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Risk Assessment generated by a regulatory process
(RA)
published: 01 Apr 2008
last updated: 25 Mar 2025
Determination for the Safety Assessment of Combined Trait Product Cotton MON 88913 ×MON 15985 for Direct Use as Food, Feed and for Processing
EN
20 Apr 2011
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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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MON-88913-8 × MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
The modes and sites of biological activity are significantly different for CP4 EPSPS and Cry1 proteins and there is no known or conceivable mechanism of interaction between these proteins leading to adverse health effects in animals or man. The two proteins accumulate in different subcellular compartments of the plant parts. There is no evidence to indicate that are any potential interactions between CP4 EPSPS and the Cry proteins.
Refined cottonseed oil and cellulose from processed linters are the two components of cotton used in human foods. Refined oil is generally accepted as being devoid of protein.
EN
Refined cottonseed oil and cellulose from processed linters are the two components of cotton used in human foods. Refined oil is generally accepted as being devoid of protein.
There is no possible unexpected effect of the combined genes on the metabolism of the cotton plant.
EN
Combined trait product cotton: MON 88913× MON 15985 applied for direct use shows no evidence of interaction of the resulting gene product and is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
A biosafety notification for combined trait product cotton MON 88913 × MON 15985 and all progenies derived from crosses of the product with any conventionally-bred cotton and cotton containing approved-biotech events for direct use as food, feed and for processing was issued to Monsanto, Philippines, Inc. Cotton MON 88913 × MON 15985 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Cotton MON 88913 × MON 15985 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of the combined trait product cotton MON 88913 × MON 15985. This LMO will be directly used for food, feed and for processing.
EN
For individual events, MON 88913 and MON 15985, in the combined trait product MON 88913× MON 15985, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
EN
Yes
Yes
Yes
Yes
Yes
Combined trait product cotton. MON 88913× MON 15985 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 during the evaluation of this combined trait product.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
- OECD Consensus Document on Cotton [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
