Scott v. Food and Drug Admin., s. 82-3544

• Decision Date: 23 February 1984
• Docket Number: 82-3759,Nos. 82-3544,s. 82-3544
• Citation: 728 F.2d 322
• Parties: Glenn M.W. SCOTT, Petitioner, v. FOOD AND DRUG ADMINISTRATION, Respondent.
• Court: U.S. Court of Appeals — Sixth Circuit

Page 322

728 F.2d 322

Glenn M.W. SCOTT, Petitioner, v. FOOD AND DRUG ADMINISTRATION, Respondent.

Nos. 82-3544, 82-3759.

United States Court of Appeals Sixth Circuit.

Argued Jan. 25, 1984.

Decided Feb. 23, 1984.

Glenn M.W. Scott argued, pro se.

Donald O. Beers, Food and Drug Admin., Rockville, Md., John J. Powers, II, Margaret G. Halpern argued, Dept. of Justice, Antitrust Div., Washington, D.C., for respondent.

Ellen J. Flannery, Covington & Burling, Washington, D.C., for amicus curiae Cosmetic, Toiletry and Fragrance Assn.

Daniel R. Thompson, Mark W. Smith, Washington, D.C., for amicus curiae Certified Color Mfrs. Assn.

Before ENGEL, KRUPANSKY and WELLFORD, Circuit Judges.

PER CURIAM.

Petitioner, acting pro se, seeks judicial review of 21 C.F.R. 74.1205, a regulation issued by the Food and Drug Administration (FDA) authorizing the permanent listing and therefore the continued use of a color additive, D & C Green No. 5, in drugs and cosmetics. ¹ This regulation was promulgated by the FDA after it determined through tests required under the Color Additive Amendments of 1960 that D & C Green No. 5, then provisionally listed, was safe for said use. Judicial review of this regulation is authorized by 21 U.S.C. Sec. 371(f)(1), (3).

D & C Green No. 5 contains another color additive, D & C Green No. 6, manufactured through the use of p-toluidine, which has been proven to be a carcinogenic when tested separately, and which is present in minute quantities as a chemical impurity in D & C Green No. 5. After extensive tests, the FDA determined that D & C Green No. 5, as a whole, did not cause cancer in test animals. It also determined that p-toluidine was not itself a color additive. It concluded, therefore, that the Delaney Clause, contained in the Food, Drug and Cosmetic Act, 21 U.S.C. Sec. 301, et seq., regulating the use of color additives, did not bar the permanent listing of D & C Green No. 5. This clause provides:

A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety or additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal ....

21 U.S.C. Sec. 376(b)(5)(B) (emphasis added).

Having found the Delaney Clause inapplicable, the FDA then evaluated the risk posed by the presence of p-toluidine in D & C Green No. 5 under the General Safety Clause of the Food, Drug and Cosmetic Act, which provides:

The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe ....

21 U.S.C. Sec. 376(b)(4).

The FDA regulations governing approval of color additives define "safe" as meaning "that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive." 21 C.F.R. Sec. 70.3(i).

The FDA first isolated the trace amounts of p-toluidine contained in D & C Green No. 5 and determined that the maximum life-term average individual exposure to p-toluidine from use of D & C Green No. 5 would be 50 nanograms per day. The FDA then extrapolated from the level of risk found in animal bioassays to the conditions of probable exposure for humans using two different risk assessment procedures. Under the first procedure, the upper limit individual's life time risk of contracting cancer from exposure to 50 nanograms per day of p-toluidine through the use of D & C Green No. 5 was 1 in 30 million; the second procedure resulted in a calculation of a 1 in 300 million risk. The agency concluded "that there is a reasonable certainty of no harm from the exposure to p-toluidine that results from the use of D & C Green No. 5." Fed.Reg. 24284 (1982).

Petitioner asserts on appeal that by permanently listing the color additive D & C Green No. 5, the FDA violated the Delaney Clause and the General Safety Clause of the Food, Drug, and Administration Act. Petitioner does not contest the validity of the tests employed by the FDA in determining that D & C Green No. 5 was safe for its intended uses but rather asserts that the Delaney Clause, as a matter of law, prohibits approval of a color additive when it contains a carcinogenic impurity in any amount and that the FDA has no discretion to find D & C Green No. 5 "safe" under the General Safety Clause because "[it is not] possible to establish a safe level of exposure to a carcinogen." The Agency found essentially that D & C Green No. 5, after studying the tests, did not cause cancer in test animals.

The decision of the FDA to approve permanent listing of color additive D & C Green No. 5 may be overturned by this court only if that decision was arbitrary and capricious, an abuse of discretion, or not in accordance with the law. 5 U.S.C. Sec. 706(2)(A). The FDA's interpretation of the Food, Drug, and Cosmetic Act is entitled to considerable deference. See, e.g., Hill v. Tennessee Valley Authority, 549 F.2d 1064, 1070 (6th Cir.1977), aff'd., 437 U.S. 153, 98 S.Ct. 2279, 57 L.Ed.2d 117 (1978). Even when there "is more than one reasonable interpretation of this ... [Act], the court should follow the interpretation urged by the FDA." United States v. Colahan, 635 F.2d 564, 567-68 (6th Cir.1980), cert. denied, 454 U.S. 831, 102 S.Ct. 127, 70 L.Ed.2d 108 (1981) (citations omitted).

We affirm the judgment of the Food and Drug Administration. Petitioner's arguments are found to be without merit. The FDA's finding that the Delaney Clause is inapplicable to the instant case because D & C Green No. 5 does not cause cancer in humans is in accordance with the law. In its final order, the FDA stated its rationale for its conclusion, and it was fully mindful of the Delaney Clause in making its decision:

[T]he Agency does not believe that it is disregarding the Delaney Clause. In drafting the Delaney Clause, Congress implicitly recognized that known carcinogens might be present in color additives as intermediaries or impurities but at levels too low to trigger a response in conventional test systems. Congress apparently concluded that the presence of these intermediaries or impurities at...