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Health Canada has notified Monsanto Canada Inc and KWS SAAT AG that it has no objection to the food use of sugar from glyphosate tolerant sugar beet lines containing event H7-1. The Department conducted a comprehensive assessment of this sugar beet 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 KWS, and the evaluation by Heath Canada and contains no confidential business information.
Monsanto and KWS have developed sugar beet (Beta vulgaris L..) lines based upon transformation event Roundup Ready« sugar beet H7-1 (H7-1). Sugar beet varieties containing this event 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 (603, 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 sugar beet event H7-1 these lines contain 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 sugar beet event H7-1 was developed; how the composition and nutritional quality of sugar derived from sugar beet varieties containing this event compare to the sugar of non-modified sugar beet varieties; and what the potential is for sugar derived from lines containing this event 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). Sugar derived from sugar beet lines containing event H7-1 is 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
2. Development of the Modified Plant
Roundup Ready sugar beet (Beta vulgaris ssp vulgaris) event H7-1 was developed through recombinant DNA technology. The epsps coding sequence from Agrobacterium sp. CP4 (cp4 epsps), was introduced into a proprietary sugar beet multigerm line designated as 3S0057. The transforming plasmid PV-BVGT08 carried a transfer DNA (T-DNA) sequence comprised of the cp4-epsps gene cassette. The genetic elements of this cassette include the Figwort mosaic virus 35S promoter (P-FMV), the Arabidopsis thaliana -terminal chloroplast transit peptide (ctp2), the Agrobacterium sp. strain CP4 epsps coding region (cp4-epsps) and the polyadenylation sequence from the Pisum sativum rbcS E9 gene (E9 3'). Agrobacterium-mediated transformation results in the transfer of only the T-DNA sequence of PV-BVGT08 into the plant genome.
3. Characterization of the Modified Plant
Southern blot and PCR analysis of sugar beet lines containing the event H7-1 demonstrated the insertion of one copy of the T-DNA of PV-BVGT08 in the sugar beet 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.
In addition, both the inserted DNA and plant genome flanking DNA were sequenced at the transgene locus. The sequence data confirmed that the inserted DNA consists only of the 35S promoter sequence, N-terminal chloroplast transit peptide, the cp4-epsps gene, and the polyadenylation sequence from the Pisum sativum rbcS E9 gene
Stability of the inserted cp4-epsps gene cassette was evaluated in different sugar beet genetic backgrounds over multiple generations of conventional breeding at various locations. The results obtained demonstrate the stability of the event H7-1 at the genomic level in different environments.
4. Product Information
Sugar beet event H7-1 differs from its traditional counterpart 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. Refined sugar does not contain any detectable protein and only the refined sugar from sugar beet lines containing sugar beet event H7-1 will be available for human consumption.
5. Dietary Exposure
Refined sugar derived from sugar beet lines containing event H7-1 is expected to be used by the food industry in applications similar to sugar derived from other non-transgenic sugar beet varieties.
The nutritional analysis of sugar beet event H7-1 was undertaken on both top (leaf) and root (brei) and determined the levels of 25 nutrients and other components. A comparison of this data was made between event H7-1 sugar beet and its non-transgenic counterpart, to several commercial varieties and to a check variety. A total of 55 statistical comparisons were made that showed few statistically significant differences to the check variety, but were always within the expected range of values expected for the non-transgenic controls and published data on commercial sugar beet varieties. These results show that sugar beet event H7-1 is compositionally equivalent to transgenic and commercial varieties. The data from analysis of key nutrients (proximates, sugar, amino acids) do no indicate any safety or nutritional concerns.
The potential for toxicity for CP4 EPSPS protein expressed in sugar beet lines containing event H7-1 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 thane the range associated with proteins, the lack of sequence homology between CP4 EPSPS protein and known anti-nutrients, 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 anti-nutrients from the product derived from sugar beet containing event H7-1 when compared to non-transgenic varieties. The endogenous anti-nutrient, saponin, in the event H7-1 sugar beets was demonstrated to be present at identical concentrations to non-transgenic sugar beet. In both cases, the concentrations of these natural anti-nutrients in sugar beet derived sugar are not a human health concern.
The possibility that the CP4 EPSPS protein would be an allergen in sugar beet lines containing event H7-1 was also considered unlikely. This was based on the negligible amount of protein in edible parts of the sugar beet plant, 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 combined with the absence of CP4 EPSPS protein detected in refined sugar suggests that sugar derived from sugar beet lines containing event H7-1 would not pose any greater allergenic risk than non-transgenic sugar beet sugar.
At the expected level of consumption, there was no greater concern with sugar derived from sugar beet lines containing event H7-1 than the sugar derived from non-transgenic sugar beets, with respect to its potential for toxicity or allergenicity.
Health Canada's review of the information presented in support of the food use of sugar from glyphosate tolerant sugar beet lines containing event H7-1 concluded that the food use of sugar from sugar beet lines containing this event does not raise concerns related to safety. Health Canada is of the opinion that sugar from sugar beet lines containing event H7-1is as safe and nutritious as sugar from current commercial sugar beet varieties.
Health Canada's opinion deals only with the food use of glyphosate tolerant sugar beet lines containing event H7-1. 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:
xNovel Foods Section
Health Products and Food Branch
Ottawa, Ontario K1A 0L2
Telephone: (613) 941-5535
Facsimile: (613) 952-6400