Philippines | BCH-RA-PH-115902 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General information
Determination for the Safety Assessment of ALFALFA KK179 for Direct Use as Food, Feed and for Processing
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  • - Competent National Authority: BCH-CNA-PH-46524-5 | BCH-CNA-PH-46524-5
    Competent National Authority
    Department of Agriculture ()
    Elliptical Road, Diliman
    Quezon City,
    1100, Philippines
    Phone: +632 920-3986, +632 924-1278 local 2802,
    Fax: +632 920-3986,
Risk assessment details
  • MON-ØØ179-5 - Reduced Lignin Alfalfa
    | Changes in quality and/or metabolite content - Lignin Resistance to antibiotics - Kanamycin
Methodology and points to consider
Alfalfa forage contains well described classes of anti-nutrient compounds including saponins, condensed tannins, and phytoestrogens. There are no reported cases of allergic reactions to alfalfa in humans. However, alfalfa forage contains saponins and canavanine. Saponins can produce toxic effects, primarily by medicagenic and zanhic acids.
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Alfalfa KK179 does not contain any recombinant genes, which encode proteins. Analysis of dsRNA-encoding KK179 DNA segments indicates that protein production by the dsRNA encoded by the insert in KK179 is highly unlikely.   No evidence of mammalian toxicity or allergenicity to RNA or DNA has been reported.
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Chi square (χ²) analysis over several generations was used to generate segregation data in order to assess the heritability and stability of the T DNA I present in KK179.  Three generations of backcrosses were tested. The χ2 value for three generations (two backcrossed generations and one synthetic self-cross generation) indicated no significant difference between the observed and expected segregation ratios. The results are consistent with the molecular characterization data that indicate KK179 contains a single, intact copy of the CCOMT suppression cassette that was inserted into the alfalfa genome at a single locus.
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Collectively, there is enough evidence to support the conclusion that reduced lignin alfalfa KK179 is as safe and nutritious as its conventional alfalfa and does not pose greater risk to biodiversity, human and animal health than its conventional counterpart. Its direct use whether for food, feed or for processing will not cause any significant adverse effect on the environment.
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The data summarized in this document support a conclusion that reduced lignin alfalfa KK179 is as safe and nutritious as its conventional alfalfa and does not pose greater risk to biodiversity, human and animal health than its conventional counterpart. A biosafety permit for direct use can be issued for the said event.
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Alfalfa KK179 and its progenies are not significantly different from conventional alfalfa in terms of compositional, nutritional, and safety aspects, except for the introduced trait for reduced guaiacyl lignin subunits (G lignin) and total lignin. This product does not change nutrients relevant to feed and food consumption. 
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The application of ALFALFA KK179 is not for propagation. This LMO will be directly used for food, feed and for processing.
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Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
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Information sharing with other databases
No
No
No
No
No
Additional Information
ALFALFA KK179 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 during the evaluation of this combined trait product.
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