Jumping the pond: transnational law and the future of chemical regulation

Vanderbilt Law Review

Volumn 62, Issue 6, 2009, Pages 1817-1869

  Sachs, Noah M ^a  

^a UNIVERSITY OF RICHMOND   (United States)

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EID: 74549193486     PISSN: 00422533     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (319)

1. U.S.C. §§ 2601-92 (2006).
2. See Wendy Wagner, Using Competition-Based Regulation to Bridge the Toxics Data Gap, 83 IND. L.J. 629, 636 n.40 (2008) (listing expert studies that express concern over the lack of information about adverse effects of chemicals);
3. see also David Roe, Ready or Not: The Coming Wave of Toxic Chemicals, 29 ECOLOGY L.Q. 623, 641 n.59 (listing Government Accountability Office reports critical of TSCA).
4. For scholarly critiques of TSCA, see John S. Applegate, Synthesizing TSCA and REACH: Practical Principles for Chemical Regulation Reform, 35 ECOLOGY L.Q. 721, 734-40 (2008) [hereinafter Applegate, Synthesizing TSCA and REACH];
5. John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 COLUM. L. REV. 261, 315-30 (1991) [hereinafter Applegate, 77ie Perils of Unreasonable Risk];
6. Mary L. Lyndon, Information Economics and Chemical Toxicity: Designing Laws to Produce and Use Data, 87 MICH. L. REV. 1795, 1822-25 (1989);
7. Noah Sachs, Blocked Pathways: Potential Legal Responses to Endocrine Disrupting Chemicals, 24 COLUM. J. ENVTL. L. 289, 313-15 (1999);
8. Wendy Wagner, Commons Ignorance: The Failure of Environmental Law to Produce Needed Information on Health and the Environment, 53 DUKE L.J. 1619, 1663-705 (2004) [hereinafter Wagner, Commons Ignorance];
9. Wagner, supra note 2, at 631-37.
10. See Oversight on the Toxic Substances Control Act and the Chemicals Management Program at EPA- Hearing Before S. Comm. Environment & Public Works, 109th Cong. 2 (2006) [hereinafter Hearing] (testimony of Lynn R. Goldman, Professor, Environmental Health Science, Johns Hopkins University, Bloomberg School of Public Health) ("TSCA is probably the EPA statute that has seen the least change in the last 30 years.").
11. Commission Regulation 1907/2006, 2006 O.J. (L396) 1 (EC) [hereinafter REACH].
12. See, e.g., John S. Applegate, Bridging the Data Gap: Balancing the Supply and Demand for Chemical Information, 86 TEX. L. REV. 1365, 1389-90 (2008) (advocating placing the burden of proof of chemical safety on chemical manufacturers);
13. Wendy Wagner & David Michaels, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 AM. J.L. & MED. 119, 128-35, 151-54 (arguing that TSCA's confidential business information provisions have been abused and need reform).
14. See GOV'T ACCOUNTABILITY OFFICE, CHEMICAL REGULATION: COMPARISON OF U.S. AND RECENTLY ENACTED EUROPEAN UNION APPROACHES TO PROTECT AGAINST THE RISK OF TOXIC CHEMICALS 7 (2007), available at http://www.gao.gov/new.items/d07825.pdf ('TSCA does not require companies to develop information for either new or existing chemicals, whereas REACH generally requires companies to submit and, in some circumstances, requires companies to develop such information for both kinds of chemicals.").
15. The rise of Europe as a global standard-setter is a reversal of past trends in which U.S. innovations in domestic environmental law influenced European law.
16. See GIANDOMENICO MAJONE, REGULATING EUROPEV 53 (Jeremy Richardson ed., 1996) (explaining that Europe has often benefited from the results of U.S. regulatory experiments). Examples of European imports of U.S. innovations include environmental impact review, tradeable emissions permits, pollution taxes, and advocacy of cost-benefit analysis in environmental law.
17. id.
18. The rising European influence in global environmental affairs has been documented in both scholarly literature and the popular media.
19. See, e.g., MARK SCHAPIRO, EXPOSED: THE TOXIC CHEMISTRY OF EVERYDAY PRODUCTS AND WHAT'S AT STAKE FOR AMERICAN POWER 8-IO (2007) (describing the increasing influence of EU environmental regulation in the United States);
20. Ragnar E. Lofstedt & David Vogel, The Changing Character of Regulation: A Comparison of Europe and the United States, 21 RISK ANALYSIS: INTL J. 399, 399-400 (2001) (listing European regulatory methods that have been adopted by the United States);
21. Henrik Selin & Stacy D. VanDeveer, Raising Global Standards: Hazardous Substances and E-Waste Management in the European Union, ENVIRONMENT, Dec. 2006 , at 6, 7 (stating that the EU has become a "global leader on hazardous substances policy");
22. David Wirth, The EU's New Impact on U.S. Environmental Regulation, FLETCHER F. WORLD AFF., Summer 2007, at 91, 103-04 (arguing that EU policy is increasingly influencing U.S. environmental regulation);
23. Tobias Buck, Standard Bearer: How the European Union Exports Its Laws, FIN. TIMES, July 10, 2007, Analysis, at 13 (describing the increasing global adoption of EU environmental innovations and the political and economic mechanisms through which the EU is exerting a global influence);
24. Mark Schapiro, New Power for 'Old Europe', NATION, Dec. 27, 2004, at 11 (discussing the significance of REACH for the U.S. chemical industry).
25. Sheldon Kamieniecki & Michael E. Kraft, Series Foreword to GREEN GIANTS? ENVIRONMENTAL POLICIES OF THE UNITED STATES AND THE EUROPEAN UNION, at vii (Norman J. Vig & Michael G. Faure eds., 2004).
26. See, e.g., Applegate, supra note 6 , at 1377-1406 (discussing the gap between the supply and demand of data on chemical toxicity);
27. Daniel C. Esty, Environmental Protection in the Information Age, 79 N.Y.U. L. REV. 115, 197-209 (2004) (arguing that new information technologies will help to close data gaps and improve environmental protection);
28. Douglas A. Kysar & James Salzman, Foreword: Making Sense of Information for Environmental Protection, 86 TEX. L. REV. 1347, 1350-61 (2008) (arguing that a central concern of environmental law is the development of information for regulatory decision making);
29. James Salzman, Beyond the Smokestack: Environmental Protection in the Service Economy, 47 UCLA. L. REV. 411, 480-88 (1999) (advocating a variety of informational tools for environmental protection, with a focus on retailers as a leverage point for environmental improvement);
30. Wagner, supra note 2, at 640-46 (advocating using competition within industries to produce information on chemical toxicity).
31. See, e.g., DANIEL W. DREZNER, ALL POLITICS IS GLOBAL: EXPLAINING INTERNATIONAL REGULATORY REGIMES 43-51 (2007) (discussing global regulatory coordination);
32. Frank Dobbin et al., The Global Diffusion of Public Policies: Social Construction, Coercion, Competition, or Learning?, ANN. REV. SOC. 449, 450-62 (2007) (reviewing the literature on transnational diffusion of policies);
33. David Lazer, Regulatory Interdependence and International Governance, 8 J. EUR. PUB. POL"Y 474, 474-82 (2001) (discussing regulatory interdependence of states). For earlier examples of this literature,
34. see RICHARD ROSE, LESSON-DRAWING IN PUBLIC POLICY: A GUIDE TO LEARNING ACROSS TIME AND SPACE 103-10 (1993);
35. George Hoberg, Sleeping with an Elephant: The American Influence on Canadian Environmental Regulation, 11 J. PUB. POL'Y 107, 107-25 (1991);
36. Peter Gourevitch, The Second Image Reversed: The International Sources of Domestic Politics, 32 INT'L ORG. 881, 892-93 (1978).
37. In 1994, the U.S. General Accounting Office estimated that EPA had reviewed the risks of only 2 percent of the 62,000 existing" chemicals that had been introduced before 1979. U.S. GEN. ACCOUNTING OFFICE, TOXIC SUBSTANCES CONTROL ACT: LEGISLATIVE CHANGES COULD MAKE THE ACT MORE EFFECTIVE 3 (1994), available at http://archive.gao.gov/t2pbat2/152799.pdf. Since 1994, additional screening-level data has been developed for approximately two thousand High Production Volume chemicals, infra text accompanying notes 65-67, but data is still lacking for the vast majority of chemicals.
38. The sales figures, compiled by the European Chemical Industry Council, are from 2007.
39. See EUROPEAN CHEMICAL INDUSTRY COUNCIL, PROFILE OF THE CHEMICAL INDUSTRY (2009), http://www.cefic.org/factsandfigures/level02/profile-index.html.
40. See EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE GENERAL, REACH IN BRIEF 18 (2007) [hereinafter REACH IN BRIEF], available at http://ec.europa.eu/environment/chemicals/ reach/pdf/2007-02-reach-in-brief.pdf (outlining data submission and authorization procedures of REACH and stating that authorization may be withdrawn if a suitable substitute becomes available).
41. See, e.g., Applegate, Synthesizing TSCA and REACH, supra note 3, at 721 (despite some differences, "REACH follows many of TSCA's fundamental approaches to chemical regulation.");
42. Ortwin Renn & E. Donald Elliott, Precautionary Regulation of Chemicals in the U.S. and EU, in THE REALITY OF PRECAUTION: COMPARING RISK REGULATION IN THE U.S. AND EUROPE (Jonathan B. Wiener et al. eds., forthcoming 2009) (finding similarities in the levels of precaution embodied in the European and U.S. systems of chemical regulation).
43. Standard and Poor's Industry Surveys: Chemicals (Jan. 2008), available at homepage.smc.edu/thomas-phillip/rpt/Chemicals.pdf (2006 sales figures).
44. See S. REP. No. 94-698, at 5 (1976), reprinted in 1976 U.S.C.C.A.N. 4491, 4495 ('The most effective and efficient time to prevent unreasonable risks to public health or the environment is prior to first manufacture. It is at this point that the costs of regulation in terms of human suffering, jobs lost, wasted capital expenditures, and other costs are lowest.").
45. U.S. GOV'T ACCOUNTABILITY OFFICE, CHEMICAL REGULATION: OPTIONS EXIST TO IMPROVE EPA's ABILITY TO ASSESS HEALTH RISKS AND MANAGE ITS CHEMICAL REVIEW PROGRAM 2 (2005), available at http://www.gao.gov/new.items/d05458.pdf.
46. See U.S. EPA, 2006 INVENTORY UPDATXZE REPORTING: DATA SUMMARY 15 (2006), available at 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 EPA. id. at 1.
47. REACH IN BRIEF, supra note 15, at 3.
48. In a 2003 biomonitoring study, the Environmental Working Group found that of 210 synthetic chemical substances analyzed in a population of volunteers, 167 synthetic chemicals were present in the tissue of at least one person. JANE HOULIHAN ET AL., ENVTL. WORKING GROUP, BODY BURDEN: THE POLLUTION IN PEOPLE 3 (2003), available at http:// archive.ewg.org/reports/bodyburdenl/pdf/BBreport-final.pdf. On average, participants in the study had fifty-three carcinogens, fifty-eight known endocrine disrupting chemicals, fifty-three immunotoxins, and fifty-five chemicals linked to birth defects or abnormal development in their tissue samples. id. For a detailed study of human exposure to chemicals, see generally NAT"L 48 CTR. FOR ENVTL. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION, THIRD NATIONAL REPORT ON HUMAN EXPOSURE TO ENVIRONMENTAL CHEMICALS 13-443 (2005).
49. SEE JANE HOULIHAN ET AL., ENVIRONMENTAL WORKING GROUP, BODY BURDEN: THE POLLUTION IN NEWBORNS 13-15 (2005), available at http://ewg.org/reports-content/bodyburden2/ pdf/bodyburden2-final-r2.pdf.
50. Kim Hooper & Thomas A. McDonald, The PBDEs: An Emerging Environmental Challenge and Another Reason for Breast-Milk Monitoring Programs, 108 ENVTL. HEALTH PERSP. 387, 387 (2000).
51. RICHARD A. DENISON, ENVTL. DEF. FUND, NOT THAT INNOCENT: A COMPARATIVE ANALYSIS OF CANADIAN, EUROPEAN UNION, AND UNITED STATES POLICIES ON INDUSTRIAL CHEMICALS, at 1-3 (2007).
52. Chemical manufacturers have little incentive to conduct toxicity testing voluntarily because toxicity data is a form of informational commons. Wagner, Commons Ignorance, supra note 3, at 1640-41. The benefits of additional toxicity information inure to society as a whole, while the costs of toxicity testing are privately borne.
53. See id. at 1640 n.61 (stating that toxicity information is a public good and that providers "are not capturing the full economic benefit" of their production). No single manufacturer has an incentive to contribute to the informational commons because disclosure of toxicity data can lead to reductions in sales or to potential civil liability.
54. id. at 1636-37.
55. Government regulation therefore becomes necessary to overcome what Wagner has identified as manufacturers' "strategic ignorance," their underlying incentive not to find and disclose toxicity information.
56. id. at 1682, 1726.
57. See Applegate, supra note 6, at 1395-96 (advocating reducing data demand by lowering the informational predicates for regulatory action);
58. Esty, supra note 11, at 142 (arguing that high transaction costs for private parties to collect environmentally-relevant information suggest the need for regulatory agencies to fill the gaps);
59. Kysar & Salzman, supra note 11, at 1350 (presenting a model of how information flows through regulatory institutions);
60. Sidney A. Shapiro & Rena Steinzor, Capture, Accountability, and Regulatory Metrics, 86 TEX. L. REV. 1741, 1769 (2008) (supporting well-publicized informational metrics that would focus the public and oversight authorities on an agency's core missions);
61. Wagner, Commons Ignorance, supra note 3, at 1791 (suggesting institutional and legal reforms to cope with the toxicity data gap).
62. See Holly Doremus, Scientific and Political Integrity in Environmental Policy, 86 TEX. L. REV. 1601 (2008) (noting examples of agency misuse of scientific information);
63. Mary L. Lyndon, Secrecy and Access in an Innovation Intensive Economy: Reordering Information Privileges in Environmental, Health, and Safety Law, 78 U. COLO. L. REV. 465, 491-501 (2007) (trade secret protections);
64. infra text accompanying note 39 (statutory barriers);
65. infra text accompanying note 45 (judicial review requirements).
66. TSCA § 1, 15 U.S.C. § 2601 (2006).
67. U.S. GOV'T ACCOUNTABILITY OFFICE, REPORT TO THE CONGRESS, HIGH-RISK SERIES: AN UPDATE 22 (2009), available at http://www.gao.gov/ new.items/d09271.pdf.
68. Id. at 9, 21 ("Without greater attention to EPA's efforts to assess toxic chemicals, the nation lacks assurance that human health and the environment are adequately protected.").
69. John S. Applegate & Robert L. Fischman, Missing Information: The Scientific Data Gap in Conservation and Chemical Regulation, 83 IND. L.J. 399, 402-03 (2008).
70. See TSCA § 5(a) (pre-manufacture notices required only for new chemicals introduced after 1979). EPA can require testing of existing chemicals on a case-by-case basis, but there are numerous hurdles to promulgating and enforcing a test rule.
71. See infra text accompanying notes 38-41 (describing statutory and judicial hurdles); TSCA § 4(a) (listing required agency findings before testing).
72. The old-new distinction in TSCA provided a means of reducing political opposition from the chemical industry by regulating new entrants and leaving existing products untouched. Applegate, Synthesizing TSCA and REACH, supra note 3, at 732.
73. GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 2, 4.
74. Joel A. Tickner et al., The U.S. Experience in Promoting Sustainable Chemistry, 12 ENVTL. SCI. & POLLUTION RES. 115,116 (2005).
75. Applegate, Synthesizing TSCA and REACH, supra note 3, at 735.
76. Applying new environmental standards only to new entrants is a common feature in U.S. environmental law. Richard B. Stewart, Regulation, Innovation, and Administrative Law: A Conceptual Framework, 69 CAL. L. REV. 1256, 1270 (1981). Such grandfathering provisions can retard industry innovation and often provide a competitive advantage to existing facilities or practices. Such grandfathering is often justified on the grounds that it would be unreasonably costly to retrofit existing plants to conform to the latest pollution control standards, and on the grounds that existing plants will soon cease operation, due to natural turnover in the capital stock. These assumptions have not proven correct even in the case of major stationary sources of emissions.
77. See Jonathan Remy Nash & Richard L. Revesz, Grandfathering and Environmental Regulation: The Law and Economics of New Source Review, 101 Nw. U. L. REV. 1677, 1708-09 (2007) (discussing evidence that grandfathering provisions result in delayed plant retirement). And these assumptions clearly do not hold in the context of chemical regulation. Older, "existing" chemicals should be subject to testing because they can continue to be used for decades, they are usually produced in the highest volumes, and they are unlikely to be phased out due to years in use.
78. TSCA § 5(a), 15 U.S.C. § 2604(a) (2006). EPA has ninety days to object or seek more information before the manufacture of new chemicals (or significant new uses of existing chemicals) can commence. TSCA § 5(c). As of June 2005, EPA review of premanufacture notices resulted in some action being taken to reduce risks of over 3,500 of the 32,000 new chemicals that companies have submitted for review since TSCA's enactment. U.S. GOV'T ACCOUNTABILITY OFFICE, CHEMICAL REGULATION: APPROACHES IN THE UNITED STATES, CANADA, AND THE EUROPEAN UNION 2 (2005), available at http://www.gao.gov/new.items/d06217r.pdf.
79. C.F.R. § 720.50(aMb) (2009).
80. Not surprisingly, only 15 percent of PMNs contain any health and safety information, and the GAO has reported that only 20 percent of PMNs receive a detailed review by EPA. GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 12. In the absence of chemical-specific test data, EPA uses computer models and structure activity relationships ("SARs") to compare new chemicals with chemicals of similar molecular structure on which toxicity data is available. id. at 11.
81. Specifically, EPA can require additional testing only when the agency finds that the chemical (1) may present an unreasonable risk of injury to health or the environment; or (2) is or will be produced in substantial quantities, and (a) there is or may be significant or substantial human exposure to the chemical or (b) the chemical enters or may reasonably be anticipated to enter the environment in substantial quantities. TSCA § 4(a).
82. See Applegate, 77ie Perils of Unreasonable Risk, supra note 3, at 319 (noting that in practice, EPA often conducts a quantitative risk assessment on a chemical prior to issuance of a test order);
83. see also Daniel A. Farber, Five Regulatory Lessons from REACH 9 (Univ. Cal. Berkeley Pub. Law, Research Paper No. 1,301,306, 2008), available at http://papers.ssrn.com /sol3/papers.cfm?abstract-id=1301306 (arguing that TSCA embodies a "reverse precautionary principle" because it allows "information to be gathered only when a risk is already known to exist").
84. GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 9.
85. TSCA § 19(c)(1)(B).
86. GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 4.
87. id. at 18.
88. TSCA Section 8, for example, imposes a requirement to "immediately inform" EPA if a manufacturer, processor, or distributor of a chemical obtains studies or data indicating that a chemical poses a "substantial risk" of injury to human health or the environment. TSCA § 8(e). In practice, the intended early warning system of Section 8 has not promoted consistent reporting to regulatory authorities, and it instead creates perverse incentives not to undertake voluntary testing of chemicals. Determining whether a study suggests a "substantial risk" from a chemical is left largely to the discretion of the manufacturer.
89. See Applegate, Synthesizing TSCA and REACH, supra note 3, at 736 ("Both Congress and the EPA define 'substantial risk' in a way that leaves reporting largely to the manufacturer's own judgment."). Moreover, manufacturer compliance with Section 8 has been sporadic.
90. See Hearing, supra note 4, at 3 (testimony of Lynn R. Goldman) (noting recurring problems with companies withholding data required to be disclosed under Section 8). In the early 1990s, EPA established a self-audit program that offered firms reduced penalties and penalty caps in exchange for implementing a compliance audit program requiring them to submit overdue Section 8 data. More than 120 companies sent EPA more than 11,000 studies on chemicals that had never been seen by the agency and that should have been submitted years earlier.
91. See Keith M. Casto & Tiffany Potter, Environmental Audits: Barriers, Opportunities, and a Recommendation, 5 HASTINGS W.-Nw. J. ENVTL. L. & FoVY 233, 251 (Spring 1999).
92. Freedom of Information Act of 1966, 5 U.S.C. § 552 (2008).
93. National Environmental Policy Act of 1969, 42 U.S.C. §§ 4321, 4331-35, 4341-47 (2000).
94. Emergency Planning and Community Right to Know Act, 42 U.S.C. §§ 11001-05, 11021-23, 11040-50 (2000).
95. Specifically, the statute states: If the Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment, the Administrator shall" restrict the chemical "to the extent necessary to protect adequately against such risk using the least burdensome requirements[.]" TSCA § 6(a).
96. See TSCA § 6(c) (outlining the factors that must be considered and published in any chemical restriction rule promulgated by EPA);
97. Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1215-17 (5th Cir. 1991) (interpreting the "unreasonable risk" standard to include analysis of the costs of any proposed restriction);
98. Applegate, Synthesizing TSCA and REACH, supra note 3, at 756 ('The 'unreasonable' terminology in TSCA is notably unspecific, and intentionally so, but it is clear that EPA must consider cost as well as risk in the determinations of 'unreasonable risk.' ")
99. TSCA § 6 (a), (c).
100. TSCA § 19(c)(1)(B).
101. GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 18. The five chemicals or chemical classes are polychlorinated biphenyls (PCB), fully halogenated chlorofluoroalkanes, dioxin, asbestos, and hexavalent chromium. id.
102. See 40 CFR §§ 763.160-763.179 (1989) (Subpart I, prohibiting "the Manufacture, Importation, Processing and Distribution" of various asbestos products). As the GAO has noted, Corrosion Proof Fittings was widely considered to be a severe blow to EPA and to the effectiveness of TSCA because "asbestos is generally regarded as one of the substances for which EPA has the most scientific evidence or documentation of substantial adverse health effects." GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 20.
103. Corrosion Proof Fittings, 947 F.2d at 1229-30. For additional discussion of Corrosion Proof Fittings, see Farber, supra note 43, at 12-14.
104. Applegate, Perils of Unreasonable Risk, supra note 3 , at 266.
105. See S. REP. NO. 94-698 , at 1 (1976), reprinted in 1976 U.S.C.C.A.N. 4491 ("The purpose of S. 3149 is to prevent unreasonable risks of injury to health or the environment associated with the manufacture, processing, distribution in commerce, use, or disposal of chemical substances. The bill is designed to fill a number of regulatory gaps which currently exist.").
106. See Applegate, Perils of Unreasonable Risk, supra note 3 , at 330 ("As an umbrella for collecting, coordinating, and creating information, [TSCA].. has the potential to be the vehicle for supplying data to other regulatory programs.").
107. See John C. Dernbach, The Unfocused Regulation of Toxic and Hazardous Pollutants, 21 HARV. ENVTL. L. REV. 1, 2 (1997) (arguing that the differences among the lists of hazardous substances regulated under various environmental statutes are "a major underlying reason for costliness and inefficiency in the current regulatory structure.").
108. In 1984, for example, the Senate rejected a TSCA amendment that would have required toxicity testing for very high volume chemicals-those produced or imported in annual quantities of 100 million pounds or more. See S. 3075, 98th Cong. § 4(b) (1984).
109. TSCA had minor amendments in 1986 to address asbestos in schools, in 1988 to regulate indoor radon gas, and in 1992 to regulate hazards from lead paint. None of these amendments altered the core provisions or incentives of TSCA.
110. See Robert B. Haemer, Reform of the Toxic Substances Control Act: Achieving Balance in the Regulation of Toxic Substances, 6 ENVTL. L. 99, 119-22 (1999-2000).
111. See DARYL DITZ, CTR. FOR INT- ENVTL. L., CLOUDY SKIES, CHANCE OF SUN: THE FORECAST FOR U.S. REFORM OF CHEMICAL POLICY I, 2 (2006), available at http://www.ciel.org/ Publications/Cloudy-Skies-9May06.pdf ('The chemical industry remains satisfied with the law as it stands.").
112. The largest of these voluntary initiatives has been the High Production Volume ("HPV") Challenge, launched with great fanfare in 1998 as a joint project of the ACC (then known as the Chemical Manufacturers Association), the EPA, and the Environmental Defense Fund. Under the HPV Challenge, industry agreed to provide toxicity data on 2800 chemicals produced in volumes exceeding one million pounds per year, and individual chemical manufacturers agreed to "sponsor" the testing for particular chemicals.
113. RICHARD A. DENISON, ENVTL. DEF. FUND, HIGH HOPES, LOW MARKS: A FINAL REPORT CARD ON THE HIGH PRODUCTION VOLUME CHEMICAL CHALLENGE 3-4 (2007), available at http://www.edf.org/documents/6653-HighHopesLowMarks. pdf.
114. Eleven years after the HPV Challenge was launched, and five years after the data sets were due, about 280 of the HPV chemicals still remain "orphans," lacking a sponsor to pay for their testing.
115. See id. at 4. Moreover, manufacturers have submitted final data sets on just over half of the chemicals that were sponsored for testing. id. at 3. EPA committed to mandate testing for any orphan chemicals under the HPV program, but EPA did not issue a test rule until 2006, and that rule covered only 16 of the 280 orphan chemicals.
116. See EPA Regulatory Actions for Unsponsored Chemicals, http://www.epa.gov/HPV/pubs/general/regactions.htm (last visited Oct. 8, 2009). Thus, the most ambitious effort ever undertaken in the United States to assess the toxicity of widely-used chemicals is still incomplete a decade after its inception. The Environmental Defense Fund concluded in 2007 that the program is still "well away from delivering on the promises it made." DENISON, supra note 66, at 3.
117. See Applegate, Synthesizing TSCA and REACH, supra note 3, at 740.
118. See GOVT ACCOUNTABILITY OFFICE, supra note 19, at 9 (because TSCA's testing provisions are "burdensome and too time consuming for EPA to administer," EPA "uses voluntary programs to help gather more data to assess risks on certain chemicals").
119. Applegate, Synthesis of TSCA and REACH, supra note 3, at 743.
120. See EUROPEAN CHEMICAL INDUSTRY COUNCIL, supra note 14.
121. For an overview of the origins of chemical legislation in the European Community, see RONALD BRICKMAN, SHEILA JASANOFF & THOMAS ILGEN, CONTROLLING CHEMICALS: THE POLITICS OF REGULATION IN EUROPE AND THE UNITED STATES 276 (1985).
122. For a concise summary of the EU chemical legislation that existed prior to REACH, see FRANK ACKERMAN & RACHEL MASSEY, GLOBAL DEV. & ENV'T INST., TUFTS U., THE TRUEV COSTS OF REACH 19-23 (2004), available at http://www.euractiv.com/29/images/ TuftsStudyonREACH-tcm29-130918.pdf.
123. For further information on European politics leading to REACH'S enactment, see Henrik Selin, Coalition Politics and Chemicals Management in a Regulatory Ambitious Europe, 7 GLOBAL ENVTL. POL. 63 (2007).
124. See REACH IN BRIEF, supra note 15, at 3; Commission White Paper on Strategy for a Future Chemicals Policy, at 19, COM (2001) 88 final (Feb. 27, 2001) (noting the incentives for industry to delay risk assessments under the prior EU chemicals legislation).
125. See ANDREW FASEY, LOWELL CTR. FOR SUSTAINABLE PROD., REACH IS HERE: THE POLITICS ARE OVER, NOW THE HARD WORK STARTS 3 (2008), www.chemicalspolicy.org /downloads/REACHisHere4-2008.pdf; Memorandum from the Directorate General Communication of the European Commission, Q and A on the New Chemicals Policy, REACH, MEMO/06/488 (Dec. 13, 2006), available at http://europa.eu/rapid/pressReleasesAction.do? reference=MEMO/06/488&format= PDF&aged=l&language=EN&guiLanguage=en.
126. Commission White Paper, supra note 74, at 6. Of the new chemicals evaluated between 1981 and 2003, the European Commission concluded that 70 percent had one or more dangerous properties. Commission Working Paper: Extended Impact Assessment, at 26-27, COM (2003) 644 final (Oct. 29, 2003), available at http://ec.europa.eu/enterprise/sectors/chemicals/files/ reach/eia- sec-2003-1171-en.pdf (discussing the knowledge gap created by the EU's earlier chemical regulations and its effect on accurate assessment of the risks of certain chemicals).
127. The costs of REACH are addressed, infra, Part (I)(C).
128. See REACH arts. 5-7, 20. Under REACH, ECHA plays a coordination role and provides the scientific expertise for evaluating chemicals. Actual regulatory authority, however, remains with the European Commission and the various Member States of the EU.
129. See Applegate, Synthesizing TSCA and REACH, supra note 3, at 741. Joint registration is permitted when numerous firms manufacture or import the same product. REACH art. 11. The term "substances" includes most chemicals but excludes foodstuffs, pharmaceuticals, many naturally occurring ores and minerals, and polymers.
130. See REACH, Exemptions From the Obligation to Register in Accordance With Article 2(7)(a), Annex IV; REACH, Exemptions From the Obligation to Register in Accordance With Article 2(7)(b), Annex V (exempting certain substances, such as sugars, oils, amino acids, fatty acids, and "basic elemental substances for which hazards and risks are already well known" from the registration requirement).
131. See REACH IN BRIEF, supra note 15, at 7 (explaining that under REACH, the tonnage of a chemical acts as a rough surrogate for potential exposure, so the amount of required testing escalates as the tonnage increases). id. For the list of tests that must be conducted on substances in the different tonnage bands, see REACH Annex VII-X.
132. See GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 41; Mark A. Greenwood, TSCA Reform: Building a Program That Can Work, 39 ENVTL. L. REP. 10034, 10040 (2009) ("[TJhe best approach for addressing the age-old new versus existing chemical issue is to remove it from the discussion.").
133. See GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 17, 43-47 (comparing the number of chemical tests under TSCA and REACH). One common criticism of REACH is that at low volume thresholds (between one and ten tons per year), REACH imposes relatively few testing requirements. Prior EU law required notification for all new substances marketed in excess of ten kilograms per year, so it is true that REACH has raised the tonnage threshold for new chemical testing.
134. See DENISON, supra note 25, at 8-10. However, the European Commission retains the authority to require testing for low-volume substances on a case-by-case basis.
135. See Commission White Paper, supra note 74, at 18. For chemicals produced or imported above ten tons per year (approximately 10,000 substances), REACH represents a significant improvement over prior EU legislation and over TSCA.
136. REACH art. 5.
137. TSCA § 6(a), 15 U.S.C. § 2601 (2006).
138. See GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 4 ("REACH is based on the principle that chemical companies have the responsibility to demonstrate that the chemicals they place on the market, distribute, or use do not adversely affect human health or the environment, while TSCA generally requires EPA to demonstrate that chemicals pose risks to human health or the environment prior to controlling risks.").
139. Applegate, Synthesizing TSCA and REACH, supra note 3, at 746.
140. Hearing, supra note 4, at 4 (testimony of Lynn R. Goldman); Sachs, supra note 3, at 348-49;
141. see also Applegate, supra note 6, at 1389 (advocating shifting the burden of proof on chemical safety to manufacturers a strategy to increase the supply of chemical data).
142. Hearing, supra note 4, at 2 (testimony of Lynn R. Goldman).
143. To be sure, an industry burden of proof heightens the possibility of Type I errors (false positive decisions in which a substance may be forced off the market even if it poses little or no actual risk). However, in balancing Type I and Type II errors, precautionary regulation should aim to minimize Type II errors, given the potential for adverse effects on human health and the environment. For more discussion on the balance of potential decision errors in a setting of scientific uncertainty,
144. see Lars Koch & Nicholas A. Ashford, Rethinking the Role of Information in Chemicals Policy: Implications for TSCA and REACH, 14 J. CLEANER PROD. 31, 34 (2006).
145. REACH IN BRIEF, supra note 15, at 12-13.
146. See REACH art. 57 (substances subject to authorization);
147. see also REACH IN BRIEF, supra note 15, at 16 (explaining that chemicals of very high concern include "[c]arcinogenic, mutagenic, or reprotoxic substances").
148. REACH, art. 58(l)(c).
149. REACH IN BRIEF, supra note 15, at 16. Industry groups have criticized REACH on the grounds that it lacks priority-setting mechanisms, given that industry must spend substantial resources on registration of thousands of chemicals, when only a small portion of these chemicals will ultimately be deemed "very high concern" under
150. REACH. See Harvey Black, Chemical Reaction: The U.S. Response to REACH, 116 ENVTL. HEALTH PERSP. 125, A126 (2008). But comprehensive identification of hazard and exposure data in the registration process, far from being a drawback of the legislation, should be seen as an advantage. It means that risk assessments will be based on full, rather than fragmentary, information, and that substances will not presumptively be deemed safe without submission of the test data and exposure information to back up that claim.
151. REACH art. 60(2).
152. REACH presumes that risks cannot be adequately controlled for persistent and bioaccumulative chemicals and for chemicals that do not have a known safe threshold below which a lack of adverse effects can be documented. id. art. 60(3).
153. id. art. 60(4).
154. id. arts. 31-32.
155. id. art. 37;
156. see also KEN GEISER & JOEL TICKNER, LOWELL CTR. FOR SUSTAINABLE PROD., NEW DIRECTIONS IN EUROPEAN CHEMICALS POLICY: DRIVERS, SCOPE, AND STATUS l, 143 (2003), available at http://www.chemicalspolicy.org/ downloads/newdirectionsfinal.pdf ("As chemical manufacturers and importers have responsibility to assess risks, there is an incentive for them to more effectively communicate with downstream users to obtain critical use data and for downstream users to ensure that they obtain hazard data from manufacturers.").
157. REACH IN BRIEF, supra note 15, at 11.
158. See id. at 8 (explaining that REACH makes both chemical manufacturers and downstream users responsible for the safe handling and use of chemicals).
159. GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 37;
160. see also Tickner, supra note 36, at 6 (explaining that chemical manufacturers often know very little about the uses of their own chemicals more than one or two steps down the supply chain and arguing that "[i]t is virtually impossible to manage chemicals without this knowledge").
161. For more information on the right-to-know provisions of REACH, see Applegate, Synthesizing TSCA and REACH, supra note 3, at 750-51.
162. See REACH art. 77(2)(e) (mandating that information is to be made publicly available over the Internet, except where a specific request for confidentiality is deemed justified).
163. In a 2007 report, the U.S. Government ACCOUNTABILITY Office noted persistent problems with overbroad confidentiality claims by the chemical industry under TSCA. GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 26 (noting that challenging confidentiality claims is "resource-intensive" for EPA and that many confidentiality claims, when challenged, are found to be inappropriate).
164. In contrast, "REACH places substantial restrictions on the types of data that chemical companies may claim as confidential." id. at 27.
165. REACH art. 33. This requirement is triggered if the product contains any substance that is subject to authorization, at greater than 0.1 percent by weight. id.
166. id.
167. Green chemistry refers to designing products and substances in ways that minimize chemical risks to human health and the environment.
168. See PAUL ANASTAS & JOHN WARNER, GREEN CHEMISTRY: THEORY AND PRACTICE 11, 30 (1998) (defining green chemistry and outlining its twelve principles, including designing chemical substances that have little or no toxicity and using safer solvents and chemicals that degrade into innocuous substances).
169. See Hearing, supra note 4, at 2 (testimony of Michael P. Wilson) (explaining that in California, businesses that use chemicals do not have sufficient data to find the least hazardous choices).
170. REACH pmbl. 12;
171. see also REACH IN BRIEF, supra note 15, at 8 (stating that one objective of REACH is to "encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available. The increased ACCOUNTABILITY of downstream users and better public information will create a strong demand for substitute chemicals that have been sufficiently tested and that are safe for the envisaged use.").
172. REACH art. 62(4)(e).
173. id. art. 62(4)(f).
174. id. art. 60(5)(a).
175. id. art. 64(2).
176. See 15 U.S.C. § 2605(c)(1) (2009) (requiring the Administrator to publish a statement along with any rule restricting a chemical, which must include, among other things, the benefits of the restricted chemical, the availability of substitute chemicals, and "the reasonably ascertainable economic consequences of the rule..").
177. GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 18.
178. Royal Society of Chemistry, REACH: The RSC Response, http://www.rsc.org/Science AndTechnology/Policy/Bulletins/Issuel/REACH.asp (last visited Oct. 8, 2009) ('There is concern that REACH could lead to useful chemicals being withdrawn unnecessarily due to the high cost of testing, rather than for health, safety or environmental reasons.").
179. But see ACKERMAN & MASSEY, supra note 72, at 10 (arguing that if a chemical essential to downstream users is withdrawn from the market because its manufacturer believes it is not worth paying the costs of REACH compliance, then the chemical is probably underpriced).
180. REACH IN BRIEF, supra note 15, at 11.
181. ACKERMAN & MASSEY, supra note 72, at 33.
182. id. at 43.
183. For an extensive discussion of the various cost-benefit analyses prepared when REACH was under discussion in the EU,
184. see GEISER & TICKNER, supra note 97, at 113-18.
185. id. at 139.
186. ACKERMAN & MASSEY, supra note 72, at 51. Only a few studies have attempted to monetize the public health and environmental benefits of REACH. The European Commission monetized the benefits of reduced disease and death from occupational exposures to harmful chemicals at ∈50 billion over thirty years, using a figure for the value of each life saved that is lower than figures generally used in the United States. id. Another study by the World Wildlife Fund-UK concluded that the benefits of REACH from reduced disease, mortality, and reduced productivity loss from chemical exposures will be ∈57 billion to ∈283 billion over twenty years. id. at 52.
187. See Transatlantic Business Dialogue, Trade Facts: Transatlantic Trade, http://www. abd.com/index.php?option=com-content&task=view&id= 19&Itemid=48 (last visited Oct. 8, 2009) ("Imports of chemicals by the United States from the European Union rose. to almost $78 billion in 2007.").
188. See, e.g., David Lazer, Regulatory Capitalism as a Networked Order: The International System as an Informational Network, 598 ANNALS AM. ACAD. POL. & SOC. SCI. 52, 64 (2005) ("[V]ery often policy makers have an interest in the dissemination of policies, either because of motivations around the beliefs of what is for the greater global good or because there is some benefit to the adoption by other jurisdictions of the policy maker's innovation.").
189. See Dobbin et al., supra note 12, at 450 (reviewing and distinguishing four theories explaining diffusion of policies across nations);
190. David Dolowitz & David Marsh, Learning from Abroad: The Role of Policy Transfer in Contemporary Policy-Making, 13 GOVERNANCE: INT'L J. POCY & ADMIN. 5, 506 (2000) (analyzing the relationship between voluntary and forced policy transfer);
191. Lazer, supra note 12, at 475 (highlighting three modes of regulatory interdependence and applying them to the regulation of fish inspection);
192. Jonathan M. Miller, A Typology of Legal Transplants: Using Sociology, Legal History and Argentine Examples to Explain the Transplant Process, 51 AM. J. COMP. L. 839, 839 (2003).
193. See Miller, supra note 124, at 839 (defining legal transplant as "the movement of laws and legal institutions between states").
194. See David Levi-Faur & Jacint Jordana, Regulatory Capitalism: Policy Irritants and Convergent Divergence, 598 ANNALS AM. ACAD. POL. & SOC. SCI. 191, 192-93 (2005) ("[W]hen a foreign rule is imposed. [i]t is not transplanted into another organism, rather it works as fundamental irritation which triggers a whole series of new and unexpected events.").
195. EU legislation on emissions controls for cement kilns, for example, would be unlikely to affect the cement industry outside the EU. The reach of the legislation would be limited to cement kilns located within the political boundaries of the EU.
196. See Richard B. Stewart, Environmental Regulation and International Competitiveness, 102 YALE L.J. 2039, 2043-45 (1993) (distinguishing between process standards and product standards and concluding that "the common interest in harmonizing process standards is typically weaker than the common interest in harmonizing product standards, where harmonization can increase the economic welfare of all nations by removing trade barriers").
197. Two-way trade (exports and imports) between the United States and the European Union exceeded $600 billion in 2007, which was almost twice as high as U.S.-China trade and nearly three times as high as U.S.-Japan trade.
198. See Transatlantic Business Dialogue, Trade Facts: Transatlantic Trade, http://www.tabd.com/index.php?option=com-content&task=view&id= 19&Itemid=48 (last visited Oct. 8, 2009) (noting that chemical exports from the United States to the European Union grew by 66 percent from 2003 to 2007).
199. Dow created twenty-three research teams to gather the chemical toxicity data needed for REACH'S pre-registration deadline of December 1, 2008. Sara Goodman, New European Disclosure Law Shifts 'Burden of Proof to Industry, GREENWIRE, June 23, 2008, http://www.eenews.net/gw. REACH also applies to any product that contains chemicals intended for release during normal or foreseeable use (such as air fresheners or ink-jet printer cartridges), REACH art. 7.1(b), so the legislation affects many large U.S. consumer product manufacturers selling in Europe, such as Procter & Gamble and Hewlett Packard.
200. NINJA REINEKE, HOW IS THE US RESPONDING TO NEW EUROPEAN CHEMICALS LAW? THEIMPACT OF EUROPE'S REACH DEBATE ON CHEMICALS POLICY DEVELOPMENT IN THE US 10 (Feb. 2008), available at http://assets.panda.org/downloads/how-is-the-us-responding-to -the-new-european-chemicals-law.pdf (explaining that "toxic lock out" occurs when products are denied access to a market because of their toxic content or their non-compliance with environmental regulations).
201. See, e.g., ChemSafe, Consulting Services for Chemical Industry, http://www.chemsafe- consulting.com/reach/consulting-firm.html (last visited Oct. 8, 2009).
202. See Appellate Body Report, European Communities-Measures Concerning Meat and Meat Products, 6, WT/DS26/AB/R, WT/DS48/AB7R (Jan. 16, 1998) (ruling that the European Community's measure was inconsistent with WTO law);
203. Panel Report, European Communities- Measures Affecting the Approval and Marketing of Biotech Products, 1, WT/DS291/R, WT/DS292/R, WT/DS293/R (Sept. 29, 2006) (ruling that parts of the European Community's regulatory regime for the approval and marketing of biotech products violated the Agreement on the Application of Sanitary and Phytosanitary Measures).
204. In January 2009, for example, the United States filed a complaint with the WTO challenging an EU ban on U.S. poultry treated with pathogen reduction chemicals. Press Release, Office of the United States Trade Representative, U.S. Files WTO Case Challenging EU Restrictions on U.S. Poultry Exports (Jan. 16, 2009), available at http://www.ustr.gov/about- us/press-office/press- releases/2009/january/us-files-wto-case-challenging-eu-restrictions-us-p.
205. See Wirth, supra note 9, at 94 (finding that "structured negative harmonization" results in "relaxation of the rigor of regulatory standards").
206. According to Wirth, the task of trade law is "to distinguish between those unilateral measures ostensibly intended to promote environmental, consumer protection, or public health goals that are legitimate exercises of governmental regulatory powers and those that are, by contrast, pretexts for protectionism." id. at 95.
207. See Tseming Yang & Robert Percival, The Emergence of Global Environmental Law 10- 12 (Vt. Law Sch. Legal Studies Research Paper Series, Research Paper No. 09-09, 2008), available at http://papers.ssrn.com/ sol3/papers.cfra?abstract-id=1269157 (describing the environmental impact assessment procedures adopted by various nations).
208. Miller, supra note 124, at 846.
209. Slaughter has defined "transgovernmental networks" as "pattern[s] of regular and purposive relations among like government units working across the borders that divide countries from one another and that demarcate the 'domestic' from the 'international' sphere." ANNE-MARIE SLAUGHTER, A NEW WORLD ORDER 14 (2004). Similarly, Kal Raustiala has defined transgovernmental networks as "loosely-structured, peer-to-peer ties developed through frequent interaction rather than formal negotiation." Kal Raustiala, The Architecture of International Cooperation: Transgovernmental Networks and the Future of International Law, 43 VA. J. INT'L L. 1, 5 (2002). Examples of these networks include the International Organization of Securities Commissioners, the International Association of Insurance Supervisors, the International Maritime Organization, and the Organization for Economic Co-operation and Development.
210. See id. at 18 (explaining the "power-shift" from the state to nongovernmental organizations). For a detailed discussion on the role of the OECD in generating transnational legal norms,
211. see James Salzman, Decentralized Administrative Law in the Organization for Economic Cooperation and Development, 68 LAW & CONTEMP. PROBS. 189, 220-21 (2005).
212. See Raustiala, supra note 139, at 52-53;
213. Anne-Marie Slaughter, Global Government Networks, Global Information Agencies, and Disaggregated Democracy, 24 MICH. J. INT'L L. 1041, 1057 (2003) (arguing that although transgovernmental networks rarely make binding rules, the information-exchange function of policy networks is invaluable to domestic regulators looking for guidance on best practices).
214. Wirth, supra note 9, at 93. Wirth notes that the OECD has had less success in coordinating national policies on a minimum set of pre-market data for new chemicals. An OECD effort to establish such a minimum data set in the early 1980s failed when the United States did not accept the plan, largely because the proposal exceeded the requirements of TSCA and other domestic legislation. id. at 99.
215. See Per-Olof Busch, Helge Jorgens & Kerstin Tews, The Global Diffusion of Regulatory Instruments: The Making of a New International Environmental Regime, 598 ANNALS AM. ACAD. POL. & SOC. SCI. 146, 152 (2005) (discussing the result of economic competition as a " 'race to the top' whereby countries seek to emulate new and ambitious regulatory approaches. and not lag behind other countries");
216. see also Jacob Park, Unbundling Globalization: Agent of Policy Convergence?, 4 INT'L STUD. REV. 230, 232 (2002) ("[I]t is frequently overlooked that it is more expensive for MNCs [multinational corporations] to maintain different regulatory standards than to maintain one global standard and to upgrade the environmental standards of the laggard facilities.").
217. See Lazer, supra note 12, at 477 (noting the incentive for jurisdictions to adhere to standards that are compatible with other jurisdictions).
218. See ELIZABETH DESOMBRE, DOMESTIC SOURCES OF INTERNATIONAL ENVIRONMENTAL POLICY: INDUSTRY, ENVIRONMENTALISTS, AND U.S. POWER 5-7 (2000) (describing the "phenomenon of internationalization of environmental policies").
219. See Yang & Percival, supra note 137, at 7 ("[R]egulatory innovations spread not only through the work of government regulators but also through the responses of the regulated communities.").
220. See DAVID VOGEL, TRADING UP: CONSUMER AND ENVIRONMENTAL REGULATION IN A GLOBAL ECONOMY 5-8 (1995);
221. Wirth, supra note 9, at 96-97 (discussing California effect).
222. See VOGEL, supra note 146, at 6. Vogel argues that the race to the top can occur under two conditions: (1) where domestic firms align themselves with environmental groups to push for strict domestic environmental standards to keep out foreign competition (a so-called "Baptist-bootlegger" coalition), and (2) where multinational corporations selling in many national markets push for harmonized national standards to achieve economies of scale and reduce barriers to global distribution. id. at 7-8, 20.
223. As Kal Raustiala explained, jurisdictions actively promote adoption of their standards abroad because they "reap the gains of convergence around their preferred outcome." Raustiala, supra note 139, at 68.
224. See JOSEPH S. NYE, JR., SOFT POWER: THE MEANS TO SUCCESS IN WORLD POLITICS, at X (2004) (defining soft power as "the ability to get what you want through attraction rather than coercion or payments").
225. Another example of a "California effect" in environmental regulation is the global spread of rules mandating double hulls for oil tankers. Such rules were enacted in multiple jurisdictions after the United States mandated double hulls for most tankers in its territorial waters, following the Exxon Valdez oil spill. See Oil Pollution Act of 1990, 46 U.S.C. § 3703a(a) (2009); NATIONAL RESEARCH COUNCIL, DOUBLE-HULL TANKER LEGISLATION: AN ASSESSMENT OF THE OIL POLLUTION ACT OF 1990 1 (1998) (noting that the Oil Pollution Act, and the subsequent adoption of a double-hull requirement in international maritime law, has led to double-hull tankers becoming the "industry standard").
226. Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, 2003 O.J. (L 37) 19.
227. See Rob Spiegel, Is Asia Ready for RoHS?, ELECTRONIC NEWS, Mar. 5, 2006, available at http://www.edn.com/article/CA6313998.html (outlining Asia's ability to meet the EU's RoHS directive).
228. See, e.g., Suzanne Deffree, China RoHS: Ready or Not, It's Here, ELECTRONIC NEWS, Mar. 12, 2007, at 2;
229. Tam Harbert, China Flexes Environmental Muscles, ELECTRONIC BUSINESS, Sept. 1, 2006, at 34 (outlining China's regulation of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl, and polybrorainated diphenyl ether).
230. Cal. Health & Safety Code § 25214.10(b) (West 2006);
231. see also Noah Sachs, Planning the Funeral at the Birth: Extended Producer Responsibility in the European Union and the United States, 30 HARV. ENVTL. L. REV. 51, 93-94 (2006) (discussing the transnational effects of the ELPs RoHS directive).
232. See Peter P. Swire, The Race to Laxity and the Race to Undesirability: Explaining Failures in Competition Among Jurisdictions in Environmental Law, 14 YALE L. & POLY REV. 67, 88-89 (1996) (describing this inter-jurisdictional "race to the bottom").
233. Raustiala, supra note 139, at 67-68;
234. see also DREZNER, supra note 12, at 5 ("Whether regulatory coordination takes place is a function of the adjustment costs actors face in altering their preexisting rules and regulations. When the adjustment costs are sufficiently high, not even globalization's powerful dynamics can push states into cooperating.").
235. See Colin Bennet, What is Policy Convergence and What Causes It?, 21 BRIT. J. POL. SCI. 215, 216 (1991) (critiquing the argument that industrialization sets in motion "certain deterministic processes.. which tend over time to shape social structures, political processes, and public policies in the same mould");
236. Daniel W. Drezner, Globalization and Policy Convergence, 3 INT'L STUD. REV. 53, 53 (2001) ("An implicit assumption of most policy analysts and some academics is that globalization leads to a convergence of traditionally national policies governing environmental regulation, consumer health and safety, the regulation of labor, and the ability to tax capital.").
237. See DREZNER, supra note 12, at 4 (discussing literature on the decline of the state in the era of globalization).
238. Park, supra note 142, at 231.
239. Legislation that tightens information flows can have similar extraterritorial effects. Gregory Shaffer has demonstrated, for example, that an EU data privacy directive enacted in 1998, which authorized the European Commission to ban data transfers from the EU to countries that do not ensure "an adequate level of protection" for data privacy, had the effect of raising the stringency of data privacy protections globally.
240. See Gregory Shaffer, Globalization and Social Protection: The Impact of EU and International Rules in the Ratcheting Up of U.S. Privacy Standards, 25 YALE J. INT'L L. 1, 7-8 (2000).
241. See David Lazer, Global and Domestic Governance: Modes of Interdependence in Regulatory Policymaking, 12 EUR. L.J. 455, 455-56 (2006) [hereinafter Lazer, Global and Domestic Governance];
242. Lazer, supra note 123, at 52;
243. Lazer, supra note 12, at 474 (discussing the interdependence of different countries' regulatory policies).
244. Lazer, supra note 12, at 480-82.
245. Lazer, Global and Domestic Governance, supra note 161, at 463.
246. Lazer, supra note 12, at 481 (noting that the initial epidemiological studies on the hazards of asbestos were conducted in Britain, and then spurred regulatory action in the United States).
247. See id. at 480 ('To the extent that states have similar policy preferences, this information becomes a public good, readily usable by any other states that might consider similar regulatory policies.").
248. See id. at 475 ('The regulatory choices of other states provide signals. to good policy options.").
249. id. at 480.
250. Lazer, supra note 123, at 53.
251. See id. at 53 (conceptualizing the international system as an informational network in which sovereign nations both produce and process information).
252. See Lazer, Global and Domestic Governance, supra note 161, at 464-65 (noting that policymakers can pay attention to only a small fraction of the informational signals from other countries about policy options).
253. See Harold Hongju Koh, The 1998 Frankel Lecture: Bringing International Law Home, 35 HOUS. L. REV. 623, 647-48 (1998) (providing examples of transnational norm entrepreneurs and governmental norm sponsors).
254. H.R. COMM. ON GOV'T REFORM-MINORITY STAFF, SPECIAL INVESTIGATIONS Drv., 108TH CONG., A SPECIAL INTEREST CASE STUDY: THE CHEMICAL INDUSTRY, THE BUSH ADMINISTRATION, AND EUROPEAN EFFORTS TO REGULATE CHEMICALS 2 (COMM. PRINT 2004).
255. For more information on opposition to REACH by the United States, see id. at 2-3;
256. GEISER & TICKNER, supra note 97, at 137-38,
257. Marc Schapiro, Toxic Inaction, HARPER'S, Oct. 2, 2007, at 78, 81-82.
258. COMM. ON GOV'T REFORM, supra note 172, at 4.
259. See Schapiro, supra note 173, at 81-82 (detailing the reactions to REACH by various groups in the United States).
260. See Wirth, supra note 9, at 102 & n.30 (describing October 9, 2006 email from the U.S. Mission to the EU to members of the European Parliament containing the subject line "REACH Second Reading: U.S. Views" and beginning "Attached is our 'voting' list on some of the amendments you will be voting on tomorrow").
261. GEISER & TICKNER, supra note 97, at 137-38;
262. COMM. ON GOV'T REFORM, supra note 172, at 15.
263. U.S. MISSION TO THE EUROPEAN UNION, U.S. SUBMITS COMMENTS ON EC'S REACH PROPOSAL TO WTO COMMITTEE, NOTIFICATION G/TBT/N/EEC/52 REGARDING EUROPEAN COMMISSION REGULATION COM (2003), available at http://dublin.usembassy.gov/irelanoV eechemical-proposals.html. Among the U.S. concerns presented were that REACH was too complex and represented an "unworkable" regulatory approach; that its key definitions and terms were vague; that it would disrupt global trade; and that the legislation would impose "burdensome analytical, reporting and administrative requirements" on downstream users of chemicals. id.
264. See, e.g., GREENPEACE, Toxic LOBBY: How THE CHEMICALS INDUSTRY IS TRYING TO KILL REACH 16-17 (2006), available at http://www.greenpeace.org/raw/content/international /press/reports/toxic-lobby- how-the-chemical.pdf ("Such an international lobbying strategy, closely coordinated with industry representatives, proved to be extremely effective especially in watering down the draft REACH proposal, leading to a much weaker final draft in October 2003.").
265. See DlTZ, supra note 65, at 2 ('The long stalemate over TSCA is beginning to shift. Public concerns about specific chemicals are giving way to a look at systemic failures and root causes.").
266. UNTV. OF PITTSBURGH EUR. UNION CTR. OF EXCELLENCE & UNRV. OF PITTSBURGH GRADUATE SCH. OF PUB. HEALTH, A NEW EU APPROACH TO CHEMICAL SAFETY: LESSONS FOR THE UNITED STATES? A CONFERENCE ON THE EUROPEAN UNION (EU) REGULATION PROVIDING FOR REGISTRATION, EVALUATION, AUTHORIZATION, AND RESTRICTION OF CHEMICALS (REACH) 10 (2007), available at http://www.ucis.pitt.edu/euce/events/policyconf/07/PDFs/ ReachReport.pdf.
267. See Michael Wilson & Megan Schwarzman, California Chemicals Policy and the European Union, Address at California-EU Regulatory Cooperation Project 3-4 (Feb. 22-23, 2008), available at http://repositories.cdlib. org/cgi/viewcontent.cgi?article=1157&context=igs (noting that the California Green Chemistry initiative was spurred, among other things, by the enactment of REACH and lack of federal attention to chemical policy reform);
268. see also Memorandum from Linda S. Adams, Cal. Sec'y for Envtl. Prot., to Chairpersons and Dirs. of the Bds., Dep'ts, and Office 1 (Apr. 20, 2007), available at http://www.dtsc.ca.gov/Pollution Prevention/ GreenChemistrylnitiative/upload/CalEP A-Green-Chemistry-Initiative-Memo.pdf (noting that in 2007 alone, fifty bills addressing chemical safety and regulation were introduced in the California legislature).
269. See Nat'l Caucus of Envtl. Legislators, Enacted Laws, Executive Orders & 2007 Introduced Bills: PBDE Legislation (July 13, 2007), available at www.ncel. net/articles/PBDE.Legislation.Laws.Website.doc (listing the eleven states with brominated flame retardant restrictions);
270. Jennifer 8. Lee, California to Ban Chemicals Used as Flame Retardants, N.Y. TIMES, Aug. 10, 2003, at N14 (noting that California followed the Ell's lead).
271. Assem.B. 1879, 2008 Cal. Legis. Serv. 559 (West) (codified as amended at CAL. HEALTH & SAFETY CODE §§ 25252-55, 25257);
272. accord. Margot Roosevelt, California Officials Launch Green Chemistry Initiative, L. A. TIMES, Dec. 17, 2008, at Bl;
273. see also S.B. 509, 2008 Ca. Legis. Serv. 560 (West) (establishing an online clearinghouse for information on toxic chemicals in consumer products).
274. An Act for a Healthy Massachusetts: Safer Alternatives to Toxic Chemicals, S. 2481, 2008 Leg., 185th Sess. (Mass. 2008).
275. See Daryl Ditz, The States and the World: Twin Levers for Reform of U.S. Federal Law on Toxic Chemicals, 8 SUSTAINABLE DEV. L. & POLY 27, 30 (2007) ('The current upsurge of state laws on chemicals aims not only to protect their own citizens, but also to create a political environment for long overdue national reform.");
276. cf. J.R. DeShazo & Jody Freeman, Timing and Form of Federal Regulation: The Case of Climate Change, 155 U. PA. L. REV. 1499, 1533 (2007) (arguing that state-level climate change legislation is hitting a political "sweet spot" that is creating pressure on federal legislators to adopt a climate change bill).
277. See Democrats Roll Out Broad Chemical Risk Management Reform Bill, INSIDE EPA WKLY. REPORT, May 30, 2008, at 18; accord. Pat Phibbs, Report Lists Actions Congress Could Take to Improve EPA Assessments under TSCA, 29 Chem. Reg. Rep. (BNA) 702 (July 18, 2005) (quoting Sen. Lautenberg: "Europe gave us the inspiration to look hard at our own chemical law and ways to improve it.").
278. Kid-Safe Chemicals Act of 2008, S. 3040, 110th Cong. (2008);
279. H.R. 6100, 110th Cong. (2008);
280. S.1391, 109th Cong. (2005) (introduced as the Child, Worker, and Consumer-Safe Chemicals Act of 2005). Sen. Lautenberg has indicated he intends to introduce the Kid-Safe Chemicals Act in the 111th Congress. Scientific Integrity and Transparency Reforms at the Environmental Protection Agency: Hearing Before the H. Comm. and Subcomm. on Oversight, 111th Cong. (2009) (statement of Sen. Frank Lautenberg), available at http://lautenberg. senate.gov/newsroom/Hearings/060909.cfm.
281. S. 3040 § 3. The Kid-Safe Chemicals Act mandates that all existing and new chemicals be reviewed for prioritization, that a priority list of at least 300 chemicals be developed by EPA, and that EPA determine whether the manufacturer has met the "reasonable certainty of no harm" test within three years of a chemical being placed on the list.
282. See H.R. 6100 (listing Waxman as a co-sponsor);
283. Zachary Coile, EPA Was Stymied by White House, GAO Reports, S.F. CHRON., Apr. 30, 2008, at Al (indicating Boxer's support for chemical regulation reform).
284. See REINEKE, supra note 131, at 4 ("NGOs believe that a more comprehensive approach is needed and would like to see some paradigm shifts similar to the ones REACH was aiming for.").
285. See GOV'T ACCOUNTABILITY OFFICE, supra note 19, at 3-6;
286. GOV'T ACCOUNTABILITY OFFICE, supra note 30, at 2;
287. GOV'T ACCOUNTABILITY OFFICE, supra note 39, at 2-16.
288. See David P. Baron & Daniel Diermeier, Strategic Activism and Non-Market Strategy 4 (2006), available at http://papers.ssrn.com/sol3/ papers.cfm?abstract-id-897324 (noting that activist campaigns may target manufacturers directly or may aim further "downstream," such as by boycotting retailers that sell goods from certain manufacturers).
289. See GEISER & TlCKNER, supra note 97, at 144 (noting that "the U.S. is at least several years behind European countries in public discussions on chemicals.").
290. Revisiting the Toxic Substances Control Act of 1976: Hearing Before the Subcomm. on Commerce, Trade, and Consumer Prot. of the H. Comm. on Energy and Commerce, 111th Cong. 2 (2009) (Statement of Cal Dooley, President, AM. Chemistry Council) (emphasis in original), available at http://energycommerce.house.gov/Press-111/20090226/testimony-acc.pdf.
291. id. at 1.
292. AMERICAN CHEMISTRY COUNCIL, TEN PRINCIPLES FOR MODERNIZING TSCA (2009), available at http://www.americanchemistry.com/s-acc/sec-mediakits.asp?CID=2178&DID=9938.
293. Giandomenico Majone, Cross-National Sources of Regulatory Policy-Making in Europe and the United States, 11 J. PUB. POL"Y 79, 98 (1991).
294. BRICKMAN, ET AL., supra note 72, at 302-03.
295. The limits of the High Production Volume Challenge program were discussed supra, notes 66-67. The future of a second voluntary testing program for lower production volume chemicals, called the Chemical Assessment and Management Program ("ChAMP"), is in question due to EPA's surprise June 2009 decision to suspend risk assessments under the program. Cheryl Hogue, EPA Suspends Part of Chemicals Program, CHEMICAL & ENGINEERING NEWS, June 19, 2009, available at http://pubs.acs.org/cen/news/87/i25/8725news7.html. The ChAMP program, launched at the end of the Bush Administration, was widely seen as an attempt by the Administration to head off the pressure for REACH-like legislation in the United States. To Head off REACH Effort, EPA Unveils a Series of Fixes for TSCA Rules, INSIDE EPA WKLY. REP., Mar. 21, 2008, at 6;
296. see also Industry Intensifies Lobbying Against 'REACH'-Like Chemical Bills, INSIDE EPA WKLY. REP., June 20, 2008, at 4, 5. ChAMP was criticized by the NGO community, see Press Release, Envtl. Def. Fund, CHAMP Just Doesn't Have the REACH (May 2, 2008), available at http://www.edf.org/pressrelease.cfm?ContentID=7873, and the suspension of the ChAMP risk assessments may indicate that EPA is reconsidering its overall approach to chemical regulation.
297. UNTV. OF PITTSBURGH EUR. UNION CTR. OF EXCELLENCE & UNIV. OF PITTSBURGH GRADUATE SCH. OF PUB. HEALTH, supra note 181, at 40. This may be indicative of a larger trend toward public disclosure of potential chemical risks by U.S. firms. In March 2009, the SC Johnson Co., manufacturer of Windex, Shout, Glade, and other household products, announced that it would voluntarily disclose product ingredients on the Internet. Press Release, SC Johnson, Phthalates Phasing Out and Innovative Ingredient Communication Launched (Mar. 12, 2009), available at http://www.scjohnson.com/family/fam-pre-pre-news.asp?art-id=390. The website containing the ingredient disclosures is available at http:// whatsinsidesciohnson.com.
298. David Levi-Faur & Jacint Jordana, Preface: The Making of a New Regulatory Order, 598 ANNALS AM. ACAD. POL. &Soc. Sci. 6,8 (2005).
299. As the UC-Berkeley political scientist David Vogel has stated, in explaining the growing influence of EU environmental standards: "Even if a country does not adopt [European] standards, the firms that export to the EU do. And since most firms do export to the EU, they have adopted the EU's more stringent standards." Buck, supra note 9, at 13.
300. See Samuel Boxerman, Christopher Bell, & Kristina Nordlander, Are You Ready for REACH?, CHEMICAL ENGINEERING, Mar. 2008, at 38-39 (noting that "the initial and most visible impact of REACH might be seen in contracts, purchase orders, and so-called 'supplier declarations' [on compliance with REACH]").
301. In a 2008 study, which was updated in January 2009, the Environmental Defense Fund examined 267 chemicals that it believed met the definition of "very high concern" chemicals subject to authorization under REACH. It then examined the commercial profile of these same chemicals in the United States. It found that at least 37 percent of these chemicals are currently being produced or imported into the United States above 25,000 pounds annually, that at least 235 different companies are producing or importing these chemicals in the United States, and that only about one third of these chemicals have been subject to testing under TSCA or under voluntary programs such as the HPV Challenge. RICHARD A. DENISON, ENVTL. DEF. FUND, ACROSS THE POND: ASSESSING REACH'S FIRST BIG IMPACT ON U.S. COMPANIES AND CHEMICALS 4-5, (2008, REV. 2009).
302. Ernie Rosenberg, Changes Do Not Necessarily Bring About Change, 39 Envtl. L. Rep. (Envtl. L. Inst.) 10,074, 10,076 (Jan. 2009) (noting that deselection can happen quickly because unlike formal legal controls on chemicals, purchasing decisions "are not subject to legal, political, or scientific discipline.").
303. 2007 Outlook: REACH, New Regulations in U.S. States Suggest Volatile Year for Manufacturers, 12 Daily Env't Rep. (BNA), at B-2 (Jan. 19, 2007);
304. accord. WAL-MART, SUSTAINABILITY PROGRESS TO DATE 2007-2008, at 56, available at http://walmartstores.com/sites/ sustainabilityreport/2007/documents/ SustainabilityProgressToDate2007-2008.pdf.
305. See MICHAEL WALLS, REACH 101: UNDERSTANDING AND PREPARING FOR THE NEW EU CHEMICALS LEGISLATION 638 (2008), available at http://files.ali-aba.org/ thumbs/ datastorage/skoobesruoc/pdf/CN044-chapter-27-thumb.pdf (noting the "black-list" effect of being placed on the candidate list for authorization). Consumers may become aware of the chemical constituents of products sold in the United States through the disclosure requirements of REACH Article 33, which mandates disclosure and safe handling instructions for any articles sold in Europe that contain substances of very high concern. While REACH primarily applies to raw chemical inputs, rather than to finished consumer products, Article 33 is a notable exception. It will, for the first time, require disclosures of many hazardous product ingredients.
306. Stefan Baumgarten, Regulatory Bubble, ICIS CHEMICAL BUS., Jan. 21, 2008, at 14.
307. See TSCA § 4, 15 U.S.C. § 2601 (2006) and discussion supra notes 30, 52-59 and accompanying text, for further explanation of TSCA testing and information requirements.
308. TSCA § 11(c). EPA would have to be willing to use its existing subpoena power to obtain these documents. But see Greenwood, supra note 80, at 10,039 (noting that EPA has "virtually ignored" its Section 11 subpoena power to date).
309. TSCA § 8(e); see also discussion of EPA's prior implementation of Section 8, supra note
310. Organization for Economic Co-operation and Development [OECD], Decision Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, OECD Doc. C(81)30 (May 12, 1981), as amended by OECD, OECD Doc. C(97)186 (Nov. 26, 1997), available at http:// webdominol.oecd.org/ horizontal/oecdacts.nsf/linkto/C(81)30;
311. OECD, Decision-Recommendation on Compliance with Principles of Good Laboratory Practice, OECD Doc. C(89)87 (Oct. 2, 1989), as amended by OECD, OECD Doc. C(95)8 (Mar. 9, 1995), available at http://webdominol. oecd. org/horizontal/oecdacts.nsf/linkto/C(89)87.
312. See MICHAEL P. WILSON ET AL., GREEN CHEMISTRY IN CALIFORNIA, A FRAMEWORK FOR LEADERSHIP IN CHEMICALS POLICY AND INNOVATION 63 (2006), available at http://coeh. berkeley.edu/docs/news/06-wilson-policy.pdf (arguing that REACH represents an opportunity for California "to gather information on the physical attributes and basic toxicological properties of many chemicals in commercial circulation" in the state).
313. See Sachs, supra note 3, at 326-41 (outlining hurdles to bringing tort suits over chemical exposures).
314. See Black, supra note 92, at A127 (stating that "information provided by REACH should begin to help overcome the difficulty in linking specific health problems with exposures to specific chemicals or mixtures of chemicals");
315. MARSH INC., REACH: NEW EU REGULATION FOR THE CHEMICALS INDUSTRY 3 (2007), available at http://global.marsh.com/documents/ Internationalbriefings/ REACH-International-Bulletin.pdf (noting that information generated for REACH compliance could be used in litigation in non-EU jurisdictions).
316. See, e.g., Wagner, supra note 2, at 631 (arguing that existing incentives not to undertake toxicity testing could be reversed if manufacturers could petition EPA to have their products certified as superior from the standpoint of safety);
317. Applegate, Perils of Unreasonable Risk, supra note 3, at 328-29 (advocating replacement of the "substantial evidence" standard for judicial review of TSCA test orders with an "arbitrary and capricious" standard).
318. See Wagner, Commons Ignorance, supra note 3, at 1622-25.
319. SLAUGHTER, supra note 139, at 156-65.