Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety Approval for Commercial Planting Purposes of a Plant Genetically Modified For Herbicide Tolerance from Monsanto Canada Inc.

The PNT was developed through recombinant DNA technology. In order to assess the modification process, the following has been submitted:

• Description of the transformation system/modification process
• Description of the transformation method
• Nature and source of the carrier DNA
• Description of the genetic material delivered to the plant
• Components of the vector
• Summary of all genetic components
• Description of the herbicide tolerance gene – cp4 epsps
• Description of the promoter and terminator
• Portion and size of the inserted sequence
• Location, order and orientation in the vector
• Function of the cp4 epsps gene in the plant
• Source of the cp4 epsps gene (donor organism – bacteria)
• Level of expression of CP4 EPSPS protein in forage and grain
• Review of the toxicity and pathogenic ability of the genetic components to plants and other organisms
• Review of the toxicity and pathogenic ability of the donor organisms to plants and other organisms
• History of use of the cp4 epsps gene
• Detailed map of the vector

In order to assess the inheritance and stability of the genetic modification, the following has been submitted:

• Analysis of stability over multiple generations

In order to characterize the DNA inserted in the plant, the following has been submitted:

• Information for all coding areas
• Information on plant promoters: Southern analysis of the cp4 epsps  coding region and its promoter Southern analyses of other genetic elements that are incorporated into the soybean genome but are not expressed
• Characterization of expressed CP4 EPSPS protein in soybean

The toxicity of the CP4 protein on pest and non-pest species, humans and animals. The following have been previously submitted, reviewed, and published:

• Decision Document DD95-02: Determination of Environmental Safety of Monsanto Canada Inc.’s Roundup Ready® Herbicide-Tolerant Brassica napus Canola Line GT73
• Decision Document DD95-05: Determination of Environmental Safety of Monsanto Canada Inc.’s Glyphosate Tolerant Soybean (Glycine max L.) Line GTS 40-3-2
• Decision Document 2002-35: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Corn (Zea mays L) Line 603
• Decision Document 2005-53: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Alfalfa (Medicago sativa  L) Events J101 and J163
• Decision Document 2005-54: Determination of Safety of Monsanto Canada Inc.’s and KWS SAAT AG’s Roundup Ready® Sugar Beet (Beta vulgaris spp vulgaris L.) Event H7-1
• Decision Document 2005-56: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Flex Cotton (Gossypium hirsutum  L) Line MON 88913
• Decision Document 2006-57: Determination of Safety of Monsanto Canada Inc.’s Glyphosate-Tolerant, Corn-Rootworm-Protected Corn (Zea mays  L.) Event MON 88017
• Hammond, B. R.L. Fuchs et al. 1996. The feeding value of soybeans fed to rats, chickens, catfish, and dairy cattle is not altered by genetic incorporation of glyphosate tolerance. J. Nutr. 126: 717-727.
• Harrison, L., M. et al. 1996. The expressed protein in glyphosate-tolerant soybean, 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice.  J. Nutr. 126:728-740.
• McCann, M. et al. 2005. Glyphosate-tolerant soybeans remain compositionally equivalent to conventional soybeans (Glycine max L) during three years of field testing. J. Ag. & Food Chem. 53(13): 5331-5335
• Park, J. et al. 2001. Comparison of allergens in genetically modified soybean with conventional soybean. Yahak Hoeji. 45(3): 293-301

In order to assess nutritional aspects of the novel plant, the following has been submitted:

• The nutritional composition of the novel plant has been compared to unmodified soybean. The following have been considered:
  • Proximate composition (protein, fat, ash, carbohydrates)
  • Composition of amino acids, fatty acids, and minerals 
  • Acid detergent fiber and neutral detergent fiber
  • Micro-nutritional elements (vitamins, etc) and anti-nutrients for soybean

In order to assess allergenicity and toxicity of the novel proteins, the following has been submitted:

• Comparison of the amino acid sequence similarity of cp4 epsps protein expressed in MON 89788 to known protein allergens or toxins through bioinformatics analysis

The following has been previously submitted:

• Analysis the amino acid sequence similarity of cp4 epsps or protein expressed in other crops or products to known protein allergens or toxins through bioinformatics analysis

In order to assess the environmental impact of the novel plant, the following has been submitted:

• Examination for potential weediness of the PNT
• Examination of seed yield of the PNT
• Examination of reproductive features of the PNT
• Examination of phenotypic characteristics of the PNT
• Examination of seed dormancy and germination of the PNT
• Examination of the response to biotic and abiotic stressors on the PNT
• Examination of the PNT’s potential to become a plant pest
• Examination of gene flow from the PNT to wild relatives based on literature
• Examination of plant pest and non-pest impacts of the PNT
• Stewardship and mitigation plans

Feed Section
Animal Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
(613) 225-2342