Argentina is the third largest grower of biotech crops in the world, after the United States 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.

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]

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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 Córdoba, 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 company’s Roundup herbicide.[10]

�Epidemiological surveys were conducted in 2001–2002 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]

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III.  Structure of Pertinent Legislation

GMOs are regulated in Argentina under the general Law on Seeds and Phytogenetic Creations (Ley de Semillas y Creaciones Fitogéneticas, LS)[12] and the Law on the Promotion of the Development and Production of Modern Biotechnology (Ley de Promoción del Desarrollo y Producción de la Biotecnología Moderna, LB).[13]

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 (Resolución 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 Biosafety[25] in 2000,�but has not yet ratified it.[26]  The Protocol, which regulates transboundary movements of GMOs, adopts the “precautionary 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]

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IV.  Restrictions on Research, Production, and Marketing

 A.  Responsible Agencies

The Secretary of Agriculture, Livestock, Fisheries and Food(Secretaría de Agricultura, Gandería, Pesca y Alimentación, 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 ecosystem, with respect to both experiments on GMOs in greenhouses and their release into the environment;
• (2)  a review of their safety as food additives or ingredients; and
• (3)  an evaluation of the impact that their commercialization would have on Argentina’s international trade. [30]

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 Argentina’s trade partners.  This is critical because agricultural commodities are Argentina’s main exports.[31]  In many cases, GMOs that have been proved safe for the agricultural ecosystem and approved for use in the raw components for food are still not permitted to be commercialized until approval is received from the importing country’s authorities.[32]

A Biotechnology Office has been created to coordinate seed registration and control and to participate in international negotiations in biotechnology matters. This office has the authority to decide on biosecurity issues, to design and implement guidelines and administrative procedures, and to set biotechnology and agricultural policies.[33]

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V.  Restrictions on Releasing Organisms into the Environment

Subject to regulatory approval, Argentina allows GMOs to be released into the environment, under either confined or unconfined circumstances.  Regulatory approval may be obtained for confined releases in three situations: (1) cultivation in greenhouses, (2) field trials, and (3) production of regulated seeds.[34]  Permission for unconfined planting of GM crops is granted only after a comprehensive study assessing whether free planting of the crop would be safe for the agricultural ecosystem.[35]

Regulatory approval requires the applicant to provide pertinent technical information on the crop that is analyzed by the National Advisory Commission on Agricultural Biotechnology (Comisión Nacional Asesora de Biotecnología Agropecuaria, CONABIA).  The approval process includes an evaluation of the risks that a GM crop would pose to the agricultural ecosystem.[36]

Authorizations are subject to specific conditions, including appropriate environmental risk management and risk mitigation measures, isolation distances, the availability of specific detection methods, and restrictions on the use of both the harvested material and the field plot in future seasons.[37]  Production of regulated seed is permitted only under stringent isolation and seed processing conditions designed to prevent the regulated material from entering the commercial chain.[38]

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VI.  Restrictions on GMOs in Foodstuffs

SENASA has the authority to evaluate the risks to human and animal health of food derived from GMOs.[39]  The risk evaluation includes an assessment of whether such food is harmful, its nutritional characteristics, and a comparison between the GM-derived food and its conventional counterpart.  For a GM-derived food to be approved, it must be as safe and nutritious as conventional food already in the market.  As new scientific and technical information becomes available, the food’s risk assessment is reevaluated accordingly.[40]

Detailed requirements, forms, and procedures that need to be submitted for approval of GM-derived food are included in Annexes II and III of Resolution 412/2002.[41]

Labelling of food containing GMO material is not required, although several bills requiring the labelling of food with GMO elements for human or animal consumption have been submitted and are pending congressional debate.[42]

The labeling of food and agricultural products with GMOs being imported in the European Union from Argentina and the US, among other countries, was the subject of consultation and a trade dispute before the World Trade Organization in 2003.  The exporting countries maintained that the EU required labeling of such imports constituted an undue restriction of agricultural product restrictions.[43]

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VII.  Liability Regime

Liability for damage to the environment in Argentina is provided for in the General Law on the Environment (Ley General del Ambiente, LGA),[44] which defines environmental damage as any relevant alteration that negatively modifies the environment, its resources, the balance of ecosystems, or collective values or assets.[45]

The LGA establishes a general principle of civil liability that anyone who causes current or future degrading effects to the environment is responsible for the costs of preventive and corrective actions, regardless of other environmental liabilities that may arise.[46]  Whoever causes environmental damage is subject to strict liability to restore the environment to its prior condition before the damage occurred.[47]  An allegedly responsible party may be exonerated from liability only by proving that all measures aimed at preventing the damage were taken and the damage was caused exclusively by the victim or a third party.[48]

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VIII.  Prominent Judicial Decisions

On September 4, 2012, a Criminal Court of Appeals of the Córdoba Province rendered a decision convicting a farmer and a crop-spraying pilot for spraying agrochemicals in the suburbs of the provincial capital neighborhood.  It appears that the herbicides were applied to a GM soy variety.  During the criminal proceeding, it was proved that 114 out of 142 children in the same neighborhood had agrochemicals in their blood.  The medical expert in the case testified that he had found children in the area with more than five herbicides and insecticides in their blood. This is an unprecedented decision, since it is the first case in which pollution and harm to public health is treated as a crime and prosecuted in a Criminal court, under the Law 24051 on Hazardous Products[49], which punishes offenders with between five and ten years in prison for polluting soil, water, air, or the environment in a manner that is harmful to health.  The ruling points specifically to two agrochemicals: endosulfan and glyphosate.[50] This case may highlight the popular concern about the increased use of herbicides on herbicide-resistant GM crops.

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Graciela Rodriguez-Ferrand
Senior Foreign Law Specialist
March 2014

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