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Risk Assessment
Record information and status
Record ID
109792
Status
Published
Date of creation
2016-03-11 09:37 UTC (ralphklapps@gmail.com)
Date of publication
2016-03-14 02:19 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of Monsanto's Canola MON 88302 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2015-04-14
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-883Ø2-9 - TruFlex Roundup Ready™ Canola
Resistance to herbicides - Glyphosate
Show detection method(s)
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 CP4 EPSPS protein in MON 88302 has also been assessed for its potential allergenicity according to safety assessment guidelines and has demonstrated not to be allergenic. The CP4 EPSPS protein showed lack of structural similarity to known toxins, allergens or biologically active or anti-nutritional proteins known to have adverse effects on mammals. Digestibility studies in SGF and SIF show that CP4 EPSPS is rapidly digestible indicating that it is highly unlikely that these proteins will pose any safety concern to human and animal health.

Finally acute toxicity studies with adult mice found no adverse effects when CP4 EPSPS protein was administered at dose far exceeding those that would be experienced consuming grain produced by MON 88302.

Based on the weight of evidence, it is concluded that the CP4 EPSPS protein expressed in MON 88302 is safe and poses no concerns for humans, animals and the environment.
Possible consequences:
Oilseed rape contains anti-nutrient components, phytic acid, sinapine and tannins. Phytic acid chelates mineral nutrients, including calcium, magnesium, potassium, iron, and zinc, rendering them biologically unavailable to mono-gastric animals consuming the seed. Sinapine imparts a bitter taste and reduces palatability of the seed for some animal species. Tannins are a third anti-nutrient found in canola seed for some animal species.  Although tannins have been shown to have anti-oxidant properties, they also chelate metals such as iron and zinc reducing the absorption of these nutrients. In the combined-site analysis, no significant difference (= 0.05) was observed between MON 88302 and the conventional control for indolylglucosinolates, total glucosinolates, phytic acid, sinapine and tannins. The statistical analyses found a combined-site significant difference in alkyl glucosinolates that was lower than the conventional mean value. The mean alkyl glucosinolates value for MON 88302 was within the natural variability of commercial canola defined by the 99% tolerance interval established from the concurrently grown commercial reference varieties with a history of safe consumption, and the value was within the safety threshold for canola. Total glucosinolate levels in seed from MON 88302 was  within the standard for canola. Thus, an evaluation of anti-nutrient components in seed supports the conclusion that MON 88302 is as safe as and compositionally equivalent to conventional canola.
Estimation of the overall risk
Canola MON 88302 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
A biosafety permit for herbicide tolerant canola MON 88302 and all progenies derived from crosses of the product with any conventionally bred canola and canola containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. Canola MON 88302 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
Canola MON 88302 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 Canola MON 88302. 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
Canola MON 88302 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

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