Health Canada has notified Monsanto Canada Inc. that it has no objection to the food use of refined oil from the transgenic cotton line 1445, which is tolerant to glyphosate herbicide. The Department conducted a comprehensive assessment of cotton line 1445 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.
The following provides a summary regarding the Monsanto Canada Inc. notification to Health Canada and contains no confidential business information.
Cotton line 1445 is tolerant to glyphosate, the active ingredient in Roundup™ herbicide. The herbicide tolerant cotton product is called Roundup Ready™ Cotton. The modification permits growers to use the broadspectrum herbicide for weed-control in the cultivation of cotton.
Cotton plants were developed using the Agrobacterium tumefaciens transformation system to introduce a gene from a strain of a common soil bacterium from the genus Agrobacterium. The introduced gene encodes the enzyme 5-enolpyruvyl shikimate-3-phosphate synthase (EPSPS). Also introduced into the cotton is the nptII gene, which encodes a selectable marker, neomycin phosphotransferase II (NPTII), used to identify cotton cells that contain the introduced EPSPS gene during the transformation process. A second selectable marker for bacterial manipulation, the aad gene, which encodes aminoglycoside adenyltransferase was also introduced, but is under the control of a bacterial promoter and not expressed in the modified cotton plants. The transformed cotton line was designated line 1445.
Expression of the introduced EPSPS gene in cotton plants results in the expression of the EPSPS enzyme which catalyzes a reaction in the aromatic amino acid biosynthesis pathway that is found only in green plants, fungi and certain bacteria. The introduced enzyme is much more tolerant to inhibition by glyphosate than the version of EPSPS commonly found in green plants; thus, the insertion of the bacterial gene and successful expression of the alternative EPSPS enzyme permits the modified cotton plants to tolerate applied glyphosate herbicide. Cotton line 1445 differs from non-transgenic cotton only in the insertion of three new genes, EPSPS, nptII, and aad, and in the expression of two new proteins, , EPSPS and NPTII. The aad gene is not expressed in the modified cotton. The new proteins are expressed in all tissues of the plant and throughout the plant's lifecycle, and average less than 0.001% of cotton seed protein.
Approximately 40% of the cottonseed crop is used as animal feedstuff while the remainder is used in processed goods and as a food ingredient. 73% of cottonseed oil in North America is used in salad and cooking oil. About 21% of the oil is baking and frying, 2% is used in margarine and 1% is used for inedible products. Refined, bleached and deodorized cottonseed oil, the oil used for human consumption, derived from cotton line 1445 was demonstrated to contain no detectable protein. Therefore, there would be no dietary exposure to the proteins introduced into cotton line 1445.
Compositional comparison of cottonseed oil from line 1445 was made to commercial non-transgenic cottonseed oil. Comparison included the fatty acid profile of the oils, vitamin E levels and levels of cyclopropenoid fatty acids and "-tocopherol. The composition of the oil from cotton line 1445 was comparable to that for cottonseed oil from non-transgenic commercial cotton varieties and components were within the normal range reported for cottonseed oil.
Health Canada's review of the information presented in support of the food use of refined oil from cotton line 1445 concluded that this refined oil does not raise concerns related to safety. Health Canada is of the opinion that refined oil from cotton line 1445 is as safe and nutritious as cottonseed oil from current commercial cotton varieties.
Health Canada's opinion deals only with the food use of refined cottonseed oil from the glyphosate tolerant cotton line 1445. Issues related to growing cotton line 1445 in Canada and its use as animal feed have been addressed separately through existing regulatory processes in Agriculture & Agri-Food Canada.
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
Health Protection Branch
Ottawa, Ontario K1A 0L2
Telephone: (613) 952-5137
Facsimile: (613) 952-6400