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Country's Decision or any other Communication
Record information and status
Record ID
114779
Status
Published
Date of creation
2019-05-30 03:51 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:51 UTC (estaciojulietafe@gmail.com)

General information
Country submitting the decision or communication
  • Philippines
Competent National Authority(ies) responsible for the decision or communication
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
Title / Reference number of the decision or communication
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 decision
2003-12-05
Is the decision taken prior to entry into force of the Protocol?
No
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Exporter’s contact details
Arnette Basey
Monsanto Company
800 N. Lindbergh Blvd.
St. Louis, MO
United States of America, 63167
Phone:001-314-2755700
Email:arnette.basey@monsanto.com
Importer’s or Applicant’s contact details
Dr. Gabriel Ortega Romero
Regulatory Affairs Manager
MONSANTO PHILIPPINES, INC.
7th Floor, Ayala Life-FGU Center Alabang Zapote Rd. Cor. Acacia Ave. Madrigal Business Center Alabang
Muntinlupa City, Metro Manila
Philippines, 1770
Phone:(632)809 4848
Fax:(632) 809 8071
Email:gabriel.ortega.romero@monsanto.com
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions

The permittee shall duly inform the public by way of publishing in any one (1) of the top three (3) leading newspapers in the country that import of this product is covered by conditions for approval as provided in
Department of Agriculture Memorandum Circular No.8, Series of 2003.
Reasons
A violation of this condition shall lead to revocation of this permit as provided in DA Administrative Order No. 8, Series of 2002.
LMO identification
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)
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)
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
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)
Additional Information
Additional Information
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel  (STRP) member during the evaluation of New Leaf ®Y Potato Events RBMT15-101, SEMT15-02 and SEMT15-15.

Suggested methods for safe handling, storage, transport and use: Methods and Protocol for safety handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines (NCBP).