| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Country's Decision or any other Communication
Record information and status
Record ID
6567
Status
Published
Date of creation
2004-10-08 10:02 UTC (US-BCH)
Date of last update
2018-12-13 21:26 UTC (SchmidtWD1@state.gov)
Date of publication
2018-12-13 21:26 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. 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
Title / Reference number of the decision or communication
Agency Response Letter Re: FMF 526 and Docket No. 91A-0330
Date of the decision
1994-05-17
Is the decision taken prior to entry into force of the Protocol?
Yes
Jurisdiction
  • United States of America
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
Calgene Inc.
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
CGN-89564-2 - FLAVR SAVR™ tomato
Changes in physiology and/or production - Ripening Resistance to antibiotics - Kanamycin Selectable marker genes and reporter genes
Risk assessment
Agency Response Letter Re: FMF 526 and Docket No. 91A-0330
CGN-89564-2 - FLAVR SAVR™ tomato
Changes in physiology and/or production - Ripening
Resistance to antibiotics - Kanamycin
Selectable marker genes and reporter genes
Decision document