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Risk Assessment
Record information and status
Record ID
109886
Status
Published
Date of creation
2016-03-23 02:12 UTC (estaciojulietafe@gmail.com)
Date of publication
2016-03-23 02:12 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
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
Date of the risk assessment
2003-12-05
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
NMK-8993Ø-4 - Shepody NewLeaf™ Y potato
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
NMK-89653-6 - New Leaf™ Y Russet Burbank potato
Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
NMK-89935-9 - Shepody NewLeaf™ Y potato
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
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 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.
Possible consequences:
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.
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
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.
Receiving environment(s) considered
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.
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
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.
Other relevant website address or attached documents

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