Determination of the Safety of Monsanto's Corn MON 87427 For Direct use as Food, Feed, and for Processing | BCH-IRA-SCBD-109791 | Risk Assessment generated by an independent or non-regulatory process | Biosafety Clearing-House

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Risk Assessment generated by an independent or non-regulatory process (IRA)
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BCH-IRA-PH-109791-1   |   PDF   |   Print   |  
last updated: 11 Mar 2016
General Information
Determination of the Safety of Monsanto's Corn MON 87427 For Direct use as Food, Feed, and for Processing
EN
28 Nov 2014
Risk assessment details
Methodology and points to consider
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The MON 87427- produced CP4EPSPS protein and the E. coli-produced CP4EPSPS protein was shown to be biochemically, structurally, and functionally equivalent. Western blot analysis confirmed the greater than 98% of the E.coli produced CP4EPSPS was digested in SGF within 15 seconds. In summary, the results of these experiments confirmed that the E coli produced CP4EPSPS proteins was rapidly digested after incubation in SGF and is therefore unlikely to pose a human health concern.
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Corn grain contains two main anti-nutrients: phytic acid and  raffinose.  Phytic acid is present in corn grain, where it chelates mineral nutrients including calcium, magnesium, potassium, iron and zinc rendering them biologically unavailable to monogastric animals consuming the grain. Raffinose is a low molecular weight non-digestible carbohydrate present in corn grain that is considered to be an anti nutrient due to the gas production and resulting flatulence caused by consumption (Liener, 2000).
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Corn MON 87427 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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A biosafety permit for Corn MON 87427 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. Corn MON 87427 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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Corn MON 87427 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the Corn MON 87427. This LMO will be directly used for food, feed and for processing.
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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 may be used.
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Additional information
Corn MON 87427 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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