| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Risk Assessment
Record information and status
Record ID
109885
Status
Published
Date of creation
2016-03-20 11:49 UTC (ralphklapps@gmail.com)
Date of last update
2016-03-23 02:49 UTC (estaciojulietafe@gmail.com)
Date of publication
2016-03-23 02:49 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Monsanto's  Alfalfa Events J101 and J163 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2006-08-09
Institution 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
Contact details of the main responsible risk assessor
Ms. Merle B. Palacpac
Chief
Post Entry Quarantine Station
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:merle.palacpac@gmail.com
Url:http://bpi.da.gov.ph
Risk assessment details
Living modified organism
MON-ØØ1Ø1-8 x MON-ØØ163-7 - Roundup Ready™ alfalfa
Resistance to herbicides - Glyphosate
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The protein product of the inserted gene (cp4 epsps) does not in any way, interfere with normal functioning of the shikimate acid pathway, where EPSPS lies within, as evidenced by the levels of key downstream metabolites such as aromatic amino acids. There are also no nucleic acid sequences that code for a protein toxic to humans or antibiotic resistance introduced into the alflafa lines.  Similarly, no significant homology was demonstrated for the cp4 epsps gene with known allergens and neither protein was stable in a simulated gastric fluid.  The protein has little probability of being allergenic.
Possible consequences:
Potential anti-nutritional factors present in alfalfa are lignin and phytoestrogen in the form of coumestrol. The level of lignin in events J101 and J163 are comparable to the lignin levels in conventional alfalfa. Similarly, there were no significant difference in the levels of coumestrol in the forage of alfalfa J101 and J163 compared to that of control alfalfa.
Estimation of the overall risk
Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
A biosafety notification for alfalfa events 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 or for processing was issued to Monsanto Philippines, Inc. Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Need(s) for further information on specific issues of concern
Alfalfa Events J101 and J163 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the Alfalfa Events J101 and J163. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR may be used.
Additional Information
Additional Information
Alfalfa Events J101 and J163 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 and DA Regulatory Agencies during the evaluation of this event.
Other relevant website address or attached documents

Records referencing this document (1)
IDDescription
1record(s) found
Country's Decision or any other Communication1 record