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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 23 Mar 2016
Determination of the Safety of Monsanto's New Leaf ®Y Potato (Potato Virus Y and Colorado Potato Beetle resistant-potato) for Direct Use as Food, Feed and for Processing
EN
05 Dec 2003
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,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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NMK-8993Ø-4 - Shepody NewLeaf™ Y potato| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato virus Y (PVY))
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NMK-89653-6 - New Leaf™ Y Russet Burbank potato| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato virus Y (PVY))
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NMK-89935-9 - Shepody NewLeaf™ Y potato| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato virus Y (PVY))
- DA-Biotech Website [ English ]
EN
The Cry3A and NPTII proteins have been thoroughly tested for potential mammalian toxicity and shown to be non-toxic to humans and non-target organisms and non-allergenic to people through history of safe use as well as through numerous safety studies. Both Cry3A and NPTII proteins are rapidly digested in gastric fluids and do not contain amino acid sequences matching those of known allergens or toxins. PVYcp is assumed not to be an allergen since it is commonly consumed in the food supply with no documented ill effects. In conventional potatoes, PVY replicates in potato plant tissues; therefore humans and animals have routinely consumed PV virions and PVY capsid proteins in potatoes without deleterious health effects. There is a long history of using spores of Bacillus thuringiensis, which contain insecticidal proteins, in commercial agriculture globally; these products have been demonstrated safe for humans and the environment. NPTII protein is produced by microorganisms normally present in mammalian intestines.
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Lectins are (glyco)proteins which occur in virtually all living organisms and have the common property of binding to specific carbohydrate structures on cell surfaces, e.g. on intestinal or blood cells. Some lectins found in beans are known to cause serious health effects when ingested by humans and animals. As lectins are inactivated during heating, only consumption and feeding of raw or inadequately cooked potatoes may cause adverse effects. Negative effects of lectins on animal’s health and their performance are not yet known in detail.
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New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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A biosafety permit for New Leaf ®Y Potato and all progenies derived from crosses of the product with any conventionally-bred potato and potato containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15. This LMO will be directly used for food, feed and for processing.
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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.
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New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15 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.
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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.
- CERA [ English ]
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