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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-273628-1   |   PDF   |   Print   |  
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last updated: 26 Sep 2024
General Information
Safety Assessment of Canola RF3 for Direct Use as Food, Feed, or for Processing
EN
22 Nov 2016
Risk assessment details
  • ACS-BNØØ3-6 - InVigor™ canola
    | Bayer CropScience | Changes in physiology and/or production (Fertility restoration), 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 RF3 is as safe for human food and animal feed as its conventional counterpart and (2) Canola RF3 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 inhibitor (Barstar) can potentially be new allergens or toxins, or share biologically significant similarity with known allergens or toxins.
EN
On the exposure of humans to the novel proteins, assessors noted that PAT is detectable only at the dry seed at trace levels while Barstar is detectable only in flower buds during pollen development. Further, the assessors noted that pollen is not normally ingested. Therefore, exposure to these proteins is highly unlikely.
EN
The potential allergenicity and toxicity of the novel proteins PAT and Barstar 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 investigations led the assessors to conclude that the PAT and Barstar proteins expressed in Canola RF3 are not toxic or allergenic.
EN
The novel proteins PAT and Barstar have been found to have no pathogenic properties and no biologically significant sequence similarities with any known toxins or allergens. PAT and Barstar were found to be rapidly digested as demonstrated by digestibility studies using simulated gastric fluid with pepsin. Assessors noted that PAT protein was not degraded after heat treatment (90°C at 60 min) as evidenced by the persistence of the resulting band from SDS-PAGE and Western bot. On the other hand, Barstar protein produced soluble oligomers after heat treatment which suggested that it is not stable at 95°C. Meanwhile, acute oral toxicity test results indicate that the No Observed Effect Levels (NOEL) for PAT and Barstar are >2000 mg/kg bodyweight and >1000 mg/kg bodyweight, respectively. These values cannot be realistically ingested, especially when considering the level of expression of PAT and Barstar in the plant tissues. The assessors additionally concurred that the processing of the oilseed rape grain into refined and food-grade oil will result to the degradation of all protein components. In view of these, the pathway to harm for PAT and Barstar cannot be realized. Therefore the overall risk for Canola RF3 is negligible to very minimal.
EN
Considering the possible effects of viable forms of the regulated article to the environment, the assessors noted that Canola RF3 will not pose any danger to the environment if transported in a non-viable form. Further, the assessors find that Canola RF3 does not require changes in the usual practices in loading and unloading, hauling, transport and storage, and processing and, therefore, does not pose any significant risk to human and animal health and the environment during these processes.

Risk assessors concurred that enough evidence support the substantial equivalence of Canola RF3 with its conventional counterpart. It is therefore concluded that Canola RF3 is as safe as its conventional counterpart. The assessors agreed to recommend for the issuance of a biosafety permit for direct use as food and feed or for processing for Canola RF3.
EN
The DENR-BC recommended that the BPI require a specified Environmental Management Plan (EMP) for the issuance of import permits relevant to the regulated article.
EN
Canola RF3 was applied for direct use, hence, no actual propagation or planting shall be allowed to occur. The scope of this application only covers the importation and use for food and feed, or for processing of Canola RF3 and its derived products in the Philippines. Therefore, considerations on the receiving environment, e.g., effects on biological diversity, were not deliberated.
EN
Canola RF3 can be detected via event-specific quantitative real-time quantitative PCR.
EN
Information sharing with other databases
No
Additional information
EN
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