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Évaluation des risques générée par un processus de réglementation
(RA)
published: 11 mars 2023
last updated: 03 mars 2025
Determination for the Safety Assessment of Soybean DAS 81419-2 for Direct Use as Food, Feed and for Processing
EN
20 janv. 2017
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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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DAS-81419-2 - Conkesta™ Soybean| Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glufosinate)
- DA-BPI Biotechnology Office [ English ]
The assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that soybean DAS 81419-2 is as safe for human food and animal feed as its conventional counterpart. The Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), after a thorough scientific review and evaluation of the documents related to Environmental Risk along with the submitted sworn statement and accountability of the proponent, recommended the issuance of a biosafety permit for this regulated event provided the conditions set by DENR are complied. Also, the Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of documents related to Environmental Health Impact, concluded that soybean DAS 81419-2 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. DOH-BC also recommended for the issuance of biosafety permit for soybean DAS 81419-2. Furthermore, the Socio-economic, Ethical and Cultural (SEC) Considerations expert also recommended for the issuance of biosafety permit for this regulated article after assessing the socioeconomic, social and ethical indicators for the adoption of Genetically Modified Organisms.
Possible changes at the level of DNA, protein and in the whole food; compositional analyses; unintended changes; and the potential for the newly expressed proteins to be either allergenic or toxic in humans.
Comprehensive molecular analyses of soybean line DAS-81419-2 indicate that it contains a single intact copy of T-DNA containing all the expected elements from pDAB9582 in DAS-81419-2 soybean genome.
Southern blot analysis of restricted DNA of DAS-81419-2 probed with 6 probes specific for backbone sequences showed absence of plasmid backbone in DAS-81419-2. There has not been any disruption of endogenous genes as a result of the transformation procedure. The introduced genetic elements are stably inherited from one generation to the next.
Assessments show that soybean DAS-81419-2 demonstrates agronomic, phenotypic and compositional equivalence to non-transgenic soybean. It has also been established that it is highly unlikely that Cry1F, Cry1Ac and PAT proteins will be toxic or allergenic making the risk negligible that DAS-81419-2 will cause adverse effects in humans or animals.
Bioinformatic analyses revealed no meaningful homologies to known or putative allergens or toxins for the Cry1Ac and Cry1F amino acid sequence. Both Cry1Ac and Cry1F hydrolyzed rapidly in simulated gastric fluid and glycosylation analysis revealed no detectable covalently linked carbohydrates in Cry1Ac and Cry1F.
Additionally, neither protein caused adverse effects in mouse acute oral toxicity studies. Therefore, the low level Cry1Ac and Cry1F content in soybean DAS-81419-2 relative to total plant proteins presents a low exposure risk to humans and animals, and the results of the overall safety assessment of the Cry1Ac and Cry1F proteins indicate that the proteins are unlikely to cause allergenic or toxic effects in humans or animals.
The risks are acceptable/manageable.
The molecular characterization data provided for soybean DAS-81419-2 did not give rise to safety issues. No concerns regarding the potential toxicity or allergenicity of the newly expressed Cry1F, Cry1Ac and the PAT proteins were identified, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-81419-2 was found. The nutritional value of food and feed derived from soybean DAS-81419-2 is not expected to differ from that of food and feed derived from non-GM soybean varieties.
The application concerns import of soybean line DAS-81419-2 for food, feed and processing. In case of spillage, DAS-81419-2 soybean seed may be released into the environment. Soybean seeds rarely display dormancy and poorly survive in soil. Soybean volunteers are rare throughout the world and do not effectively compete with other cultivated plants and weeds. In addition, volunteers are easily controlled mechanically or chemically. There are no indications that soybean line DAS-81419-2 has an increased potential to survive or establish feral populations in case of incidental spillage.
Event specific real-time quantitative PCR based method for detection of the genetically modified soybean DAS-81419-2
Oui
Oui
Oui
Oui
Oui
The introduced traits in soybean DAS-81419-2 are of agronomic interest, and are not intended to change any nutritional aspects of this soybean. Hence, this soybean is not expected to be more or less attractive for use as food (or feed), for processing, or as a food (or feed) ingredient. Therefore, anticipated dietary intake of soybean-derived foods and feeds is not expected to be altered upon commercialization of DAS-81419-2 soybean grain, and no nutritional imbalances are expected as a result of the use of DAS-81419-2 soybean grain.
