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Gene stacking in transgenic plants: towards compliance between definitions, terminology, and detection within the EU regulatory framework

Published online by Cambridge University Press:  29 October 2008

Isabel Taverniers
Affiliation:
Institute for Agricultural and Fisheries Research (ILVO), Unit Technology and Food (T&V), Burg. Van Gansberghelaan 115 bus 2, 9820 Merelbeke, Belgium
Nina Papazova
Affiliation:
Institute for Agricultural and Fisheries Research (ILVO), Unit Technology and Food (T&V), Burg. Van Gansberghelaan 115 bus 2, 9820 Merelbeke, Belgium
Yves Bertheau
Affiliation:
Institut National de la Recherche Agronomique (INRA), SPE, Centre de Versailles-Grignon, RD 10 (Route de St Cyr), 78026 Versailles Cedex, France
Marc De Loose
Affiliation:
Institute for Agricultural and Fisheries Research (ILVO), Unit Technology and Food (T&V), Burg. Van Gansberghelaan 115 bus 2, 9820 Merelbeke, Belgium
Arne Holst-Jensen
Affiliation:
National Veterinary Institute (NVI), Ullevaalsveien 68, P.O. Box 750 Sentrum, 0106 Oslo, Norway

Abstract

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The combination or stacking of different traits or genes in plants is rapidly gaining popularity in biotech crop production. Here we review the existing terminology regarding gene stacking in plants, and its implications in relation to genetics, biosafety, detectability and European regulations. Different methods of production of stacked gene traits, as well as the status of their cultivation and approval, are reviewed. Related to the different techniques of transformation and production, including classical breeding, and to differences in global authorization and commercialization practices, there are many types, definitions, and perceptions of stacking. These include: (1) stacking of traits and (2) stacking of events, which are the most widely accepted perceptions of stacking, and (3) stacking of genes, which from the analytical and traceability point of view may be a more appropriate perception. These differences in perceptions and definitions are discussed, as are their implications for analytical detection and regulatory compliance according to (in particular) European Union (EU) regulations. A comprehensive terminology regarding gene stacking with regulatory relevance is proposed. The haploid genome equivalent is proposed as the prevailing unit of measurement at all stages throughout the chain, in order to ensure that terminology and definitions of gene stacks are adapted to analytical detection, traceability, and compliance with EU regulations.

Type
Research Article
Copyright
© ISBR, EDP Sciences, 2008

References

AgBios (2008) AgBios, Ontario, Canada. GMO database. http://www.agbios.com/dbase.php (accessed July 1st 2008)
Akiyama, H, Watanabe, T, Wakabayashi, K, Nakade, S, Yasui, S, Sakata, K, Chiba, R, Spiegelhalter, F, Hino, A, Maitani, T (2005) Quantitative detection system for corn sample containing combined-trait genetically modified corn. Anal. Chem. 77: 74217428 CrossRef
Allnutt T, McMillan J, McArthur R, Henry C (2006) VS0136; A combined protocol for PCR Detection of GM in Seed. CSL, York, UK. http://www.gm-inspectorate.gov.uk/documents/ COPsFinalReportweb_000.pdf (accessed July 1st 2008)
Aono, M, Akiyama, S, Nagatsu, M, Nakajima, N, Tamaoki, M, Kubo, A, Saji, H (2006) Detection of feral transgenic oilseed rape with multiple herbicide resistance in Japan. Environ. Biosafety Res. 5: 7787 CrossRef
Carter, CA, Gruere, GP (2003) International approaches to the labeling of genetically modified foods. Choices 18: 14. http://www.choicesmagazine.org/2003-2/2003-2-01.htm (accessed July 1st 2008)
CFIA (2004) Canadian Food Inspection Agency, Plant Products Directorate, Plant Biosafety Office. Directive 94-08 (Dir94-08), Assessment Criteria for Determining, Environmental, Safety of Plants With Novel Traits. http://www.inspection.gc.ca/english/plaveg/bio/dir/ dir9408e.pdf (accessed July 1st 2008)
CMOA (1996) Ministry of Agriculture, People's Republic of China. Order No. 7, the safety administration implementation regulation on agricultural biological genetic engineering. http://www.cbi.pku.edu.cn/mirror/binas/Regulations/ full_regs/china/c2.htm (accessed March 1st 2007)
CTNBio (2005) National Technical Commission on Biosafety, Brazil. Implementation of the provisions of the biosecurity law 11.105. http://www.ctnbio.gov.br/index.php/content/view/ 3670.html?toPrint=yes (accessed July 1st 2008)
Cummins J (2004) GM rice in India. ISIS press release, 30/11/2004. http://www.i-sis.org.uk/GMRII.php (accessed July 1st 2008)
De Schrijver, A, Devos, Y, Van Den Bulke, M, Cadot, P, De Loose, M, Reheul, D, Sneyers, M (2007) Risk assessment of GM stacked events obtained from crosses between GM events. Trends Food Sci. Technol. 18: 101109 CrossRef
EC (2001) Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Off. J. Eur. Union 106: 138
EC (2003a) Regulation 1829/2003/EC on genetically modified food and feed. Off. J. Eur. Union 268: 123
EC (2003b) Regulation (EC) 1830/2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Off. J. Eur. Union 268: 2428
EC (2004a) Commission regulation (EC) No 641/2004 on detailed rules for implementation of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the application and authorization of new genetically modified food and feed, the notification of existing products and adventitious and technically unavoidable presence of genetically modified material which has benefited from a favorable risk evaluation. Off. J. Eur. Union 102: 1425
EC (2004b) Commission recommendation 2004/787/EC on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) No 1830/2003. Off. J. Eur. Union 348: 1826
EFSA (2004) European Food Safety Authority. Guidance document of the scientific panel on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. The EFSA J. 99: 194
EFSA (2006) European Food Safety Authority. Public consultation of the document “Risk assessment of plants containing genetic modification events combined crossing”. http:// www.efsa.europa.eu/en/science/gmo/gmo_consultations/ gmo_hybrids_publcons.html (accessed April 10th 2007)
FDA (1992) Food and Drug Administration, USA. Statement of policy: foods derived from new plant varieties; notice. Federal Register 57 (104): 22983–23001. http://www.agbios.com/docroot/articles/01-319-004.pdf (accessed March 1st 2007)
Halpin, C (2005) Gene stacking in transgenic plants – the challenge for 21st century plant biotechnology. Plant Biotech. J. 3: 141155 CrossRef
Holst-Jensen A, De Loose M, Van den Eede G (2006) Coherence between legal requirements and approaches for detection of genetically modified organisms and their derived products. J. Agric. Food Chem. 54: 2799–2809
James C (2007) Global status of commercialized biotech/GM crops in 2007. ISAAA Brief 37: Executive Summary
Kobilinsky, A, Bertheau, Y (2005) Minimum cost and acceptance sampling plans for grain control, with application to GMO detection. Chemom. Intell. Lab. Syst. 75: 189200 CrossRef
Laffont, J-L, Remund, KR, Wright, D, Simpson, RD, Gregoire, S (2005) Testing for adventitious presence of transgenic material in conventional seed or grain lots using quantitative laboratory methods: statistical procedures and their implementation. Seed Sci. Res. 15: 197204 CrossRef
Lezaun, J (2006) Creating a new object of government: making genetically modified organisms traceable. Soc. Stud. Sci. 36: 499531 CrossRef
Ma, BL, Subedi, K, Evenson, L, Stewart, G (2005) Evaluation of detection methods for genetically modified traits in genotypes resistant to European corn borer and herbicides. J. Environ. Sci. Health. Part B 40: 633644 CrossRef
Messéan, A, Sausse, C, Gasquez, J, Darmency, H (2007) Occurence of genetically modified oilseed rape seeds in the harvest of subsequent conventional oilseed rape over time. Europ. J. Agronomy 21: 115122 CrossRef
Monsanto (2007) Monsanto - Dow Agrosciences Collaborative Agreement SmartStax: New industry-standard stacked-trait platform, Sept. 14, 2007. http://www.monsanto.com/pdf/investors/2007/09-14-07.pdf
OECD (2006) Organisation for Economic Co-operation and Development. OECD Environment, Health and Safety Publications, Series on Harmonisation of Regulatory Oversight in Biotechnology, no. 23. Revised 2006: OECD guidance for the designation of a unique identifier for transgenic plants, ENV/JM/MONO(2002)7/REV1. http://www.olis.oecd.org/olis/2002doc.nsf/ ENGREFCORPLOOK/NT000059E2/ $FILE/JT03217233.PDF (accessed July 1st 2008)
OGTR (2000) Office of the Gene Technology Regulator of Australia. The Gene Technology Act 2000. Attorney-General's Department, Canberra, Australia. http://scaletext.law.gov.au/html/pasteact/3/3428/top.htm (accessed July 1st 2008)
OGTR (2007) Office of the Gene Technology Regulator of Australia. Compilation of the Gene Technology Amendment Regulations 2006 with the Gene Technology Regulations 2001 (commencement date 31 March 2007, subject to disallowance). http://www.ogtr.gov.au/pubform/legislation.htm (accessed July 1st 2008)
Orson J (2002) Gene stacking in herbicide tolerant oilseed rape: lessons from the North American Experience. English Nature Research Reports 43, ISSN 0967-876X. http://www.agbios.com/articles.php (accessed July 1st 2008)
Ow, DW (2007) Site-specific recombination for plant genetic engineering: Strategy for agro-mediated gene stacking. Proc. of the Intern. Symp. on Biotechnol. of Temperate Fruit Crops and Trop. Spec. 738: 117127. In Litz RE, Scorza R, eds, Acta Horticulturae, Book series, 2007
Ruf, S, Karcher, D, Bock, R (2007) Determining the transgene containment level provided by chloroplast transformation. Proc. Natl. Acad. Sci. USA 104: 69987002 CrossRef
SAGPyA 39/03 (2003) Application for permit to release genetically modified plant organisms into the environment. http://www.agbios.com/docroot/decdocs/06-325-001.pdf (accessed July 1st 2008)
Saji, H, Nakajima, N, Aono, M, Tamaoki, M, Kubo, A, Wakiyama, S, Natase, Y, Nagatsu, M (2005) Monitoring the escape of transgenic oilseed rape around Japanese ports and roadsides. Environ. Biosafety Res. 4: 217222 CrossRef
Shrawat, AK, Lörz, H (2007) Agrobacterium-mediated transformation of cereals: a promising approach crossing barriers. Plant Biotechn. J. 4: 575603 CrossRef