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Risk Assessment generated by a regulatory process
(RA)
last updated: 19 Jul 2012
Determination of the Safety of Syngenta' s Com MIR162 (Insect Resistant Corn) for Direct use as Food, Feed, and for Processing
EN
11 Feb 2010
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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SYN-IR162-4 - Agrisure™ Viptera maize| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
- DA-BPI Biotech Website [ English ]
Bioinformatic studies with the Vip3Aa20 and PMI proteins have confirmed the absence of any biologically significant amino acid sequence similarity to known protein toxins or allergens and digestibility studies have demonstrated that both proteins would be rapidly degraded in the stomach following ingestion, similar to other dietary proteins. Acute oral toxicity studies in mice with both proteins have also confirmed the absence of toxicity. Taken together, the evidence indicates that both proteins are unlikely to be toxic or allergenic in humans.
EN
Potential adverse effects to human and animal health arising from Vip3Aa20 and PMI have previously been assessed and it was concluded that the potential toxic effects to humans and animals of these proteins could be considered negligible.
EN
The potential toxicity and allergenicity of the Vip3Aa20 and PMI proteins expressed in event MIRI62 maize was evaluated by acute oral toxicity testing, digestive fate, and heat stability studies. The search of protein databases showed a wide variation of expressible vip3Aa20 gene value but generally low values, suggesting low probability of homology to known human toxins. The PMI amino acid sequence showed no homology to any proteins known to be toxins. The expressible pmi gene values are below the threshold of 10-3 suggesting no evidence of toxicity nor allergenicity by homology to known toxins and allergens.
EN
Corn MIR 162 is comparable with its conventional counterpart and will not pose any significant risk through consumption by both animals (for feed) and humans (for food).
EN
Biosafety permit for Corn MIR 162 and all progenies derived from crosses of the product with any conventionally-bred com and com containing approved-biotech events for direct use as food, feed or for processing was issued to SYNGENTA Philippines, Inc.
EN
Corn MIR 162 is as safe as the conventional corn taking into account dietary impact of any changes in nutritional content or value. Corn MIR 162 is safe to human and animals,and as nutritious as conventional com. Corn MIR162 is very effective in controlling Lepidopteran insects.
EN
This LMO will be directly used for food, feed and for processing. This application is not for propagation of Corn MIR 162.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
Methods and protocols for safe handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines
EN
Methods and protocols for safe handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines
Corn MIR 162 is intended for direct use as food, feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of this event.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of this event.
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