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Risk Assessment
Record information and status
Record ID
105097
Status
Published
Date of creation
2013-11-01 04:51 UTC (anita@nre.gov.my)
Date of publication
2013-11-01 07:05 UTC (johnny@nre.gov.my)

General Information
Country
  • Malaysia
Title of risk assessment
Risk Assessment Report of the Genetic Modification Advisory Committee (GMAC) for an Application for Approval for Release of Product of Imidazolinone-Tolerant CV127 Soybean for Supply or Offer to Supply
Date of the risk assessment
2013-10-02
Competent National Authority(ies) responsible for the risk assessment
Department of Biosafety Malaysia
Level 1, Podium 2, Wisma Sumber Asli
No. 25, Persiaran Perdana, Precinct 4
Putrajaya
Malaysia, 62574
Phone:+603 8886 1579,+603 8886 1746
Fax:+603-8890 4935
Email:dob@biosafety.gov.my
Url:Department of Biosafety Malaysia
Contact details of the main responsible risk assessor
Dato' Letchumanan Ramatha
Expert Member of National Biosafety Board (Retired)
Ministry of Water, Land and Natural Resources Malaysia (KATS)
Asia Retreat Centre, Brahma Kumaris Malaysia,
Jalan BK1, Jalan Selangor Dredging
Dengkil, Selangor
Malaysia, 43800
Phone:+60 322822310
Email:bkletchu@yahoo.com
Risk assessment details
Living modified organism
BPS-CV127-9 - Herbicide-tolerant soybean
BASF S.A. Resistance to herbicides - Imidazolinone, Sulfonylurea
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Potential adverse effects identified in the risk assessment
Please refer to the Risk Assessment Report
Likelihood that the potential adverse effects will be realized
Please refer to the Risk Assessment Report
Possible consequences:
Please refer to the Risk Assessment Report
Estimation of the overall risk
Please refer to the Risk Assessment Report
Recommendation(s)
GMAC has conducted a thorough evaluation of the application for approval for importation for release [sale/placing on the market - for direct use as food, feed and for processing (FFP)] of a product of a Living Modified Organism (Imidazolinone-Tolerant CV127 soybean) and has determined that the release of this product does not endanger biological diversity or human, animal and plant health. GMAC recommends that the proposed application for release be APPROVED WITH TERMS AND CONDITIONS subject to approval by other relevant agencies.
LMO detection and identification methods proposed
The event-specific method for the quantification of CV127 soybean is based on a real-time quantitative TaqMan PCR procedure to determine the relative content of CV127 to total soybean DNA in a sample. The protocol was shown to be capable of detecting 0.04 % CV127 soybean DNA in a mixture of non-transgenic soybean DNA. The protocol consists of a method module for DNA extraction from soybeans and a method module for event-specific quantification of CV127 soybean DNA. For quantitative event-specific detection of CV127 soybean two real-time PCR systems are used: a soybean-specific reference PCR system and a PCR system for event- specific detection of CV127 soybean. The soybean-specific reference PCR system is based on the sequences of the soybean Le1 (lectin) gene. The event-specific real- time PCR system for CV127 soybean is located at the 3' insert-to-genomic soybean DNA junction. The forward primer-binding site is located in the CV127 insert, the binding site of the reverse primer is within genomic soybean DNA and the binding site of the probe spans the junction between the CV127 insert and genomic DNA.
Additional Information
Other relevant website address or attached documents

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