1 Report of the WTO Panel, European Communities – Measures Affecting the Approval and Marketing of Biotech Products, 21 November 2006, WT/DS291/R, WT/DS292/R, and WT/DS293/R (‘EC–Biotech’).
2 Report of the Appellate Body, European Communities – Measures Concerning Meat and Meat Products, 13 February 1998, WT/DS26/AB/R and WT/DS/48/AB/R (‘EC–Hormones’).
3 Agreement on Sanitary and Phytosanitary Measures (‘SPS Agreement’ or ‘SPS’), reprinted in The Results of the Uruguay Round of Multilateral Trade Negotiations: The Legal Texts (Geneva: World Trade Organization, 1999) (‘The Legal Texts’), 69–84.
4 Guzman, A. T., ‘Food Fears: Health and Safety at the WTO’, 45 Virginia J. Int'l L 1 (2004) at 13.
5 Winickoff, D., Jasanoff, S., Busch, L., Grove-White, R., and Wynne, B., ‘Adjudicating the GM Food Wars: Science, Risk, and Democracy in World Trade Law’, 30 Yale J. Int'l L 81 (2005) at 98.
6 Amicus Curiae Brief, Submitted to the Dispute Settlement Panel of the World Trade Organization in the case of EC: Measures Affecting the Approval and Marketing of Biotech Products, authored by L. Busch (Michigan State University), R. Grove-White (Lancaster University), S. Jasanoff (Harvard University), D. Winickoff (Harvard University), and B. Wynne (Lancaster University), 30 April 2004 (‘amicus brief’). See also, C. E. Foster, ‘Social Science Experts and Amicus Curiae Briefs in International Courts and Tribunals: the WTO Biotech Case’, LII Netherlands International Law Review, 433 (2005).
7 Funtowicz, S. and Ravetz, J. R., ‘Three Types of Risk Assessment and the Emergence of Post-Normal Science’, in Krimsky, S. and Golding, D. (eds.), Social theories of risk (Westport, CN: Praeger, 1992), 251–274 and Funtowicz, S. and Ravetz, J. R., ‘Science for a post-normal age’, 25(7) Futures 739 (1993).
8 Request for a panel by the United States, WT/DS291/23 (7 August 2003).
9 Request for a panel by Canada, WT/DS292/17 (7 August 2003).
10 Request for a panel by Argentina, WT/DS293/17 (7 August 2003).
11 Foster, ‘Social Science Experts and Amicus Curiae Briefs’, above n. 6, 438.
12 Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms, OJ 2001 L 106/1 thereby replacing Council Directive 90/220/EEC, OJ 1990 L 117/15, as amended by Council Directive 94/15/EC, OJ 1994 L 103/20 and Directive 97/35/EC, OJ 1997 L169 (‘Deliberative Release Directive’).
13 Council Regulation (EC) 258/97, OJ 1997 L 43/1 concerning novel foods and novel food ingredients (‘Novel Foods Regulation’). Although not relevant to the case of EC–Biotech, this Regulation has subsequently been replaced by Regulation 1829/2003/EC of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, OJ 2003, L 268/1; see further E. Brosset, ‘The Prior Authorisation Procedure Adopted for the Deliberate Release into the Environment of Genetically Modified Organisms: the Complexities of Balancing Community and National Competences', 10 European Law Journal 555 (2004).
14 For further details of the EC's approval scheme, see Brosset, ibid., 556.
15 EC–Biotech, above n. 1, para. 2.5 and Foster, ‘Social Science Experts and Amicus Curiae Briefs’, above n. 6, at 437–439.
16 A. Klinke and O. Renn, ‘A New Approach to Risk Evaluation and Management: Risk-Based, Precaution-Based and Discourse-Based Strategies’, 22:6 Risk Analysis 1071 (2002).
17 EC-Biotech, above n. 1, para. 2.5.
18 Brosset, above n. 13, at 566–567 and 572–573.
19 Article 2.2 SPS, The Legal Texts, above n. 3, 70.
20 Article 5.1 SPS, ibid., 72.
21 Article 5.7 SPS, ibid., 73.
22 Article 5.5 SPS, ibid., 72–73.
23 ‘Declaration on Science and Use of Scientific Knowledge’ and the ‘Science Agenda – Framework for Action’, adopted by the International Council of Scientific Unions (ICSU) at the World Conference on Science, ‘Science for the 21st Century’, Budapest 1999, to be found in the Special Issue of Science International (Paris: ICSU, September, 1999).
24 See for example Gallopín, G. C., Funtowicz, S., O'Connor, M., and Ravetz, J., ‘Science of the 21st Century; from Social Contract to the Scientific Core’, 53 (Issue 168) International Journal of Social Science, 219 (2001).
25 Kuhn, T. S., The Structure of Scientific Revolutions, 3rd edn (Chicago, IL: University of Chicago Press, 1996), 36.
26 R. Strand, ‘What is Post-Normal Science?’, adapted from a lecture given at the University of South Carolina (Columbia) and Virginia Tech (Blacksburg), November 2002.
27 Funtowicz and Ravetz, ‘Science for a Post-Normal Age’, above n. 7, 739.
30 Fisher, E., ‘Risk and Environmental Law: A Beginner's Guide’, in Richardson, Benjamin J and Wood, Stephan (eds), Environmental Law for Sustainability (Oxford and Portland, Oregon: Hart Publishing, 2006), 97, at 104–107.
31 Crawford-Brown, D., Pauwelyn, J., and Smith, K., ‘Environmental Risk, Precaution and Scientific Rationality in the Context of WTO/NAFTA Trade Rules’, 24(2) Risk Analysis 461 (2004) at 467.
32 De Marchi, B. and Ravetz, J. R., ‘Risk Management and Governance: A Post-Normal Science Approach’, 31 Futures 743 (1999).
37 Article 5.1 SPS, The Legal Texts, above n. 3, 72.
38 Annex A.4 SPS, Ibid., 79.
39 Fisher, ‘Risk and Environmental Law’, above n. 30, at 104. Challenges to governmental decisions in US courts are easier. Regulatory agencies can be more readily sued for setting standards that producers consider too stringent or public interest groups (civil society) consider not stringent enough; see Funtowicz, Miege and Shepherd, Summary of a Workshop, on Science and Governance, Brussels, 29–30 March 2000 and Jasanoff, S., Science at the Bar: Law Science and Technology in America (Cambridge, MA/London, England: Harvard University Press, 1995), at 37–39.
40 See Fisher, ‘Risk and Environmental Law’, above n. 30, at 112. Due to the earlier accountability crises in EC public administration a division between science and politics was seen as a necessary way of ensuring that EC decision makers did not usurp their powers; see further Fisher, E. and Harding, R., ‘The Precautionary Principle and Administrative Constitutionalism: The Development of Frameworks for Applying The Precautionary Principle’, in Fisher, E., Jones, J., and von Schomberg, R., Implementing the Precautionary Principle: Perspectives and Principles (Cheltenham, UK/Northampton, MA: Edward Elgar, 2006), 113 at 125 and footnote 10 at 133.
41 Holland, I. and Kellow, A., ‘Trade and Risk Management: Exploring the Issues’, in Robertson, D. and Kellow, A., Globalization and the Environment: Risk Assessment and the WTO (Cheltenham, UK/Northampton, MA: Edward Elgar, 2001), 229, at 232.
42 D. Kriebel, J. Tickner, and C. Crumbley, ‘Appropriate Science: Evaluating Environmental Risks for a Sustainable World’, paper presented at a conference on Education for Sustainable Development, Committee on Industrial Theory and Assessment, University of Massachusetts, Lowell, MA, 23–24 October 2003, available at: http://www.uml.edu/com/cita/Kriebel.pdf.
43 Fisher, ‘Risk and Environmental Law’, above n. 30, at 112 and Fisher and Harding, ‘The Precautionary Principle and Administrative Constitutionalism’, above n. 40, at 125 together with footnote 11 at 133, noting that the EC's approach is based on the distinction between risk assessment and risk management, pursued by the US government in the National Research Council (NRC) Report of 1983, otherwise known as the ‘Red Book’; see also Commission of the European Communities (European Commission), Communication from the Commission on the Precautionary Principle, Brussels, 2 February 2000 COM(2000) 1, Final, which maintains this distinction and includes risk communication as a third element of any risk analysis.
44 De Marchi and Ravetz, ‘Risk Management and Governance’, above n. 32, 743.
45 Fisher, ‘Risk and Environmental Law’, above n. 30, 105. The Appellate Body in EC–Hormones, above n. 2, paras. 181 and 187, has subsequently stated that there is no authority for making such a clear distinction between risk assessment and risk management and that to do so could exclude from the scope of the analysis ‘all matters not susceptible of quantitative analysis’, thereby broadening the scope of a risk assessment to include qualitative factors.
46 Holland and Kellow, ‘Trade and Risk Management’, above n. 41, at 232.
48 G. J. Lake, Directorate-General for Research, ‘2(b) or not 2(b): that was the question: commitology, scientific advice and uncertainty, and open decision-making in the EU – an up-date’, paper presented at the seminar Handling Scientific Uncertainty in EU Decision-Making organized by the Green Alliance (et al.), London, 17–18 April 2000, who also describes the arcane ‘com(m)itology’ process in EC scientific decision-making.
49 Case T-13/99 Pfizer Animal Health SA v. Council of the European Union  ECR II-03305, para. 172.
50 Amicus brief, above n. 6.
51 The panel in EC–Biotech (para. 7.11) stated in a very manner-of-fact way that it ‘accepted the information submitted by the amici curiae into the record’ but in rendering its decision the panel ‘did not find it necessary to take the amicus curiae briefs into account’.
52 One of those was prepared on behalf of the so-called Amicus coalition – a transnational coalition of 15 NGOs, submitted by the Foundation for International Environmental Law and Development (FIELD), London. Another was from a group of five NGOs – Center for International Environmental Law (CIEL), Friends of the Earth – United States (FOE–US), Defenders of Wildlife, the Institute for Agriculture and Trade Policy (IATP) and the Organic Consumers Association – United States (OCA–USA).
53 Amicus brief, above n. 6, p. 6 under point 1, supported by arguments at §IV. A, pp. 20–21.
54 Ibid., p. 6, under point 2.
55 Ibid., p. 22 and conclusion 1B under §VI, at p. 44.
56 Ibid., p. 6, under point 3, supported by arguments at §IV. A.1–3, at pp. 22–23 and conclusions 1A, 1C, and 1D at §VI, at p. 44.
57 Article 8 SPS, above n. 3, 74.
58 Annex C.1(a), Ibid., 82.
59 Amicus brief, above n. 6, §IV.D.4 at p. 32.
60 Ibid., at §V.B at pp. 39–40.
61 EC–Hormones, above n. 2, para. 181.
62 Amicus brief, above n. 6, §III.A.1 at pp. 12–13.
63 Ibid., §III.B.1 at p. 15.
64 Ibid., §IV.B.3 at p. 24, citing EC–Hormones, above n. 2, para. 187.
65 Ibid., §III.C.3 at p. 18 and §IV.B.4 at pp. 24–25.
66 Ibid., §III.C.3 at p. 18.
67 Ibid., §IV.D.3 at p. 31.
68 Ibid., §IV.B.5 at p. 26.
70 Ibid., at §IV.A.1 on p. 22.
71 Ibid., at §IV.A.3 on p. 23; see Fisher, ‘Risk and Environmental Law’, above n. 30, at 124–125 who argues broadly along the same lines.
72 EC–Hormones, above n. 2, Appellate Body Report, paras. 193 and 194, taken up in EC–Biotech, above n. 1, para. 7.3028.
74 EC–Biotech, above n. 1, para. 7.3059.
77 Ibid., para. 7.3258–7.3259.
79 Annex K, being addendum 9 to the Panel Reports in EC–Biotech, above n. 1, pp. K-1 to K-2. It records the Panel's view that insufficiency of scientific evidence can be assessed both quantitatively and qualitatively, risk can be assessed as risk in the real world rather than simply under laboratory conditions, WTO Members retain their freedom of action with respect to new scientific evidence and the possibility remains that where scientific evidence is sufficient for a risk assessment at a particular time, it may prove insufficient at a later time.
80 Amicus brief, above n. 6, §V.D. at p. 41.
81 EC–Biotech, above n. 2, paras. 7.20–7.30 and Annex J, being a ‘Transcript of the Panel's Joint Meeting with Scientific Experts of 17 and 18 February 2005’.
82 Winickoff et al., ‘Adjudicating the GM Food Wars’, above n. 5 at 97–98.
83 Crawford-Brown et al., ‘Environmental Risk, Precaution and Scientific Rationality’, above n. 31, 462.
84 Amicus brief above n. 6, §III.A at p. 12.
85 Crawford-Brown et al., ‘Environmental Risk, Precaution and Scientific Rationality’, above n. 31, 468; for a view on the use of expert scientific review (or advisory) groups, see Theofanis Christoforou, ‘Settlement of Science-Based Trade Disputes in the WTO: A Critical Review of the Developing Case-Law in the Face of Scientific Uncertainty’, 8 NYU Env L J 622 (2000).
86 Foster, ‘Social Science Experts and Amicus Curiae Briefs’, above n. 6, 452.