FDA'S INTERPRETATION OF THE DELANEY CLAUSE TO
PERMIT APPROVAL OF SUBSTANCES THAT DO NOT PRESENT
ANY RISK OF CANCER TO THE PUBLIC IS REASONABLE . . 16

A.

By Failing To Request a Hearing, Petitioners
Have Conceded the Facts That Quantitative Risk
Assessment Is an Appropriate Scientific
Procedure for Estimating the Human Risk of

These Color Additives and That These Additives
"Impose No Additional Risk of Cancer to
the Public"

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B.

The De Minimis Doctrine Is a Well-Established
Principle of Construction of Regulatory
Statutes.

19

FDA Is Not Required To Prohibit
De Minimis Risks. .

Congress Intended FDA To Apply a Standard of
Reasonableness in Implementing the Delaney

Clause.

1. The De Minimis Policy Is a Reasonable
and Necessary Regulatory Response to
the Change in Circumstances That Has
Resulted From Findings That Carcinogens
Are Ubiquitous in the Food Supply. .

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39

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42

CASES:

TABLE OF AUTHORITIES

Page

*Alabama Power Co. v. Costle,

204 U.S. App. D.C. 51, 636 F.2d 323 (1979) American Federation of Government Employees v. FLRA, 250 U.S. App. D.C. 229, 778 F.2d 850 (1985).

American Tobacco Co. v. Patterson,

456 U.S. 63 (1982)

NRDC,

366 F.3d 177 (7th Cir. 1966)

California v. United States EPA, 774 F.2d 1437 (9th Cir. 1985).

*Chevron U.S.A. Inc. v. NRDC,

467 U.S. 837 (1984).

Connecticut Fund for the Environment, Inc. v. EPA, 696 F.2d 179 (2d Cir. 1982).

Consumers Union v. Heimann,

191 U.S. App. D.C. 8, 589 F.2d 531 (1978).

Ethyl Corp. v. EPA,

176 U.S. App. D.C. 373, 541 F.2d 1 (en banc),
cert. denied, 426 U.S. 941 (1976).

Firefighters Local Union No. 1784 v. Stotts, 467 U.S. 561 (1984).

Industrial Union Dep't, AFL-CIO v. American Petroleum
Institute,

448 U.S. 607 (1980).

McIlwain v. Hayes,

223 U.S. App. D.C. 304, 690 F.2d 1041 (1982)

Page

21

21

198 U.S. App. D.C. 214, 613 F.2d 947 (1979).

Motor Vehicle Manufacturers Ass'n v. State Farm Mutual
Automobile Insurance Co.,

253 U.S. App. D.C. 18, 791 F.2d 189 (1986)

United States v. Dotterweich,

320 U.S. 277 (1943).

39

United States v. General Foods Corp.,

446 F. Supp. 740 (N.D.N.Y.), aff'd, 591 F.2d
1332 (2d Cir. 1978).

United States v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33 (1952) .

*United States v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914).

Page

United States v. 1,500 Cases More or Less, Tomato Paste, 236 F.2d 208 (7th Cir. 1956)

23

Washington v. Washington State Commercial Passenger
Fishing Vessel Ass'n,

443 U.S. 658 (1979). .

Washington Ass'n for Television and Children v. FCC,
229 U.S. App. D.C. 363, 712 F.2d 677 (1983).
Weinberger v. Bentex Pharmaceuticals, Inc.,
412 U.S. 645 (1973).

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