Lack of Sherpas for a GMO Escape Route in the EU

German Law Journal

Volumn 10, Issue 8, 2009, Pages 1169-1199

  Carrau, Javier Guillem ^a  

^a Valencian Parliament   (Spain)

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EID: 84863692835     PISSN: None     EISSN: 20718322     Source Type: Journal    
DOI: 10.1017/S2071832200001541     Document Type: Article

References (84)

1. In Rome, member states agreed to a common market supported by several pillars, initially adopting the free movement of goods and other production factors, and later adopting the Single European Act (SEA) to reach an internal market by revising the concept common market into the single market. Looking for a stronger common market and a more efficient economic integration, the Maastricht and Amsterdam Treaties have added relevant rules to get the Internal Market throughout two basic and complementary principles: free movement of goods and free competence. Harmonisation of national laws, the third dimension of the internal market, is the pathway of execution of both principles. JEAN-MARC FAVRET, DROIT COMMUNAUTAIRE DU MARCHE INTERIEUR 17 (Gaulino ed., 2000) In the context of the strategy of internal market implementation, the European Commission develops very important tasks, basically, in terms of prevention and sanction, promoting the co-operation between national authorities, notification of national technical rules, and derogatory measures. P.P. CRAIG & GRAINNE DEBURCA, EU LAw 548 (2d ed. 1998)
2. Peter O'Donnell & Jennifer Rankin, BarrosoLacksSherpasfor GM EscapeRoute, EUROPEAN VOICE, June 26, 2008, at 1.
3. Case T-42/05, Williams v. Comm'n, 2008 E.C.R. 1-6308, availableat http://curia. europa. eu/jcms/jcms/Jol_6308/curia.
4. Bernard Chevassus-au-Iouis, OMG et Agriculture: options pourl'octionpublique, LA DOCUMENTATION FRAÑAISE (2001).
5. Ernesto Guerra Daneri, Aspectos juridicosde10 responsabilidad en 10 agriculturatransqenica, RIVISTA DE DIRITTO AGRARIO, April/June 2000 at 207.
6. MARIALEE, EU REGULATIONS INGMO: LAw DECISION-MAKING FOR A NEW TECHNOLOGY 190 (2008).
7. STEPHANIE MAHIEU, LE DROIT DE LASOCIETE DE L'ALIMENTATION 409 (2007).
8. 1d. at 407.
9. At this point, Zarrilli considers that, given the lack of scientific evidence of the actual or potential impact of agricultural biotechnology on human and animal health and on the environment, the debate on GMOs continues to be vocal and emotional. See Simonetta Zarrilli, International TradeinGMOsand GM products:Nationaland Multilateral LegalFrameworks, 29 POL'yISSUES IN INT'LTRADE & COMMODITIES, STUDIES SERIES, 2 (2005). Slavic points out that "Danger is real, risk is socially constructed." See PAUL SLaVIC, TRUST, EMOTION, SEX, POLITICS AND SCIENCE: SURVEYING THE RISK-ASSESSMENT BATTLEFIELD IN THE PERCEPTION OFRISK 390 (2000). Consequently, in order to define the "risk" associated with biotechnology, we should also take into account public opinion. This is a critical point, since public debate does not normally follow the same rules as scientific discussion. Once the item is explained to the public, the scientific facts are opened to a great number of different social agents. See Robert F. Durant & Jerome S. Legge, Jr., PublicOpinion,RiskPerceptions,andGeneticallyModifiedFood Regulatory Policy: Reassessingthe Calculus of Dissent among EuropeanCitizens, 6 EUROPEAN UNIONPOLITICS 181, 197 (2005). Public opinion covers, as has been mentioned above, environmental, ethical and religious factors. Experience and education are key points to understand the perception of risks associated with biotechnological products. See Mercedes Sanchez & Ramo Barrena, EIconsumidor ante los alimentos de nueva generaci6n: alimentos funcionales y alimentos transqenicos, 204 ESTUDIOS AGROSOCIALES Y PESQUEROS 95 (2004).
10. Andrea Lorenzet & Federico Neresini, Science,riskandsocial representation, 82 THE IPTS REPORT (2004).
11. CASS R.SUNSTEIN, LAws OFFEAR: BEYOND THE PRECAUTIONARY PRINCIPLE 126 (2005).
12. In EU food law, Article 6 of Regulation ECnumber 178/2002 says that in order to achieve the general objective of a high level of protection of human health and life, "food law shall be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure. . . . " Therefore, risk assessment shall be based on "the available scientific evidence and undertaken in an independent, objective and transparent manner" and risk management "shall take into account the results of risk assessment", and, in particular, the opinions of the EFSA(European Food Safety Authority), other factors legitimate to the matter under consideration and the precautionary principle "where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5". Commission Regulation 178/2002, art. 6, 2002 O.l (L 31) 8.
13. In relation to GMO, among other factors, the health risk is assessed in terms of toxicity, allergies and other pathological elements. However, it is known that allergic reactions to tacos made from "Star Link" GM corn in the USA have been detected. See Colin Carter & Allen Smith, Univ. of California, Dept. of Agricultural and Resource Economics, The Market Effect ofaFoodScare:TheCase of GM StarLinkCorn, Paper No. 04/012, 2004). It is also true that there is the lengthy question of genetic transfer to bacterial and antibiotic resistance, and it is obviously difficult to prove that there are no long-term effects.
14. See Theofanis Christofourou, The Regulation of Genetically Modified Organisms intheEuropeanUnion:The Interplay of Science,LawandPolitics, 41 COMMON MKT. L. REV. 637, 709 (2003); Theofanis Christofourou, The Precautionary PrincipleinEuropean Community LawandScience,in PRECAUTION, ENVIRONMENTAL SCIENCE AND PREVENTIVE PUBLIC POLICY 243 (lA. Tickner ed., 2003).
15. LUIS MELLADO RUIZ, BIOSEGURIDAD Y DERECHO: LA ADMINISTRACION ANTE LOS RIESGOS DE LA TECNOLOGIA DE LA VIDA 145 (2004).
16. German legal scientists have configured the Vorsongeprinzip as the necessary intervention of public administration, although scientific evidence may not be certified. In the USA, the Delaney clause of section 409 of the 1958 Federal Food, Drug and Cosmetic Act included a zero risk concept: "the Secretary of the Food and Drug Administration shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals". Principle 15 of Rio Declaration 1992 and Cartagena Protocol has fixed the precautionary principle in the context of environmental policies. See Peter Montague, The Precautionary Principle, RACHEL'S ENVIRONMENT AND HEALTH WEEKLY, Feb. 19, 1998.
17. The application of the precautionary principle in matters concerning human health has been declared by ECJ, among others, in Case C-180/96, United Kingdom v. Commission, 1998 E.eR. 1-02265, and T-33/99, Pfizer Animal Health v. Council, 2002 E.eR. 11-3305. In particular, we must highlight the simultaneous application of the precautionary principle and proportionality by the ECJ in United Kingdom v. Commission and Great Britain's beef embargo by resolution of 12 July, 1996.
18. TheGeneralPrinciples ofFoodLawintheEuropeanUnion, COM (1997) 176 (April 30, 1997).
19. In the Communication, the European Commission states that "The precautionary principle is not defined in the Treaty, which prescribes it only once - to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community." Communication onthe Precautionary Principle, COM (2000) 1 final (Feb. 2, 2000).
20. General principles and new requirements of food law are contained in Regulation 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the EFSAand laying down the procedures in matters of food safety. See Commission Regulation, supra note 12. The EFSAis in charge of scientific risk assessment and has no powers of risk management. Risk management is the power of public authorities, as is risk communication.
21. For instance, ECJ has confirmed the validity of several articles of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Joined Cases C-154/04 & C-155/04, The Queen ex parte Alliance for Natural Health v. Secretary of State for Health and National Assembly of Wales, 2005 E.eR. 1-06451.
22. Javier Lezaun, CreatingaNew Object of Government: MakingGenetically Modified OrganismsTraceable,36 Soc. STUD. SCI. 500 (2006).
23. Gonzalez Vaque, EITJCE confirmasu jurisprudencia relativaalprincipiadeprecauci6n:laSentencia "Monsanto agriculturaItaliaSpAyotros, 6 UNION EUROPEA ARANZADI 5, 5-15 (2004).
24. US policy-makers have expressed that "there are two major perils associated with an extreme approach to precaution. One is that technological innovation will be stifled, and we all recognize that innovation has played a major role in economic progress throughout the world. A second peril, more subtle, is that public health and the environment would be harmed as the energies of regulators and the regulated community would be diverted from known or plausible hazards to speculative and ill-founded ones." John D. Graham, The Heritage Foundation Washington, D.C., ThePerils of the Precautionary Principle:Lessonsfromthe American andEuropeanExperience, REGULATORY FORUM, Oct. 20, 2003, available http://www. whitehouse.gov/omb/inforeg/speeches/031020graham.pdf. The deepest objection to the at precautionary principle is methodological: the precautionary principle focuses on risks in isolation. Sunstein categorizes it among approaches to environmental protection that are "unhelpful, sometimes, even, ludicrous". The legitimacy of the precautionary principle will be undermined if it comes to apply to just any fear that people happen to have in regard to new technologies. SUNSTEIN, supra note 11, at 55, 100, 120. Nevertheless, some authors have supported a precautionary principle interpretation more connected to the European one. Lisa Heizerling, ClimateChange,HumanHealth,andthe Post-Cautionary Principle, 96 GEO. LJ. 445 (2008).
25. See Cornpes L6pez & Guillem Carrau, Regulation of GMOs:TheCommercialConflict Between theUnited States andtheEuropeanUnion, 3 NEWMEDIT 3,3-10 (2002).
26. The us is the world's primary producer of genetically modified agricultural products and has not committed to the Cartagena Protocol. One of the principal reasons for us leadership inGMOsis the flexibility of their regulation. The regulatory procedures for the approval of GMOs in the EU differ significantly from those of exporting third-party countries, including differences in the time for processing authorisation dossiers. The time it takes forGMO authorisations to be completed in the EUis over 2)1, years, as opposed to a us average of fifteen months. The growth of this technique in the second half of the 90s has been so spectacular that, at the present time, a very high percentage ofits production of maize, soya or cotton is already organic. The first GM product on the world market was a variety of herbicide-resistant soya exported from the us to Europe and Australia during 1996 Following the 2007 International Service for the Acquisition of Agri-biotech Applications (ISAAA) information, in 2006, the first year of the second decade of commercialization of biotech crops 2006-2015, the global area of biotech crops continued to grow for the tenth consecutive year at a sustained double-digit growth rate of 13%,or12 million hectares, reaching 102 million hectares. GMO producers are 10.3 million people in22 States and, nowadays, 29 countries have authorised the imports ofGMOas food. The value is US$6.15 billion; more or less 16 per cent of the global crop market. The us is the primary producer, followed by Argentina, Brazil, Canada, India and China. In this context, Spain continues to lead the European continent, planting 60,000 hectares in 2006. Clive James, Global Status of Commercialized Biotech/GM Crops:2006, ISAAA BRIEF 35-2006: HIGHLIGHTS (2006), http://www.isaaa.org/resources/publications/briefs/35/highlights/default.html.Critics have expressed concern that the ISAAA makes outrageous claims, inflates its figures and ignores negatives. For instance, the report emphasises that 10.3 million farmers grew GM crops in 2006, but this is just 0.7% of farmers world-wide. And just 600,000 farmers grew 85% ofallGM crops on industrial farms in North and South America. Small third world farmers are abused and misused as fodder forISAAA's PRo
27. See Patrycja Dabrowska, Risk,PrecautionandtheInternalMarket:WhoWontheDayinthe Recent Monsanto Judgement of EOon GM foods, 5 GERM. L.J. 151 (2004).
28. In 1992, asa general rule, the USA considered that transgenic food did not need a particular regulation separate from the standards of food commercialization. Statements of Policy:FoodsDerivedfromNewPlant varieties, 52Fed.Reg. 22984 (U.S. Food and Drug Administration, May29, 1992). This position is based on the affirmation of the Science National Academy, which considers that the transgenic products have the same risks that a conventional one. The basic institutional structure for regulation ofall biotechnology products in the USis the "Coordinated Framework for Regulation of Biotechnology" established in 1986. See GianCarlo Moschini, Iowa State Univ., Working Paper No. 06-WP 429, 2006, Pharmaceutical andIndustrialTraitsin GM crops:Co-existence with Conventional Agriculture, 8, availableat http://www.card.iastate.edu (last visited Sept. 12,2007). TheUS federal agencies working jointly on the approval of GMOs, are APHIS (Animal and Plant Health Inspection Service), the EPA (Environmental Protection Agency) and the FDA (Food and Drug Administration). By mandate of the National Institute of Health (NIH),a Biosecurity Committee evaluates every genetic improvement's project before its launch and itis able to recommend that a project is not developed. These agencies are those responsible in the main for the environment and consumer health protection. On the one hand, when an application is presented, APHIS should deliver authorizations in order to:be able to use some facilities (greenhouses) to develop the cultivation; carry out trials in fields; transport seeds from the greenhouse to the trial fields; and to determine the status of "not regulated" that allows cultivation, use and marketing of the product. The process lasts approximately ten months. On the other, the EPAis responsible for authorizing release in the environment and authorizing pesticides obtained by means of genetic manipulation and plants modified to have pesticide characteristics. In particular, the EPA should authorize the following acts: trials in exploitations over 10 acres; establishing tolerance thresholds (maximum limitsof modified proteins in food from the plant); registering products for commercial use.Finally, the FDA,as the agency responsible for the security ofall foods, advises and supervises companies in the GMOs' development phase. The advice process is voluntary, but the requirements are compulsory, and all the companies involved tend to keep onit. Labelling is also ruled by the general principle that products obtained by means of genetic manipulation are not different the conventional products (they are "substantially equivalent", according to the concept coined by the OECDand the WHO) and, because ofthis, they are regulated by identical norms. TheFDA only requires specific labelling ofGM content when the product carries with it some element ofrisk(an allergic reaction, for example) orifits nutritional characteristics or composition are significantly different from its equivalent conventional one; in this case, the difference should be indicated on the label. This regulation, however, may change in the near future. Food scandals, like the one unleashed by the appearance ofGMOsin certain foods of the TacoBell chain of restaurants, have opened a debate on the segregation ofGMOs from conventional foods in the North American food chain. In this sense, certain opinion groups have made Congress admit legislation establishing a compulsory pre-marketing test forGMOs, which ought to be carried out by the FDA,aGMO product labelling and an obligation for biotechnological companies to assume responsibility for problems derived from their products. In this line, the FDAhas presented in February of this year a proposal that determines the mandatory communication of foods coming from biotechnology, prior to their commercialization, with the purpose of highlighting its coherence with the FFDCA. Concerning co-existence, US regulation in this area at present presumes a zero tolerance levelin the food supply. Moschini considers that for first-generation GM products co-existence does not carry health or environmental risks because the health and environmental safety ofGM products is assessed prior to approval. The additional riskof second generation products points out that the coexistence of traditional agriculture with crops transformed to express pharmaceutical and industrial traits will,inhis opinion, take quite a different form than the first generation ofGM products in the US.
29. See LukaszA. Gruszczynski, ScienceintheProcess ofRiskRegulationundertheWTO AgreementonSanitaryand Phytosanitary Measures, 7 GERM. L.J. 371 (2006).
30. The difficulties of admitting the patentability of microorganisms were solved by the US Supreme Court on June is" 1980 in Diamond v. Chakrabarty because the microorganism was an invention of the laboratory and not of nature. See Diamond v. Chakrabarty, 447 U.S. 303 (1980). In particular, the Court declared that living organisms which are products of human ingenuity are patentable. Seeid. In the EU, Directive 98/44, on the legal protection of biotechnological inventions, has stated the common provisions for patentability of biotech inventions byEU Law.Council Directive 98/44, 1998 O.J.(L 213)13, 13-21. For Romero, this exposes the main elements of the EU evolution in the context of the Munich Convention. See Romero Fernandez, Lapatentabilidad delas invenciones biotecnol6gicas, 5829 LA LEY: REVISTA JURIDICA ESPANOLA DE DOCTRINA, JURISPRUDENCIA Y BIBLIOGRAFIA 1, 3 (2003), availableat http://www.epo.org/patents/law/legal-texts/html/epc/1973/e/ma1.html.
31. To date, 142 instruments of ratification or accession have been deposited with the UN Secretary-General from the following Parties to the Convention on Biological Diversity. See Convention on Biological Diversity, http://www.cbd.int/biosafety/default.shtml.
32. See Cara Fuentes, Riesgo y Derechocomunitario: modificaciones qeneticas enel ambito de10agricola,33 ACTUALIDAD ADMINISTRATIVA 963 (2000).
33. See Mahieu, supra note 7, at 415.
34. See Joanne Scott, EuropeanRegulation ofGMOsandtheWTO, 9 COlUM.J. EUR. L. 213 (2003).
35. See Alberto Germano, Corsodidiritto agrolimentare, G. GIAPPICHElLi EDITORE 94 (2007).
36. Related to the legal basis, some debates have been finally solved by ECJ concerning the legal basis of the so-called Biotech Directive. Malcolm Maclaren, Patently Unsatisfactory? Community Legislative Competence and theEOBiotechDecision, 2 GERM. LJ. 18 (2001).
37. It should be highlighted that, for a long time, those who have exercised prominent influence on biotechnology policy were France, the UK, and (in part) Germany, but also smaller countries such as Denmark and the Netherlands. Austria, in contrast, was hardly visible in terms of political influence, although in retrospect, the Austrian policy seems to anticipate early elements of what was to come later in other European countries See Helge Torgensen, AustriaandtheTransatlanticAgricultural Biotechnology Divide, 24 Sci. Comm. 174 (2002). The ministers of the new partners participated for the first time at the Environment Council of Ministers of June 2004, and on the agenda was the debate about the controversial point of commercialisation of another strain of GM maize, NK603. On the one hand, Cyprus, Hungary, Latvia, Malta and Lithuania were against the authorisation of GM maize NK603; on the other, the Czech Republic, Poland and Estonia were in favour and Slovakia and Slovenia abstained. Following the scheme of the transitional voting system, applied at the Council of Ministers until October 2004, the majority was against the authorisation and commercialisation (16in favour/IS against/6 abstentions). Seealso Dabrowska, supra note 27.
38. th and zs" June 1999, the French, Greek, Italian, Luxembourg and Danish delegations passed a declaration deciding to block any new commercialization application whilst the system did not warrant transparency and perfect traceability. Therefore, a moratorium was actually decided and revision process of the system began. From October 1991, when the Directive came into force untilJuly 2000, 18 authorizations were approved, with14 pending, withno authorization from 1998. In fact, no product had been authorized until March 2003.
39. The most relevant affairs have been Novartis maize and Monsanto soya. See DavidKelch,Mark Simone & Madell, Biotechnology inAgricultureConfronts Agreements intheWTO, WTO/WRS/98/44 (Dec. 1998).
40. U.S.Food and Drug Administration, Voluntary Labeling Indicating Whether FoodsHaveorHaveNotBeen Developed Using Bioengineering (2001) (draft released for comment), http://www.fda.gov/OHRMS/DOCKETS/98fr /001S98gd. pdf.
41. The US, Canada and the European Union have agreed that the reasonable period of time for the EU to implement the recommendations expires on 21 November 2007. See WT/DS291/35, June 26, 2007.
42. t h 2004 on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation EC1830/2003. Secondly, at execution level, to be precise, twelve GMO dossiers have been authorised in EU up until June 2007 (maize NK603, maize MON863, maize 1507, maize MON 863 x MON 810, carnation 123.2.38, rape GT73, rape MS8, RF3 and MS8 x RF3, maize Btl1, maize NK603, maize MON 863, maize GA21 and maize 1507). Thirdly, the European Commission has sent to ten Member States a letter of "mise en demeure" because of they had not implemented Directive EC/2001/18 in time. See Case C-419/03, Comm'n v. France, 2004 E.C.R. The European Commission has claimed that the French Republic failed to comply with the judgment of the Court of July is". 2004 and the Court ordered France to pay a lump sum for failing to comply swiftly with the 2004 Judgement of the Court establishing its failure to fulfil obligations concerning GMOs. See Case C-121-07, Comm'n v. France, 2008 E.C.R. Recently, the ECJ has dismissed an appeal of Austria and its Land Oberi:isterreich seeking to have set aside the Judgment in Joined Cases T-366/03 & T-235/04, Land Oberi:isterreich and Austria v Comm'n, 2005 E.C.R. 4005, by which the Court of First Instance dismissed their actions seeking the annulment of Commission Decision 2003/653/EC of September 2"', 2003, relating to national provisions on banning the use of genetically modified organisms in the region of Upper Austria notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty. See Joined Cases C-439/05 P & C-454/05 P, Land Oberi:isterreich and Austria v. Commission, 2007 E.C.R. Seealso Commission Recommendation on Guidelines for the Development of Strategies and Best Practices to Ensure the Co-Existence of Genetically Modified (GM) Crops with Conventional and Organic Farming, DG AGRI Report (2003), available http://ec.eu ropa. eu/agricultu re/pu bli/reports/coexistenc e2/gui de_en. pdf. at
43. See Vaque, supra note 23,at9. Gonzalez Vaquesays that this means that the compulsory labelling would be justified ifthe GM product were substantially equivalent to the conventional product. Ifthe products were "alike" or "similar", obligation would not be justified, because the only difference would reside ina characteristic of the productive process-the transgenic techniques-that does not influence the appreciable characteristics of the final product orits safety, and this would also suppose a treatment discrimination that is not accepted by the Agreement. Therefore, ifitisnot possible to demonstrate that the products are different or that the transgenic is not safe, then the products are "similar", andit the compulsory labelis not justified-although the voluntary one is-nor any other measure restricting imports. See Case C-236/01, Monsanto Agricoltura Italia,2003E.eR. 11-8105; Case C-296/01, Comm'n v. France, 2003E.eR.1-13909 and Joined Cases C-439/05 P & C-454/05P, Land Oberi:isterreich and Austriav. Comm'n, 2004 E.eR.1-07141. Related to ECJ resolutions, among others, seealso EFIC Judgement ofMay io".joined cases T-366/03 & T-235/04 Land Oberi:isterreich and Austriav. Comm'n, 2005 E.eR. 11-4005; Case C-132/03 Ministero della Salute v Codacons and Federconsumatori 2005E.eR.1-4167;CaseC-456/03 Comm'n vItaly2005E.eR.1-5335. Related to this approach, Dabrowska considered that in the Monsanto case "the Courthas perhaps sought to prevent Member States supporting the moratorium onallGM products fromusing the safeguard clause for purely political reasons." Inherview, this Judgment is the first case inwhich the Courthas directly invoked the precautionary principle regarding Member States' power to adopt a provisional prohibition on the marketing of GMO-derived novel foods. See Dabrowska, supra note 26,at4and7; but see Thijs Etty & Han Somsen, CaseC-236/01: Monsanto AgricolturaItaliaSPAand others vs.PresidenzadelConsigliodei Ministeriandothers, 13 EUR. ENVTL. L. REV. 14(2004).
44. See Lezaun, supra note 22,at500.
45. See Communication fromtheCommissiontotheCouncil,the EP, theEuropeanEconomicandSocial Committee andthe Committee ofRegionsontheMidTermReview ofthe Strategy onLifeSciencesandBiotechnology, at441, COM(2007)175final(Oct.4,2007).
46. SeeConsequences, Opportunities andChallenges of Modern Biotechnology forEurope (April 20, 2007), available at http://bi04eu.jrc.ec.europa.eu/documents/eur22728en.pdf; EconomicImpacts of GeneticallyModifiedCrops ontheAgri-FoodSector (Commission of the European Communities, Working Document No. Rev.2 DG AGRI, 2000).
47. See Case C-552/07, Commune de Sausheim v. Pierre Azelvandre, 2009 E.eR. 00000; Case T-42/05, Williams v. Comm'n, 2008 E.eR.
48. SeeReportonthe implementation of RegulationEC 1830/2003 concerningthe traceability andlabelling of genetically modified organisms andthetraceability offoodand feed products produced from genetically modified organisms and amending Directive2001/18/EC, COM (2008) 560 final (Sept. 17, 2008).
49. EUR. VOICE, May 8, 2008, at 8.
50. See MAHIEU, supra note 7, at 400.
51. Historically, the EUFood Safety system maybe understood in the context ofthe Common Market and the goals of the Common Agriculture Policy(CAP).The objectives of the CAP are the following: ensure availability of supply; increase productivity; stabilize markets; reasonable prices; and fair standard oflivingfor farmers. Nowadays, the CAP reforms and the internal market strategy are the keys to explain the EUFood Safety. Certainly, the agro food safety crisison the 90's and the review ofthe European food lawhas developed a system where the European Food Safety Authority (EFSA) playsakeyrole.Aimingfora higher levelof consumer protection, the European Commission's White Paper ona Common Food Safety Strategy was the new approach to the food sector known "from farm to the table" that assures traceability throughout the food chain and states aRapidAlert System forFood and Feed (RASFF). TheEU integrated approach to food safety aims to assure ahigh levelof food safety, animal health, animal welfare and plant health within the European Union through coherent farm-to-table measures and adequate monitoring, while ensuring the effective functioning of the internal market. The European Commission continues the enforcement ofits mission to determine legislative and other actions: to assure effective control systems and evaluate compliance with EUstandards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EUand in third countries in relation to their exports to the EU; to manage international relations with third countries and international organisations concerning food safety, animal health, animal welfare, animal nutrition and plant health; to manage relations with the European Food Safety Authority (EFSA) and ensure science-based risk management. PAUL NIHOUL & STEPHANIE MAHIEU, LA SECURITE ALiMENTAIRE ET LA REGLEMENTATION DES OGM: PERSPEUIVES NATIONALE, EUROPEENNE ET INTERNATIONALE 182 (2005); Lezaun, supra note 22,at502.
52. Mahieu has explained that the applicants foraGMO authorization whose products are not goingto feed humans or animals willbe concerned onlybyDirective 2001/18/EC and the applicants foraGMO authorization whose products are intended to feed humans or animals willbe subjected to the Regulation EC 1829/2003/EC. Mahieu has stated that the applicants can introduce filesby both administrative ways and, indeed, many of the applicants use both procedures. MAHIEU, supra note 7,at455,456.
53. The European Commission has invited Member States toactat the domestic levelin order to regulate compensations for damages due to cross border contamination. See Commission Recommendation 556ofMarch s".2003. However, it would be inexact to state the evolution of Member States' decisions without a mention of some restrictive administrations. EUPolicyin Biotechnology, DG ENVI (2006), available at http://ec.europa.eu/environment/biotechnology/pdf/eu_policLbiotechnology.pdf. At the EUlevel, the GMO legal framework is not acceptable for Member States orlocal and regional authorities. Particularly, there has been areply to the ECRecommendation. In November 2003, a group of "GM-free regions" was created and now comprises 164 European regions. For instance, in France, close to38million people livein areas whose local authorities have declared their opposition toGMOs.For instance, inItaly, the Act 52005 about co-existence has produced constitutional problems, since the divisionof powers between National and Regional Administrations has not made it possible. Corte Costituzionale [Constitutional Court]150(2006); Corte Costituzionale [Constitutional Court]116(2006).In that context, the goalof the EUis the harmonization of national laws. Takinginto account commercial goals, the harmonization willbe more efficient if the National Administration is the body empowered to regulate coexistence. Themainissue, therefore, istoknowhow national and regional systems are coordinated and the degree of collaboration between the different bodies and institutions of each administration. Always based on the identity of traditional production and regional peculiarities, these authorities are against the homogenization and expansion ofGM crops because itis not compatible with respect for ethnographic heritage. Noneof these regional governments have forbidden GM crops, but have conferred powers to farmers for the creation ofnon-GM areas establishing a special administrative authorisation to those producers interested in the useofGM seeds. 10 EUR. VOICE 30,20 (2004).
54. RUIZ, supra note 15, at 289.
55. For instance, in German law, the authorization must be conferred when, according to the state of the art, damage expected for health and environment is justified in order to comply with marketing goals. GenTG (Gesetz zur Reglung der Gentechnik) [Law Regulating Genetic Engineering] '1116(2) (1993) (F.R.G.). The justifiability clause has been criticised by Mir Puigpelat because the rule legitimates some kind of damage, which is always expected in medicines (side effects listed in the prospectus) but not in food. ORIOl MIR PUIGPElAT, TRANSGENICOS YDERECHO: LA NUEVA REGULACION DE lOSORGANISMOS MODIFICADOS GENETICAMENTE 205 (2004).
56. As Germany, France, Luxembourg, Portugal and Austria have done in Novartis BTgrain case. First and foremost, it should be stressed that a political agreement at the European Council could have the power to silence the technical objections laid down by Member States' competent authorities. Mellado hasa critical view of the European phase of the process, considering that risk assessment and risk management should not be matters of transaction. MELLADO, supra note 15,at174.
57. Case C-6/99, Greenpeace et aI., 2000 E.R.C. 1-1651.
58. See Council Directive 01/18, arts. 4.5, 8.2, 19.4, 20.3 and 23, 2001 (EC).
59. See Greenpeace et aI., supra note 57, describing the interpretation of Article 13.2 of Council Directive 90/220/EEC, 1990 O.J. (L 117), on the deliberate release into the environment of genetically modified organisms, as amended by Commission Directive 97/35/EC, 1997 O.J. (L 31) adapting to technical progress for the second time Council Directive 90/220.
60. The safeguard clause was invoked on nine separate occasions under Directive 90/220/EEC, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom. The scientific evidence provided by these Member States as justification for their measures was submitted to the Scientific Committee(s) of the EU for opinion. In all of these cases, the Committee(s) deemed that there was no new evidence justifying overturning the original authorisation decision. In spite of the repeal of Directive 90/220/EEC, eight of the nine bans remained in place (the UK withdrew its ban) and were considered under the safeguard provision (Article 23) of Directive 2001/18/EC. The GMOs in question (Bt 176, T25 and MON 810 maize, MslxRfl and Topas 19/2 oilseed rape) had been authorised under Directive 90/220 for all uses (including cultivation) with the exception of Topas 19/2 (import and processing). The Commission examined the additional information provided by certain Member States, which was also reviewed by EFSA. In addition, in January 2005, Hungary invoked the safeguard clause in order to prohibit the cultivation of MON 810 in its territory. In June 2005, the Environment Council reached a qualified majority against eight proposals to lift the eight bans invoked by five Member States. As a result, DG for the Environment consulted EFSA again in order to obtain an updated opinion. The Commission now has three options, namely to submit either the same or amended proposals back to the Councilor to submit proposals for adoption through co-decision, on the basis of EFSA's awaited opinion. See EU Policy, supra note 53.
61. LEE supra note 6, at 245.
62. CODEX ALiMENTARIUS COMMISSION, PRINCIPLESFOR THE RISK ANALYSIS OF FOODS DERIVED FROM MODERN BIOTECHNOLOGY, GUIDELINE FORTHE CONDUCT OF FOOD SAFETYASSESSMENTOF FOODS DERIVED FROM RECOMBINANT-DNA PLANTS, AND GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS PRODUCED USING RECOMBINANT-DNA MICROORGANISMS (2003); CODEX AD Hoc INTERGOVERNMENTAL TASK FORCE ON FOOD DERIVED FROM BIOTECHNOLOGY, ELABORATION OF STANDARDS, GUIDELINES OROTHER PRINCIPLES FOR FOODS DERIVED FROM BIOTECHNOLOGY (1997).
63. DABROWSKA, supra note 27.
64. Specific dispositions exist for the forest material of reproduction and for the vineyard, for medical products for human and veterinary use, workers' protection and transport. Plants authorised before 1997 were not subjected to compulsory labelling (one soya, one maize and two rapeseed plants).
65. Commission of the European Communities, Traceability and Labelling of GMO and Products Containing GM, Working Document ENVI/620/2000, 2000).
66. See supra note 42.
67. SeeEC Report, supra note 48.
68. Communication fromtheCommissiononthe Mid-Term-Review of theLifeSciencesand Biotechnology Strategy, 7 COM (2007) 175 final, and Strategy forEuropeonLifeSciencesandBiotechnology, COM 27 final (2002).
69. After a period of decline in optimism about biotechnology, the 2005 Euro-barometer showed an increase in optimism since 1999 (52% say biotechnology will improve their life), and an overall support for many biotech applications (such as gene therapy, biofuel and bioplastics). It also shows that knowledge about biotechnology and genetics, although improved, remains limited. However, 58% of respondents oppose GM food while 42% do not. The Euro-barometer also confirmed that there were major differences in acceptance levels between Member States, in that 50% or more say they would buy GM food if it were healthier, if it contained less pesticide residues, or if were more environmentally friendly. See Europeans and Biotechnology in 2005: Patterns and Trends (2006), availableat http://www. ec.europa. eu/research/press/2006/pdf/pr1906_eb_64_3_final_reportmay2006_en.pdf.
70. Richard Shepherd & Lassen Frewer, Risk Communication, in TENNANT, D.R.: FOOD CHEMICAL RISK ANALYSIS 399, 407 (1997).
71. Ben Duncan, PublicPerceptionandEfficientRisk Communication, IPTSREPORT82 (2004).
72. See Williams, supra note 42.
73. Lezaun, supra note 22,at521.
74. Puigpelat, supra note 53,at224.
75. TheStarLink case isa clear example of the need for appropriate rulesfor authorisation and traceability ofa GMO (Declaration of European Union Trade Directorate, availableat http://europa.eu.int/comm/trade/goods/agri/pr130503_en.htm).
76. Report on thelimplementation of Regulation EC1830/2003, supra note 48,at4.
77. 1d. at6.
78. Without decreasing health and safety risks,a certain environmental riskhas been detected, where GMO seeds are employed, associated with changes in biomass. MAHIEU, supra note 7,at405.In relation to the risk communication, US judgements and European authorities have considered some risks relating to plant varieties resistant to antibiotics as unacceptable, and "communication risk strategy hasfailedor there is certain contradiction between the risk assessment's conclusions and the European authorities' acts." Escajedo San Epifanio, Losretosde 10 requiacionjurfdicadeloscultivos transqenicos: su investiqaclon, cultivo y comerciaiizaclon, 7 REVISTA ARANZADI DE DERECHO AMBIENTAL 115(2005).
79. A Strategic Review of Better RegulationintheEuropeanUnion, COM (2006) 689, availableat http://europa.eu/legislation_summaries/institutional_affairs/decisionmaking_process/110103_en. htm.
80. RUIZ, supra note 15, at 133.
81. Economic Impact of UnapprovedGMOsonEUFeedImportsandLivestockProduction, 7 (2007) COM, available at http://ee.europa.eu/agriculture/envir/index_es.htm#gmo.
82. As the EC points out, the enforcement of EFSA's mission determines legislative and other actions, including the assurance of effective control systems, evaluation of compliance with EU standards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EU and in third countries in relation to their exports to the EU, management of international relations with third countries and international organisations concerning food safety, animal health, animal welfare, animal nutrition and plant health, management of relations with the EFSA, and insurance of science-based risk management. The EFSA collects information and analyses new scientific developments so it can identify and assess any potential risks to the food chain. In the context of the debate of independent agencies and food safety, we find the two different European and North American models. In the EU institutional structure, the agencies have contributed to the execution of specific EU programmes in order to promote social dialogue and the internal market or to protect consumer safety. Despite the diversity of denominations and activities of EU agencies, they have similar basic organizations of board, executive director and scientific or technical committees. They also have in common the intervention (intervention or exclusion?) from the European Court of Auditors and the European Commission. Financial revenues are generally from subsidies and taxes. In the EU, agencies form a kind of network with other national and European administrations as a model of collaboration (Art. 10 of the Treaty) and show the relevance of administrative law and the concept of delegation of powers to third bodies in EU law. Recuerda Girela & Miguel Angel, SEGURIDAD ALiMENTARIA YNUEVaS ALiMENTOS: REGIMEN JURIDICO-ADMINISTRATIVO 102(2006).
83. Benedicta Nicolini, Lesrisques alimentaires lies au conditionnement desvins, RAPPORT ANNUEL ICV 3 (2000).
84. On 23 March 2005, the European Council requested "the Commission and the Council to consider a common methodology for measuring administrative burdens with the aim of reaching an agreement by the end of 2005." On 16 March 2005 the Commission's Communication on Better Regulation proposed to start work on a limited number of administrative burden reduction proposals that were likely to generate significant benefits through minor changes in the underlying legislation. "A quick harvest of these 'low hanging fruits' would be tangible evidence of the commitment of the European Institutions to this agenda and would allow significant results to be achieved at an early stage." It is proposed that these low-hanging fruits be identified in the early 2007 Action Programme following consultation on this Commission working paper, while duly taking into account planned and ongoing policy review processes. AnEUCommon Methodology forAssessing Administrative Costs Imposed by Legislation, COM (2005) 518 and Staff Working Paper, Annex tothe2005 Communication onBetterRegulationfor GrowthandJobsintheEuropeanUnion,Minimizing Administrative Costs Imposed byLegislation,DetailedOutline of aPossibleEUNet Administrative CostModel 175 SEC 12 (2005). In the second strategy review, the European Commission focused, among others, on Regulation 1830/2003 GMOs, in regard to traceability rules that require operators to have in place a system to hold information for 5 years in the priority area of Food Law. The information obligation has been categorized in the following items: provision of information about the presence of GMOs in products; keeping information available about the presence of GMOs in products and the identity of suppliers and receivers; and labelling of pre-packaged products and non-pre-packaged products. Reducing Administrative BurdensintheEuropeanUnion2007ProgressReportand2008Outlook, at 35, COM (2008) 13.