Loading...
Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-273632-3   |   PDF   |   Print   |  
published: 26 Sep 2024 last updated: 28 Mar 2025
General Information
Safety Assessment of Canola MS8 for Direct Use as Food, Feed, or for Processing
EN
22 Nov 2016
Risk assessment details
  • ACS-BNØØ5-8 - InVigor™ canola
    | Bayer CropScience | Changes in physiology and/or production (Reproduction, Male sterility), Resistance to antibiotics (Kanamycin), Resistance to herbicides (Glufosinate)
After reviewing the risk assessment report and the attached technical dossier, the assessors- the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)- concurred that (1) Canola MS8 is as safe for human food and animal feed as its conventional counterpart and (2) Canola MS8 will not pose any significant risk to health and the environment.
EN
Methodology and points to consider
The novel proteins Streptomyces hygroscopicus phosphinothricin N-acetyltransferase (PAT) protein and Bacillus amyloliquefaciens barnase ribonuclease enzyme (Barnase) can potentially be new allergens or toxins, or have homology with known allergens or toxins.
EN
The expression of the novel proteins were studied to assess the likelihood of exposure. The assessors noted that the PAT protein was detected in all tissues, with leaves and flower buds registering a higher amount. On the other hand, the Barnase enzyme was not detected in the root, young and mature leaf, and flower bud tissues. The expression patterns of these novel proteins can be attributed to the promoters controlling the localization of expression. The PssuAt promoter, which drives the expression of the PAT protein, is responsible for the expression in green tissues like leaves. Meanwhile, the pta29 promoter restricts the expression of the Barnase enzyme to the tapetal cell layer during anther development. It was additionally noted that Canola MS8 is male sterile and could not produce any seed, thereby, eliminating the possibility of any sole product of Canola MS8 to be present in food. It was further noted that canola event MS8 is intended to be used as a component in a hybridization system, thus, the regulated article and its products will not enter the food chain. Taken together, exposure to the novel proteins PAT and Barnase is unlikely since these are expressed in tissues that are not used to produce the commerciable product.
EN
The potential allergenicity and toxicity of the novel proteins PAT and Barnase were investigated via in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. A thorough scientific review of the results of these tests led the assessors to conclude that the PAT and Barnase proteins expressed in Canola MS8 are not toxic or allergenic.
EN
Digestibility assays showed that PAT was rapidly degraded at 30 seconds in the presence of pepsin at pH 1.2, with less than 10% residual protein visible. Monitoring of SDS-PAGE results following incubation at different temperatures up to 90°C for up to 60 minutes indicated that the molecular weight of PAT is retained but is likely completely thermo-inactivated. Acute oral toxicity of PAT indicated that the NOEL was 2000 mg/kg bodyweight. Additionally, the novel proteins PAT and Barnase were compared to allergen and toxin databases and no biologically significant similarities were noted. Considering the unlikely exposure to the novel proteins due to their restricted expression and the results of the toxicological and allergenicity assessments of PAT and Barnase, the assessors deemed that the overall risk for Canola MS8 is negligible.


EN
Considering the evidences presented, the risk assessors concurred that Canola RF3 is as safe as its conventional counterpart and does not pose any significant risk to human and animal health and the environment. The assessors, therefore, recommend for the approval and issuance of a biosafety permit for direct use as food and feed or for processing for Canola MS8.

Risk assessors additionally set conditions for the transport of Canola MS8. Spillage shall be collected and cleaned up immediately and the transport of the consignment shall be in closed containers only.
EN
Assessors recommend that the strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse be conducted.
EN
Canola MS8 is applied for direct use, hence the scope of the risk assessment for the application did not cover considerations on the receiving environment.
EN
Canola MS8 event is detectable using event-specific real-time quantitative PCR-based method.

EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1