Summary of results of the risk assessment from the notifier.
Conclusion
MON89788 soybean is as safe as conventional soybean and therefore its placing on the market for processing and food and feed use is unlikely to have an adverse effect on human or animal health or, in the context of its proposed use, on the environment.
Comparative study
Basis of comparison
Conventional
Asgrow variety A3244 with similar genetic background
Qualities of the plant
No significantly result from conventional soybeans in
composition and in agriculture.
Compositional analysis
Proximate analysis: fiber
fractions, fatty acid profile, amino acid composition, anti-nutrients (such as
trypsin inhibitors), vitamin E, secondary metabolites:
No statistical differences were observed.
Safety of food and feed
New protein
cp4 epsps
Feeding studies on mice: no reference to acute toxicity.
The protein is not homologous to known protein toxins
Allergenicity of the new protein
This lack of allergenicity was expected based on the rapid degradation of the protein and its enzymatic activity in simulated human gastric and intestinal fluids.
The protein is not homologous to known protein allergens.
Assessment for gm food and feed
A 90-days
feeding study in rats compared the feeding value of Roundup Ready soybeans to that of the parental control:
No significant differences in feed intake, body weights, and behaviour of the
animals as well as haematological changes were observed.
Nutritional equivalence
A
42-days animal feeding study with broiler chicken showed no harmful to health effects.
Enviromental safety
Survivebility
Soybean plants are annuals and do not survive vegetatively or by seed from one growing season to the next.
Cross- pollination
Cultivated soybean is essentially self-pollinated. Cross-pollination is generally very low.
Cultivated soybean is sexually compatible only with members of the genus Glycine. The genus Glycine is of Asian and Australian origin.
Field trails
In
Argentina (2004-2005) and the United States (2005-2007).