The trade implications of the post-moratorium European union approval system for genetically modified organisms

Journal of World Trade

Volumn 46, Issue 5, 2012, Pages 1207-1238

  Viju, Crina ^a   Yeung, May T ^b   Kerr, William A ^c  

^a CARLETON UNIVERSITY   (Canada)

^b Estey Centre for Law and Economics in International Trade   (Canada)

^c UNIVERSITY OF SASKATCHEWAN   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EUROPEAN UNION; GENETICALLY MODIFIED ORGANISM; REGULATORY FRAMEWORK; TRADE FLOW; TRADE PERFORMANCE; TRADE RELATIONS; WORLD TRADE ORGANIZATION;

CANADA; UNITED STATES;

EID: 84870005841     PISSN: 10116702     EISSN: None     Source Type: Journal    
DOI: 10.54648/trad2012037     Document Type: Article

References (120)

1. The Amflora potato is the first GM product to be assessed and approved by the post-moratorium regulatory regime. While Maize 810 is also approved for cultivation in the EU, it was approved in 1998, prior to the moratorium, under the previous regulatory system.
2. See S. Smyth, P.W.B. Phillips and W.A. Kerr, "Global Governance Quandries Regarding Transformative Technologies for Bioproducts, Crops and Foods", Journal of World Trade, 43, 6(2009), pp. 1299-1323.
3. SeeW.A. Kerr, Sanitary Barriers and International Trade Governance Issues for the NAFTA Beef Market, in R.M.A. Loyns, R.M.A., K. Meilke, R.D. Knutson & A. Yunez-Naude eds., Keeping the Borders Open 26-49 (U. Guelph 2004).
4. See G.E. Isaac, Sanitary and Phytosanitary Issues, in W.A. Kerr & J.D. Gaisford eds., Handbook on InternationalTrade Policy 383-393 (Edward Elgar 2007).
5. There are three international organizations that establish international SPS standards that are recognized by the WTO.
6. See Art. 2.2 of the Agreement on the Application of Sanitary and Phytosanitary Measures.
7. Isaac, Register of Question. at 385.
8. The first major SPS case dealing with an EU ban on imports of beef produced using growth hormones actually pre-dates the SPS agreement-for a discussion of the hormone case see W.A. Kerr & J.E. Hobbs, The North American-European Union Dispute Over Beef Produced Using Growth Hormones:A MajorTest for the New InternationalTrade Regime, 25World Econ. 283-296 (2002).
9. For example, the concern that transgenic gene insertions were not achievable through natural selection and, hence, those using the technology are playing God.
10. SeeW.A. Kerr, TheWorld Trade Organization and the Environment, in H.J. Michelman, J. Rude, J. Stabler & G. Storey eds., Globalization and AgriculturalTrade Policy, 53-65 (Lynne Rienner 2001).
11. See N. Perdikis &W.A. Kerr, Can Consumer-Based Demands for Protection Be Incorporated in the WTO?-The Case of Genetically Modified Foods, 47 Canadian J. Agric. Economics 457-465 (1999). and W.A. Kerr, What is New in Protectionism?: Consumers, Cranks and Captives, 58 Canadian J. Agric. Economics 5-22 (2010).
12. Hereinafter 'the Biosafety Protocol (BSP)'.
13. Isaac, Register of Question.
14. See G.E. Isaac, M. Phillipson & W.A. Kerr, International Regulation of Trade in the Products of Biotechnology (Estey Centre Research Papers No. 2, Estey Centre for Law and Economics in InternationalTrade 2002).
15. Isaac, Register of Question.: Smyth, Phillips & Kerr, Register of Question.
16. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006) at 386.
17. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006) at 387-388.
18. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006) at 388.
19. Isaac divides risks into three categories: (1) recognized risks (for which there are data for determining risks).
20. See W.A. Kerr & J.E. Hobbs, Consumers, Cows and Carousels:Why the Dispute Over Beef Hormones is Far More Important than Its Commercial Value, in N. Perdikis & R. Read eds., The WTO and the Regulation of InternationalTrade 191-214 (Edward Elgar 2005) and G. E Isaac &W.A. Kerr, GMO's at the WTO-A Harvest ofTrouble, 37 J. WorldTrade 1083-1095 (2003).
21. See Art. 5.7 of the Agreement on the Application of Sanitary and Phytosanitary Measures.
22. For example, pregnant women taking a specific combination of drugs at the same time as consuming a GM-food.
23. See S.J. Smyth, W.A. Kerr & P.W.B. Phillips, Recent Trends in the Scientific Basis of Sanitary and Phytosanitary Trade Rules and Their Potential Impact on Investment, 12 J. World Investment & Trade 5-26 (2011).
24. SeeW.A. Kerr & G.E. Isaac, The International Treatment of Biological Material as Intellectual Property, 2 J. Intl. Biotechnology L. 105-111 (2005).
25. See H. Van den Belt, Debating the Precautionary Principle: 'Guilty Until Proven Innocent' or 'Innocent Until Proven Guilty'? at 132 Plant Physiology 1122-1126 (2003) (available at http://www.plantphysiol. org/cgi/reprints/132/3/1122.pdf).
26. Isaac & Kerr, Register of Question.
27. See W.A. Kerr & S.L. Hall, Multilateral Environmental Agreements and Agriculture: Commitments, Cooperation and Conflicts, 5 Current Agric., Food & Resource Issues 39-52 (2004) and K. Belcher, Trade Agreements and Multilateral Environment Agreements, in W.A. Kerr & J.D. Gaisford eds., Handbook on InternationalTrade Policy 427-438 (Edward Elgar 2007).
28. See A.L. Hobbs, J.E. Hobbs &W.A. Kerr, The Biosafety Protocol: Multilateral Agreement on Protecting the Environment or Protectionist Club? 39 J. WorldTrade 281-300 (2005).
29. Isaac, Phillipson & Kerr, Register of Question.
30. See R. Falkner, Negotiating the Biosafety Protocol:The International Process, in C. Bail, R. Falkner & Helen Marquard eds., The Cartagena Protocol on Biosafety, Reconciling Trade in Biotechnology with Environment and Development? 3-22 (Royal Institute of International Affairs, and Earthscan Publications Ltd. 2002).
31. See Holtby, Kerr & Hobbs, Register of Question. at 19.
32. See C. Bail, J. P. Decaestecker & M. Jorgensen, European Union, in C. Bail, R. Falkner & Helen Marquard eds., The Cartagena Protocol on Biosafety, Reconciling Trade in Biotechnology with Environment and Development? at 166-185 (Royal Institute of International Affairs and Earthscan Publications Ltd. 2002).185.
33. See C. Enright, United States, in C. Bail, R. Falkner & Helen Marquard eds., The Cartagena Protocol on Biosafety, ReconcilingTrade in Biotechnology with Environment and Development? at 95-104 (Royal Institute of International Affairs and Earthscan Publications Ltd. 2002).
34. Belcher, Register of Question. at 435.
35. Hobbs, Hobbs & Kerr, Register of Question.
36. Holtby, Kerr & Hobbs, at 51.
37. See G. Backus, P. Berkhout, D. Eaton, T. de Kleijn, E. van Mil, P. Roza, W. Uffelmann, L. Franke & B. Lotz, EU Policy on GMOs:A Quick Scan of the Economic Consequences, Report 2007-070, at 64 (LEI Wageningen UR 2008).
38. EC, GM Food and Feed: An Introduction, List of GMOs Authorized in the EU, http://ec.europa.eu/food/dyna/gm_register/index_en.cfm.
39. While maize MON 810 is also approved for cultivation in the EU, it was approved in 1998, prior to the embargo on GMOs that began in 1999.
40. See Kerr, Sanitary Barriers and International Trade Governance Issues for the NAFTA Beef Market id. for a discussion of political precaution.
41. Isaac, Phillipson & Kerr, Register of Question.
42. See R.B. Freeman, Trade Wars: The Exaggerated Impact of Trade in Economic Debate (NBER Working Paper No. 10000, National Bureau of Economic Research 2003).
43. See EC Regulation No 178/2002 of the European Parliament and of the Council of 28 January 2002: Laying Down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authorityand Laying Down Procedures in Matters of Food Safety, Celex # 32002R0178 (Official Journal of the European Communities 2002), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uriLOJ:L:2002:031:0001:0024:EN:PDF.
44. Kerr, Sanitary Barriers and InternationalTrade Governance Issues for the NAFTA Beef Market.
45. See EC Regulation No 1829/2003 of the European Parliament and of the Council Regulation of 22 September 2003 on Genetically Modified Food and Feed, Celex #32003R1829 (Official Journal of the European Communities 2003), http://eur-lex.europa.eu/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf.
46. See EFSA, Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed, 99 EFSA J. 1-100 (2006), http://www.efsa.europa.eu/en/efsajournal/pub/99.htm.
47. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
48. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
49. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
50. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
51. The GMO Panel consists of twenty-one independent experts supported by a number of specialized Working Groups drawing on a pool of more than forty external experts in fields such as allergenicity, ecology, microbiology, toxicology, plant physiology and molecular genetics. All Scientific Panel and Working Group members are required to comply with EFSA's policy on Declaration of Interests including declaring any potential conflicting interests in advance of each meeting. Their Declarations are thoroughly screened by EFSA following strict internal procedures.
52. EFSA, FAQ on Genetically Modified Organisms (European Food Safety Authority), http://www.efsa.europa.eu/en/faqs/faqgmo.htm.
53. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
54. As stated on the EFSA website in Jan. 2011.
55. Freeman Register of Question.
56. EFSA, FAQ on Genetically Modified Organisms.
57. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
58. Backus, Berkhout, Eaton, de Kleijn, van Mil, Roza, Uffelmann, Franke & Lotz, Register of Question.
59. Lists all current and recent GMO applications for which EFSA is undertaking or has undertaken risk assessments. Available at http://registerofquestions.efsa.europa.eu/roqFrontend/questions ListLoader?panelLGMO&questiontypeG2
60. The existing authorization submitted via the UK is for derived food or feed use. The current application filed through Sweden is for food and feed use, import, processing and cultivation.
61. In the Netherlands, the application is for MON8903 x 1507 x NK607 for food/feed, import and processing purposes. In the Czech Republic, MON 89034 x 1507 x MON88017x 59122 for food/feed, import and processing purposes.
62. As listed on EFSA's Register of Question, as of February 9, 2011, available at http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panelrGMO&questiontypeG2
63. McLeod, Register of Question. at 16.
64. EFSA, Register of Question (European Food Safety Authority), http://registerofquestions.efsa. europa.eu/roqFrontend/questionsListLoader?paneleGMO&questiontypeG2.
65. McLeod, Register of Question.
66. EFSA, Register of Question.
67. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
68. See D. Plan & G. Van den Eede, The EU Legislation on GMOs: An Overview, European Commission, Joint Research Centre (Institute for Health and Consumer Protection 2010).
69. See McLeod, Register of Question. and GMO Compass, The Long Road to Authorization (2006), http://www.gmo-compass.org/eng/regulation/regulatory_process/157.eu_gmo_authorisation_procedures.html.
70. Plan & Van den Eede, Register of Question.
71. EFSA, FAQ on Genetically Modified Organisms and EFSA, Register of Question.
72. Plan & Van den Eede, Register of Question.
73. Backus, Berkhout, Eaton, de Kleijn, van Mil, Roza, Uffelmann, Franke & Lotz, Register of Question.
74. EFSA, FAQ on Genetically Modified Organisms, and EFSA, Register of Question.
75. For example, on the basis of the results of the post-market monitoring programme.
76. EC, GMOs in a Nutshell, http://ec.europa.eu/food/food/biotechnology/qanda/c4_en.htm#c.
77. Since Dec. 1, 2009, Art. 289 of the Treaty on the Functioning of the EU (TFEU), Lisbon Treaty and Council Decision 2006/512/EC amending the 1999 Decision on Comitology (1999/468/EC). More specifically pertaining to GMOs, Decision 2008/27 amends 2001/18 addressing the power of the Commission regarding the deliberate release of GMOs into the environment.
78. General Scope Issues are subject to a different legislative process known as Regulated Procedure with Scrutiny (RPS) which provides the European Parliament (EP) the power to veto legislation that they lack in Regular Procedure. See Eurlex, 2006/512/EC of 30 Mar. 2006-Celex #32006D0512 (regulatory procedure with scrutiny). The RPS was only put into legislation between 2006 and 2009 (when the Treaty of Lisbon came into force). The EP has the legislative power to co-decide the legislative acts on which the individual GMO authorizations are based, not the authorizations themselves. For example, the RPS is only foreseen in Art. 21 on labelling (threshold levels), Art. 26 (labelling), Art. 27 (annex changes) and Art. 16 (criteria and information) of Regulation 2001/18/EC governing the release of GMOs into the environment. These are general scope tasks that will impact the legislation governing the processing of an individual GMO authorization. See C. Viju, M.T. Yeung & W.A. Kerr, Post-Moratorium EU Regulation of Genetically Modified Products:Trade Concerns (CATPRN Commissioned Paper, No 2011-02, Canadian Agricultural Trade Policy and Competitiveness Research Network 2011), available at http://www. uoguelph.ca/catprn/PDF-CP/CP-2011-02-Viju.pdf.
79. See Eurlex, 1999/468/EC of 28 June 1999-Celex# 31999D0468 (regulatory procedure) and Viju, Yeung & Kerr, Register of Question.
80. A qualified majority is when 255 out of 345 votes is reached, representing a majority of the Member States and must also represent at least 62% of the EU population. See Europa, Glossary, http://europa.eu/legislation_summaries/glossary/. Qualified majority is defined by the Treaty of Nice where each Member State is allotted a specific number of votes according to its population. See GMO Compass, Register of Question. Under the LisbonTreaty, the existing QMV system will change in 2014.
81. Viju, Yeung & Kerr, Register of Question.
82. See H. Brans, EU-27: Lisbon Treaty-Delegated and Implementing Acts, GAIN Report E50029 (USDA FAS 2010) andViju, Yeung & Kerr, Register of Question.
83. EurActiv, Delegated and Implementing Acts: The New Comitology (Jan. 5, 2011), http://www. euractiv.com/en/future-eu/delegated-and-implementing-acts-new-comitology-analysis-501001.
84. The Treaty stipulates two kinds of Acts-Delegated and Implementing Acts. Delegated Acts are not relevant to this particular discussion on GMOs. Art. 291 TFEU governs Implementing Acts.
85. Advisory Procedures are not relevant to a GMO application.
86. Under Art. 5 of the Implementing Act.
87. This is the only role for the European Parliament in the approval of a GMO authorization.
88. See A. Hardacre & M. Kaeding, Delegated and Implementing Acts: The New Comitology, EIPA Essential Guide (European Institute of Public Administration 2010) http://www.eipa.eu/files/publications/Comitology_Brochure_web.pdf
89. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006) & Brans, Register of Question.
90. Given that GMOs are often considered as part of consumer health and safety, the Commission could conceivably be barred from ever adopting a GMO draft decision should the Examination Committee be unable to achieve QMV, and the Commission will need to submit to the Appeals Committee.
91. Hardacre & Kaeding, Register of Question.
92. Viju, Yeung & Kerr, Register of Question.
93. Hardacre & Kaeding, Register of Question.
94. Hardacre & Kaeding, Register of Question. and Viju, Yeung & Kerr, Register of Question.
95. Viju, Yeung & Kerr, Register of Question.
96. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
97. Plan & Van den Eede, Register of Question.
98. Prior to 2003, highly refined food products such as oil obtained from GM soy or corn did not have to be labelled as GM. The same was true for feed containing GM soy or corn.
99. Plan & Van den Eede, Register of Question.
100. McLeod, Register of Question.
101. New evidence produced by their relevant national authorities, whether citing an independent study or one conducted on the behalf of or by the national authorities.
102. Safeguards were invoked thrice by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the UK through the late 1990s and in 2000. The UK eventually withdrew its ban. See EC, GMOs in a Nutshell.
103. On 29 Mar. 2006 Greece notified the EC of its prohibition for 18 months of the marketing of seeds of 31 maize MON 810 varieties, based on the safeguard clause of Directive 2001/18/EC. On 7 November 2006 EFSA adopted an opinion stating that the cultivation of MON810 in Greece is unlikely to have adverse effects on human health or on the environment. SCoFCAH offered no opinion in February 2009 and the matter is still in process. See EC, Summary Record of the Standing Committee on the Food Chain and Animal Health (European Commission 2009)http://ec.europa.eu/food/committees/regulatory/scfcah/biosafety/sum_16022010_en.pdf.
104. The EC examined a request from Poland to invoke the safeguard clause for the use of 16 varieties of MON810 on its territory (under Art. 16(2) b) of Directive 2002/53/EC). On 1 Mar. 2006 the EC authorized Poland to prohibit the use of these varieties of MON810 because they were considered not suitable to be cultivated in Poland due to their too high maturity class. See EC, GMOs in a Nutshell.
105. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
106. Comitology is the EU's system of committees that assist the EC in the management of the Union where decision-making is achieved through QMV. The process is similar to that discussed for the legislative approval process for GMO authorizations.
107. For example, the EC submitted draft decisions twice to the ECM requesting Austria to repeal its ban on the use and sale of maize MON810. The ECM Environment Council opposed the decision, forcing the EC to revert to EFSA for an assessment of MON 810's safety for the third time. EFSA returned the same favourable result on MON810's safety and, hence, the EC did not amend its draft proposal for Austria to lift its safeguard measures on MON 810 and resubmitted it to the ECM which then adopted the proposal on Oct. 9, 2006. Austria was ordered by the ECM to comply within twenty days of the ECM's decision. See EurLex, 2006/0509 of 9 Oct. 2006-Celex# 52006PC0509, 'Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line MON 810) pursuant to Directive 2001/18/EC of the European Parliament and of the Council'. Austria notified the EC of its ban on MON810 in June 1999.
108. See EC, Questions and Answers on the EU's New Approach to the Cultivation of GMO's, Memo 10/325, July 13, 2010, http://europa.eu/rapid/pressReleasesAction.do?referenceJMEMO/10/325&formatM HTML&agedH0&language0EN&guiLanguagegen.
109. EC, GMOs: Member States to be Given Full Responsibility on Cultivation in Their Territories (Press Release IP/10/921, July 13, 2010) (available at http://europa.eu/rapid/pressReleasesAction.do?referenceI IP/10/921&formataHTML&agedH0&language0EN&guiLanguageEen).
110. MEEP, New Recommendation on Co-existence of Genetically Modified Organisms (Manual of European Environmental Policy 2010) (available at http://www.europeanenvironmentalpolicy.eu/applib/newsitem/14/new-recommendation-on-coexistence-of-genetically-modifiedorganisms;jsessionidi09 20A5AD02D81DE8105024905274E4F4).
111. EC, Questions and Answers on the EU's New Approach to the Cultivation of GMO's.
112. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
113. EC, GMOs: Member States to be Given Full Responsibility on Cultivation in TheirTerritories.
114. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
115. EC, Questions and Answers on the EU's New Approach to the Cultivation of GMO's.
116. EC, GMOs: Member States to be Given Full Responsibility on Cultivation in TheirTerritories.
117. Thomas Cottier & Petros C. Mavroidis, Intellectual Property: Trade Competition and Sustainable Development 232 (4th ed., U. Mich. Press 2006)
118. For example, in June 2011, the level of AP threshold of GM at which shipment lots are rejected or must be labelled as GM is not consistent among MS.
119. McLeod, Register of Question. at 14.
120. FAS, Biotechnology, USDA Foreign Agricultural Service, US Mission to the European Union, Aug. 31, 2010 (available at http://www.fas.usda.gov/posthome/useu/GMOs.html).