Restrictions on Genetically Modified Organisms

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<ul><li><p>The Law Library of Congress, Global Legal Research Center (202) 707-6462 (phone) (866) 550-0442 (fax) law@loc.gov http://www.loc.gov/law </p><p>Restrictions on Genetically Modified Organisms </p><p>Argentina Belgium Brazil Canada China Egypt England and Wales European Union France Germany Israel Italy Japan Lebanon Mexico Netherlands New Zealand Norway Russian Federation </p><p>South Africa South Korea Sweden United States </p><p>International Protocols Bibliography </p><p>March 2014</p></li><li><p>Contents Argentina..........................................................................................................................................1 Belgium ............................................................................................................................................8 Brazil ..............................................................................................................................................17 Canada............................................................................................................................................31 China ..............................................................................................................................................41 Egypt ..............................................................................................................................................52 England and Wales ........................................................................................................................55 European Union .............................................................................................................................64 France .............................................................................................................................................80 Germany .........................................................................................................................................89 Israel ...............................................................................................................................................98 Italy ..............................................................................................................................................106 Japan ............................................................................................................................................114 Lebanon........................................................................................................................................123 Mexico .........................................................................................................................................126 Netherlands ..................................................................................................................................132 New Zealand ................................................................................................................................146 Norway .........................................................................................................................................157 Russian Federation .......................................................................................................................166 South Africa .................................................................................................................................175 South Korea .................................................................................................................................185 Sweden .........................................................................................................................................196 </p></li><li><p> United States ................................................................................................................................208 International Protocols .................................................................................................................223 Bibliography ................................................................................................................................230 </p></li><li><p>The Law Library of Congress 1 </p><p>Argentina Graciela Rodriguez-Ferrand </p><p>Senior Foreign Law Specialist SUMMARY Argentina is the third largest grower of biotech crops in the world, after the United States </p><p>and Brazil. GMOs are regulated in Argentina under the Law on Seeds and Phytogenetic Creations and the Law on the Promotion of the Development and Production of Modern Biotechnology, and under administrative regulations issued by the Secretary of Agriculture, Livestock, Fisheries and Food. Argentina has not ratified the Cartagena Protocol on Biosafety. </p><p> I. Introduction Argentina was among the first countries in the world to use genetically modified (GM) crops in agriculture,1 using GM technologies in the production of soybeans, corn, and cotton. Argentina first started using GM technologies in 1996 with the introduction of soybeans tolerant of the herbicide glyphosate.2 Since then, Argentina has increased its production of GM crops to become the third largest grower of biotech crops in the world, after the United States and Brazil.3 GM technologies applied in agriculture have resulted in economic benefits for Argentina, a commodities exporting country, of about US$72.6 billion through 2011. The introduction of GM technologies in agriculture in Argentina has resulted in the creation of an estimated 1.8 million jobs through 2011.4 Of the US$72.6 billion in economic benefit, $65.4 billion is attributable to herbicide-tolerant soybeans. Regarding the distribution of economic benefits from cultivating such soybeans, 72.4% went to farmers, 21.2% to the national government in the form of export taxes and other duties, and the remaining 6.4% to seed and herbicide suppliers.5 </p><p> 1 Rosario Silva Gilli, Genetically Modified Organisms in Mercosur, in THE REGULATION OF GENETICALLY MODIFIED ORGANISMS: COMPARATIVE APPROACHES 274, 281 (Luc Bodiguel &amp; Michael Cardwell eds., 2010). 2 Eduardo J. Trigo, Fifteen Years of Genetically Modified Crops in Argentine Agriculture 4 (Consejo Argentino para la Informacin y el Desarrollo de la Biotecnologa, Nov. 2011), http://www.argenbio.org/adc/uploads/15_years_ Executive_summary_of_GM_crops_in_Argentina.pdf. 3 Moises Burachik, Regulation of GM Crops in Argentina, 3 GM CROPS &amp; FOOD: BIOTECHNOLOGY AGRIC. &amp; FOOD CHAIN 48 (2012), https://www.landesbioscience.com/journals/gmcrops/2011GMC0034R.pdf. 4 Trigo, supra note 2, at 4. 5 Id. </p></li><li><p>Restrictions on Genetically Modified Organisms: Argentina </p><p>The Law Library of Congress 2 </p><p>II. Public and Scholarly Opinion In general, basic knowledge of the use of biotechnology in agriculture and food is limited.6 In a 2004 survey, only 39% of the polled population knew that Argentina produced GM soybeans. In the same poll, 51% said they prefer to consume non-GM food, even if it costs more.7 Only 12% said they believe GM crops benefit the population, while 51% said they believe big corporations, especially foreign ones, are the main beneficiaries.8 There have been recent demonstrations against the US company Monsanto in Malvinas, in the Province of Crdoba, near the main entrance of a new seed plant currently under construction.9 Monsanto is planning to start construction of 240 silos for the storage of GMO corn that is chemically treated. These silos have shafts that need ventilation through fans. The population living close to the future plant opposes the exposure to the chemical dust that those fans would spread throughout the area. Monsanto has been blamed for damage to the health of persons allegedly caused by long-term exposure to the companys Roundup herbicide.10 Epidemiological surveys were conducted in 20012002 in areas treated with Roundup. Results of those surveys revealed rates of birth defects and malformations in children, cancer, and miscarriages one hundred times higher than the national average, coinciding with the increase of GM soy cultivation and herbicide spraying near populated areas.11 III. Structure of Pertinent Legislation GMOs are regulated in Argentina under the general Law on Seeds and Phytogenetic Creations (Ley de Semillas y Creaciones Fitogneticas, LS)12 and the Law on the Promotion of the Development and Production of Modern Biotechnology (Ley de Promocin del Desarrollo y Produccin de la Biotecnologa Moderna, LB).13 </p><p> 6 ALICIA DIAMANTE &amp; JUAN IZQUIERDO, MANEJO Y GESTIN DE LA BIOTECNOLOGA AGRCOLA APROPIADA PARA PEQUEOS PRODUCTORES: ESTUDIO DE CASO ARGENTINA 59 (Apr. 2004), http://www.argenbio.org/adc/uploads/pdf/ manejo_y_gestion.doc. 7 Id. at 6061. 8 Id. 9 Liberaron a los Ambientalistas y Monsanto Suspende la Obra, LA VOZ (Sept. 30, 2013), http://www.lavoz.com. ar/politica/liberaron-las-ambientalistas-y-monsanto-suspende-la-obra. 10 Blockade Against Monsanto in Malvinas Argentinas, REVOLUTION NEWS (Oct. 15, 2013), http://revolution-news.com/blockade-against-monsanto-in-malvinas-argentina/. 11 Id. 12 Ley de Semillas y Creaciones Fitogneticas [L.S.] [Law on Seeds and Phytogenetic Creations], Ley 20247, BOLETIN OFICIAL [B.O.], Mar. 30, 1973, http://www.infoleg.gob.ar/infolegInternet/anexos/30000-34999/34822/texact.htm. 13 Ley de Promocin del Desarrollo y Produccin de la Biotecnologa Moderna [L.B.] [Law on the Promotion of the Development and Production of Modern Biotechnology], Ley 20270, B.O., July 25, 2007, http://www.infoleg.gob. ar/infolegInternet/anexos/130000-134999/130522/norma.htm. </p></li><li><p>Restrictions on Genetically Modified Organisms: Argentina </p><p>The Law Library of Congress 3 </p><p>The LS is intended to promote the efficient production and marketing of crops by providing farmers with assurances as to the identity and quality of seeds that they acquire while protecting the property of phytogenetic innovations.14 It provides a definition of seeds that is broad enough to include transgenic crops, since it includes all vegetable matter susceptible to sowing or propagation.15 The LS sets forth a general legal framework for the commercialization of crops, including their import and export,16 as well as seed classification and registration requirements and procedures.17 It established the National Commission on Seeds within the Ministry of Agriculture and Cattle as the enforcement authority empowered to determine which species will be subject to control and registration under the law.18 It also provided for the establishment of the National Registry of Cultivars, in which seeds that are open to the public or offered to consumers in any way are identified.19 Regarding GM seeds, Resolution 46/2004 on Genetically Modified Plant Organisms (Resolucin 46/2004 de Organismos Vegetales Geneticamente Modificandos)20 requires an additional registration in a specific National Registry of Operators of Genetically Modified Plant Organisms by all those who conduct experiments, import or export, produce or reproduce, or carry out any activity related to GM plants that have not been approved for commercialization in Argentina.21 Registration is a prerequisite to request authorization for the release of genetically modified organisms (GMOs) for purposes of testing.22 Registration is also required to obtain authorization for import or export of GM plants.23 The LB is intended to promote the development and production of modern biotechnology by granting tax incentives to qualifying research and production projects that meet safety and health standards.24 Argentina signed the Cartagena Protocol on Biosafety25 in 2000, but has not yet ratified it.26 The Protocol, which regulates transboundary movements of GMOs, adopts the precautionary 14 L.S. art. 1. 15 Id. art. 2. 16 Id. arts. 1115. 17 Id. arts. 1630. 18 Id. art. 7. 19 Id. arts. 9, 1618. 20 Resolucin 46/2004 de Organismos Vegetales Geneticamente Modificandos, Jan. 28, 2004, http://www.infoleg. gob.ar/infolegInternet/verNorma.do;jsessionid=578413824CD6FF46DB9979BD5F4EDD86?id=92241. 21 Id. art. 1. 22 Id. art. 3. 23 Id. art. 4. 24 L.B. arts. 6, 7, 13, 14. 25 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 39 I.L.M. 1027, available at http://bch.cbd.int/protocol/text/. </p></li><li><p>Restrictions on Genetically Modified Organisms: Argentina </p><p>The Law Library of Congress 4 </p><p>principle, which entitles the member parties to restrict or prohibit the import of GMOs if there is no sufficient or conclusive information as to its safety.27 Major world producers of GMOs such as the US, Canada, and Argentina have not ratified it, however, largely due to concerns that the restrictions that it would impose on the free trade of GMOs would be detrimental to their agricultural exports.28 IV. Restrictions on Research, Production, and Marketing A. Responsible Agencies The Secretary of Agriculture, Livestock, Fisheries and Food (Secretara de Agricultura, Gandera, Pesca y Alimentacin, SAGPA) is in charge of granting permits for the release and commercialization of GMOs. Its permitting decisions are undertaken with the assistance of expert advisory commissions.29 The review process for granting such permits involves (1) an assessment to verify that biosafety standards are met with regard to the agricultural </p><p>ecosystem, with respect to both experiments on GMOs in greenhouses and their release into the environment; </p><p>(2) a review of their safety as food additives or ingredients; and </p><p>(3) an evaluation of the impact that their commercialization would have on Argentinas international trade. 30 </p><p>The first two steps, the environmental and food safety assessments, are based exclusively on scientific data and conducted by expert commissions composed of representatives of both the public and private sectors. The evaluation of environmental safety is assigned to the Biotechnology Directorate (BD) and food safety review is carried out by the National Service on Agricultural Food Health and Quality (Servicio Nacional de Sanidad y Calidad Agroalimentaria, SENASA). The assessment of the impact of the GMO on international commerce is assigned to the Agriculture Market Directorate (AMD), which evaluates whether authorizing commercialization is compatible with the standards of Argentinas trade partners. This is critical because agricultural commodities are Argentinas main exports.31 In many cases, GMOs that 26 MARA CRISTINA RODRGUEZ, MODERNA BIOTECNOLOGA AGRCOLA: NORMATIVA Y JURISPRUDENCIA NACIONAL, COMUNITARIA E INTERNACIONAL 21 (2009), bibliographic information available at http://lccn.loc.gov/ 2010503912. 27 Biosafety Protocol, GREENPEACE, http://...</p></li></ul>