1See Administrative Procedure Act, 5 U.S.C. § 553 (1994).
2See Community Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C. Cir. 1987) (quoting Chisholm v. FCC, 538 F.2d 349, 393 (D.C. Cir. 1976); Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir. 1975); Pacific Gas & Elec. Co. v. Federal Power Comm’n, 506 F.2d 33, 37 (D.C. Cir. 1974)).
3See, e.g., 5 U.S.C. § 553; White v. Shalala, 7 F.3d 296, 303 (2d Cir. 1993); United States Dep’t of Justice, Attorney General’s Manual on the Administrative Procedure Act 9 (1947, Wm. W. Gaunt & Sons, Inc., unabridged republication 1979).
4See infra notes 9–112 and accompanying text.
5See infra notes 113–63 and accompanying text.
6See infra notes 164–293 and accompanying text.
7See infra notes 164–293 and accompanying text.
8See infra notes 164–293 and accompanying text.
9See, e.g., 1 Kenneth Culp Davis & Richard J. Pierce, Jr., Administrative Law Treatise 7 (3d ed. 1994); Jerry L. Mashaw et al., Administrative Law: The American Public Law System 4 (4th ed. 1998); J. Sanders, Evolution of Executive Departments of the Continental Congress 1774–89, at 187–92 (1935).
10See United States v. Grimaud, 220 U.S. 506, 517 (1910) (noting that Congress may delegate rulemaking authority to agencies); National Petroleum Refiners Ass’n v. FTC, 482 F.2d 672, 678 (D.C. Cir. 1973) (upholding FTC’s authority to create legislative-type rules); Davis & Pierce, supra note 9, at 6 (size and scope of agency activity has increased during every period of U.S. history); Mashaw et al., supra note 9, at 4–6, 15 (noting that Congress has created many agencies and delegated to them rulemaking authority and other powers).
11See Mashaw et al., supra note 9, at 56 (stating: “[v]irtually all agency action begins with a statute”); Richard J. Pierce, Jr. et al., Administrative Law and Process 35, 220 (1985) (noting that enabling statutes, also referred to as “organic,” convey powers to agencies); Stephen F. Williams, The Era of “Risk-Risk” and the Problem of Keeping the APA up to Date, 63 U. Chi. L. Rev. 1375, 1384 (1996). Statutes, however, are not the only means by which an agency comes into being. See Mashaw et al., supra note 9, at 12. Presidential executive orders have created many federal agencies, such as the Environmental Protection Agency and the Army Corps of Engineers. See id.
12See Administrative Procedure Act, 5 U.S.C. §§ 551, 553–557 (1994); Mashaw et al., supra note 9, at 13–15.
13See James Willard Hurst, Law and Social Order in the United States 150–51 (1977) (noting the growth of administrative state fostered fragmentation of policy making).
14See id.; Mashaw et al., supra note 9, at 9.
15See 5 U.S.C. §§ 553–557 (codifying method for rulemaking and for judicial review of agency action); White v. Shalala, 7 F.3d 296, 303 (2d Cir. 1993) (noting that the APA invests unrepresentative agencies with public participation and fairness); Mashaw et al., supra note 9, at 148 (noting that the APA systematized agency procedures); U.S. Dep’t of Justice, supra note 3, at 9 (nothing that the purposes of APA are to provide for public participation, public awareness, uniformity and judicial review of agency actions). For a history of the APA, see generally Peter L. Strauss, Changing Times: the APA at Fifty, 63 U. Chi. L. Rev. 1389 (1996).
16See 5 U.S.C. §§ 551, 553–596, 701–706; Mashaw et al., supra note 9, at 148; U.S. Dep’t of Justice, supra note 3, at 9–10.
17See Mashaw et al., supra note 9, at 148; U.S. Dep’t of Justice, supra note 3, at 9–10.
18See Mashaw et al., supra note 9, at 459; Pierce et al., supra note 11, at 37; U.S. Dep’t of Justice, supra note 3, at 9–10.
19See Mashaw et al., supra note 9, at 459.
20See id.
21See 5 U.S.C. § 553. Courts tend to treat interpretative rules, policy statements, guidelines and their ilk as virtually the same. See Community Nutrition Inst. v. Young, 818 F.2d 943, 945 (D.C. Cir. 1987) [hereinafter “CNI”]; see also Syncor Int’l Corp. v. Shalala, 127 F.3d 90, 93–94 (D.C. Cir. 1997) (stating that “[f]urther confusing the matter is the tendency of courts and litigants to lump interpretative rules and policy statements together in contrast to substantive rules, a tendency to which we have ourselves succumbed on occasion.”). In the last few years, the District of Columbia Circuit Court of Appeals has stressed the differences between interpretative rules and policy statements. See Hudson v. Federal Aviation Admin., 192 F.3d 1031, 1036 (D.C. Cir. 1999); Syncor, 127 F.3d at 94. Some legal scholars have analyzed all nonlegislative rules as being similar, while others have found interpretative rules and policy statements to be quite distinct. Compare Robert A. Anthony, Interpretative Rules, Policy Statements, Guidances, Manuals, and the Like—Should Federal Agencies Use Them to Bind the Public?, 41 Duke L.J. 1311, 1323–27 (1992) [hereinafter Interpretative Rules] (analyzing interpretative rules and policy statements as completely different legal instruments), with Ronald M. Levin, Nonlegislative Rules and the Administrative Open Mind, 41 Duke L.J. 1497, 1499 (1992) (stating: “the proper distinction to be drawn here is between legislative rules . . . and nonlegislative rules . . . .”). This Note will not explore extensively all of the nuances between the two types of nonlegislative rules.
22See, e.g., 5 U.S.C. §§ 553, 556–557; White, 7 F.3d at 303.
23See Anthony, Interpretative Rules, supra note 21, at 1319; Richard M. Thomas, Prosecutorial Discretion and Agency Self-Regulation: CNI v. Young and the Aflatoxin Dance, 44 Admin. L. Rev. 131, 134 (1992).
24See 5 U.S.C. § 553(a), (b)(A), (b)(B).
25This Note will refer to the statutory provision as “5 U.S.C. § 553(b)(A).” Because the statute’s format is ambiguous, however, many courts and scholars refer to the exception as “5 U.S.C. § 553(b)(3)(A).” See, e.g., CNI, 818 F.2d at 945; Elizabeth Williams, What Constitutes “Interpretative Rule” of Agency so as to Exempt Such Action From Notice Requirement of Administrative Procedure Act (5 U.S.C.A. § 553(B)(3)(A)), 126 A.L.R. Fed. 347, 347 (1995). Most authorities, however, refer to the exception as falling within 5 U.S.C. § 553(b)(A). See, e.g., Thomas v. New York, 802 F.2d 1443, 1447 (D.C. Cir. 1986); Michael Asimow, Nonlegislative Rulemaking and Regulatory Reform, 1985 Duke L.J. 381, 381 n.5 (1985); Daniel A. Kracov & Robert P. Brady, Food and Drug Administration Advisory Opinions and Guidance Documents After Community Nutrition Institute v. Young, 48 Food & Drug L.J. 47, 47 n.1 (1993).
Other rules exempted from § 553 rulemaking requirements include rules relating to the military, foreign affairs, agency management, agency personnel, public property, or when there is good cause for an agency to avoid rulemaking procedures. See 5 U.S.C. § 553(a), (b)(B). This Note will not discuss these other exceptions.
26See 5 U.S.C. §§ 553, 556–557; Mashaw et al., supra note 9, at 459.
27See 5 U.S.C. §§ 553, 556–557; Mashaw et al., supra note 9, at 459.
28See 5 U.S.C. §§ 553, 556–557; Davis & Pierce, supra note 9, at 288; Mashaw et al., supra note 9, at 459; Andrew F. Popper, Administrative Law in the 21st Century, 49 Admin. L. Rev. 187, 191 (1997).
29See 5 U.S.C. § 553. See generally Davis & Pierce, supra note 9, at 287–375; Richard J. Pierce, Jr., Rulemaking and the Administrative Procedure Act, 32 Tulsa L.J. 185, 185–201 (1996). To execute informal rulemaking, an agency must undergo numerous actions. See 5 U.S.C. § 553; Pierce et al., supra note 11, at 321. First, the agency must publish a notice of proposed rulemaking in the government’s official publication, the Federal Register. See 5 U.S.C. § 553(b); Federal Register Act, 44 U.S.C. §§ 1501–1511 (1994); DeBraun v. Meissner, 958 F. Supp. 227, 228 (E.D. Pa. 1997); Office of the Federal Register, National Archives and Records Administration, The Federal Register: What It Is and How to Use It 3–4 (Jim Wickliffe & Ernie Sowada eds., rev. 1992). The notice of proposed rulemaking includes the actual terms or the substance of the proposed rule and the legal authority behind it. See 5 U.S.C. § 553(b); Davis & Pierce, supra note 9, at 298–99. Private parties may submit commentary to the agency. See 5 U.S.C. § 553(c); Davis & Pierce, supra note 9, at 299–300. The agency considers the commentary then publishes a final rule in the Federal Register. See Freedom of Information Act of 1966, 5 U.S.C. § 552(a)(1)(D) (1994); 5 U.S.C. § 553(c); Office of the Federal Register, supra, at 4; Pierce et al., supra note 11, at 321; see also Wagner Electric Corp. v. Volpe, 466 F.2d 1013, 1016, 1019–20 (3d Cir. 1972) (noting that the final rule must resemble the proposed rule enough so that public had opportunity for meaningful comment). When the agency publishes the final rule, the agency must address the significant commentary in a “concise general statement” of the rule’s basis and purpose. See 5 U.S.C. § 553(c); Reytblatt v. United States Nuclear Regulatory Comm’n, 105 F.3d 715, 722 (D.C. Cir. 1997); South Carolina ex rel. Tindal v. Block, 717 F.2d 874, 886 (4th Cir. 1983); PPG Indus., Inc. v. Costle, 630 F.2d 462, 466 (6th Cir. 1980); see generally Davis & Pierce, supra note 9, at 309–20. The duration between publishing a notice of proposed rulemaking and issuing the final rule ranges, but can last a year or more. See Office of the Federal Register, supra, at 7. This procedure exists to ensure the public has an opportunity to participate in agency action. See, e.g., Chrysler Corp. v. Brown, 441 U.S. 281, 316 (1979); Tindal, 717 F.2d at 885; American Bus. Ass’n v. United States, 627 F.2d 525, 528 (D.C. Cir. 1980); Pierce et al., supra note 11, at 321; U.S. Dep’t of Justice, supra note 3, at 9.
30See 5 U.S.C. § 553; Anthony, Interpretative Rules, supra note 21, at 1319; Thomas, supra note 23, at 134.
31See 5 U.S.C. §§ 553, 556–557; Mashaw et al., supra note 9, at 459–60.
32See Mashaw et al., supra note 9, at 459; Pierce et al., supra note 11, at 330–31.
33See, e.g., National Petroleum, 482 F.2d at 673–98 (presuming agencies have rulemaking authority); Mashaw et al., supra note 9, at 459.
34See Automotive Parts & Accessories Ass’n v. Boyd, 407 F.2d 330, 337 (noting that when the organic statute is ambiguous, it is appropriate to presume the agency may employ § 553 informal rulemaking rather than §§ 553, 556–557 formal process); Mashaw et al., supra note 9, at 459.
35See 5 U.S.C. § 553(b)(A).
36See id.
37Id.
38See, e.g., 5 U.S.C. §§ 551, 553; Chrysler, 441 U.S. at 302 n.31; Federal Labor Relations Auth. v. United States Dep’t of Navy, 966 F.2d 747, 762 n.14 (3d Cir. 1992) [hereinafter “FLRA”]; CNI, 818 F.3d at 946; Pacific Gas & Elec. Co. v. Federal Power Comm’n, 506 F.2d 33, 37–38 (D.C. Cir. 1974).
39See, e.g., 5 U.S.C. § 553(b)(A); Thomas, 802 F.2d at 1446; Batterton v. Marshall, 648 F.2d 694, 702 n.34 (D.C. Cir. 1980); Guardian Fed. Sav. & Loan Ass’n v. Federal Sav. & Loan Ins. Corp., 589 F.2d 658, 666 (D.C. Cir. 1978); U.S. Dep’t of Justice, supra note 3, at 30 n.3.
40See, e.g., 5 U.S.C. §§ 551, 553; American Mining Congress v. Mine Safety & Health Admin., 995 F.2d 1106, 1109 (D.C. Cir. 1993); FLRA, 966 F.2d at 762 n.14; CNI, 818 F.3d at 946; Kracov & Brady, supra note 25, at 49–50; Marianna E. Beem, Good Guidance Improves Regulations: a Case Study with the FDA, 15 No. 4 ALA News 23, 23-24 (1996).
41See, e.g., Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 99 (1995); Chrysler, 441 U.S. at 302 n.31.
42See, e.g., Chrysler, 441 U.S. at 302 n.31; Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council Inc., 435 U.S. 519, 546 (1978); Davis & Pierce, supra note 9, at 13–14; Mashaw et al., supra note 9, at 9.
43See U.S. Dep’t of Justice, supra note 3, at 30 n.3. According to the Attorney General’s Manual, interpretative rules are “rules or statements issued by an agency to advise the public of the agency’s construction of the statutes and rules which it administers” and general statements of policy are “statements issued by an agency to advise the public prospectively of the manner in which the agency proposes to exercise a discretionary power.” Id. The Manual, however, provides almost no information regarding rules of agency organization. See id.
44See id. at 22–23, 30 n.3; see also Anthony, Interpretative Rules, supra note 21, at 1321 n.37 (lamenting how courts and agencies use the term “substantive rules” in place of “legislative rules”).
45See Chrysler, 441 U.S. at 301–02; Perales v. Sullivan, 948 F.2d 1348, 1354 (2d Cir. 1991); Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537 (D.C. Cir. 1986); Marshall, 648 F.2d at 701–02; Pacific Gas, 506 F.2d at 38.
46See Chrysler, 441 U.S. at 301–02; Cathedral Bluffs, 796 F.2d at 537; see also Pierce, supra note 29, at 186 (stating: “legislative rules . . . have effects that are functionally indistinguishable from those of statutes”).
47See, e.g., Chrysler, 441 U.S. at 301–02, 315–16; Batterton v. Francis, 432 U.S. 416, 425 n.9 (1977); Perales, 948 F.2d at 1354; Cathedral Bluffs, 796 F.2d at 536–38; Marshall, 648 F.2d at 701–02; Guardian Federal, 589 F.2d at 666; Pacific Gas, 506 F.2d at 38.
48See 5 U.S.C. § 553.
49See, e.g., Chrysler, 441 U.S. at 316. One caveat: the requirements for notice-and-comment and the nonlegislative rule exception only applies to rules. See, e.g., Lincoln v. Vigil, 508 U.S. 182, 198 (1993); Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 414 (1971). According to the APA, a “rule” is “the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure or practice requirements of an agency . . . .” 5 U.S.C. § 551(4). Other agency activities, such as expenditures of funds or investigations, are not rules, so agencies need not perform any procedure before implementing them. See, e.g., Overton Park, 401 U.S. at 414; Environmental Defense Fund, Inc. v. Costle, 636 F.2d 1229, 1254–56 (D.C. Cir. 1980). For example, in 1993, in Lincoln v. Vigil, the Supreme Court held that the Indian Health Service could discontinue a benefits program without following notice-and-comment procedure. See 508 U.S. at 195–99. The court explained that whether or not the decision to cease the allocation of funds to Native Americans was a rule was irrelevant to the holding. See id. at 196–97. The court reasoned that the agency action could have been a funding decision within agency discretion and not subject to rulemaking procedures. See id. at 197–98. Likewise, the decision could have been a rule of agency organization or a general statement of policy falling within agency discretion, so even if it had been a “rule,” informal rulemaking process was unnecessary. See id. at 195–99; Overton Park, 401 U.S. at 414.
50See Chrysler, 441 U.S. at 316; Guardian Federal, 589 F.2d at 662; U.S. Dep’t of Justice, supra note 3, at 9.
51See 5 U.S.C. §§ 553, 556–557; U.S. Dep’t of Justice, supra note 3, at 26.
52See, e.g., Chrysler, 441 U.S. at 316; New Jersey Dep’t of Envtl. Protection v. United States Envtl. Protection Agency, 626 F.2d 1038, 1045 (D.C. Cir. 1980) [hereinafter “NJDEP”]; U.S. Dep’t of Justice, supra note 3, at 26.
53See, e.g., Chrysler, 441 U.S. at 316; Guardian Federal, 589 F.2d at 663.
54See Morton v. Ruiz, 415 U.S. 199, 232 (1974).
55See Guardian Federal, 589 F.2d at 662.
56See id.
57See id.
58See id.
59See id. In 1979, in Chrysler Corp. v. Brown, the Supreme Court wrote that “[i]n enacting the APA, Congress made a judgment that notions of fairness and informed administrative decisionmaking require that agency decisions be made only after affording interested persons notice and an opportunity to comment.” 441 U.S. at 316.
60See, e.g., Marshall, 648 F.2d at 702 n.34; Pacific Gas, 506 F.2d at 38; see also Asimow, supra note 25, at 385–88 (defending utility of interpretative rules and policy statements); Lars Noah, The FDA’s New Policy on Guidelines: Having Your Cake and Eating it Too, 47 Cath. U. L. Rev. 113, 122–25 (1997) (noting that nonlegislative rules benefit public and agency by providing consistency); Beem, supra note 40, at 23 (asserting pharmaceutical industry depends on nonlegislative rules); Joel E. Hoffman, Public Participation and Binding Effect in the Promulgation of Nonlegislative Rules: Current Developments at FDA, Admin. & Reg. L. News, Spring 1997, at 1 (stating that the practical importance of nonlegislative rules is “undeniable”).
61See Marshall, 648 F.2d at 702 n.34; Pacific Gas, 506 F.2d at 38.
62See Chrysler, 441 U.S. at 310 n.41; Marshall, 648 F.2d at 702 n.34.
63See Pacific Gas, 506 F.2d at 38.
64See id.
65See Dole v. United Steelworkers of Am., 494 U.S. 26, 33 (1990) (noting that agencies develop expertise in their fields); Bowen v. Massachusetts, 487 U.S. 879, 908 (1988) (noting that agencies deserve discretionary power because of their technical expertise).
66See Pacific Gas, 506 F.2d at 38 (stating that nonlegislative rules assist long-term planning of regulated parties); Beem, supra note 40, at 23 (noting that industries rely on nonlegislative rules to plan ahead); Hoffman, supra note 60, at 1 (same).
67See, e.g., CNI, 818 F.2d at 945–47 (finding that the agency tried to mislabel substantive rule as interpretative); American Bus., 627 F.2d at 531–32 (same); Bellarno Int’l Ltd. v. FDA, 678 F. Supp. 410, 415–16 (E.D.N.Y. 1988) (same); Robert A. Anthony, “Well, You Want the Permit, Don’t You?” Agency Efforts to Make Nonlegislative Documents Bind the Public, 44 Admin. L. Rev. 31, 31 (1992) [hereinafter Well, You Want the Permit] (arguing that agencies misuse § 553(b)(A) exception to create rules to bind the public).
68See Anthony, Interpretative Rules, supra note 21, at 1320. The term “nonlegislative rules” is used in this Note as an inclusive term meaning not only “interpretative rules, general statements of policy, and rules of agency organization, procedure, or practice,” but also “advisory opinions,” “guidance documents,” “opinion letters, policy statements, program policy letters, Dear Colleague letters, regulatory guidance letters, . . . guidelines, staff instructions, manuals, questions-and-answers, bulletins, advisory circulars, models, enforcement policies, action levels, press releases” and other terms employed by federal agencies for those rules created without rulemaking procedures. See, e.g., Advisory Opinions, 21 C.F.R. § 10.85 (1998) (employing the term “advisory opinions” for the FDA); Good Guidance Practices, 62 Fed. Reg. 8961, 8967 (1997) (employing the term “guidance documents” for the FDA); Anthony, Interpretative Rules, supra note 21, at 1320 (mentioning other designations). The Court of Appeals for the District of Columbia Circuit states it has “lump[ed]” together the various statements for the purposes of legal analysis. See Syncor, 127 F.3d at 93–94.
69See, e.g., CNI, 818 F.2d at 945; Anthony, Well, You Want the Permit, supra note 67, at 31–33.
70See, e.g., CNI, 818 F.2d at 946–47; Anthony, Well, You Want the Permit, supra note 67, at 31–33. In defense of federal agencies, they often provide for public participation when unnecessary. See Asimow, supra note 25, at 381 n.5.
71See, e.g., CNI, 818 F.2d at 946. The distinction between legislative rules and nonlegislative rules has been described as “tenuous,” “enshrouded in considerable smog” and “fuzzy.” Id. (quoting Chisholm v. FCC, 538 F.2d 349, 393 (D.C. Cir. 1976); Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir. 1975); Pacific Gas, 506 F.2d at 37).
72See, e.g., Chrysler, 441 U.S. at 315; CNI, 818 F.2d at 945, 948–49; American Bus., 627 F.2d at 526, 531–32.
73See, e.g., Chrysler, 441 U.S. at 315; CNI, 818 F.2d at 945, 948–49; American Bus., 627 F.2d at 526, 531–32; Cooper v. Glickman, 50 F. Supp. 2d 489, 502–03 (M.D.N.C. 1999).
74See, e.g., CNI, 818 F.2d at 946–49 (invalidating Food and Drug Administration’s “action levels” because produced without notice-and-comment yet applied as law); American Bus., 627 F.2d at 531–34 (invalidating Interstate Commerce Commission “pronouncement” because produced without notice-and-comment yet applied as law); Texaco v. Federal Power Comm’n, 412 F.2d 740, 744 (10th Cir. 1969) (invalidating Federal Power Commission “order” because produced without notice-and-comment yet applied as law).
75See Alcaraz v. Block, 746 F.2d 593, 612 (9th Cir. 1984) (quoting American Fed’n of Gov’t Employees v. Block, 655 F.2d 1153, 1156 (D.C. Cir. 1981)); NJDEP, 626 F.2d at 1045–46.
76See, e.g., Syncor, 127 F.3d at 93; CNI, 818 F.2d at 946.
77See, e.g., Chrysler, 441 U.S. at 301–02.
78See, e.g., id.
79See id. at 315–16; Perales, 948 F.2d at 1354; Linoz v. Heckler, 800 F.2d 871, 877 (9th Cir. 1986); Alcaraz, 746 F.2d at 613; Marshall, 648 F.2d at 701–02.
80See Hudson, 192 F.3d at 1034-35; Fertilizer Inst. v. United States Envtl. Protection Agency, 935 F.2d 1303, 1307–08 (D.C. Cir. 1991); Jerri’s Ceramic Arts, Inc. v. Consumer Prod. Safety Comm’n, 874 F.2d 205, 208 (4th Cir. 1989); General Motors Corp. v. Ruckelshaus, 742 F.2d 1561, 1565 (D.C. Cir. 1984); Levesque v. Block, 723 F.2d 175, 182–83 (1st Cir. 1983).
81See, e.g., CNI, 818 F.2d at 946; American Bus., 627 F.2d at 529; Guardian Federal, 589 F.2d at 666.
82See, e.g., Cathedral Bluffs, 796 F.2d at 536–38 (citing Guardian Federal, 589 F.2d at 666); American Bus., 627 F.2d at 530; cƒ. Syncor, 127 F.3d at 95 (rule stating radiopharmaceuticals “should” be regulated found to be substantive).
83See 5 U.S.C. § 552(a)(1)(D). In 1935, Congress passed the Federal Register Act, which established the Federal Register as the government’s official publication in which offices of the government may disseminate information. See 44 U.S.C. §§ 1501–1511; Office of the Federal Register, supra note 29, at 1. Publication in the Federal Register provides official notice of a document’s existence and its contents, establishes the text as a true copy of the original document and authenticates evidence for trial. See Office of the Federal Register, supra note 29, at 1. Each federal working day, the Office of the Federal Register publishes the Federal Register, providing a uniform system for federal agencies and the President to notify the public. See id. at 28. Since 1935, Congress has passed other statutes imposing additional obligations on agencies to publish certain statements in the Federal Register. See id. at 113–15. According to the Freedom of Information Act, federal agencies must publish in the Federal Register:
rules of procedure, . . . substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency. . . . Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published.
5 U.S.C. § 552(a).
For a rule to be legislative and have substantive effects, it should be published in the Federal Register. See, e.g., id.; Cathedral Bluffs, 796 F.2d at 538–39. The converse, however, is not true; if an agency publishes a rule in the Federal Register, that does not necessarily make the rule legislative. See 5 U.S.C. § 552(a); Cathedral Bluffs, 796 F.2d at 538–39. Agencies publish many, but not all, nonlegislative rules in the Federal Register. See, e.g., 5 U.S.C. § 552(a); Cathedral Bluffs, 796 F.2d at 538–39. Often, agencies publish certain information only in internal agency materials. See, e.g., Ruiz, 415 U.S. at 204–05. Courts have held that such information should not have general applicability and usually relates to internal policies. See, e.g., id. at 235 (noting that the Bureau of Indian Affairs conceded “real legislative rule[s]” should be published in Federal Register); Cathedral Bluffs, 796 F.2d at 538–39 (noting that failure to publish in Federal Register indicates rule was not meant to bind).
84See, e.g., Mejia-Ruiz v. INS, 51 F.3d 358, 365 (2d Cir. 1995); Phillips Petroleum Co. v. Johnson, 22 F.3d 616, 619 (5th Cir. 1994); CNI, 818 F.2d at 946; Cathedral Bluffs, 796 F.2d at 537–38; General Motors, 742 F.2d at 1565.
85See, e.g., Chrysler, 441 U.S. at 302 n.31, 315–16 (noting that interpretative rules inform the public how an agency interprets a statute or how it administers its substantive rules and that interpretative rules do not create binding law); Alcaraz, 746 F.2d at 613 (noting that interpretative rules are essentially hortatory and instructional and they are used more for discretionary fine-tuning than for general law making); Pickus v. United States Bd. of Parole, 507 F.2d 1107, 1113 (D.C. Cir. 1974) (noting that interpretative rules interpret statutes while substantive rules create procedures expected to be followed by agency personnel and the public).
86Compare, e.g., American Bus., 627 F.2d at 531–32 (finding agency pronouncement immediately altered restrictions for trade between United States and Canada), and Bellarno, 678 F. Supp. at 411, 416 (holding interpretative rule invalid because it provided for automatic detention of merchandise), with Pacific Gas, 506 F.2d at 41–43 (holding rule assigning who receives allotments of natural gas during possible national shortages to be valid interpretative rule because tentative and prospective).
87 See Chrysler, 441 U.S. at 310 n.41; Marshall, 648 F.2d at 702 n.34.
88See CNI, 818 F.2d at 945–49. The Court of Appeals for the District of Columbia Circuit hears the majority of cases involving federal agencies, so the court is regarded as having developed a level of expertise for administrative law. See Stone v. INS, 514 U.S. 386, 404 (1995); Vermont Yankee, 435 U.S. at 535 n.14.
89See CNI, 818 F.2d at 945–49.
90See id. at 945.
91See id.
92See id. at 945, 949.
93See id. at 945.
94See CNI, 818 F.2d at 947.
95See id.
96See id. at 947–48.
97See id. at 948; Ashutosh Bhagwat, Three-Branch Monte, 72 Notre Dame L. Rev. 157, 165–66 (1996).
98See CNI, 818 F.2d at 948.
99See id. at 947–49.
100See id.
101See id. at 945–49. As a contrasting example, in 1974, in Pacific Gas & Electric Co. v. Federal Power Commission, the United States Court of Appeals for the District of Columbia Circuit upheld a general statement of policy as a valid nonlegislative rule because it prospectively addressed possible situations, lacked significant effects and created no binding law. See 506 F.2d at 35, 42–43, 45. In Pacific Gas, the Federal Power Commission issued a statement describing how it would allocate natural gas in case of a national shortage. See id. at 35–36. Several consumers of natural gas, particularly electric generating companies, challenged the statement by arguing it was substantive and should have been generated through § 553 process. See id. at 36. The court explained that although legislative rules establish standards of conduct with the force of law, general statements of policy merely announce what the agency seeks to establish as policy. See id. at 38. The court concluded that the policy statement was merely an announcement of the agency’s future plans, so it did not require notice-and-comment process. See id. at 41, 45. The court noted that the critical distinction between general statements of policy and legislative rules is that policy statements have no binding effect on future administrative proceedings while legislative rules create new law which courts must follow. See id. at 38. Because the statement of policy was prospective and created no law, the court held it was a nonlegislative rule and, therefore, valid. See id. at 42–43, 45.
102See, e.g., Phillips Petroleum, 22 F.3d at 620–21; Alexandria v. Helms, 728 F.2d 643, 647–48 (4th Cir. 1984); Pickus, 507 F.2d at 1112–13.
103See, e.g., Alexandria, 728 F.2d at 647–48; Pickus, 507 F.2d at 1112.
104See, e.g., Phillips Petroleum, 22 F.3d at 620–21. For example, in 1994, in Phillips Petroleum Co. v. Johnson, the United States Court of Appeals for the Fifth Circuit held that the Department of Interior (“DOI”) should have subjected a disputed “procedure paper” to notice and comment process because it had a substantial impact on the natural gas industry. See 22 F.3d at 621. The procedure paper established new criteria for valuing natural gas liquid products. See id. at 618. The DOI argued the procedure paper was merely the agency’s interpretation of a legislative rule. See id. at 619–20. Because the new rule instructed the DOI to change its valuation method from considering the range of various types of natural gas prices to considering only “spot” market prices, the court reasoned that the rule “dramatically” affected the royalty values of all oil and gas leases. See id. at 620–21. Despite how the agency labeled the rule, the court struck it down because it was created without process and it substantially impacted private parties. See id. at 619, 621.
105See, e.g., Alcaraz, 746 F.2d at 613; Levesque, 723 F.2d at 182; Elizabeth Williams, supra note 25, § 8 (1995). In Vermont Yankee, the Court did not explicitly undo the substantial impact test, but the Court undermined the test to such a degree that it is no longer dispositive. See Vermont Yankee, 435 U.S. at 524, 543–45. The Supreme Court held that courts cannot order agencies to conduct more process than already prescribed by statute or substantive rule. See id. at 543–44. The Court found unpersuasive plaintiffs’ argument that because the subject matter of the case—construction of a nuclear power plant—was an “[i]ssue[] of Great Public Import,” the court should order the agency to conduct additional procedure before issuing a rule. See id. at 543–45.
106See id. at 549; Alcaraz, 746 F.2d at 610.
107See Chevron, United States, Inc. v. Natural Resources Defense Council, 467 U.S. 837, 865–66 (1984); Vermont Yankee, 435 U.S. at 524, 543–50.
108See Chevron, 467 U.S. at 865–66.
109See id.
110See id.; Vermont Yankee, 435 U.S. at 549; Alcaraz, 746 F.2d at 610.
111See Chevron, 467 U.S. at 865–66; Vermont Yankee, 435 U.S. at 549; Alcaraz, 746 F.2d at 610.
112See Chevron, 467 U.S. at 864–65; Vermont Yankee, 435 U.S. at 549; Alcaraz, 746 F.2d at 610.
113See Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 99 (1995); Chrysler Corp. v. Brown, 441 U.S. 281, 295, 315–16 (1979).
114See Bureau of Alcohol, Tobacco & Firearms v. Federal Labor Relations Auth., 464 U.S. 89, 98 n.8 (1983); Chrysler, 441 U.S. at 295, Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537 (D.C. Cir. 1986); Pacific Gas & Elec. Co. v. Federal Power Comm’n, 506 F.2d 33, 38 (D.C. Cir. 1974).
115See, e.g., Guernsey, 514 U.S. at 99; Chrysler, 441 U.S. at 315–16; Linoz v. Heckler, 800 F.2d 871, 877 (9th Cir. 1986).
116See Anthony, Interpretative Rules, supra note 21, at 1328–29.
117See, e.g., Hudson v. Federal Aviation Admin., 192 F.3d 1031, 1034-35 (D.C. Cir. 1999); Guernsey, 514 U.S. at 99; Chrysler, 441 U.S. at 315–16.
118See, e.g., Smith v. Midland Brake, Inc., 180 F.3d 1154, 1165–67 (10th Cir. 1999).
119See, e.g., Guernsey, 514 U.S. at 99; Chrysler, 441 U.S. at 315–16.
120See Thomas v. New York, 802 F.2d 1443, 1445–47 (D.C. Cir. 1986).
121See id. at 1445–46.
122See id. at 1444–45. For a brief description of Thomas, see Robert L. Brubaker & Judith L. French-Berry, Is a Rule by Any Other Name Still a Rule?: Case Answers Under the Clean Air Act, 18 N. Ky. L. Rev. 271, 273–76 (1991). For a more thorough history and analysis, see Carol Garland, Acid Rain over the United States and Canada: The D.C. Circuit Fails to Provide Shelter under Section 115 of the Clean Air Act While State Action Provides a Temporary Umbrella, 16 B.C. Envtl. Aff. L. Rev. 1, 18–29 (1988).
123See Thomas, 802 F.2d at 1445; Jeffrey L. Roelofs, United States-Canada Air Quality Agreement: A Framework for Addressing Transboundary Air Pollution Problems, 26 Cornell Int’l L.J. 421, 436–37 (1993).
124See Thomas, 802 F.2d at 1446.
125See id. at 1445.
126See id.
127See id. at 1445–46; Shawn M. Rosso, Acid Rain: The Use of Diplomacy, Policy and the Courts to Solve a Transboundary Pollution Problem, 8 J. Nat. Resources & Envtl. L. 421, 431–32 (1992–1993).
128See Thomas, 802 F.2d at 1446–47; Steve Russell, Comment, Potential Fallout From the National Acid Precipitation Assessment Program, 6 BYU J. Pub. L. 423, 430 (1992). For the definition of a rule, see 5 U.S.C. § 551(4).
129See Thomas, 802 F.2d at 1447.
130See id. at 1447–48.
131See, e.g., Chrysler, 441 U.S. at 301–03, 315–16; Batterton v. Marshall, 648 F.2d 694, 701–02 (D.C. Cir. 1980); Pacific Gas, 506 F.2d at 38–39.
132See Anthony, Interpretative Rules, supra note 21, at 1328–30.
133See id.
134See Asimow, supra note 25, at 384.
135See Anthony, Interpretative Rules, supra note 21, at 1328–31.
136See United States v. Picciotto, 875 F.2d 345, 346 (D.C. Cir. 1989); Jerri’s Ceramic Arts, Inc. v. Consumer Prod. Safety Comm’n, 874 F.2d 205, 206–07 (4th Cir. 1989); Anthony, Interpretative Rules, supra note 21, at 1333.
137See 875 F.2d at 348–49.
138See id. at 346.
139See id.
140See id.
141See id.
142See Picciotto, 875 F.2d at 346.
143See id. at 346–49.
144See id.
145See, e.g., United States v. Apex Oil Co., 132 F.3d 1287, 1288–89, 1291 (9th Cir. 1997) (upholding dismissal of oil tanker captains indicted by the Coast Guard for causing oil pollution according to the terms of a nonlegislative rule); American Bus. Ass’n v. United States, 627 F.2d 525, 527, 531–34 (D.C. Cir. 1980) (holding nonlegislative rules regarding applications to transport goods to Canada to be substantive and therefore invalid); Anthony, Interpretative Rules, supra note 21, at 1333, 1340.
146See, e.g., Levesque v. Block, 723 F.2d 175, 177–78 (1st Cir. 1983) (involving “interim rules,” issued by the Secretary of Agriculture, which reduced expenditures to New Hampshire Food Stamp program); Marshall, 648 F.2d at 696–99 (involving “Balance of State procedure,” issued by the Department of Labor, which reduced expenditures to Maryland unemployment program). See also Anthony, Interpretative Rules, supra note 21, at 1353.
147See, e.g., Picciotto, 875 F.2d at 349 (reversing trial court’s conviction based on nonlegislative rule); United States v. American Nat’l Red Cross, 1993 WL 186094, at *1–*2 (D.D.C. 1993) (issuing injunction ordering company to abide by numerous nonlegislative rules).
148See 1993 WL 186094, *1–*2; see generally Dept. of Justice, Injunction Gives FDA Broad Power over Red Cross, Dep’t of Justice Alert, May 1993, at 13–15 [hereinafter Injunction]. Created by an act of Congress, the Red Cross is a private corporation that supplies blood to health care facilities. See Red Cross, 1993 WL 186094, at *1.
149See, e.g., 21 C.F.R. §§ 210–11, 600–80 (1998); Red Cross, 1993 WL 186094, at *1–*2. Both the FDA and the Red Cross have been targets in lawsuits by families of those who contracted AIDS from blood transfusions. See, e.g., Doe v. American Nat’l Red Cross, 112 F.3d 1048, 1048–50 (9th Cir. 1997).
150See Red Cross, 1993 WL 186094, at *2. The opinion states:
Within the time frames specified in this Decree, [the Red Cross] shall take steps necessary to ensure compliance with: (a) the provisions set forth in this Decree; (b) the [Food, Drug and Cosmetics Act], the [Public Health Service Act], and all applicable regulations (hereafter, collectively, “the law”); and (c) [the Red Cross] standard operating procedures, including, but not limited to, Blood Services Directives (“BSDs”), Blood Service Letters (“BSLs”), regional and local standard operating procedures, and any other instruments (hereafter, collectively, “SOPs”).
Id. (emphasis added).
Throughout the injunction, the court ordered the Red Cross to follow the SOPs. See id. at *1–*14; see also Injunction, supra note 148, at 13 (noting injunction’s provisions “detailed,” “broad” and “numerous”).
151See Red Cross, 1993 WL 186094, at *2.
152See id. at *1–*2.
153See id.; see also, e.g., Morton v. Ruiz, 415 U.S. 199, 235 (1974) (noting that rules with binding effects should be published); Marshall, 648 F.2d at 701–02 (noting that nonlegislative rules do not impose obligations); Alcaraz v. Block, 746 F.2d 593, 613 (9th Cir. 1984) (interpretative rules do not create new law); American Bus., 627 F.2d at 531–32 (noting that interpretative rules may not have immediate effects).
154See Red Cross, 1993 WL 186094, at *1–*2.
155See, e.g., 5 U.S.C. § 553 ; Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1027–28 (D.C. Cir. 1978) (stating that the APA infuses the administrative process with “openness, explanation and participatory democracy”); Red Cross, 1993 WL 186094, at *1–*2.
156See Anthony, Interpretative Rules, supra note 21, at 1327–32; Asimow, supra note 25, at 384.
157See, e.g., Alcaraz, 746 F.2d at 613 (noting that interpretative rules are essentially hortatory and instructional and they are used more for discretionary fine-tuning than for general law making).
158Cf. Noah, supra note 60, at 120–27 (suggesting that nonlegislative rules should bind because that would foster agency consistency).
159See 5 U.S.C. § 553.
160See, e.g., Guardian Fed. Sav. & Loan Ass’n v. Federal Sav. & Loan Ins. Corp., 589 F.2d 658, 666 (D.C. Cir. 1978).
161See Good Guidance Practices, 62 Fed. Reg. 8961, 8967–71 (1997) (to be codified at 21 C.F.R. pt. 10).
162See id.
163See infra, notes 164–293 and accompanying text.
164See, e.g., Committee on Governmental Affairs, The Regulatory Improvement Act of 1999, S. Rep. No. 106–110, at 5–6 (1999) (language identical to Committee on Governmental Affairs, The Regulatory Improvement Act of 1998, S. Rep. No. 105–188, at 5–6 (1998)).
165See, e.g., S. Rep. No. 106–110, at 1–4 (language identical to S. Rep. No. 105–188, at 1–4).
166See id.; see also Hoffman, supra note 60, at 10–11 (noting that the FDA created Good Guidance Practices because the agency had become potential target for Congress to enact administrative reform).
167See Good Guidance Practices, 62 Fed. Reg. at 8967–71.
168See id. The FDA previously requested suggestions on how best to improve its procedures addressing interpretative rules. See Request for Comments Regarding the FDA’s Development and Use of Guidance Documents, 61 Fed. Reg. 9181, 9181 (1996).
169See Good Guidance Practices, 62 Fed. Reg. at 8967.
170See id. at 8967–71.
171See id. at 8969.
172See id. at 8967. “Guidance documents” include:
documents prepared for FDA staff, applicants/sponsors, and the public that: (1) Relate to the processing, content, and evaluation/approval of submissions; (2) relate to the design, production, manufacturing, and testing of regulated products; (3) describe the agency’s policy and regulatory approach to an issue; or (4) establish inspection and enforcement policies and procedures. “Guidance documents” do not include documents relating to internal FDA procedures, agency reports, general information documents provided to consumers, speeches, journal articles and editorials, media interviews, press materials, warning letters, or other communications directed to individual persons or firms.
Id.
173See id. at 8969.
174See Good Guidance Practices, 62 Fed. Reg. at 8969. For example, the FDA published lists of guidance documents in the Federal Register at: Update of Guidance Documents at the Food and Drug Administration, 64 Fed. Reg. 42,382, 42,382–91 (1999); Annual Comprehensive List of Guidance Documents at the Food and Drug Administration, 64 Fed. Reg. 31,228, 31,228–80 (1999); Quarterly List of Guidance Documents at the Food and Drug Administration, 64 Fed. Reg. 888, 888–903 (1999); Quarterly List of Guidance Documents at the Food and Drug Administration, 63 Fed. Reg. 36,413, 36,413–24 (1998); Comprehensive List of Current Guidance Documents at the Food and Drug Administration, 63 Fed. Reg. 9795, 9795–9843 (1998).
175See Good Guidance Practices, 62 Fed. Reg. at 8969.
176See id. at 8968–69.
177See id. at 8968. For an example of a level 1 guidance, see the guidance for industry entitled Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (visited Oct. 1, 1999) <http://www.fda.gov/cder/guidance/2836dft.htm> (notice of availability published at 64 Fed. Reg. 29,657, 29,657 (1999)). For an example of a level 2 guidance, see the compliance guide entitled Evaluation and Processing Post Donation Information Reports (visited Oct. 1, 1999) <http://www.fda.gov/ora/compliance_ref/cpg/cpgbio/cpg230–140.htm> (notice of availability published at 64 Fed. Reg. 44,740, 44,740–41 (1999)). Note that the FDA also publishes guidances without classifying them as either level 1 or 2. See International Conference on Harmonisation; Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 64 Fed. Reg. 44,928, 44,929 (1999).
178See Good Guidance Practices, 62 Fed. Reg. at 8968 (mentioning FDA WWW home page, at <http://www. fda.gov>).
179See id. The GGPs provide three exceptions, allowing the FDA to issue level 1 guidance without prior public input if:
(1) there are public health reasons for immediate implementation; (2) there is a new statutory requirement, executive order, or court order that requires immediate implementation and guidance is needed to help effect such implementation; or (3) the guidance is presenting a less burdensome policy that is consistent with public health.
Id.
180See id.
181See id. at 8967, 8969.
182See Good Guidance Practices, 62 Fed. Reg. at 8969. The entire provision states:
Absence of Mandatory Language. Because guidance documents are not binding, mandatory words such as “shall,” “must,” “require” and “requirement” are inappropriate unless they are being used to describe or discuss a statutory or regulatory requirement. Before a new guidance is issued, it should be reviewed to ensure that mandatory language has not been used.
Id.
183Id. at 8967. When the FDA published the GGPs in the Federal Register, the agency stated that the GGPs were, ironically enough, still nonbinding guidance documents, pending the amendment of FDA’s regulations. See id. at 8961. The FDA intimated that it planned to update its current legislative rules, which state that an FDA interpretative rule “obligates the agency to follow it.” See Advisory Opinions, 21 C.F.R. § 10.85 (1998); Good Guidance Practices, 62 Fed. Reg. at 8961. In its commentary on the GGPs, the FDA asserted that it would begin adhering to the GGPs although it has not yet fully implemented them. See Good Guidance Practices, 62 Fed. Reg. at 8961.
184Id. at 8969.
185Id. at 8967.
186See id. at 8961–71; Hoffman, supra note 60, at 11 (noting that commentators applauded FDA’s effort, but highly criticized GGPs).
187See Good Guidance Practices, 62 Fed. Reg. at 8961–71; infra notes 196–236 and accompanying text.
188See Good Guidance Practices, 62 Fed. Reg. at 8969.
189See id.
190See id.
191See id. at 8968–69.
192See id. at 8968; Nancy K. Plant, Prescription Drug Promotion on the Internet: Tool for the Inquisitive or Trap for the Unwary?, 42 St. Louis U. L.J. 89, 93 n.26 (1998).
193See Good Guidance Practices, 62 Fed. Reg. at 8968.
194See id.
195See id.; see also, e.g., Community Nutrition Inst. v. Young, 818 F.2d 943, 948 (D.C. Cir. 1987) (noting that nonlegislative rules cannot restrain agency discretion).
196See Good Guidance Practices, 62 Fed. Reg. at 8968.
197See id.; Plant, supra note 192, at 93 n.26.
198See Good Guidance Practices, 62 Fed. Reg. at 8968.
199See id.
200See id.
201See id.; see, e.g., Guardian Fed. Sav. & Loan Ass’n v. Federal Sav. & Loan Ins. Corp., 589 F.2d 658, 662 (D.C. Cir. 1978) (noting that public participation improves agency rulemaking).
202See American Mining Congress v. Mine Safety & Health Admin., 995 F.2d 1106, 1109–10 (D.C. Cir. 1993).
203See Chevron, United States, Inc. v. Natural Resources Defense Council, 467 U.S. 837, 865–66 (1984); see also Hudson v. Federal Aviation Admin., 192 F.3d 1031, 1035 (D.C. Cir. 1999) (upholding policy statement that negated prior policy statement).
204See Good Guidance Practices, 62 Fed. Reg. at 8968.
205See id.
206See id. at 8967, 8969.
207See id. at 8967.
208See id. at 8967, 8969.
209See Good Guidance Practices, 62 Fed. Reg. at 8967, 8969.
210See id. at 8967.
211See id.
212See id.
213See id.
214See Good Guidance Practices, 62 Fed. Reg. at 8967.
215See id.
216See id.
217See id.; Hoffman, supra note 60, at 11 (pointing out that commentators have noted the GGPs pay insufficient attention to ensuring FDA personnel will follow them).
218See Good Guidance Practices, 62 Fed. Reg. at 8967, 8969.
219See, e.g., Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 536–38 (D.C. Cir. 1986); Good Guidance Practices, 62 Fed. Reg. at 8967, 8969.
220See Good Guidance Practices, 62 Fed. Reg. at 8967, 8969. In a comment written in 1996, the Community Nutrition Institute (“CNI”) recommended the FDA specify that its guidelines have no legal effect in judicial proceedings and that the FDA should not expect courts to defer to those guidance documents. See David Wirth, Comments of the Community Nutrition Institute on FDA’s Notice Concerning Development and Use of Guidance Documents 4–8 (1996) (on file with author). Following that logic, the CNI also suggested the FDA should specify in all of its guidance documents that the guidelines do not limit agency discretion. See id. at 4–8. As the CNI suggested, the FDA would do better to establish the presumption that the agency may not always follow guidance documents because they are never legally binding. See id. at 4–8. The CNI also recommended that the GGPs should specify guidance documents are final agency actions and should explain standards for judicial review of guidance documents. See id.
221See Good Guidance Practices, 62 Fed. Reg. at 8967.
222See id.
223See, e.g., Cathedral Bluffs, 796 F.2d at 536–38.
224See Good Guidance Practices, 62 Fed. Reg. at 8967, 8969.
225See id.; Anthony, Interpretative Rules, supra note 21, at 1332–55.
226See Good Guidance Practices, 62 Fed. Reg. at 8967.
227See id.
228See id. at 8967–69.
229See id. at 8967.
230See 5 U.S.C. § 553(b)(A); Good Guidance Practices, 62 Fed. Reg. at 8967.
231See 5 U.S.C. § 553(b)(A); Good Guidance Practices, 62 Fed. Reg. at 8967.
232See Good Guidance Practices, 62 Fed. Reg. at 8967.
233See id. at 8967, 8969.
234See id.
235See id.
236See 5 U.S.C. § 553(b)(A); Good Guidance Practices, 62 Fed. Reg. at 8967–71.
237See The Regulatory Improvement Act of 1999, S. 746, 106th Cong. §§ 601–12, 621–29, 631–32, 641–44 (1999). In 1997, Senator Levin first introduced the Regulatory Improvement Act during the 105th Congress. See S. 981, 105th Cong. (1997). Senator Thompson was one of the bill’s first co-sponsors, and people often refer to the bill as the Levin-Thompson Regulatory Improvement Act. See John F. Cooney, Regulatory Reform: The Long and Winding Road, 23 Admin. & Reg. L. News, Fall 1998, at 1. During 1998, the bill’s title changed to the Regulatory Improvement Act of 1998. See S. 981, 105th Cong. (1998). For the 106th Congress, Senator Levin reintroduced the bill, virtually unchanged, in 1999 as S. 746, the Regulatory Improvement Act of 1999.
238See Committee on Governmental Affairs, The Regulatory Improvement Act of 1999, S. Rep. No. 106–110. In 1998, the Senate Committee on Governmental Affairs published a report describing the proposed act, then bill S. 981. See Committee on Governmental Affairs, The Regulatory Improvement Act of 1998, S. Rep. No. 105–188. In 1999, the Senate Committee on Governmental Affairs issued another report—almost identical to the 1998 report—to accompany the proposed statute. See S. Rep. No. 106–110.
239See S. Rep. No. 106–110, at 5–6 (language identical to S. Rep. No. 105–188, at 5–6).
240See id.
241See S. 746. A “major rule” is a rule that:
(A) the agency proposing the rule or the Director [of the Office of Management and Budget] reasonably determines is likely to have an annual effect on the economy of $100,000,000 or more in reasonably quantifiable costs; or
(B) is otherwise designated a major rule by the Director on the ground that the rule is likely to adversely affect, in a material way, the economy, a sector of the economy, including small business, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments, or communities . . . .
S. 746 § 621(7). For a brief overview of the proposed statute, see generally Cooney, supra note 237, at 1.
242See S. 746 § 623(b), (c).
243See id. § 624.
244See Office of the Management and Budget Act, 31 U.S.C. §§ 501–22 (1994); S. 746 § 642.
245See S. 746 § 621(10)(A).
246S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
247See id.
248See id.; Daniel Cohen, S. 981, The Regulatory Improvement Act of 1998: The Most Recent Attempt to Develop a Solution in Search of a Problem, 50 Admin. L. Rev. 699, 705–06 (1998).
249See S. 746 § 621(10); S. Rep. No. 106–110, at 26-27 (language identical to S. Rep. No. 105–188, at 22–23). For a criticism of the proposed Act, see generally Cohen, supra note 248; Esther Boykin, Poor Proposal on Federal Regulatory Changes, The Times-Picayune, July 19, 1999, at B4. For an argument in support of the bill, see C. Boyden Gray, Regulatory Reform: Past and Future, Nat. Resources & Env’t, Winter 1998, at 158–59; Jeff Stier, Better Ways to Regulate, J. of Com., July 8, 1998, at 7A.
250See S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
251See id.
252See id.
253See id.; see also Anthony, Interpretative Rules, supra note 21, at 1318 (discussing how agencies inclined to use § 553(b)(A) exception to avoid rulemaking procedures).
254See S. 746 §§ 621(7), 623–24.
255See id. § 621(7); see, e.g., Phillips Petroleum Co. v. Johnson, 22 F.3d 616, 618, 621 (5th Cir. 1994) (noting that the agency placed nonlegislative label on substantive rule “dramatically” affecting oil and gas royalty values).
256See S. 746 §§ 623, 642.
257See id. § 642; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
258See S. 746 § 642; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
259See S. 746 §§ 623–24; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23); Anthony, Interpretative Rules, supra note 21, at 1319 (noting that some agencies already view rulemaking procedure as burdensome).
260See S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
261See S. 746 § 621; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
262See S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
263See id.
264See S. 746 § 621(10)(A); S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
265See S. 746 § 621(7); see, e.g., Thomas v. New York, 802 F.2d 1443, 1447 (D.C. Cir. 1986) (implying letter was substantive because its enforcement would cause considerable economic impact).
266See 5 U.S.C. § 553(b)(A); S. 746 § 621(10)(A); S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
267See S. 746 § 621(10)(A); S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
268See 5 U.S.C. §§ 553, 556–57; White v. Shalala, 7 F.3d 296, 303 (2d Cir. 1993).
269See S. 746 § 621; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23).
270See S. 746 § 621. Much debate still encircles the proposed Act, and members of Congress currently are considering amending the bill. See William A. Niskanen, Legislative Implications of Reasserting Congressional Authority over Regulations, 20 Cardozo L. Rev. 939, 943–44 (1999).
271See 5 U.S.C. § 553; S. 746 § 642; S. Rep. No. 106–110, at 27 (language identical to S. Rep. No. 105–188, at 23). Differing from this Note’s argument, the American Bar Association has voiced its support for the proposed Act because it would increase uniformity between federal agencies and provide for systemic review of agency rules. See Warren Belmar, Chair’s Message, Admin. & Reg. L. News, Spring 1998, at 2. Nevertheless, the proposed Act has failed to garner widespread support. See Marc Landy & Kyle D. Dell, The Failure of Risk Reform Legislation in the 104th Congress, 9 Duke Envtl. L. & Pol’y F. 113, 131 n.83 (1998). But see Office of the General Counsel, SEC, Recent Legislative Developments Affecting the Work of the Securities and Exchange Commission 536–37 (1998) (suggesting the bill has considerable support because only two witnesses voiced opposition to it during a hearing before the Senate Governmental Affairs Committee).
272See Anthony, Interpretative Rules, supra note 21, at 1316, 1327–55.
273See, e.g., Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 99–100 (1995) (noting that nonlegislative rules lack the force and effect of law); CNI, 818 F.2d at 948 (noting that nonlegislative rules cannot restrain agency discretion); Cathedral Bluffs, 796 F.2d at 536–38 (noting that nonlegislative rules should only use tentative language); Good Guidance Practices, 62 Fed. Reg. at 8967–71 (recommending uniform nomenclature, listing all nonlegislative rules, eschewing mandatory language and that nonlegislative rules may not bind public or agency).
274See U.S.C. § 553(b)(A).
275See, e.g., 5 U.S.C. § 551, 553; Chrysler Corp. v. Brown, 441 U.S. 281, 302 n.31 (1979); CNI, 818 F.2d at 946; Noel v. Chapman, 508 F.2d 1023, 1029–30 (2d Cir. 1975).
276See S. Rep. No. No. 105–188, at 23.
277See 5 U.S.C. §§ 551, 553; Mashaw et al., supra note 9, at 148. Congress, however, has made few substantial changes to the APA over its 53-year history. See Mashaw et al., supra note 9, at 149; Strauss, supra note 15, at 1391–92.
278See Cindy Skrzycki, The Regulators: The Costs and Benefits of Cost-Benefit Analysis, The Wash. Post, Aug. 6, 1999, at E1 (stating that the Senate Governmental Affairs Committee is currently pushing Regulatory Improvement Act toward Senate floor).
279See 5 U.S.C. § 553.
280See, e.g., Chrysler, 441 U.S. at 315; Cathedral Bluffs, 796 F.2d at 537–38; American Bus. Ass’n v. United States, 627 F.2d 525, 529–30 (D.C. Cir. 1980).
281See, e.g., United States v. American Nat’l Red Cross, 1993 WL 186094, *1–*2 (D.D.C. 1993); Anthony, Interpretative Rules, supra note 21, at 1315–16.
282See, e.g., 5 U.S.C. § 553(a), (b)(B); Morton v. Ruiz, 415 U.S. 199, 230–38 (1974) (holding that rule relating to benefits program, and created without notice-and-comment, was binding because it was exempted under § 553(a)(2)). The other exceptions—rules relating to the military, foreign affairs, agency management, public property, public contracts or for emergencies—are more clear than the vague terms “interpretative rules” and “general statements of policy,” so they generate less litigation and controversy. See 5 U.S.C. §§ 553(a)(1), (a)(2), (b)(B).
283See Good Guidance Practices, 62 Fed. Reg. at 8969.
284See id. at 8967, 8969.
285See Chrysler, 441 U.S. at 301–02; American Bus., 627 F.2d at 528.
286See Perales v. Sullivan, 948 F.2d 1348, 1354 (2d Cir. 1991); Linoz v. Heckler, 800 F.2d 871, 877 (9th Cir. 1986).
287See Good Guidance Practices, 62 Fed. Reg. at 8967–71.
288See id.
289See id. at 8969.
290See id.; Asimow, supra note 25, at 386 (stating that “[b]ecause the public must live with agency interpretations, it should have the fullest possible access to them.”).
291See supra notes 196–236 and accompanying text.
292See Good Guidance Practices, 62 Fed. Reg. at 8967.
293See id. at 8967–71.
294When it published the GGPs in 1997, the FDA stated it would review them three years after their implementation. See Good Guidance Practices, 62 Fed. Reg. at 8969.