1 The precautionary principle was included in the Treaty and referenced in EU secondary legislation without any definition. Article 191(2) of the TFEU (ex Article 174 TEC) merely declares that the EU's environmental policy “shall be based on the precautionary principle.” Although the Treaty provides no basis for doing so, the principle has also been applied to regulation of health and safety risks, and the Court has endorsed this extension.

2 There are two types of bird flu: (i) Highly Pathogenic Avian Influenza (HPAI), which spreads rapidly and results in high mortality rates within days; and (ii) Low Pathogenic Avian Influenza (LPAI), which causes generally mild disease, and may go undetected. This Summer, Italy experienced six outbreaks of HPAI in the region Emilia-Romagna. European Commission, DG Health and Consumers, Avian Influenza, http://ec.europa.eu/food/animal/diseases/controlmeasures/avian/ The World Organization for Animal Health (OIE) operates an information system providing bird flu assessment reports. OIE, http://www.oie.int/animal-health-in-the-world/update-on-avian-influenza/2013/ For a map of Europe showing cases of avian flu reported in 2006, see Joint Research Centre, Avian Flu Disease Monitoring, 2006, http://disasters.jrc.it/AvianFlu/index.asp?europe=true Some specific subtypes of HPAI, including H5N1, have infected human beings. World Health Organization, Avian Influenza in Humans, available at http://www.who.int/influenza/human_animal_interface/avian_influenza/en/

3 In a recent case in this journal, Paul Craig reviewed some key issues relating to the EU's extra-contractual liability. Paul Craig. Review, Risk, Legality and Damages. Case C-221/10P, Artegodan v European Commission and Federal Republic of Germany, EJRR 3/2013, pp. 399–403. This note does not discuss that topic.

4 EFSA, Scientific Opinion on Animal health and welfare aspects of Avian Influenza, EFSA-Q-2004-075, The EFSA Journal (2005) 266, 1–21.

5 Commission Decision 2005/760/EC of 27 October 2005 concerning certain protection measures in relation to highly pathogenic avian influenza in certain third countries for the import of captive birds, OJ L 285, 60. The term ‘poultry’ covers fowl, turkeys, guinea fowl, ducks, geese, quails, pigeons, pheasants and partridges and ratites (ostriches, emus etc) reared or kept in captivity for breeding, the production of meat or eggs for consumption, or for re-stocking. Article 1.1.a, Council Directive 1990/539/EEC.

6 Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC, OJ L 268, 24.9.1991, p. 56–68.

7 Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries OJ L 24, 30.1.1998, p. 9.

8 Commission Decisions 2005/862, 2006/79, 2006/405, 2006/522, 2007/21, and 2007/183.

9 EFSA. Scientific Opinion on Animal health and welfare risks associated with the import of wild birds other than poultry into the European Union, EFSA-Q-2005-057. The EFSA Journal (2006) 410, 1–55.

10 Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC, OJ L 268, 14.9.1992, p. 54.

11 Commission Regulation (EC) No 318/2007 of 23 March 2007 laying down animal health conditions for imports of certain birds into the Community and the quarantine conditions thereof, OJ L 84/7 (24.03.2007).

12 The report about Surinam later turned out to be inaccurate.

13 Not once, but twice, the Court states that the applicant did not argue that the final measure violated the proportionality principle due to its geographic scope. Did the Court intend to suggest that the outcome might have been different if the applicant had done so? Animal Trading, para. 149 and 165.

14 EFSA-Q-2005-057, p.5.

15 EFSA-Q-2004-075, p. 7.

16 Recitals 1 and 2, Commission Decision 2005/760/EC of 27 October 2005 concerning certain protection measures in relation to highly pathogenic avian influenza in certain third countries for the import of captive birds, OJ L 285, 60.

17 Animal Trading, para. 85 and 91. Citing Denkavit, the Court added, however, that a measure could also be justified “when new information significantly alters the perception of the danger represented by the disease.”

18 Animal Trading, para. 89.

19 Cf. Article 5.7, SPS Agreement (“[i]n cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information”).

20 Note that the EFSA opinion distinguishes between anseriformes (ducks, geese, and swans, the family of the Anatidae) and other wild birds. EFSA-Q-2005-057, p. 41.

21 See EFSA, Scientific Statement on Migratory birds and their possible role in the spread of highly pathogenic avian influenza, EFSA-Q-2005-243, 4 April 2006.

22 Recital 9, Regulation 318/2007

23 EFSA-Q-2004-075, p. 5. “HPAI of the H5N1 subtype has spilled over to the wild bird population” and “the consequences of this epidemiological situation could be unpredictable.” Id.

24 The Court notes that the Commission had asserted that “wild birds had played a greater role in the dissemination of avian influenza since 2006.” Animal Trading, para. 129.

25 EFSA-Q-2005-057, p. 7.

26 Hardman, D. K. and Ayton, P., 1997. Arguments for qualitative risk assessment: The StAR risk adviser. Expert Systems, 14 (1) pp. 24–36.CrossRefGoogle Scholar

27 In comparison, chemical safety assessment under REACH requires that “[w]hen it is not possible to establish the quantitative dose (concentration)- response (effect) relationship, then this should be justified and a semi- quantitative or qualitative analysis shall be included.” Regulation 1907/2006, Annex I, under 1.1.2.

28 The EFSA's risk assessment is relative in the sense that it attempts to rank risks relative to each other, and that each qualitative risk is relative to the unknown, which is the prevalence of the disease in wild bird populations and the rate of transmission in the process of catching and transporting. See EFSA-Q-2005-057, p. 22, 50, 54 (“little is known of the prevalence of infectious, transmissible diseases of wild birds in their natural environment”).

29 The words “low,” “moderate,” and “high,” without any range of probability being provided, require subjective interpretation in quantitative terms to have any meaning. As EFSA itself put it, “[v]erbal expressions are inherently ambiguous.” EFSA, Scientific Opinion on Risk Assessment Terminology, EFSA Scientific Committee, EFSA Journal 2012;10(5):2664.

30 Art 5.1, SPS Agreement provides as follows: “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.”

31 The standard of review is whether the “risk assessment is supported by coherent reasoning and respectable scientific evidence and is, in this sense, objectively justifiable.” Appellate Body Reports, US/Canada — Continued Suspension, para. 590.

32 WTO Appellate Body, Australia – Measures Affecting the Importation of Apples from New zealand, AB- 2010-2, WT/DS367/AB/R, 29 November 2010, para. 220. The Appellate Body added that “[a] panel should first determine whether the scientific basis relied upon by the risk assessor is “legitimate” before reviewing whether the reasoning and the conclusions of the risk assessor that rely upon such a scientific basis are objective and coherent.

33 Under the WTO case law, a qualitative risk assessment may be sufficient to meet the Article 5.1 requirement, but that does not mean that any qualitative risk assessment will be deemed sufficient.

34 The OIE defines “risk” as “likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse event or effect to animal or human health.” OIE Terrestrial Animal Health Code, Glossary, available at http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/2010/en_glossaire.htm#terme_appreciation_du_risque

35 OIE Terrestrial Animal Health Code, Glossary, available at http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/2010/en_glossaire.htm#terme_appreciation_du_risque

36 Industrial Union Department v. American Petroleum Institute (Benzene), 448 U.S. 607 (1980), at 653. See also L. Bergkamp and L Kogan, Trade, the Precautionary Principle, and Post-Modern Regulatory Process: Regulatory Convergence in the Transatlantic Trade and Investment Partnership. EJRR, 2013, pp. 493–507.

37 Industrial Union Department v. American Petroleum Institute (Benzene), 448 U.S. 607 (1980), at 656.

38 Referring to Gowan, paras. 78 and 73 and the judgments cited therein.

39 Referring to Case T-475/07, Dow AgroSciences Ltd v European Commission, 9 September 2011.

40 To support this finding, the Court refers to Pfizer and Alphapharma.

41 Cf. Gowan, para. 78.

42 Cf. Gowan, para. 75.

43 Gowan Comércio Internacional e Serviços, C-77/09, ECR I-13533.

44 The “necessity” of bird imports was not an issue in the case, but it may have been in the back of the judges’ minds.

45 Commission of the European Communities. Communication from the Commission on the precautionary principle, COM(2000), Brussels, 02.02.2000.

46 Id., p. 4.

47 The precautionary principle can be viewed as the post-modernist revenge for the embarrassment caused by the publication of Sokal's hoax article by a leading academic post-modernist journal. L. Bergkamp and L Kogan, Trade, the Precautionary Principle, and Post-Modern Regulatory Process: Regulatory Convergence in the Transatlantic Trade and Investment Partnership, EJRR, 4/2013, pp. 493–507.

48 David Vogel, The New Politics of Risk Regulation in Europe, LSE, London, 2001, available at: http://eprints.lse.ac.uk/35984/1/Disspaper3.pdf

49 Cass R. Sunstein, Irreversibility (July 12, 2008) Oxford University Press, Law, Probability and Risk, Forthcoming; Harvard Public Law Working Paper No. 08-25; Harvard Law School Program on Risk Regulation Research No. 08-1