Open secrets: The widespread availability of information about the health and environmental effects of chemicals

Law and Contemporary Problems

Volumn 69, Issue 3, 2006, Pages 141-166

  Conrad Jr , James W ^a,b  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

^b HAVERFORD COLLEGE   (United States)

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[No Author keywords available]

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EID: 33750060999     PISSN: 00239186     EISSN: 00239186     Source Type: Journal    
DOI: None     Document Type: Article

References (226)

1. The symposium was sponsored by the Project on Scientific Knowledge and Public Policy (SKAPP), based at the George Washington University School of Public Health and Health Science. The articles are derived from papers presented at SKAPP's 2004 Coronado Conference II: "Sequestered Science: The Consequences of Undisclosed Knowledge." See Project on Scientific Knowledge and Public Policy, Coronado Conference Papers, http://www.defendingscience.org /coronado_conference_Papers/ Coronado-Conference-Papers.cfm (last visited June 6, 2006) (providing information about SKAPP and the Coronado conferences, and promising to publish forthcoming papers from the conference online);
2. see also discussion infra Part IV. This article was solicited after the conference.
3. David Michaels and Neil Vidmar, Sequestered Science: The Consequences of Undisclosed Knowledge (Oct. 19, 2004) (unpublished symposium proposal, on file with Law & Contemporary Problems).
4. Id.
5. Another article in this issue conveys the perspective of the pharmaceutical industry in the regulatory setting, so this article does not discuss that aspect. See Scott M. Lassman, Transparency and Innuendo: An Alternative to Reactive Over-Disclosure, 69 Law & Contemp. Probs. 69 (Summer 2006).
6. The author is unaware of controversy over restrictions on access to health or safety information premised on privacy reasons. Some debate has emerged about whether and how the government might use concepts like "for official use only" and "sensitive but unclassified" to restrict access to government-funded research. See Leslie Jacobs, A Troubling Equation in Contracts for Government Funded Scientific Research: "Sensitive But Unclassified" = Secret But Unconstitutional, 1 J. Nat'l Security L. & Pol'y 113, 113-17 (2005) (discussing how secrecy clauses and government-contracted research by private scientists connect to influence the content and flow of scientific information, and under what circumstances the use of such clauses is constitutional in view of the First Amendment).
7. U.S.C. § § 2601-2692 (2000).
8. See id.
9. "[TSCA] covers all chemicals planned for production, manufactured in, imported to, or exported from the United States." U.S. Envtl. Protection Agency, Overview: Office of Pollution Prevention and Toxics Programs 2 (Draft Version 2.0, 2003), http://www.epa.gov/opptintr/ oppt101c2.pdf [hereinafter EPA Overview].
10. The only "[s]ubstances not covered under TSCA are pesticides; tobacco (or tobacco products); firearms and ammunition; source material by-products or special nuclear material defined by the Atomic Energy Act; and food, food additives, drugs, or cosmetics covered under the Federal Food, Drug and Cosmetic Act." Id. at 2 n.3.
11. The EPA program office tasked with implementing TSCA is called the Office of Pollution, Prevention and Toxics, sometimes referred to as "OPPT." EPA Overview, supra note 7, at 1. For simplicity, this article refers to EPA as a whole.
12. 15 U.S.C § 2604(a).
13. "When TSCA was passed in 1976, it was not known how many chemicals were in commerce in the U.S., in what quantities or where they were produced and/or imported." EPA Overview, supra note 7, at 2.
14. TSCA therefore required persons manufacturing, importing or processing chemicals to notify EPA. Id. at 5.
15. This resulted in the initial TSCA Chemical Substance Inventory of "existing" chemicals in 1979. Id. at 5-6.
16. As persons notify EPA of "new" chemicals they propose to manufacture or import, these are added to the inventory. Id.
17. 15 U.S.C. § 2604(d)(1).
18. "Test data" is defined broadly to include data that is "related to the effect of any manufacture, processing, distribution in commerce, use, or disposal of such substance or any article containing such substance, or of any combination of such activities, on health of the environment." Id. § 2604(d)(1)(B).
19. As a result of the PMN requirement, EPA has reviewed every new chemical prior to its commercialization, or a total of about 36,600 PMNs from 1979 through 2003. EPA Overview, supra note 7, at 8-10.
20. Only about half of such new chemicals were ever commercialized. Id. at 11.
21. About ten percent of PMNs reviewed between 1979 through 2003 have resulted in EPA requiring testing or submission of additional information, agreements by companies to limit the uses of production volume of a chemical, restrictions on uses of a chemical, or withdrawal of the submission. Id at 9-11.
22. Id. § 2603(a).
23. See 40 C.F.R. § 792.120 (2004) (listing fifteen nonexclusive guidelines and requiring that any variation from the guidelines be documented and explained).
24. Id. Part 792.
25. See also William L. Anderson et al., Daubert's Backwash: Litigation-Generated Science, 34 U. Mich. J. L. Reform 619, 632-33, 675 (2001) (noting that "[GLP Standards] offer evidence that the study was rigorously conducted" for both regulatory review and purposes of litigation). Anderson et al. wrote: Laboratories performing work for regulatory purposes ... are required to conform to strict laboratory protocols .... The regulators will reject studies that do not meet these criteria.... Because of the financial implications of poorly documented studies, company laboratories are generally careful about the [Good Laboratory Practice] quality of their work.
26. Id at 632-33.
27. 15 U.S.C. § 2607(d).
28. 40 C.F.R. § 716.5(a)(1) (2004).
29. 40 C.F.R. § 716.65 (2004).
30. The reporting period after the rule is published may be extended, but in no event may it exceed two years. Id.
31. See also 40. C.F.R. § 716.120 (2004) (listing chemicals for which reporting is required, including the effective date of such requirement).
32. EPA Overview, supra note 7, at 17.
33. To put these numbers into context, only 9000 organic chemicals were reported as being produced or imported in annual quantities of 10,000 pounds or more when the TSCA inventory of chemicals was updated in 2002. Id. at 14 n.9;
34. see also U.S. Envtl. Protection Agency, Inventory Update Rule, http:// www.epa.gov/opptintr/iur/tools/iur02/index.htm (last visited Apr. 17, 2006) (providing certain information on chemicals updated every two years). EPA estimates that today there could be as many as 6000 additional chemicals currently in commerce, a figure that presumably includes inorganic chemicals and chemicals produced or imported in quantities less than 10,000 pounds
35. EPA estimates that today there could be as many as 6000 additional chemicals currently in commerce, a figure that presumably includes inorganic chemicals and chemicals produced or imported in quantities less than 10,000 pounds. EPA Overview, supra note 7, at 14 n.9.
36. See discussion infra Part II.C.1;
37. see also U.S. Envtl. Protection Agency, Policy Regarding Acceptance of New Commitments to the High Production Volume (HPV) Challenge Program 1-3 (June 2005), http://www.epa.gov/chemrtk/hpvpolcy.pdf (providing an overview of the program).
38. 15 U.S.C. § 2607(c) (2000).
39. Records to be maintained include "records of consumer allegations of personal injury or harm to health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source. Id.
40. Id. § 2607(e).
41. U.S. Envtl. Protection Agency, Substantial Risk Information: TSCA Section 8(e), http://www.epa.gov/oppt/itc/pubs/sect8e.htm (last visited Apr. 17, 2006).
42. Section 8(e) submissions are publicly available at U.S. Envtl. Protection Agency, Chemical Testing Overview, http://www.epa.gov/ opptintr/chemtest/view.htm (last visited Apr. 17, 2006).
43. EPA alleged that in 1981 DuPont failed to report the results of a blood test showing that trace amounts of perfluorooctanoic acid from drinking water may cross from a mother's blood through the placenta to a fetus. Answer and Request for Hearing at 1-3, In re Matter of E.I. du Pont de Nemours and Co., Nos. TSCA-HQ-2004-0016, RCRA-HQ-2004-0016 (filed Aug. 11, 2004), available at http://www2.dupont.com/PFOA/en_US/Pdf/ answer_and_request_for_hearing.pdf.
44. DuPont and others believe that this information, in and of itself, does not demonstrate a "substantial risk." See Press Release, I.E. du Pont de Nemours and Co., Dupont Responds to EPA Complaint on Alleged PFOA Reporting Violations, (Aug. 12, 2004), http://www.dupont.com/ (follow "Media Center" hyperlink; follow "News Releases" hyperlink; then follow "2005 Archives" hyperlink) (explaining the company response to three EPA claims).
45. For the resolution of this administrative case via settlement, see generally Juliet Eilperin, DuPont, EPA Settle Chemical Complaint, Washington Post, Dec. 15,2005, at D3 (reporting DuPont paid a multimillion dollar administrative penalty without any admission that it deliberately withheld information from EPA).
46. See, e.g., Latham & Watkins Env't, Land and Resources Dep't, EPA Steps Up Enforcement of TSCA Section 8(e) "Substantial Risk" Reporting Requirements, Client Alert 3, Apr. 11, 2005, http://www.Iw.com /resource/ Publications/_pdf/pub1236_1.pdf (last visited Apr, 17 2006) (suggesting that advances making it more feasible to collect biomonitoring data, such as measuring trace amounts of chemicals in the human body, will raise additional questions about when TSCA section 8(e) reporting obligations arise).
47. Press release, I.E. du Pont de Nemours and Co., DuPont Receives Department of Justice Subpoena for Information on PFOA (May 19, 2005), http://www.dupont.com/ (follow "Media Center" hyperlink; follow "News Releases" hyperlink; then follow "2005 Archives" hyperlink).
48. The company announced that the Enviromnental Crimes Section of the Environment and Natural Resources Division of the U.S. Department of Justice served the company with a grand jury subpoena from the U.S. District Court for the District of Columbia in connection with three named chemicals. Id. Given the uncertainty regarding whether the facts in this case presented a "substantial risk," it seems a stretch to argue that DuPont knowingly failed to report a substantial risk.
49. Questions regarding what is reportable under section 8(e) led EPA to initiate a one-time, voluntary Compliance Audit Program (CAP) under which companies could submit information that arguably should previously have been submitted under section 8(e) and pay stipulated penalties of up to $1,000,000. See U.S. Envtl. Protection Agency, Registration and Agreement for TSCA Section 8(e) Compliance Audit Program, 56 Fed. Reg. 4128 (Feb. 1, 1991).
50. EPA spent from 1991 to 2003 reconsidering what sorts of environmental data were reportable under section 8(e). See U.S. Envtl. Protection Agency, Notice: Registration and Agreement for TSCA Section 8(e) Compliance Audit Program Modification, 56 Fed. Reg. 28458, 28459 (June 20, 1991) (extending the time to file under the CAP and providing for further clarification of reporting environmental data under section 8(e)); U.S. Envtl.
51. U.S. Envtl. Protection Agency, Notice: TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance, 68 Fed. Reg. 33129, 33130 (June 2, 2003) (revising and clarifying provisions of the TSCA section 8(e) policy statement issued in 1978; all guidance is now in the current document, obviating the need to refer back to older documents).
52. 15 U.S.C. § 2613(b)(1)(2000).
53. See 40 C.F.R. § 716.3 (2004) (defining "health and safety study" and providing applicable examples). In particular, "[a]ny data that bear on the effects of a chemical substance on health or the environment would be included. Chemical identity is part of, or underlying data to, a health and safety study."
54. Id. § 716.3(1). EPA PMN rules use a different but comparable definition.
55. See 40 C.F.R. § 720.3(k) (2004).
56. 15 U.S.C. § 2613(a)-(b) (2000). Such business information can be highly valuable to competitors, as evidenced by the fact that most Freedom of Information Act requests come from businesses or agents for undisclosed companies.
57. See Heritage Foundation Center for Media & Public Policy, Special Report: Few Journalists Use the Federal Freedom of Information Act, http://www.heritage.org/Press/MediaCenter/FOIA.cfm (last visited Apr. 17, 2005) (reporting a study of such requests during the first half of 2001).
58. See also discussion infra Part III.4.
59. 15 U.S.C § 2613(a)(3) (2000).
60. Id. § § 2615(a)-(b).
61. See supra notes 22, 24 (discussing the civil and criminal aspects of the DuPont case).
62. See the False Identification Crime Control Act, 18 U.S.C. § 1001(a) (2004) (allowing for fines and imprisonment up to five years for intentional fraud or misrepresentation).
63. 7 U.S.C. § § 136-136y (2000).
64. See id.
65. See U.S. Envtl. Protection Agency, Pesticides: Regulating Pesticides, http://www.epa.gov/pesticides/regulating/index.htm (last visited on Apr. 17, 2006) (describing EPA pesticide regulation).
66. The regulatory tests are described in greater detail at U.S. Envtl. Protection Agency, Pesticides: Regulating Pesticides Data Requirements, http://www.epa.gov/pesticides/regulating/data.htm (last visited on Apr. 17, 2006).
67. 7 U.S.C. § 136a (2000).
68. See Crop Life America, Learn More About... Pesticide Regulation, http://www.croplifeamerica.org/learn_more/pesticide_reg.htm (last visited Apr. 17, 2006) (summarizing briefly pesticide regulation).
69. 7 U.S.C. § 136a-1(a) (2000).
70. See 40 C.F.R. § 160.120 (2004) (setting forth GLP Standards).
71. See also discussion supra Part II.A.1.
72. 7 U.S.C. § 136d(a)(2) (2000) (requiring submission of such adverse effects information "at any time" after the pesticide is registered). EPA has issued a class determination under the Freedom of Information Act that adverse effects information is categorically not protected as confidential business information.
73. See U.S. Envtl. Protection Agency, Notice: Disclosure of Information Obtained Regarding Unreasonable Adverse Effects of Pesticides on the Environment; Class Determination, 64 Fed. Reg. 70019 (Dec. 1, 1999) (denying confidentiality to safety and efficacy information both currently in EPA possession or later acquired).
74. 7 U.S.C. § 136(j) (2000).
75. "Environment" is defined to include "water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these." Id.
76. Id. § 136h(d)(1).
77. Id. § 136h(d)(1)-(d)(3).
78. Id. § 136h(d)(2)-(d)(3).
79. Under FIFRA Section 3(c)(1)(F), prospective registrants relying on another registrant's data may be required to pay the original registrant to use that data. See 7 U.S.C. § 136a(c)(1)(F) ("The terms and amount of compensation may be fixed by agreement ... [or] binding arbitration...").
80. 29 C.F.R. § 1910.1200(g)(1) (2003).
81. Id § 1910.1200(b).
82. See the Emergency Planning and Community Right-to-Know Act, 42 U.S.C. § 11021(a) (2000) (setting forth the basic requirements for submitting MSDSs or lists);
83. see also 29 C.F.R. § 1910.1200(g) (detailing the contents of an MSDS).
84. 29 C.F.R. § 1910.1200(g)(11).
85. 42 U.S.C. § 11021(a)(1);
86. 40 C.F.R. § 370.21 (2004).
87. See generally 40 C.F.R. § 370.20 (2004) (discussing various threshold requirements triggering the obligation to make an MSDS available to certain parties).
88. 42 U.S.C. § 11021(c)(2).
89. 29 C.F.R. § § 1910.1200(g)(i), 1200(i).
90. 5 U.S.C. § 552(b)(4) (2000).
91. See 18 U.S.C. § 1905 (2000) (regarding disclosure of confidential information).
92. See also generally U.S. Department of Justice Office of Information and Privacy, Freedom of (May 2004), http://www.usdoj.gov/oip/foi-act.htm (discussing cases and Department of Justice policy on coextensive definitions of trade secrets).
93. See discussion supra Part II.A.1.b, Part II.A.2.
94. See, e.g., Clean Water Act, 33 U.S.C. § 1319(b) (2000);
95. Resource Conservation and Recovery Act, 42 U.S.C. § 6927(6)(1) (2000);
96. Clean Air Act, 42 U.S.C. § 7414(c) (2000);
97. Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. § 9604(e)(7)(2000);
98. Emergency Planning and Community Right-to-Know Act, 42 U.S.C. § 11042(f) (2000).
99. 42 U.S.C. § 11042(a), 11042(h) (2000). For example, information claimed as a "trade secret" must meet four factors, including chemical identity not being "readily discoverable through reverse engineering."
100. Id. at § 11042(b)(4).
101. Id. § 9604(e)(7)(F).
102. Id. § 7414(c). EPA rules define "emission data" to include "[i]nformation necessary to determine the identity, amount, frequency, concentration, or other characteristics (to the extent related to air quality) of any emission which has been emitted by the source...."
103. 40 C.F.R. § 2.301(a)(2)(i)(A) (2004).
104. 33 U.S.C. § 1318(b) (2000). EPA rules define "effluent data" to include "[i]nformation necessary to determine the identity, amount, frequency, concentration, temperature, or other characteristics (to the extent related to water quality) of any pollutant which has been discharged by the source...."
105. 40 C.F.R. § 2.302(a)(2)(i)(A)(2004).
106. 17 C.F.R. § 229.303(a)(3)(ii) (2005).
107. 18 U.S.C.S. § 1350(a), (b) (2000).
108. Id. § 1350(c).
109. Id.
110. See, e.g., Clean Water Act, 33 U.S.C. § 1367(a) (2000);
111. Resource Conservation and Recovery Act, 42 U.S.C. § 6971(a) (2000);
112. C0lean Air Act, 42 U.S.C. § 7622(a) (2000);
113. Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. § 9610(a) (2000).
114. See, e.g., 42 U.S.C. § 7622(a) (2000).
115. Id. § 7622(b).
116. 31 U.S.C. § § 3729-3733 (2000).
117. Id. § 3730(d).
118. Id. § 3730(b).
119. Id. § 3730(b)(4).
120. Id. § 3730(d)(2).
121. Id. § 3729(a)(7) (establishing liability for one who "knowingly makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the Government").
122. See, e.g., United States ex rel. Bain v. Georgia Gulf Corp., 386 F.3d 648, 657-58 (5th Cir. 2004) (reversing and remanding the denial of a motion to dismiss for the relator's failure to state a cognizable claim; no relationship, economic or otherwise, existed between the government and defendant that would give rise to a financial transfer or payment upon which to base a reverse false claim).
123. See, e.g., United States ex rel. Sequoia Orange Co. v. Oxnard Lemon Co., 1992 WL 795477, at 7-11 (E.D. Cal. May 4,1992) (unreported opinion) (denying motion to dismiss reverse false claim).
124. See generally Restatement (Third) of Torts: Liab. for Physical Harm (Basic Principles) § 7 (Tentative Draft No. 1, 2001) (discussing duty as a qualification for liability for negligence).
125. See generally id. at § 18 (discussing negligent failure to warn).
126. See generally Restatement (Third) of Torts: Prod. Liab. § 2 (1998) (establishing separate standards of liability for manufacturing defects, design defects, and defects based on inadequate instructions or warnings). "The rule for manufacturing defects ... imposes liability whether or not the manufacturer's quality control efforts satisfy standards of reasonableness."
127. Id. at § 2 cmt. a.
128. American Chemistry Council, Overview: Guiding Principles, http://www.rctoolkit.com/overview_principles.asp (last visited April 13, 2006). Responsible Care® is the chemical industry's global initiative to improve health, safety, environmental, and security performance.
129. Id.
130. See Letter from Carol M. Browner, Former Administrator, U.S. Envtl. Protection Agency, to Manufacturers/Importers (Oct. 9, 1998), available at http://www.epa.gov/chemrtk/ceoltr1.htm (announcing the launch of the HPV Challenge Program in correspondence to the chief executive officers of more than 900 chemical companies);
131. see also U.S. Envtl. Protection Agency, High Production Volume (HPV) Challenge Program, available at http://www.epa.gov/chemrtk/volchall.htm (last visited Apr. 13, 2006) (providing information about the program, chemicals, and program participants);
132. see generally EPA Overview, supra note 7, at 31-34 (describing the HPV Challenge Program). The HPV Challenge Program grew out of an Environmental Defense Fund report and similar evaluations asserting a lack of publicly available hazard information for various subsets of HPV chemicals.
133. See, e.g., U.S. Envtl. Protection Agency, Office of Pollution Prevention and Toxics, Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (Apr. 1998), available at http://www.epa.gov/chemrtk/hazchem.pdf ("EPA's 1998 Baseline of Hazard Information that is Readily Available to the Public"). All of these evaluations were limited to publicly available, electronically searchable information sources, and only identified chemical-specific studies, rather than all relevant information. These limitations resulted in a profound underestimation of the available information.
134. EPA Overview, supra note 7, at 32.
135. News Release, Chemical and Consumer Product Makers Promise More Public Information on Chemical Safety 1 (Mar. 15, 2005), http:// www.americanchemistry.com/s_acc/ bin.asp?CID=206&DID=829&DOC=FILE.PDF (announcing the start of the Extended HPV Program and summarizing the impact of the preceding HPV Challenge Program).
136. Id. at 1-2.
137. See generally U.S. Envtl. Protection Agency, Office of Pollution Prevention and Toxics, Guidance for Meeting the SIDS Requirements (Nov. 3, 1998), http://www.epa.gov/chemrtk/sidsappb.pdf [hereinafter EPA Guidance for Meeting the SIDS Requirements].
138. See generally Organization for Economic Co-operation and Development, Description of OECD Work on Investigation of High Production Volume Chemicals, http://www.oecd.org/document/21/ 0,2340,en_2649_34379_1939669_1_1_1_1,00.html (last visited Apr. 13, 2006) (describing how SIDS fit within international investigation of HPV chemicals).
139. EPA Guidance for Meeting the SIDS Requirements, supra note 82.
140. See U.S. Envtl. Protection Agency, Determining the Adequacy of Data, Appendix C (Feb. 10, 1999 Draft), http://www.epa.gov/chemrtk/ datadfin.htm (explaining test plans in further detail).
141. The test plans are posted at U.S. Envtl. Protection Agency, Robust Summaries and Test Plans, http://www.epa.gov/chemrtk/hpvrstp.htm (last visited Apr. 13, 2006).
142. News Release, supra note 80, at 2.
143. See U.S. Envtl. Protection Agency, Robust Summaries and Test Plans, http://www.epa.gov/chemrtk/hpvrstp.htm (last visited Apr. 17, 2006) for results for the U.S. HPV Challenge Program.
144. Results from its international counterparts are available at Organization for Economic Cooperation and Development, OECD Integrated HPV Database, http://cs3hq.oecd.org/scripts/hpv/ (last visited Apr. 13, 2006).
145. News Release, supra note 80, at 1;
146. see also American Chemistry Council et al., Questions and Answers on the Extended HPV Program (Mar. 15, 2005), http://www.americanchemistry.com/ s_acc/bin.asp?CID=199&DID=536&DOC=FILE.PDF (explaining the similarities and differences between the HPV Challenge Program and its subsequent counterpart).
147. News Release, supra note 80, at 1.
148. Id. at 4.
149. Id. at 2.
150. See generally American Chemistry Council Home Page, http://www.americanchemistry.com/s_acc/ sec_initiatives.asp?CID=157&DID=202 (last visited Apr. 17, 2006) (stating that seventy-three panels and two councils have addressed chemistry- or product-related issues).
151. Final reports are sent routinely to eight agencies: the Agency for Toxic Substances & Disease Registry, the Consumer Product Safety Commission, EPA, the Food and Drug Administration, the National Cancer Institute, the National Institute of Environmental Health Sciences, the National Institute for Occupational Safety and Health, and OSHA.
152. See generally U.S. Envtl. Protection Agency, Voluntary Children's Chemical Evaluation Program (VCCEP), http://www.epa.gov/chemrtk/vccep (last visited Apr. 13, 2006) (providing program overview) [hereinafter VCCEP].
153. Id.
154. Id.
155. The companies and consortia are listed at U.S. Envtl. Protection Agency, Who's Participating?, http://www.epa.gov/chemrtk/vccep/whosspon.htm (last visited Apr. 17, 2006).
156. VCCEP, supra note 94.
157. Id.
158. Id.
159. See U.S. Envtl. Protection Agency, How to Access Assessments/Reports/ Decisions, http://www.epa.gov/_chemrtk/vccep/access.htm (last visited Apr. 17, 2006).
160. American Chemistry Council, Long-Range Research Initiative 2004 Annual Report, 1 http://www.uslri.org/documents/cat_14/doc_437.pdf, (last visited Apr. 13, 2006) [hereinafter LRI Annual Report].
161. See generally American Chemistry Council, Long-Range Research Initiative Home Page, http://www.ustri.org (last visited Apr. 13, 2006).
162. LRI Annual Report, supra note 101, at 7.
163. Id. at 1.
164. Id.
165. American Chemistry Council, Long-Range Research Initiative Home Page, Funding Opportunities, http://www.uslri.org/home.cfm?id=funding (last visited Apr. 13, 2006).
166. Id.
167. Id.
168. Id.
169. LRI Annual Report, supra note 101, at 32.
170. Id.
171. Steven D. Levitt & Stephen J. Dubner, Freakonomics: A Rogue Economist Explores the Hidden Side of Everything 13 (2005) ("Incentives are the cornerstone of modern life. And understanding them - or, often, ferreting them out - is the key to solving just about any riddle, from violent crime to sports cheating to online dating.") (emphasis in original).
172. Salt Inst. v. Thompson, 345 F. Supp. 2d 589, 592-93, 603 (E.D. Va. 2004) (granting motion to dismiss claims, inter alia, for lack of standing), appeal docketed, No. 05-1097 (4th Cir. Jan. 25, 2005). The NHLBI is part of the Department of Health and Human Services.
173. Id. This research was funded before the effective date (April 17, 2000) of the so-called "Shelby Amendment," which requires government agencies to publicly disclose the results of federally funded research, subject to personal privacy protections.
174. Id. at 595.
175. For the text of the Shelby Amendment, see Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999, Pub. L. No. 105-277, 112 Stat. 2681.
176. The two-sentence Shelby Amendment required the Office of Management and Budget to revise its Circular A-110 to ensure that all data from federally funded research be made publicly available pursuant to the Freedom of Information Act. Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations, 65 Fed. Reg. 14406 (Mar. 16, 2000) (to be codified at 7 C.F.R. pt. 3019).
177. See Thompson, 345 F. Supp. 2d at 597-98.
178. The American Chemical Society is unrelated to the American Chemistry Council.
179. See Susan R. Morrissey, NIH and ACS Spar over PubChem: Agency's New Chemical Database Draws Concern From ACS for Similarities to CAS Registry, 83 Chem. & Engineering News 23-25 (2005) (discussing the creation, content, and scope of the private CAS Registry and "unfair competition" arguments against the government-sponsored rival database, PubChem). The free PubChem database is available at National Center for Biotechnology Information, PubChem Text Search, http:// pubchem.ncbi.nlm.nih.gov (last visited Apr. 13, 2006). The CAS Registry is accessible on a fee basis through SciFinder, Product Overview, http:// www.cas.org/SCIFINDER (last visited Apr. 13, 2006).
180. The House Appropriations Committee report accompanying the Fiscal Year 2006 spending bill for NIH "urges NIH to work with private sector providers to avoid unnecessary duplication and competition with private sector databases." See H.R. Rep. No. 109-143, at 112 (2005).
181. For example, the Clean Water Act directs EPA to identify "toxic" water pollutants, 33 U.S.C. § 1317(a)(1) (2000), to set effluent limitations for such pollutants that reflect "the best available technology economically achievable" for new sources discharging them,
182. id. § 1317(a)(2),
183. and to determine that such limitations provide "an ample margin of safety," id. § 1317(a)(4).
184. Again, for example, the goals and policy of the Clean Water Act are expressed entirely in terms of "eliminat[ing]" and "prohibit[ing]" discharges of pollutants. See 33 U.S.C. § 1251(a).
185. FIFRA is a rare, partial counterexample in that it requires EPA, when deciding whether to "register" a pesticide, to consider "the economic, social, and environmental costs and benefits" of its use. See 7 U.S.C. § 136a(a) (2000) (pesticide registrations are to include any limits needed to prevent "unreasonable adverse effects on the environment"; costs and benefits of pesticide use are relevant to determining such effects).
186. Office of Management and Budget, Proposed Bulletin on Peer Review and Information Quality, 68 Fed. Reg. 54,023, 54,024 (Sept. 15, 2003).
187. Robert W. Hahn, Disclosing Conflicts of Interest: Some Personal Reflections 8 n.25 (AEI-Brookings Joint Ctr. for Regulatory Studies, Working Paper 02-2, 2002).
188. See C. Arden Pope, III et al., Particulate Air Pollution as a Predictor of Mortality in a Prospective Study of U.S. Adults, 151 Am. J. Respir. Crit. Care Med, 669 (1995). This study, which concluded that very small particles less than or equal to 2.5 microns were associated with significant public mortality, was influential in leading EPA to revise its national ambient air quality standards to include stringent limits on such particles.
189. See National Ambient Air Quality Standards for Particulate Matter, 62 Fed. Reg. 38,652-01, 38655 n.7 (July 17, 1997) (to be codified at 40 C.F.R. pt. 50) (providing final PM-2.5 rule, citing Pope study).
190. See supra note 112.
191. See supra notes 112-113 and accompanying text.
192. Malcolm Gladwell, Wrong Turn; How the Fight to Make America's Highways Safer Went Off Course, The New Yorker, June 11, 2001, at 50, 56 (Ralph Nader was one of several high-profile advocates "consumed by the battle to force a reluctant Detroit to make the air bag mandatory equipment"). These advocates thought air bags would be more effective than seatbelts because air bags require no human action to work.
193. Id.
194. See generally id. at 58-61. "[T]oday it is seatbelts, not air bags, that are providing the most important new safety advancements."
195. Id. at 58. A seatbelt alone cuts the chance of dying in an accident by forty-three percent, while an air bag alone only does so by thirteen percent.
196. Id.
197. See David B. Ottaway & Warren Brown, From Life Saver to Fatal Threat: How the U.S., Automakers and a Safety Device Failed, Wash. Post, June 1, 1997, at A01 (explaining that the federal government was expected to give drivers the option of deactivating air bags). NHTSA ultimately decided that persons within four "risk groups" can have their air bags turned off after securing approval from NHTSA.
198. See 49 C.F.R § 595.5 (2005) (setting forth requirements to have air bags turned off).
199. Ottaway & Brown, supra note 126.
200. Claybrook became head of NHTSA in 1977 and went on to run Public Citizen in 1980. Gladwell, supra note 124, at 58-60.
201. Ottaway & Brown, supra note 126.
202. See National Toxicology Program, Report of the Endocrine Disruptors Low-Dose Peer Review, iv, 1-4 to 1-5 (August 2001), http:// ntp-server.niehs.nih.gov/ntp/htdocs/liason/LowDosePeerFinalRpt.pdf (mouse colony in which low-dose endocrine effects - not reproduced elsewhere - were observed by Frederick vom Saal "is no longer available"; raw data supporting his oral presentation and two other papers was not provided to peer reviewers). Vom Saal is associated with non-governmental organizations supporting the notion that very low doses of some chemicals can cause adverse effects on the endocrine systems of organisms.
203. See, e.g., Greenpeace Int'l, Poisoning the Future: Impacts of Endocrine Disrupting Chemicals on Wildlife and Human Health (Oct. 1997), http:// archive.greenpeace.org/toxics/reports/ptf/ptf.html (citing multiple papers authored or coauthored by Vom Saal).
204. See John A. McLachlan, Synergistic Effect of Environmental Estrogens: Report Withdrawn, 227 Science 462, 462-63 (1997) (withdrawing earlier report on behalf of the author and coauthor Steven F. Arnold).
205. See also Case Summaries, Newsletters, (U.S. Dep't of Health and Human Services Office of Research Integrity), Dec. 2001, http://permanent.access.gpo.gov/lps17396/ori.dhhs.gov/html/publications/ newsletters_vol10no1.asp.htm#CASE%20SUMMARIES (follow "Case Summaries" hyperlink) (detailing Arnold's admission of scientific misconduct).
206. Brian Martinson et al., Scientists Behaving Badly, 435 Nature 737 and Table 1 (2005).
207. U.S. 579, 591-97 (1993) (establishing the trial judge as a gatekeeper for gauging the reliability of scientific evidence in federal courts). "The fact of publication (or lack thereof) in a peer reviewed journal [is] a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which the opinion is premised."
208. Id at 593-94.
209. See Anderson et al., supra note 13, at 624-27, 660-62 (discussing, for example, Natl Bank of Commerce v. Dow Chemical Co., 965 F. Supp. 1490 (E.D. Ark. 1996)
210. and Bourne v. E.I. DuPont de Nemours & Co., No. 2:97-0090 (S.D. W. Va. Dec. 31, 1996)).
211. See Valentine v. Pioneer Chlor Alkali Co., 921 F. Supp. 2d 666, 670 n.3 (D. Nev. 1996) (questioning publication of an article in a journal apparently missing from the comprehensive Index Medicus of the National Library of Medicine, but weighing "apparent obscurity" with other factors in deciding the admissibility of plaintiff's expert testimony based on article).
212. For example, the International Journal of Occupational Medicine and Toxicology was relied on by plaintiffs in both Valentine, 921 F. Supp. 2d at 670 n.3,
213. and Natl Bank of Commerce, 965 F. Supp. 2d at 1499.
214. second journal, the Archives of Environmental Health, was also relied on by the plaintiff's expert in Nat'l Bank of Commerce. Id.
215. Kaye H. Kilburn, who is the president of his own consulting and expert firm (Kaye H. Kilburn, Curriculum Vitae, http://www.neuro-test.com/ Khk_cv.htm, last visited Apr. 13, 2006), edits the latter journal and authored the relevant article in the former journal, whose "apparent obscurity" was noted by the court in Valentine, 921 F. Supp. 2d at 670 n.2, n.3.
216. See supra note 122.
217. See Nat'l Bank of Commerce, 965 F. Supp. at 1499.
218. Anderson et al., supra note 13, provides a thoughtful and evenhanded analysis of how courts should address the challenges posed by "litigation science."
219. E.g., Daniel J. Givelber & Anthony Robbins, Public Health Versus Court-Sponsored Secrecy, 69 Law & Contemp. Probs. 130 (Summer 2006).
220. In re Silica Products Liability Litigation, MDL No. 1553 (S.D. Tex. June 30, 2005), slip op. at 149-50, available at http://www.txs.uscourts.gov/ notablecases/203md1553/203md1553-1902.pdf.
221. Of course, the judge also indicated her belief that the case involved not "an industrial disaster of unprecedented proportion" - 20,479 silicosis cases were "identified" in Mississippi in three years, when twenty-four would have been expected - "[but] something else entirely." Id. at 11-15.
222. SKAPP Self-description, supra note 1.
223. For example, review the articles from the first SKAPP Coronado Conference, compiled in Symposium, 95 Am. J. Pub. Health, Supplement 1 (2005) (entitled "Scientific Evidence and Public Policy").
224. See supra Part II.A.1, Part II.A.2.
225. See Anderson et al., supra note 13, at 632-33, 675.
226. The proceedings of the first Coronado conference were published in Symposium, supra note 140.