Comparing approaches towards governing scientific advisory bodies on food safety in the United States and the European union

Wisconsin Law Review

Volumn 2010, Issue 2, 2010, Pages 627-671

  Stephanie, Tai ^a,b  

^a UNIVERSITY OF WISCONSIN LAW SCHOOL   (United States)

^b GEORGETOWN UNIVERSITY LAW CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78650821170     PISSN: 0043650X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (351)

1. See Robert V. Tauxe, Emerging Foodbome Diseases: An Evolving Public Health Challenge, 3 EMERGING INFECTIOUS DISEASES 425 (1997);
2. see also Memorandum from Jenny Broome et al., Univ. of Cal. Agrie. & Natural Res., Livestock and Crop Interface: Preventing Food-borne Illness to Interested Agriculture Producers in Yolo, Sacramento, and Solano Counties (Mar. 29, 2007), available at http://ceyolo.ucdavis.edu/newsletterfiles/Plant- Pathologyll231.pdf.
3. See Linus U. Opara, Traceability in Agriculture and Food-Supply Chain: A Review of Basic Concepts, Technological Implications, and Future Prospects, 1 J. FOOD, AGRIC, & ENV'T 101 (2003).
4. Peter Barton Hutt, The State of Science at the Food and Drug Administration, 60 ADMIN. L. REV. 431, 444-47 (2008).
5. Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 [hereinafter EC General Principles of Food Law].
6. See Ellen Vos & Frank Wendler, Food Safety Regulation at the EU Level, in FOOD SAFETY REGULATION IN EUROPE: A COMPARATIVE INSTITUTIONAL ANALYSIS 65, 66 (Ellen Vos & Frank Wendler eds., 2006);
7. see also EC General Principles of Food Law, supra note 4, pmbl. 18.
8. See, e.g., Orly Lobel, Citizenship, Organizational Citizenship, and the Laws of Overlapping Obligations, 97 CAL. L. REV. 433, 471 (2009) ("Under the new governance model, the agency, when feasible, asks the regulated private companies to identify problems and risks and to continuously reflect on possible solutionseffectively, to self-regulate. In turn, the agency offers consultation and assistance. It also offers practical and reputational rewards through safe havens, variance accommodation, and the public certification of responsible practices.");
9. see also Orly Lobel, The Renew Deal: The Fall of Regulation and the Rise of Governance in Contemporary Legal Thought, 89 MINN. L. REV. 342 (2004).
10. See Jane E. Henney, Remarks of the Commissioner of Food and Drugs, 55 FOOD & DRUG L.J. 1, 3 (2000);
11. see also Hutt, supra note 3, at 444-47 (noting that the lack of funding available to the FDA also creates additional need to leverage outside resources).
12. See Lobel, Citizenship, Organizational Citizenship, and the Laws of Overlapping Obligations, supra note 6;
13. see also On Amir & Orly Lobel, Stumble, Predict, Nudge: How Behavioral Economics Informs Law and Policy, 108 COLUM. L. REV. 2098, 2131 (2008) (book review describing the approach of new governance theorists).
14. Kenneth W. Abbott & Duncan Snida, Strengthening International Regulation Through Transnational New Governance: Overcoming the Orchestration Deficit, 42 VAND. J. TRANSNAT'L L. 501, 528-29 (2009).
15. Cf. Elizabeth R. Glodé, Advising Under the Influence?: Conflicts of Interest Among FDA Advisory Committee Members, 57 FOOD & DRUG L.J. 293, 294-95 (2002) (identifying a number of potential reasons for the use of advisory committees in the pharmaceutical context, including economic efficiencies, insulation from special interest pressure, and workload remediation).
16. See Cary Coglianese & David Lazer, Management-Based Regulation: Prescribing Private Management to Achieve Public Goals, 37 LAW & SOC'Y REV. 691, 696-98 (2003);
17. William H. Simon, Toyota Jurisprudence: Legal Theory and Rolling Rule Regimes, in LAW AND NEW GOVERNANCE IN THE EU AND THE US 37, 55 (Gráinne de Burea & Joanne Scott eds., 2006);
18. but see Stephanie Tai, Uncertainty About Uncertainty: The Impact of Judicial Decisions on Assessing Scientific Uncertainty, 11 U. PA. J. CONST. L. 671, 681-82 (2009) (cautioning that asymmetries in information production may lead to a skewing of the regulatory process in favor of particular stakeholders to the detriment of the public).
19. See Coglianese & Lazer, supra note 11, at 696-98.
20. See id.
21. See id.
22. See, e.g., David Michaels & Celeste Monforton, Scientific Evidence in the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory System, 13 J.L. & POL'Y 17, 17 (2005) (arguing that "polluters and manufacturers of dangerous products have waged sophisticated campaigns to manufacture uncertainty about the scientific evidence used to support public health protection and victim compensation");
23. see also John S. Applegate & Robert L. Fischman, Missing Information: The Scientific Data Gap in Conservation and Chemical Regulation, 83 IND. L.J. 399 (2008) (introducing a symposium on scientific data gaps in risk regulation);
24. Albert C. Lin, Beyond Tort: Compensating Victims of Environmental Toxic Injury, 78. S. CAL. L. REV. 1439, 1520-22 (2005) (criticizing the tort system as failing to generate appropriate incentives for non-ends-oriented scientific research into health risks);
25. Wendy E. Wagner, Commons Ignorance: The Failure of Environmental Law to Produce Needed Information on Health and the Environment, 53 DUKE L.J. 1619, 1628-33 (2004) (describing how parties likely to be sued under environmental statutes resist producing information regarding the risks generated by their activities, even though such parties are those best situated to conduct such research);
26. Wendy Wagner & David Michaels, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 AM. J.L. & MED. 119, 122 (2004) (describing how, where stakes are high, sponsors of scientific research "face strong incentives to design and report research in ways most favorable to their interests and to suppress adverse results provided they can do so without detection").
27. See Steve Fuller, The Constitutively Social Character of Expertise, in THE PHILOSOPHY OF EXPERTISE 342 (Evan Selinger & Robert P. Crease eds., 2006).
28. Id.
29. See Evan Selinger & Robert P. Crease, Introduction to THE PHILOSOPHY OF EXPERTISE 2, 2-3 (Evan Selinger & Robert P. Crease eds., 2006);
30. see also BRUCE L.R. SMITH, THE ADVISERS: SCIENTISTS IN THE POLICY PROCESS 1-10 (1992) (describing the developing role of the scientific advisory process in the United States).
31. Selinger & Crease, supra note 18, at 1 (stating that "[t]he lack of explicit philosophical inquiry is surprising, given how thoroughly experts and expertise permeate society, on many levels and in both the public and private spheres").
32. Id. at 3.
33. See, e.g., Stephen Turner, What is the Problem with Expertise?, in THE PHILOSOPHY OF EXPERTISE 164 (Evan Selinger & Robert P. Crease eds., 2006) (pointing out that "[e]xperts are not democratically accountable, but they nevertheless exercise authority-like powers over questions of belief").
34. Selinger & Crease, supra note 18.
35. Turner, supr anote 21, at 164 (internal citation omitted).
36. See Steve Fuller, The Constitutively Social Character of Expertise, in THE PHILOSOPHY OF EXPERTISE 342-55 (Evan Selinger & Robert P. Crease eds., 2006).
37. See John Harding, Epistemic Difference, in THE PHILOSOPHY OF EXPERTISE 328-29 (Evan Selinger & Robert P. Crease eds., 2006).
38. See, e.g., Alvin I. Goldman, Experts: Which Ones Should You Trust?, in THE PHILOSOPHY OF EXPERTISE 21 (Evan Selinger & Robert P. Crease eds., 2006) (exploring five possible bases for lay people to trust one putative expert over another).
39. See H.M. Collins & Robert Evans, The Problem of Legitimacy and the Problem of Extension, in THE PHILOSOPHY OF EXPERTISE 59 (Evan Selinger & Robert P. Crease eds., 2006) (distinguishing between no expertise, interactional expertisei.e., expertise sufficient to interact with experts in a given scientific field-and contributory expertise-i.e., expertise sufficient to contribute to the given scientific field).
40. See Turner, supra note 21, at 165-77.
41. See Evan Selinger & Robert P. Crease, Dreyfus on Expertise: The Limits of Phenomenological Analysis, in THE PHILOSOPHY OF EXPERTISE 2, 2-3 (Evan Selinger & Robert P. Crease eds., 2006).
42. Paul Feyerabend, How to Defend Society Against Science, in THE PHILOSOPHY OF EXPERTISE 358-69 (Evan Selinger & Robert P. Crease eds., 2006);
43. but see Jeffrey D. Kovac, Essay, Science, Law, and die Ethics of Expertise, 67 TENN. L. REV. 397, 402-03 (2000) (arguing that the scientific treatment of truth as provisional itself provides a form of internal organized skepticism).
44. See, e.g., Edward Said, Opponents, Audiences, Constituencies, and Community, in THE PHILOSOPHY OF EXPERTISE 377 (Evan Selinger & Robert P. Crease eds., 2006) ("Let us grant. . . that it would be a long and potentially impossible task to prove empirically that, on one hand, there could be objectivity so far as knowledge about human society is concerned or, on the other, that all knowledge is esoteric and subjective.").
45. See Goldman, supra note 26, at 30 (describing the former approach as reliance on a form of meta-expertise of numbers and arguing that such an approach is only weakly justified when those relying on that expertise lack an independent basis for evaluating those meta-experts).
46. See also Scott Brewer, Scientific Expert Testimony and Intellectual Due Process, in THE PHILOSOPHY OF EXPERTISE 141-43 (Evan Selinger & Robert P. Crease eds., 2006) (describing the regress problem in overreliance on credentials in the context of expert witnesses at trials).
47. See Goldman, supra note 26, at 21.
48. See id.
49. Edward Said, Opponents, Audiences, Constituencies, and Community, in THE PHILOSOPHY OF EXPERTISE 384 (Evan Selinger & Robert P. Crease eds., 2006).
50. But see Turner, supra note 21, at 164 (criticizing citizen oversight committees as "legal fictions" because they may still lack cognitive authority despite their purported use).
51. See H.M. Collins & Robert Evans, The Third Wave of Science Studies: Studies of Expertise and Experience, in THE PHILOSOPHY OF EXPERTISE 83-85 (Evan Selinger & Robert P. Crease eds., 2006).
52. See id. at 90.
53. See id. at 94.
54. See Don Ihde, Why Not Science Critics?, in THE PHILOSOPHY OF EXPERTISE 393-403 (Evan Selinger & Robert P. Crease eds., 2006) (arguing that lay people who become informed about certain scientific matters can perform a whistleblowing role).
55. See Julia Annas, Moral Knowledge as Practical Knowledge, in THE PHILOSOPHY OF EXPERTISE 280-301 (Evan Selinger & Robert P. Crease eds., 2006).
56. Cf. Goldman, supra note 26, at 21 (listing this as one of "five possible sources of evidence that a novice might have, in a novice/2-experts situation, for trusting one putative expert more than another");
57. see also Goldman, supra note 26, at 24.
58. See Collins & Evans, supra note 37, at 94;
59. see also Ihde, supra note 40.
60. See Collins & Evans, supra note 37, at 80-82.
61. Id. at 82.
62. See Holly Doremus, Precaution, Science, and Learning While Doing in Natural Resource Management, 82 WASH. L. REV. 547, 560-61 (2007).
63. See Turner, supra note 21, at 169-77.
64. See Cary Coglianese & Gary E. Marchant, Shifting Sands: The Limits of Science in Setting Risk Standards, 152 U. PA. L. REV. 1255, 1275 (2004). As explained by Professors Coglianese and Marchant: Risk assessment is based extensively on scientific information, supplemented with what have been termed "risk assessment policy" judgments to bridge gaps and uncertainties in the scientific evidence. Risk assessment is therefore considered to be predominantly-though not exclusively-based on scientific evidence and analysis. Risk management, on the other hand, is "an agency decision-making process that entails consideration of political, social, economic, and engineering information with risk-related information to develop, analyze, and compare regulatory options and to select the appropriate regulatory response to a potential chronic health hazard."
65. Id. at 1275-76 (citations omitted);
66. see also Ravi Afonso Pereira, Why Would International Administrative Activity Be Any Less Legitimate? - A Study of the Codex Alimentarius Commission, 9 GERMAN L.J. 1693, 1701 (2008) ("The functional separation between risk assessment and risk management informs us that it is up to scientific bodies to calculate risk and up to accountable decision-makers to determine what level of risk is acceptable. Whenever risk is not quantifiable, that is in situations of scientific uncertainty, science runs out and it is up to decision-makers to regulate on the basis of what they believe are their constituents' desires.") (citation omitted).
67. See Collins & Evans, supra note 37, at 48-50;
68. see also Robert G. Hetes, Science, Risk, and Risk Assessment and Their Role(s) Supporting Environmental Risk Management, 37 ENVTL. L. 1007, 1007 (2007) ("Risk assessment is a necessary tool used to inform decisions where direct measurements are not possible. While risk assessment involves science and is a scientific activity, it is best described as "transscientific"; normative elements and judgment are inherent");
69. Tai, supra note 11, at 679-80 (describing how normative considerations can still arise in the risk-assessment process, despite its characterization as science based and thus "neutral").
70. See, e.g., Am. Trucking Ass'n v. EPA, 283 F.3d 355, 378-79 (D.C. Cir. 2002) (upholding the ozone National Ambient Air Quality Standard promulgated by the EPA contrary to the recommendations of the Clean Air Scientific Advisory Committee due to EPA's reactions to the report, and giving deference to the EPA's resolution of uncertainties in the data).
71. Collins & Evans, supra note 37, at 48-50.
72. Turner, supra note 21, at 160.
73. See NEIL KOMESAR, IMPERFECT ALTERNATIVES 53-97 (1994) (describing the wide variety of influences factoring into the political process).
74. Compare Goldman, supra note 26, at 21-34 (evaluating how those without expertise are to evaluate which experts upon which to rely, albeit recognizing that different degrees of expertise do exist), with Collins & Evans, supra note 37, at 58-61 (arguing for explicitly addressing different levels of expertise).
75. See, e.g., JAMES M. LANDIS, THE ADMINISTRATIVE PROCESS 23-24 (1938) (describing agencies as fulfilling a need for expertness "for the art of regulating an industry requires knowledge of the details of its operation, ability to shift requirements as the condition of the industry may dictate, the pursuit of energetic measures upon the appearance of an emergency, and the power through enforcement to realize conclusions as to policy").
76. See Collins & Evans, supra note 37, at 62 (pointing out that for "groups of experts to talk to each other, translation may be necessary" and for a category of expertise that focuses on the ability to do that translation);
77. but see Evan Selinger & John Mix, On Interactional Expertise: Pragmatic and Qntological Considerations, in THE PHILOSOPHY OF EXPERTISE 316-17 (Evan Selinger & Robert P. Crease eds., 2006) (critiquing Collins's characterization of interactional expertise as, among other things, "unduly limitfing] the contributory potential of interactional expertise").
78. See Collins & Evans, pra note 37, at 59 (arguing for a category of expertise to describe those with "enough expertise to interact interestingly with [those in a given scientific area]").
79. See id. at 59 (arguing for a category of "contributory expertise" to describe those with "enough expertise to contribute to the science of the field").
80. See, e.g., PHILIP KITCHER, THE ADVANCEMENT OF SCIENCE 314-22 (1993) (addressing how scientists ascribe authority to other experts).
81. 21 C.F.R. §14.100(g)(2)(ii) (2009);
82. see also FDA, Food Advisory Committee, http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/default.htm (last visited Mar. 14, 2010) (describing the purpose of the committee as providing "advice ... on emerging food safety, food science, nutrition, and other food-related health issues that the FDA considers of primary importance for its food and cosmetics programs").
83. 21 C.F.R. §14.100(a)(2) (2009);
84. see also FDA, Science Board to the Food and Drug Administration, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ ScienceBoardtotheFoodandDrugAdministration/default.htm (last visited Mar. 14, 2010) (charging the committee with keeping the FDA up-to-date with developing scientific information relevant to the agency's missions).
85. FDA, Questions and Answers Regarding Advisory Committee Membership, http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ CommitteeMembership/ucml 17646.htm (last visited Mar. 14, 2010);
86. see also 21 C.F.R. §14.80 (2009).
87. 21 C.F.R. §14.80(a)(1) (2009);
88. see also FDA, Questions and Answers Regarding Advisory Committee Membership, supra note 62.
89. FDA, Applying for Membership, http://www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/CommitteeMembership/ApplyingforMembershi p/default.htm (last visited Mar. 14, 2010).
90. 21 C.F.R. §14.84 (2009) (describing the selection process for voting members);
91. 21 C.F.R. §14.84(c) (2009) (describing the selection process for nonvoting members representing consumer interests);
92. C.F.R. §14.84(d) (2009) (describing the selection process for nonvoting members representing industry interests).
93. FDA, Membership Types, http://www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/CommitteeMembership/MembershipTypes/default.htm (last visited Mar. 14, 2010) (also listing a fourth type, "patient representatives," more relevant in the pharmaceutical context).
94. See, e.g., 21 C.F.R. §14.84(c) (describing selections process for consumer member);
95. id. §14.84(d) (describing selections process for industry member);
96. id. §14.86(a), (c) (2009) (describing all nonvoting members as having the responsibility of representing the generalized interest of consumers and industry).
97. Id. §14.80(b)(1)(i) (2009) (describing voting members of technical advisory committees as having those with "expertise in the subject matter with which the committee is concerned," a description fitting the FDA Web site category of "Academician/Practitioner"). The nonvoting members, in contrast, are described in the regulations as those representing consumer and industry interests.
98. Id. §14.84(c)-(d).
99. Id. §14.82 (2009).
100. Id. §14.80(b)(1)(i).
101. FDA, Applying for Membership, supra note 64.
102. 21 C.F.R. §14.80(d) (2009).
103. Id. §14.84(c)-(d);
104. see also id. §14.80(b)(2) (describing nonvoting members as those selected by interested organizations, "as provided in 14.84").
105. FDA, Membership Types, supra note 66.
106. See id.;
107. see also 21 C.F.R. §14.86(a) (describing liaison purpose);
108. id. § 14.86(c)(1) (describing class representation purpose).
109. FDA, Membership Types, supra note 66.
110. 21 C.F.R. §14.84(c)(1), (3) (2009).
111. Id. §14.84(c)(1), 14.84(c)(3).
112. Id. §14.84(c)(4).
113. Id. §14.86(c)(4).
114. Id. §14.84(d) (2009).
115. Id.
116. FDA, Roster of the Food Advisory Committee, http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/ucml206 72.htm (last visited Mar. 14, 2010).
117. FDA, Roster of the Science Board to the Food and Drug Administration, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ ScienceBoardtotheFoodandDrugAdministration/ucm115370.htm (last visited Mar. 14, 2010).
118. 21 C.F.R. §14.80(b)(i) (2009).
119. Id. §14.80(f) (2009).
120. 18 U.S.C. §208(a) (2006);
121. see also FDA, Applying for Membership, supra note 64 ("Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest.").
122. 21 C.F.R. §14.80(a)(2) (2009).
123. 18 U.S.C. §208(b)(3) (2006).
124. See, e.g., Glodé, supra note 10, at 294;
125. see also id. at 304-15 (describing criticism from various other sources);
126. Steven P. Croley & William F. Funk, The Federal Advisory Committee Act and Good Government, 14 YALE J. ON REG. 451, 498-99 (1997);
127. Mary Kathryn Palladino, Ensuring Coverage, Balance, Openness, and Ethical Conduct for Advisory Committee Members Under the Federal Advisory Committee Act, 5 ADMIN. L.J. 231, 266-71 (1991);
128. Whitt Steineker, Who's Guarding die Henhouse?: Conflicts of Interest and the FDA Advisory Committee Regime, 20 GEO. J. LEGAL ETHICS 935 (2007);
129. but see Erika Leitzan, Advisory Committees at FDA: The Hinchey Amendment and "Conflict of Interest" Waivers, 39 J. HEALTH L. 415 (2006) (arguing that certain overemphasis on conflicts would restrict the FDA from obtaining the expertise it needs to resolve its regulatory issues).
130. See Glodé, supra note 10, at 318-22.
131. Id. at 320-21.
132. FDA, GUIDANCE FOR FDA ADVISORY COMMITTEE MEMBERS AND FDA STAFF: VOTING PROCEDURES FOR ADVISORY COMMITTEE MEETINGS (2008), available at http://www.fda.gov/downloads/Regulatorylnformation/Guidances/UCM125641.pdf [hereinafter FDA GUIDANCE ON VOTING PROCEDURES].
133. Id. at 5.
134. Id.
135. Id. at 4.
136. 21 C.F.R. §§1425, 1429 (2009).
137. 5 U.S.C. app. §10(b) (2006) (incorporating the open meeting requirement of the Sunshine Act, 5 U.S.C. §552, for federal agencies).
138. Moreover, various administrative remedies are available to enforce these transparency requirements. 21 C.F.R. §14.7 (2009).
139. 5 U.S.C. app. §2(b)(5) (2006).
140. 21 C.F.R. §14.65(c) (2009) (requiring committee records to be made available upon request); id. §14.70 (2009) (including minutes and transcripts of open portions of meetings as part of the committee record, as well as information considered by the committee).
141. Id. §§14.25(a)-(b), 14.27(a), 14.29(b);
142. see also FDA, DRAFT GUIDANCE, THE OPEN PUBLIC HEARING: FDA ADVISORY COMMITTEE MEETINGS 3-4 (2005), available at http://www.fda.gov/downloads/ RegulatoryInformation/Guidances/UCM125734.pdf.
143. 21 C.F.R. §14.29(a) (2009).
144. Id. §14.20 (2009).
145. Id. §14.22(b) (2009).
146. See FDA, GUIDANCE FOR INDUSTRY: ADVISORY COMMITTEE MEETINGSPREPARATION AND PUBLIC AVAILABILITY of INFORMATION GIVEN TO ADVISORY COMMITTEE MEMBERS 4-15 (2008), available at http://www.fda.gov/downloads/Regulatory Information/Guidances/UCM125650.pdf.
147. 21 C.F.R. §14.27(b) (2009).
148. Id. §14.27(b)(2) (stating that "[a] portion of a meeting may be closed only if the Commissioner determines that the closing is permitted under 5 U.S.C. 552b(c) (2006) [part of the Federal Advisory Committee Act], and that the closing is necessary").
149. 5 U.S.C. §552b(c)(2) (2006); 21 C.F.R. §14.27(b)(3).
150. 5 U.S.C. §552b(c)(4); 21 C.F.R. §14.27(b)(3).
151. 5 U.S.C. §552b(c)(6); 21 C.F.R. §14.27(b)(3).
152. 5 U.S.C. §552b(c)(7); 21 C.F.R. §14.27(b)(3).
153. 21 C.F.R. §14.27(b)(3).
154. James T. O'Reilly, Advisers and Secrets: The Role of Agency Confidentiality in the Federal Advisory Committee Act, 13 N. KY. L. REV. 27, 48-49 (1986).
155. 21 C.F.R. §14.27(b).
156. Id. §14.25(c) (2009).
157. Id. §14.27(c)(1)-(2) (2009).
158. Id. §14.27(c)(3).
159. Id. §14.27(c)(4).
160. 21 U.S.C. §331(a), (b), (c), (g) (2006) (prohibiting adulteration of foods, as well as sale, manufacture, and receipt of adulterated foods).
161. 42 U.S.C. §264 (2006).
162. 21 C.F.R. §14.5(a) (2009).
163. Id. §14.1(a)(2)(ii)-(iv) (2009) (including FDA review of the safety of color additives, human prescription drugs, and over-the-counter drugs).
164. See FDA, DRAFT GUIDANCE FOR THE PUBLIC AND FDA STAFF ON CONVENING ADVISORY COMMITTEE MEETINGS (2008), available at http://www.fda. gov/downloads/Regulatorylnformation/Guidances/UCM 125651. pdf.
165. Id. at 4.
166. See FOOD ADVISORY COMMITTEE MEETING, APPROACHES TO ESTABLISH THRESHOLDS FOR MAJOR FOOD ALLERGENS AND FOR GLUTEN IN FOOD 2005.
167. See FDA, INTRODUCTION, available at http://www.fda.gov/ohrms/dockets/ac/ 03/briefing/3925bl-Introduction.pdf (last visited Mar. 14, 2010).
168. See FDA, BACKGROUND AND QUESTIONS: FOOD AND DRUG ADMINISTRATION FOOD ADVISORY COMMITTEE INFANT FORMULA TASK FORCE (2002).
169. 21 C.F.R. §14.5(b) (2009);
170. see also Steineker, supra note 90, at 941-42, n.52 (describing FDA rejection of advisory committee's recommendation to approve the Plan B emergency contraception pill).
171. Tummino v. Von Eschenbach, 427 F. Supp. 2d 212, 232-33 (E.D.N.Y. 2006).
172. 21 C.F.R. §14.1(b)(5)(i) (2009).
173. Id. §14.1(b)(5)(a).
174. Id. §14.1(b)(5)(iii).
175. Id. §14.1(b)(5)(iv);
176. see also Food Chem. News v. Young, 900 F.2d 328, 333 (D.C. Cir. 1990), rev'g709 F. Supp. 5, 9 (D.D.C. 1989), cert, denied, 111 S. Ct. 132 (1990) (holding that advisory panels set up as part of a contract do not fall within FACA's "established by" definition).
177. 67 Fed. Reg. 69,225 (Nov. 15, 2002).
178. Transcript of the Meeting of the Food Advisory Committee, Contaminants and Natural Toxicants Subcommittee at 5-7 (Dec. 4, 2002) [hereinafter FAC Dec. 4, 2002 Transcript] (on file with author). Three of these members had been granted conflict-of-interest waivers to allow them to participate. Id. at 9.
179. Id. at 19-21.
180. See, e.g., id. at 53-257; Transcript of the Food Advisory Committee, Contaminants and Natural Toxicants Subcommittee at 2-8 (Dec. 5, 2002) [hereinafter FAC Dec. 5, 2002 Transcript] (on file with author).
181. FAC Dec. 4, 2002 Transcript, supra note 136, at 258-311.
182. FAC Dec. 5, 2002 Transcript, supra note 138, at 127.
183. Id. at 128.
184. Id.
185. Id. at 128-29.
186. Id. at 125.
187. Food Advisory Committee, Transcripts at 25 (Feb. 24, 2003), http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3925tl.doc [hereinafter FAC Feb. 24, 2003 Transcripts].
188. 68 Fed. Reg. 5297 (Feb. 3, 2003) (announcing advisory committee meeting).
189. FOOD ADVISORY COMMITTEE ON ACRYLAMIDE, GUEST SPEAKERS (2003), http://www.fda.gov/ohrms/dockets/ac/03/roster/3925r1-guest%20speakers%20roster. pdf.
190. Transcript of the Food Advisory Committee, Contaminants and Natural Toxicants Subcommittee at 93 (Feb. 25, 2003) [hereinafter FAC Feb. 25, 2003 Transcript] (on file with author).
191. Id. at 129.
192. Id. at 133.
193. Id. at 138.
194. Id. at 150.
195. Id. at 144-45.
196. Id. at 146.
197. Id. at 152.
198. FDA, FDA Action Plan for Acrylamide in Food, Mar. 2004, http ://www.fda. gov/Food/FoodSafety/FoodContaminantsAdulteration/ChemicalContam inants/Acrylamide/ucm053519.htm.
199. Id.
200. FDA, Acrylamide in Food: Request for Comments and for Scientific Data and Information, 74 Fed. Reg. 43,134, 43,136 (Aug. 26, 2009).
201. FDA, Acrylamide in Food, Aug. 2009, http://www.fda.gov/food/foodsafety/ foodcontaminantsadulteration/chemicalcontaminants/acrylamide/default.htm.
202. FDA, Acrylamide Questions and Answers, May 2009, http ://www. fda. gov/Food/FoodSafety/FoodContaminantsAdulteration/ChemicalContam inants/Acrylamide/ucm053569.htm.
203. FDA Action Plan for Acrylamide in Food, supra note 156 ("As messages are developed and refined, FDA will recruit the aid of agricultural extension services and home economics, diet, and nutrition organizations, such as the Institute of Food Technologists, American Society for Clinical Nutrition, and the American Society for Nutritional Sciences, in getting its message out to consumers.").
204. See EC General Principles of Food Law, supra note 4, at art. 1(2).
205. See Vos & Wendler, supra note 5, at 76.
206. Id. at 79-81 (citing Address by Robert Medlin, Director General DG SANCO, ECOSA, Edinburgh, Apr. 2005).
207. See EC General Principles of Food Law, supra note 4, at art. 28(5).
208. Id.; see also EFSA, Decision of the Executive Director Concerning the Selection of Members of the Scientific Committee, Scientific Panels and External Experts (June 19, 2009), http://www.efsa.europa.eu/en/keydocs/docs/ expertselection.pdf [hereinafter EFSA Scientific Selection Decision].
209. See EC General Principles of Food Law, supra note 4, at art. 25(1).
210. Id.
211. Id.
212. EFSA, Decision Concerning the Establishment and Operations of the Scientific Committee and Panels, art. 1(1) (Dec. 17, 2009), available at http://www.efsa.europa.eu/en/keydocs/docs/paneloperation.pdf [hereinafter EFSA Scientific Operations Committee Decision].
213. See EFSA Scientific Selection Decision, supra note 166, at art. 3.
214. See id. at art. 5.
215. See id. at art. 4(2).
216. EFSA, CONTAM - CONTAM Panel 2009-2012, https://doi.efsa.europa. eu/doi/doiweb/panel/CONTAM/wg/75463;
217. see also Vos & Wendler, supra note 5, at 80-81 (discussing the broad geographical representation of the scientists on the panels).
218. See EFSA Scientific Committee Operations Decision, supra note 170, at art. 6(1);
219. see also EFSA, Expert Database, http://www.efsa.europa.eu/EFSA/AboutEfsa/ WhoWeAre/efsa locale-1178620753812 1178712806106.htm (last visited Mar. 14, 2010).
220. Commission Decision 2004/613/EC, Concerning the Creation of an Advisory Group on Food Chain and Animal and Plant Health, 2004 O.J. (L 275/17) (EC).
221. But see EFSA Scientific Committee Operations Decision, supra note 170, at art. 23 (allowing Panel members to be dismissed "for actions which are conflicting with the [EFSA]'s internal rules").
222. See EC General Principles of Food Law, supra note 4, at art. 37(2).
223. See id. at art. 37(2).
224. Vos & Wendler, supra note 5, at 100.
225. Id.
226. Id. at 100-01.
227. See EC General Principles of Food Law, supra note 4, at art. 28(7).
228. See FDA GUIDANCE ON VOTING PROCEDURES, supra note 93.
229. See EFSA Scientific Committee Operations Decision, supra note 170, at art. 12.
230. See id. at art. 14.
231. see id. at art. 13.
232. See id. at art. 16.
233. See id. at art. 17.
234. See id. at art. 19.
235. See EC General Principles of Food Law, supra note 4, at art. 30.
236. See id. at art. 30(2).
237. See id. at art. 30(3)-(4).
238. See id. at art. 28(1) (stating that the panels "shall have the possibility, where necessary, of organising public hearings").
239. EFSA, Decision of the Management Board of the European Food Safety Authority Concerning Implementing Measures of Transparency and Confidentiality Requirements, art. 2 (Mar. 10, 2005), http://www.efsa.europa.eu/EFSA/ DocumentSet/mb-transparency-confidentiality-requirementsl,4.pdf?ssbinary=true [hereinafter EFSA Transparency Decision].
240. See Vos & Wendler, supra note 5, at 104-05 (describing the nonpublic nature of Scientific Panel meetings so that "participants feel able to discuss issues without inhibition and thereby achieve high quality opinions").
241. EC General Principles of Food Law, supra note 4, at art. 28(8).
242. Id. at art. 38(1);
243. see also EFSA Transparency Decision, supra note 195, at art. 4.
244. Id. at art. 6(1).
245. Id. at art. 6(2).
246. EFSA, EFSA's Approach on Public Consultations on Scientific Outputs, available at http://www.efsa.europa.eu/en/keydocs/docs/consultationpolicy.pdf (last visited Apr. 14, 2010) [hereinafter EFSA Public Consultation Approach].
247. Id. at 3.
248. See EC General Principles of Food Law, supra note 4, at art. 42.
249. EFSA Public Consultation Approach, supra note 201, at 3.
250. Id. at 4-5.
251. Id. at 6-7.
252. Id.
253. See EC General Principles of Food Law, supra note 4, at art. 28(2).
254. See id. at art. 28(4).
255. 21 C.F.R. §14.1(a) (2009) (describing the scope of advisory committee governance as pertaining to when the FDA Commissioner concludes in its discretion that it is in the public interest to convene an advisory committee meeting).
256. See EC General Principles of Food Law, supra note 4, at art. 29(1)(1). Such requests, in turn, may be either at the discretion of the Commission or Member States, or required under the General Principles of Food Law.
257. See Vos & Wendler, supra note 5, at 88-89 (describing a number of areas in which risk assessments by EFSA are required for exercising regulatory decision-making authority).
258. See EC General Principles of Food Law, supra note 4, at art. 29(1)(b).
259. See id. at art. 29(5).
260. See id. at art. 34.
261. See id. at art. 23;
262. see also Vos & Wendler, supra note 5, at 88 (pointing out that division of tasks between the EFSA and the Commission is the division between risk assessment and risk management, and an expression of the political opinion of the Community institutions regarding appropriate decision-making authority).
263. See Vos & Wendler, supra note 5, at 87 n. 155.
264. See, e.g., EC General Principles of Food Law, supra note 4, pmbl. 53 ("The Commission remains fully responsible for communicating risk management measures.").
265. EFSA Panel on Contaminants in the Food Chain [CONTAM], Scientific Opinion on Arsenic in Food, 7(10) EFSA J. 1351 (2009), available at http://www.efsa.europa.eu/en/scdocs/doc/1351.pdf [hereinafter EFSA, Arsenic].
266. EFSA Panel on Contaminants in the Food Chain [CONTAM], Nitrite as Undesirable Substances in Animal Feed, 1017 EFSA J. 1 (2009), available at http://www.efsa.europa.eu/en/scdocs/scdoc/1017.htm [hereinafter EFSA, Nitrite].
267. EFSA, Panel on Contaminants in the Food Chain [CONTAM], Review of the Criteria for Acceptable Previous Cargoes for Edible Fats and Oils, 1110 EFSA J. 1 (2009), http://www.efsa.europa.eu/en/scdocs/scdoc/1110.htm [hereinafter EFSA, Acceptable Previous Cargoes].
268. EFSA, Arsenic, supra note 218, at 147.
269. EFSA, Nitrite, supra note 219, at 35.
270. EFSA, Acceptable Previous Cargoes, supra note 220, at 19.
271. EFSA, Arsenic, supra note 218, at 147-48.
272. 21 C.F.R. §14.1(b)(2) (2009).
273. Id.
274. 21 C.F.R. §14.5(b) (2009).
275. EC, Scientific Committee on Food, Opinion of die Scientific Committee on Food on New Findings Regarding the Presence of Acrylamide in Food, SCF/CS/CNTM/CONT/4 Final 13-14 (July, 3 2002), available at http://ec.europa.eu/ food/fs/sc/scf/out131 en.pdf.
276. Id. at 13.
277. Id.
278. FAO/WHO Consultation on the Health Implications of Acrylamide in Food, 25-27 June 2002, Final Report of a Meeting Held in Geneva, available at http://www.who.int/foodsafety/publications/chem/en/acrylamide-full.pdf. These principles included not cooking food excessively, though thoroughly enough to destroy foodborne pathogens; eating a balanced thet and avoiding fatty foods which may lead to the generation of acrylamide; and investigating food production changes that can reduce the levels of acrylamide in food.
279. Id. at 21.
280. EFSA, Statement of the Scientific Panel on Contaminants in the Food Chain to a Summary Report on Acrylamide in Food of the 64th Meeting of the Joint FAO/WHO Expert Committee On Food Additives 1 (Apr. 19, 2005), available at http://www.efsa.europa.eu/en/scdocs/doc/contam-acrylamide- statement1.0.pdf [hereinafter EFSA, Statement on 2005FAO/WHO Report onAcrylamide].
281. Joint FAO/WHO Expert Committee on Food Additives Sixty-Fourth Meeting, Summary and Conclusions, JECFA/64/SC (Feb. 8-17, 2005), available at http://www.who.int/ipcs/food/jecfa/summaries/summary-report-64-final.pdf.
282. See id. at 17.
283. Id.
284. This data was collected from various Web sites and is on file with the author.
285. EFSA, Statement on 2005 FAO/WHO Report on Acrylamide, supra note 232.
286. Id. at 2;
287. but see EFSA, Acrylamide, http://www.efsa.europa.eu/EFSA/efsa-locale- 1178620753812-1178659331266.htm (stating that in responding to the 2005 Joint" Report "the Panel endorsed the conclusions of JECFA that acrylamide poses a human health concern and that efforts should be made to reduce exposure").
288. EFSA, Statement on 2005 FAO/WHO Report on Acrylamide, supra note 232, at 1.
289. Id. at 2.
290. Commission Recommendation of 3 May 2007 on the Monitoring of Acrylamide Levels in Food, C(2007) 1873, 13, 2007 O.J. (L 123/33).
291. EFSA, Results on the Monitoring of Acrylamide Levels in Food, 285 EFSA Sci. REP. 1-26 (2009) http://www.efsa.europa.eu:80/cs/BlobServer/Report/datex- report-acrylamide-en.pdf?ssbinary=true.
292. Id. at 24.
293. EFSA, Scientific Colloquium Series, Acrylamide Carcinogenicity - New Evidence in Relation to Dietary Exposure, Briefing Notes for Discussion Groups 2 (May 22-23, 2008) available at http://www.efsa.europa.eu/en/events/documents/ colloque080522-ax2.pdf.
294. EFSA, Scientific Colloquium Series, Acrylamide Carcinogenicity - New Evidence in Relation to Dietary Exposure, Series Participants (May 22-23, 2008), available at http://www.efsa.europa.eu/en/evente/documents/colloque080522-ax3. pdf.
295. EFSA, Scientific Colloquium Series, Acrylamide Carcinogenicity - New Evidence in Relation to Dietary Exposure, Series Program (May 22-23, 2008), available at http ://www.efsa.europa.eu/en/events/event/colloque080522-a.pdf.
296. EFSA, Scientific Colloquium Series, Acrylamide Carcinogenicity - New Evidence in Relation to Dietary Exposure, Summary Report 26-27 (May 22-23, 2008), available at http://www.efsa.europa.eu/en/events/event/colloque080522-m. pdf.
297. See supra Part I.A.I.
298. See Goldman, supra note 26, at 24.
299. See id. at 33-34.
300. See Vos & Wendler, supra note 5, at 80-81.
301. See supra Part I.A.I.
302. See supra Part I.A.1.
303. see supra Part I.B.1.
304. supra Part I.B.1.
305. See supra Part I.A.1.
306. See Selinger & Crease, supra note 29, at 229-34.
307. Id. at 229.
308. See, e.g., Steineker, supra note 90, at 942.
309. See Goldman, supra note 26, at 30-31.
310. Id. at 31.
311. See generally LANDIS, supra note 55.
312. See supra Part I.A. 1-2.
313. See supra Part I.B. 1-2.
314. See supra Part I.A.I.
315. See generally Annas, supra note 41, at 280-301.
316. FDA, Membership Types, supra note 66.
317. See Ihde, supra note 40, at 402.
318. See Turner, supra note 21, at 164.
319. FDA Food Advisory Committee, Overview of Approaches to Establishing Thresholds: Allergies (July 13, 2005), available at http://www.fda.gov/ohrms/ dockets/ac/05/transcripts/2005-4160t1-01.pdf.
320. See discussion, supra Part I.A.4. In the twenty-four FDA Food Advisory Committee meetings listed on the FDA Web site held between 1997-2005, four meetings had no public comments, eighteen had one to ten public comments, and only two had ten or more public comments.
321. See U.S. Food & Drug Administration, Food Advisory Committee, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ FoodAdvisoryCommietee/default.htm (last visited Mar. 13, 2010) (data compiled by author).
322. See Said, supra note 31, at 384.
323. EC General Principles of Food Law, supra note 4, pmbl. §56.
324. EFSA Public Consultation Approach, supra note 201.
325. Id. at 3 (citation omitted).
326. Id. at 6.
327. Id.
328. See supra Parts I.A.2,1.B.2.
329. Cf. Goldman, supra note 26, at 21 (listing this as one of "five possible sources of evidence that a novice might have, in a novice/2-experts situation, for trusting one putative expert more than another").
330. See Collins & Evans, supra note 37, at 82.
331. See Turner, supra note 21, at 164.
332. See supra Part I.B.2.
333. See EC General Principles of Food Law, supra note 4, at art. 40(2).
334. See id.
335. Collins & Evans, supra note 37, at 62.
336. But see Vos & Wendler, supra note 5, at 104-05 (suggesting that the nonpublic nature of Scientific Panel meetings was designed in order to avoid any constraint on discussion, and thus perhaps to avoid any translational pressure that might be felt by an open discussion requirement).
337. But see Collins & Evans, supra note 37, at 62 (suggesting that expertise sufficient to interact in multiple areas may be insufficient to provide translational expertise, and might instead entail "extra bit[s]" having to do with "the skills of the journalist, the teacher, the novelist, the playwright, and so forth, skills notoriously hard to explain-as qualitative sociologists know to their cost"); see also EFSA Scientific Selection Decision, supra note 166, at art. 4(2) (including proven scientific communication skills as one factor for choosing Scientific Panel members, which may reflect an evaluation of the translational expertise of potential members).
338. See supra Parts I.A.3,1.B.3.
339. See Feyerabend, supra note 30, at 365 ("Scientists may be consulted on important projects but the final judgement must be left to the democratically elected consulting bodies. These bodies will consist mainly of laymen. Will the laymen be able to come to a correct judgement? Most certainly, for the competence, the complications and the successes of science are vastly exaggerated. ... It is an intellectual discipline that can be examined and criticized by anyone who is interested and that looks difficult and profound only because of a systematic campaign of obfuscation carried out by many scientists (though, I am happy to say, not by all).");
340. see also Sheila Jasanoff & Dorothy Nelkin, Science, Technology, and the Limits of Judicial Competence, 214 SCIENCE 1211, 1213 (1981) (arguing that regulators may inappropriately conflate discussions of science and social value);
341. Jerry L. Mashaw, Law and Engineering: In Search of the Law-Science Problem, LAW & CONTEMP. PROBS., Autumn 2003, at 135, 153 ("[W]e do not always want the law to follow science, even law as made by administrators. . . . The problem from this perspective is not how to reform law to better accommodate science, but how to reframe our aspirational norms about administrative law to better accommodate what we really seem to demand of administration.").
342. See Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUM. L. REV. 1613, 1628-50 (1995);
343. see also Oliver A. Houck, Damage Control: A Field Guide to Important Euphemisms in Environmental Law, 15 TUL. ENVTL. L.J. 129, 130 (2001) ("Under what circumstances is science good? When it supports your position.");
344. Howard Latin, Good Science, Bad Regulation, and Toxic Risk Assessment, 5 YALE J. ON REG. 89, 90 (1988) (criticizing "the conventional view that scientific perspectives should dominate the risk-assessment process").
345. See supra Part I.B.3.
346. Cf. Tai, supra note 11, at 679 (" [Normative uncertainties can, for example, arise in research decisions to explicitly model exposures faced by the least well-off, or to treat all exposures equally, regardless of the nature of those likely to face those exposures. They might also involve decisions to count only fatalities as negative events, or to also include chronic effects that may impair, but not kill, an individual, or to place greater weight on avoiding certain types of risks versus others.").
347. See supra Parts I.A.4,1.B.4.
348. See Collins & Evans, supra note 37, at 48.
349. See supra Parts I.A.4, I.B.4.
350. Collins & Evans, supra note 37, at 63.
351. Id. at 59.