Supplement to: Decision Document: DD96-07: Determination of Environmental Safety of Monsanto Canada Inc.'s Roundup® Herbicide-Tolerant Brassica napus Canola Line GT200

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Issued: 1997-10

This supplement to Decision Document has been prepared to explain the regulatory decision reached under the guideline Dir95-03 Guidelines for the Assessment of Livestock Feed from Plants with Novel traits.

The Canadian Food Inspection Agency (CFIA), specifically the Plant Biosafety Office of the Plant Health and Production Division, has evaluated information submitted by Monsanto Canada Inc. regarding the canola line GT200. This line has Roundup-Ready™ genes that express novel tolerance to glyphosate, the active ingredient of Roundup® herbicide. The Agency has determined that this plant does not present altered environmental interactions when compared to existing commercialized canola varieties in Canada.

The Feed Section of the Animal Health and Production Division has evaluated information submitted by Monsanto Canada Inc., regarding the Roundup® tolerant canola line GT200 and has determined that it is substantially equivalent to existing commercialized canola varieties.

Feed Use of canola line GT200 and its byproducts is therefore authorized. Any other Brassica napus lines and intra-specific hybrids derived from the original transformant may also be considered substantially equivalent, provided the intended use is similar and provided it is known that these plants do not display any additional novel traits

Table of Contents

  1. Brief Identification of the Plant with Novel Traits (PNT)
  2. Background Information
  3. Livestock Feed Assessment
    1. Compositional Analysis
    2. Antinutritional Factors
  4. Regulatory Decision

I. Brief Identification of the Plant with Novel Traits (PNT)

Designation(s) of the PNT: GT200 or RT200

Applicant: Monsanto Canada Inc.

Plant Species: Brassica napus canola

Novel Traits: Novel tolerance to glyphosate, the active ingredient of Roundup® herbicide, expressed by the Roundup-Ready™ genes

Trait Introduction Method: Agrobacterium tumefaciens-mediated transformation

Proposed Use of PNT's: This experimental line will not be commercialized.

II. Background Information

Monsanto Canada Inc. has developed a Brassica napus canola line, GT200, derived from the variety Westar, which expresses their proprietary Roundup-Ready™ genes. These confer novel tolerance to glyphosate, the active ingredient of Roundup® herbicide, which can control or suppress economically important weeds in canola production. Line GT200 is very closely related to line GT73, that was authorized for environmental release in 1995 (see DD95-02).

The development of GT200 was based on recombinant DNA technology, by the introduction into the variety Westar of a genetic construct containing two bacterial derived genes (the Roundup-Ready™ genes). One gene imparts reduced sensitivity to Roundup® at the biochemical site of the herbicide's activity and the other expresses an enzyme that enables the plant to degrade glyphosate. The expression of both genes is directed to the chloroplasts, the site of the herbicide activity, by the addition of genetic coding sequences of a plant derived transit peptide. No antibiotic resistance marker genes were introduced into GT200.

For further information on the novel trait and a description of the environmental interactions of the novel plant, please refer to Decision Document DD96-07, Determination of the Environmental Safety of Monsanto Canada Inc.'s Roundup® Herbicide-Tolerant Brassica napus Canola Line GT200.

III. Livestock Feed Assessment

We have reviewed the data package submitted for the transformed GT-200 canola line (Brassica napus). These plants have been transformed with genes that confer tolerance to glyphosate, the active ingredient of Roundup® herbicide. The genes are linked and inherited as a single dominant trait and shown to be stable over successive generations. There has been no significant change in phenotype compared to Westar, except for the tolerance to glyphosate (based on valid statistical analysis of protein and glucosinolate profiles, comparing GT200 and Westar). Therefore, it is assumed that no other metabolic pathways are significantly affected. There should be no direct health impact resulting from the ingestion of GT200 by livestock as there is no remaining enzyme activity in processed meal. The protein itself would not have any toxicological impact and it is not likely that allergenicity will be a consequence through exposure.

1. Compositional Analysis:

From 1992 field trials in Canada, data is available on canola seed, meal, and oil containing a mixture of 53% GT200:47% GT73, and 53% GT73:47% GT200. Individual samples of GT200, GT73, and Westar (control) from seven sites were also analysed for proximates, glucosinolates, amino acids and fatty acids.

Based on the information submitted, proximate (protein, fat, fibre, ash) analysis, amino acid profile and fatty acid profile, of the mixed samples of GT-200/GT-73, are within the accepted ranges of these nutrients for traditional canola meal.

2. Antinutritional Factors:

Based on the pure sample data (individual samples from 7 sites), there was no difference between GT-200 and Westar for alkyl glucosinolates (means 10.8 vs 8.8 µg/g fat free meal), and both were below the maximum of 30 umol/g fat free meal for canola.

For erucic acid, GT-200 contained significantly less erucic acid than Westar (0.14% vs 0.40% of fatty acids). These values are well below the maximum of 2% allowed for canola.

IV. Regulatory Decision:

Based on the review of the submitted data and information, the Feed Section of the Animal Health and Production Division has concluded that the novel trait does not in itself raise any concerns regarding the safety or nutritional composition of canola line GT200. Canola, canola oil and canola meal are currently listed in Schedule IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. As canola line GT200 has been assessed and found to be substantially equivalent to existing commercialized canola vanities, canola line GT200 and its byproducts are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Feed Use of canola line GT200 and its byproducts is therefore authorized. Any other Brassica napus lines and intra-specific hybrids derived from the original transformant may also be considered substantially equivalent, provided the intended use is similar and provided it is known that these plants do not display any additional novel traits.

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