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Risk Assessment
Record information and status
Record ID
115902
Status
Published
Date of creation
2021-02-19 08:23 UTC (lorelieu5@gmail.com)
Date of publication
2021-02-19 08:23 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of ALFALFA KK179 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Risk assessment details
Living modified organism
MON-ØØ179-5 - Reduced Lignin Alfalfa
Changes in quality and/or metabolite content - Lignin Resistance to antibiotics - Kanamycin
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
Methodology and points to consider
Potential adverse effects identified in the risk assessment
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.
Likelihood that the potential adverse effects will be realized
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.
Possible consequences:
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.
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
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. 
Receiving environment(s) considered
The application of ALFALFA KK179 is not for propagation. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
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.
Additional Information
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.