Philippines | BCH-RA-PH-258562 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 06 Jan 2022
General Information
Determination for the Safety Assessment of Canola DP73496 for Direct Use as Food, Feed and for Processing
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Date not available
Risk assessment details

http://biotech.da.gov.ph/Decision_docs_jdc_direct.php?fbclid=IwAR1DfDu4QHnejzgzo7mOdByQboQaHxxmQzFUMcRI6EoKw492O0RgFQ6ZzNY
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Methodology and points to consider
Brassica napus was considered unsuitable as a source of food for either humans or animals, because the seed naturally contains erucic acid and glucosinolates, which are toxic to humans and other organisms.
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Intensive breeding programs produced high quality varieties that were significantly lower in erucic acid and glucosinolates. The term ‘canola’ refers to those varieties of B. napus that meet specific standards on the level of erucic acid and glucosinolates.

Results of the toxicological and allergenicity assessment indicate that GAT4621 protein being expressed in DP73496 is not toxic or allergenic to humans.

Amino acid sequence comparison was conducted using techniques such as homology search using BLASTp program, a search for continuous, identical stretches of 8 amino acid residues in length, and an identity search using the FASTA35 alignment algorithm to search for alignments of 80 residues or longer possessing a sequence identity of 35%. Results showed that GAT4621 protein has no homology to any known toxins or allergens.

The acute oral toxicity study indicated that administration of 2000 mg/kg GAT4621 protein to 5 male and 5 female mice did not resulted to mortality, treatment-related clinical observations of toxicity, gross lesions at necropsy body weight losses, change in food consumption, and macroscopic changes at necropsy. The No Observed Effect Level (NOEL) for GAT4621 protein is 2000 mg/kg body weight.
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Molecular characterization of DP73496 canola demonstrated that a single, intact, copy of the PHP28181A DNA fragment was stably incorporated into the genome at a single site.

A consistent hybridization pattern was seen across all plants from five generations, indicating stable genetic inheritance of the inserted DNA. Probes to the entire backbone region of plasmid PHP28181 were hybridized to both Nco I-digested genomic DNA and demonstrated that plasmid sequences outside of the PHP28181A fragment were not present in DP73496 canola.

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Canola DP73496 applied for Direct Use as Food, Feed or for Processing (FFP) is safe as its conventional counterpart and shall not pose any significant risk to human and animal health and environment.     
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Genetic stability in the transgenic crop is ensured such that no unintended horizontal gene transfer shall occur to unrelated species. 
The data evaluated support the conclusion that the regulated article is as safe as its conventional counterpart. A biosafety permit for direct use can be issued for the said event.
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The introduction of DP73496 canola will not change the consumption patterns of population subgroups, as its use is not addressed to any specific group. The DP73496 canola can be substituted for all uses of conventional canola.
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The application of DP73496 canola is not for propagation. This LMO will be directly used for food, feed and for processing.
Genetic stability in the transgenic crop is ensured such that no unintended horizontal gene transfer shall occur to unrelated species;
The protein product produced by the transgenic crop will degrade upon exposure to the natural environment and general conditions (i,e. high temperatures (60 C and above), varying pH, enzyme digestion, etc.)
The protein product will not increase the weediness potential of the transgenic crop.
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Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
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Information sharing with other databases
No
Additional information
DP73496 canola is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
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