Nov 21, 2008 | 1:57 am

Soybean MON40-2-3 (RoundupReady)

Summary of risk assessment

Summary of results of the risk assessment from the notifier.
Conclusion MON40-3-2 soybean is as safe as conventional soybean, and releasing MON40-3-2 for processing and food and feed use is unlikely to have an adverse effect on human or animal health and the environment.

 

Comparative study
Basis of comparison Conventional counterpart A5403 (isogenic line)
Qualities Several parameters were compared including morphology and seed production.
Compositional analysis Proximate analysis was conducted on parameters such as: protein, fat, fiber, ash, carbohydrates, moisture, anti-nutrients (trypsin inhibitors), isoflavones, fatty acid profile, and amino acid composition. No statistically significant 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 The new protein is rapidly broken down and inactivated when treated with simulated human gastric and intestinal fluids.

No correspondence with known allergens (amino acid sequence comparison)

Assessment for food and feed A 15-week feeding study with rats and mice compared Roundup Ready soybeans with the isogenic line. No significant differences in growth, nutritional value, or the histopathology of immune-related organs were observed.

Feeding studies with MON40-2-3 on cows revelead no adverse effects on milk or rumen.

Nutritional equivalence Animal feeding studies have been conducted on rats, dairy cow, pigs, chicken, catfish and quail. Animals were fed either with raw cracked soybean, unprocessed soybeans, or processed soybean meal. No results revelead harmful health effects.

 

Enviromental safety
Survivability Soybean plants are annuals and do not survive vegetatively or by seed from one growing season to the next.
Cross-pollination Cultivated soybeans are sexually compatible only with other members of the genus Glycine. The genus Glycine is of Asian and Australian origin.

Cultivated soybeans are essentially self-pollinated. Cross-pollination is very rare. At distances of more than 4.5 meters from the pollen source, natural cross-pollination in soybean occurs at rates of less than 0.02%, and is most often undetectable.

Field trails Evaluation of field trials in the United States, Central and South America, Europe, and Canada since 1991. Data has been collected from over 150 field trials.