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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 04 avr. 2025
Safety Assessment of Soybean MON87708 x MON89788 for Direct Use as Food and Feed, or for Processing
EN
22 avr. 2016
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Autorité nationale compétente :Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesTéléphone : (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Télécopieur :Site Web : http://www.da.gov.ph,
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Organisation :Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesTéléphone : 8524-9588 local 230,Télécopieur :E-mail : bpibiotech@buplant.da.gov.ph,Site Web : https://biotech.buplant.da.com.ph/,
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MON-877Ø8-9 × MON-89788-1 - Herbicide tolerant soybean| Monsanto | Resistance to Dicamba, Résistance aux herbicides (Glyphosate)
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 (DOH-BC)— concurred that there is no significant difference between the stacked soybean line and its conventional counterpart. Further, the assessors concluded that Soybean MON87708 x MON89788 will not pose any significant risk to human and animal health, and to the environment.
The novel proteins— DMO and cp4EPSPS— may have unintended interactions, leading to adverse effects.
Due to the different modes of action and biochemical pathways of the novel proteins, it is improbable that they will interact to produce a new allergen or toxin. DMO is involved in the oxidative demethylation of dicamba, a broadleaf herbicide while cp4EPSPS is involved in the biosynthesis of aromatic amino acids.
A detailed description of the biochemical pathways of the novel proteins has shown that the novel proteins have different substrates and modes of biological action. Each protein, thus, functions differently and independently of each other and are not expected to interact and affect the metabolism of the plant.
Gene expression study using the enzyme-linked immunosorbent assay (ELISA), also showed that the levels of expression of DMO and cp4EPSPS in Soybean MON87708 x MON89788 do not differ significantly from that of single events MON87708 and MON89788, which carry the novel proteins individually.
Gene expression study using the enzyme-linked immunosorbent assay (ELISA), also showed that the levels of expression of DMO and cp4EPSPS in Soybean MON87708 x MON89788 do not differ significantly from that of single events MON87708 and MON89788, which carry the novel proteins individually.
Given that (1) there is equivalence of the stacked soybean line with its constituent single event lines in terms of expression levels and nutritional data, and that (2) the novel proteins DMO and cp4EPSPS function independently of each other and are not expected to interact, Soybean MON87708 x MON89788, developed through conventional breeding, does not have any significant risk.
Based on the above evidences, the assessors recommended for the issuance of a biosafety permit for the direct use of Soybean MON87708 x MON89788.
The DENR-BC provided a set of conditions for the approval of Soybean MON87708 x MON89788. The DOH-BC also set a list of measures that the applicant has to comply with following the approval of the regulated article.
The DENR-BC provided a set of conditions for the approval of Soybean MON87708 x MON89788. The DOH-BC also set a list of measures that the applicant has to comply with following the approval of the regulated article.
FR
The unintended release of the regulated article in the Philippines is improbable due to the predominantly self-pollinating nature of soybean. Human intervention is required for the soybean plant to be established.
Event specific real-time quantitative PCR based methods for MON-877Ø8-9 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø8-9 × MON-89788-1 soybean.
Oui
Oui
Oui
Oui
Oui
FR
