Roundup Ready Soybean. Herbicide Tolerance. Key facts

Transcription

1 Roundup Ready Soybean Herbicide Tolerance Key facts Monsanto Europe-Africa February 2009

2 Roundup Ready Soybean Soybean, a key crop Soybean (Glycine max) is a high-protein legume grown mainly as food for humans and livestock. It is also used in industrial products including oils, soaps, cosmetics, resins, plastics, inks, solvents, and biodiesel. The first record of domesticated soybean dates back to the 17 th and 11 th centuries BC in the eastern half of China where it was grown as food. Soybean was cultivated for the first time in Europe in the early 1700 s and in North America in the early 1800's. In 2006, 92.9 million hectares of soybean were harvested globally (FAO Database, PageID=567 Significant areas of production included the U.S.A., Brazil, Argentina, China and India representing 31%, 23%, 16%, 9% and 8% of the global soybean hectares, respectively. The EU is not a significant soybean producer. In 2006, the soybean area harvested in the EU-27 accounted for approximately 480 thousand hectares (FAO Database, PageID=567 distributed principally between Italy and Romania (36% of the harvested area each), France (9%) and Hungary (7%). Because of its low production and its high demand, especially for animal consumption, the EU is the world s largest importer of soybean meal (22 million metric tons of soybean meal were imported in the EU-27 during the period ) and the second largest importer of whole soybeans, after China (15 million metric tons of soybeans were imported in the EU-27 during the period , The development of herbicide tolerant soybean Early in its development (about 4 to 6 weeks after emergence), soybean is very sensitive to competition with weeds for light, nutrients and water. Weed control in soybean usually starts early in the growing season (pre- to early post-emergence of the crop) to remove small weeds that would soon compete aggressively with the crop. Weed control methods include selection of varieties and planting date, seed bed preparation and chemical control. Herbicide-tolerant crops were developed in the 1980 s to respond to a demand from farmers for simpler, more efficient and environmentally friendlier weed control technology. The herbicide-tolerant traits were designed to allow more flexible weed control using fewer active ingredients. Today, the only commercialized genetically modified herbicide-tolerant soybean varieties are Roundup Ready, which are tolerant to glyphosate-based herbicides. Roundup Ready soybean : mode of action Roundup Ready soybean plants (hereafter referred to as ) are genetically modified to express tolerance to glyphosate-based Roundup herbicides, allowing its use for weed control in the crop not just in pre-emergence, but also throughout the growing season. Glyphosate is a broad-spectrum herbicide that acts via inhibition of the protein 5-enolpyruvyl-shikimate-3- phosphate synthase (EPSPS) in the green parts of plants. This protein, found naturally in all plants, fungi and bacteria, is important in the production of essential aromatic amino acids. Inhibition of EPSPS by glyphosate blocks the production of these amino acids, interfering with growth and leading ultimately to plant death (Alibhai and Stallings, 2001) produces a glyphosate-tolerant EPSPS. This ensures the continued function of the aromatic amino acid pathway, even in the presence of the herbicide (Figure 1). Resistant EPSPS-CTP Chloroplast Resistant EPSPS + CTP Phosphoenol Shikimate-3 EPSP Aromatic pyruvate + X -phosphate + Pi + amino acids Plant EPSPS sugars glyphosate degradation EPSPS: 5-enolpyruvyl-shikimate-3-phosphate synthase, CTP: chloroplast transport protein Figure 1: Mode of action of glyphosate-tolerant Roundup Ready is a registered trademark of Monsanto Technology LLC Roundup Ready Soybean Key facts 2/5

3 What is ? is Monsanto s first generation glyphosatetolerant soybean encodes a glyphosatetolerant EPSPS enzyme (CP4 EPSPS), derived from the CP4 strain of the common soil bacterium Agrobacterium sp. The DNA sequence encoding this enzyme was introduced into soybean using the particle-acceleration transformation method. More information on this product can be obtained from idx=25 Worldwide plantings and regulatory status of was first planted commercially in the USA on 200 thousand hectares in Since then, has become the genetically modified (GM) crop with the largest hectares planted in the world. The major producers of are USA, Argentina, Brazil, Paraguay and Canada. In the USA, 87% of the soybeans grown in 2005 were glyphosate-tolerant. In Argentina, where the adoption rate is estimated at 98%, glyphosate tolerant soybeans were grown on more than 15 million hectares in 2006 ( tor/financial/reports/2006/q42006acreage.pdf). Globally, biotech soybean continued to be the principal biotech crop grown in 2006, occupying 58.6 million hectares and representing 57% of all transgenic crops has already been approved for different uses in Argentina, Australia, New Zealand, Bolivia, Brazil, Canada, China, EU, Japan, Korea, Mexico, Paraguay, Philippines, Russia, South Africa, Switzerland, U.S.A., Taiwan and Uruguay. Applications for import, cultivation, and food and feed use of are currently under review in other countries and regions around the world. The status of these pending regulatory reviews depends on the world area and its local regulatory framework. Further information on the regulatory status of applications can be found under A strict regulatory system for genetically modified crops in the EU In the EU, the regulatory system for GM crops comprises several regulations and directives, including Directive 2001/18/EC for deliberate release of genetically modified organisms (GMOs) in the environment (repealing Directive 90/220/EEC) and Regulation (EC) N 1829/2003 on genetically modified food and feed (replacing Regulation (EC) N 258/97 on novel foods and novel food ingredients for GM products). Furthermore, a new regulation on traceability and labeling of GMOs and products produced from GMOs (Regulation (EC) N 1830/2003) entered into application on 18 April Regulatory status of in the EU Import and use In November 1994, Monsanto submitted an application for import and use of to the Competent Authority of the United Kingdom under Directive 90/220/EEC. It was concluded that no adverse effects on human health and the environment are to be expected from the use of this soybean and therefore, an approval was granted on 3 April 1996 (Commission Decision 96/281/EC Official Journal of the European Communities L107/ ) ( erv.do?uri=celex:31996d0281:en:html) Food and feed In addition to the consent received under Directive 90/220/EEC, national approvals for the food and feed use of and its derivatives were received prior to the entry into force of Regulation (EC) N 258/97. In July 1994, Monsanto provided the UK Advisory Committee on Novel Foods and Processes (ACNFP) with a complete dossier on In February 1995, the UK Ministry of Agriculture, Fisheries and Food (MAFF) accepted the advice from the ACNFP that concluded that the GM soybeans and the products derived from them are comparable to, and as safe for human consumption as conventional, unmodified soybeans and products derived from them and approved the food and feed uses of Subsequently, national approvals for the food use of and its derivatives were granted in the Netherlands (Ministry of Health, Welfare and Sports of the Netherlands, May 1996) and Denmark (National Food Agency of Denmark, November 1996). Due to the coming into force of Regulation (EC) N 1829/2003, food and feed products containing, consisting of or produced from were notified in July 2004 according to this regulation and were placed in the Community Register of GM Food and Feed in April 2005 ( dyna/gm_register/gm_register.cfm?gm_id=26). In October 2005, Monsanto submitted an application for the cultivation of varieties in the EU under Regulation (EC) No 1829/2003 to the European Food Safety Authority (EFSA), via the Dutch Competent Authority. On 29 September 2006, the application was deemed valid and the EFSA scientific evaluation period started Roundup Ready Soybean Key facts 3/5

4 Traceability, labelling, unique identifier Operators handling or using and derived foods and feeds in the EU are required to be aware of the legal obligations regarding traceability and labelling of these products, laid down in Regulations (EC) No 1829/2003 and 1830/2003. The unique identifier for is MON-Ø4Ø32-6. Food, feed and environmental safety of Food and feed safety The food and feed safety of was established based on: The evaluation of CP4 EPSPS activity and its homology to EPSPS proteins present in a diverse group of plants, including those used for foods; The long history of safe use of CP4 EPSPSproducing crops, such as Roundup Ready maize NK603 and Roundup Ready oilseed rape GT-73, which were commercialized starting from 1997; The rapid digestibility of CP4 EPSPS protein in in vitro digestibility models; The lack of toxicity or allergenicity of EPSPS proteins generally and as demonstrated with bioinformatics as well as in vitro and in vivo safety studies, A large margin of safety resulting from the low dietary exposure to the introduced CP4 EPSPS protein in was found to be as safe and nutritious as conventional soybean by analysis of key nutrients, including protein, fat, carbohydrates, amino acids, fatty acids and minerals, as well as by feed performance studies using vertebrate animals. Further details on the safety of this soybean are available in a product safety summary at: put_traits/products/roundup_ready_soybeans.asp Environmental safety The UK Advisory Committee on Releases to the Environment (ACRE) who reviewed the environmental aspects of application under Directive 90/220/EEC stated that the risk of marketing this product would be no different from that of other soybeans marketed for the same purposes. ACRE also concluded that the risk of harm to humans and other animals from exposure was very low ( Environmental studies and more than ten years of experience with cultivation in North America support the fact that poses negligible risk to the environment. Soybean does not have wild relatives in Europe to which the introduced trait could outcross. The likelihood of this soybean spreading into the nonagronomic environment is negligible, since it is not more invasive in natural habitats than conventional soybean. The ecological interactions of with non-target organisms or soil processes are not different from those of conventional soybean. The environmental impact of growing is not different from growing conventional soybean. It is actually expected that the production of using Roundup herbicides could have less impact than the agronomic practices used to grow conventional soybean today, and in addition, provide benefits to farmers and the environment (see below) , the benefits benefits both farmers and the environment by providing: A broad-spectrum weed control option in soybean and increased simplicity and flexibility to treat weeds (Carpenter et al. 2002); In the USA, an estimated soybean production-cost saving of between $60 and $78/ha (based on a comparison of conventional herbicide regimes in the early 2000s required to deliver a comparable level of weed control to soybean system). These savings come from lower herbicide costs plus a $6/ha to $10/ha savings in labor and machinery costs (Brookes and Barfoot, 2008); Resource conservation linked to reduced herbicide use, e.g. conservation of fuel used in cultivation and herbicide applications (Carpenter et al., 2002; Brookes and Barfoot, 2008); The opportunity to replace several selective herbicides by a single broad-spectrum herbicide with a favorable human health and environmental profile. The active ingredient glyphosate is nonpersistent and has limited mobility as it binds tightly to soil. The compound presents very low toxicity to humans. Furthermore, it does not bioaccumulate and presents minimal risk to terrestrial and aquatic species including fish, birds, mammals and invertebrates (Giesy et al., 2000; Williams et al., 2000); An excellent fit with reduced tillage systems, which are linked to many environmental advantages including improved soil and water quality, reduced soil erosion and runoff, improved wildlife habitat and reduced fuel use and CO 2 emissions (Fawcett and Towery, 2002; Brookes and Barfoot, 2008). According to Brookes and Barfoot (2008) the carbon sequestration resulting from more plant residue being stored in the soil because of reduced tillage, saved the equivalent of almost 14 billion kilograms of carbon dioxide emissions in Roundup Ready Soybean Key facts 4/5

5 Literature cited Alibhai M. F. and Stallings W.C. (2001). Closing down on glyphosate inhibition with a new structure for drug discovery. Proceedings of the National Academy of Science USA. 98(6): Brookes G. and Barfoot P. (2008). GM crops: global socio-economic and environmental impacts PG Economics Ltd., UK. Carpenter J., Felsot A., Goode T., Hammig M., Onstad D. and Sankula S. (2002). Comparative environmental impacts of biotechnology-derived and traditional soybean, corn, and cotton crops. Council for Agricultural Science and Technology CAST: Fawcett R. and Towery D. (2000). Conservation tillage and plant biotechnology: how new technologies can improve the environment by reducing the need to plow. Report of the Conservation Technology Information Center (CTIC). Paper.pdf Giesy J. P., Dobson S. and Solomon K. R. (2000). Ecotoxicological risk assessment for Roundup herbicide. Reviews of Environmental Contamination and Toxicology 167: Williams G. M., Kroes R. and Munro I. C. (2000). Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans. Regulatory Toxicology and Pharmacology. 31: Roundup Ready Soybean Key facts 5/5