From brussels with love: The transatlantic travels of European law and the chemistry of regulatory attraction

American Journal of Comparative Law

Volumn 57, Issue 4, 2009, Pages 897-942

  Scott, Joanne ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

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EID: 72449153509     PISSN: 0002919X     EISSN: None     Source Type: Journal    
DOI: 10.5131/ajcl.2008.0029     Document Type: Article

References (310)

1. Judith Resnik, Law's Migration: American Exceptionalism, Silent Dialogues, and Federalism's Multiple Ports of Entry, 115 Yale L. J. 1564 (2006) [hereinafter Law's Migration].
2. See also, Judith Resnik, Foreign as Domestic Affairs: Rethinking Horizontal Federalism and Foreign Affairs Preemption in light of Translocal Internationalism, 57 Emory L. J. 31 (2007) [hereinafter Foreign as Domestic Affairs].
3. See, for a somewhat analogous and fascinating account of the impact of EU data privacy standards in the United States, Gregory C. Shaffer, Globalization and Social Protection: The Impact of EU and International Rules in the Ratcheting up of U. S. Data Privacy Standards, 25 Yale L. J. 1 (2000).
4. Regulation 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 2007 O. J. (L136) 3.
5. This term is defined in the glossary of the Commission's White Paper (White Paper: Strategy for a Future Chemicals Policy) (COM (2001) 88 final) [hereinafter White Paper] in the following way: "Burden of the Past: The 30, 000 'existing' chemicals estimated to be on the EU market, for which little or no information is available, in particular about their long-term effects on human health or the environment."
6. Existing substances represent more than ninety-nine percent by volume of the total substances on the market.
7. See the Commission's White Paper, id., at Section 2.1.
8. This was required by Directive 67/548, on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, 1967 O. J. (L196) 8, for substances placed on the market at or above a 10 kg volume threshold.
9. REACH, art. 5.
10. See the report by the United States House of Representative Committee on Government Reform-Minority Staff Special Investigations Division, A Special Interest Case Study: The Chemical Industry, the Bush Administration, and European Efforts to Regulate Chemicals, Apr. 2004, prepared for Rep. Henry A. Waxman. This, and related documents, can be accessed at http://oversight.house. gov/story.asp?ID=427. It not only charts these efforts in some detail, but also reveals the very close connections between The American Chemistry Council and the U. S. government in organizing these efforts.
11. This language is found in a message written by the then Secretary of State, Colin Powell, and addressed to thirty-six U. S. diplomatic missions in Europe, instructing them to oppose REACH. For copies of this and other such documents
12. see http://oversight.house.gov/story.asp?ID=427. This language also found its way into the U. S. submissions to the Technical Barriers to Trade Committee (TBT Committee) of the World Trade Organisation (WTO).
13. See, for example, G/TBT/M/33, para. 37.
14. For example, one of the most important international arenas for discussing REACH was the TBT Committee. This committee comprises representatives of WTO Member States, and certain international inter-governmental organizations are admitted as observers. Non-governmental actors, including, for example, consumer or environmental groups, are not allowed access to these meetings.
15. See, for the classic article on polyphonic federalism, Robert A. Schapiro, Polyphonic Federalism: State Constitutions in the Federal Courts, 87 Cal L. Rev. 1409 (1999). In polyphonic federalism, states and the federal government enjoy concurrent powers, and polyphonic federalists consider it unwise and unrealistic to try to separate their respective powers. For a similar argument in an environmental context
16. see Kirsten H. Engel, Harnessing the Benefits of Dynamic Federalism in Environmental Law, 56 Emory L. J. 159 (2006).
17. This concept will be introduced in the next section of this paper. The concept derives from REACH, art. 57.
18. Toxic Substances Control Act. Pub. L. No. 94-469, 90 Stat. 2003 (codified at. 15 U. S. C. § 2601-2692).
19. For a fuller account, see, in relation to the former, Elizabeth Fisher, The "Perfect Storm'of REACH: Charting Regulatory Controversy in The Age of Information, Sustainable Development, and Globalization, 11 Journal of Risk Research 541 (2008) ;
20. Veerle Heyvaert, No Data, No Market. The Future of EU Chemicals Control Under the REACH Regulation, 9 Environmental L. Rev. 201 (2007) ;
21. Joanne Scott, REACH: Combining Harmonisation with Dynamism in the Regulation of Chemicals, in Environmental Protection: European Law and Governance 56 (Joanne Scott ed., 2009) and the references therein;
22. in relation to the latter, John S. Applegate, Synthesizing TSCA and REACH: Practical Principles for Chemicals Regulation Reform 35 (4) Ecology L. Q. 721 (2009).
23. Supra note 1.
24. The language of "ports of entry" is drawn from the title of Resnik's article, Law's Migration, supra note 1.
25. Michael P. Wilson with Daniel A. Chia & Bryan C. Ehlers, Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation, (California Policy Research Center, 2006) ;
26. Executive Summary, at xii, 32-35, at http://www.ucop. edu/cprc/documents/greenchemistryrpt.pdf [hereinafter Executive Summary]. This also highlights the environmental justice dimension of this issue, reporting that in California, lower-income groups and minority populations are at an increased risk of exposure to hazardous chemicals and chemically induced disease (at 26).
27. Id.
28. Id., at 26-28 for an overview of the evidence.
29. See the results of the Centers for Disease Control and Prevention, Third National Report on Human Exposure to Environmental Chemicals, (CDC, 2005) and the discussion id.
30. See also the recent report by the Environmental Working Group on Fire Retardants in Toddlers and their Mothers, (2008) at http://www.uspirg.org/ uploads/19/cC/19cCFr7sXSV8Tm70PpkiLQ/Fire-Retardants-in-Toddlers-and-Their- Mothers. pdf. It established that children in the United States have much higher levels of chemicals known as PBDEs (Polybrominated diphenylethers) in their blood than their parents, and that they have among the highest levels in the industrialized world (Executive Summary, at 3). The U. S. Environmental Protection Agency (EPA) acknowledges that "[t]here is growing evidence that PBDEs persist in the environment and accumulate in living organisms, as well as toxicological testing that indicates these chemicals may cause liver toxicity, thyroid toxicity, and neurodevelopmental toxicity"
31. see http://www.epa.gov/oppt/pbde/).
32. Executive Summary, supra note 16, at xii and 29.
33. World wide sales in 2007 are said to have amounted to €1820 billion, an increase of four percent over the previous year.
34. See http://www.cefic.be/factsandfigures/level02/profile-index.html. This also points to the rise of Asia (including China and India) as a manufacturer of chemicals.
35. The figures for the United States are taken from the American Chemistry Council, "US Chemistry Industry Profile" at http://www. americanchemistry.com/s-acc/bin. asp?CID=473&DID=1596&DOC=FILE. PDF. The American Chemistry Council is the principal trade association in the United States, representing the leading chemicals companies. For further details
36. see its website at www.americanchemist ry.com/. The data relate to the year 2006.
37. The figures for the European Union are taken from the European Chemical Industry Council Website (CEFIC) at www.cefic.be/factsandfigures/. This is the industry association representing the European chemical industry. These figures relate to the year 2007.
38. The figures on EU/NAFTA imports and exports comes from the CEFIC site, id.
39. For BASF
40. see BASF Facts and Figures at http://berichte.basf.de/en/2008. For Dow
41. see the Dow Corporate Report 2008 at http://www.dow.com/corporatereport/ 2008/.
42. Toxic Substances Control Act, supra note 12.
43. Applegate, supra note 13, offers an excellent account of the TSCA's promise and limitations. The discussion here draws heavily on his account.
44. See Applegate, supra note 13, and the references therein. A variety of NGOs have also been vociferous critics. This is especially true of the Centre for International Environmental Law (for details of its Chemical Program
45. see http://www.ciel.org/Chemicals/chem-program.html) and the Environmental Defense Fund (for details of its work on chemicals
46. see http://www.edf.org/page.cfm?tagID=90). Richard Denison is a Senior Scientist at Environmental Defense.
47. See Richard Denison, Not that Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals (Environmental Defense, 2007), at http://www.chemicalspolicy.org/downloads/6150- NotThatInnocent-ExecSum.pdf.
48. The Government Accountability Office has been vocal in its criticisms.
49. See its Chemicals Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Mange its Chemical Review Program, GAO-05-485 (Washington, D. C., June 13, 2005) [hereinafter GAO, 2005] and its Chemicals Regulation: Comparison of U. S. and Recently Enacted European Union Approaches to Protect Against the Risks of Toxic Chemicals, GAO-07-825 (Washington D. C., Aug. 17, 2007).
50. Executive Summary, supra note 16.
51. Wilson, supra note 16, at ch. 3.
52. There are around 62, 000 existing substances.
53. GAO, 2005, supra note 29, at 10.
54. Applegate, supra note 13, at 13. Applegate points out that only 140 of these were imposed by rule, rather than undertaken with the consent of the manufacturer.
55. James W. Conrad Jr., Open Secrets: The Widespread Availability of Information About the Health and Environmental Effects of Chemicals, 69 Law & Contemporary Problems 141 (2007). For an overview of these programs in the chemicals sectors
56. see GAO, 2005, supra note 29, at 40-43. The most important voluntary initiative is the High Production Volume (HPV) Challenge Program. It provides for the voluntary submission of data on chemicals which are produced or imported at high volume (the threshold is set at one million pounds or the equivalent of 500 metric tons). There are around 2, 800 chemicals in this category. For more details about this program
57. see http://www.epa.gov/HPV/.
58. Applegate, supra note 13, at 14. Applegate discusses in particular the HPV program, offering an overview of various studies of it. He concludes that they "paint a remarkably consistent picture of the lack of data (publicly available data, to be sure, but the existence of private data cannot be verified) concerning HPV chemicals, the chemicals that one would expect to support the greatest amount of risk research."
59. See GAO, 2005, supra note 29. Many concerns arise in relation to these voluntary programs, in particular the HPV program. One is that volume is not a good proxy for risk. Also, information has not been provided for a significant number of high production volume chemicals (around 300). Even when it is provided, doubts have been expressed whether the information is adequate to allow the EPA properly to assess risks.
60. U. S. EPA, Office of Inspector General, Evaluation Report: Voluntary Programs Could Benefit from Internal Policy Controls and a Systematic Management Approach, Report No. 2007-P-00041 (Sept. 25, 2007), at http://www.epa.gov/oig/ reports/2007/20070925-2007-P-00041.pdf. This report covers all voluntary programs and not only those that relate to chemicals.
61. This standard applies to existing chemicals and to new chemicals which have been included in the TSCA inventory. The EPA has additional powers to restrict new chemicals before they are marketed, and has done so in around ten percent of cases. Bearing in mind the data deficit that exists even in relation to new chemicals, these powers are not sufficient to close the safety gap.
62. These are polychlorinated biphenyls (PCBs), fully halogenated chlorofluroalkanes, dioxins, asbestos, and hexavalent chromium.
63. See Corrosion Proof Fittings, Inc. v. EPA, 947 F.2d 1201 (5th Cir. 1991).
64. Wilson, supra note 16, at 19.
65. As John Applegate puts it, "[w]hile neither the White Paper nor the Explanatory Memorandum that accompanied the actual legislation mention TSCA by name, it is hard to read them as anything other than an effort to be everything that TSCA was not, " supra note 13, at 19. Applegate also points out how important the development of new environmental principles has been over the last decade.
66. See supra note 3, and in particular Section 2:1, for a discussion of the problems inherent in the existing legislative framework and necessitating the adoption of REACH.
67. REACH, art. 5.
68. REACH, art. 6 (1). Note the elaborate provisions laid down in the regulation relating to data sharing between companies, particularly in respect of data deriving from studies involving tests on vertebrate animals (REACH, arts. 25-27 and arts. 29-30). Note also the important and complex provisions on joint registration in cases where a given substance is to be manufactured in the EU, or imported into the EU, by more than one company (REACH, art. 11). This joint registration requirement has led to the establishment of industry registration consortia.
69. See, by way of example, the Ethanol REACH Association, at http://www.etoh-reach.com/templates/mercury.asp ?page-id=1492. There are 3, 374 companies that pre-registered ethanol.
70. REACH, art. 6 (1). The definition of a preparation is given in REACH, art. 3 (2). It is a mixture or solution composed of two or more substances.
71. REACH, art. 7 (1). This is subject to the one ton threshold. An article is defined in art. 3 (3) REACH. The object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition. Application of this definition to specific products has proved controversial.
72. See the relevant Chemical Agency guidance document at http://reach.jrc.it/docs/guidance-document/articles-en. pdf.
73. REACH, art. 12 (1). A guidance note on information requirements is set out in Annex VI but does little to build upon this. It does make it clear that registrants have to be somewhat proactive in collating information by, for example, undertaking a literature search.
74. There is one exception. More information has to be submitted for Annex III phase-in substances than for non-Annex III phase-in substances. For the latter, no toxicological or ecotoxicological information is required, but only physicochemical information in accordance with s. 7 of Annex VII. Annex III substances include category 1 and 2 carcinogens, mutagens, and reproductive toxicants (CMRs), those which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) and meet Annex XIII criteria, as well as substances with dispersive or diffuse effects for which it is predicted that they are likely to meet the classification criteria for any human health or environmental effects endpoints under Directive 67/548, supra note 5.
75. For the lowest tonnage (up to 10 tons) the standard requirements in Annex VII will apply. Every time a new tonnage threshold is met (10 tons, 100 tons and 1000 tons), an additional annex will apply, imposing additional informational demands.
76. See REACH, art. 14 and also Annex I containing general provisions for assessing substances for preparing Chemical Safety Reports (CSR). A CSR must include human health, environment, and physicochemical hazard assessments, as well as an assessment of whether the substance may be characterized as PBT or vPvP. For dangerous substances and those which are PBT/vPvB, an enhanced CSR will be required, to include an exposure assessment and risk characterization.
77. REACH, art. 56.
78. These are category 1 and 2 carcinogens, mutagens and reproductive toxicants (CMRs), as well as substances which are persistent, bioaccumulative and toxic (PBTs) or very persistent and very bioaccumulative (vPvBs) and meet Annex XIII criteria.
79. REACH, art. 57 (f). This singles out endocrine disruptors on the one hand, and chemicals which are PBT or vPvB but do not meet Annex XIII criteria and so are not covered by sub-paragraphs d or e. These are the most obvious candidates for extending the categories, but not the only possible ones.
80. REACH, art. 59 (1). For the first candidate list
81. see http://echa.europa.eu/doc/press/pr-08-38-candidate-list-20081028.pdf. This includes fifteen substances.
82. REACH, art. 58. ECHA is recommending that seven substances be included on this final list: http://echa.europa.eu/doc/press/pr-09-07-annex-xiv-rec- 20090602. pdf.
83. REACH, art. 60 (4). I say "in most cases" because the Article 60 (4) conditions apply to the kinds of chemicals listed in Article 60 (3). The only chemicals to which the Article 60 (2) conditions apply are CMRs in relation to which it is possible to identify a safe use threshold, and any new categories which are added under Article 57 (f), except where it is not possible to identify a safe use threshold or where they are PBT or vPvB.
84. REACH, art. 60 (5). Where an alternative is available, the applicant is required to submit a substitution plan with the application for authorization. This must include a timetable for proposed action in relation to substitution.
85. See REACH, art. 62 (4X0.
86. REACH, art. 62 identifies the information which is to be included and which may be included. This includes a Chemical Safety Report (where not submitted in registration) and an analysis of alternatives. Article 60 (2) permits authorization when the risk is adequately controlled "as documented in the applicant's chemical safety report." Article 60 (4) states that authorization may be granted "if it is shown" that the conditions are met. The initial burden of showing this lies with the applicant, though the expert committees of the Chemicals Agency will be required to issue opinions on whether the conditions have been met.
87. The precautionary principle is listed as a principle of European environmental law in Article 175 EC Treaty and it has been found to apply also in the area of public health. See Case C-180/96, United Kingdom and Northern Ireland v. Commission, 1996 E. C. R I-3903.
88. Case T-13/99, Pfizer v. Council, 2002 E. C. R II-335, at para. 142.
89. Id., para. 143.
90. This should be read along with Article 67 (1), REACH which provides that no substance may be manufactured, placed on the market or used, except in accordance with these restrictions. It also contains a scientific research and development exception.
91. REACH, art. 68 (1).
92. Especially in accordance with the constraints imposed by the European Court of First Instance in Pfizer, supra note 62.
93. Toxic Substances Control Act, supra note 12, § 2617.
94. Id. § 2617 (a) (B).
95. Id. § 2617 (b). Conditions apply including a requirement that the state level law achieve a significantly higher degree of protection than federal law and that it not impose an undue burden on commerce. For a detailed discussion of pre-emption
96. see Preemption Choice: The Theory, Law and Reality of Federalism's Core Question (William W. Buzbee ed., 2009).
97. It is relevant here to note that the phenomenon under discussion in this paper is in large part a result of polyphonic federalism and the existence of overlapping powers at the state and federal levels in the United States. Ironically perhaps, the EU's conception of "federalism" is somewhat different in relation to REACH. That it takes the form of an exhaustive harmonisation measure is made clear by the free movement clause in REACH, Article 128. As such, Member States are in general precluded from adopting standards which are stricter than those laid down by REACH. There is a narrow safeguard clause in REACH, Article 129. While this permits emergency measures by Member States when urgent action is required to protect human health or the environment, any Member State measure must be confirmed or abrogated by the EU within sixty days. It is also true that individual Member States enjoy certain agenda setting privileges under REACH. For example, individual states can push for new substances to be added to the list of SVHC (REACH, art. 59 (3))
98. or for new restrictions on specific chemicals to be introduced (REACH, art. 69 (4)). Hopefully, these agenda setting privileges will allow for information and experience from individual Member States to feed in and shape EU-level decision-making, and to sustain learning from the Member State to the EU level. Whether or not this turns out to be true in practice remains to be seen. Be that as it may, at a conceptual level it is important for the EU to note that the United States does not share its presumption that product regulation should, in general, take the form of exhaustive harmonization in order to ensure the proper functioning of an integrated market, but that, on the contrary, in the United States, polyphonic federalism can find expression even in relation to product regulation such as the TSCA.
99. Three examples of this will be offered. In a recent report, the Lowell Center for Sustainable Production at the University of Massachusetts, notes in its report, Options for State Chemicals Policy Reform: A Resource Guide (January 2008), at http://www.chemicalspolicy.org/downloads/ OptionsforStateChemicalsPolicyReform. pdf, that "recent discussions and actions in at least eight states have raised the prospect" of chemicals reform at this level (Executive Summary, at 1). Washington state, as well as Michigan, Oregon, New York, Vermont, and Illinois have also been particularly active in this sphere, and a significant number of other states have adopted specific bans relating to particular chemicals. Choosing to offer examples from the state level does not mean that developments of this kind are not happening elsewhere. For example, certain cities in the United States have taken steps to ban particular chemicals.
100. See, for example, Prohibiting the Sale of Toys and Child Care Articles Made with Bisphenol-A or Phthalates, San Francisco Board of Supervisors, Ordinance No. 120-06 (June 15, 2006). The task of keeping track of state and local reforms in this sector has been eased considerably the recent establishment of a State Legislation Database by the Lowell Center. This includes local as well as state-level initiatives. See http://chemicalspolicy. org/uslegislationsearch.php. It also includes details of pending and proposed legislation and is fully searchable.
101. Wilson, supra note 16. Green Chemistry is defined here as "[t]he design, development and implementation of chemical processes and manufactured products that are intended to reduce or eliminate substance hazardous to human health and the environment" (at 5).
102. Wilson, supra note 16, at preface.
103. Executive Summary, supra note 16, at xiv. The arena discussed here is cleaner technologies rather than chemicals per se. Note that the report looks at a range of EU environmental initiatives and not just at REACH. Notably, it looks also at EU initiatives in the area of electronic waste. Previously, the California legislature chose to model its law on the EU's electronic waste directive (Directive 2002/95, on the restriction of the use of certain hazardous substances in electrical and electronic equipment, 2002 O. J. (L137) 19). This is known as the RoHS Directive, and the California law is known as Cal RoHS ((California Health and Safety Code Section 25214.9-25212.10.2).
104. See http://www.dtsc.ca.gov/HazardousWaste/RoHS.cfm. It is especially notable that it bans certain electronic devices from being sold in California where its sale would be banned in the EU, due to the presence of specified heavy met al.s. Significantly, amendments to the EU directive are to be automatically incorporated into Californian law
105. see § 25214.10 (b) of the California Health and Safety Code.
106. Wilson, supra note 16, at 63.
107. Id.
108. Id., at 63-64.
109. Id., at 64.
110. Executive Summary, supra note 16, at xv.
111. Wilson, supra note 16, at 92.
112. The Green Chemistry report (id.) was published in 2006 and this initiative was launched in April 2007.
113. See http://www.dtsc.ca.gov/PollutionPrevention/Green ChemistryInitiative/ index.cfm.
114. Http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/up load/SAP-Report.pdf.
115. Even where the report does not explicitly refer to REACH, the parallels can be obvious.
116. See, by way of illustration, options 25, 28, 29, 30, and 35.
117. Supra note 82, at 36-37.
118. Id., at. 42.
119. Id., at 44. It notes hat California exported $2.4 billion in chemicals to the EU, roughly ten percent of the state's $26 billion total exports to that region.
120. A. B. 1879, 2007-08 Cal. Leg., Reg. Sess., (Cal. 2008) (to be codified at Cal. Health & Safety Code §§ 25252, 25252.5, 25253, 25254, 25255, 25257) (California Chemicals of Concern).
121. See http://gov. ca.gov/index.php?/press-release/10666/.
122. § 25252 (b) (2), id., California Chemicals of Concern (emphasis added).
123. In February 2007, Senator S. Joseph Simitian introduced a chemicals bill S. B. 578, 2007-08 Leg., Reg. Sess. (Cal. 2007) (High Production Volume Chemicals). The bill did not succeed. It would have required the submission by manufacturers of information about high production volume chemicals. Among the data to be submitted was "environmental health information. " This was defined a meaning the information required under Annex X of REACH (§ 25430 (c)).
124. This picks up on the suggestion in the Lowell Report (supra note 71) that states may be able to take advantage of the chemical information submitted to European governmental authorities under REACH (at 6), and also on policy option 22 from the California Green Chemistry Report (supra note 82) laid out above.
125. S. B. 509, 2007-08 Cal. Leg., Reg. Sess., (Cal. 2008) (to be codified at Cal. Health & Safety Code §§ 25251, 25256, 25256.1, 25256.2, 25256.3, 25257.1).
126. California Clearing House, id. § 25256.3.
127. California's Green Chemistry Initiative: Final Report (December, 2008), at http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/ GREEN-Chem.pdf.
128. Id., at 25-26. While according to this recommendation, only non-confidential information would be publicly available; confidential business information should still be accessible to a designated state agency. The final report notes that "[u]sing the online product ingredient network, businesses can avoid selecting the toxic ingredients which could otherwise injure their reputation, create toxic tort liability, endanger worker protection, or result in costly waste management or clean-up liabilities" (at 26).
129. Id., at 26.
130. Id., at 27-29.
131. Id., at 27. The EU is cited, along with Canada and Japan as an example of potential sources.
132. See, in particular, REACH, art. 120 which would permit the European Chemicals Agency to disclose data to any government or national authority of a third country with which it has entered into an agreement, subject to compliance with two conditions. The purpose of the agreement must be cooperation on the implementation or management of legislation concerning chemicals covered by REACH, and the third party must protect the confidential information as mutually agreed. While REACH refers to the possibility of concluding an agreement with a national authority in third country (such as the state of California), the relevant treaty provision (art. 181a (3)) only refers to the possibility of the European Community entering into agreements with third countries and competent international organizations. It would be necessary to read "third country" here as permitting the conclusion of an agreement with a sub-national actor.
133. Id., at 30-32.
134. Id., at 31.
135. S. No. 558, 185th Gen. Ct., Gen. Sess. (Ma. 2007) (An Act for a Healthy Massachusetts).
136. See also S. No. 2406, 185th Gen. Ct., Gen. Sess. (Ma. 2007)
137. S. No. 2479, 185th Gen. Ct., Gen. Sess. (Ma. 2008) for proposed amendments.
138. See also the companion bill, S. No. 2481, 185th Gen. Ct., Gen. Sess. (Ma. 2008) (Safer Alternatives).
139. For another example
140. see S. 292, 2007-2008 Leg., Reg. Sess. (Vt. 2008), proposed in Vermont. The preamble to the proposed Vermont law acknowledges the international context by stating: " (4) Other countries have already adopted policies-such as the European Union Directive on General Product Safety and the European Union Scientific Committee on Consumer Products-that are focused on consumer health and safety and that are more restrictive regarding the use of toxic chemicals."
141. § 25 (A), An Act for a Healthy Massachusetts, supra note 101. Also, the ten substances identified as priority substances in Section 24, Senate No. 558 (An Act for a Healthy Massachusetts) are to be categorized as of high concern.
142. Recall the criteria listed in art. 57. PBTs are not included in the Massachusetts list, in contrast to REACH. But endocrine disrupters are included, while under the EU scheme they appear only in art. 57 (f) and hence require special justification to be included in the candidate or final list of substances requiring authorization.
143. § 25 (A), An Act for a Healthy Massachusetts, supra note 101.
144. § 35, id., which states that all chemicals of high concern used in Massachusetts must be put on the list of priority toxia substances within one year from the publication of the Refined Chemicals Classification List. § 25 (B) provides that this list is to be published within four years of the publication of the Preliminary Chemicals Categorization list.
145. A person manufacturing or distributing a product in Massachusetts containing a priority substance will be required to file a notice (§ 25A). This information will be used in the course of conducting alternatives assessments. Where recourse to safer alternatives would require extensive capital expenditure or training, the regulator must implement a business assistance or employee transition program, setting out a timetable for completing substitution quickly (§ 29 (5) (b)). Where there is no feasible alternative, research and development (R&D) activities will be undertaken (§ 29 (5) (c)).
146. Recall that the Massachusetts regulator will be proactive in seeking to reduce these constraints, both by engaging in focused R&D activities, and by providing assistance to firms.
147. Task Force to Promote Safer Chemicals in Consumer Products (Dec, 2007), at http://www.state.me.us/dep/oc/safechem/saferchemfinrpt.htm.
148. Me. Rev. Stat. Ann. tit. 38, §§ 1691-1699-B (2008) (Maine Toxic Chemicals in Toys Act). For similar initiatives in Washington State, Connecticut, and Illinois
149. see The Children's Safe Products Act, 2008 Wash. Sess. Laws 288
150. Act Concerning Child Product Safety, H. B. 5650, 2008 Gen. Assemb., Feb. Sess. (Conn. 2008)
151. Child-Safe Chemical Act, H. B. 5705, 95th Gen. Assemb., Reg. Sess. (I11. 2008) ;
152. S. B. 2868, 95th Gen. Assemb., Reg. Sess. (I11. 2008).
153. § 1691 (7), Maine Toxic Chemicals in Toys Act, supra note 110.
154. § 1696 (1), id.
155. § 1693 (1)
156. id. See supra note 54 for clarification regarding these acronyms.
157. For an international example
158. see Sec. 3, para. 1, Maine Toxic Chemicals in Toys Act, supra note 110, which refers to the World Health Organisation's list of category 1 and category 2A carcinogens. For a federal example
159. see Sec. 3, para. 2, concerning chemicals known or reasonably anticipated to be human carcinogens by the Secretary of the United States Department of Public Health and Human Services, pursuant to specified statutory powers. For a state level example
160. see para. 7. A. concerning the State of Washington's Department of Ecology, in relation to PBTs.
161. See Sec. 3, para. 6, Maine Toxic Chemicals in Toys Act, supra note 133, in relation to endocrine disruptors, and para. 7 in relation to vPvBs.
162. § 1694 (1), Maine Toxic Chemicals in Toys Act, supra note 110.
163. § 1694 (1) (F), id.
164. See also § 1696 (2), id. While a safer alternative will be presumed to be available if it is sold in the Untied States, the same is not true if it is being sold in the EU. Also, a safer alternative will be presumed to be available if the priority chemical has been banned by another state in the EU, but the same is not true if it has been banned by the EU.
165. The Senate Bill was sponsored by Senator Frank Lautenberg and five co-sponsors: Senators Boxer, Clinton, Kerry, Menendez, and Whitehouse (S3040). The House Bill was sponsored by Representatives Solis, Lee, Miller, and Waxman (H. R.6100). The Senate Bill is currently before the Senate Committee on
166. GAO, 2005, supra note 29. It did so in response to a request by two of the Senatorial bill's sponsors (Senators Jeffords and Lautenberg), along with Senator Leahy.
167. Id., at 37.
168. GAO, 2007, supra note 29.
169. Http://epw.senate.gov/public/index.cfm?FuseAction=Hearings. Hearing&Hearing-ID=78361662-802a-23ad-48ec-4d8bfb5ef337.
170. See also the testimony of the Honorable James B. Guilliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances at the EPA who refers to on-going chemical assessment and management efforts outside of the United States and to the fact of on-going consultations with Commission officials dealing with REACH and with OECD countries. He believes that "it is vitally important to invest in this coordination, to the greatest extent possible, so that our efforts and the international efforts to assess and manage chemicals are utilized to leverage work, avoid duplication, and improve protection of public health and the environment, both at home and abroad" (at 5-6).
171. See, for example, http://Avww.nexreg.com/regulatorynews/index.php/ category/agency/kids-safe-chemical-act/"on a bill that sounds an awful lot like the EU's REACH."
172. GAO, 2005, supra note 30, at 37. This is also reflected in the California Green Chemistry report (supra note l) and in the Lowell Center report (supra note 94).
173. Supra note 142, § 502 (a) (2).
174. Id., § 506.
175. See esp. REACH, arts. 118-19.
176. At least one campaigning group has realized that this seems a good time to push hard for reform.
177. See the letter to President Obama calling upon his administration to reform U. S. chemicals policy by, among other things, aligning it with REACH, at http://www.louisvillecharter.org/whatsnew.obama.shtml. It was penned by the Louisville Charter for Safer Chemicals, A Platform for Creating a Safe and Healthy Environment through Innovation.
178. Http://energycommerce.house.gov/.
179. Http://epw.senate.gov/public/?CFID=955523&CFTOKEN=90003509.
180. The Subcommittee on Commerce, Trade and Consumer Protection re-visited the subject of reforming the TSCA at a hearing on Feb. 29, 2009. In his opening statement, Rep. Henry Waxman noted: "We will learn from what has been done in the states and in other countries to create a more effective system of protecting against the dangers of toxic Chemicals." (http://energycommerce. house.gov/Press-lll/20090226/hawopen-ct.pdf). Richard Denison who played a central part in bringing the "SIN-List I" to the United States in his role of senior scientist at the Environmental Defense Fund testified at these hearings, calling careful attention to the reforms introduced in the EU as a result of REACH (http://energycommerce.house.gov/Press-lll/20090226/testimony denison. pdf).
181. REACH, arts. 5-7.
182. See REACH, Recital 7, Preamble, which makes it clear that in so far as obligations under REACH apply to the manufacturing of substances, they also apply if substances manufactured in the EU are exported.
183. REACH, art. 7 (2). Additional information will also be generated during the authorization processes for substances included on the final list of substances requiring authorization.
184. It does not apply, for example, when the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use, including disposal. The burden to demonstrate this will rest on the producer or exporter, and the data will be read in the light of the precautionary principle.
185. See art. 7 (3) and supra note 89.
186. REACH, arts. 118-19.
187. Art. 33 (2) refers to art. 59 (1) of REACH, which concerns the candidate and not the final list. This is not subject to the exception highlighted in supra note 136.
188. Art. 33 (2)
189. REACH. This is subject to a concentration threshold of 0.1% w/w. The obligation in art. 33 (2) is not, however, subject to the one-ton volume threshold which applies to registration and notification requirements, including the notification requirement relating to SVHC in articles (
190. see art. 7 (2)).
191. In contrast to most of the terms used, the concept of a consumer is not defined by reference to geographical location. Other concepts, also highly relevant in determining the extent of the various information burdens arising under the Regulation, are defined to exclude those who are not established in the EU. This includes references to downstream users which must, be definition, be established in the EU (art. 2 (13)) REACH.
192. For information on the Globally Harmonised System
193. see http://www.unece.org/trans/danger/publi/ghs/ghs-welcome-e.html. For a useful discussion of the background to this in the EU
194. see http://ec.europa.eu/enterprise/reach/docs/ghs/ghs-further-background- en. For the EU proposal
195. see OM (2007) 355. For the U. S. situation
196. see http://epa.gov/oppfeadl/international/globalharmon. htm. This page includes links to the EPA and other relevant agencies detailing implementation in the United States.
197. There is one minor exception. Note also that Annex XVII REACH restrictions may impose additional labeling requirements. When they do, labeling requirements should be treated as manufacturing requirements, and hence as applying also in the case of exported goods. Note though that a proposal is pending to ensure that the EU "eco-label" may not be attached to any product containing a substance of very high concern (http://chemicalwatch.com/ 1814).
198. For a discussion
199. see Clifford Rechtschaffen & Patrick William, The Continued Success of Proposition 65 in Reducing Toxic Exposures, 35 Enviro. L. Rev. 10850. Rechtschaffen and Williams offer many examples of companies, confronted with a labeling requirement, choosing instead to reformulate their products. In one example, having reformulated the product, the company began to advertise it as lead-free. The authors also offer examples, in which the introduction of labeling requirements led, over time, to the withdrawal of the product from the market, sometimes nationwide. Among the many rich details emerging from this account is the important role that NGOs have played in exploiting Proposition 65's potential.
200. Recall that this will be the case when one of the thresholds for registration or notification of substances in articles in art. 7 is not met, or when a manufacturer has succeeded in discharging its burden of proof under art. 7 (3) in relation to SVHC, and has demonstrated that exposure to humans or the environment will be excluded during normal or reasonably foreseeable conditions of use.
201. For the website of the Swedish-based NGO, see http://www.chemsec.org/. The International Chemical Secretariat is a non-profit organization "dedicated to working towards a toxic-free environment."
202. See also the recent report published by this group entitled, Campaigning Against Toxics: Using REACH Outside Europe (2008), at http://www.chemsec.org/ downloads/?filename=using-reach outside-europe.pdf.
203. Id., at 12.
204. Id., at 19.
205. Id., at 20.
206. Id., at 20-22. The first California green chemistry report offers the example of BASF which continues to produce and sell the chemical DEHP in the United States even though it has been banned and replaced with a safer substitute in Europe (Wilson, supra note 16, at 64). DEHP is used in the production of PVC and is classified in the United States as a probable human carcinogen.
207. See http://www.epa.gov/ttn/atw/hlthef/eth-phth.html.
208. Supra note 146, at 16.
209. Id., at 20.
210. Even the ChemSec report discussed above includes a section outlining its shortcomings (supra note 146, 11). This focuses on the limitations in its scope in terms of the chemicals it regulates, the weakness of the substitution requirement in relation to SVHC, and the confidentiality exception when it comes to public access to information on the Chemicals Agency database.
211. See http://echa.europa.eu/doc/press/pr-08-38-candidate-list-20081028.pdf.
212. * List. The aim of this project is to ensure that Authorisation is an effective tool to fast-track the most urgent Substances of Very High Concern for substitution, and to facilitate toxic use reduction by businesses. http://www.chemsec.org/issues/reach/REACH-sin-list.php. This was done in collaboration with an NGO advisory Committee consisting of the European Environmental Bureau, the WWF European Policy Office, Friends of the Earth Europe, the Greenpeace European Unit, the Institute Sindical de Trabajo Ambiente y Salud, the European Consumers Organisation, Women in Europe for a Common Future, the Center for International Environmental Law, and the Health and Environment Alliance.
213. See http://www.chemsec.org/documents/081021-what-is-the-sin-list.pdf.
214. For the full list and searchable database
215. see http://www.chemsec.org/list/database/index.php.
216. Http://www.chemsec.org/documents/080917-SIN-List-methodology.pdf.
217. For the program of the San Francisco workshop
218. see SIN List Initiative Spreads Influence to USA, at http:// chemicalwatch.com/1661 and http://sinlist.eventbrite.com/. It is entitled "Substitute it Now: Understanding the Origins and Exploring the Potential of ChemSec's Bold List of "Bad Actor" Chemicals."
219. The program for the RAPRA workshop (consultants to the rubber and plastics industry) can be found at http://www.rapra.net/products-and-services/ Conferences/REACH-HOUSTON-2009. asp. The discussion of the SIN List is just before lunch on day three.
220. Note also the various campaigning activities of the Center for International Environmental Law, which was a member of the Advisory Committee for the development of SIN List 1.0, and in particular the work of Daryl W. Ditz, a Senior Policy Advisor at CIEL. For an example
221. see Daryl W. Ditz, Targeting SVHCs: A Sneak Preview of the CHEMSec "SIN List, at http://www.reach-usa.com/presentations/REACH 2008-session%202d-ditz.pdf. This campaigning work is directed not only at consumers but also at suppliers, rεtailers, and investors.
222. Richard A. Denison, Across the Pond: Assessing REACH'S First Big Impact on U. S. Companies and Chemicals (Sept., 2008), at http://www.edf.org/documents/ 8538-Across-Pond-Report.pdf.
223. Id., at 6.
224. Id., at 3.
225. Id., at 4.
226. Id., at 16.
227. Environmental Defense Fund, Hundreds of U. S. Chemicals and Companies Will Be Impacted By European Union REACH Regulation: Report identifies companies in U. S. making chemicals called dangerous by EU, (Press Release, Sept. 30, 2008), at http://www.edf.org/pressrelease.cfm?contentID=8397.
228. See id.
229. See http://www.healthytoys.org/product.searchname.php?archive=false. The substances in question are lead, bromine, cadmium, chlorine, arsenic, and mercury.
230. American Chemistry Council Statement, ACC Believes NGO Reports on REACH Impacts Create Unnecessary Confusion and Public Concern, at http://www. americanchemistry.com/s-acc/sec-news-article.asp?CID=206&DID=8271 (Sept. 30, 2008).
231. Http://www.momsrising.org/node/1204.
232. This now defunct website was previously found at http://change.gov/
233. was the precursor to the still live http://www.obamaschange.com/.
234. Says the Co-Founder, Joan Blades, at http://www.louisvillecharter.org/ press. obama.shtml.
235. See http://www.greenbiz.com/news/2006/10/31/wal-mart-use-preferred-subs tances-chemical-intensive-products and Walmart's Chemicals Intensive Products Fact Sheet, at walmartstores.com/download/2341.pdf. Walmart is by no means alone in this. It has been reported that [m]ajor businesses from virtually every downstream sector are taking action on chemicals of concern. Whether it is Wal-Mart and Marks & Spencer in the retail sector, Nokia and HP in the ICT sector, Volvo and Volkswagen in the automotive sector, or Nike and the Gap in the apparel sector, all of these companies have identified chemicals of concern and are seeking to screen them from their supply-chains.
236. See the short article written by the group "SustainAbility" entitled Chemicals and the consumer: the implications of REACH from laboratory to shop-shelf, (2007), available at http://www.sustainability.com/ researchandadvocacy/issuebriefs.asp?id=751. Note also the expression of similar sentiment in the first California green chemistry report, Wilson, supra note 16, at 64.
237. Id. (SustainAbility article).
238. Id. (SustainAbility article).
239. Kerstin Heitmann & Antonia Reihlen, Case Study on "Announcement Effect" in the Market Related to the Candidate List of Substances Subject to Authorisation: Final Report (Jan. 2007), at http://ec.europa.eu/environment/ chemicals/reach/background/docs/report-announcement-effect.pdf.
240. See David. W. Case, Corporate Environmental Reporting as Informational Regulation: A Law and Economics Perspective, 76 U Col. L. Rev. 379 (2005). Case points to the important role of well organized and well resourced environmental groups in inducing "beyond-compliance" environmental performance. He emphasizes the crucial role that mandatory information disclosure requirements can have in facilitating the performance by these groups of their monitoring function (pp. 420-22).
241. A prominent and systemic example in the United States is the "Scorecard" initiative at http://www.scorecard.org/. Based on data compiled under the Toxic Release Inventory, this allows internet users to find out about pollution in their community. It is possible to search by postal code and also by company, location, chemical, or sector. It is also possible to ascertain "[w]ho's polluting?", "[w]here is the worst pollution?", and to "[c]ompare communities and states." TRI does not, however, collate information on the presence of substances in consumer articles, but is rather concerned with releases to the environment.
242. Art. 69 (6) REACH.
243. Art. 59 (4) REACH.
244. See, for example, art. 64 (3), 70 and 71 (2) REACH.
245. Electronic forms are provided on the ECHA website in order to facilitate submission of comments and information, making it easy to participate regardless of geographical location. The recorded minutes of the 3rd meeting of the Member State Committee September 30, 2008, record that a number of interested parties participated in the consultation process in relation to the sixteen dossiers submitted to encourage the inclusion of certain chemicals on the list of substances of very high concern. While the identity of these interested parties is not disclosed, the record states that "[a]ll proposals have been commented. Comments have been received from seven Member States, national and international NGOs, industry associations, companies, national authorities as well as individual persons from EU, US and Japan. " This clearly attests to the possibility for third country actors to participate.
246. See Item 11, at http://echa.europa.eu/doc/about/organisation/msc/meet- min-msc-3-20080903. pdf.
247. Recall again the discussion in Section 1, in relation to the conditions for authorization of SVHC.
248. Art. 60 (5) REACH.
249. As discussed supra in section 2.
250. See also arts. 60 (2) and 60 (4).
251. Art. 64 (3) REACH.
252. Art. 64 (4) (b), REACH.
253. Art. 64 (3), REACH.
254. Art. 64 (5), REACH.
255. See http://www.chemicalspolicy.org/.
256. See http://www.chemicalspolicy.org/about.shtml.
257. Wendy E. Wagner, "Using Competition-Based Regulation to Bridge the Toxic Data Gap" 83 Ind. L. J. 609 (2008). It should be noted that Wagner expresses disappointment with REACH for not going down this road (at 641). My argument here is that there is a stronger element of competition-based regulation than she suggests.
258. Id., at 642.
259. Id., at 643.
260. Id., at 645.
261. Id.
262. Id.
263. Id., at 649. The other problems anticipated by Wagner include the danger that there might not be significant safety differences between many chemical substances, the resource, and informational challenge that this approach would present to regulators in making superiority determinations, the fact that the resource demands on competitors might be excessive compared to anticipated benefit, as well as First Amendment and potential anti-trust problems with superiority certification and labeling schemes of this kind.
264. Id., at 648.
265. Id., at 650.
266. This paper can therefore be viewed as having much in common with the democratic experimentalist literature. For a brief overview in the environmental sphere
267. see Charles Sabel et al., Beyond Backyard Environmentalism (2000). Here the authors confine their discussion to the United States and describe what they call a "rolling-rule regulation. " This combines regulatory autonomy at the local level, information pooling between localities, and benchmarking of performance and revision of minimum standards on the basis of the actual performance of the best performing localities. This, they argue, offers a fruitful combination of localism and the benefits of regulatory decentralization on the one hand, and the discipline of national coordination on the other. Of course, what this paper describes is more ad hoc and spontaneous than the institutional framework for experimentalist federalism put forward by these authors. Nonetheless, there are common elements. This paper illustrates some of the benefits that the authors identify, in particular the importance of regulatory experimentation and the resulting possibility for regulatory learning.
268. Supra note 1. For a somewhat similar project in relation to international law, highlighting the myriad points of entry for international law
269. see Janet K. Levit, A Bottom-Up Approach to International Law Making: The Tale of Three Trade Finance Instruments 30 Yale J. Int'l. L. 125 (2005). For two (of many) leading examples of discussion of foreign law in the United States that focus upon the role of the federal courts acting as conduits for foreign law
270. see Vicki C. Jackson, Constitutional Law and Transnational Comparisons: The Youngstown Decision and American Exceptionalism, 30 Harv. J. L. & Pub. Pol'y 191 (2006) ;
271. Jeremy Waldron, Foreign Law and the Modern Ius Gentium, 119 Harv. L. Rev. 129 (2006).
272. Law's Migration, supra note 1.
273. See supra note 10.
274. Foreign as Domestic Affairs, supra note 1, at 41.
275. Law's Migration, supra note 1, at 1630-1633, 1652-1656.
276. See also Judith Resnik, Law as affiliation: "Foreign" law, democratic federalism, and the sovereigntism of the nation-state, 6 Int'l J. Const. L. (I-CON) 33 (2008), in particular at 59-62.
277. Resnik also seeks to explore what she calls the "translocal, " a term she uses to describe translocal organizations of state officials (supra note 1, at p. 34 (Foreign as Domestic Affairs)). There is only limited evidence of this as far as REACH is concerned. Nonetheless, one organization bringing together environmental regulators from different states recently engaged in an "international dialogue on ecological policy, " in part specifically in relation to REACH.
278. See the program for the 2007 Annual Workshop of this group at http://www.mswg.org/documents/2007/Madison/MSWG-Madison-interim-report-8-2-07. doc. The author of this paper addressed this workshop twice, each time including a discussion of REACH, and Robert Donckers from the European Commission also spoke specifically on this subject. The state officials present expressed much interest in REACH at this meeting.
279. Shaffer also places considerable emphasis upon the role of non-governmental actors, especially business and privacy advocates, in facilitating the impact of EU data privacy standards in the United States. Supra note 1.
280. Recall that as an objective of its Chemical Policy Initiative, it lists the goal to "[a]ssist in the development of sustainable chemicals management outside of the U. S."
281. See http://www.sustainableproduction.org/proj.chem.abou.shtml.
282. Supra note 71, REACH is referred to seven times in the fourteen page executive summary alone.
283. Supra note 71.
284. See, for example, its report on Taking it to the States: A Call for Action on Comprehensive Chemicals Policy Development (2006) which calls for California and New York "to drive innovation in creating a chemicals policy that protects human health and the environment, by applying lessons of the European Union where significant strides have been made" (at 4), at http://www.wellnetwork.org/well-network% 20PDF%20for%20download%209-19-06.pdf. With regard to the interaction between the Well Network and Lowell, there is evidence, for example, that staff of the womenled network attended a Lowell Center Conference on Framing a Future Chemicals Policy.
285. Applegate, supra note 13, at 1.
286. As described in The Economist, see Brussels rules OK: How the European Union is becoming the world's chief regulator, Sept. 20 2007, at http://www.economist. co.uk/research/articlesbysubject/displaystory.cfm? subjectid=348981&story-id=98329 00. This article refers to Mark Schapiro, Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power (2007).
287. Id., especially chap. 7. Schapiro uses arguments of global prestige and influence to press his case for regulatory change.
288. This is by contrast to the California RoHS example highlighted in supra note 74.
289. This is significant in view of the important critique of "rules globalization" put forward by Veerle Heyvaert, Globalizing Regulation: Reaching Beyond the Borders of Chemical Safety. 36 J. Law & Soc. 110 (2009). The author argues that the globalization of the regulation of one polity can result in a mismatch between global norms and local priorities, especially for developing countries, and thus damage regulatory diversity.
290. Supra note 93.
291. Recall the discussion at the beginning of section 3. Consumers can access information about which SVHC are included in articles, but they are obliged to request that the supplier provide it to them.
292. See REACH, Article 33 (3). The final green chemistry report notes almost with a sense of pride that a database of this kind would be a first for California (supra note 166, at 25).
293. This is clear from both the recently adopted Californian act on Chemicals of Concern (supra note 87) and from the final green chemistry report (supra note 94, at 28).
294. Even in Massachusetts, where aspects of the proposed legislation are closely modeled on REACH, the proposal departs in one important respect from it. By contrast to REACH, it chooses to treat endocrine disrupting chemicals like other chemicals of high concern (for example, carcinogens). In the EU, endocrine disrupting chemicals can only be included on the candidate or final list of SVHC where there is scientific evidence that they have probable serious effects on human health or the environment, and where this gives rise to a level of concern equivalent to that associated with the other substances included on the candidate list.
295. See REACH, Article 57 (f).
296. See especially REACH Art, 138. This requires the Commission to carry out a variety of specific reviews of the provisions of REACH, in accordance with a pre-determined timetable. It refers to a number of important matters including, for example, the scope of the regulation in terms of the chemicals which it covers, the information to be submitted as part of the registration process (especially for substances in relation to which no CSR is required at present), and the scope of the supply-chain information requirements in Article 33. Also included in this list is an obligation for the Commission to review whether to amend the authorization conditions for substances with endocrine disrupting effects. Experience from abroad could clearly be valuable here especially given the situation in Massachusetts previously described.
297. See also Shaffer's account (supra note 1, at 4) of the impact of EU data privacy standards in the United States and his discussion of its reasons. There is some overlap between the reasons cited here and those highlighted by Shaffer, especially in relation to EU market power and to the capacity of foreign law to alter power dynamics within a disaggregated state. Shaffer makes this latter point nicely when he writes, "The war over privacy standards is fought not just between Europe and the United States. It is a civil war as well, fought within the United States itself, with European law changing the balance of power on the fields where U. S. interest groups clash.".
298. Supra note 1. This fear is also expressed by Schapiro in his book, supra note 213, at 13. He worries that the United States might become a dumping ground for products forbidden because of their toxic effects in other countries.
299. David A. Wirth, The EU's New Impact on U. S. Environmental Regulation, The Fletcher Forum of World Affairs, Vol. 31, No. 2, Summer 2007, Boston College Law School Research Paper No. 144. Available at SSRN: http://ssrn. com/abstract= 1028733.
300. See Frank Ackermann, Elizabeth Stanton & Rachel Massey, European Chemical Policy and the United States: The Impacts of REACH, Global Development and Environment Institute Working Paper N. 06-06, Tufts University, 2006, at http://econpapers.repec.org/paper/daedaepap/06-06.htm, for more detailed facts and figures. They show that almost $14 billion of U. S. exports are subject to REACH and that there are 54, 000 jobs associated with them. It is notable that their analysis does not include substances in articles and, as they acknowledge, that their inclusion would lead to an increase in the figures presented (at 4-5).
301. Recall the information provided in supra note 25.
302. This is an international variation on a familiar theme in the U. S. literature. There has been considerable discussion about the tendency of California to adopt higher standards and for these standards to become the de facto standard of the United States as a whole. This is due in significant part to the size of the California economy.
303. See the discussion in Wirth, supra note 224.
304. See David Vogel, Trading Up: Consumer and Environmental Regulation in a Global Economy (1995). Vogel points to many examples of U. S. environmental regulation resulting in a ratcheting up of European standards. It is thus especially significant to find EU standards serving as a catalyst for higher levels of environmental protection in the United States.
305. Recall that the EU's initial candidate list includes 15 substances and the SIN List 267.
306. We should not assume that non-governmental actors will always organize to promote an acceptance of foreign law. Resnik offers the example of an ad hoc private group in the United States, set up to "oppose U. S. affiliation with the Kyoto Protocol." Supra note 205, at 60 ("Law as Affiliation").
307. I say this because of the unjustifiable restrictions on freedom of expressions that would be necessary in order to do so. Of course there are limits to the protections offered by the First Amendment, particularly in relation to commercial speech. For a discussion of these limits, in relation to product labeling and corporate campaigns
308. see Douglas A. Kysar, Preferences for Processes: The Process/Product Distinction and the Regulation of Consumer Choice, 118 Harv. L. Rev. 525 (2004).
309. See again the report in supra note 7.
310. Applegate, supra note 13, at 52.