Dyestuffs and Chemicals, Inc. v. Flemming, No. 16225.

CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)
Writing for the CourtGARDNER, VOGEL and VAN OOSTERHOUT, Circuit
Citation271 F.2d 281
Decision Date30 October 1959
Docket NumberNo. 16225.
PartiesDYESTUFFS AND CHEMICALS, INC., Petitioner, v. Arthur S. FLEMMING, Secretary of Health, Education, and Welfare, Respondent.

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.


271 F.2d 282

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

271 F.2d 283
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
271 F.2d 284
"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,
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25 practice notes
  • United States v. Consolidated Mines & Smelting Co., Ltd., No. 25164
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • December 12, 1971
    ...States v. Storer Broadcasting Co., 351 U.S. 192, 205, 76 S.Ct. 763, 100 L.Ed. 1081 (1956); Dyestuffs and Chemicals Inc. v. Flemming, 271 F.2d 281, 286-287 (C.A.8, 1959), cert. den. 362 U.S. 911; Sun Oil Co v. FPC, 256 F.2d 233, 240-241 (C.A.5, 1958), cert. den. 358 U.S. 872, 79 S.Ct. 111, 3......
  • J. R. Norton Co. v. Agricultural Labor Relations Bd., AFL-CI
    • United States
    • United States State Supreme Court (California)
    • December 12, 1979
    ...Power Comm'n v. Texaco (1964) 377 U.S. 33, 39, 84 S.Ct. 1105, 12 L.Ed.2d 112; Dyestuffs and Chemicals, Inc. v. Flemming (8th Cir. 1959) 271 F.2d 281, 284-287; Pharmaceutical Manufacturers Ass'n v. Richardson (D.Del.1970) 318 F.Supp. 301, 311-313.) The rationale for this principle of statuto......
  • American Bancorporation, Inc. v. Board of Governors of Federal Reserve System, Nos. 73--1637
    • United States
    • U.S. Court of Appeals — Eighth Circuit
    • December 30, 1974
    ...207 (1973); Cooper Laboratories, Inc. v. Commissioner, 501 F.2d 772, 785--786 (D.C. Cir. 1974); Dyestuffs & Chemicals, Inc. v. Flemming, 271 F.2d 281, 286--287 (8th Cir. 1959), cert. denied, 362 U.S. 911, 80 S.Ct. 681, 4 L.Ed.2d 619 Page 39 The Board entered its order conditionally approvin......
  • Pactra Industries, Inc. v. Consumer Product Safety Commission, Nos. 74-2902
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • May 2, 1977
    ...to bypass the hearing and record-making procedures prescribed by statute, the Commission cites Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281 (8th Cir. 1959), where the Court of Appeals for the Eighth Circuit (T)he objections, in order to be effective and necessitate the hearing re......
  • Request a trial to view additional results
17 cases
  • United States v. Consolidated Mines & Smelting Co., Ltd., No. 25164
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • December 12, 1971
    ...States v. Storer Broadcasting Co., 351 U.S. 192, 205, 76 S.Ct. 763, 100 L.Ed. 1081 (1956); Dyestuffs and Chemicals Inc. v. Flemming, 271 F.2d 281, 286-287 (C.A.8, 1959), cert. den. 362 U.S. 911; Sun Oil Co v. FPC, 256 F.2d 233, 240-241 (C.A.5, 1958), cert. den. 358 U.S. 872, 79 S.Ct. 111, 3......
  • J. R. Norton Co. v. Agricultural Labor Relations Bd., AFL-CI
    • United States
    • United States State Supreme Court (California)
    • December 12, 1979
    ...Power Comm'n v. Texaco (1964) 377 U.S. 33, 39, 84 S.Ct. 1105, 12 L.Ed.2d 112; Dyestuffs and Chemicals, Inc. v. Flemming (8th Cir. 1959) 271 F.2d 281, 284-287; Pharmaceutical Manufacturers Ass'n v. Richardson (D.Del.1970) 318 F.Supp. 301, 311-313.) The rationale for this principle of statuto......
  • American Bancorporation, Inc. v. Board of Governors of Federal Reserve System, Nos. 73--1637
    • United States
    • U.S. Court of Appeals — Eighth Circuit
    • December 30, 1974
    ...(1973); Cooper Laboratories, Inc. v. Commissioner, 501 F.2d 772, 785--786 (D.C. Cir. 1974); Dyestuffs & Chemicals, Inc. v. Flemming, 271 F.2d 281, 286--287 (8th Cir. 1959), cert. denied, 362 U.S. 911, 80 S.Ct. 681, 4 L.Ed.2d 619 Page 39 The Board entered its order conditionally approvin......
  • Pactra Industries, Inc. v. Consumer Product Safety Commission, Nos. 74-2902
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • May 2, 1977
    ...to bypass the hearing and record-making procedures prescribed by statute, the Commission cites Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281 (8th Cir. 1959), where the Court of Appeals for the Eighth Circuit (T)he objections, in order to be effective and necessitate the hearing re......
  • Request a trial to view additional results

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