Nyu project on International gmo regulatory Conflicts

From the public sector: two representatives from INASE (instead of just its national director); four representatives from SENASA (instead of just its general administrator; of those, “two specialized in animal sanitary and quality matters,” and “two specialized in plant sanitary and quality matters”); two representatives from the Secretariat of Natural Resources and Environmental Policies; two representatives from the Secretariat of Health at the Ministry of Health. From the private sector: two representatives from the Argentine Ecology Society (SAE); two representatives from the Argentine Chamber of Plant Health and Fertilizer Products Manufacturers (CASAFE).

329 The general co-ordinator functions are: “to assist the SAGPyA in the issues within the competence of the Biotechnology Office, in order to provide a stable and simultaneous development of the policies, the implementation rules and the regulation procedures”; “to assist the SAGPyA in the actions concerted with other areas and related organisms”; “to develop and to suggest the promotion of issues of interest for the development of the activities, and everything that allow the solicitors to appreciate the institutional work of the SAGPyA as a regulation authority from the process of environmental release of a GMO until the granting of the corresponding trading permits”; and “to be in charge of the executive secretariat of CONABIA.” The executive co-ordinator functions are: “to assist the General Co-ordinator, and to replace him/her in case of absence or impediment, especially regarding the management of the regulation actions.”

330 Two representatives from the National University of Mar del Plata; two representatives from the National University of Quilmes; two representatives from the National University of Comahue; two representatives from the National Institute of Fisheries Research and Development.

331 Burachik and Traynor (2002), p. 20.

332 Moisés Burachik, general coordinator, Biotechnology Office, personal communication, Buenos Aires, May 2005.

333 Burachik and Traynor (2002), pp. 34-37. See also Part V.

334 Idem, p. 21.

335 Idem, p. 13. See also Part III.

336 Idem, p. 13.

337 Huerga, Gladys, technical coordinator of regulatory design, Biotechnology Office, personal communication, Buenos Aires, September 2005.

338 Idem, p. 13.

339 Idem, p. 32, and Huerga, Gladys (2005), technical coordinator of regulatory design, Biotechnology Office, personal communication, Buenos Aires, September 2005.

340 Idem, p. 14.

341 From the public sector: National Drug Institute, National Food Institute, National Food Directorate, and National Administration of Food, Drugs and Medical Technology, ANMAT (the four of them, part of the Ministry of Health and Environment); National Directorate of Agri-Food Quality (SENASA); Food Directorate (SAGPyA); public universities; National Science and Technology Research Council (CONICET); and CONABIA (SAGPyA). From the private sector: Argentine Seed Growers Association (ASA); Argentine Agrarian Federation; Coordination of the Food Products Industry (COPAL); Argentine Rural Confederation; Agricultural Inter-cooperative Confederation (CONINAGRO); Argentine Rural Society (SRA); Action in Defense of Consumers; Argentine Oil Industry Chamber; Argentine Supermarket Chamber.

342 Cohen et al. (2001b), p. 5.

343 Burachik and Traynor (2002), p. 14.

344 Idem, p. 15.

345 Description of the regulatory process is mostly based on Burachik and Traynor (2002), pp. 22-29.

346 For example, in 1998, an application requesting “flexibilization”—currently, the second stage of environmental assessment—of a Bt corn expressing a gene, Cry9C, from Bacillus thuringiensis subsp. tolworthi, prompted outside consultation. Data analyzed by CONABIA showed the Cry9C protein exhibited resistance to hydrolysis under simulated gastric conditions, and led CONABIA experts to consult with two external experts: a physician and two biochemists from the School of Pharmacy and Biochemistry, University of Buenos Aires. It is also important to note that, in this case, CONABIA concern had to do with food safety (SENASA area), not with its specific area, that is, environmental assessment. Idem, p. 25.

347 Idem, p. 24.

348 Regarding authorizations for field trials, those are not always taken by consensus. Huerga, Gladys, technical coordinator of regulatory design, Biotechnology Office, personal communication, Buenos Aires, September 2005.

349 Burachik and Traynor (2002), p. 23.

350 Idem, p. 25.

351 Idem, p. 26.

352 Idem. p. 27.

353 Idem, p. 22.

354 Idem, p. 34.

355 Idem, p.30.

356 Vicién, Carmen (2004), p. 7.

357 Idem, p. 14.

358 Idem, p. 14.

359 An example usually put forward is a GM potato present in a snack produced in the US imported in the 1990s.

360 Burachik and Traynor (2002), p. 33.

361 Huerga, Gladys, technical coordinator of regulatory design, Biotechnology Office, personal communication, Buenos Aires, September 2005.

362 Burachik and Traynor (2002), p. 33.

363 “Etiquetas para los alimentos transgénicos,” La Nación, March 24, 2003. Available at: http://www.lanacion.com.ar/483202.

364 One of these companies is La esquina de las flores.

365 Trigo et al. (2002) p. 110.

366 The whole information regarding field trials performed from 1991 to 2004 is available at SAGPyA website: http://www.sagpya.mecon.gov.ar

367 Idem.

368 Trigo et al. (2002) p. 110.

369 Burachik and Traynor (2002), p. 23.

370 SAGPyA (2005), Campaña agricola 2005/2005. Cifras al 13/5/2005. Available at: http:///www.sagpya.mecon,gov.ar.

371 Andreni, Pablo (2005), “El aceite de girasol recupera mercados,” La Nación, June 4, Campo section, p. 5.

372 Burachik and Traynor (2002), p. 30.

373 The study is discussed in “Se abre el debate con los transgénicos,” La Nación, November 27, 2004, Campo section, p. 8.

374 Andreani (2005), “El aceite de girasol…”

375 Poverene and Cantamutto (2003), p. 32.

376 United Nations Development Program (2001a), “Although controversial, GMOs could be a breakthrough technology for developing countries,” Human Development Report 2001 press release, July 10. Available at: http://hdr.undp.org/reports/global/2001/en/pdf/pr2.pdf

377 United Nations Development Program (2001b), Human Development Report 2001. Making Technologies Work for Human Development (New York/Oxford: Oxford University Press), p. 76. Available at: http://www.hdr.und.org/report/global/2001/pdf/completenew.pdf

378 Cohen et al. (2001a), p. 23.

379 Idem, p. 22.

380 Idem, p. 23-24.

381 Idem, p. 24.

382 Idem, p. 24.

383 Quoted in 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. 20-21. Available at: http://www.ejb.org/content/vol3/issue1/full/2.

384 MacKenzie (2001) p. 14.

385 Idem, p. 14.

386 The complete text of Alinorm 01/34A article 20—reproduced in SENASA Resolution 412/02 Annex I, Article 13—states: “Post-market monitoring may be an appropriate risk management measure in specific circumstances. Its need and utility should be considered, on a case-by-case basis, during risk assessment and practicability in addition during risk management. Post-market monitoring may be undertaken for the purpose of:

A) verifying conclusions about the absence or the possible occurrence, impact and significance of

potential consumer health effects; and

B) monitoring changes in nutrient intake levels, associated with the introduction of foods likely to significantly alter nutritional status, to determine their human health impact.”

387 Silverman, Ozzie (2000), International Approaches to Non-Science Issues in Regulating the Products of Biotechnology, prepared for The Canadian Biotechnology Committee Project Steering Committee on the Regulation of Genetically Modified Foods, November. Available at http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/RegulatingProds_Silverman_e.pdf/$FILE/RegulatingProds_Silverman_e.pdf.

388 Silverman (2000), p. 64.

389 Oliver, María Fabiana (2001), “El comercio de transgénicos en América del Sur. Elementos politicos – jurídicos para su tratamiento en el marco de la integración regional,” in Nicolás Luco (ed.), Cinco Estudios Sudamericanos sobre Comercio y Ambiente (Buenos Aires: Grupo Zapallar), pp. 83-105. Available at: http://www.farn.org.ar/docs/p25.pdf and http://www.farn.org.ar/grupozapallar/docs/cesca.pdf

390 Idem, p. 98

391 Idem, p. 98

392 Idem, p. 99.

393 Burachik and Traynor (2002).

394 This paper has made extensive use of this aspect of Burachik and Traynor’s paper, as other studies have done—such as Jaffe’s, Nap et al.’s and Pachico’s, which will be commented later on.

395 Idem, pp. 7-8.

396 Burachik (2005), personal communication, Buenos Aires, May.

397 Burachik and Traynor (2002), pp. 37-47.

398 Jaffe, Gregory (2004), “Regulating transgenic crops: a comparative analysis of different regulatory processes”, Transgenic Research 13, pp. 5-19, p. 5.

399 Idem, pp. 14-15.

400 Idem, pp. 9 and 15.

401 Idem, pp. 10 and 16.

402 Idem, p. 16.

403 Burachik and Traynor (2002), p. 13.

404 Idem, p. 16.

405 Idem, pp. 10 and 16-17.

406 Idem, p. 17.

407 Idem. pp. 17-18.

408 Idem, p. 18.

409 Nap, Jan-Peter, Meter L. J. Metz, Marga Escaler, and Anthony J. Conner (2003), “The release of genetically modified crops into the environment. Part I. Overview of current status and regulations,” The Plant Journal, 33, pp. 1-18.

410 Pachico, Douglas (2003), “Regulation of transgenic crops: an international comparison,” 7^th International Consortium on Agricultural Research (ICABR) International Conference on Public Policy for Agricultural Biotechnology, Ravello, Italy, June 29-July 3, 2003.

411 Nap et al. (2003), p. 13

412 Huerga, Gladys (2004) “Protocolo de Cartagena y su implementación. Situación en Argentina. Aspectos de Bioseguridad”, 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. 3.

413 Idem, p. 3.

414 Hopp, Esteban (2001), “Applying science to take conscious advantage of the benefits and address the issues of agricultural biotechnology in a developing country,” abstract of the New Biotechnology Foods and Crops: Science, Safety and Society, Bangkok Conference, 10-12 July. Available at: http://www1.oecd.org/bangkok/preshopp.htm, p. 2.

415 Vicién (2004), p. 10. See also the title of the paper presented by Hopp—member of CONABIA—in Bangkok, note 414. A more import

416 Jaffe (2004), p. 7.

417 Nap et al. (2003), p. 15.

418 Waisbord, Silvio (2000), Watchdog Journalism in South America. News, Accountability and Democracy, New York, Columbia University Press.

419 Worldwide Register of GM Contamination, http://www.gmcontaminationregister.org.

420 Transparency International reports quoted in “La percepción de la corrupción no tuvo cambios en la Argentina,” La Nación, October 20, main section. Available at: http://www.lanacion.com.ar/politica/nota.asp?nota_id=646574.

421 Burachik (2004), p. 2.

422 SAGPyA (2004), Plan Estratégico para el Desarrollo de la Biotecnología Agropecuaria 2005-2025, Buenos Aires, December, p. 3.

423 Idem, p. 31.

424 Cohen et al. (2001b).

425 Puig de Stubrin, Lilia, “Otra mirada al presupuesto de ciencia y tecnología,” La Nación, November 6, 2003. Available at: http://www.lanacion.com.ar/03/11/06/sl_542632.asp

426 C. M. (1998), “Argentina gives peer review a boost,” Nature, Vol. 391, 5 February, p. 525; and Macilwain, Colin (1999), “Science in Latin America,” Nature, Vol. 398, Supp., 1 April 1999, p. A15. C.M speaks of U$S 900, and Macilwain, of U$S 800.

427 Indicadores de Ciencia y Tecnología, Argentina-1999, SECyT. Quoted in Cohen et al. (2001b), p. 22.

428 Indicadores de Ciencia y Tecnología, Argentina-1999, SECyT. Quoted in Cohen et al. (2001b), p. 22.

429 Stubrin.

430 Cohen et al. (2001b), p. 22.

431 Idem, p. 22.

432 Stubrin (2003).

433 Macilwain (1999), A15.

434 Oesterheld, Martín (2004), “Fortalezas y debilidades de las ciencias agropecuarias en la Argentina”, paper presented at XVII Congreso Nacional CREA, Mar del Plata, Argentina, September 1-3. See also: Oesterheld, Martín, María Semmartin and Antonio Hall, “Análisis bibliográfico de la investigación agronómica en la Argentina” (2002), Ciencia Hoy , Volume 12, number 170, August-September, pp. 52-62.

435 Burachik and Traynor (2002), p. 9.

436 Idem, pp. 10-11.

437 Burachik and Traynor (2002), pp. 10-11.

438 Bio Sidus has already obtained a transgenic cow, Pampa Mansa, which produces human growth hormone. See Bär, Nora (2003), “Mansa, una ternera única en el mundo,” La Nación, October 2. Available at: http://www.lanacion.com.ar/03/10/02/sl_532215.asp; and “Un laboratorio obtuvo leche medicinal de una vaca clon,” Clarín, October 2, 2003. Available at http://old.clarin.com/diario/2003/10/02/s-02907.htm.

439 Mira, Cristian (2002), “Productores agropecuarios se unen e invierten en biotecnología,” La Nación, August 21. Available at: http://www.lanacion.acom.ar/02/08/21/de_424206.asp.

440 Mira, Cristian (2005c), “Buscan inversores para un proyecto de biotecnología,” La Nación, Economía & Negocios section, August 13, p. 8.

441 Gasparetti, Walter (2003), “Impulsan en Rosario un polo biotecnológico,” La Nación, July 12. Available at: http://www.lanacion.acom.ar/suples/campo/0328/db_510573.asp.

442 Mira (2005c), p. 8.

443 REDBIO website: www.rlc.fao.org/redes/redbio/html/home.htm.

444 Trigo, Eduardo, Greg Traxler, Carl Pray, and Ruben Echeverría (2001), “Agricultural Biotechnology in Latin America and the Caribbean,” in Philip Pardey, The Future of Food. Biotechnology Markets and Policies in an International Setting (Washington: International Food Policy Research Institute), chapter 11.

445 Trigo et al. (2001), p. 229.

446 “CamBioTec Network promotes exchanges between Canada and Latin America,” The Biotech HR Pulse (Ottawa, Biotechnology Human Resources), September 02, 2000. Available at: http://www.bhrc.ca/Pulse/Pulse_Issues/Sept7Pulse.pdf

447 Burachik and Traynor (2002), p. 9.

448 Cohen, Joel I. (2005), “Poorer nations turn to publicly develop GM crops”, Nature Biotechnology, Volume 23, Number 1, January, pp. 27-33, p. 28. In this report, an event is defined as “a stable transformation—the incorporation of foreign DNA into a living plant cell—undertaken by a single institute among the participant countries, thereby providing a unique crop-and-trait combination” (Idem, p. 27).

449 Idem, p. 32-33.

450 Dhalmini, Z., C. Spillane, J. P. Moss, J. Ruane, N. Urquia, A. Sonnino (2005), Status of Research and Application of Crop Biotechnologies in Developing Countries”, Food and Agricultural Organization, Rome, pp. 43-50.

451 Simpson, A. J. G. et al. (2000),“The genome sequence of the plant pathogen Xylella fastidiosa,” Nature, 406, pp. 151-157, 13 July; Yu, Jun et al. (2002), “A draft sequence of the rice genomics (Oryza sativa L. ssp. indica), Science 296, 5565 (April 5), pp. 79-92.

452 Enriquez, Juan (2001), “Technology, gene research and national competitiveness,” in Solbrig et al. (2001), pp. 225-254, p. 247. It is important to note that it is not only Latin America that is being left behind by multinationals’ innovative and patenting efforts: as Enriquez points out, “IBM alone has produced more patents than 139 of the world’s countries combined.” Idem, p. 247-248.

453 Albornoz, Mario, Situación de la Ciencia y la Tecnología en las Américas (Buenos Aires: Centro Redes, 2002). Available at: http://www.centroredes.org.ar/documentos/files/Doc.Nro3.pdf

454 Felice, Carmelo José (2002). El patentamiento y la generación de riquezas a partir de la ciencia en la Argentina (Buenos Aires). Manuscript. Available at: http://www.ibi.herrera.unt.edu.ar/Patente/Patentes.PDF.

455 Trigo et al (2002), p. 108.

456 Trigo, Eduardo, personal communication, Buenos Aires, May 2005.

457 M. C. (1998), “Argentina…”, p. 525.

458 “Científicos en empresas,” La Nación, November 7, 2003. Available at: http://www.lanacion.com.ar/03/11/07sl_543014.asp.

459 “Fomento al cultivo de girasol en la Argentina,” La Nación, November 8, 2003. Available at: http://www.lanacion.com.ar/03/45/db_543i66.asp

460 Trigo, Eduardo J. (2000), “The situation of agriculture biotechnology capacities and exploitation in Latin America and the Caribbean ,” in Matin Qaim, Anatole F. Krattinger and Joachim von Braum, Agricultural Biotechnology in Developing Countries: Towards Optimizing the Benefits for the Poor (Boston: Kluwer Academic Publishers), pp. 73-90, p. 74.

461 Trigo (2000), p. 88.

462 SAGPyA (2005), Plan Estratégico…, p. 36.

463 Guerrero, Veronica (2005), “Argentina gets serious about biotech,” New@Nature website, published online on 8 September, doi:10.1038/bioent880. Available at: http://www.nature.com/news/2005/050912/pf/bioent880_pf.html

464 “Proyecto de estímulo a la biotecnología,” La Nación, August 19, 2005, p. 14.

465 Phillips, Peter W. B. (2003), “Policy, national regulation, and international standards for GM food,” Research at a Glance, Biotechnology and Genetic Resource Policies, Washington, International Food Policy Research Institute, Brief 1, January. He bases his analysis on: Buckingham, Donald E. and Peter W.B. Phillips (2001), “Hot potato, hot potato,” Journal of World Trade 35 (1): 1-31.

466 Philips (2003), p. 3.

467 Stearman, Kaye (2005), “United States tries to derail discussion on labelling of GM food,” press release of Consumers International, Kota Kinabalu, Malasya, May 11. Available at: http://www.gmwatch.org/archive2.asp?arcid=5228