Commercialization of Perennial GE Crops: Looming Challenges for Regulatory Frameworks
- 157 Downloads
Overall, the deregulation of genetically engineered (GE) crops for commercial cultivation in North America has been a success story. In several cases, however, GE crops have sparked concerns and disagreements among the stakeholders and there are incidences of court lawsuits, including a recent one on glyphosate resistant (GR) alfalfa (Medicago sativa, L.). While GE crops can provide operational benefits to farmers, challenges are looming from commercialization of perennial GE crops. The unique ecology and biology of these crops and GE alfalfa in particular can facilitate adventitious presence (AP) of GE traits and it makes more visible that economic risks for conventional growers and food/feed producers have not been adequately addressed by the GE regulatory system in the United States (US). Asynchronous market approvals and the existence of a number of GE sensitive export markets create uncertainties among the exporters. Policy development in these fields may be helpful for ensuring a broader acceptance and market success of GE agriculture in general. The analysis is focusing on the US, although many diagnosed problems are also relevant to other jurisdictions—in particular if no co-existence policy is in place.
KeywordsGenetic engineering GE alfalfa Adventitious presence Co-existence Regulatory framework
The authors are grateful for funding from the Agri-Food Research and Development Initiative (ARDI) of the governments of Manitoba and Canada, the Natural Sciences and Engineering Research Council (NSERC), and a University of Manitoba Graduate Fellowship (UMGF) and Manitoba Graduate Scholarship (MGS) for M. Bagavathiannan. This work was also supported by a visiting research fellowship to M. Bagavathiannan from the Institute for Advanced Studies on Science, Technology and Society (IAS-STS), Graz, Austria. We would also like to thank the two anonymous reviewers who made helpful comments on an earlier version of this paper.
- ARD (Agriculture and Rural Development). (2007). Liability and compensation schemes for damage resulting from the presence of genetically modified organisms in non-GM crops. http://ec.europa.eu/agriculture/analysis/external/liability_gmo/index_en.htm. Accessed 22 March 2010.
- Agbios. (2008). Global status of approved genetically modified plants. http://www.agbios.com/dbase.php?action=Synopsis. Accessed 15 January 2009.
- APHIS (Animal and Plant Health Inspection Service). (2005). Monsanto Co. and Forage Genetics International; availability determination of nonregulated status for alfalfa genetically engineered for tolerance to the herbicide glyphosate, [Docket No. 04-085-3]. Federal Register, 70(122), 36917–36918.Google Scholar
- APHIS (Animal and Plant Health Inspection Service). (2007). Return to regulated status of alfalfa genetically engineered for tolerance to the herbicide glyphosate [Docket No. 04-085-4]. Federal Register, 72(56), 13735–36.Google Scholar
- APHIS (Animal and Plant Health Inspection Service). (2009a). Non-compliance history. http://www.aphis.usda.gov/biotechnology/compliance_history.shtml. Accessed 26 January 2010.
- APHIS (Animal and Plant Health Inspection Service). (2009b). APHIS’s Biotechnology Quality Management System. http://www.aphis.usda.gov/biotechnology/news_bqms.shtml. Accessed 18 March 2010.
- APHIS (Animal and Plant Health Inspection Service). (2010). Glyphosate-tolerant alfalfa events J101 and J163: Request for nonregulated status. http://www.aphis.usda.gov/biotechnology/downloads/alfalfa/gealfalfa_deis.pdf. Accessed 18 March 2010.
- Bagavathiannan, M. V., Gulden, R. H., Begg, G. S., & Van Acker, R. C. (2010). The demography of feral alfalfa (Medicago sativa L.) populations occurring in roadside habitats in Southern Manitoba, Canada: implications for novel trait confinement. Environmental Science & Pollution Research (In press).Google Scholar
- CEC (Commission of the European communities). (2003). Commission recommendation on guidelines for the development of a national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming. http://ecob.jrc.ec.europa.eu/documents/Recommendation_2003_556.pdf. Accessed 19 March 2010.
- CFIA (Canadian Food Inspection Agency). (2005). Decision document –DD 2005-53: Determination of the safety of Monsanto Canada Inc.’s Roundup Ready alfalfa events J101 and J163. http://www.Inspection.gc.ca/English/blaveg/bio/dd/dd0553e.shtml. Accessed 28 December 2009.
- CFIA (Canadian Food Inspection Agency). (2008). Biology documents: Companion documents for directive 94-08. http://www.inspection.gc.ca/english/plaveg/bio/dir/biodoce.shtml. Accessed 04 January 2009.
- CFS (Centre for Food Safety). (2006). First amended complaint for declaratory and injunctive relief (FRCP-15a). Case no.Co6-1075 CRB, p. 48.Google Scholar
- CFS (Centre for Food Safety). (2007). Initial lawsuit filed against the deregulation of Roundup Ready alfalfa. The United States District Court for the Northern District of California San Francisco Division, Case no.C06-1075 CRB.Google Scholar
- Co-Extra. (2009). Summary of main Co-Extra deliverables and results, perspectives, information dissemination and application. http://www.coextra.eu/pdf/report1471.pdf. Accessed 19 March 2010.
- COFEPRIS (Comision Federal Para La Protection Contra Riesgos Sanitarios). (2005). GMO liberacion, Mexico. http://www.cofepris.gob.mx/pyp/biotec/OMG.pdf. Accessed 24 October 2008.
- EC-JRC (European Commission Joint Research Centre). (2008a). Commission Decision 2008/289/EC of 3 April 2008 on emergency measures regarding the unauthorized genetically modified organism ‘Bt 63’ in rice products. http://gmo-crl.jrc.ec.europa.eu/doc/Bt63_2008_289_EC.pdf. Accessed 20 March 2010.
- EC-JRC (European Commission Joint Research Centre). (2008b). The first global conference on GMO analysis. http://gmoglobalconference.jrc.ec.europa.eu/menu.htm. Accessed 22 March 2010.
- EFSA (European Food Safety Authority). (2009). Scientific opinion on guidance for the risk assessment of genetically modified plants used for non-food or non-feed purposes. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902783659.htm. Accessed 16 March 2010.
- FSANZ (Food Standards Australia New Zealand). (2006). Final assessment report—Food derived from glyphosate-tolerant lucerne J101 and J163. http//www.foodstandards.gov.au/_srcfiles/FAR_A575_Glyphosate_tolerant_Lucerne.pdf. Accessed 25 October 2008.
- GAIN (Global Agricultural Information Network). (2006). Germany biotechnology annual 2006, Report no. GM6021. http://www.fas.usda.gov/gainfiles/200606/146198089.doc. Accessed 20 January 2009.
- GAIN (Global Agricultural Information Network). (2007). Biotech traces in German rapeseed seeds, Report number GM7042. http://www.fas.usda.gov/gainfiles/200709/146292339.doc. Accessed 22 January 2009.
- Griffiths, K., Partis, L., Croan, D., Wang, N., & Emslie, K. R. (2002). Review of technologies for detecting genetically modified materials in commodities and food (p. 128). Fisheries and Forestry, Australia: Department of Agriculture.Google Scholar
- ISAAA (International Service for the Acquisition of Agri-biotech Applications). (2009). Global status of commercialized biotech/GM crops: 2009. ISAAA brief 41-2009 executive summary. http://www.isaaa.org/resources/publications/briefs/41/executivesummary/default.asp. Accessed 19 March 2010.
- JBCH (Japan Biosafety Clearing House). (2006). Approved LMOs. http://www.bch.biodic.go.jp/english/lmo_2006.html. Accessed 24 October 2008.
- JRC-IPTS (European Commission Joint Research Centre—Institute for Prospective Technological Studies). (2009). The global pipeline of new GM crops: implications of asynchronous approval for international trade. http://ftp.jrc.es/EURdoc/JRC51799.pdf. Accessed 19 March 2010.
- KBCH (Korean Biosafety Clearing House). (2008). Korean decisions. http://www.biosafety.or.kr/english/index.asp. Accessed 24 October 2008.
- Knispel A. L., & McLachlan, S. M. (2010). Landscape-scale distribution and persistence of genetically modified oilseed rape (Brassica napus) in Manitoba, Canada. Environmental Science and Pollution Research, 17, 13–25.Google Scholar
- McCaslin, M. (2008). An update on roundup ready alfalfa. In Proceedings of the Washington State Hay Growers Association Annual Conference. http://www.wa-hay.org/Proceedings/08%20Proceedings/Update%20on%20RR%20Alfalfa%20-%20McCaslin.pdf. Accessed 15 January 2009.
- Monsanto Company. (2008). Roundup Ready alfalfa: farmers benefits, environmental safety and stewardship. http://www.monsanto.com/pdf/products/alfalfa_benefits.pdf. Accessed 15 January 2009.
- NAFA (National Alfalfa Forage Alliance). (2008a). Coexistence for alfalfa hay export markets. http://alfalfa.ucdavis.edu/+producing/files/biotech/CSExportHay.pdf. Accessed 19 January 2009.
- NAFA (National Alfalfa Forage Alliance). (2008b). Coexistence for alfalfa seed export markets. http://alfalfa.ucdavis.edu/+ producing/files/biotech/CSExportSeed.pdf. Accessed 18 January 2009.
- NASS (National Agricultural Statistical Service). (2008). Data and statistics. http://www.nass.usda.gov/Data_and_Statistics/index.asp. Accessed 25 October 2008.
- NBCP (National Biosafety Committee of the Philippines). (2006). Determination of the safety of Monsanto’s alfalfa (Herbicide Tolerant Alfalfa) for direct use as food, feed and for processing. http:www.biotech.da.gov.ph/document%20for%20the%20web/Decision%20Documents/Alfalfa.pdf. Accessed 25 October 2008.
- Putnam, D. (2006). Methods to enable coexistence of diverse production systems involving genetically engineered alfalfa, Agricultural Biotechnology in California Series, Publication 8193.Google Scholar
- Remund, K. M., Dixon, D. A., Wright, D. L., & Holden, L. R. (2001). Statistical considerations in seed purity testing for transgenic traits. Seed Science Research, 11, 101–119.Google Scholar
- SOD (Saskatchewan Organic Directorate) (2006). Position paper on the introduction of genetically modified alfalfa. http://www.saskorganic.com/oapf/pdf/SOD_GMO_Alfalfa_Position_Paper.pdf. Accessed 17 January 2009.
- SWSS (Southern Weed Science Society). (1998). Weeds of the United States and Canada. Champaign, IL: Southern Weed Science Society Publications.Google Scholar
- USDA (United States Department of Agriculture). (2005). USDA/APHIS environmental assessment and finding of no significant impact. http://www.aphis.usda.gov/brs/aphisdocs2/04_11001p_com.pdf. Accessed 20 January 2009.
- USDC (United States District Court). (2007). Memorandum and order re: permanent injunction report from the United States District Court for the Northern District of California, order No. C06-01075 CRB.Google Scholar
- USDA-AMS (United States Department of Agriculture—Agricultural Marketing Service). (2009). National organic program. http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template = TemplateA&navID = NationalOrganicProgram&leftNav = NationalOrganicProgram&page = NOPNationalOrganicProgramHome&acct = nop. Accessed 22 January 2009.
- USDA-ERS (United States Department of Agriculture—Economic Research Service). (2005). Organic production. http://www.ers.usda.gov/Data/Organic/index.htm#tables. Accessed 20 January 2009.
- USDA-FAS (United States Department of Agriculture—Foreign Agricultural Service). (2009). Market and trade data. http://www.fas.usda.gov/seeds/seedstats.html. Accessed 17 January 2009.
- USGAO (United States Government Accountability Office). (2008). GAO Report to the committee on agriculture, nutrition, and forestry, U.S. senate genetically engineered crops: agencies are proposing changes to improve oversight, but could take additional steps to enhance coordination and monitoring. November 2008, GAO-09-60, p 103.Google Scholar
- Viljoen, J., Griffiths, K., & Murphy, B. (2004). Segregating GM and non-GM grain in the Australian grain storage system. http://www.daff.gov.au/__data/assets/pdf_file/0003/182829/Final_GM_Report_July_04.pdf. Accessed 20 January 2009.
- Watrud, L. S., Lee, E. H., Fairbrother, A., Burdick, C., Reichman, J. R., Bollman, M., et al. (2004). Evidence for landscape-level, pollen-mediated gene flow from genetically modified creeping bentgrass with CP4 EPSPS as a marker. Proceedings of the National Academy of Sciences, 101, 14533–14538.CrossRefGoogle Scholar
- Woodward, W. T. W. (2006). Roundup Ready alfalfa test kits and influence on the market place. In Proceedings of the Washington State Hay Growers Association Annual Conference. http://www.wa-hay.org/Proceedings/06%20Proceedings/Roundup%20Ready%20Alfalfa%20Test%20Kits%20and%20Influence%20-%20Woodward.pdf. Accessed 18 January 2009.