Judicial review of agency guidance documents: Rethinking the finality doctrine

Administrative Law Review

Volumn 60, Issue 2, 2008, Pages 371-408

  McKee, Gwendolyn ^a  

^a NONE

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EID: 79551538258     PISSN: 00018368     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (299)

1. See Final Bulletin for Agency Good Guidance Practices, 72 Fed. Reg. 3432, 3432 (Jan. 25, 2007) ("[A]gencies increasingly have relied on guidance documents to inform the public and to provide direction to their staffs.");
2. Jeff Bowen & Susan Rose-Ackerman, Partisan Politics and Executive Accountability: Argentina in Comparative Perspective, 10 SUP. CT. ECON. REV. 157, 196 (2003) ("[E]ven in the United States the president and the administrative agencies try to circumvent procedural requirements. Guidance documents or policy statements are increasingly used by agencies to articulate general policies without needing to follow APA procedures.").
3. See Memorandum from Susan B. Hazen, EPA, to the Record, Consideration of Prions As a Pest Under FIFRA (Apr. 29, 2004), available at http://www.epa.gov/ oppad001/records-of-decision-on-prions.pdf (recording the determination process for the inclusion of prions under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) statutory umbrella). All living things are, at a certain level, collections of genetic material and protein.
4. See Tami Port, Cells & Viral Pathogenic Microbes Differences of Living Organisms & Acellular Viruses, Viroids, Prions, SUITE101.COM http://SUITE101.COM, Oct. 14, 2007, http://microbiology.suitel01.com/article. cftn/cells-and-viruses. Living things synthesize protein to perform many functions including replication of genetic material.
5. Cf Id. (explaining that cells compose all living things and that acellular particles like viruses do not have the ability to synthesize protein). Viruses are not considered living things.
6. Id. Although viruses consist of genetic material and protein, viruses cannot use their protein to make new copies of their genetic material
7. Id. Instead, the viral protein is just used for packaging
8. Id. To replicate itself, a virus must use special proteins in a living cell to make new genetic material and packaging protein
9. Id. Prions, like viruses, are also not considered living things
10. Id. However, prions are even more primitive than viruses.
11. See Stanley B. Prusiner, Prion Diseases and the BSE Crisis, 278 SCI. 245, 245-51 (1997) (discussing the distinguishing features of prion diseases). Prions do not contain any genetic material and instead only consist of normal protein that has become misshapen
12. Id. at 245-47. Prions are misshapen protein that can make normal protein also become misshapen
13. Id. Because of this, prions are distinguishable from both living cells and viruses
14. Id. The FIFRA, which authorizes the Environmental Protection Agency (EPA) to conduct a notice and comment rulemaking to determine whether a virus or a living organism should be considered a pest, would not apply to a prion. The EPA bypassed this statute and the notice and comment process when it issued a guidance document declaring that prions are pests.
15. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, SAFE WORK PRACTICES FOR MARINE HANGING STAGING: AN OSHA GUIDANCE DOCUMENT 1,4-6 (Apr. 2005), available at http://www.osha.gov/dts/maritime/marine-hanging-staging/marine-hanging- staging.pdf.
16. See Final Guidance on Maintaining, Collecting, and Reporting Racial and Ethnic Data to the U.S. Department of Education, 72 Fed. Reg. 59, 266, 59, 266-67 (Oct. 19, 2007) (mandating that agencies use a two part question to determine the origin of Hispanic students).
17. FDA, GUIDE TO MINIMIZE MICROBIAL FOOD SAFETY HAZARDS OF FRESH-CUT FRUITS AND VEGETABLES (Mar. 2007), available at http://www.cfsan.fda.gov/-dms/prodgui3. html[hereinafter FDA FOOD GUIDE].
18. Had the EPA issued its decision in a notice and comment rulemaking, a challenger would have had a strong argument that the decision was unlawful because it fell outside the authority granted to the EPA; however, because the decision was issued in an informal guidance document, it is not clear whether it would qualify as "final agency action" under the Bennett test and an affected party might not be able to obtain judicial review at all. In the case of the Food and Drug Administration (FDA) guidance document, although the Federal Food, Drug, and Cosmetic Act contains a specific provision dealing with guidance documents, the provision does not directly grant or deny access to judicial review. See 21 U.S.C. § 371(h) (2000). The closest the Act comes to addressing the issue is a provision stating that "[s]uch documents shall not create or confer any rights for or on any person ...." Id.
19. 520 U.S. 154, 177-78 (1997) (quoting Chi. & S. Air Lines, Inc. v. Waterman S.S. Corp., 333 U.S. 103, 113 (1948), and Port of Boston Marine Terminal Ass'n v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71 (1970)). In Bennett, Oregon ranchers and two water districts in Oregon challenged a decision by the Fish and Wildlife Service to protect two species of fish by maintaining higher water levels in the Klamath Irrigation Project, from which the plaintiffs received their water
20. Id. at 157. The case addressed a number of points relevant to administrative law, including questions of standing and what is required to bring suit under the Endangered Species Act. The discussion in this Article concerns only the final point the Court dealt witlh- that a party may bring a suit under the Administrative Procedure Act (APA), provided the plaintiff meets the two part finality test set forth in the opinion and discussed in this Article beginning in Part II.
21. See Id. at 177-78 (requiring that the decision under review be the "'consummation' of the agency's decisionmaking process") (citations omitted).
22. Id. (requiring that the decision under review be "one by which 'rights or obligations have been determined,' or from which 'legal consequences will flow'") (citations omitted).
23. See sources cited supra note 1.
24. Id.
25. See Final Bulletin for Agency Good Guidance Practices, 72 Fed. Reg. 3432, 3432 (Jan. 25, 2007) ("As the scope and complexity of regulatory programs have grown, agencies increasingly have relied on guidance documents....");
26. Robert A. Anthony, Interpretive Rules, Policy Statements, Guidances, Manuals, and the Like-Should Federal Agencies Use Them to Bind the Public?, 41 DUKE L.J. 1311, 1316 (1992) (observing that it is acknowledged, although difficult to prove explicitly, that the use of rules promulgated without the benefit of the APA rulemaking requirements is "widespread");
27. See also M. Elizabeth Magill, Agency Choice of Policymaking Form, 71 U. CHI. L. REV. 1383, 1411 (2004) (discussing an evolution within agencies from adjudication to rulemaking and eventually to guidance documents as the preferred mode of policymaking).
28. 5 U.S.C. §§551-559, 701-706 (2000).
29. Exec. Order No. 13, 422 §3(g), 72 Fed. Reg. 2763 (Jan. 23, 2007).
30. See 5 U.S.C. §553 (setting forth requirements that all rules must meet unless one of the statutory exemptions is applicable).
31. Id. § 553(b)(3)(A).
32. In this Article, I use the terms "informal rulemaking" and "notice and comment rulemaking" interchangeably.
33. See, e.g., Peter L. Strauss, Publication Rules in the Rulemaking Spectrum: Assuring Proper Respect for an Essential Element, 53 ADMIN. L. REV. 803, 804 (2001) (describing non-notice and comment rules as "an important element in the hierarchy of agency law");
34. Todd D. Rakoff, The Choice Between Formal and Informal Modes of Administrative Regulation, 52 ADMIN. L. REV. 159 (2000) (discussing the benefits and tradeoffs of less formal agency action and concluding that agencies need a variety of tools to function most effectively).
35. See Anthony, supra note 12, at 1315-16 (stating that agencies should be required to follow the procedures in §553 for rules they intend to be binding or explicitly make them nonbinding under the exception for general policy statements).
36. But See Lars Noah, The FDA 's New Policy on Guidelines: Having Your Cake and Eating It Too, 47 CATH. U. L. REV. 113, 142 (1997) (deeming unnecessary a move by the FDA to explicitly make guidance documents and similar documents nonbinding).
37. Exec. Order No. 13, 422, 72 Fed. Reg. 2763 (Jan. 23, 2007).
38. See Final Bulletin for Agency Good Guidance Practices, 72 Fed. Reg. 3432 (Jan. 25, 2007).
39. See Exec. Order No. 12, 866, 58 Fed. Reg. 51, 735, 51, 737-38 (Oct. 4, 1993) (discussing the requirements for regulatory planning and review).
40. 5 U.S. (1 Cranch) 137 (1803).
41. Id. at 177.
42. See 5 U.S.C. § §702, 704 (2000) (allowing for judicial review of agency action).
43. LOUIS L. JAFFE, JUDICIAL CONTROL OF ADMINISTRATIVE ACTION 320 (1965).
44. 467 U.S. 837 (1984).
45. Id. at 843n.9.
46. See generally Thomas O. McGarity, Some Thoughts on " Deossifying" the Rulemaking Process, 41 DUKE L.J. 1385, 1386 (1992) (condemning the "ossification" of the rulemaking process as one of the most "serious problems facing regulatory agencies").
47. Further, in a large number of cases, judicial review simply never occurs. However, the mere possibility of judicial review has a benefit: ensuring that the agency takes the time to provide a basis for each rule such that, were review to occur, the rule would be upheld. Along these lines, academicians have noted that one important function of judicial review is not the review itself but merely "the judiciary's ability to induce the political branches and the public" to ensure proper attention has been given to the conclusion reached. Jonathan T. Molot, Reexamining Marbury in the Administrative State: A Structural and Institutional Defense of Judicial Power over Statutory Interpretation, 96 Nw. U. L. REV. 1239, 1316 (2002) (citing competing interpretations of prior scholarship).
48. For more on the debate over the proper place of judicial review, compare Larry D. Kramer, Popular Constitutionalism, Circa 2004, 92 CAL. L. REV. 959 (2004) (describing new uses of judicial review), with
49. Erwin Chemerinsky, In Defense of Judicial Review: A Reply to Professor Kramer, 92 CAL. L. REV. 1013 (2004) (responding to Professor Kramer's discussion of judicial review).
50. But See Nina A. Mendelson, Regulatory Beneficiaries and Informal Agency Policymaking, 92 CORNELL L. REV. 397, 401 (2006) (describing how the FDA alone has set forth regulations governing the issuance of guidance documents).
51. See discussion infra Part II.
52. FDA FOOD GUIDE, supra note 5.
53. Id.
54. Id. The disclaimer states: This guidance represents the Food and Drug Administration's (FDA) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
55. Id.
56. Id. (citing unpublished data from the FDA).
57. See Id. (referencing 21 U.S.C. § 321 (gg) (2000)).
58. Id.
59. Id.
60. Id.
61. See 21 U.S.C. §371(h) (giving general guidance to agencies on how to produce documents but not requiring specific provisions).
62. See supra note 6.
63. See 21 U.S.C. §371(h)(1)(B) (stating "guidance documents shall not be binding on the Secretary").
64. The bill was signed into law on November 21, 1997. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (codified at 21 U.S.C. § 301 (2000)).
65. As of January 2008, courts have never cited to an FDA guidance document in a judicial challenge since the Act went into effect. See, e.g., Ctr. for Sci. in the Pub. Interest v. FDA, No. 03-1962, 2004 U.S. Dist. LEXIS 18541, at *9-15 (D.D.C. July 30, 2004) (deciding that plaintiffs' claim was not ripe for adjudication because the FDA guidance had not caused an injury separate from an alleged procedural violation, and plaintiffs would not suffer any hardship resulting from the court's decision to withhold judicial review).
66. It is particularly notable that Congress failed to mention judicial review in the provision, which it certainly could have done had it so desired. See 21 U.S.C. § 371(h) ("The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents with this subsection.").
67. See Califano v. Sanders, 430 U.S. 99, 107 (1977) (concluding that "the APA does not afford an implied grant of subject-matter jurisdiction permitting federal judicial review of agency action").
68. See Bennett v. Spear, 520 U.S. 154, 175 (1997) ("The APA, by its terms, provides a right to judicial review...." (citing 5 U.S.C. § 704 (1994))).
69. 430 U.S. 99 (1977).
70. Id. at 100-01.
71. 387 U.S. 136,141 (1967);
72. See also infra Part IV.B (discussing Abbott Labs.).
73. See Califano, 430 U.S. at 105 (reasoning that congressional action indicated that the "APA is not to be interpreted as an implied grant of subject-matter jurisdiction").
74. Id. (quoting Pub. L. No. 94-574, 90 Stat. 2721 (1976) (amending 28 U.S.C. § 1331(a))). Congress has further broadened the language.
75. See infra note 61.
76. See Califano, 430 U.S. at 105-06 (recognizing the new amendment as indication of congressional intent).
77. Id. at 102. An administrative law judge had denied the plaintiffs initial claim and the agency's appeals council affirmed
78. Id. While the Social Security Act (SSA) provided for judicial review of final administrative decisions, the plaintiff did not Seek judicial review at that time
79. Id. Seven years later, the plaintiff again filed for disability benefits, based on the same claim of disability
80. Id. This time, the administrative law judge found the claim barred by res judicata and decided not to reopen the administrative record, finding no error on the face of the evidence
81. Id. at 102-03. The case was brought Seeking judicial review of this decision
82. Id. at 103.
83. Id. at 108 (citing 42 U.S.C. § 405 (b) (Supp. V 1975)).
84. See Id. at 103-04 (rejecting the claim that the APA granted subject matter jurisdiction to the Court).
85. Id. The plaintiff also argued that he had brought the claim within sixty days of the agency decision not to reopen the case, but the Court refused to allow that action to serve as the relevant agency action, finding that doing so would also wipe out the strict time limits intended in the Act.
86. Id.
87. Id. at 109.
88. E.g., 28 U.S.C. § 1331 (2000) ("The district courts shall have original jurisdiction of all civil actions arising under the Constitution, laws, or treaties of the United States.").
89. Califano, 430 U.S. at 108 (citing 42 U.S.C. § 405(b) (Supp. V 1975)).
90. Id. at 108-09.
91. 520 U.S. 154(1997).
92. Id. at 175.
93. See Qr. for Auto Safety v. Nat'l Highway Traffic Safety Admin., 452 F.3d 798, 806 (D.C. Cir. 2006) ("'The Supreme Court has clearly indicated that the Administrative Procedure Act itself, although it does not create subject-matter jurisdiction,
94. Califano v. Sanders, [430 U.S. 99 (1977)], does supply a generic cause of action in favor of persons aggrieved by agency action.'"
95. (quoting Md. Dep't of Human Res. v. Dep't of Health & Human Servs., 763 F.2d 1441, 1445 n.1 (D.C. Cir. 1985)));
96. Trudeau v. Fed. Trade Comm'n, 456 F.3d 178, 185 (D.C. Cir. 2006) ("Although the APA does not confer jurisdiction, what its judicial review provisions, 5 U.S.C. § § 701-06, do provide is a limited cause of action for parties adversely affected by agency action.");
97. Fund for Animals, Inc. v. U.S. Bureau of Land Mgmt., 460 F.3d 13, 18 & n.4 (D.C. Cir. 2006) (stating that the APA grants a cause of action rather than subject matter jurisdiction);
98. Marceau v. Blackfeet Hous. Auth., 455 F.3d 974, 985 (9th Cir. 2006) ("The APA grants a cause of action to persons injured by administrative action." (citing 5 U.S.C. § 702 (2000));
99. Utah Shared Access Alliance v. Carpenter, 463 F.3d 1125, 1134 (10th Cir. 2006) ("Because none of the statutory or regulatory provisions in question provide[s] for a private cause of action, the judicial review provisions of the APA govern this suit.");
100. Michael Reese Hosp. & Med. Ctr. v. Thompson, 427 F.3d 436, 440 (7th Cir. 2005) ("[Plaintiff] relies on the APA, which provides a cause of action ....").
101. 5 U.S.C. § § 702, 704, 706 (2000).
102. Id. § 704.
103. Id. § 551 (13).
104. Guidance documents fall within the broad category of "rule" and therefore constitute agency action under the APA. See Id.
105. See Bennett v. Spear, 520 U.S. 154, 177 (1997) (finding that the issue of whether an action is final is a separate and distinct question).
106. Id. at 177-78
107. (quoting Chi. & S. Air Lines, Inc. v. Waterman S.S. Corp., 333 U.S. 103, 113 (1948), and Port of Boston
108. Marine Terminal Ass'n v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71 (1970)).
109. Id. (quoting Chi. & S. Air Lines, 333 U.S. at 113, and Rederiaktiebolaget, 400 U.S. at 71)).
110. Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, 72 Fed. Reg. 11, 364 (Mar. 13, 2007).
111. Bennett, 520 U.S. at 178.
112. FDA FOOD GUIDE, supra note 5.
113. Id.
114. Given the focus of the Article, it is important to note that the cases discussed herein were not chosen because of the compelling public policy behind the need for review in the case, or because the Article claims that egregious errors were made by the agency, but rather to show the current inconsistencies in the finality doctrine.
115. See, e.g., Appalachian Power Co. v. EPA, 208 F.3d 1015, 1021-23 (D.C. Cir. 2000) (holding that the document at issue met both prongs of Bennett's two-part test).
116. See, e.g., Nat'l Ass'n of Home Builders v. Norton, 415 F.3d 8, 14-17 (D.C. Cir. 2005) (holding that the document at issue met Bennett's first prong of consummation, but rejecting the claim that it was binding).
117. 208 F.3d 1015 (D.C. Cir. 2005).
118. Id. at 1019. Petitioners brought this case under the judicial review provisions of the Clean Air Act, 42 U.S.C. § 7607 (2000), rather than directly under the APA, but the case is still the most thorough analysis of Bennett's two-prong requirement
119. Id. at 1028.
120. Id. at 1022. The court also disagreed with the government's argument that merely categorizing the document as a "guidance document" inherently meant the document could not be final as required for judicial review
121. Id. at 1021.
122. See Id. at 1023 (explaining that the guidance at issue read like "a ukase" because "[i]t commands, it requires, it orders, it dictates").
123. See Id. (stating that the guidance document had legal consequences for both state agencies and companies who must obtain permits to continue their operations).
124. Id. at 1022.
125. Id. at 1023. The court rejected as mere boilerplate the following disclaimer, placed at the end of the document: "The policies set forth in this paper are intended solely as guidance, do not represent final [EPA] action, and cannot be relied upon to create any rights enforceable by any party."
126. Id.
127. (quoting EPA, PERIODIC MONITORING GUIDANCE 19 (1998), available at http://www.epa.gov/Region7/programs/artd/air/title5/t5memos/pmguide.pdf). The FDA similarly relies heavily on the use of disclaimers to signify the nonbinding nature of FDA guidance documents.
128. See FDA FOOD GUIDE, supra note 5 (classifying the guidance documents as a "draft final guidance," which is not binding on the public).
129. 415 F.3d 8 (D.C. Cir. 2005).
130. See Id. at 16 (distinguishing the statutory scheme in Appalachian Power from that at issue in this case).
131. Id. at 9.
132. Appellants' Opening Brief at 13, Home Builders, 415 F.3d 8 (No. 04-5048) (D.C. Cir. June 10, 2004).
133. See Id. (proclaiming the protocol the exclusive method to survey). According to the survey procedures, only agency licensed biologists could detect the presence of the butterfly during the annual four to six week flight cycle that begins between late February and May of each year
134. Id. at 5. Surveys, such as weekly checks for adults during the potential flight cycle, were to take place over an extended period of time
135. Id. at 23.
136. Id. at 25. In addition, surveys in which no butterflies were found could be, and were, rejected as false negatives if they were near a known butterfly habitat
137. Id. at 6. When this happened, the landowner would need to wait an additional year and compete yet again for one of the few trained butterfly surveyors.
138. Id.
139. Building on a butterfly habitat would count as "taking" an endangered species Id. at 29-30. "Taking" an endangered species, which includes destroying the habitat of the species, can result in civil and criminal penalties
140. Id. at 28.
141. Id. at 33. The EPA expected homeowners and counties to use required surveys since it listed the survey procedures as one of the actions it was taking as part of its required recovery plan for the butterfly
142. Id. at 25-26.
143. Nat'l Ass'n of Home Builders v. Norton, 415 F.3d 8,14 (D.C. Cir. 2005).
144. See Id. at 15-17 (rejecting a finding of justiciability such as that found in
145. Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir. 2002),
146. McLouth Steel Prods. Corp. v. Thomas, 838 F.2d 1317 (D.C. Cir. 2002),
147. Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000),
148. and Cmty. Nutrition Inst. v. Young, 818 F.2d 943 (D.C. Cir. 1987) and distinguishing these cases from the case at hand).
149. See Id. at 14 (reasoning that the agency had previously referred to the protocols as nonmandatory).
150. Id. The court next discounted the argument that the protocols should be considered practically binding, rationalizing that the protocols neither created a safe harbor nor changed the burden faced by the government
151. Id. at 14-15.
152. Id. at 15.
153. Id. at 16.
154. Id.
155. Id.
156. Id. Finally, the court rejected a reiteration of the safe harbor argument made through analogy to Cmty. Nutrition, citing the lack of mandatory language in the protocols.
157. Id. at 17 (citing Cmty. Nutrition Inst. v. Young, 818 F.2d 943 (D.C. Cir. 1987) (discussed infra Part III.B.1.a).
158. See Appalachian Power Co. v. EPA, 208 F.3d 1015, 1023 (D.C. Cir. 2000) (noting that although the EPA argued that the policy at issue was not final, the EPA created procedures that it forced the states to implement and follow).
159. FDA FOOD GUIDE, supra note 5.
160. Would this outcome have been different had the analysis proceeded to the factors for ripeness? Perhaps not, as no agency action had even been brought for failing to follow the protocols, but it does begin to demonstrate some of the inconsistency in applications of Bennett and the need to more rationally delineate ripeness and finality.
161. 5 U.S.C. §551(4) (2000).
162. Id. §553. This occurs unless a party invokes the formal rulemaking requirements of §§556 and 557.
163. Id. §§556-557.
164. Id. §553(b)(3)(A). The statute also allows for exceptions to agency procedural rules, which are generally not implicated when a document is alleged to be an invalidly promulgated rule.
165. See discussion infra Part III.B.1. a-b.
166. See 42 U.S.C. §6976 (2000) (establishing the circumstances in which judicial review of final regulations may take place).
167. 818 F.2d 943 (D.C. Cir. 1987).
168. See id. at 945 (explaining that the Community Nutrition Institute filed a suit in which it claimed that the FDA's action level violated the APA and the Federal Food, Drug, and Cosmetic Act).
169. Id. at 946 (quoting Am. Bus. Ass'n v. United States, 627 F.2d 525, 529 (D.C. Cir. 1980).
170. See id. at 947 ("The language employed by FDA in creating and describing action levels suggests that those levels both have a present effect and are binding.").
171. Id. (quoting 21 C.F.R. §109.4 (1986).
172. See id. (finding that the language used in the regulation "clearly reflects an interpretation of action levels as presently binding norms").
173. See id. (determining that the need to secure an exception to the action level confirms the fact that action levels have a present, binding effect).
174. See id. at 947-48 (quoting the telegram as stating that any shipment exceeding the level of twenty parts per billion would "be considered adulterated and subject to condemnation").
175. Id. at 948.
176. Id.
177. See id. (finding that the action level narrowly limits administrative discretion and thus will be taken as a "binding rule of substantive law").
178. See id. at 949 ("Having accorded such substantive significance to action levels, FDA is compelled by the APA to utilize notice-and-comment procedures in promulgating them."). The court did note, however, that were the FDA to change the manner in which it treated the action levels, it could potentially reissue them as policy statements in the future.
179. Id.
180. Id. at 948.
181. 42 U.S.C. §6976 (2000). While the statute allows review of "final regulations promulgated pursuant to this chapter and the Administrator's denial of any petition for the promulgation, amendment, or repeal of any regulation under this chapter," a guidance document put out by the Agency would not be considered a denial of a petition for review and does not figure in the analysis.
182. Id. §6976(a).
183. 197 F.3d 543 (D.C. Cir. 1999).
184. See id. at 544-45 (describing the distinction between beneficiation waste, which agencies exclude from certain regulations, and processing waste, which agencies regulate more heavily).
185. See id. at 545 (arguing that the EPA mischaracterized Molycorp's operations as processing and explaining that these operations were extraction or beneficiation).
186. Id.
187. See id. (claiming that the agency should have issued the document in accordance with notice and comment rulemaking, and that the document was unlawfully vague in its definition of disposal methods).
188. Id. (citing FIa. Power & Light Co. v. EPA, 145 F.3d 1414,1418 (D.C. Cir. 1998)).
189. See id. at 545 (noting that the third factor is the "ultimate focus of the inquiry" and that the first two criteria "serve to illuminate" it).
190. Id. at 546.
191. Id.
192. Cmty. Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C. Cir. 1987)
193. (quoting Am. Bus. Ass'n v. United States, 627 F.2d 525, 529 (D.C. Cir. 1980).
194. Molycorp, 197 F.3d at 545
195. (citing Fla. Power & Light, 145 F.3d at 1418) (emphasis added).
196. 290 F.3d 377 (D.C. Cir. 2002).
197. 15 U.S.C. § 2618(a)(1)(A) (2000). The two sides argued over whether courts should give "rule" the broad construction that it has in the APA (encompassing legislative and interpretive rules as well as policy statements) or the narrow construction that it has in RCRA and similar statutes (encompassing only legislative rules).
198. See Gen. Elec. Co., 290 F.3d at 381 (discussing the meaning of "rule"). The court found that it need not decide the issue, since the document in question qualified as a legislative rule.
199. Id. at 382.
200. See Gen. Elec. Co., 290 F.3d at 382 (reasoning that the two tests overlap at the third prong of Molycorp).
201. See id. at 385 (concluding that the guidance document's requirement that applicants submit a specific type of application for risk-based cleanup plans was enough to render it a legislative rule).
202. Id. A similar result occurred in Croplife Am. v. EPA. 329 F.3d 876 (D.C. Cir. 2003). Here, review was sought under 21 U.S.C. §346a(h)(1), a judicial review provision like RCRA that allowed review only of regulations, although the statute specified "regulations" rather than "final regulations." The challengers sought review of a press release issued by the EPA announcing that it would no longer accept the results of third party toxicity studies when evaluating pesticides. Croplife, 329 F.3d at 878. Prior Agency policy had been to consider such studies on a case-by-case basis, and previous pesticides had been approved, at least in part, on the basis of third party studies.
203. Id. at 880. These approval decisions had prompted public criticism that led to the press release in question.
204. Id. The Agency responded to this criticism by asking the National Academy of Scientists to comment on the use of such studies.
205. Id. The Agency then issued a press release saying that, while waiting for a response from the Academy, the Agency would no longer consider third party studies unless legally required to do so.
206. Id. at 881. The court found that this statement indicated the agency was binding both itself and parties submitting pesticide statements.
207. Id. at 883. The court reiterated the importance of the two tests to determine whether a given document functioned as a legislative rule, and, noting its binding nature, held the press release to be a reviewable regulation.
208. Id. at 884. As the Agency again conceded that it had not completed the procedures required for the promulgation of legislative rules, the document was vacated, and the court reinstated the agency policy of allowing evidence from third party studies.
209. Id. at 884-85.
210. 434 F.3d 584 (D.C. Cir. 2006).
211. Id. at 587.
212. See id. at 595-96 (concluding that the document was not binding because the agency failed to publish it).
213. Id. at 596.
214. See id. (noting that the document required adherence by low level personnel unless waived by "the Secretary, the Assistant Secretary, or the Director" (quoting NAT'L PARK SER v., DEP'T OF INTERIOR, NPS D1416, MANAGEMENT POLICIES 2001, at 4 (2000), available at http://www.nps.gov/refdesk/ mp/cover.pdf)).
215. See id. (reasoning that the fact that the document did not arise from a congressional mandate presents proof of its nonbinding nature).
216. Id. at 596-97. However, the court in the prior paragraph had called the Management Policies a "nonbinding, internal agency manual," indicating that in fact, it felt the document should fall under the §553 exception for "rules of agency organization, procedure, or practice."
217. Id. at 596; 5 U.S.C. § 553(b)(3)(A) (2000).
218. See Wilderness Soc'y, 434 F.3d at 597 (denying the Wilderness Society's statutory claims as "predicated on unenforceable agency statements of policy").
219. While making this distinction is technically not what the court was doing in General Electric Co. v. EPA, any error would have been harmless. This is because the court did not transform the statute to require a legislative rule to obtain review; it merely reserved the question of the type of rule required under the statute, holding instead that agency action qualifying as a legislative rule was affirmatively entitled to review. Gen. Elec. Co. v. EPA, 290 F.3d 377, 385 (D.C. Cir. 2002).
220. 127 F.3d 90 (D.C. Cir. 1997).
221. Id. at 93-94 (citing Cmty. Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C. Cir. 1987)).
222. See id. at 92 (noting the FDA announcement called for regulation under the statute's drug provisions).
223. Id. at 94 (citing Paralyzed Veterans of Am. v. D.C. Arena L.P., 117 F.3d 579, 588 (D.C. Cir. 1997)). The agency made this argument because the document mandated that positron emission tomography (PET) drugs follow general drug requirements, and was therefore a definite statement of agency expectations, rather than suggested behavior.
224. Id. at 92.
225. See id. at 95 (concluding that the FDA's wording used terminology consistent with rulemaking).
226. See id. at 96 (reasoning that the rule lacked characteristics of interpretive rules).
227. 291 F.3d 49 (D.C. Cir. 2002).
228. See id. at 52-53 (outlining the specific determinations contained in the letter).
229. Id. at 53.
230. See id. at 53-54 (pointing out the inconsistency between the letter and a previous regulation).
231. See id. at 56-58 (declaring that the letter's interpretation of the previous regulation was exempt from notice and comment requirements).
232. See id. at 56 (concluding that the FAA's interpretation of the required rest regulation was reasonable).
233. See id. at 53 (citing Flight Crewmember Flight Time Limitations and Rest Requirements, 66 Fed. Reg. 27, 548, 27, 549 (May 17, 2001)) (stating that six months after publishing notification of the letter at issue in the Federal Register, the Agency would begin enforcing the requirements in the letter).
234. 452 F.3d 798 (D.C. Cir. 2006). In Ctr. for Auto Safety, the problem started when the court held that the APA required the challenger to demonstrate that the document in question was final agency action under 5 U.S.C. §704 or that the document constituted a legislative rule in order to have a right to judicial review.
235. Id. at 806. While the court noted in its statement of the alternative analysis that meeting the legislative rule test was merely sufficient, rather than necessary, to qualify as final agency action, importing the two legislative/nonlegislative tests as an alternative analysis effectively elevates the legislative rule to a necessary requirement.
236. Id. Although this alternative analysis appears to be similar to what Bennett actually requires, as discussed in the analysis, this is also one of the problems with Bennett. The court then cited the two-part analysis in Bennett, and, after laying this foundation, brought in the "two lines of inquiry" that had developed to determine when agency action should be considered a legislative rule.
237. Id. at 806-07.
238. Id. at 80(H) 1 (citing 49 U.S.C. §30, 118(c));
239. id. at 803-04.
240. See id. at 802 (describing the regional recalls policy). An example of such a regional recall would be fixing parts prone to corrosion from salt only in areas of the country where it snowed.
241. Id. at 803-04.
242. Id. at 803 (quoting Generic Version of 1998 Letter from NHTSA to Manufacturers [hereinafter Letter] at 1, reprinted in Joint Appendix at 80, Ctr. for Auto Safety v. Nat'l Highway Traffic Safety Admin., 452 F.3d 798 (No. 04-5402) (D.C. Cir. Sept. 7, 2006)).
243. Id. (citing Letter, supra note 168, at 2).
244. See id. at 804 (arguing that the agency's policy constituted a "de facto legislative rule issued without the opportunity for public notice and comment").
245. See id. at 807-08 (holding that the guidelines did not constitute "final agency action" because they were "general policy statements with no legal force").
246. See id. at 808-09 (explaining why the guidelines do not have any force of law).
247. Id. at 809.
248. See id. (stating that the agency may exercise discretion in evaluating possible recalls).
249. See id. at 810 (concluding that the author of the guidelines did not have the "authority to issue guidelines with binding effect").
250. See id. at 810-11 (classifying automakers' adherence to the practices established by guidelines as a practical consequence).
251. See id. ("[D]e facto compliance is not enough to establish that the guidelines have had legal consequences.") (emphasis omitted).
252. Id. at 811 (reasoning why the "adverse effects flowing from the regional recall practices... are not a legal consequence of the guidelines").
253. See id. ("The adverse effects flowing from the regional recall practices surely are not a legal consequence of the guidelines, not only because the effects preceded the guidelines, but, more importantly, because the agency has never codified the practices in binding regulations.").
254. The fact that relatively few cases have attempted to challenge both the procedure and the merits does not mean that foreclosing this argument has been simply harmless error. Instead, it merely reflects the fact that the case law has increasingly indicated this is not a viable argument.
255. United States v. Mead Corp., 533 U.S. 218 (2001).
256. Skidmore v. Swift & Co., 323 U.S. 134 (1944).
257. See Mead, 533 U.S. at 228-29, 234-38 (recognizing varying levels of deference by finding that although an agency ruling may not claim judicial deference under Chevron, Skidmore entitles the ruling to some deference);
258. Skidmore, 323 U.S. at 139-40 (holding that an agency's rulings, interpretations, or opinions under a statute deserve some level of respect given the information available to an agency and its specialized experience compared to a court).
259. Other commentators have also noted this phenomenon. See, e.g., Anthony, supra note 12, at 1317-18 (noting the numerous advantages an agency obtains by foregoing the notice and comment process, including the possibility of completely avoiding judicial review).
260. The exact level of deference would depend on the court's interpretation of the deference due under Skidmore and Mead. See Mead, 533 U.S. at 228-29, 234-38 (according a Customs ruling letter a lower level of deference under Skidmore despite its failing to qualify under Chevron);
261. Skidmore, 323 U.S. at 139-40 (giving weight to administrative decisions and interpretations due to the administrative body's experience and informed judgment, despite not being "controlling upon the courts by reason of their authority").
262. See discussion supra Part III.B.
263. Id.
264. 307 U.S. 125 (1939).
265. Id. at 143 (footnote omitted).
266. 383 U.S. 576 (1966).
267. Id. at 602 (emphasis added).
268. See 28 U.S.C. § 2342 (2000 & Supp. V 2005) (providing the court of appeals exclusive jurisdiction over rules, regulations, and final orders for specific federal agencies as well as for all final agency actions described in 49 U.S.C. § 20, 114(c)).
269. See id. (establishing review of certain final agency orders arising from the Federal Communications Commission, the Secretary of Agriculture, the Secretary of Transportation, the Federal Maritime Commission, the Atomic Energy Commission, the Surface Transportation Board, and §812 of the Fair Housing Act).
270. See 5 U.S.C. § 551 (4) (2000) (defining "rule");
271. id. § 551(13) (2000) (defining "agency action");
272. see also supra text accompanying note 70.
273. See 5 U.S.C. §704 (establishing that final agency actions are
274. Bennett v. Spear, 520 U.S. 154, 178 (1997)
275. (quoting Port of Boston Marine Terminal Ass'n v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71 (1970)).
276. See H.R. REP. NO. 79-1980, at 43 (1946) ("'Final' action includes any effective or operative agency action for which there is no other adequate remedy in any court.") (emphasis added);
277. S. REP. NO. 79-752, at 27 (1945) ("'Final' action includes any effective agency action for which there is no other adequate remedy in any court.") (emphasis added). 198.
278. See Abbott Labs. v. Gardner, 387 U.S. 136, 140-41 (1967) (stating "the Administrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation.... [O]nly upon a showing of 'clear and convincing evidence' of a contrary legislative intent should the courts restrict access to judicial review.") (citations omitted).
279. See DaimlerChrysler Corp. v. Cuno, 126 S. Ct. 1854, 1867 (2006) ("The doctrines of mootness, ripeness, and political question all originate in Article Ill's 'case' or 'controversy' language, no less than standing does.").
280. See Utah v. Dep't of the Interior, 210 F.3d 1193, 1196 n.1 (10th Cir. 2000) ("[R]ipeness can be raised at any time, even by the court sua sponte for the first time on appeal.").
281. See United States v. Lazarenko, 476 F.3d 642, 649 (9th Cir. 2007) (explaining that ripeness has a "constitutional component, rooted in the Constitution's case-or-controversy requirement, and a prudential component, which embraces judicially self-imposed restraints on federal jurisdiction").
282. See Thomas v. Anchorage Equal Rights Comm'n, 220 F.3d 1134, 1139 (9th Cir. 2000) (en banc) (analogizing a ripeness inquiry to a standing inquiry in that jurisdiction under both concepts requires "a constitutional 'case or controversy,' that the issues presented are 'definite and concrete, not hypothetical or abstract'"
283. (quoting Ry. Mail Ass'n v. Corsi, 326 U.S. 88, 93 (1945))).
284. Abbott Labs., 387 U.S. at 148 (providing the basic rationale for the ripeness doctrine).
285. See id. at 149 (expressing that ripeness is best determined in a two part analysis);
286. see also United States v. Loy, 237 F.3d 251, 257 (3d Cir. 2001) (stating that these ripeness factors are prudential);
287. Simmonds v. INS, 326 F.3d 351, 359 (2d Cir. 2003) (applying the two part ripeness test to "analyz[e] the prudence of hearing a claim of future injury").
288. See Abbott Labs., 387 U.S. at 149 (finding the issue before the court to be "purely legal" and the regulations at issue to be a "final agency action").
289. Although this finality requirement also originates from §704 of the APA, there is surprisingly no overlap in the case law between the finality requirement in Bennett and the finality requirement that is part of the fitness prong of the ripeness test. The best explanation for this lack of overlap is that after Bennett, the finality requirement in ripeness generally receives very little analysis, if any; instead, courts address this requirement as part of the regular Bennett analysis.
290. Ohio Forestry Ass'n v. Sierra Club, 523 U.S. 726, 733 ( 1998).
291. 523 U.S. 726 (1998).
292. Id. at 733.
293. See id. at 734 ("[B]efore the Forest Service can permit logging, it must focus upon a particular site, propose a specific harvesting method, prepare an environmental review, permit the public an opportunity to be heard, and (if challenged) justify the proposal in court."). While the Court admitted this would be more burdensome than a single challenge to the validity of the plan, it was unwilling to find a case ripe based on increased litigation costs alone.
294. See id. at 734-35 (suggesting that one initial site-specific victory would have the same effect as a single challenge against the entire Land and Resource Management Plan).
295. See id. at 733 (finding that the provisions of the challenged plan did not create "adverse effects of a strictly legal kind, that is, effects of a sort that traditionally would have qualified as harm").
296. More specifically, Bennett asks whether legal consequences flow, presuming mat if legal consequences do not flow, the party is not actually harmed.
297. See Matthew Diller, The Revolution in Welfare Administration: Rules, Discretion, and Entrepreneurial Government, 75 N.Y.U. L. REV. 1121, 1188-89 (2000) (stating the APA was a compromise intended to address the accountability concerns present during the New Deal).
298. See supra notes 20-21 and accompanying text.
299. This Article only addresses finality, attempting to create a more streamlined approach to the review of documents. Documents that pass finality could still fail to obtain review under ripeness, particularly since there is also case law that appears to unnecessarily restrict what is considered ripe.