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Risk Assessment generated by a regulatory process
(RA)
last updated: 11 Mar 2023
Determination for the Safety Assessment of Canola DP73496 for Direct Use as Food, Feed and for Processing
EN
25 Jul 2017
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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DP-Ø73496-4 - Optimum® Gly Canola| Pioneer Hi-Bred International Inc. | Resistance to herbicides (Glyphosate)
- BIOTECH [ English ]
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.
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.
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.
Low erucic acid rapeseed contains pigments such as chlorophyllides and pheophorbides which may present nutritional effect due to their phototoxicity which may be followed by photosensitive dermatitis.
In conducting a safety assessment of food derived from canola line DP73496, a number of criteria have been addressed including: characterization of the transferred genes including their origin, function and stability in the canola genome; the nature of the introduced protein and its potential to be either allergenic or toxic in humans; compositional analyses and any resultant changes in the whole food. This approach evaluates the intended and any unintended changes in the plant. No potential public health and safety concerns have been identified in the assessment of canola line DP73496.
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 DP773496 canola is as safe as its conventional counterpart.
On the basis of the data required from the applicant, and other available information, food derived from herbicide tolerant canola line DP73496 is as safe for human consumption as food derived from conventional canola varieties.
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.
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.
No
Data on the compositional analysis has confirmed no significant differences between canola line DP73496 and conventional varieties already in the food supply. Oil is extracted and processed in the same way regardless of whether the seed was obtained from GM or non-GM plants. Therefore, the possibility of an adverse reaction (eg. food intolerance or allergy) to other substances that might be present in canola oil (eg. a preservative) would be the same regardless of whether the oil was derived from non-GM canola or from canola line DP73496.
