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Country's Decision or any other Communication
Record information and status
Record ID
Date of creation
2009-05-13 10:53 UTC (US-BCH)
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
5100 Paint Branch Parkway
College Park, MD
USA, 20740
Title / Reference number of the decision or communication
Biotechnology Consultation Agency Response Letter BNF No. 000080
Date of the decision
Is the decision taken prior to entry into force of the Protocol?
  • United States of America
Is this an amendment to a previous decision / communication?
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?
Importer’s or Applicant’s contact details
Monsanto Company
Result of the decision
  • Approval of the import and/or 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