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General information
Country submitting the decision or communication
  • United States of America
Competent National Authority(ies) responsible for the decision or communication
U.S. Department of Agriculture
USDA, APHIS, BRS
4700 River Road, Unit 133
Riverdale, MD
USA, 20737-1236
Email:usbiotechregs@aphis.usda.gov
Url:www.aphis.usda.gov
U.S. Food and Drug Administration
DHHS/FDA/CFSAN
5100 Paint Branch Parkway
College Park, MD
USA, 20740
Email:biotechfood@fda.gov
U.S. Environmental Protection Agency
U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Code 7101
1200 Pennsylvania Ave, NW
Washington, DC
USA, 20460
Email:biotech.reg@epa.gov
Url:http://www.epa.gov/pesticides/biopesticides/,http://www.epa.gov/scipoly/oscpbiotech.htm,http://www.epa.gov/opptintr/biotech/
Title / Reference number of the decision or communication
Biotechnology Consultation Agency Response Letter BNF No. 000033
Date of the decision
1996-04-04
Is the decision taken prior to entry into force of the Protocol?
Yes
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
Yes
Importer’s or Applicant’s contact details
Monsanto Company
Result of the decision
  • Approval of the import/use of the LMO(s) without conditions
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
Yes
LMO identification
NMK-89576-1 - Superior NewLeaf™ potato
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Risk assessment
Biotechnology Consultation Note to the File BNF No. 000033
NMK-89761-6 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89367-8 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89613-2 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-8917Ø-9 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89279-1 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89576-1 - Superior NewLeaf™ potato
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89724-5 - Superior NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Decision document