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Health Canada has notified Monsanto Canada Inc that it has no objection to the food use of alfalfa from glyphosate tolerant alfalfa lines containing events J101 and J163. The Department conducted a comprehensive assessment of these lines according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.
The following provides a summary of the notification from Monsanto, and the evaluation by Heath Canada and contains no confidential business information.
Monsanto has developed alfalfa (Medicago sativa L.) lines based upon transformation events J101 and J163. Alfalfa varieties containing these events express the CP4 5-enolpyruvylshikimate-3-phosphate (cp4-epsps) gene which confers tolerance to glyphosate herbicides (trade name, Roundup«). Health Canada has previously indicated no objection to the sale of glyphosate tolerant corn (NK603, Mon 802, Mon 832), cotton (1445), canola (GT 200, GT 73) and soybean (GTS 40-3-2) lines for human food applications in Canada. Like alfalfa events J101 and J163 these lines express the CP4 EPSPS enzyme which confers tolerance to glyphosate herbicides
The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how alfalfa events J101 and J163 were developed; how the composition and nutritional quality of alfalfa varieties containing these events compare to non-modified alfalfa varieties; and what the potential is for alfalfa derived from lines containing these events to be toxic or cause allergic reactions.
The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from alfalfa lines containing events J101 and J163 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that
Roundup Ready alfalfa events J101 and J163 were developed through Agrobacterium-mediated transformations. Glyphosate tolerant callus was selected for the Roundup Ready trait through the addition of glyphosate to the plant culture media, and then cultured in tissue culture medium for plant regeneration. The cp4 epsps gene expression cassette is fused to a chloroplast transit peptide (CTP2) sequence that targets the CP4 EPSPS protein to the chloroplasts, the site of aromatic amino acid synthesis. Constitutive expression of cp4 epsps was controlled by inclusion of the figwort mosaic virus promoter FMV (e35S), the petunia hsp70 heat shock protein to stabilize the level of gene transcription, and the E9 3' polyadenylation sequence from pea.
Southern blot and PCR analysis of alfalfa containing the events J101 and J163 demonstrated the insertion of one copy of the T-DNA of PV-MSHT4 in the alfalfa genome. Southern blot analysis also demonstrated the integrity of the cp4-epsps gene and regulatory elements, as well as the absence of plasmid-derived sequences outside of the T-DNA region.
Stability of the inserted cp4-epsps gene cassette was evaluated in different alfalfa genetic backgrounds over multiple generations of conventional breeding at various locations. The results obtained demonstrate the stability of the events J101 and J163 at the genomic level in different environments.
Alfalfa events J101 and J163 differ from their traditional counterparts by the addition of the cp4-epsps gene sequence into the genome, and the expression of the CP4 EPSPS protein. The protein encoded by this gene is expressed at different levels throughout the plant tissue and throughout the life of the plant.
No significant differences were observed on the reproductive and survival biology of alfalfa events J101 and J163 where it was determined that stand establishment, growth, vigor or stand longevity; susceptibility to plant pests and diseases; forage and seed yield; and seed dormancy were within the normal range of these traits currently displayed by commercial alfalfa varieties.
Alfalfa is used primarily as an animal feed, with only minor uses as a human food or dietary supplement. Monsanto does not intend to introduce Roundup Ready alfalfa into the food supply, either as compressed leaf material or as sprouts. Roundup Ready alfalfa will be sold solely to producers of forage for use as animal feed.
The analysis of nutrients from Roundup Ready alfalfa events J101 and J163 and control and conventional alfalfa did not reveal any significant differences in the levels of protein, fat, ash, moisture, fibre, carbohydrates, amino acids, minerals, vitamins and anti-nutrients. In each case the level of each respective component was comparable to the control and within the reported range for conventional alfalfa. The consumption of products from alfalfa events J101 and J163 will have no significant impact on the nutritional quality of the Canadian food supply.
The potential for toxicity for CP4 EPSPS protein expressed in alfalfa lines containing events J101 and J163 was considered remote. This conclusion was based on the low amount of CP4 EPSPS protein found in the edible part of the plant, the absence of demonstrated acute toxicity to CP4 EPSPS in mice at doses orders of magnitude greater than the range associated with proteins, the lack of sequence homology between CP4 EPSPS protein and known toxins, and the likelihood that the protein will be degraded under conditions similar to those in the human gastrointestinal tract. There were no additional health concerns regarding endogenous toxins from the product derived from alfalfa containing events J101 and J163 when compared to non-transgenic varieties.
The possibility that the CP4 EPSPS protein would be an allergen in alfalfa containing events J101 and J163 was also considered unlikely. This was based on the lack of sequence homology between CP4 EPSPS protein and known allergens, and CP4 EPSPS protein's likely digestion in simulated gastric and intestinal fluids. These results suggest that products derived from alfalfa lines containing events J101 and J163 would not pose any greater allergenic risk than non-transgenic alfalfa.
At the expected level of consumption, there was no greater concern with alfalfa lines containing events J101 and J163 than non-transgenic alfalfa, with respect to its potential for toxicity or allergenicity.
Health Canada's review of the information presented in support of the food use of glyphosate tolerant alfalfa lines containing events J101 and J163 concluded that the food use of alfalfa lines containing this event does not raise concerns related to safety. Health Canada is of the opinion that alfalfa lines containing events J101 and J163 are as safe and nutritious as current commercial alfalfa varieties.
Health Canada's opinion deals only with the food use of glyphosate tolerant alfalfa lines containing events J101 and J163. Issues related to its use as animal feed have been addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.
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For further information, please contact:
|Novel Foods Section
Health Products and Food Branch
Ottawa, Ontario K1A 0L2
|Telephone: (613) 941-5535
Facsimile: (613) 952-6400