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Risk Assessment generated by an independent or non-regulatory process (IRA)
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BCH-IRA-SCBD-109885-3   |   PDF   |   Print   |  
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published: 20 Mar 2016 last updated: 23 Mar 2016
General Information
Determination of the Safety of Monsanto's  Alfalfa Events J101 and J163 for Direct use as Food, Feed, or Processing
EN
09 Aug 2006
Risk assessment details
  • BCH-LMO-SCBD-16135-7
    MON-ØØ1Ø1-8 × MON-ØØ163-7 - Roundup Ready™ alfalfa
    | Monsanto | Resistance to herbicides (Glyphosate)
Methodology and points to consider
EN
The protein product of the inserted gene (cp4 epsps) does not in any way, interfere with normal functioning of the shikimate acid pathway, where EPSPS lies within, as evidenced by the levels of key downstream metabolites such as aromatic amino acids. There are also no nucleic acid sequences that code for a protein toxic to humans or antibiotic resistance introduced into the alflafa lines.  Similarly, no significant homology was demonstrated for the cp4 epsps gene with known allergens and neither protein was stable in a simulated gastric fluid.  The protein has little probability of being allergenic.
EN
Potential anti-nutritional factors present in alfalfa are lignin and phytoestrogen in the form of coumestrol. The level of lignin in events J101 and J163 are comparable to the lignin levels in conventional alfalfa. Similarly, there were no significant difference in the levels of coumestrol in the forage of alfalfa J101 and J163 compared to that of control alfalfa.
EN
Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety notification for alfalfa events J101 and J163, and all progenies derived from crosses of the product with any conventionally bred alfalfa and alfalfa containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines, Inc. Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
This application is not for propagation of the Alfalfa Events J101 and J163. This LMO will be directly used for food, feed and for 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 may be used.
EN
Additional information
Alfalfa Events J101 and J163 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.
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1

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