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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Alfalfa KK179 × J101 for Direct Use as Food and Feed, or for Processing
EN
25 Jun 2020
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MON-ØØ179-5 × MON-ØØ1Ø1-8 - Herbicide tolerant, reduced ligning alfalfa| Monsanto | Changes in quality and/or metabolite content (Lignin), Resistance to herbicides (Glyphosate)
After reviewing the technical dossier provided by the applicant, the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC) concurred that Alfalfa KK179 × J101 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and to the environment.
The gene products of Alfalfa KK179 × J101— CCOMT partial transcript and cp4EPSPS— may potentially interact, leading to unintended effects or to the production of a new allergen or toxin.
The expression of the gene products were considered in assessing the potentiality of the adverse effects being realized. The CCOMT partial transcript exists as an RNA duplex and does not proceed to translation to produce a protein. The cp4EPSPS, in turn, is expressed at low levels (500μg/g dry weight). Therefore, exposure through diet and, by extension, the likelihood of realization of potential adverse effects is minimal.
The gene products have been shown to have distinct modes of action and therefore, is unlikely to interact with each other. The likelihood of interaction among the gene products is not considered significant enough to affect the stability and expression level of each other. There is no known mechanism through which RNA-based suppression and cp4EPSPS could interact and lead to adverse effects.
Given the minimal exposure and marginal harm potentially caused by Alfalfa KK179 × J101, the overall risk is estimated to be negligible.
The assessors recommended for the approval and issuance of a biosafety permit for direct use as food and feed, or for processing of Alfalfa KK179 × J101.
An environmental management plan indicating the possible risk and harm to the environment, particularly on biodiversity, as well as the mitigating measures and contingency plan was provided.
An environmental management plan indicating the possible risk and harm to the environment, particularly on biodiversity, as well as the mitigating measures and contingency plan was provided.
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The assessors noted that alfalfa hay does not contain viable plant materials and that alfalfa is unlikely to be invasive. Therefore, gene flow to wild relatives is highly unlikely to occur in nature.
Event-specific qPCR detection methods for alfalfa events KK179 and J101.
Yes
Yes
Yes
Yes
Yes
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