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Risk Assessment generated by a regulatory process (RA)
  |  
BCH-RA-PH-46820-6   |   PDF   |   Print   |  
published: 18 Sep 2008 last updated: 26 Mar 2025
General Information
Determination for the Safety Assessment of Alfalfa J101 and J163 for Direct Use as Food, Feed and for Processing
EN
09 Aug 2006
Risk assessment details
  • MON-ØØ1Ø1-8 × MON-ØØ163-7 - Roundup Ready™ alfalfa
    | Monsanto | Resistance to herbicides (Glyphosate)
Methodology and points to consider
EN
Bioinformatics analysis performed on proteins toxicants that may be present in genetically enhanced alfalfa strengthens the safety of the crop as this shows the absence of biologically relevant structural similarities to any toxin observed for CP4 EPSPS protein.CP4 EPSPS is claimed to be easily digested in vitro and in mammalian digestive fluids upon ingestion. It is non toxic to acutely gavaged mice that refers to the safety of the protein (Harrison et al., 1996) and has no direct effect on metabolic pathways.Assessment of the CP4 EPSPS protein involved the use of an allergen sequence database which demonstrated absence of protein sequences which are potentially risky for humans.  The 8 contiguous amino acids indicative of immunologicaly allergenic sequence or epitopes were not detected.  This, then strengthens safety of the CP4 EPSPS protein in events J101 and J163.Degradation of CP4 EPSPS in simulated digestive fluids (SDS) and gastric fluids (SGF) was rapid with a half-life data of less than 15 seconds in the stomach and less than 10 minutes in the intestines.  The digestibility of CP4 EPSPS was evaluated by SDS-PAGE gel staining, Western blot analysis and enzymatic activity assay.  SDS-PAGE colloidal blue gel staining demonstrated that 98% of the protein was digested in SGF as confirmed by Western blot analysis.  This explains safe consumption of the crops harboring the protein.  The highest concentration of CP4 EPSPS protein (572 mg/kg) did not elicit any adverse effect in mice. No treatment related effects on body weight, food consumption, survival, clinical observations or gross pathology confirms non-toxicity of the protein.
EN
Safety assessment of CP4 EPSPS protein in J101 and J163 included digestibility in simulated gastric-fluids, bioinformatics analysis of the structural  similarity to known proteins (including protein toxins), acute oral toxicity of mouse gavage, and an evaluation of the protein to EPSPSs naturally present in foods with a long history of safe use (e.g., soybeans and corn).  From these studies, there appears to be no known pathogenicity or allergenicity of the encoded protein.Bioinformatics analysis was performed with allergens, toxin and public domains to assess the potential of CP4 EPSPS protein for allergenicity, toxicity and pharmacological activity.  No biological relevant similarity in amino acid sequence to allergens, toxins or pharmacological active proteins were apparently observed.
EN
Alfalfa J101 and J163 are as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Alfalfa 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 and for processing was issued to Monsanto Philippines Inc. Alfalfa J101 and J163 is found to be as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
Alfalfa J101 and J163 is found to be as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
EN
This application is not for propagation of Alfalfa 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.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
Alfalfa J101 And J163 is intended for direct use as food, or 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 during the evaluation of alfalfa J101 and J163

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of alfalfa J101 and J163
EN
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