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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 11 Mar 2016
Determination of the Safety of Monsanto's Canola MON 88302 for Direct use as Food, Feed, or Processing
EN
14 Apr 2015
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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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Person:Ms. Merle B. PalacpacChief, Post Entry Quarantine StationEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: merle.palacpac@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: merle.palacpac@gmail.com,Website: http://bpi.da.gov.ph,
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MON-883Ø2-9 - TruFlex Roundup Ready™ Canola| Monsanto | Resistance to herbicides (Glyphosate)
- DA-BPI Biotech Website [ English ]
EN
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.
EN
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.
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.
EN
Canola MON 88302 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
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.
EN
Canola MON 88302 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
This application is not for propagation of the Canola MON 88302. This LMO will be directly used for food, feed and for processing.
EN
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.
EN
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.
EN
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.
- OECD [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |