Rescuing the strong precautionary principle from its critics

University of Illinois Law Review

Volumn 2011, Issue 4, 2011, Pages 1285-1338

  Sachs, Noah M ^a  

^a UNIVERSITY OF RICHMOND   (United States)

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EID: 80053595359     PISSN: 02769948     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (335)

1. Toxic Substances Control Act, 15 U.S.C. §§ 2601-2692 (2006).
2. For scholarly criticisms of the Toxic Substances Control Act (TSCA)
3. see John S. Applegate, Synthesizing TSCA and REACH: Practical Principles for Chemical Regulation Reform, 35 ecology L.Q. 721 (2008).
4. Noah M. Sachs, Jumping the Pond: Transnational Law and the Future of Chemical Regulation, 62 vand. l. Rev. 1817 (2009)
5. Wendy E. Wagner, Commons Ignorance: The Failure of Environmental Law to Produce Needed Information on Health and the Environment, 53 duke L.J. 1619 (2004). For governmental criticisms of TSCA
6. see U.S. Gov't Accountability Office, GAO- 09-428T, Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act (2009) [hereinafter GAO, Enhancing TSCA]
7. U.S. Gov't Accountability Office, GAO-05-458, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (2005) [hereinafter GAO, Options Exist]
8. See Office of Pollution Prevention & Toxics, U.S. Envtl. Prot. agency, 2006 Inventory Update Reporting: Data Summary 15 (2008), http://www.epa.gov/iur/pubs/2006-data-summary.pdf (reporting approximately twenty-seven trillion pounds of chemicals produced or imported in the United States in 2005). This figure is likely an underestimate of total U.S. chemical production, because low-volume chemical production, below 25,000 pounds per year at one site, did not need to be reported to the Environmental Protection Agency (EPA). Id. at 1.
9. See Dep't of Health & Human Servs. et al., Fourth National Report on Human Exposure to Environmental Chemicals (2009), http://www.cdc.gov/ exposurereport/pdf/Fourth Report-ExecutiveSummary.pdf
10. Tracey J. Woodruff et al., Environmental Chemicals in Pregnant Women in the US: NHANES 2003-2004, ENVTL. HEALTH PERSP. 878, 879 tbl.1 (2011)
11. see also Richard A. Denison, Ten Essential Elements in TSCA Reform, 39 Envtl. L. Rep. 10020,10023 (2009).
12. Safe Chemicals Act of 2010, S. 3209,111th Cong. (2010).
13. Toxic Chemicals Safety Act of 2010, H.R. 5820,111th Cong. (2010).
14. See U.S. Envtl. Prot. Agency, essential principles for reform of chemicals Management Legislation (2010), http://www.epa.gov/oppt/ existingchemicals/pubs/principles.pdf.
15. See States' Principles on Reform of the Toxic Substances Control Act (Dec. 2, 2009), http://www.saferstates.com/attachments/StatePrinciples.pdf.
16. See Safer Chemicals, Healthy Families, A Platform for Reform of the Toxic Substances Control Act (Aug. 4, 2009), http://www.saferchemicals.org/PDF/SCHF- Campaign-Platform.pdf.
17. See Am. Chemistry Council, 10 Principles for modernizing TSCA (2009), http://www.americanchemistry.com/Policy/Chemical-Safety/TSCA/ 10-Principles-for-Modernizing-TSCA.pdf.
18. See Linda Breggin, A Critical Juncture in Fed-State Roles, ENVTL. F., Jan.-Feb. 2011, at 10 (discussing recent toxics regulatory initiatives in California, Massachusetts, and Washington).
19. See Sachs, supra note 2.
20. A variety of definitions for the Strong Precautionary Principle may be found in the literature. Two common elements of the Principle are an anticipatory approach to managing risks and a shift in the burden of proof on whether a risky activity should be allowed to proceed.
21. See Cass R. Sunstein, Laws of Fear: Beyond the Precautionary Principle (2005)
22. A.W. Harris, Derogating the Precautionary Principle, 19 Vill. Envtl. L.J. 1, 63 (2008)
23. Justin Wade, Sunstein's Blunder; Or, the Perils of Reconstructing Precaution, 20 geo. int'l envtl. L. Rev. 473,485 (2008).
24. The term "unreasonable risk" occurs more than thirty-five times in the text of TSCA, and in every case the EPA bears the burden to prove "unreasonable risk" for a chemical.
25. John S. Applegate et al., The Regulation of Toxic Substances and Hazardous Wastes 276 (2d ed. 2011). Most importantly, the EPA bears the burden of proving "unreasonable risk" in the crucial provisions of TSCA Section 6, governing restrictions on hazardous chemicals. 15 U.S.C. § 2605(a) (2006). For a discussion of the problems with the vague "unreasonable risk" standard and a governmental burden of proof in chemical regulation.
26. see John S. Applegate, The Perils of Unreasonable Risk: information, Regulatory Policy, and Toxic Substances Control, 91 colum. L. Rev. 261 (1991).
27. Toxic Substances Control Act and the Chemicals Management Program at EPA: Hearing Before the S. Comm. on Env't & Pub. Works, 109th Cong. 75 (2006) (statement of Lynn R. Goldman, Professor, Environmental Health Services, Johns Hopkins University).
28. Cass R. Sunstein, Beyond the Precautionary Principle, 151 U. Pa. L. Rev. 1003,1008 (2003).
29. Cass r. Sunstein, Your Money or Your Life, New republic, Mar. 5,2004, at 27,30.
30. See also Aaron Wildavsky, But Is It True? A Citizen's Guide to Environmental Health and Safety Issues, 429-30 (1995) (stating profound objections to the Precautionary Principle's reversal of causality, in which individuals and businesses must prove that they will do no harm).
31. See, e.g., Jonathan H. Adler, More Sorry Than Safe: Assessing the Precautionary Principle and the Proposed International Biosafety Protocol, 35 Tex. Int'L L.J. 173,195 (2000) ("The problem is that by focusing on one set of risks-those posed by the introduction of new technologies with somewhat uncertain effects-the precautionary principle turns a blind eye to the harms that occur, or are made worse, due to the lack of technological development.")
32. Sunstein, supra note 15, at 1020 ("The most serious problem with the strong version of the precautionary principle is that it offers no guidance-not that it is wrong, but that it forbids all courses of action, including inaction.")
33. Jonathan Baert Wiener & John D. Graham, Resolving Risk Tradeoffs, in Risk versus risk: tradeoffs in Protecting Health and the Environment 226,226 (John D. Graham & Jonathan Baert Wiener eds., 1995) ("Each intervention to protect against a target risk can simultaneously generate countervailing risks; these risk tradeoffs at least reduce the gross benefits of the intervention and in some cases mean that the intervention will do more harm than good.").
34. Sunstein, supra note 15, at 1003.
35. Sunstein heads the influential Office of Information and Regulatory Affairs (OIRA) in the Executive Office of the President.
36. See Benjamin Wallace-Wells, Cass Sunstein Wants to Nudge Us, N.Y. Times Mag., May 16, 2010, at 38 (describing Sunstein's role at OIRA and his involvement in Obama Administration debates over cost-benefit analysis, valuation of human life, and climate change).
37. I define terms, including the differences between "weak" and "strong" versions of the Precautionary Principle, infra, Part I. Clarity of definitions is vital. Confusing and inconsistent definitions of "precaution" and "precautionary principle" have clouded the scholarship in this area for decades.
38. See, e.g., John S. Applegate, Embracing a Precautionary Approach to Climate Change, in Economic Thought and u.S. Climate Change Policy 171 (David M. Driesen ed., 2010) [hereinafter Applegate, Climate Change]
39. John S. Applegate, The Taming of the Precautionary Principle, 27 Wm. & Mary Envtl. L. & Pol'Y. Rev. 13 (2002) [hereinafter Applegate, The Taming]
40. Douglas A. Kysar, It Might Have Been: Risk, Precaution and Opportunity Costs, 22 J. land use & Envtl. L. 1 (2006)
41. Elizabeth Fisher, Opening Pandora's Box: Contextualising the Precautionary Principle in the European Union, in uncertain risks regulated 21 (Michelle Everson & Ellen Vos eds., 2009)
42. Gregory N. Mandel & James Thuo Gathii, Cost-Benefit Analysis Versus the Precautionary Principle: Beyond Cass Sunstein's Laws of Fear, 2006 U. ILL. L. rev. 1037 (2006)
43. Robert V. Percival, Who's Afraid of the Precautionary Principle?, 23 pace Envtl. L. Rev. 21 (2005).
44. Advocates of the Strong Precautionary Principle write primarily outside of the legal academy, perhaps reflecting the marginalization of the Principle in past legal scholarship. For work supporting the Principle.
45. see collected essays in Precaution, Environmental Science, and Preventive Public Policy (Joel A. Tickner ed., 2003)
46. collected essays in Protecting Public Health & the Environment: Implementing the Precautionary Principle (Carolyn Raffensperger & Joel A. Tickner eds., 1999)
47. Carl F. Cranor, Toward Understanding Aspects of the Precautionary Principle, 29 J. med. & Phil. 259 (2004)
48. Sven Ove Hansson, Can We Reverse the Burden of Proof?, 90 toxicology Letters 223 (1997).
49. See, e.g., John D. Graham, Admin., Office of Info. & Regulatory Affairs, The Role of Precaution in Risk Assessment and Management: An American's View, Address at The US, Europe, Precaution and Risk Management: A Comparative Case Study Analysis of the Management of Risk in a Complex World (Jan. 11-12, 2002), http://www.whitehouse.gov/omb/inforeg/eu-speech.html ("[W]e do not recognize any universal precautionary principle. We consider it to be a mythical concept, perhaps like a unicorn.")
50. Lawrence A. Kogan, What Goes Around Comes Around: How UNCLOS Ratification Will Herald Europe's Precautionary Principle As U.S. Law, 7 Santa clara J. int'l L. 23, 27 (2009) ("[T]he Precautionary Principle⋯ entails a radical change in outlook.").
51. See discussion of the Principle's application in the FDA review process and other regulatory regimes in Part II, infra.
52. See Joel A. Tickner, A Map Toward Precautionary Decision Making, in protecting public Health & the Environment, supra note 23, at 162, 163 (noting that the Precautionary Principle asks a different set of questions from traditional risk assessment: '"How much contamination can be avoided while still maintaining necessary values?'; 'What are the alternatives to this activity that achieve a desired goal⋯?'; and 'Do we need this activity in the first place?'").
53. David Dana, The Contextual Rationality of the Precautionary Principle, 35 QUEEN'S L.J. 67, 68 (2009).
54. See, e.g., James E. Hickey, Jr. & Vera R. Walker, Refining the Precautionary Principle in International Environmental Law, 14 Va. Envtl. L.J. 423,432-36 (1995) (identifying fourteen "articulations of the Precautionary Principle in the major environmental instruments")
55. Per Sandin, Dimensions of the Precautionary Principle, 5 HUM. & ecological risk assessment 889 (1999) (cataloging nineteen different versions of the Precautionary Principle)
56. Joel A. Tickner et al., A Compass for Health: Rethinking Precaution and Its Role in Science and Public Health, 32 int'l J. epidemiology 489, 489 (2003) (describing the five-part definition of precaution in the 2001 Lowell Statement on Science and the Precautionary Principle).
57. United Nations, UN Conference on Environment and Development (1992), http://www.un.org/geninfo/bp/enviro.html (last visited June 2,2011).
58. United Nations Conference on Environment and Development, Rio de Janiero, Braz., June 3-14, 1992, The Rio Declaration on Environment and Development, U.N. Doc. A/CONF.151/5/Rev.l (Jun. 13,1992), reprinted in 311.L.M. 874,879 (1992).
59. See Eur. Env't Agency, Late Lessons from Early Warnings: The Precautionary Principle 1896-2000 (2001)
60. See Consolidated Version of the Treaty on the Functioning of the European Union art. 191, Sept. 5, 2008, 2008 O.J. (C 115) 47,132 [hereinafter TFEU)
61. United Nations Conference on Environment and Development: Convention on Biological Diversity, pmbl., June 5,1992, 31 I.L.M. 818, 822 (1992)
62. United Nations Framework Convention on Climate Change, art. 3(3), May 9, 1992, S. Treaty Doc. No. 102-38 (1992), reprinted in 311.L.M. 849,854 (1992)
63. Bamako Convention on the Ban of the Import into Africa and the Control of Transboundary Movement and Management of Hazardous Wastes Within Africa, art. 4,1 3(f)-(h), Jan. 29,1991,301.L.M. 773,781-82 (1991).
64. As John Applegate has noted, while there is no U.S. statute that explicitly references the Precautionary Principle, the Principle is reflected operationally in six kinds of provisions commonly found in U.S. environmental statutes: "planning and alternatives analysis, special regulatory treatment of certain categories of harm, the transition from tort to risk-based regulation, the adoption of margins of safety in standard setting, the policy of erring on the side of safety in risk management, and the shifting of the burden of proof' in some contexts.
65. See John S. Applegate, The Precautionary Preference: An American Perspective on the Precautionary Principle, 6 hum. &ecological risk Assessment 413,420 (2000).
66. See Daniel Bodansky, The Precautionary Principle in U.S. Environmental Law, in Interpreting the Precautionary Principle 203 (Timothy O'Riordan & James Cameron eds., 1994). Despite clearly precautionary language in many U.S. environmental and health statutes, many scholars contend that the precautionary thrust of the statutes have been eroded through changes to the U.S. regulatory system since the 1970s, including comprehensive cost-benefit analysis requirements and more skeptical judicial review.
67. See, e.g., Applegate, supra note 33, at 430-31.
68. sunstein, supra note 12, at 18.
69. see also Jonathan B. Wiener, Precaution in a Multirisk World, in Human and Ecological Risk Assessment: Theory and Practice 1509,1509 (Dennis J. Paus- tenbach ed., 2002) (explaining that weak versions of the Principle are unobjectionable).
70. Edward Soule, Assessing the Precautionary Principle, 14 PUB. AFF. Q. 309,315 (2000).
71. SUNSTEIN, supra note 12, at 24.
72. See Percival, supra note 22, at 36-37 (arguing that "despite the regulatory statutes' commitment to preventative regulation," environmental law remains largely reactive, and regulation is rarely imposed until damage to public health has occurred).
73. See 150 Cong. Rec. 23,369 (2004) (statement of Sen. Inhofe) ("[Global warming] alarmists often trot out a concept known as the precautionary principle-which is that it is better to be safe than sorry. But [t]he science of global warming is uncertain, the costs of capping our economy with carbon restriction are high, and even if the doomsayers were correct, it would do little to nothing to reduce the temperature increases.
74. Gary E. Marchant & Kenneth L. Mossman, Arbitrary and Capricious: The Precautionary Principle in the European Union Courts 1 (2004) ("Perhaps the most common criticism of the precautionary principle ⋯ is that it is inherently ambiguous and arbitrary.").
75. Lawrence A. Kogan, The Extra-WTO Precautionary Principle: One European "Fashion" Export the United States Can Do Without, 17 temp. pol. & Civ. Rts. L. Rev. 491, 506-07 (2008) (stating that the Precautionary Principle asks legislators "to evaluate public risks based on political, ethical, and/or social science concerns, rather than upon common-sense or hard, empirical, sound science")
76. Soule, supra note 36, at 313.
77. Partnership for sound science in environmental Policy, Precautionary Principle Overview 1, (n.d), http://cicc.org/jru/031306/pp-overview.pdf ("[t]he Precautionary Principle diverts the attention of regulators and resources from real issues to speculative concerns⋯ Implementing the Precautionary Principle can cause more harm than good⋯" (emphasis omitted)).
78. The Treaty on the Functioning of the European Union is typical in this regard, as it declares that EU environmental policy "shall be based on the precautionary principle," without defining the Principle in the treaty.
79. See TFEU art. 191. Partly to fill that gap, the European Commission has issued its own (caveated) interpretation of the meaning of the Precautionary Principle.
80. See COMM'N OF the European Cmtys., Communication From the Commission on the Precautionary Principle (2000).
81. See Applegate, The Taming, supra note 22, at 23-24 (documenting progressively softer and less aggressive interpretations of the Precautionary Principle in risk regulation since the early 1990s).
82. The precautionary measures that can be applied under the Principle will necessarily vary, depending on the magnitude of the expected risk and the strength of the scientific evidence.
83. See infra Part II.
84. By emphasizing that precautionary measures "should be taken" in response to threats to human health or the environment, the Strong Precautionary Principle represents an affirmative call to action, whereas the Weak Precautionary Principle is phrased in the negative (scientific uncertainty should not be used as a reason for postponing cost-effective regulatory measures) and, therefore, can be seen as less demanding or less action-forcing.
85. Sunstein, supra note 12, at 19.
86. See, e.g., Edward Soule, Morality & Markets: The Ethics of Government Regulation 147 (2003).
87. Protecting Public Health & the Environment, supra note 23 app. A, at 353-54 (quoting the Wingspread Statement on the Precautionary Principle).
88. See also id. intro., at 7-9 (discussing the history of the Wingspread Conference).
89. There are many other formulations of the Strong Precautionary Principle in the literature, including some that suggest that any risk-producing activity must be halted until it is proven safe. These highly aggressive, zero-risk standards should be rejected, as I explain in Part II. These outliers need not deflect our attention from exploring versions of Strong Precaution that have some political viability. Defending the Strong Precautionary Principle does not mean aligning oneself with the most extreme, risk-intolerant formulations of it.
90. See, e.g., Marchant & Mossman, supra note 39, at 1; Sunstein, supra note 15, at 1003.
91. See Kysar, supra note 22, at 7 n.32 (2006) ("Important implementation issues then include: (1) the degree of credibility or seriousness of threat required in order to trigger the precautionary obligation; (2) the precise form that regulatory response should take; (3) and the manner in which the regulatory response should be revisited and revised over time.").
92. See Applegate, Climate Change, supra note 22,171-72 (noting that the Rio Declaration required twenty-seven principles to outline a broad framework for sustainable development and that the Precautionary Principle is but one component of this framework).
93. The founding documents of the containment strategy, such as National Security Council Memorandum 68 (NSC 68), used broad and open-ended language to describe the kinds of U.S. responses that would be appropriate to counter Soviet power and expansionism. The meaning of containment, therefore, was left to a discursive process of interpretation and implementation that occurred over decades among the White House, Congress, the Pentagon, and other national security agencies. NSC 68 stated, in part: For us the role of military power is to serve the national purpose by deterring an attack upon us while we seek by other means to create an environment in which our free society can flourish Our free society, confronted by a threat to its basic values, naturally will take such action, including the use of military force, as may be required to protect those values In the words of the Federalist (No. 28) "The means to be employed must be proportioned to the extent of the mischief."⋯ Our aim in applying force must be to compel the acceptance of terms consistent with our objectives, and our capabilities for the application of force should, therefore, within the limits of what we can sustain over the long pull, be congruent to the range of tasks which we may encounter. Nat'l Sec. Council, A Report to the National Security Council by the Executive Secretary, nsc 68 (Apr. 14, 1950), reprinted in U.S. dep't of state, pub. No. 8887, 1 foreign Relations of the United States 234,244 (1950).
94. See Roger S. Whitcomb, The Cold War in Retrospect: The Formative Years 87-88 (1998).
95. Literature on the Strong Precautionary Principle has rarely addressed this core issue of who should decide whether the burden of proof has been met. The Lowell Statement on Science and Precautionary Principle, for example, states that "responsibility" should be placed on "originators of potentially dangerous activities to thoroughly study and minimize risks, and to evaluate and choose the safest alternatives to meet a particular need, with independent review." Tickner et al., supra note 28, at 489 (emphasis added). The entity that should conduct that independent review is not specified, however.
96. See also Protecting Public Health & the Environment, supra note 23 intro., at 8 (stating that the "proponent of an activity⋯ should bear the burden of proof' but not identifying who will judge whether the proponent has met that burden).
97. Sallie Baliunas, Warming Up to the Truth: The Real Story About Climate Change, heritage Found. (Aug. 22, 2002), available at http://www.heritage.org/ research/lecture/the-real-story-about-climate-change.
98. sunstein, supra note 12.
99. John D. Graham, The Perils of the Precautionary Principle: Lessons from the American and European Experience (Oct. 20, 2003), in Heritage Lectures, Jan. 15, 2004, at 1-4.
100. See, e.g., Adler, supra note 18, at 174; Graham, supra note 56, at 1-4.
101. The Rio Declaration on Environment and Development, supra note 30, at 879.
102. Ronald Bailey, Precautionary Tale, REASON, Apr. 1999, at 37,37.
103. See Steven Shavell, Liability for Harm Versus Regulation of Safety, 13 J. LEGAL STUD. 357 (1984) (analyzing shortcomings of tort liability for addressing certain types of harms, including diffuse harms and harms where the tortfeasor may escape full internalization of the harm because it is judgment proof).
104. Nat'l Comm'n on the BP Deepwater Horizon Oil Spill & Offshore Drilling, Deep Water: The Gulf Oil Disaster and the Future of Offshore Drilling 77-85 (2011) (detailing ethical lapses, mismanagement, and lax oversight in the Department of Interior and criticizing the categorical exemptions of site-specific Gulf of Mexico drilling plans from the review procedures of the National Environmental Policy Act).
105. See Douglas A. Kysar, Regulating From Nowhere: Environmental Law And The Search For Objectivity 9 (2010) ("Proponents of the precautionary approach ⋯ emphasize the limits of human knowledge and the frequency of unpleasant surprises from technology and industrial development; thus, they advocate an ex-ante governmental stance of precaution whenever a proposed activity meets some threshold possibility of causing severe harm to human health or the environment.").
106. See Noah Sachs, Blocked Pathways: Potential Legal Responses to Endocrine Disrupting Chemicals, 24 COLUM. J. ENVTL. L. 289 (1999) (detailing obstacles to private tort litigation over chemical exposures).
107. The informational benefits of the Precautionary Principle have been widely noted in the literature.
108. See Applegate, supra note 33.
109. Carl F. Cranor, Asymmetric Information, the Precautionary Principle, and Burdens of Proof, in protecting public health & the environment, supra note 23, at 74,81-82.
110. See, e.g., Administrative Procedure Act, 5 U.S.C. § 556(d) (2006) ("Except as otherwise provided by statute, the proponent of a rule or order has the burden of proof.").
111. Wagner, supra note 2, at 1685.
112. GAO, Options Exist, supra note 2, at 19-26.
113. This "data drought" has many causes, including that: (1) TSCA provides no mandate for routine toxicity testing for most chemicals on the market, (2) the statute in practice requires EPA to assemble substantial information on the risks of a chemical just to issue an order to require testing, and (3) industry has frequently litigated over the few testing orders that the EPA has issued.
114. See Sachs, supra note 2, at 1827-28 (outlining features of TSCA that limit data supply).
115. Dana, supra note 27, at 83.
116. See id. (explaining that "rational, profit-maximizing corporations and other actors will not invest in testing and monitoring" under certain conditions, including "when particular products pose theoretical risks but not empirically-established ones; when any adverse effects would likely occur only in the relatively distant future; and when the link between the product and any distant adverse effects could well escape notice, or at least be difficult to establish as a matter of 'but for' causation").
117. Kysar, supra note 22, at 28 ("[Proponents of the [Precautionary Principle] recognize that uncertainty itself is a subject of power, influence, and control ⋯ Thus, the content of scientific knowledge and the manner of its production are not treated exogenously by the [Precautionary Principle], but instead are made a central focus of the regulatory program.").
118. Douglas A. Kysar & James Salzman, Making Sense of Information for Environmental Protection, 86 Tex. L. Rev. 1347,1351-1352 (2008).
119. Commission Regulation 1907/2006,2006 O.J. (L 396) 1 (EC) [hereinafter REACH],
120. Sachs, supra note 2, at 1834-35.
121. Id. at 1835. The preamble to REACH states that the regulation "is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment." REACH, supra note 75, at 47.
122. Only seventy chemical risk assessments were required by government regulators in the prior thirty years, out of a universe of more than 30,000 chemicals produced in quantities greater than one ton. Sachs, supra note 2, at 1833-34.
123. See id. at 1862-67 (analyzing the extraterritorial impacts of REACH).
124. John Applegate's distinction between "filling strategies" and "bridging strategies" to overcome data gaps in chemical regulation has been an important contribution to the debate over TSCA reform.
125. See John S. Applegate, Bridging the Data Gap: Balancing the Supply and Demand for Chemical Information, 86 Tex. L. Rev. 1365 (2008). Applegate argues that "filling strategies," involving more research, often have diminishing returns due to the time and expense of chemical testing and residual scientific uncertainty about the extent of risk even when testing is conducted. Id. at 1385-89. "Bridging strategies," on the other hand, are designed to "bridge" the data gap by reducing the overall regulatory demand for information. Id. at 1395-1406. Bridging strategies include technology standards, shifts in the burden of proof, and incentives for safer substitute chemicals.
126. See also David E. Adelman, A Cautiously Pessimistic Appraisal of Trends in Toxics Regulation, 32 WASH U. J.L. & Pol'Y 377, 381 (2010) ("[T]oxics regulation should avoid the deep epistemic gaps to the extent that it can.").
127. See Hansson, supra note 23, at 227 (arguing that in implementing a burden shift in chemical regulation, where there are "diverging but scientifically sound interpretations of toxicological data, precedence should be given to the interpretations that support the most pessimistic predictions with respect to human health"). 82 GAO, Options Exist, supra note 2, at 18.
128. 947 F.2d 1201 (5th Cir. 1991). One reason that the court rejected the asbestos ban was because EPA had not performed a comprehensive cost-benefit analysis for intermediate measures short of a complete ban under the complex procedures of the statute. Id. at 1230.
129. Dan Fagin & Marianne Lavelle, Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law and Endangers Your Health 138 (1996).
130. Robert V. Percival, Responding to Environmental Risk: A Pluralistic Perspective, 14 pace Envtl. L. Rev. 513 (1997).
131. Sachs, supra note 65, at 324.
132. Cranor, supra note 23, at 271.
133. Kysar, supra note 22, at 12.
134. Wendy E. Wagner, The Precautionary Principle and Chemical Regulation in the U.S., 6 Hum. & Ecological Risk Assessment 459,468 (2000) (arguing that TSCA reflects an "unprecautionary principle").
135. See, e.g., Julian Morris, Defining the Precautionary Principle, in rethinking risk and the Precautionary Principle 1 (Julian Morris ed., 2000).
136. Frank B. Cross, Paradoxical Perils of the Precautionary Principle, 53 Wash. & Lee L. Rev. 851 (1996).
137. Graham, supra note 24.
138. See, e.g., Graham, supra note 24.
139. SUNSTEIN, supra note 12, at 25.
140. Graham, supra note 56, at 3.
141. Henry I. Miller & Gregory Conko, The Science of Biotechnology Meets the Politics of Global Regulation, Issues in Sci. & tech. Online (2000), http://www.nap.edU/issues/17.l/miller.htm.
142. See, e.g., Kogan, supra note 39, at 601-03.
143. See Miller & Conko, supra note 92.
144. See Cass R. Sunstein, The Precautionary Principle As a Basis for Decision Making, 2 Economists' Voice 1,5 (2005) (claiming that the Precautionary Principle "attempts) to prevent even speculative harm").
145. See Bailey, supra note 59, at 37.
146. Kogan, supra note 39, at 601-03 (contrasting the Precautionary Principle with the "founding principles of our society, chief among them economic and political freedom and the rule of law").
147. Miller & Conko, supra note 92.
148. See Sunstein, supra note 12, at 14-15.
149. Id. In another example, Sunstein notes that many chemical agents may be carcinogenic at very low levels, while others may be beneficial at very low levels even if harmful at high levels (the so- called "hormesis" effect). Id. at 30-31. Therefore, the "simultaneous possibility of benefits at low levels and of harms at low levels makes the Precautionary Principle paralyzing." Id.
150. Sunstein argues that five different cognitive biases operate to make the Strong Precautionary Principle appear functional: (1) individuals focus on salient risks that come to mind from media reports or recent memory, and they ignore less visible risks; (2) probability neglect leads people to concentrate on worst-case outcomes, even if they are highly improbable; (3) loss aversion causes people to avoid changes from the status quo, even if the status quo poses its own risks; (4) a widespread belief that nature is benign makes human-created risks seem particularly suspect; and (5) system neglect prevents people from appreciating opportunity costs and the substitute risks that may arise when a particular technology or product is restricted.
151. See id. at 36-49; Sunstein, supra note 15, at 1011 (arguing that the Principle's "puzzling appeal" reflects its dependence on cognitive biases).
152. Sunstein, supra note 12, at 129 (cost-benefit analysis gives people "a more accurate sense of the actual harms against which protection is sought" and provides "a clearer sense of the stakes").
153. Graham & Wiener, supra note 18, at 19-22. Graham and Wiener describe risk tradeoff analysis as a three-part process that identifies tradeoffs that might result from an intervention, weighs the comparative importance of target risks and countervailing risks, and analyzes the possibility of "risk-superior" moves that might result in overall risk reduction. Id.
154. Sunstein, supra note 95, at 6 ("We do not believe there is any principled way of making policy decisions without making the best possible effort to balance all the relevant costs of a policy against the benefits.").
155. See, e.g., Kogan,supra note 39, at 493.
156. Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §§301-399 (2006). The FFDCA was enacted in 1938 and was substantially amended in 1962 to require the affirmative approval of the FDA before a new drug could be marketed. Prior to 1962, new drug applications were deemed approved unless a contrary order was issued.
157. See USV Pharm. Corp. v. Weinberger, 412 U.S. 655 (1962).
158. See 21 U.S.C. § 321(g) (definition of "drug")
159. Id. § 321(p) (definition of "new drug").
160. See id. § 355(a) (prohibiting the sale of new drugs without FDA approval); Id. § 355(b)-(d) (describing the application and approval process).
161. Id. § 333(b) ("[A]ny person who violates [the FFDCA] by⋯ knowingly selling, purchasing, or trading a drug⋯ shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.").
162. See supra note 92 and accompanying text.
163. It was the unregulated introduction of an antibiotic, causing widespread illness in the 1930s, which led to public outcry in favor of a premarket government review system. The purported antibiotic was called "Elixir Sulfanilamide," and more than one hundred people were poisoned by it in Tennessee before the FFDCA was enacted.
164. See Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1761-1764 (1996) (describing the origins
165. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. (2006).
166. See U.S. Envtl. Prot. agency, Pesticides, Regulating Pesticides, http://www.epa.gov/pesticides/regulating/index.htm ("EPA must first ensure that the pesticide⋯ can be used with a reasonable certainty of no harm to human health and without posing unreasonable risks to the environment. To make such determinations, EPA requires more than 100 different scientific studies and tests from applicants.").
167. See 7 U.S.C. § 136a(a) ("Except as provided by this [Act], no person in any State may distribute or sell to any person any pesticide that is not registered under this [Act].").
168. See Applegate, supra note 33, at 430 ("With the notable exception of FIFRA, the burden of proving the existence and magnitude of an environmental risk is uniformly placed on the agency seeking to impose restrictions.").
169. See id. §7409 (2006) (requiring EPA to set National Ambient Air Quality Standards (NAAQS) at a level that "protects] the public health" with "an adequate margin of safety"). In 2001, the Supreme Court affirmed that the NAAQS are health-based standards that EPA must establish without reliance on cost-benefit analysis. Whitman v. Am. Trucking Ass'n, Inc., 531 U.S. 457, 471 (2001).
170. 42 U.S.C. § 6925 (2006).
171. To be sure, there are also many examples of U.S. regulatory regimes grounded in precautionary standard setting without a switch in the burden of proof, such as the initial establishment of the NAAQS under the Clean Air Act. Id. § 7409. There are also many examples of ex post interventions, such as the product recall authority of the Consumer Product Safety Commission or the authority of the EPA to issue removal orders in response to hazardous substance releases.
172. See 15 U.S.C. § 2064(b) (2006).
173. 42 U.S.C. § 9606(a) (2006). Taken as a whole, the U.S. approach to addressing health and environmental risks is a complex pastiche of different kinds of ex ante and ex post interventions.
174. Graham, supra note 56, at 5.
175. See, e.g., Giandomenico Majone, What Price Safety? The Precautionary Principle and Its Policy Implications, 40 J. COMMON MARKET STUD. 89,101 (2002).
176. Christopher D. Stone, Is There a Precautionary Principle, 31 ENVTL. L. REP. 10790,10791 (2001).
177. Bailey, supra note 59, at 39.
178. See Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607,642 (1980) ("'[S]afe' is not the equivalent of 'risk-free.' There are many activities that we engage in every day-such as driving a car or even breathing city air-that entail some risk of accident or material health impairment, nevertheless, few people would consider these activities 'unsafe.'").
179. Sunstein, supra note 12, at 24; see also Sunstein, supra note 15, at 1018.
180. sunstein, supra note 12.
181. Sunstein, supra note 15. In addition, at the end of Laws of Fear, Sunstein described the Precautionary Principle as "a plea for aggressive regulation of risks that are unlikely to come to fruition." sunstein, supra note 12, at 224.
182. In defining Strong Precaution, Sunstein relies on some rather obscure pronouncements as representative examples of the Principle. In particular, Sunstein's definition of the Principle echoes two obscure and highly risk-averse definitions that he discusses in Laws of Fear.
183. See Sunstein, supra note 12, at 19-20 (quoting Dr. Brent Blackwelder, President, Friends of the Earth, Address Before the Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services (Jan. 24, 2002) ("[T]he Precautionary Principle mandates that when there is a risk of significant health or environmental damage ⋯, and when there is scientific uncertainty [about the risk], then decisions should be made so as to prevent such activities from being conducted unless and until scientific evidence shows that the damage will not occur.")).
184. Final Declaration of the First European Seas at Risk Conference, Oct. 26-28, 1994, Annex 1, 1 4. ("[I]f the 'worst case scenario' for a certain activity is serious enough then even a small amount of doubt as to the safety of that activity is sufficient to stop it taking place."). Sunstein describes both formulations of Strong Precaution as being at the "extreme" end of a continuum. Sunstein, supra note 12, at 18. Such statements have never had much influence on the practical design of regulatory regimes in the United States. Nonetheless, Sunstein incorporates strikingly similar language into his own definition of the Strong Precautionary Principle, and then proceeds to attack it. See id. at 18-20.
185. SUNSTE1N, supra note 12, at 24.
186. The Wingspread Statement, for example, provides that the burden of proof shall be borne by the proponent of the activity, but it does not itself supply the standard for determining when the burden of proof is met.
187. See Toxic Substances Control Act § 6(a), 15 U.S.C. § 2605(a) (2006) (stating that the EPA must prove "unreasonable risk" to restrict a chemical).
188. Clean Air Act § 109, 42 U.S.C. § 7409(b)(1) (2006) (stating that the EPA is required to set ambient air quality standards at a level "requisite to protect the public health" with an "adequate margin of safety").
189. See, e.g., Frank Ackerman & Lisa Heinzerling, Priceless: On Knowing the Price of Everything and the Value of Nothing 10 (2004) ("Cost-benefit analysis of health and environ-raental protection rests on simplistic, implausible hypotheses ⋯)
190. "); Kysar, supra note 64, at 71-75 (contrasting situations of "risk," which can be modeled reasonably well because outcomes and probabilities are well defined, with situations of "uncertainty" and "ignorance," typical in environmental policy making, in which probabilities are poorly defined).
191. Sunstein "reconstructs" the Precautionary Principle as an Anti-Catastrophe Principle, and he argues that so reconstructed, his Anti-Catastrophe Principle "deserves to play a role in regulatory choices." sunstein, supra note 12, at 114. His description in Laws of Fear of how an Anti- Catastrophe Principle might operate is quite vague, however. He contends that policy makers should identify and then address worst-case scenario risks, but only when that scenario is in some sense "catastrophic," and even then, only "when the costs of reducing those dangers are not huge and when incurring those costs does not divert resources from more pressing problems." Id. But this leaves a very small scope for precautionary thinking in regulatory law, since addressing catastrophic risks (his primary example is global warming) will almost always necessitate large costs. Moreover, the Strong Precautionary Principle, properly understood, has much wider applications than addressing planet- altering "catastrophic" risks affecting hundreds of millions of people. As the examples in this Article illustrate, the Principle can be applied in a variety of contexts on a more quotidian basis to protect health and safety.
192. That Strong Precaution may introduce values other than strict economic efficiency into the regulatory process is one of the reasons it has drawn such heated criticism. But many existing health, safety, and environmental statutes also impose requirements other than strict cost-benefit tests, such as the use of minimum safety equipment, the adoption of best-available technology, or the avoidance of significant risk.
193. See statutes cited supra notes 114-124. As Sunstein himself has noted, a democratic society may appropriately set regulatory standards with reference to values other than economic efficiency.
194. See sunstein, supra note 12, at 129 ("Efficiency is relevant, but it is hardly the only goal of regulation. Citizens in a democratic society might well choose to protect endangered species, or wildlife, or pristine areas, even if it is not efficient for them to do so.").
195. See, e.g., Sunstein, supra note 95, at 6 ("Without helping to answer" questions such as the tradeoff between present and future risks and the valuation of a life, "the principle is not useful.").
196. See Sunstein, supra note 12, at 51 ("[T]he Precautionary Principle is a crude, indirect, and sometimes perverse way of incorporating distributional concerns.").
197. But see Applegate, Climate Change, supra note 22, at 176 (arguing that it is "patently not [the] purpose" of the Precautionary Principle to resolve distributional concerns).
198. The necessity of interpretation through implementation does not, however, carve out so much from the Principle itself that the Principle dissolves into vacuity, as discussed in Part I.
199. See also David A. Dana, A Behavioral Economic Defense of the Precautionary Principle, 97 Nw U. L. Rev. 1315,1317 ("Principles can express and reinforce value commitments and procedurally structure decisionmaking without dictating a single set of specific, substantive outcomes ⋯" " (emphasis omitted)). Moreover, in existing legislation that incorporates a Strong Precautionary approach, the burden that the proponent or applicant must carry is typically substantial. There is little point in shifting the burden of proof, of course, if the ultimate burden the proponent must carry is a de minimis one. In the ex ante regulatory regimes described supra, the proponent bears a substantial burden to prove that risks or impacts will be within acceptable bounds-a burden that normally takes significant investment of time and resources to meet. The burden-shifting mechanism therefore does real "work" in allocating responsibilities.
200. Kogan, supra note 39, at 494 (The Precautionary Principle "favors banning or severely restricting broad classes of substances, products, and activities if it is merely possible that they⋯ pose potentially serious but unknown health or environmental harm.").
201. Dave Owen, Probabilities, Planning Failures, and Environmental Law, 84 TUL. L. Rev. 265,270 n.31 (2009) ("A strong precautionary principle might⋯ ban environmentally threatening activities.").
202. Indeed, it would be a gross waste of resources to implement the same precautionary measures for chemicals whose effects on human health cannot be determined with accuracy as for chemicals that are known carcinogens. "Precautionary measures should be taken in both cases, but with different degrees of stringency." Hansson, supra note 23, at 224.
203. Dana, supra note 141, at 1333 ("[T]he precautionary principle may have a role to play as a corrective of cognitive biases" in situations where we face "choices between the avoidance of sure, immediate losses and the avoidances of unsure, future losses.").
204. See Steffen Foss Hansen & Joel A. Tickner, Putting Risk-Risk Tradeoffs in Perspective: A Response to Graham and Wiener, 11 J. risk RES. 475, 476 (2008) (arguing that many purported risk- risk tradeoffs are hypothetical, never emerged in practice, or were adequately addressed through precautionary regulation).
205. Applegate, Climate Change, supra note 22, at 173,183-84 (explaining that the function of the Precautionary Principle is primarily procedural and evidentiary).
206. Kysar, supra note 22, at 9 ("Undoubtedly, CBA proponents are correct to note that no society should flatly ignore the opportunity costs of precautionary regulation. But this is a trivial observation, for no serious proponent of the [Precautionary Principle] disagrees with it.").
207. Scholarship on weak versions of the Precautionary Principle has focused overwhelmingly on the decisions of regulatory agencies.
208. See, e.g., Elizabeth Fisher & Ronnie Harding, The Precautionary Principle and Administrative Constitutionalism: The Development of Frameworks for Applying the Precautionary Principle, in implementing the precautionary principle: perspectives and Prospects 113,116 (Elizabeth Fisher et al. eds., 2006) (The Principle applies to "administrative activities" that are "delegated by a primary law maker to a non-elected secondary law maker."). The Strong Precautionary Principle, however, more directly addresses legislative design, given that the key choices, such as the degree of risk that will trigger burden shifting and the showing that must be made to overcome default prohibitions, are usually legislative choices.
209. Interest in risk-risk tradeoff analysis arose in the 1980s and 1990s in tandem with the rise of cost-benefit analysis in regulatory decision making, and, according to some scholars, risk-risk tradeoff analysis consequently developed a distinct antiregulatory bias.
210. Samuel J. Rascoff & Richard L. Revesz, The Biases of Risk Tradeoff Analysis: Towards Parity in Environmental and Health-and-Safety Regulation, 69 u. chic. L. Rev. 1763,1793 (2002). In particular, Rascoff and Revesz find bias in the identification of the countervailing risks from regulation, without attention to the ancillary benefits of regulation. As an illustrative example of ancillary benefits, they explain that statutes aimed at reducing carbon dioxide emissions, through fuel switching or energy efficiency measures, would also lead to reductions in conventional pollutants such as sulfur dioxide and ozone. Id. at 1808. They conclude that "(r]isk tradeoffs and ancillary benefits are simply mirror images of each other. There is no justification for privileging the former and ignoring the latter.
211. While cost-benefit analysis is mandated for the major rules of federal regulatory agencies through executive order, Exec. Order No. 12,866, 58 Fed. Reg. 51,735 (Oct. 4, 1993), Congress has chosen, wisely, not to bind itself formally to that requirement through its own rules of procedure.
212. Even in the regulatory arena, where formal risk assessment and cost-benefit analysis are strongly institutionalized in U.S. law, it is often difficult to forecast risk-risk tradeoffs or to estimate their magnitude. Consider a risk-risk tradeoff explored by Sunstein in a 2002 article: promulgating strict standards for arsenic (ten parts per billion or less) under the Safe Drinking Water Act might incentivize households, because of the expense of complying with the standard, to switch to private wells that often contain polluted or contaminated water.
213. Cass R. Sunstein, The Arithmetic of Arsenic, 90 GEO. L.J. 2255,2271,2294-2295 (2002). Sunstein describes this as a classic risk-risk tradeoff and reports that EPA Administrator Christine Todd Whitman "expressed concern" about this possibility in a television interview. Id. at 2294. But he does not explain how that risk-risk tradeoff could be quantified. It is doubtful that regulators could quantify how many users might actually switch to private wells, how polluted private wells are in those communities, and how users' health would be affected by exposure to diverse contaminants in private wells. This is just one example of a broader problem in risk-risk tradeoff analysis: while it may be possible to spot the existence of a countervailing risk from regulation, it can be exceedingly difficult to quantify it. Nonetheless, the presence of potential countervailing risks can be used as a rhetorical scare tactic to stop introduction of needed health and safety regulation.
214. Even in an ideal world where legislators could presciently name all the benefits and costs (including countervailing risks) that might flow from legislation, monetizing the benefit side of the equation (e.g., ecosystems protected, cancers or birth defects avoided, or life years saved) is notoriously problematic.
215. See, e.g., ackerman & heinzerling, supra note 136.
216. kysar, supra note 64.
217. Mandel & Gathii, supra note 22, at 1045-46 (describing hurdles of uncertainty and valuation in conducting cost-benefit analysis).
218. Percival, supra note 22, at 31-32 (noting that the imperative to quantify the costs and benefits of regulation "may distort decision-makers' perceptions of the levels of uncertainty associated with them").
219. Use of phthalates in children's toys provides another example of how the presence of tradeoffs need not be paralyzing to decision making. Phthalates, used to soften plastics, are known to be endocrine-disrupting chemicals that can disrupt normal development of sex organs.
220. See Ernie Hood, Are EDC's Blurring Issues of Gender?, 113 Envtl. Health Persp. A670, A671 (2005). For this reason, in 2008, Congress banned several classes of phthalates in children's toys, baby bottles, pacifiers, and other items.
221. See Consumer Product Safety Improvement Act, § 8,15 U.S.C. § 2057 (2006). It is conceivable, though speculative, that banning phthalates in children's toys could result in toy manufacturers substituting a more hazardous chemical instead. It is also foreseeable that the ban could lead to some job loss in the affected baby care industries or in the chemical industry. But Congress was not and should not be "paralyzed" by these possibilities of a risk "on the other side." There is nothing in the Precautionary Principle (weak or strong versions) that mandates that the scientifically documented risks of children's exposures to phthalates must be given the same weight in decision making as more speculative countervailing risks. The potential of a countervailing risk should not be used to forestall regulation of risks that we do know about. Moreover, the best solution here is not to accept our ignorance of the alternatives, but rather to require a minimum toxicity data set on a wide universe of chemicals so that the risks of phthalates and any potential alternative chemical in children's toys can actually be compared to each other.
222. Donald T. Hornstein, Lessons from Federal Pesticide Regulation on the Paradigms and Politics of Environmental Law Reform, 10 YALE J. ON REG. 369, 386-387 (1993).
223. see also Bradley C. Karkkainen, Framing Rules: Breaking the Information Bottleneck, 17 N.Y.U. ENVTL. L.J. 75, 81-82 (2008) (criticizing "comprehensive bureaucratic rationality" as an approach to risk).
224. See, e.g., Hansen & Tickner, supra note 145, at 477 ("[I]t is useful to consider realistic and reasonable risk-risk tradeoffs but⋯ this should not keep us from acting on a risk for which there is scientific evidence indicating concerns.").
225. see also Percival, supra note 22, at 79 (rejecting the proposition that "a never-ending quest for improved information should indefinitely postpone sensible regulatory measures").
226. Percival, supra note 22, at 79 (rejecting the proposition that " a never-ending quest for improved information should indefinitely postpone sensible regulatory measures").
227. Rascoff & Revesz, supra note 150.
228. TSCA 8 6(a), 15 U.S.C. § 2605(a) (2006).
229. See Corrosion Proof Fittings v. E.P.A., 947 F.2d 1201,1215 (5th Cir. 1991).
230. See discussion of Corrosion Proof Fittings, infra Part II.
231. See Known and Probable Human Carcinogens, AM. cancer Soc'y, http://www.cancer.org/Cancer/CancerCauses/OtherCarcinogens/ GenerallnformationaboutCarcinogens/known-and-probable-human-carcinogens (last updated Feb. 17,2011).
232. See Cass R. Sunstein & Adrian Vermeule, Is Capital Punishment Morally Required? Acts, Omissions, and Life-Life Tradeoffs, 58 STAN. L. REV. 703, 708 (2005) ("[TJhere is general agreement that whether a particular substance ought to be regulated depends on the overall effect of regulation on human well-being."). Note that Sunstein and Vermeule restrict this calculus to "human well- being," leaving impacts on nonhuman species out of the equation. Id.
233. Kysar, supra note 64, at 239.
234. In environmental law, Congress has frequently acted to protect natural resources and human health without engaging in comprehensive risk-risk analysis or cost-benefit balancing. Doug Kysar has noted, for example, that the Clean Water Act's command not to degrade the nation's pristine waters is a fairly absolute one that does not consider tradeoffs regarding how this protection might limit economic development. Id. at 248. The Endangered Species Act can also be seen as a deontological, nonutilitarian statute reflecting a national value that species should be protected.
235. SUNSTEIN, supra note 12, at 29.
236. Sunstein, supra note 15, at 1054.
237. Strict medical licensing requirements could easily lead to adverse health outcomes for patients. The Department of Health and Human Services has reported that sixty-five million Americans live in "Health Profession Shortage Areas," and that it would take an additional 16,643 primary care physicians in these areas to serve the populations adequately.
238. See Shortage Designation: HPSAs, MUAs & MUPs, Health Res. & services admin., http://bhpr.hrsa.gov/shortage/ (last updated May 28,2010).
239. See, for example, the medical licensing statutes of New York and Texas, which are virtually identical to the other states. N.Y. educ. Law § 6501 (McKinney 2010) (requiring a license to practice medicine).
240. Id. § 6512 (stating that it is a felony to practice medicine without a license); Tex. occ. Code Ann. § 155.001 (West 2007) (describing procedures for issuance of medical licenses).
241. Id. § 165.152 (stating that it is a felony to practice medicine without a license).
242. See Notice of Construction, Alteration, Activation, and Deactivation of Airports, 14 C.F.R. § 157 (2010); U.S. Dep't of Trans. & FAA, Notice of Landing Area Proposal, FAA Form 7480-1, http://www.faa.gov/documentLibrary/ media/form/faa7480-l.pdf.
243. Minn. Stat. §360.018 (2010) ("The general public interest and safety, the safety of⋯ persons and property on the ground, and the interest of aeronautical progress [require]⋯ that airports, restricted landing areas, and air navigation facilities should be suitable for the purposes for which they are designed
244. Minn. R. 8800.1400 (2007) (establishing notification and licensing requirements for new airports).
245. See Part 157 Notice of Construction, Alteration, Activation, and Deactivation, Fed. Aviation Admin., http://www.faa.gov/airports/central/ engineering/partl57/ (last updated Apr. 12,2010) ("Notification allows the FAA to identify potential aeronautical hazards in advance thus preventing or minimizing the adverse impacts to the safe and efficient use of navigable airspace.").
246. Fast Track, Accelerated Approval and Priority Review. Accelerating the Availability of New Drugs for Patients with Serious Diseases, U.S. food & drug admin., http://wvAvida.gov/ForConsumers/ByAudience/ForPatientAdvocates/ SpeedingAccesstoImportantNewTherapies/ucml28291.htm (last updated May 28,2010).
247. See, e.g., FIFRA, 7 U.S.C. § 136p (2006) (granting emergency use exemptions from the registration and preapproval process for pesticides).
248. id. § 136c (2006) (outlining experimental use exemptions).
249. Clean Air Act, 42 U.S.C. § 7475 (2006) (applying preconstruction review requirements of the Prevention of Significant Deterioration program only to "major emitting facilities," defined by pollutant tonnage thresholds).
250. Resource Conservation and Recovery Act of 1976, 42 U.S.C. §§ 6921, 6924 (2006) (outlining less-stringent storage and labeling requirements for "small quantity generators" and "conditionally exempt small quantity generators").
251. See Indur M. Goklany, The Precautionary Principle: A Critical Appraisal of Environmental Risk assessment 26-27 (2001).
252. Sunstein, supra note 12, at 32.
253. Cross, supra note 88, at 890-91.
254. Sunstein & Vermeule, supra note 161, at 707.
255. see also Richard Tren & roger bate, Competitive Enter. Inst., When Politics Kills: Malaria and the DDT Story 25-26 (2000), http://cei.org/PDFs/ malaria.pdf.
256. See goklany, supra note 175, at 27.
257. sunstein, supra note 12, at 32-33.
258. Cross, supra note 88, at 890-91.
259. sunstein, supra note 12, at 32-33.
260. see also goklany, supra note 175, at 27.
261. Stockholm Convention on Persistent Organic Pollutants, Annex B.II, May 22-23, 2001, opened for signature May 23, 2001, 40 I.L.M. 532 (2001). Under Annex B.II of the Convention, continued use of DDT is subject to developing an implementation plan that includes a search for suitable alternatives to DDT.
262. See supra notes 75-79 and accompanying text.
263. See REACH, supra note 75, at 396.
264. See Sachs, supra note 2, at 1837-38 (providing an overview of REACH).
265. Id.', see also Wagner, supra note 87, at 473 (noting that a system in which cost-benefit analysis is used by manufacturers to rebut precautionary health-based regulation would be consistent with the Precautionary Principle).
266. See Sachs, supra note 2, at 1841-42 (discussing REACH's incentives for development of substitutes for hazardous chemicals).
267. See, e.g., Protecting Public Health & the Environment, supra note 23 app. A, at 353 (emphasis added). The context of this quotation makes it clear that the authors were describing the Strong Precautionary Principle, as the Wingspread Statement goes on to provide a definition of precaution that includes burden shifting.
268. See Noah M. Sachs, Greening Demand: Energy Consumption and U.S. Climate Policy, DUKE ENVTL L. & POL'y F. 295,298 (2009).
269. I do not mean to minimize the role of precautionary steps in addressing climate change. Policy making should still be guided by weaker versions of the Precautionary Principle, allowing early action in the face of scientific uncertainty. For more on the role of precaution in the climate debate.
270. see Applegate, Climate Change, supra note 22.
271. Steve Shavell explored some of these same criteria nearly thirty years ago in his classic article on the merits of liability rules versus public regulation as tools for risk management.
272. See Shavell, supra note 62.
273. See discussion supra Part II.B.l.
274. EPA's Integrated Risk Information System, the agency's compendium of data on the health effects of chemicals, has full risk assessments for only 540 substances, and EPA reported in 2003 that 287 of these assessments may be out of date. U.S. gov't accountability office, GAO-08-743T, Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals 6 (2008). EPA has ordered testing under Section 4 of TSCA for approximately 200 of 84,000 chemicals in the TSCA inventory. GAO, enhancing TSCA, supra note 2, at 5.
275. Less than two hundred substances out of thousands of chemicals emitted to the ambient air are regulated as hazardous air pollutants under the Clean Air Act.
276. See 42 U.S.C. § 7412(b) (2006). Moreover, the firms emitting these pollutants are not required to eliminate emissions, but only to install maximum achievable control technology.
277. Kid-Safe Chemicals, Envtl. working grp., http://www.ewg.org/kid-safe- chemicals-act-blog/kid-safe-chemicals-act (last visited June 2,2011).
278. See also Envtl. Working Grp., Pollution in People: Cord Blood Contaminants in Minority Newborns (2009), http://www.ewg.org/files/2009- Minority-Cord-Blood-Report.pdf.
279. Woodruff et al., supra note 4.
280. Sachs, supra note 2, at 1825-33.
281. Some of the main players in the congressional debate viewed TSCA as a highly anticipatory statute in which chemical manufacturers would bear the principal burdens of research, testing, and disclosure.
282. See Legislative History of the Toxic Substances Control Act, 94th Congress at 215 (statement of Senator James Pearson) ("We can no longer operate under the assumption that what we do not know about a chemical substance cannot hurt us. Tragic results associated with too many toxic substances have taught us that lesson all too well. Chemicals, not people, must be put to the test.").
283. See James T. O'Reilly, Torture By TSCA: Retrospectives of a Failed Statute, natural Resources & Env't, Summer 2010, at 43, 43. O'Reilly, currently a professor at the University of Cincinnati College of Law, was a lobbyist for Procter & Gamble in the 1970s and participated in many of the crucial negotiations that led to the passage of TSCA. Looking back on the legislative debate over TSCA, he recently concluded that, "[t]his was a lobbying effort so effective, in retrospect, that TSCA has been far less successful than its sponsors had hoped. My 'side' won in 1976. TSCA has failed and left us with a mere façade of effective environmental action.
284. See U.S. Gov't Accountability Office, GAO-10-292T, Chemical Regulation: Observations on Improving the Toxic Substances Control Act 2 (2009).
285. Toxic Substances Control Act § 5(a), 15 U.S.C. § 2604(a) (2010).
286. Id. See also Adelman, supra note 80, at 389 (calling the PMN review process "perfunctory" and noting that the ninety-day window for EPA review is often "preclusive of regulatory action"). The EPA relies principally on computer modeling in its new chemical review process, and given resource constraints, only twenty percent of PMNs submitted receive a detailed review. GAO, Options Exist, supra note 2, at 11-12.
287. Manufacturers must disclose toxicity information about a new chemical only if such information is in the manufacturer's "possession or control" or if it is "known to or reasonably ascertainable by" the submitter. Premanufacture Notification, 40 CFR §§ 720.50(a)-(b) (2010). Under this "disclose it if you have it" model, it is not surprising that only fifteen percent of PMNs contain any health and safety information. GAO, options Exist, supra note 2, at 11.
288. See, e.g., Bodansky, supra note 34, at 209-10.
289. Wiener, supra note 35, at 1523.
290. Applegate, supra note 33, at 432.
291. Existing chemicals represent about seventy-eight percent of all chemicals that have been introduced into commerce in the United States. Sachs, supra note 2, at 1826-27. But by volume, pre- 1976 existing chemicals still account for ninety-nine percent of the chemicals in commerce. Adelman, supra note 80, at 389-90. So if the new chemicals program is viewed as a precautionary "pocket" in the statute, as Wendy Wagner has suggested, it is a narrow pocket indeed. Wagner, supra note 87, at 285-86. While TSCA authorizes testing of existing chemicals, "it generally provides no specific requirement, time frame, or methodology for doing so As a result, EPA does not routinely assess the risks of the more than 83,000 commercial chemicals in use." GAO, supra note 197, at 4.
292. Toxic Substances Control Act, 15 U.S.C. § 2603 (2006).
293. GAO, supra note 198, at 5.
294. See supra note 204 and accompanying text.
295. These statutory flaws have been exacerbated by insufficient funding for TSCA. Historically, the number of agency personnel devoted to TSCA implementation has been less than the number devoted to implementation of FIFRA, the statute governing pesticides, despite the fact that pesticides represent a far smaller universe of chemicals.
296. See Mark A. Greenwood, TSCA Reform: Building a Program That Can Work, 39 ENVTL. L. REP. 10034 (2009).
297. For example, EPA can enact restrictions on a chemical only after a full trial-type hearing; it must make a series of statutory findings prior to restrictions, it must choose the "least burdensome" regulatory requirement that will adequately protect against the risk, and it must demonstrate that no other statute could address the concern. 15 U.S.C. § 2605(a), (c).
298. See Denison, supra note 4, at 10022 (discussing TSCA's uniform "unreasonable risk" standard and comparing it to the goal of proportionality of regulatory response in the Precautionary Principle).
299. Sachs, supra note 2, at 1818.
300. U.S. Gov't Accountability Office, GAO-09-271, High-Risk Series: An Update 22-24 (2009) ("Without greater attention to EPA's efforts to assess toxic chemicals, the nation lacks assurance that human health and the environment are adequately protected.").
301. Lisa P. Jackson, Adm'r, Envtl. Prot. Agency, Testimony before the U.S. Senate Committee on Environment and Public Works (Dec. 2,2009).
302. Ortwinn Renn & E. Donald Elliott, Chemicals, in reality of precaution: comparing Risk Regulation in the United States and Europe (Jonathan B. Wiener et al. eds., 2011).
303. See supra note 62.
304. See also John T. Nockleby, Faces of the Tort Pyramid: Compensation, Regulation, and the Profession, in An unfinished project: Law and the possibility of justice (Scott Cummings ed., 2010) (arguing that the regulatory function of tort law is severely compromised by the vagaries of litigation, such as the desire of plaintiffs lawyers to seek out only those "ideal" plaintiffs with easy-to-prove injuries, high damages, and claims against financially solvent defendants).
305. See Wagner, supra note 87, at 469.
306. See supra Part II.C. Safe Chemicals Act of 2010, S. 3209,111th Cong. § 3(c)(1) (2010).
307. Placing the burden of data production on industry would represent a return to the original vision of TSCA, whose preamble states that development of toxicity data "should be the responsibility of those who manufacture and those who process ⋯ chemical substances and mixtures." TSCA, 15 U.S.C. § 2601(b) (2006). The substantive provisions of TSCA, however, place the burden on EPA to prove that testing should be conducted for chemicals already on the market.
308. See id. § 2603. Wendy Wagner notes that this is just one example of TSCA's "schizophrenic regulatory approach." Wagner, supra note 87, at 464 n.6.
309. See also William H. Rogers, Jr., Environmental Law 489 (2d ed. 1994) ("TSCA is teeming with contradictions ").
310. To avoid duplicative testing, a new statute should contain provisions for joint research and data sharing, similar to provisions in REACH establishing Substance Information Exchange Fora in the registration process.
311. See REACH, supra note 75, at 104.
312. see also REACH Consortia, ChemicalWatch, http://chemicalwatch.com/REACH-
313. See Sachs, supra note 2, at 1840.
314. See, e.g., SUNSTEIN, supra note 12, at 42-45.
315. In pharmaceutical regulation, Congress enacted a similar phase-in requirement for drugs already on the market when it amended the FFDCA in 1962 to require that manufacturers prove efficacy as well as safety.
316. See Note, Drug Efficacy and the 1962 Drug Amendments, 60 GEO L. J. 185,195-96 (1972) (describing transitional provisions for drugs already on the market).
317. See Sachs, supra note 2, at 1857 (discussing the informational spillover effects of REACH).
318. See id. at 1842-43 (discussing REACH cost estimates).
319. See Valerie J. Brown, REACHingfor Chemical Safety, 111 ENVTL. HEALTH PERSP., at A766, A768 (2003) (noting that the critics of REACH argue that "the combination of the increased financial burden of testing, the bureaucracy of registration and authorization, and the requirement of applying the precautionary principle will discourage innovation and could ruin many small and medium-sized enterprises").
320. See Frank Ackerman & Rachel Massey, Global Dev. & Env't Inst., The True Costs of REACH 10-11 (2004) (arguing that if a chemical essential to downstream users is withdrawn from the market because its manufacturer believes it is not worth paying testing costs, then the chemical is probably underpriced).
321. See supra Part I.
322. Risk is generally characterized as a combination of a chemical's intrinsic hazard and the degree of human exposure.
323. See applegate et al., supra note 13, at 18. Under the precautionary trigger proposed here, intrinsic hazard alone would trigger burden shifting. Exposure issues, including whether safety precautions such as ventilation or protective equipment could reduce human exposures, could then be raised by manufacturers as an argument for why the chemical should not be withdrawn. The overall regulatory architecture would therefore remain risk based, not solely hazard based.
324. REACH, supra note 75, at 142.
325. See also applegate et al., supra note 13, at 23 ("[SJubstances of very high concern should, in accordance with the precautionary principle, be subject to careful attention."). Similarly, the Maine Toxic Chemicals in Children's Products Act classifies chemicals of "high concern" as those that can cause cancer or reproductive or developmental harm; those that disrupt the endocrine system; and those that are persistent, bioaccumulative, and toxic. ME. REV. Stat. tit. 38, § 1693 (2010).
326. Q and A on the New Chemicals Policy, REACH, EUROPA (Dec. 13, 2006), http://europa.eu/ rapid/pressReleasesAction.do?reference=MEMO/06/488.
327. See generally dep't of Health & Human Servs. et al., supra note 4 (discussing the use of biomonitoring to track the U.S. population's exposure to environmental chemicals).
328. See JANE HOULIHAN ET AL., Envtl. Working Grp., Bodyburden: The Pollution in People 3,38-39(2003).
329. See Denison, supra note 4, at 10025 ("Government has yet to conduct broader, more exploratory biomonitoring-aimed at identifying the full range of xenobiotics to which humans are exposed, as one means of identifying chemicals that are priorities for further scrutiny
330. Biomonitoring, Am. Chemistry COUNCIL, http://www.americanchemistry.com/ biomonitoring (last visited June 2,2011).
331. One of the TSCA reform bills from the last Congress, the Safe Chemicals Act, relied heavily on precautionary burden shifting. Safe Chemicals Act of 2010, S. 3209,111th Cong. § 7 (2010). It required EPA, within eighteen months after enactment, to establish a rotating "priority list" of 300 substances. Id. For any substance on that list, the burden would switch to the manufacturer to prove a "reasonable certainty of no harm." Id. §§ 4,7. The bill stated that chemical substances should be added to list "at the Administrator's discretion, based on available scientific evidence, and consideration of their risk relative to other chemical substances, based upon presence in biological and environmental media, use, production volume, toxicity, persistence, bioaccumulation, or other properties indicating risk.
332. See supra Part II.B.3.C.
333. REACH presumes that risks cannot be adequately controlled for persistent and bioaccumul- ative chemicals and for chemicals that do not have a known safe threshold below which a lack of adverse effects can be documented. REACH, supra note 75, at 153.
334. See TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions: Hearing Before the Subcomm. on Commerce, Trade and Consumer Prot., U.S. Cong. Comm. on Energy and Commerce, 111th Cong. 2 (2010) (testimony of Linda E. Greer, Director, Health and Environment Program, Natural Resources Defense Council) ("Because risk assessments require a quantification of exposure levels, and because the levels of [Persistent, Bioaccumulative, and Toxic compounds] will continue to rise for as long as the contaminant is released into the environment or the food chain, [regulators] cannot adequately evaluate the harm posed by this class of compounds.").
335. Greenwood, supra note 207, at 10034.