May 2019
Background
The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) have received a submission from BASF Canada Inc. seeking an approval for unconfined environmental release and livestock feed and food use of Glycine max L. (soybean) designated as Event GMB151 , which has been genetically engineered for plant parasitic nematode-protection and herbicide tolerance. The submission received is in accordance with CFIA guidelines for the assessment of plants with novel traits for unconfined release, CFIA guidelines for the assessment of novel feeds from plants with novel traits, and Health Canada guidelines for assessment of novel foods.
Summary of the submission package
Updated scientific information may be added to this submission by the developer at a later date, or CFIA and/or Health Canada may request further information from the developer.
Description of the host plant
- The Biology of Glycine max (L.) Merr. (Soybean) Biology Document BIO1996-10
Description of the modification
GMB151 was developed through recombinant DNA technology. In order to assess the modification process the following has been submitted:
- Transformation method
- Description of vector, detailed vector map, gene constructs
- Nature and source of the carrier DNA
- Description of the genetic material delivered to the plant
- Summary of all genetic compounds
- Description of the inserted genes — cry14Ab-1.b and hppdPf-4Pa
- Source of the cry14Ab-1.b and hppdPf-4Pa genes
- Description of the promoters and terminators
- Portion and size of the inserted sequences
Inheritance and stability of the introduced trait
In order to assess the inheritance and stability of the genetic modification the following has been submitted:
- Analysis of stability of insert over multiple generations
- Mendelian segregation of the novel traits
Description of the novel traits
In order to characterize the DNA inserted in the plant, the following has been submitted:
- Function of the inserted genes in the plant
- Information for the coding areas
- Information on promoters, terminators, and enhancers of plant expressible cassettes
- Characterization of the inserted sequences by Next Generation Sequencing and Junction Sequence Analysis, Sanger sequencing, and bioinformatics analysis of the transgenic locus and flanking sequences
- Characterization of expressed Cry14Ab-l and HPPD-4 proteins in soybean plant tissue
Toxicity/allergenicity of the novel gene products
In order to assess toxicity and allergenicity of the novel proteins, the following has been submitted:
- Comparison of the amino acid sequences of the Cryl4Ab-1 and HPPD-4 proteins to known allergens and toxins
- Digestive fate in vitro studies
- Acute oral toxicity tests
Nutritional evaluation of the modified plant
In order to assess nutritional aspects of soybean GMB151 the dietary exposure has been considered and the nutritional composition of the soybean GMB151 has been compared to that of unmodified soybean.
- The following has been submitted:
- Proximate composition (crude protein, crude fat, carbohydrates, ash and fibre)
- Composition of amino acids, fatty acids, minerals, and vitamins
- Anti-nutrients for soybean (oligosaccharides, phytic acid, trypsin inhibitors, lectins, and isoflavones)
Evaluation of the environmental impact of the modified plant
In order to assess the environmental impact of soybean GMB151, the following was assessed:
- Agronomic analysis of soybean GMB151 (Yield, plant phenotype, reproductive features, seed dormancy and germination)
- Potential to become a weed
- Gene flow from PNT to sexually compatible relatives
- Potential impact on non-target organisms
- Herbicide tolerance management plan
- Disease resistance management plan
Additional information
For more information on this product, please contact:
BASF Canada Inc.
100 Milverton Drive, 5th floor
Mississauga, ON
L5R 4H1
(289) 360-1300
www.basf.ca
The CFIA and Health Canada, including their employees, are not responsible for the content of this Notice of Submission as submitted by the Applicant. All Notices of Submission are the responsibility of the Applicant submitting them and the Applicant does so at its own risk. Submission of this Notice of Submission and its subsequent posting by the CFIA on its website does not in any way whatsoever constitute acceptance, approval or certification by the CFIA or Health Canada of the Plant with Novel Trait(s) subject of the Notice of Submission and the CFIA and Health Canada reserve all their rights under all the pertinent legislation that may be applicable. The CFIA and Health Canada in no way whatsoever waives any of their rights under any of the legislation they enforce or administer by way of the CFIA posting this Notice of Submission.
The Applicant is not obliged to provide any information. The Applicant submits information that it chooses to submit. The information that the Applicant voluntarily provides on this Notice of Submission is collected by the CFIA and Health Canada for the purpose of sharing information with the public. Personal Information will be protected under the provisions of the Privacy Act, and will be stored in Personal Information Bank CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.