Malaysian Biosafety Act 2007 - NRE

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BIOSAFETY NEWSLETTERVOLUME 01 I ISSUE 01 I APRIL 2009010203Fact Sheet on Approved Eventsand Products in MalaysiaEvent: Roundup Ready Soybean for FFP* Purposes in MalaysiaCrop: Glycine max – Soybeans Applicant: Monsanto CompanyDescription:Herbicide (Glyphosate) tolerant soybean variety was produced by inserting a modified CP45-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoding gene from the soil bacteriumAgrobacterium tumefaciens into the soyabean. EPSPS is an enzyme involved in the biochemicalpathway for the production of the aromatic amino acids needed for protein synthesis, which isrequired for plant growth and maintenance. Glyphosate, selectively inhibits the activity of theEPSPS enzyme, thus shutting off the aromatic amino acid synthesis. Application of this broadspectrum, non-selective herbicide on Roundup Ready Soybean, kills all the emerged weeds withno harm to the crop itself.Safety Assessment:The nutritional equivalence and wholesomeness of Roundup Ready soybeans compared toconventional soybeans was demonstrated by the analysis of key nutrients, including proximates,amino acid and fatty acid composition, as well as anti-nutrients. The nutritional equivalence of RoundupReady soybeans to conventional soybeans was confirmed in numerous feeding studies with rats,cows, pigs, broiler chickens, fish and quail. The environmental impact of Roundup Ready soybeansis also comparable to conventional soybeans. Study results show that Roundup Ready soybeansare as safe as conventional soybeans with respect to food, feed and environmental safety.Event: NK603 Roundup Ready Maize for FFP* Purposes in MalaysiaCrop: Zea mays - Maize Applicant: Monsanto CompanyDescription:Maize tolerant to the herbicide glyphosate was produced through the introduction of a modifiedgene encoding CP4 5-enolpyruvyl shikimate-3-phosphate synthase (EPSPS), an enzyme involvedin the shikimic biochemical pathway for the production of the aromatic amino acids. The mode ofaction is similar to that of the Roundup Ready Soybean.Safety Assessment:NK603 has nutritional equivalence to conventional maize. CP4 EPSPS protein digests rapidlyand lacks toxicity and allergenicity. The environmental impact of NK603 is also comparable toconventional corn with respect to food, feed and environmental safety.Event: MON 810 YieldGard Maize against Corn-Borer for FFP* Purposes in MalaysiaCrop: Zea mays - Maize Applicant: Monsanto CompanyDescription:Mon 810 YieldGard is a variety of maize that was produced by inserting a truncated form of thecry1Ab gene (which codes for the production of the insecticidal protein) from Bacillus thuringiensissubsp. kurstaki HD-1. The genetic modification affords resistance to attack by the European cornborer (ECB), Ostrinia nubilalis, the southwestern corn borer (SWCB, Diatraea grandiosella) and thepink borer (Sesamia cretica).Safety Assessment:MON 810 improves grain quality by reducing insect (only Lepidopteran insects) damage to ears.The Cry1Ab protein has selective toxicity and is harmless to humans, fish, wildlife and beneficialinsects. Tests have shown that the Cry1Ab protein is present at very low levels in the grain and foodbut rapidly degraded in simulated gastric fluids; shows no similarity to known allergens and showsno harmful effects to animals when fed at very high levels. The forage and grain of MON810 plantsare as safe and nutritious as conventional maize varieties.12
BIOSAFETY NEWSLETTERVOLUME 01 I ISSUE 01 I APRIL 20090405Event: MON 863 YieldGard® Rootworm++ Maize for FFP* Purposes in MalaysiaCrop: Zea mays - Maize Applicant: Monsanto CompanyDescription:Maize resistant to corn root worm (Diabrotica virgifera) produced by inserting the Cry3Bb1 genefrom Bacillus thuringiensis subsp. kumamotoensis. This gene encodes for the insecticidal proteinCry3Bb1 which is toxic only to Coleopteran insects.Safety Assessment:Results of biochemical analyses of the train and forage demonstrate the compositional equivalence ofMON 863 to conventional corn varieties. The Cry3Bb1 protein is degraded rapidly, not stable in heat,not clycosylated and has no biologically relevant amino acid sequence similarity to known allergensand toxins. As for environmental safety, the Cry3Bb1 protein has no adverse effects on non targetspecies. Food and feed products derived from MON 863 are safe and nutritious for consumption asthose derived from conventional maize varieties and pose no risk to the environment.Product Name: ISP type III HPLC 12 Glacein - Ice-Structuring Protein (ISP) in FoodLMO source: Recombinant Baker’s Yeast Applicant: Unilever MalaysiaDescription:ISP is a copy of a protein found in ocean pout (fish). However, no fish components are used in thederivation or manufacture of ISP. ISP is used as a processing aid in frozen products at a level
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Malaysian Biosafety Act 2007 - NRE

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