Dyestuffs and Chemicals, Inc. v. Flemming

• Decision Date: 30 October 1959
• Docket Number: No. 16225.,16225.
• Citation: 271 F.2d 281
• Parties: DYESTUFFS AND CHEMICALS, INC., Petitioner, v. Arthur S. FLEMMING, Secretary of Health, Education, and Welfare, Respondent.
• Court: U.S. Court of Appeals — Eighth Circuit

271 F.2d 281 (1959)

DYESTUFFS AND CHEMICALS, INC., Petitioner, v. Arthur S. FLEMMING, Secretary of Health, Education, and Welfare, Respondent.

No. 16225.

United States Court of Appeals Eighth Circuit.

October 30, 1959.

Earl Susman, St. Louis, Mo., and Paul C. Warnke, Washington, D. C. (Susman, Mayer & Willer, St. Louis, Mo., and Covington & Burling, Washington, D. C., were with them on the brief), for petitioner.

William W. Goodrich, Asst. Gen. Counsel, Dept. of Health, Education, and Welfare, Washington, D. C. (Malcolm R. Wilkey, Asst. Atty. Gen., Robert S. Erdahl and Harold P. Shapiro, Attys., Dept. of Justice, Washington, D. C., and Robert H. Becker, Attorney, Department of Health, Education, and Welfare, Washington, D. C., were with him on the brief), for respondent.

Before GARDNER, VOGEL and VAN OOSTERHOUT, Circuit Judges.

VOGEL, Circuit Judge.

Petitioner, Dyestuffs and Chemicals, Inc., herein seeks judicial review of an order promulgated by the respondent, Secretary of Health, Education, and Welfare, 24 F.R. 883, entitled "In the matter of amending the color-certification regulations with respect to FD&C Yellow No. 1, FD&C Yellow No. 2, FD&C Yellow No. 3 and FD&C Yellow No. 4." Jurisdiction of this court to review the order complained of is based upon 21 U.S.C.A. § 371(f) (1).

21 U.S.C.A. § 346(b) (§ 406(b) of the Federal Food, Drug and Cosmetic Act) provides that:

"(b) 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 harmful diluents."

Petitioner is a producer of food colors, including certain coal tar colors known as FD&C Yellows 3 and 4 which have been widely used in the coloring of edible fat products, principally butter and oleomargarine. FD&C Yellows 3 and 4 have been certified by the respondent and his predecessors under § 346(b) as safe for such use for approximately the past 40 years. On January 24, 1957, the Deputy Commissioner of Food and Drugs published in the Federal Register, 22 F.R. 478, a notice of his proposal to amend the Food and Drug Administration regulations by removing FD&C Yellow Nos. 1, 2, 3 and 4 from the approved list for unrestricted use. This notice solicited the views and comments of interested parties. After receiving comments, including those of the Certified Color Industry Committee of which petitioner is a member, the Commissioner on May 4, 1957, published an order removing the colors in question from the approved list, 22 F.R. 3173, because they "are not harmless and suitable for use within the meaning of" 21 U.S.C.A. § 346(b). Such order was to become effective 90 days after publication unless stayed by the filing of proper objections. On May 27, 1957, within the time provided by law, the Certified Color Industry Committee filed objections to the order and requested a hearing thereon in accordance with the provisions of 21 U.S.C.A. § 371(e) (2, 3). The objections, which will be subsequently discussed in more detail, were mainly on the ground that the term "harmless" had long been judicially and administratively construed to mean "harmless and suitable for use in food" under the intended conditions of their use and that petitioner's product could so qualify when used within certain stated tolerances.

Pharmacological studies conducted in the Food and Drug Administration's scientific laboratories had established that the colors in question were toxic when fed to laboratory animals, in that, while they produced no adverse physiological effects at 500 parts per million (0.05%) of the test animals' diets, they did produce such adverse effects at 1,000 ppm (0.1%) in the test diets. These studies and experiments formed the basis for the Deputy Commissioner's order of January 24, 1957, removing the coal tar colors in question from the harmless list.

After the objections were filed, a conflict arose between two Courts of Appeals over the construction of § 346(b) as applied to the use of red coal tar colors. The 2nd Circuit, in Certified Color Industry Committee v. Secretary of Health, Education and Welfare, 1956, 236 F.2d 866, sustained the power of the Secretary to delist those colors where laboratory tests showed that their addition to food might be injurious to health. The 5th Circuit, however, in Florida Citrus Exchange v. Folsom, 1957, 246 F.2d 850, held to the contrary and concluded that the Secretary could certify red coal tar colors for use in food on the basis of tolerances within which their use was harmless. Pending a resolution of this conflict by the Supreme Court, the delisting of the colors was stayed by administrative action, 22 F.R. 6612, August 17, 1957.

On December 15, 1958, the Supreme Court, in Flemming v. Florida Citrus Exchange, 358 U.S. 153, 166, 167, 79 S. Ct. 160, 168, 3 L.Ed.2d 188, reversed the holding of the 5th Circuit, 246 F.2d 850, and in effect sustained that of the 2nd Circuit by holding that "where a coal-tar color is not harmless, it is not to be certified" and, therefore, that the Secretary "is without power to permit the use of harmful coal-tar colors in specific foods through a system of tolerances."

On February 6, 1959, the Deputy Commissioner, without a hearing as provided for in 21 U.S.C.A. § 371(e) (2, 3), published the final order delisting the colors in question. The order explained the failure to grant a hearing as follows:

"The Supreme Court\'s (Flemming v. Florida Citrus Exchange, supra) decision having established the proper construction of the law, the objection of the Certified Color Industry Committee to the delisting of FD&C Yellow Nos. 1, 2, 3, and 4 is without substance, and no purpose could be served by holding a public hearing. The Department has no authority to certify colors that are themselves toxic, as is the case with FD&C Yellow Nos. 1, 2, 3, and 4, and the Department has no authority to establish a tolerance for such a color, as requested by the Industry Committee."

In this appeal, the petitioner requests that this court:

"1. Review and set aside the Respondent\'s Order of February 6, 1959, insofar as it affects the production, sale and use of FD&C Yellows 3 and 4 for coloring edible fats, as being unsupported by substantial evidence of record adduced at a public hearing; and that the Court order the Respondent to hold a public hearing as required by the Federal Food, Drug, and Cosmetic Act; and "2. Direct that there be full consideration at such hearing of the effect of legislation enacted by Congress and proposed by Respondent since the decision in Flemming v. Florida Citrus Exchange, supra, in establishing the principle that coal tar colors may be approved under conditions appropriate to assure the safety of such use."

Petitioner's first contention is that the respondent's refusal to hold a public hearing invalidates the order. 21 U.S. C.A. § 371(e) (2, 3) provide that:

"(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) of this subsection is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. * * *

"(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. * * *"

Petitioner contends that the foregoing constitute an unconditional statutory requirement for a hearing upon the filing of objections and that they were wholly disregarded by the order deleting the colors from the harmless list, with the result that no chance was afforded petitioner and others to raise any objections that might be available or to question and refute the pharmacological evidence referred to in the Secretary's order.

Respondent counters by claiming that the grounds set forth in petitioner's objections were wholly insufficient to warrant a hearing in that they sought the promulgation of regulations that were beyond the Department's authority.

Petitioner's "grounds for objection" were four in number. The first asserted that, "The colors affected by the order serve a useful and desirable purpose in coloring food and drugs," and that they had been so used for many years, principally with margarine and butter. Objection No. 2 alleged:

"The evidence of potential injury from the use of FD&C Yellow Nos. 1, 2, 3 and 4 is inadequate to justify the order. Although there has not been any report of injury to humans from any of the four colors (as acknowledged by the Commissioner in a public statement of January 23, 1957), the order will prohibit their use in foods and internal drugs and cosmetics solely on the basis of pharmacological tests on animals in which the ingestion of massive doses of FD&C Yellow Nos. 1, 3 and 4 over long periods of time.

"(a) produced no adverse physiological effects at a concentration of 500 ppm (0.05%) of the animals\' total diet; but

"(b) but produced some adverse physiological effects at a concentration of 1,000 ppm (0.1%) of the animals\' total diet.

"The `no-harm\' level thus shown (500-1,000 ppm) is so far in excess of the level of actual use in the human diet that those results do not afford any basis for the order."

Objection No. 3 asserted that:

"The reasonably anticipated uses of the

...