Certified Color Ind. Com. v. SECRETARY OF HEALTH, E. & W., No. 361

• Court: United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
• Writing for the Court: MEDINA and WATERMAN, Circuit , and MURPHY
• Citation: 236 F.2d 866
• Parties: The CERTIFIED COLOR INDUSTRY COMMITTEE, Allied Chemical & Dye Corporation, American Cyanamid Company, Bates Chemical Co., Inc., Dyestuffs and Chemicals, Inc., H. Kohnstamm & Co., Inc., Wm. J. Stange Co., Sterwin Chemicals, Inc. and Warner-Jenkinson Mfg. Co., Petitioners, v. The SECRETARY OF HEALTH, EDUCATION AND WELFARE, Marion B. Folsom, Respondent.
• Docket Number: No. 361,Docket 23983.
• Decision Date: 10 August 1956

236 F.2d 866 (1956)

The CERTIFIED COLOR INDUSTRY COMMITTEE, Allied Chemical & Dye Corporation, American Cyanamid Company, Bates Chemical Co., Inc., Dyestuffs and Chemicals, Inc., H. Kohnstamm & Co., Inc., Wm. J. Stange Co., Sterwin Chemicals, Inc. and Warner-Jenkinson Mfg. Co., Petitioners,
v.
The SECRETARY OF HEALTH, EDUCATION AND WELFARE, Marion B. Folsom, Respondent.

No. 361, Docket 23983.

United States Court of Appeals Second Circuit.

Argued May 14, 1956.

Decided August 10, 1956.

236 F.2d 867

Cravath, Swaine & Moore, New York City (Albert R. Connelly, New York City, and Michael F. Markel, Washington, D. C., of counsel), for petitioners.

Warren Olney III, Asst. Atty. Gen., John T. Grigsby and Frank J. Kiernan, Attorneys, Dept. of Justice, Washington, D. C. (Paul M. Steffy, and William W. Goodrich, Washington, D. C., of counsel), for respondent.

Before MEDINA and WATERMAN, Circuit Judges, and MURPHY, District Judge.

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.

This order was made November 10, 1955, effective February 10, 1956. Petitioners 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

236 F.2d 868

Act, § 406(b), 21 U.S.C.A. § 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.A. § 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 contains 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...