerce any food bearing or containing such color. The Secretary did not determine that the color was harmful for human consumption in the amounts used in coloring oranges but only that the color itself was not "harmless and suitable for use in food" within the meaning of § 406 (b), and he took the position that he had no authority to determine whether it was "required in the production" of food within the meaning of § 406 (a) or to promulgate thereunder a safe tolerance for its use on oranges. In a review proceeding under § 701 (f), the Court of Appeals set aside the order insofar as it removed the certification of that color as harmless and suitable for use as external coloring on oranges. Held: The Secretary's order was lawful, and the judgment is reversed. Pp. 154-168.

1. The Secretary's order revoking certification of the color under § 406 (b) as "harmless and suitable for use in food" was in accordance with the language and intent of the Act, and it must be sustained. Pp. 160-165.

(a) In §§ 402 (c) and 406 (b), dealing specifically with coaltar colors, Congress carefully outlined the special treatment to be given to coal-tar colors: the test of certification provided concentrates on the color substance itself; it is to be certified only if it is harmless. Pp. 160-162.

(b) This special method of dealing with coal-tar colors relieves the Secretary from showing in each case that a food containing

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358 U.S.

them raises a possibility of injury to health; and it makes no requirement that the colors be tested by experimental feeding in the proportions in which they are used in specific food products. Pp. 162-164.

(c) The evidence justified the Secretary's finding that the color here involved was poisonous. P. 164, n. 13.

(d) In forbidding the use of coal-tar colors in foods, the Secretary is not required to restrict his prohibition to specific food uses in which the color is shown to have a deleterious effect. Pp. 164-165.

2. The Secretary is not authorized by § 406 (a) to permit the use of harmful coal-tar colors in specific foods through a system of tolerances, since that section does not apply to § 402 (c)'s flat prohibition against the use of uncertified coal-tar colors. Pp. 165-167.

3. That special legislation has permitted the use of the color here involved solely in application to the skin of oranges for a temporary period ending March 1, 1959, does not render this case moot or prevent respondents from being persons "adversely affected" by the Secretary's order within the meaning of § 701 (f). Pp. 167-168.

246 F. 2d 850, reversed.

William W. Goodrich argued the cause for petitioner. With him on the brief were Solicitor General Rankin, Assistant Attorney General Anderson and Beatrice Rosenberg.

J. Hardin Peterson argued the cause and filed a brief for the Florida Citrus Exchange et al., respondents.

J. Lewis Hall argued the cause for Schell, respondent. With him on the brief was Morris E. White.

Richard W. Ervin, Attorney General, filed a brief for the State of Florida, as amicus curiae, urging affirmance.

MR. JUSTICE BRENNAN delivered the opinion of the Court.

Commercially grown Florida and Texas oranges have for many years been colored with a red coal-tar color. In 1939

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Opinion of the Court.

the Food and Drug Administration, after testing and pursuant to § 406 (b) of the Federal Food, Drug, and Cosmetic Act, certified this color, FD&C Red No. 32 (hereafter Red 32), to be harmless and suitable for use in food. However, the Secretary of Health, Education, and Welfare, on November 10, 1955, ordered Red 32 and two other coal-tar colors to be removed from the certified list, after new tests in 1951-1953 cast doubt whether Red 32 was harmless, and after public hearings were held upon the matter on notice published in the Federal Register. The consequence of the Secretary's order was that under § 402 (c) of the Act any food bearing or containing such colors would be deemed to be adulterated.

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The validity of the Secretary's order was attacked in petitions under § 701 (f) of the Act filed in several

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1 The Act, as amended, is 52 Stat. 1040, 21 U. S. C. § 301 et seq. Section 406 (b), 52 Stat. 1049, 21 U. S. C. § 346 (b) provides:

"The Secretary shall promulgate regulations providing 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, with or without harmless diluents."

2 Section 402 (c), 52 Stat. 1047, 21 U. S. C. § 342 (c), provides that a food shall be deemed to be adulterated "If it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 406 . . . ."

Section 301 of the Act prohibits the introduction or delivery for introduction into interstate commerce, or the receipt in interstate commerce, and the delivery thereof, of adulterated food, or the adulteration of food in interstate commerce. 52 Stat. 1042, 21 U. S. C. § 331. Sanctions for the prohibited acts, in the form of injunction proceedings, criminal prosecutions, and seizure actions, are provided in §§ 302-304, 52 Stat. 1043, 1044, 21 U. S. C. §§ 332-334.

"In a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. The summons and petition may be served at any place in the United

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358 U.S.

Courts of Appeals by persons and organizations claiming to be adversely affected. The Court of Appeals for the Second Circuit sustained the order against a general attack. Certified Color Industry Comm. v. Secretary of Health, Education and Welfare, 236 F. 2d 866. In the instant case, however, the Court of Appeals for the Fifth Circuit, by a divided vote, set aside the order insofar as

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States. The Secretary, promptly upon service of the summons and petition, shall certify and file in the court the transcript of the proceedings and the record on which the Secretary based his order." 52 Stat. 1055, 21 U. S. C. § 371 (f).

4 Review was sought in three Courts of Appeals in all. In the Court of Appeals for the Seventh Circuit, a petition was dismissed before it was adjudicated.

The persons and firms who are respondents here are all engaged in the growing, packing or marketing of Florida or Texas oranges. One is also interested in the patented process whereby the Red 32 color is applied to the skins of oranges.

The Court of Appeals set aside the order:

". . . in so far as said order removes the coal-tar color FD&C Red No. 32 from the list of colors which may be certified for use in coloring the skin of oranges meeting minimum maturity standards prescribed in the State of Florida and Texas; provided, that nothing herein or in the judgment of this Court entered pursuant hereto shall restore said coal-tar color to the list of colors which may be certified for unrestricted use in food, drugs and cosmetics but shall operate to authorize the certification of batches of said color conforming to the specifications for the color appearing at 21 C. F. R. 135.3 (1949 ed.) for the purpose of coloring the skin of mature oranges only; provided further, that the Secretary shall be required to certify only sufficient batches of FD&C Red No. 32 as may be necessary to color the skin of mature oranges from time to time; provided further, that the certificates issued for batches of FD&C Red No. 32 may be limited by their certificate for use in coloring mature oranges only; and provided further, that nothing herein or in the judgment of this Court entered pursuant hereto shall be deemed to restrict the Secretary from making further investigations and conducting hearings for a determination of whether the use of Red 32 is required in the production of oranges and to determine the tolerances, if any, that are safe and harmless, as harmless is herein construed and defined." 246 F. 2d, at 862.

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it removed the certification of Red 32 as harmless and suitable for use as external coloring on Florida and Texas oranges. 246 F. 2d 850.

The Secretary did not determine that Red 32 in the quantities used in color-added oranges was harmful for human consumption, but rather determined on the basis of the 1951-1953 tests only that Red 32 and the other suspect coal-tar colors were toxic and therefore not "harmless and suitable for use in food." The Court of Appeals held that the 1939 finding that Red 32 was harmless "should not be supplanted" by a contrary finding "unless there is evidence that, in the amounts used, and in the manner of use, oranges colored with Red 32 are unsafe for human consumption." 246 F. 2d, at 861-862. The word "harmless" was construed to be a term "of relation," preventing the Secretary from denying the continued use of Red 32 in the quantities used in color-added oranges in the absence of evidence that such quantities could not be consumed "without risk of injury or harm." Id., at 858. The Court of Appeals held further that in light of its premise that "harmless" was a term of relation and because two congressional Committees had found that the practice of adding the color to oranges was an economic necessity, it would be incumbent upon the Secretary to determine whether the use of the color was "required in the production" of food within the meaning of § 406 (a),'

752 Stat. 1049, 21 U. S. C. § 346 (a), which provides: "(a) Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2) of section 402 (a); but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2) of section 402 (a). While such a regulation