Loading...
You are viewing a DELETED record.
This record information is displayed for reference purpose only and should be not used.
This document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Risk Assessment generated by a regulatory process
(RA)
last updated: 06 Aug 2012
Determination for the Safety Assessment of Corn Bt176 for Direct Use as Food, Feed and for Processing
EN
24 Oct 2008
-
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,
-
SYN-EV176-9 - NaturGard KnockOut™ maize| Resistance to antibiotics (Ampicillin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate)
- DA-BPI Biotech Website [ English ]
EN
Facts concerning the novel proteins inserted in BT 176: 1. Cry1Ab proteina. Commercial preparation of B. thuringiensis has a long history of safe use.b. Exposure to protein through inhalation and dermal routes is not likely to occur since Btk protein is not volatile and not absorbed by the skinc. Chemical analysis did not show major changes in the nutritional composition of transgenic crop.d. Currently available data indicate that most plant pesticide proteins are rapidly degraded to the smaller non-toxic peptides and amino acids in mammalian gastric juicee. There is no evidence that Cry1Ab is accumulated in mammalian tissuef. Western blot analysis demonstrates that Cry1Ab protein is degraded in simulated gastric fluid.g. No hazardous effects were recorded in mice given single oral gavage dose of 3283 mg/kg CRY1Abh. No hazardous effects were recorded in Bobwhite quails dosed with Cry1Ab at the rate of 2000 mg/kg, equivalent to 1.4 mg Cry1Ab protein/ kgm 2. PAT proteina. Search of Gene banks revealed no known toxins were identified as having sequence homology of PAT.b. No acetylation of amino acids was detected in PAT.c. PAT degraded completely within 2 minutes in standard concentration in simulated gastric fluid.d. PAT protein activity is loss instantaneously and irreversible at 37oC in SGF.Since Btk and PAT proteins are unstable at temperature above 35 to 45 C, not glycosylated, not stable to digestion, not stable to processing and prevalent proteins in food, Cry1Ab and PAT proteins in genetically modified maize are not health concern. The amount of Cry1Ab and PAT proteins in Bt176 maize is below detection level, hence a negligible health concern.
EN
Results of scientific investigations and studies on nutritional and compositional analysis proved that Bt 176 maize and non modified maize are substantially equivalent, that inserted novel proteins are readily degraded/inactivated in acidic mammalian alimentary tract and not stable to processing/cooking and no detrimental effects were observed based on various toxicological assessments
EN
Corn Bt176 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Corn Bt176 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 was issued to Syngenta Philippines Inc.
EN
Corn Bt176 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This LMO will be directly used for food, feed and for processing. This application is not for propagation of this event.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Corn Bt176 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 Corn Bt176.
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 Corn Bt176.
- OECD Consensus Document on Corn [ English ]
Record type | Field | Record(s) | |||||
---|---|---|---|---|---|---|---|
|