Perspective pubs.acs.org/JAFC
Development of an Agricultural Biotechnology Crop Product: Testing from Discovery to Commercialization Laura S. Privalle* BASF Plant Science, LP, 26 Davis Drive, Research Triangle Park, North Carolina 27709, United States
Jingwen Chen Syngenta Biotechnology Inc., 3054 East Cornwallis Road, Research Triangle Park, North Carolina 27709, United States
Gina Clapper AOCS, 2710 South Boulder Drive, Urbana, Illinois 61802, United States
Penny Hunst Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, North Carolina 27709, United States
Frank Spiegelhalter Eurofins GeneScan, Suite 200, 2315 North Causeway Boulevard, Metairie, Louisiana 70001, United States
Cathy X. Zhong Pioneer Hi-Bred International, DuPont Agriculture Biotechnology, Wilmington, Delaware 19880, United States ABSTRACT: “Genetically modified” (GM) or “biotech” crops have been the most rapidly adopted agricultural technology in recent years. The development of a GM crop encompasses trait identification, gene isolation, plant cell transformation, plant regeneration, efficacy evaluation, commercial event identification, safety evaluation, and finally commercial authorization. This is a lengthy, complex, and resource-intensive process. Crops produced through biotechnology are the most highly studied food or food component consumed. Before commercialization, these products are shown to be as safe as conventional crops with respect to feed, food, and the environment. This paper describes this global process and the various analytical tests that must accompany the product during the course of development, throughout its market life, and beyond. KEYWORDS: GM, testing, methods, validation
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The development of GM crops as shown in Figure 1,2 from transformation and event selection through commercial authorization, is a lengthy, complex, and resource-intensive process. This paper describes this global process and the various analytical tests that must accompany the product during the course of development throughout its market life and beyond. We have divided the overall process into two major segments. The first is the development of the product and covers gene discovery through plant transformation to elite event identification. The second segment covers the safety assessment that is performed, which comprises the regulatory
INTRODUCTION “Genetically modified” (GM) or “biotech” crops (also referred to as “genetically engineered” crops) have been the most rapidly adopted agricultural technology in recent years as evidenced by a 94-fold increase from 1.7 million hectares in 1996 to 160 million hectares in 2011.1 The acreage of GM crops planted by country in 2010 is summarized in Table 1.2 Currently, >10% of the 1.5 billion hectares of the world’s crop land are planted with GM crops, an 8% increase in 2011 alone.1 This represents a very rapid rate of adoption in the 17 years since these products have been introduced. GM crops can provide many benefits to growers including (1) reduction in pesticide use; (2) less soil erosion due to the utility of no- or reduced till practices; (3) decrease in mycotoxin contamination of grain; (4) reduced use of petroleum due to a more infrequent need to enter the field and apply pesticides; and (5) increases in biodiversity.3 © 2012 American Chemical Society
Received: Revised: Accepted: Published: 10179
July 6, 2012 September 20, 2012 September 24, 2012 September 24, 2012 dx.doi.org/10.1021/jf302706e | J. Agric. Food Chem. 2012, 60, 10179−10187
Journal of Agricultural and Food Chemistry
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Table 1. Global Area of Biotech Crops in 2010 by Country rank
country
area (million hectares)
1
USA
66.8
2 3 4 5 6
Brazil Argentina India Canada China
25.4 22.9 9.4 8.8 3.5
7 8 9 10 11 12 13 14 15
Paraguay Pakistan South Africa Uruguay Bolivia Australia Philippines Myanmar Burkina Faso Spain Mexico Colombia Chile Honduras Portugal Czech Republic Poland Egypt Slovakia Costa Rica Romania Sweden Germany
16 17 18 19 20 21 22 23 24 25 26 27 28 29
total
2.6 2.4 2.2 1.1 0.9 0.7 0.5 0.3 0.3
biotech crops
maize cotton, soybean cotton maize, soybean, canola maize maize maize, potato
