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Risk Assessment generated by a regulatory process (RA)
last updated: 06 Jan 2022
Determination for the Safety Assessment of Soybean MON87751 for Direct Use as Food, Feed and for ProcessingEN
Date not available
- Competent National Authority: | BCH-CNA-PH-46524-5Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: email@example.com,Website: http://www.da.gov.ph,
Lepidopteran insect resistance – confers resistance to lepidopteran insects by selectively damaging their midgut lining;
Soybean contains several antinutrients such as heat labile trypsin inhibitors, lectins, stachyose, raffinose and phytic acid. Soybean meal contains stachyose and raffinose that cause flatulence in swine and poultry.
Soybean also contains recognized allergenic protein.
Trypsin inhibitors activities are destroyed during toasting or heating whole soybean or meal while lecithin is readily inactivated by moist heat when raw soybean is processed into defatted, toasted soybean meal. Stachyose and raffinose are reduced or decreased by processing soybean further into concentrates or isolates. For phytic acid, adding phytase into the diets of poultry and swine will release phytinbond phosphorus that decreased phytic acid in the diet.
Although, soybean contains allergenic protein, relevant estimate of its allergenic potential is not complete. There is no significant level of amino acid homology exists between the pat gene and any protein allergens.
Using a combination of sequencing, PCR and bioinformatics, MON87751 demonstrated to contain one copy of the intended transfer DNA (T-DNA I) containing the cryIa.105 and the cry2Ab2 expression cassettes stably integrated at a single locus and inherited according to Mendelian principles over multiple generations.
Based on scientific evidences, soybean MON87751 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and environment.
No significant differences were observed for lectin, trypsin inhibitors, phyticacid, and stachyose. A statistically significant difference (p e (p<0.05) was observed for raffinose. The mean difference in raffinose values between MON 87751 and the conventional control was less than the range of the conventional control values, indicating that MON 87751 does not impact levels of raffinose more than natural variation within the conventional control grown at multiple locations.
The application of Soybean MON87751is not for propagation. This LMO will be directly used for food, feed and for processing.
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 statistically significant differences were observed in the proximate levels (moisture, protein, fat, ash, carbohydrates, acid detergent fiber (ADF) and neutral detergent fiber (NDF) between the test soybean and the control soybean.