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Country's Decision or any other Communication
Record information and status
Record ID
48741
Status
Published
Date of creation
2009-05-13 10:53 UTC (US-BCH/329)
Date of last update
2018-12-17 20:03 UTC (SchmidtWD1@state.gov)
Date of publication
2018-12-17 20:03 UTC (SchmidtWD1@state.gov)

General information
Country submitting the decision or communication
  • United States of America
Competent National Authority(ies) responsible for the decision or communication
U.S. Food and Drug Administration
DHHS/FDA/CFSAN
5100 Paint Branch Parkway
College Park, MD
USA, 20740
Email:biotechfood@fda.gov
Title / Reference number of the decision or communication
Biotechnology Consultation Agency Response Letter BNF No. 000080
Date of the decision
2004-07-22
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • United States of America
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
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
Monsanto Company
Result of the decision
  • Approval of the import/use of the LMO(s) without conditions
LMO identification
MON-718ØØ-4 - Roundup Ready™ wheat
Resistance to herbicides - Glyphosate
Risk assessment
Biotechnology Consultation Note to the File BNF No. 000080
MON-718ØØ-4 - Roundup Ready™ wheat
Resistance to herbicides - Glyphosate
Decision document