ARCHIVED - Colorado Potato Beetle Resistant Potato Lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5, SPBT02-7

October 1999

Novel Food Information - Food Biotechnology


Health Canada has notified Monsanto Canada Inc. that it has no objection to the food use of the transgenic NewLeaf™ potato cultivars Atlantic (ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36) and Superior (SPBT02-5, SPBT02-7), which have been developed to be resistant to the Colorado potato beetle (CPB). The Department conducted a comprehensive assessment of the Atlantic and Superior NewLeaf™ potato cultivars according to its Guidelines for the Safety Assessment of Novel Foods (September 1994). These guidelines are based upon internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.

Background:

The following provides a summary regarding the Monsanto Canada Inc. notification to Health Canada and contains no confidential business information.

1. Introduction

The NewLeaf™ potato (Solanum tuberosum) lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5 and SPBT02-7 were developed through a specific genetic modification of cultivars Atlantic and Superior to be CPB (Leptinotarsa decemlineata Say.) resistant. The novel lines produce a version of the insecticidal protein, CryIIIA, derived from Bacillus thuringiensis. Delta-endotoxins, such as the CryIIIA protein expressed in Atlantic and Superior NewLeaf™ potatoes, act by selectively binding to specific receptors localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause paralysis and death. CryIIIA and related endotoxins are insecticidal only to lepidopteran or coleopteran insects and their specificity of action is directly attributable to the presence of specific receptors in the target insects. There are no receptors for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.

2. Development of the Modified Plant

The transgenic Atlantic and Superior potato lines were created through two separate Agrobacterium-mediated transformation events in which the transfer DNA (T-DNA) contained the gene encoding the CryIIIA protein from B. thuringiensis subsp. Tenebrionis. In addition, the T-DNA contained sequences encoding the enzyme neomycin phosphotransferase II (NPTII). The expression of NPTII was used as a selectable trait for screening transformed plants for the presence of the cryIIIA gene. Due to segregation effects, the NPTII encoding gene was not present in Superior cultivar SPBT02-5 submitted for commercial release. Additional DNA outside of the T-DNA border sequences was incorporated into the genome of Atlantic lines ATBT04-27 and ATBT04-36. These lines also contain the aad gene, which encodes the enzyme 3''(9)-O-aminoglycoside adenylyltransferase that confers bacterial resistance to spectinomycin and streptomycin. The aad gene was not expressed in plant tissue, but was present on the Ti plasmid as a selectable trait for screening bacterial colonies for the presence of plasmid vector. The data from at least 3 generations of vegetative propagation demonstrated the stability of the novel trait.

3. Product Information

The constitutive expression of CryIIIA protein was demonstrated in each of the transgenic NewLeaf™ Atlantic and Superior cultivars. On average, the amounts of CryIIIA protein produced in the leaves and tubers of Atlantic lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36 ranged between 15.7-59.3 and 0.09-0.53 µg/g fresh weight tissue, respectively. Likewise, production of NPTII was quantified in both leaf and tuber tissue at levels of 4.4-36.6 and 0.5-2.9 µg/g fresh weight tissue, respectively. The presence of NPTII protein has been judged to be insignificant with respect to any human health risk due to exposure. Solanine and chaconine are the principal glycoalkaloids commonly found in potato tubers. The average concentration of total glycoalkaloids (TGA) in tubers from each of the transgenic lines ranged between 8.7-10.5 and 8.7-10.0 mg/100g fresh weight tissue for NewLeaf™ Atlantic and Superior, respectively. In each case the level was below the administrative guideline of 20 mg/100g fresh weight that has previously been established for TGA in potato and within the range of 2.5- 16.1 mg/100g fresh weight tissue that was measured in tubers from commercial non-transgenic cultivars of Atlantic, Gemchip, Norchip and Russet Burbank. Other than resistance to CPB, the disease, pest and other agronomic characteristics of the NewLeaf™ Atlantic and Superior lines were comparable to their non-transgenic parental cultivars.

4. Dietary Exposure

Potatoes are considered to be a staple food for many Canadians, constituting up to 37% of the total average vegetable intake. The genetic modification present in the ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5 and SPBT02-7 transgenic lines will not result in any change in the consumption pattern for potatoes. Due to their protection from CPB damage, the NewLeaf™ Atlantic and Superior cultivars are expected to replace some existing commercial potato cultivars in all potato product applications. Hence, they will provide an alternate or additional choice to consumers and food manufacturers.

5. Nutrition

The analysis of macro- and micronutrients from each of the transgenic lines of Atlantic and Superior potato revealed only small differences with the respective values from non-transgenic controls and in each case the level was within the normal range of variation reported for commercial potatoes. The consumption of products from NewLeaf™ Atlantic and Superior potatoes will have no significant impact on the nutritional quality of the Canadian food supply.

6. Safety

a) Potential Toxicity:

The amino acid sequence of the CryIIIA protein expressed in NewLeaf™ potatoes is closely related to the sequence of the same proteins that are present in strains of B. thuringiensis that have been used for over 30 years as commercial organic microbial insecticides. An analysis of the amino acid sequence of the inserted CryIIIA protein did not show homologies with known mammalian protein toxins and it is not judged to have any potential for human toxicity.

b) Potential Allergenicity:

The CryIIIA protein does not possess characteristics typical of known protein allergens. There were no regions of homology when the sequence of this introduced protein was compared to the amino acid sequences of known protein allergens. Unlike known protein allergens, the CryIIIA protein is rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids. The CryIIIA protein is extremely unlikely to be allergenic.

CONCLUSION:

Health Canada's review of the information presented in support of the food use of CPB resistant ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5 and SPBT02-7 potato lines concluded that they do not raise concerns related to human food safety. Health Canada is of the opinion that products from NewLeaf™ Atlantic and NewLeaf™ Superior potato cultivars are as safe and nutritious as those available from current commercial potato cultivars.

Health Canada's opinion pertains only to the food use of these CPB resistant potato lines. Issues related to growing NewLeaf™ Atlantic and NewLeaf™ Superior potatoes in Canada and their use as animal feed are 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 Protection 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.

For further information, please contact:

Office of Food Biotechnology
Food Directorate
Health Protection Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0L2
Facsimile: (613) 952-6400
Telephone: (613) 952-5137

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