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Risk Assessment generated by a regulatory process
(RA)
published: 15 Sep 2008
last updated: 16 Aug 2012
Determination for the Safety Assessment of Corn MON 810 for Direct Use as Food, Feed and for Processing
EN
04 Dec 2002
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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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MON-ØØ81Ø-6 - YieldGard™ maize| Monsanto | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis))
- DA-BPI Biotech Website [ English ]
EN
Use of Bt formulation (as a source of Cry1Ab protein) has long history of safe use on food crops as a biopesticide with no evidence of adverse effect. Locally, Bt microbial formulations (Dipel, Thuricide) have been approved for commercial use by the Fertilizer and Pesticide Authority (FPA).The Cry1Ab protein shows no amino acid sequence homology to known protein toxins, other than other Cry proteins, and is rapidly degraded with loss of insecticidal activity under conditions that simulate mammalian digestion. The cry1Ab gene was not derived from an allergenic source, and the Cry1Ab protein does not possess immunologically relevant sequence similarity with known allergens or possess the characteristics of known protein allergens. Cry1Ab produced no adverse effects at high dose in an acute oral rodent toxicity study. The NOEL was found to be 4000 mg/kg, the highest dose level tested. These studies support the safety of Cry1Ab protein and are fully consistent with the extensive history of safe use for the Cry1Ab protein that has high selectivity for insects. Cry1Ab protein is safe to non-target organisms such as fish, birds, mammals and beneficial insects. Neither Cry1Ab had a direct or indirect effect on the arthropod population, abundance of beneficial insect community structure and earthworm population.
EN
The safety of the Cry1Ab protein in YieldGard corn has been thoroughly evaluated. Bacillus thuringiensis, the source of the cry1Ab gene, has no history of causing allergies, The protein is present at very low levels in the grain and food, is rapidly degraded in simulated gastric fluids, shows no similarity to known allergens, and shows no harmful effects to rodents when fed at very high levels.
EN
Corn MON 810 applied for direct use is safe for human food, livestock feed, for processing and for the environment.
EN
A biosafety permit for Corn MON 810 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed and for processing as well as for propagation was issued to Monsanto Philippines. Inc. Corn MON 810 is found to be as safe as its conventional counterpart and does not pose any significant risk to human, animal health or the environment.
EN
Corn MON 810 is found to be as safe as its conventional counterpart and does not pose any significant risk to human, animal health or the environment.
EN
This application is also for propagation of Corn MON 810. This LMO will be directly used for food, feed and processing.
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 MON 810 is intended for direct use as food, feed and for processing and for propagation.
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.
- OECD Consensus Document on Corn [ English ]
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