Nyu project on International gmo regulatory Conflicts


Modified-Food Labeling Begins in Europe



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Modified-Food Labeling Begins in Europe,” New York Times, April 21, p. F 6. Available at: http://proquest.umi.com/pqdlink?did=621417541&sid=2&Fmt=3&cl ientId=9269&RQT=309&VName=PQD.

236 Iolster, Andrés, from Cargill Argentina, personal communication, Buenos Aires, May 2005.

237 Ablin and Paz (2000), p. 7.

238 Trigo et al. (2002), p. 88.

239 SAGPyA (2005), “Tipos de semillas,” in Maíz. Available at: http://www.sagpya.mecon.com.ar.

240 Vallone, Pedro, Carlos Galarza, Vicente Gudelj, Guillermo Nieri, Beatriz Masiero, and Miguel Peretti, “Primera evaluación técnico económica de los maíces trasngénicos,” INTA Marcos Juárez, 2000. Available at: http://www.e-campo.com/media/news/nl/agrbiotec14.htm

241 “En las fechas de siembra atrasadas las ventajas económicas del Maíz GM son muy importantes y en estos casos no se justificaría desde ningún punto de vista dejar de usar esta tecnología, ya que en la cuarta fecha por ejemplo, la rentabilidad sobre el capital de trabajo marginal invertido, que muestra el resultado económico del ensayo, es del orden del 855 % en seis meses.” Vallone et al. (2000).

242 Vallone, Pedro, Carlos Galarza, Vicente Gudelj, Guillermo Nieri, Beatriz Masiero, and Miguel Peretti, “Maíz: actualización 2002. Información para extension no 73. July 2002. INTA EEA Marcos Juárez. A summary is available at: http://www.tranqueraabierta.com.ar/inta/rendimailz2002.htm

243 Trigo et al. (2002), p. 118.

244 They cite USDA/ERS, Genetically Engineered Crops for Pest Management, June 1999; and European Commission, Facts on GMOs in the US. Memo 0043. Brussels, July 13, 2000.

245 Ablin and Paz (2000), p. 16.

246 Benbrook, Charles M. (2001), When does it pay to plant BT corn? Farm-Level Economic Impacts of Bt corn, 1996-2001, November. Available at: http://www.biotech-info.net/Bt_corn_FF_final.pdf . As stated on its cover page, this report summarizes for farm communities the major findings of a longer technical report by Dr. Benbrook entitled ‘The Farm-Level Economic Impacts of Bt Corn from 1996 through 2001: An Independent National Assessment,” This thorough report is available at: http://www.biotech-info.net/Bt_farmlevel_IATP2001.html .

247 Benbrook (2001b), p. 18.

248 Idem, p. 29.

249 Idem, p. 30.

250 Trigo et al. (2002), p. 141. They mention Márgenes Agropecuarios magazine, December 2001. Márgenes Agropercaurios is an Argentine monthly trade magazine founded in 1985, “with a clear agro-economic orientation,” edited by Mario R. Arbolave. Its website is: http://www.margenes.com

251 Idem, pp. 141-143.

252 Trigo et al. (2002), p. 87.

253 Almeyra et al. (2003), p. 24.

254 SAGPyA (2005), Estimaciones Agrícolas. Informe Semanal al 29-04-2005, p. 14-15.

255 Almeyra et al. (2003), p. 147.

256 SAGPyA (2005), Campaňa Agrícola 2004-2005. Cifras Oficiales al 13/5/2005. Available at: http://www.sagpya.mecon.gov.ar.

257 Elena, M. G. (2001), “Ventajas económicas del algodón transgénico en Argentina,” INTA, Estación Experimental Saénz Peña, Chaco Province, Argentina. Manuscript. Available at: http://saenzpe.inta.gov.ar/Noticias/EcoAlgodBT.htm

258 Qaim, Matin and Eugenio Cap (2002), “Algodón Bt en Argentina: un análisis de su adopción y la disposición a pagar de los productores,” INTA, Instituto de Economía y Sociología. Manuscript. Available at: http://www1.inta.gov.ar/ies/publicaiones%5algodon.pdf . Similar results were presented in Matin Qaim and Alain de Janvry “Bt cotton in Argentina: analyzing adoption and farmer’s willingness to pay,” selected paper presented at the Annual Meeting of the American Agricultural Economics Association (AAEA), in Long beach, July 28-31, 2002. Available at: http://are.berkeley.edu/~sadoulet/papers/qaim.pdf . Finally, these results were also published in Matin Qaim and Alain De Janvry (2003), “Genetically modified crops, corporate pricing strategy, and farmers adoption: the case of BT cotton in Argentina,” American Journal of Agricultural Economy, 85 (4) (November): 814-828.

259 Qaim and Cap (2002), p. 27.

260 Idem, p. 30.

261 Qaim Matin, Eugenio Cap, and Alain de Janvry, “Agronomics and sustainability of transgenic cotton in Argentina, invited submission to AgBioForum, July 2003. Available at: http://are.berkeley.edu/~sadoulet/papers/Pesticide.pdf

262 Idem, pp. 14-15.

263 Idem, p. 15.

264 Trigo et al. (2002), p. 140-141.

265 Derewicki, José (2004), “Nuevos rumbos para el algodón,” La Nación, May 29, Campo section, p. 9.

266 Miller, Scott (2004), “La batalla contra los subsidios cobra fuerza con un fallo de la OMC sobre el algodón,” The Wall Street Journal Americas, in La Nación April 28, Economía & Negocios section, p. 2.

267 On problems faced by cotton production in Argentina, see: “Algodón: en busca de soluciones,” in La Nación, July 23, 2004, Economía & Negocios section, p. 7; and “Piden tres aňos sin retenciones,” in La Nación, December 31, 2004, Campo section, p. 7. On the reception of the WTO decision in Argentina, see: Liboreiro, Ernesto and Ariel Ibaňez (2005), “Avances contra el proteccionismo agrícola”; and Mira, Cristian (2005b), “La estrategia argentina es diferente del camino adoptado por Brasil,” both in La Nación, May 21, Campo section, pp. 6-7.

268 Bolton, Ernesto (2005), “Ante un nuevo horizonte productivo,” La Nación, May 21, Campo section, p. 7.

269 Trigo et al. (2002), p. 169.

270 Qaim and Cap (2002), p. 27.

271 Reboratti (2005), p. 57.

272 Nuffield Council on Bioethics (2004), The Use Of Genetically Modified Crops In Developing Countries. A Follow-up Discussion Paper, London, p. 41.

273 Idem, p. 42.

274 Oesterheld, Martín (2005), “Los cambios de la agricultura argentina y sus consecuencias,” Ciencia Hoy, Vol. 15, No. 87, June-July, pp. 6-12.

275 Reboratti (2005), p. 52.

276 Trigo and Cap (2003), p. 89.

277 INTA (2003), INTA on the Concern on Long-Run Sustainability of the Argentine Agricultural Production, December 4, p. 1. Available at: http://www1.inta.gov.ar/ies.

278 Idem, p. 3.

279 It is estimated that in 2004, soybean export tariff represented between 4,400 and 5,200 million pesos. “Agricultura, comercio exterior e ingresos fiscales,” Ciencia Hoy, Vol. 15, No. 87, June-July, p. 50.

280 Idem, pp. 3-4.

281 Commercial approval of two events of RR corn in 2004 and 2005, although seen as a concession to Monsanto, certainly shows that SAGPyA is not very worried about massive use of glyphosate, particularly considering that corn is the crop most promoted to rotate with soybean in order to increase soil organic matter.

282 It is noteworthy how SAGPyA describes soybean, corn and cotton production in the context of “agriculturization” and “sojización” –increased soybean production—in Argentina: it states that the current situation “in many provinces” is “worrying.” See: SAGPyA’s website on Maiz, Soja and Cotton at http://www.sagpya.mecon.gov.ar. Another sign of the current acknowledgment of the situation is AAPRESID concern about monoculture: its president currently states that “no till” must be understood as an integral approach which includes rotations. See: Romagnoli, Jorge (2004), “Sustentabilidad ambiental”, presentation at the Jornada sobre Sustentabilidad de la Agroindustria Argentina, Buenos Aires, October 19. A final example is the annual conference on soybean MundoSoja, first organized in 2003 by AACREA and AAPRESID explicitely to address soybean cultivation problems. See “La soja frente al desafío de la sustentabilidad,” La Nación, 2003, Campo section. Available at: http://www.lanacion.com.ar/50518. In 2005, SAGPyA and INTA participated in organizing MundoSoja. In 2005, MundoSoja eloquent slogan was: “Overcoming barriers with responsibility.” Available at: http://www.mundosoja.com.ar.

283 “Cambio de cultivo en Santa Fe,” La Nación, January 5, 2005, Economía & Negocios section, p. 1.

284 Bisang, Roberto (2004), “Innovación y estructura productiva: la aplicación de biotecnología en la producción agrícola pampeana argentina,” in Bárcena, Alicia, Jorge Katz, César Morales and Marianne Schaper, Los Transgénicos en América Latina y el Caribe: un Debate Abierto, Santiago de Chile, CEPAL, June, pp. 71-110.

285 Satorre (2001), p. 88. See also: Castro, Victor, Alberto Arizu and Marcos Gallacher (2004), Impacto Económico del Conocimiento Científico. El Caso de la Genética Vegetal, Buenos Aires, Universidad del CEMA.

286 SAGPyA, for Secretariat of Agriculture, Livestock, Fisheries, and Food.

287 Cohen, Joel I., Patricia L. Traynor, Moisés Burachik, Magdy Madkour and John Komen (2001a), “Biosafety Studies in Egypt and Argentina: Two Pathways to Implementation,” in Mclean, M. A., R. J. Frederick, P. L Traynor, J. I. Cohen, and J. Komen (eds.), A Framework for Biosafety Implementation: Report of a Meeting, The Hague, The Netherlands: International Service for National Agricultural Research Biotechnology Service, p. 23.

288 Calgene Inc. asked permission to test a Bt and Bromoxynil-tolerant cotton; Nidera S. A., to test a glyphosate-tolerant soybean; and Ciba Geigy Arg. S.A.I.C to test marker genes in corn. SAGPyA wesbsite: www.sagpya.mecon.gov.ar.

289 Burachik, Moisés and Patricia Traynor (2002), Analysis of a National Biosafety System: Regulatory Policies and Procedures in Argentina, ISNAR Country Report 63, The Hague: International Service for National Agriculture Research, p. 2. Available at: ftp://ftp.cgiar.org/isnar/Publicat/cr63.pdf and http://www.essentialbiosafety.info/docroot/articles/02-253-001.pdf. Also: Moisés Burachik, general coordinator, Biotechnology Office, personal communication, Buenos Aires, May 2005.

290 MacKenzie (2001), Donald J., International Comparison of Regulatory Frameworks for Food Products of Biotechnology, Ottawa, Canada: Canadian Biotechnology Advisory Committee, p. 62. Available at: http://strategis.ic.gc.ca/epic/internet/incbac-cccb.nsf/vwapj/InternatComparisons_MacKenzie.pdf/$FILE/InternatComparisons_MacKenzie.pdf.

291 Vicién, Carmen (2004), “El sistema regulatorio argentino en el contexto mundial,” paper presented at the II Seminario Biotecnología Agropecuaria en la Argentina. Propuestas para Enfrentar el Nuevo Contexto Internacional, UNEP-GEF and SAGPyA, Buenos Aires, May 6, p. 6.

292 Vicién, Carmen, and Perla Godoy (1997), “El marco regulatorio para la liberación al medio de oganismos genéticamente modificados en la Argentina,” in Marquard, Helen and Carmen Vicién, Bioseguridad Agropecuaria. Hacia la comercialización de vegetales y vacunas genéticamente modificados Secretaría de Agricultura, Ganadería, Pesca y Alimentación and Department of the Environment, Buenos Aires, September, pp. 68-73.

293 Cohen, Joel, John Komen, and Javier Verástegui (2001b), “Plant biotechnology research in Latin American countries: overview, strategies and development policies, paper presented at the IV Latin American Plant Biotechnology meeting, REDBIO 2001, June 4-8, Goiania, Brazil.

294 Burachik and Traynor (2002, p. 31) mention a biosafety law that would have carried penalties for violations was expected to reach the parliament in 2002. This law was not passed as expected, due to the “institutional crisis” of December 2001—which, among other consequences, led to President Fernando de la Rúa’s resignation—, according to Trigo et al. (2002).

295 The following description is based on Burachik and Traynor (2002), and SAGPyA (2005), Marco Regulatorio de la Biotecnología Agropecuaria en la República Argentina, Buenos Aires. Available at: http://www.sagpya.mecon.gov.ar. In all cases, the norms have been translated into English by the author. The use of capital letters follows the use in these norms in Spanish.

296 Burachik and Traynor (2002), p. 12.

297 SAGyP Resolution No. 656/92 states in its Annex: “The Secretary of Agriculture, Livestock, and Fisheries is the authority responsible for conceding this permit for experimentation and/or release into the environment of Genetically Modified Microorganisms, counting on the previous dictum of the National Advisory Commission on Agricultural Biotechnology. Information in this request will only be used in the evaluation of the suitability of granting permits for Genetically Modified Microorganisms. Permit will not be granted until this request is approved. The experimentation and/or release into the environment of Genetically Modified Microorganisms which do not have the due permit granted by this authority are expressly forbidden.”

298 “Flexibilization” means “that the applicant only needs to notify the release for the purpose of inspections (at planting, harvest and residue disposal). No isolation distances are required.” Burachik and Traynor (2002), 53. Regarding these two former norms, see: Idem, pp. 18-25.

299 These changes have been taken on two grounds. Regarding new genetic information required, it has been argued that there are now new analytical methods that allow for a more precise characterization of the “insert,” the inserted DNA. Regarding isolation distances and the end of the “flexibilized” status, it has been argued that since production of GM seeds for off-season exportation to the “Northern hemisphere” has increased in Argentina, and since some of the events have not been approved in Argentina or in countries that purchase Argentine crops, the “risk of contamination” due to pollen flow must be prevented “in order for the authorized materials to continue to be exportable.” See: Burachik, Moisés (2004), “Breve descripción del marco regulatorio de los organismos genéticamente modificados (OGMs) en Argentina”, paper presented at the II Seminario Biotecnología Agropecuaria en la Argentina. Propuestas para Enfrentar el Nuevo Contexto Internacional, UNEP-GEF and SAGPyA, Buenos Aires, May 6, p. 1.

300 A “Genetically Modified Organism” is defined as “any organism in which any of the genes or other genetic material have been modified by means of modern biotechnology techniques,” such as:

  • “the insertion by any method into a virus, bacterial plasmid or other vector system of a nucleic acid molecule, which has been produced by any method outside that virus, bacterial plasmid or other vector, as to produce a new combination of genetic material which is capable of being inserted into an organism in which that combination does not occur naturally and within which it will be heritable genetic material;

  • “the insertion into an organism, by micro-injection, macro-injection, micro-encapsulation or other direct means, of heritable genetic material prepared outside that organism;

  • “where they involve the use of recombinant DNA molecules in in vitro fertilization that implies the genetic transformation of an eukaryotic cell.”

The translation of this definition is mostly taken from: Flint, Jason, Lionel Gil, Javier Verastegui, Carlos Irrarzabal, and Juan Dellacha (2000) “Biosafety information management systems. A comparative analysis of the regulatory systems in Canada, Argentina, and Chile,” EJB Electronic Journal of Biotechnology, Vol. 3 No 1, April 15, pp. 9-29. Available at: http://www.ejb.org/content/vol3/issue1/full/2. This definition, in Spanish, is still available in SAGPyA website: http://www.sagpya.mecon.gov.ar

301 It is important to note that in Resolution No. 39/03, “release into the environment” (“liberación al medio”) is defined as “the deliberate introduction of a GMPO into the environment” (“la introducción intencional de un OVGM en el ambiente”). The Spanish words for “environment” are either “medio” or “ambiente,” and a combination of both (“medioambiente”) is also common in some contexts–not in SAGPyA norms—, although some experts consider it redundant. In this resolution the word “trial” (“ensayo”), is used to refer to the actual experiment to be performed.

302 The information required is: the plant scientific and common name; introduced characteristics (“as detailed as possible”); name of the event/s; introduced genes (main and accompanying, of which it is required a complete description and origin, regulatory elements, “detailed” molecular mechanism involved in the expressed phenotype, and bibliography); origin and description of the “material to be tested”; previous authorizations in other countries; data on the people and institutions who “developed or provided the GMPO”; history of the introduction of the gene/s in the same or other species; thorough description of the molecular biology of the donor-vector-recipient system relevant in the generation of the GMPO, including (if possible) quantitative data on the expressed proteins in different tissues; sequence homologies of the expressed products with known sequences of expressed products of pathogens, toxins or allergens; if the sequences incorporated have sequence homologies with the genomes of DNA viruses which can lead to recombinations, and if any of these viral species may infect the transformed species as well as those sexually compatible with it; “other possible risk factors derived from the presence of the introduced genes or their expression”; phenotypic description of the GMPO; centers if origin and genetic diversity (“if known”); brief phenotypic description of the recipient organism or the parental line; heritability pattern of the characteristic incorporated by the main gene/s; phenotypic stability of the GMPO, indicating the number of generations it was verified; and to indicate if, as a result of the genetic modification, it is expected the generation of allergenic or toxic proteins, or an increase in the expression of allergenic or toxic proteins already existent in the non-transformed material.

303 “Individual event” or “event” is defined as “the insertion into the plant genome in a stable, simultaneous form of ONE (1) or more genes that are part of a defined construction.” “Set of equivalent events” is defined as “those [events] which have been obtained by transforming a given plant species with the same vector and the same genetic construction.” “Set of related events” is defined as “those [events] which have been obtained by combining different vectors, or vectors that have different regulatory constructions or elements, but which are related to a common phenotype.”

304 Description of the “climatic and agro-ecological characteristics of the area where the release will take place” includes: description of the species taxonomically related to the GMPO which may be present in the area; possibility of cross-pollination; description of the propagation and dispersion mechanisms and periods, and conditions of latent life or inactivity; weediness potential of the GMPO; description of the possible interactions of the GMPO with “non plant organisms” in the ecosystems where it is usually planted.

305 For trials inside a greenhouse: detailed location of the greenhouse; norms for access control; quantity of the materials to be sown; which other plants will be inside the greenhouse, and measures to prevent “gene flow”; methods to prevent the entering of “any kind of vectors”; to indicate if “specific reactives” for detecting the event will be available; prospected use of the ground after the trial. For trials in open fields: on top of those requested for greenhouse trials, estimated date for sowing, flowering, and harvest, as well as date of other projected activities (infestation or inoculation, etc.), and date of final disposal of the plant materials involved; post- harvest treatment of the ground; posterior control of the field (“elimination of volunteer plants, of taxonomically related species, etc.”); contingency plans in case of a escape, among others.

306 For example, for accessing toxicity, Resolution No. 39/03 requires information on digestibility and Acceptable Daily Intake (ADI) of the newly expressed proteins, while SENASA Resolution No. 412/02 does not.

307 “Application for the Request of Flexibilized Conditions for Release into the Environment of Genetically Modified Plants for Field Trials,” an essential part of SAGyP Resolution No. 131/98, is available in English in Burachik and Traynor (2002), pp. 53-58.

308 Resolution No. 39/03 requires an “equivalence, difference and non-equivalence statement” described as follows:

“A.5.1.The petitioner will state that the GMPO is equivalent to the similar, non-GM counterpart, except for the phenotype contributed by the newly introduced gene. The statement should refer to all those characteristics of the GMPO which were not intended to be modified in the event. Reference to the studies—included as addenda—that support this statement should be QUOTED. The equivalence should refer at least to: (a) compositional analysis, processing technology, derived products, and byproducts; and (b) agricultural practices including growing and management practices, geographic areas, environment types, specific precautions for the extensive growing of it in relation to environmental effects, if there were such.

“A.5.2.The petitioner will state observations on any unintended or unexpected difference, observed on any aspect of the phenotypic expression of the GMPO compared to the non-GM counterpart. It should be INCLUDED all observations from the post-market monitoring of the event (if it has been commercially released in other countries), as well as those resulting from the studies conducted after those commercial releases:

“A.5.3. If corresponding, the petitioner will state if the kind of genetic modification has the purpose of introducing differences which determine the GMPO cannot be considered substantially equivalent to the non GMPO, briefly explaining those differences.”



309 Additional data on the insert required in Resolution No 39/03 is:

“B.3.4. Detailed information on transpositions and/or re-arrangements inside the insert present in the plant (versus the positions the genetic elements had in the vector) and/or of/with portions of the plant genome inside the insert and in the adjacent regions:

“B.3.5. Detailed information on the plant genome sequences adjacent to the insert:

“B.3.6. Detailed information on the presence/absence of fragments of the insert in regions of the plant genome outside the functional insert:”



310 For example, “Actions required in the event of an accidental release or inappropriate use” in Resolution No. 131/98 is replaced in Resolution No. 39/03 by “Methodology for the detection of adventitious presence of the GMPO in non-GM plants, seeds, and grain, and in materials derived from those.”

311 For GM potato, the required isolation distance is 10m, and the required time lag before planting potato in the same field is 3 years. For tomato, the required isolation distance is 200m, and the required time lag before planting tomato in the same field is 2 years. For wheat, the required isolation distance is only 3 m, and the required time lag before planting wheat in the same field is 2 years. For cotton, different isolation distances are required for varieties resistant to a pest, “enfermedad azul,” also known for its French-origin name, “maladie bleue”: 500m for “resistant varieties,” and 800m for “susceptible varieties.” The required time lag before planting cotton in the same field is 3 years, the same for both cases.

312 SENASA Resolution No. 511/98 was based on “FAO and WHO documents, as well as on relevant regulations from Australia, Canada, the EU, Japan and the US.” Burachik and Traynor (2002), p. 14.

313 Halsberger, Alexander (2003), “Codex guidelines for GM foods include the analysis of unintended effects,” Nature Biotechnology, volume 21, numer 7, July, pp. 739-741, p. 739.

314 Article 19 of the Appendix II states: “Risk management measures may include, as appropriate, food labelling, conditions for marketing approvals, post-market monitoring and development of analytical methods for the detection or identification of foods derived from modern biotechnology.” Article 21 of the Appendix II states: “[Risk management may include traceability.]”

315 On the organism to be assessed, it is required to inform: common and scientific name; known pathogenic characteristics; history of use as food; description of the recipient genotype (variety, cultivar).

316 On the donor organism, it is required to inform: common and scientific name; known pathogenic characteristics; history of use as food.

317 On the event, it is required to inform: introduced characteristics; introduction method. On the sequence: detailed map of the vector; main gene/s; accompanying sequence/s; number of inserts (complete or incomplete) and their sequences; genetic stability.

318 On the “products of expression,” information required is: identification of the newly expressed proteins; characteristics and biological activity; patterns and levels of expression in different tissues and ontogenic stages; nutritional characteristics.

319 On allergenicity, it is required to inform: identification of the known allergens in donor and recipient species; similarity of the newly expressed proteins to known allergens; other potentially allergenic characteristics: molecular weight, resistance to processing (heat or other), in vitro digestibility.

320 On toxicity, it is required to inform: identification of known toxins naturally occurring in donor and recipient species; identification of new substances with toxic activity derived from the transgene/s; similarity of the newly expressed proteins to known toxins; assessment of acute toxicity in animals of the newly expressed proteins with no food history; assessment of chronic or sub-chronic toxicity of the newly expressed proteins (if corresponding); assessment of chronic or sub-chronic toxicity of the whole food (if corresponding).

321 Law No. 20247, Article 1, defines “seed” as “any plant structure destined to sowing and propagation.”

322 Trigo et al. (2002), pp. 114-117; and Carullo and Dellacha (2003), pp. 52-53. Law No. 24376 explicitly states in its Article 2, that UPOV Act prevails on Law No. 20247, that is, on local legislation. Complete legislation is available at SAGPyA’s website, Marco Regulatorio de la Biotecnología en la Argentina, http://www.sagpya.mecon.gov.ar. Regarding protection of plant breeder’s rights, Trigo et al. (2002, 112-113) highlight the creation of the Argentine Association for the Protection of Obtained Plants (Asociación Argentina de Protección de las Obtenciones Vegetales, ARPOV) in 1991. This institution, along with INASE, “represent “the basis for the development of the seed market in the past two decades.”

323 Carullo and Dellacha (2003), p. 51.

324 For example, by late 2001, 31 patents on genes, vectors, plasmids or proteins in relation to Bt genes had already been granted by the National Institute of Intellectual Property (INPI). The first one, No. AR 243.234, was granted to Monsanto Company on July 7 1993. However, the first submission was presented by Mycogen Plant Science Inc. on September 24, 1984; it was granted on April 15, 1996 (No. AR 248.617). Trigo et al. (2002), p. 112-114 and 131.

325 Idem, p. 112. Regarding inconsistencies they quote Correa, C. M. (1999), “Normativa nacional, regional e internacional sobre propiedad intelectual y su aplicación en los INIAs del Cono Sur,” Programa Cooperativo para el Desarrollo Tecnológico Agropecuario del Cono Sur, PROCISUR, Montevideo.

326 Carullo and Dellacha (2003), p. 52.

327 Vicién (2004), p. 2, note 1.
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