References
- , The residue in question excludes any residue of carcinogenic con-. cern. Such a residue is governed by the DES proviso to the Delaney clause in 21 U.S.C. §§ 348(c)(3)(A), 360b(d)(l)(I), 379e(b)(5)(B), and is beyond the scope of this paper
- , Codified principally at 21 U.S.C. §§ 348, 321(s) and 342(a)(2)(C). Some food constituents, e.g., unavoidable contaminants, are regulated under different safety standards. See 21 U.S.C. § 342(a)(1) (providing that a food containing an added poisonous or deleterious substance is adulterated if the substance “may render [the food] injurious to health,” but that if the poisonous or deleterious substance is not added, the food is not adulterated unless the substance “ordinarily render[s] [the food] injurious to health”)
- , 21 U.S.C. § 321 et seq.
- , 21 U.S.C. § 321(u). Similarly, the safety of food (feed) additives and color additives comprehends the safety for human consumption of residues of the additive in the meat, milk, or eggs of the animals that consumed the feed containing the additive. Id.
- , 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.111(a)(4)
- , 21 U.S.C. § 360b(l)(A), (G), and (H); 21 C.F.R. § 514.1(b)(7), (b)(8)
- , 21 U.S.C. § 360b(d)(l)(A), (B), (D); 21 C.F.R. § 514.111(a)(1), (2), (4). Withdrawal of approval of an NADA may be predicated on similar grounds. 21 U.S.C. § 360b(e)(l)(B) and 21 C.F.R. § 514.115(b)(3)(ii)
- , By contrast, 21 U.S.C. § 360b(d)(3) contains an objective standard by which effectiveness is to be determined
- , By contrast, 21 C.F.R. § 514.111(a)(5) provides an exquisitely detailed definition of effectiveness
- 1968, Before enactment of the Animal Drug Amendments of 1968, FDA regulated new animal drugs under 21 U.S.C. § 355 (which now applies only to new human drugs). If the drug was for use in a food-producing animal and could leave a residue in edible tissue, FDA also regulated the drug under the food safety requirements of the Food Additives Amendment of 1958. The Animal Drug Amendments of 1968 established a single licensure procedure for new animal drugs, 21 U.S.C. § 360b, but did not alter the standard governing human food safety. See S. Rep. No. 1308, 90th Cong., 2d Sess. 1
- Rep H. R. 1958, No. 2284, 85th Cong., 2d Sess. 12. The Senate Report quotes the House report on this point. S. Rep. No. 2422, 85th Cong., 2d Sess. 60 (1958). This formulation is reflected in the definition of “safe” and “safety” in FDA's food additive regulations, 21 C.F.R. § 170.3(i), 570.3(i)
- House Report. 1958, supra note 11, at 13. This view was reiterated on the floor of the House. 104 Cong. Rec. 17416 (August 13,; statement of Rep. Harris); id. at 17419 (statement of Rep. Poff)
- July, 1994, See 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.1(b)(8)(iii); and FDA guidelines concerning “General Principles for Evaluating the Safety of Compounds used in Food-Producing Animals”
- For a carcinogen, FDA calculates the permitted concentration for residues from the tumor data using a statistical extrapolation procedure, See 21 C.F.R. Part 500 Subpart E
- 1984, 467 U.S. 837
- 843–44, 467 U.S. at
- Natural Resources Defense Council, Inc. 1986, Young v. Community Nutrition Institute, 416 U.S. 974, 981 [quoting Chemical Mfrs. Ass 'n v., 470 U.S. 116, 125 (1985)]
- Chevron U.S.A., Inc. 1985, Id. at 980—81; United States v. Riverside Bay view Homes, Inc., 474 U.S. 121, 131—34, 467 U.S. at 842—44 & nn. 11—14; Aluminum Co. of America v. Central Lincoln Peoples' Utility District, 467 U.S. 380, 389 (1984); United States v. Rutherford, 442 U.S. 544, 553—54 (1979)
- 1969, See Rucker v. Wabash Railroad Co., 418 F.2d 146, 149—50 (7th Cir.
- 1977, United States v. Larionoff. 431 U.S. 864, 872 [quoting Bowles v. Seminole Rock Co., 325 U.S. 410, 414 (1945)]. See also Robertson v. Methow Valley Citizens Council, 490 U.S. 332, 358 (1989); Udall v. Tollman, 360 U.S. 1,16 (1965)
- 1980, Public Citizen v. Foreman 631 F.2d 969, 975 (D.C. Cir.)
- Federal Power Comm. v. Florida Power and Light Co. 1972, 404 U.S. 453, 463
- 1992, 21 C.F.R. § 10.90(b)(1). An FDA proposal published in (57 Fed. Reg. 47,314; October 13, 1992) would revise the regulations to state that guidelines “represent the position of FDA on a procedure of practice at the time of its issuance. However, a guideline does not bind the agency, and it does not create or confer any rights, privileges, or benefits for or on any person. FDA may in its discretion, recommend or initiate legal or administrative action against a person or product with respect to an action taken in conformity with a guideline, provided that the legal or administrative action is consistent with applicable statutes and regulations.”
- , 21 C.F.R. § 10.90(b)(4), (5), and (7)
- , Chevron U.S.A., Inc., 467 U.S. at 863
- 1991; 184–86, Id. See also Rust v. Sullivan, 500 U.S. 173
- 1970, See, e.g., Greater Boston Television Corp v. FCC, 444 F.2d 841, 852 (D.C. Cir.), cert denied, 403 U.S. 923 (1971) [cited with approval in Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 57 (1983)]
- 1991, Greater Boston Television Corp v. FCC, 444 F.2d at 852 [footnotes omitted]; accord, WLOS TV, Inc. v. FCC, 932 F.2d. 993, 998 (D.C. Cir.) (Commission must “adhere to governing precedents, or explain any departure from them with the requisite forthrightness and clarity”); NAACP v. FCC, 682 F.2d 993, 998 (D.C. Cir. 1982) (court must be satisfied that agency is aware it is changing its views and has articulated permissible reasons for the change); Marine Space Enclosures, Inc. v. Federal Maritime Comm., 420 F.2d 577, 585 (D.C. Cir. 1969); New Castle County Airport Comm. v. CAB, 371 F.2d 733, 735 (D.C. Cir. 1966); NAACP, Jefferson Cty. Branch v. Donovan, 566 F. Supp. 1202 (D.D.C. 1983)