How peer review of agency science can help rulemaking: Enhancing judicial deference at the frontiers of knowledge

George Washington Law Review

Volumn 75, Issue 4, 2007, Pages 931-969

  Fuller, Patrick A ^a  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

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EID: 34548736545     PISSN: 00168076     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (370)

1. Envtl. Def. Fund, Inc. v. EPA, 489 F.2d 1247, 1252 (D.C. Cir. 1973).
2. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005).
3. See, e.g., Sidney A. Shapiro, OMB's Dubious Peer Review Procedures, 34 ENVTL. L. REP. 10,064, 10,064 (2004).
4. Consolidated Appropriations Act of 2001, Pub. L. No. 106-554, § 515, 114 Stat. 2763, 2763A-153 (2000) (codified as amended at 44 U.S.C. § 3516 note (2000)). The Information Quality Act is sometimes referred to as the Data Quality Act. Karl S. Bourdeau, Information Quality Act Challenges to Flawed Use of Science, 19 NAT. RESOURCES & ENV'T 41, 41 (2005).
5. See Thomas O. McGarity, Our Science Is Sound Science and Their Science Is Junk Sci ence: Science-Based Strategies for Avoiding Accountability and Responsibility for Risk-Producing Products and Activities, 52 U. KAN. L. REV. 897, 901 (2004).
6. See SHEILA JASANOFF, THE FIFTH BRANCH: SCIENCE ADVISORS AS POLICYMAKERS 76-79 (1990).
7. Bait. Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 103 (1983).
8. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2665.
9. See infra Part II for a detailed description of the bulletin's requirements.
10. Rick Weiss, "Data Quality" Law Is Nemesis of Regulation, WASH. POST, Aug. 16, 2004, at A1.
11. Consolidated Appropriations Act of 2001, § 515.
12. See, e.g., CHRIS MOONEY, THE REPUBLICAN WAR ON SCIENCE 68-69 (2005);
13. Donald T. Hornstein, Accounting for Science: The Independence of Public Research in the New, Subterranean Administrative Law, 66 LAW & CONTEMP. PROBS. 227, 237 (2003);
14. McGarity, supra note 5, at 901.
15. See McGarity, supra note 5, at 902 (identifying the landmark health and environmental laws of the 1970s as the stimulus pushing industries to begin efforts to fight "burdensome regulation").
16. See id. at 900 (classifying chemical, pharmaceutical, tobacco, electric power, and similar industries whose activities may have impacts on the environment or public health as "risk-producing industries").
17. See id.;
18. see also Richard A. Merrill, Foreword, 66 LAW & CONTEMP. PROBS. 1 (2003) (describing the 1970s as a period where "Congress concluded a decade of feverish legislative activity now embodied in such laws as the National Traffic and Motor Safety Act, the Clean Air Act, the Occupational Safety and Health Act, the Clean Water Act, amendments to the federal pesticide law, the Toxic Substances Control Act, the Safe Drinking Water Act, and the Resource Conservation and Recovery Act") (citations omitted).
19. Merrill, supra note 14, at 2 (2003) ("By the early 1980s, the focus of legal scholars and advocates of regulatory reform had shifted from the courts to the agencies themselves.").
20. Id.
21. See McGarity, supra note 5, at 898 ("Because appeals to economics are inherently suspect in an increasingly cynical society, it makes sense to frame self-interested claims as appeals to science.");
22. Editorial, The Art of Obfuscation, ST. LOUIS POST-DISPATCH, July 30, 2005, at 30.
23. See generally STEPHEN BREYER, BREAKING THE VICIOUS CIRCLE: TOWARD EFFECTIVE RISK REGULATION 10-23 (1993) (arguing that regulation aimed to reduce risks to health and safety is applied randomly, with inconsistent criteria, and often overregulates to the point that the costs outweigh the benefits);
24. John D. Graham, Legislative Approaches to Achieving More Protection Against Risk at Less Cost, 1997 U. CHI. LEGAL F. 13, 22-23 (1997) (discussing the misplaced priorities and inconsistencies within the current regime of regulatory risk management that results in some risks being overregulated and some being underregulated).
25. See Editorial, supra note 17, at 30 (describing the IQA as a "powerful anti-regulatory tool").
26. Id. ("Deception and denial were used to thwart regulation or dodge liability by the lead industry in the 1920s, the chemical industry in the 1950s, the asbestos industry in the 1960s, and the oil and plastics industries in the 1970s.").
27. See MOONEY, supra note 11, at 75-76 (describing several "sound science" campaigns undertaken by conservative politicians and their industry supporters).
28. THE LUNTZ RESEARCH COMPANIES, STRAIGHT TALK, THE ENVIRONMENT: A CLEANER, SAFER, HEALTHIER AMERICA 137-38 (2002), available at http://www.luntzspeak.com/graphics/LuntzResearch.Memo.pdf.
29. McGarity, supra note 5, at 905-08.
30. The strategy developed in the early 1990s included litigation, media campaigns, assembling scientific experts willing to contradict the studies, and building coalitions with other industries to attack EPA's science. Id.
31. Annamaria Baba et al., Legislating "Sound Science": The Role of the Tobacco Industry, 95 AM. J. PUB. HEALTH S20, S21 (2005).
32. Id.
33. Hornstein, supra note 11, at 237-39.
34. The Six Cities Study was a massive 20-year longitudinal study of the health effects of ozone and fine particulate matter in six American cities. Id.
35. Id. at 236.
36. The major challenge to EPA's NAAQS guidelines ended up in the Supreme Court, which held that the Clean Air Act did not permit EPA to consider the costs of their new air quality standards. Whitman v. Am. Trucking Ass'n, 531 U.S. 457, 486 (2001).
37. Rather, the agency was required to consider only what level of regulation was necessary to adequately protect public health. Id. at 465.
38. Similarly, Phillip Morris's attempts to compel data release through litigation met with only minimal success. Baba et al., supra note 24, at S22.
39. Hornstein, supra note 11, at 236 ("[H]yper-analysis in the name of 'good science' is what will become de rigeur under the Shelby Amendment and the [Information] Quality Act.").
40. Weiss, supra note 9, at Al.
41. Id. at A7.
42. Wendy E. Wagner, The "Bad Science" Fiction: Reclaiming the Debate over the Role of Science in Public Health and Environmental Regulation, 66 LAW & CONTEMP. PROBS. 63, 109 (2003).
43. Id. at 111-12.
44. Chris Mooney, Paralysis by Analysis: Jim Tozzi's Regulation to End All Regulation, 36 WASH. MONTHLY, May 2004, at 23, 25 (quoting Jim Tozzi, director of the Center for Regulatory Effectiveness and widely believed to be the author of the IQA).
45. Id.
46. Chris Mooney, Interrogations, BOSTON GLOBE, Aug. 28, 2005, at C1.
47. Hornstein, supra note 11, at 235-36.
48. MOONEY, supra note 11, at 104 (quoting William Kovacs, vice president of Environment, Technology, and Regulatory Affairs at the U.S. Chamber of Commerce).
49. See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452, 8459-60 (republished Feb. 22, 2002) (creating an administrative mechanism to allow the public to seek correction of disseminated information, and prescribing a "high degree of transparency about data and methods" for influential scientific information);
50. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2676 (Jan. 14, 2005) (allowing public participation in peer review process).
51. James W. Conrad, The Information Quality Act-Antiregulatory Costs of Mythic Proportions?, 12 KAN. J.L. & PUB. POL'Y 521, 526 (2003) (observing that federal law before the IQA did not provide "clear accountability for governmental use of information to achieve policy goals").
52. See Thomas O. McGarity, The Courts and the Ossification of Rulemaking: A Response to Professor Seidenfeld, 75 TEX. L. REV. 525, 528 (1997).
53. Id.
54. Ernest Gellhorn, Adverse Publicity by Administrative Agencies, 86 HARV. L. REV. 1380, 1382 (1973).
55. Id. at 1381-83.
56. Conrad, supra note 40, at 527.
57. One example is the Toxic Release Inventory, a "national compilation of chemical releases from facilities that the EPA was required to [make] accessible to any person." Id.
58. Id. ("Virtually all new documents released publicly by federal agencies, and many historic documents, are now available on their websites.").
59. See Rebecca Fairley Raney, New Economy: Too Much Online Data May Come to Mean Less Online Data, N.Y. TIMES, June 3, 2002, at C4;
60. see also Mooney, supra note 34, at 24 ("By the end of the 1990s, as formerly obscure government studies became widely and easily obtainable on agency websites-sometimes affecting a firm's stock valuation simply by being posted-business groups and their GOP allies made a concerted effort to make Tozzi's proposals [the IQA and Shelby Amendment] a reality.").
61. The concerns about the unintended consequences of government information dissemination took on a grave new tone after September 11, 2001, when dissemination of information became a national security concern. Conrad, supra note 40, at 531. After September 11, 2001, many agencies removed information from their websites if they thought it might be useful to terrorists; now progressive government watchdogs are concerned that September 11 is being manipulated by industry to further their anti-information- dissemination agenda.
62. See Raney, supra, at C4.
63. Weiss, supra note 9, at A7.
64. Id.;
65. see also MOONEY, supra note 11, at 103.
66. The OMB describes the events preceding the IQA's enactment as follows: Though not subject to a congressional hearing, Section 515 was not a last-minute addition to the Treasury and General Government Appropriations Act, 2001 (Public Law 106-554). Previously, language in the House Report on the Treasury, Postal Service, and General Government Appropriations Bill, 1999 (House Report No. 105-592) had urged OMB to develop "rules providing policy and procedural guidance" for ensuring the quality of information disseminated by Federal agencies. Later, the version of the Treasury and General Government Appropriations Bill, FY2001 approved by the House Subcommittee contained a requirement for OMB to issue rules on information quality. In response, a June 18, 2000 letter from the OMB Director to the Chairman of the House Committee on Appropriations included a discussion of support for certain changes in the information quality language. The Treasury and General Government Appropriations Act, 2001 (Public Law 106-554) enacted on December 21, 2000 called for OMB to issue guidance. OFFICE OF INFO. & REGULATORY AFFAIRS, OFFICE OF MGMT. & BUDGET, VALIDATING REGULATORY ANALYSIS: 2005 REPORT TO CONGRESS ON THE COSTS AND BENEFITS OF FEDERAL REGULATIONS AND UNFUNDED MANDATES ON STATE, LOCAL, AND TRIBAL ENTITIES 63-64 (2005), available at http://www.whitehouse.gov/omb/inforeg/2005_cb/ final_2005_cb_report.pdf.
67. Cf. Tammy P. Tideswell, The Information Quality Act: An Environmental Primer, 51 NAVAL L. REV. 91, 97-101 (2005) (providing extensive legislative history for the IQA).
68. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452, 8459-60 (republished Feb. 22, 2002).
69. 44 U.S.C § 3516 note (2000).
70. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005).
71. See Guidelines for Ensuring and Maximizing, 67 Fed. Reg. at 8460 (exempting adjudication but not rulemaking);
72. Stephen M. Johnson, Ruminations on Dissemination: Limits on Administrative and Judicial Review Under the Information Quality Act, 55 CATH. U. L. REV. 59, 63-67 (2005) (discussing the IQA's applicability to rulemaking).
73. See Shapiro, supra note 3, at 10,064 (describing OMB's implementation of the IQA as building an "ambitious procedural edifice").
74. Id. ("[T]he goal of ensuring the quality of information has to be reconciled with the substantive mission of an agency and the role of disseminated data in the implementation of that mission.");
75. see infra Part IV.
76. 44 U.S.C. § 3516 note. The full text of the IQA reads: (a) IN GENERAL.-The Director of the Office of Management and Budget shall, by not later than September 30, 2001, and with public and Federal agency involvement issue guidelines under sections 3504(d)(1) and 3516 of title 44, United States Code, that provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies in fulfillment of the purposes and provisions of chapter 35 of title 44, United States Code, commonly referred to as the Paperwork Reduction Act. (b) CONTENT OF GUIDELINES,-The guidelines under subsection (a) shall (1) apply to the sharing by Federal agencies of, and access to, information disseminated by Federal agencies; and (2) require that each Federal agency to which the guidelines apply (A) issue guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by the agency by not later than 1 year after the date of issuance of the guidelines under subsection (a); (B) establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the guidelines issued under subsection (a); and (C) report periodically to the Director (i) the number and nature of complaints received by the agency regarding the accuracy of information disseminated by the agency; and (ii) how such complaints were handled. Id.
77. See Sidney A. Shapiro, The Information Quality Act and Environmental Protection: The Perils of Reform by Appropriations Rider, 28 WM. & MARY ENVTL. L. & POL'Y REV. 339, 374 (2004) ("Congress failed to define any of the key terms of the IQA, hold any hearings, or develop any other legislative history.").
78. See id.;
79. see also Shapiro, supra note 3, at 10,064.
80. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452, 8458-59 (republication Feb. 22, 2002). The IQA Bulletin also requires agencies to make annual reports to OMB on the IQA complaints received by each agency and how they were resolved. Id. at 8459. By now, most agencies have complied with the mandate of this bulletin and issued their own agency-specific information quality guidelines.
81. See, e.g., OFFICE OF ENVTL. INFO., U.S. EPA, GUIDE-LINES FOR ENSURING AND MAXIMIZING THE QUALITY, OBJECTIVITY, UTILITY, AND INTEGRITY, [sic] OF INFORMATION DISSEMINATED BY THE ENVIRONMENTAL PROTECTION AGENCY (2002), available at http://www.epa.gov/oei/qualityguidelines;
82. U.S. FISH & WILDLIFE SERV., INFORMATION QUALITY GUIDELINES (2002), available at http://www.fws.gov/informationquality.
83. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. at 8459-60. The peer review bulletin partially satisfies the IQA Bulletin's mandate to "develop a process" for predissemination quality review. Id. at 8459.
84. Id.
85. Id.
86. Id.
87. One aspect of utility is "transparency," so that the agency must consider the transparency of the information when determining its utility to the public. Id.
88. Id. at 8460.
89. Id. at 8459.
90. Id.
91. This may include release of further information to provide a complete picture of the information disseminated, and "in a scientific, financial, or statistical context, the supporting data and models" will need to be released. Id.
92. Id.
93. Id. The bulletin elaborates on what standards must be met for particular types of information: scientific, financial, and statistical data must be generated and analyzed using "sound statistical and research methods."
94. Id.
95. Influential scientific, financial, and statistical information must facilitate reproducibility through "a high degree of transparency about data and methods," subject to "ethical, feasibility, or confidentiality constraints." Id. at 8460.
96. "Influential" is defined as "a clear and substantial impact on important public policies or important private sector decisions," and "reproducible" is defined as "capable of being substantially reproduced, subject to an acceptable degree of imprecision." Id.
97. Analysis of risks to human health, safety, and environment are subjected to the quality principles adopted or adapted from the Safe Drinking Water Act Amendments of 1996. Id. (citing 42 U.S.C. § 300g-1(b)(3)(A)-(B) (2000)). The Safe Drinking Water Act Amendments of 1996 require scientific decisions to be based on the "best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices" with "data collected by accepted methods or best available methods." 42 U.S.C. § 300g-1(b)(3)(A).
98. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2664 (Jan. 14, 2005).
99. Id. at 2675.
100. Id.
101. See id. at 2665.
102. Id.
103. Id. at 2675. Despite the bulletin's insistence that reviewers are not to review policy decisions, the bulletin does ask for review of scientific assessments and judgments based on uncertain scientific evidence, both of which contain an element of policy judgment.
104. Id. at 2669, 2675.
105. Perhaps to address this complication, the supplementary information specifically warns that "the charge should make clear that the reviewers are not to provide advice on the policy (e.g., the amount of uncertainty that is acceptable or the amount of precaution that should be embedded in an analysis)." Id. at 2669.
106. Id.
107. Id. at 2675.
108. Compare id. (defining influential), with Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452, 8460 (republished Feb. 22, 2002) (using the same definition of " influential").
109. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2674.
110. There are several significant exclusions to this definition: inter- or intra-agency distribution and distribution limited to contractors or government employees; responses to requests for agency information under the Freedom of Information Act, Federal Advisory Committee Act, Privacy Act, and similar laws; distribution limited to adjudicative processes, public filings, subpoenas, correspondence, press releases, and archives; information distributed for peer review, so long as it contains a disclaimer indicating that the information has not yet been formally disseminated; and research produced by government-funded scientists, if the information does not represent the views of the agency. Id.
111. Id. at 2675.
112. It does not include opinions where the presentation makes it clear the information is "opinion rather than fact or the agency's views." Id.
113. Id.
114. As an alternative to the mandated peer review process, agencies are given three other options for complying with the bulletin. Id. at 2676.
115. They may (1) rely on a National Academy of Sciences ("NAS") report, (2) commission the NAS to peer review the draft scientific information, or (3) use a specifically approved "alternate scientific procedure or process... that ensures the agency's scientific information satisfies applicable information quality standards." Id.
116. The alternate procedure must be approved by the Office of Information & Regulatory Affairs ("OIRA") Administrator in consultation with the Office of Science and Technology Policy. Id.
117. Id. at 2675-76.
118. A highly influential scientific assessment is an "assessment that: (i) Could have a potential impact of more than $500 million in any year, or (ii) Is novel, controversial, or precedent-setting or has significant interagency interest." Id. at 2675.
119. Id.
120. Id.
121. Id.
122. Id. at 2668.
123. In other words, the agency should weigh the costs of particular peer review mechanisms (both direct and indirect costs caused by delay of action) against the benefits of increased quality and legitimacy provided by peer review. Id.
124. Id.
125. Id. at 2675.
126. Id.
127. Id.
128. Id.
129. The bulletin's conflict of interest rules require reviewer compliance with federal ethics requirements when reviewers are federal employees, and require that other reviewers be evaluated using criteria adopted or adapted from the NAS committee selection policy for private reviewers. Id.
130. For information linked to specific regulations, a reviewer's financial ties to regulated industries, other stakeholders, and the agency shall be considered. Id.
131. The bulletin requires reviewer independence, insofar as peer reviewers should not have participated in the work product. Id.
132. Otherwise, competitive, peer-reviewed research grants from an agency will typically not disqualify a researcher from serving as a peer reviewer. Id.
133. Id.
134. Id.
135. Id.
136. Id.
137. Reviewers must be notified in advance about the extent of disclosure and attribution. Id.
138. Id. at 2675-76.
139. Id.
140. Id. at 2676.
141. The government scientists eligible for the rare case exception also "must be employed by a different agency of the Cabinet-level department than the agency that is disseminating the scientific information." Id.
142. Id.
143. See Id.
144. Id.
145. Id.
146. It requires that "whenever feasible and appropriate" the draft assessment be made available for public comment at the same time it is submitted for peer review, and that the agency sponsor a public meeting where interested parties can make oral presentations to the peer reviewers. Id.
147. The OMB suggests that occasionally "an assessment may be so sensitive that it is critical that the agency's assessment achieve a high level of quality before it is publicized. In those situations, a rigorous yet confidential peer review process may be appropriate, prior to public release of the assessment." Id. at 2672.
148. Id. at 2676.
149. See id.
150. See id.
151. Id.
152. Id.
153. Id.
154. Id. at 2677.
155. Id.
156. The bulletin explicitly disclaims the possibility that it creates any free-standing private rights of action. Id. ("[T]his Bulletin . . . is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, against the United States, its agencies or other entities, its officers or employees, or any other person.")
157. Id.
158. Id.
159. Id. Agencies need not have peer review conducted on information that is: 1. Related to certain national security, foreign affairs, or negotiations involving international trade ... ; 2. Disseminated in the course of an individual agency adjudication or permit proceeding ... unless the agency determines that peer review is practical and appropriate and that the influential dissemination is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings; 3. A health or safety dissemination where the agency determines that the dissemination is time-sensitive . . . ; 4. An agency regulatory impact analysis or regulatory flexibility analysis . . . except for underlying data and analytical models used; 5. Routine statistical information released by federal statistical agencies (e.g., periodic demographic and economic statistics) and analyses of these data to compute standard indicators and trends (e.g., unemployment and poverty rates);
160. Accounting, budget, actuarial, and financial information, including that which is generated or used by agencies that focus on interest rates, banking, currency, securities, commodities, futures, or taxes; or 7. Information disseminated in connection with routine rules that materially alter entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof. Id.
161. See id.
162. Id. at 2676.
163. Id. at 2676-77.
164. Id. at 2677.
165. Id.
166. Id. at 2664.
167. U.S. EPA, Science Inventory, Peer Review Agenda, http://cfpub.epa.gov/si/ si_pr_agenda.cfm (last visited Oct. 31, 2006).
168. U.S. Dep't of Energy, Office of the Chief Information Officer, http://cio.energy.gov/infoquality.htm (last visited Mar. 5, 2007).
169. U.S. Dep't of Labor, Office of the Assistant Secretary for Policy, Department of Labor Peer Review Agenda, http://www.dol.gov/asp/peer-review/ index.htm (last visited Oct. 31, 2006).
170. Dep't of the Treasury, Information Quality Program, http://www.treas.gov/ offices/cio/information-management/infoqual.shtml, (last visited Oct. 31, 2006);
171. U.S. Department of State, Information Quality Act, http://www.state.gov/ misc/49492.htm (last visited Oct. 31, 2006).
172. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2666.
173. See generally JASANOFF, supra note 6, at 84-99, 152-79 (describing science advisory boards at EPA and Food and Drug Administration ("FDA"));
174. Thomas S. Burack, Note, Of Reliable Science: Scientific Peer Review, Federal Regulatory Agencies, and the Courts, 7 VA. J. NAT. RESOURCES L. 27, 28 (1987) (describing peer review at several federal agencies).
175. See JASANOFF, supra note 6, at 84-99, 152-79.
176. Id. at 84, 101, 124, 152.
177. See, e.g., U.S. EPA, Science Inventory, Review of National Ambient Air Quality Standards (Naaqs) for Carbon Monoxide (Co)-Exposure Analysis, http://cfpub.epa.gov/si/osp_sciencedisplay.cfm?dirEntryID=73912 (last visited Nov. 3, 2006) (referring peer review of study to the Science Advisory Board).
178. Compare Sidney Shapiro, The Case Against the IQA, ENVTL. F., July/Aug. 2005, at 26, 26 (criticizing the IQA),
179. with Mark Greenwood, A Statute for All of Us, ENVTL. F., July/Aug. 2005, at 29, 29 (supporting the IQA).
180. See also Sarah Grimmer, Public Controversy Over Peer Review, 57 ADMIN. L. REV. 275, 278-81 (2005) (summarizing public comments to OMB 's proposed peer review bulletin).
181. See, e.g., Conrad, supra note 40, at 521;
182. Greenwood, supra note 131, at 29;
183. Paul Noe, Fred Anderson & Jim Tozzi, Learning to Live With the Data Quality Act, 33 ENVTL. L. REP. 10,224, 10,225-31.
184. See, e.g., Hornstein, supra note 11, at 236, 246;
185. McGarity, supra note 5, at 914;
186. Shapiro, supra note 3, at 10,064;
187. Wagner, supra note 32, at 63.
188. Conrad, supra note 40, at 526.
189. See id. at 526-28 (describing features and examples of government information dissemination).
190. Id. at 532.
191. 5 U.S.C. §§ 553, 704 (2000).
192. See Conrad, supra note 40, at 535 ("[A]t the time the IQA was adopted, some sort of mechanism to ensure governmental accountability for erroneous or misleading information products was viewed broadly as a 'good practice' whose time had come.");
193. cf. James T. O'Reilly, Libel by Website: Federal Agency Liability for False Website Statements, 29 ADMIN. & REG. L. NEWS 2, 2 (2005) (observing that the APA provides no remedy for adverse government publicity);
194. Bruce R. Parker & Michele R. Rendus, The Data Quality Act: A New Weapon to Defeat Junk Science, FOR THE DEFENSE, July 2003, at 38, 38 (suggesting the danger of negative publicity created by government action was the impetus for the IQA).
195. See REPUBLICAN POLICY COMM., RPC BACKGROUNDER: THE DATA QUALITY ACT: HISTORY AND PURPOSE 1 (2005) available at http://rpc.senate.gov/_files/Jan1805DQAbackgrounderPG.pdf ("The use of poor quality data or bad science can lead to costly mistakes.").
196. Merrill, supra note 14, at 2.
197. Kevin P. Holewinski, Daubert-Type Challenges at Administrative Level Pursuant to Information Quality Act, CORP. COUNS., May 2002, at 4, 5.
198. Parker & Kendus, supra note 138, at 38, 43.
199. See Alexander Nathan Hecht, Administrative Process in an Information Age: The Transformation of Agency Action Under the Data Quality Act, 31 J. LEGIS. 233, 259 (2005).
200. Id.
201. James T. O'Reilly, The 411 on 515: How OIRA's Expanded Information Roles in 2002 Will Impact Rulemaking and Agency Publicity Actions, 54 ADMIN. L. REV. 835, 848 (2002).
202. See id.
203. REPUBLICAN POLICY COMM., supra note 139, at 6.
204. See Burack, supra note 127, at 31
205. ("If a study survives the criticism of peer review, it is generally considered to constitute 'good' or 'reliable' science . . . ."). But as Burack notes, surviving peer review does not guarantee that the study was not flawed in some way that will later be discovered. Id.
206. Id. at 28;
207. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2674 (Jan. 14, 2005).
208. See Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2666.
209. Id.
210. O'Reilly, supra note 145, at 848.
211. Fred Anderson et al., Regulatory Improvement Legislation: Risk Assessment, Cost-Benefit Analysis, and Judicial Review, 11 DUKE ENVTL. L. & POL'Y F. 89, 132 (2000) (discussing the Regulatory Improvement Act of 1999).
212. Press Release, Executive Office of the President, Office of Mgmt. & Budget, Release 2003-34, OMB Proposes Draft Peer Review Standards for Regulatory Science (Aug. 29, 2003), http://www.whitehouse.gov/omb/pubpress/2003-34_2.pdf (quoting John Graham).
213. See McGarity, supra note 5, at 913-14;
214. Shapiro, supra note 3, at 10,064.
215. As described in Part I, supra, these accusations of industry involvement in the IQA's passage are accurate.
216. Wagner, supra note 32, at 75, 87.
217. McGarity, supra note 5, at 913-14.
218. THOMAS O. MCGARITY ET AL., TRUTH AND SCIENCE BETRAYED: THE CASE AGAINST THE INFORMATION QUALITY ACT 2 (March 2005), http://www.progressiveregulation.org/articles/ iqa.pdf. CPR is a nonprofit organization dedicated to supporting regulatory action to protect health, safety, and the environment.
219. Id. at 32.
220. Id. at 6.
221. Id. at 6-7.
222. The EPA even had information correction mechanisms in place prior to the IQA's passage. Id. at 6.
223. Id. at 8-10 (criticizing OMB's use of the Safe Drinking Water Act Amendment standards as inappropriately restrictive and attacking the peer review guidelines as beyond the scope of the IQA, as Congress has repeatedly failed to pass laws mandating peer review and peer review is not mentioned anywhere in the IQA).
224. Id. at 10-11. For example, a salt trade association recently attempted to use the IQA to get access to the underlying data from studies that linked reduced sodium consumption with reduced blood pressure.
225. Salt Inst. v. Leavitt, 440 F.3d 156, 157 (4th Cir. 2006). The U.S. Court of Appeals for the Fourth Circuit held that the IQA did not create a right to information access that could be vindicated in court, and thus the plaintiffs lacked standing.
226. Id. at 159.
227. MCGARITY ET AL., supra note 158, at 21. This is an ironic charge because the OMB is usually one of the most enthusiastic proponents of cost-benefit analysis of federal government regulations.
228. Id.
229. Lars Noah, Scientific "Republicanism": Expert Peer Review and the Quest for Regulatory Deliberation, 49 EMORY L.J. 1033, 1045 (2000) ("Peer review, in its broadest sense, represents the scientific community's effort to police itself and to assure a certain minimum level of quality . . . .").
230. See Wagner, supra note 32, at 63.
231. Id. at 75.
232. Id. at 109-12.
233. Shapiro, supra note 3, at 10,064.
234. Id. at 10,064-65.
235. Id. at 10,065.
236. Id. at 10,065-66.
237. See MOONEY, supra note 11, at 103.
238. As described in Part II, supra, the peer review bulletin applies to all influential scientific information disseminated by the government. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2665 (Jan. 14, 2005). This Note focuses on the bulletin's implications specifically in the rulemaking context.
239. See, e.g., JASANOFF, supra note 6, at 61-83;
240. Noah, supra note 164, at 1059;
241. Lars Noah, Peer Review and Regulatory Reform, 30 ENVTL. L. REP. 10,606, 10,608-09 (2000);
242. J.B. Ruhl & James Salzman, In Defense of Regulatory Peer Review, 84 WASH. U. L. REV. 1, 19-43 (2006) (discussing the case for and against the use of peer review);
243. Burack, supra note 127, at 34-35.
244. JASANOFF, supra note 6, at 61-62.
245. Id. at 76-83.
246. Noah, supra note 174, at 10,607-08.
247. See Lars Noah, Sanctifying Scientific Peer Review: Publication as a Proxy for Regulatory Decisionmaking, 59 U. PITT. L. REV. 667, 700 (1998).
248. See id. at 702.
249. See id.
250. See JASANOFF, supra note 6, at 69-71.
251. Id. at 71-74;
252. Noah, supra note 178, at 697.
253. See, e.g., Anthony Faiola & Rick Weiss, South Korean Panel Debunks Scientist's Stem Cell Claims, WASH. POST, Jan. 10, 2006, at A9.
254. After the Korean stem cell debacle, Nature magazine (Science's principle competitor) demanded "many additional tests and an unusually thick pile of documentation" prior to accepting a German study that transformed cells from a mouse testis into stem cells-caution the study's author attributed to the Korean fraud. Rick Weiss, Embryonic Stem Cell Success, WASH. POST, Mar. 25, 2006, at All.
255. See JASANOFF, supra note 6, at 69-71;
256. Noah, supra note 178, at 704-09.
257. See JASANOFF, supra note 6, at 66-77.
258. Id. at 71-74.
259. Id. at 70-71.
260. These difficulties help explain why editors rarely relinquish the final say on whether to reject a manuscript. See Id. at 67-68.
261. See id. at 74-76.
262. Id. at 76.
263. Id. at 64,
264. See id.
265. See id. at 76.
266. See id. at 77.
267. Id. at 76-77.
268. Id. at 76-79.
269. Id. at 77.
270. Id. at 78.
271. Id. at 77.
272. Id.
273. Id.
274. Id.
275. Id.
276. See id. at 77, 79.
277. Id. at 78-79.
278. Id. at 78.
279. Id. at 79.
280. Id.
281. 5 U.S.C. §704 (2000).
282. Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).
283. Id. at 842-43 (1984),
284. United States v. Mead Corp., 533 U.S. 218, 234 (2001).
285. Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
286. Mead, 533 U.S. at 237.
287. 5 U.S.C. §706 (2000).
288. Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416, 419 (1971).
289. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2675 (Jan. 14, 2005).
290. Overton Park, 401 U.S. at 415.
291. Id. at 416.
292. Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983).
293. Id. at 43.
294. Bait. Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 103 (1983).
295. Id.
296. See JASANOFF, supra note 6, at 248-49 (arguing that courts should be highly deferential to a scientific record that has undergone peer review).
297. But see Noah, supra note 174, at 10,612-13 (arguing that peer review of regulatory science should not be allowed to supplant judicial review).
298. See Hercules, Inc. v. EPA, 598 F.2d 91, 106-07 (D.C. Cir. 1978);
299. Envtl. Def. Fund v. EPA, 598 F.2d 62, 80-81 (D.C. Cir. 1978);
300. Ethyl Corp. v. EPA, 541 F.2d 1, 67 (D.C. Cir. 1976);
301. Certified Color Mfrs. Ass'n v. Mathews, 543 F.2d 284, 294 (D.C. Cir. 1976);
302. Envtl. Def. Fund v. EPA, 489 F.2d 1247, 1253 (D.C. Cir. 1973);
303. JASANOFF, supra note 6, at 49.
304. SHEILA JASANOFF, SCIENCE AT THE BAR: LAW, SCIENCE, AND TECHNOLOGY IN AMERICA 76-78 (1995).
305. JASANOFF, supra note 6, at 49-50.
306. See JASANOFF, supra note 225, at 78.
307. Id.
308. Ethyl Corp., 541 F.2d at 1.
309. Ethyl Corp. contains a vivid example of the debate occurring in the D.C. Circuit over the proper role of the courts in reviewing science-based decisions. Id. at 66-67.
310. In addition to Judge Wright's deferential majority opinion, it also features Chief Judge Bazelon's argument that courts should review such decisions solely for procedural regularity, id. at 68 (Bazelon, CJ., concurring), and Judge Leventhal's exhortation for judges to steep themselves in enough technical knowledge to provide a meaningful review of the substance of the decision (but still deferring to the agency's reasonable judgments),
311. id. at 68-69 (Leventhal, J., concurring).
312. Chief Judge Bazelon's approach, which sometimes included remand to require additional procedures not mandated by statute, was rejected by the Supreme Court in Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc., 435 U.S. 519, 546-48 (1978).
313. Ethyl Corp., 541 F.2d at 28.
314. See Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst. (Benzene), 448 U.S. 607, 639-40 (1980).
315. Id. at 631, 634. The Court created a "rule of reason" (significant risk) not present in the statute or the agency interpretation, but failed to understand both the difficulty in getting the quantitative risk assessment they wanted and demonstrated a limited understanding of the practice and limitations of risk assessment.
316. Id. at 639-40. OSHA had determined that it could not extrapolate a reliable dose-response curve from the high level exposure data it had and the low level exposure it was trying to regulate, so it assumed there was no safe level of benzene exposure and set what it felt was a feasible limit for exposure.
317. Id. at 624-25.
318. The Court seemed to want an actual demonstration or mathematical assessment of risk at ten ppm, but failed to understand how unreliable that assessment would be. JASANOFF, supra note 6, at 58.
319. Benzene, 448 U.S. at 628-29 ("[A]s presently formulated, the benzene standard is an expensive way of providing some additional protection for a relatively small number of workers.").
320. Id. at 631 ("[The record] does not, however, provide direct support for the Agency's conclusion .... The evidence in the administrative record of adverse effects of benzene exposure at 10 ppm is sketchy at best.").
321. See Balt. Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 97-98, 103 (1983).
322. Id. at 105-06;
323. see also JASANOFF, supra note 225, at 85 (describing Baltimore Gas & Electric as a "decision [that] can only be understood as a generalized plea for judicial restraint").
324. Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 866 (1984) (holding that because agencies are part of the politically accountable executive branch, it is appropriate for courts to defer to agency interpretations when the statutory language is not clear).
325. Whitman v. Am. Trucking Ass'n, 531 U.S. 457 (2001).
326. Id. at 475-76.
327. JASANOFF, supra note 225, at 92.
328. See 1 RICHARD J. PIERCE, JR, ADMINISTRATIVE LAW TREATISE §7.4, at 444-45 (4th ed. 2002).
329. Id. at 444-45;
330. McGarity, supra note 41, at 528.
331. PIERCE, supra note 241, at 442.
332. Id. at 445;
333. see also Richard L. Revesz, Environmental Regulation, Ideology, and the D. C. Circuit, 83 VA. L. REV. 1717, 1766-67 (1997) (providing an empirical analysis of D.C. Circuit voting patterns and arguing that judges employ a "strategically ideological approach to judging");
334. Sidney A. Shapiro & Richard E. Levy, Judicial Incentives and Indeterminacy in Substantive Review of Administrative Decisions, 44 DUKE L.J. 1051, 1062-64 (1995) (arguing that the indeterminate doctrinal requirements of substantive administrative review allow judges to pursue their favored outcomes while still complying with doctrinal requirements).
335. See Wagner, supra note 32, at 74-76 (arguing there is very little evidence of low quality agency science).
336. See Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2665;
337. Noah, supra note 174, at 10,611.
338. See Burack, supra note 127, at 107 ("[W]here an agency can show, on the basis of independent peer review, that it has done the best job it can with the scientific data available at the frontiers of science, the courts will be more likely to grant extra deference to the agency's final decision.").
339. See Noah, supra note 174, at 10,611.
340. See id.;
341. Burack, supra note 127, at 107.
342. See Noah, supra note 174, at 10,611. ?
343. Cf. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2665 (Jan. 14, 2005) ("[N]otice-and-comment procedures for agency rulemaking do not provide an adequate substitute for peer review, as some experts-especially those most knowledgeable in a field-may not file public comments with Federal agencies.").
344. See id.
345. This assumes that agencies are able to avoid the issues of bias discussed in Part IV,A., supra. Agencies will need to be careful in their selection of reviewers to ensure their reviewers are capable of independent and disinterested criticism. Situations where reviewers are too close to the agency and appear biased will undermine both the quality of criticism received from the peer review process and the deference that an unbiased peer review should receive from the courts. See JASASNOFF, supra note 6, at 69-71.
346. See Noah, supra note 174, at 10,608 ("[P]eer review . . . creates opportunities for dialogue and feedback designed to improve scientific work.").
347. Id.
348. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2668.
349. See Noah, supra note 174, at 10,611;
350. Ruhl & Salzman, supra note 174, at 44-45;
351. Burack, supra note 127, at 110.
352. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2668. This may be especially true when the IQA and the peer review bulletin give the plaintiff one or multiple chances to comment on the study prior to the rulemaking. See Parker & Kendus, supra note 138, at 38. If the plaintiff already had one bite at the apple, courts may not be as receptive to a second challenge.
353. Id.
354. In fact, some supporters of deregulation fear that "by creating an official peer-review process, the OMB will effectively shield regulatory agencies from legitimate and needed scrutiny-not only by its own staff, but by judges reviewing a rulemaking record." Peering at Regulatory Science, REGULATION, Winter 2003-2004, at 5, 5;
355. cf., Noah, supra note 174, at 10,613 (warning that courts should not be overly deferential to the contents of peer review reports).
356. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. at 2669.
357. See THOMAS O. MCGARITY ET AL., SOPHISTICATED SABOTAGE: THE INTELLECTUAL GAMES USED TO SUBVERT RESPONSIBLE REGULATION 32 (2004) ("While it is important for regulatory agencies to marshal the most rigorous possible empirical evidence and scientific analysis, any regulatory decision ultimately reflects certain ethical judgments, social priorities and, yes, political values.");
358. Ruhl & Salzman, supra note 174, at 45 (explaining that regulatory peerreview should "encourage agencies to provide sharper delineations between scientific and policy bases for decisions").
359. JASANOFF, supra note 6, at 78.
360. See Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 865 (1984) (holding that "the Administrator's interpretation represents a reasonable accommodation of manifestly competing interests and is entitled to deference" especially when "the regulatory scheme is technical and complex").
361. See supra notes 48-51 and accompanying text.
362. See Randolph J. May, OMB's Peer Review Proposal-Swamped by Science?, 29 ADMIN. & REG. L. NEWS 4, 4-5 (2004) (arguing from the perspective of a fan of deregulation that peer review guidelines are not a good idea because they are wasteful and duplicative).
363. Samuel J. McNaughton, What Is Good Science?, 13 NAT. RESOURCES & ENV'T 513, 515-16 (1999).
364. Id.
365. See MCGARITY ET AL., supra note 158, at 20-21.
366. Id. at 21.
367. See JASANOFF, supra note 6, at 14, 95-99, 236 (describing how "boundary work"-attempting to draw a clear line between science and policy-can lend itself to manipulation by participants in the regulatory process).
368. Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664, 2676 (Jan. 14, 2005).
369. Id. at 2668-69.
370. Id. at 2675.