Philippines | BCH-RA-PH-46805 | 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-46805-7   |   PDF   |   Print   |  
last updated: 17 Aug 2012
General Information
Determination for the Safety Assessment of  Sugar beet 77 for Direct Use as Food, Feed and for Processing
EN
20 Oct 2004
Risk assessment details
  • SY-GTSB77-7 - InVigor™ Sugar Beet
    | Monsanto | Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
Methodology and points to consider
EN
A report claimed that anti-nutritional or other adverse effects to human or animal health due to beet (root) components have not been found during their long history of safe use. Saponins are the only known toxicants found in sugar beet and are actively eliminated during sugar processing. The levels of saponins in GTSB line 77 are comparable to that of conventional sugar beet.There is no evidence to indicate that there is any potential for the CP4 EPSPS, GUS or Protein 34550 to be either toxic or allergenic to humans. Proteins from the EPSPS or GUS family of proteins are naturally present in our food supply or expressed in human intestinal microflora. Although the truncated GOX protein (Protein 34550) is not present in foods normally, it does not possess any of the characteristics common to many allergens or toxins or any significant sequence similarity to any known allergens or toxins.
EN
Food products derived from sugar beet 77 should pose no greater risk as a source of toxins or allergens than food products derived from conventional sugar beets.
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Glyphosate Tolerant Sugar beet 77 is as safe as its conventional counterpart and is equivalent to other commercially available sugar beet with respect to composition and nutritional quality and does not pose any significant risk to animal and human health.
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A biosafety permit for Sugar beet 77 and all progenies derived from crosses of the product with any conventionally-bred sugar beet and sugar beet containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines. Inc. Sugar beet 77 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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Sugar beet 77 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health
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This application is not for the direct propagation of this event. This LMO will be directly used for food, feed and for processing.  This application is not for the direct propagation of this event.
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Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
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Additional information
Sugar beet 77 is intended for direct use as food and 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 Sugar beet 77.
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