Philippines | BCH-RA-PH-108050 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-108050-1   |   PDF   |   Print   |  
last updated: 27 May 2015
General Information
Determination of the Safety of Monsanto's Corn MON 87460 For Direct use as Food, Feed, and for Processing
EN
15 Nov 2012
Risk assessment details
Methodology and points to consider
Based on the data and information presented, it was concluded that corn grain and forage derived from MON 87460 are compositionally and nutritionally equivalent to those of conventional corn under well-watered condition and water-limited condition.
EN
A history of safe use has been established for MON 87460 CSPB protein.CSPB shares homology with a variety of proteins that are present in commonly used foods and have a history of safe use. CSPB is not homologous to known toxic or bioactive proteins. Also CSPB protein was shown to be rapidly degraded in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) indicating that it is highly unlikely that the CSPB protein and its fragment will reach absorptive cells of the intestinal mucosa. Finally CSPB did not exhibit any signs of toxicity when administered to mice via oral gavage.
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Corn MON 87460 and all progenies derived from crosses of this product with any conventionally-bred corn except when such cross involves another transformation event is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed and for processing.
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Corn MON 87460 is as safe for human food, livestock feed and for processing as its conventional counterparts
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A biosafety permit for Drought tolerant  Corn event MON 87460, 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 Monsanto Philippines Inc.
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Corn MON 87460 is as safe as the conventional corn taking into account the safety and nutritional quality of MON 87460.
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This LMO will be directly used for food, feed and processing. This does not include cultivation of Corn MON 87460 in the Philippines.
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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.
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Additional information
Corn MON 87460 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.
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