Food Master Files & Food Additive Petitions

 Food Master File 000763 - Bt 10 Evaluation

  • Sponsor: Syngenta Seeds
  • Food: Corn
  • Designation: Bt 10
  • Trait: Resistance to European corn borer, tolerance to glufosinate-ammonium
  • Gene products: Cry1Ab and phosphinothrycin acetyltransferase (regulated by EPA)
  • Source of genetic material: Bacillus thuringiensis var kurstaki strain HD-1 and Streptomyces viridochromogenes strain Tu494
  • Memorandum to the file (August 29, 2006)
  • Letter (September 15, 2006) 

FMF 526 and Docket No. 91A-0330 - FLAVR SAVR™ Evaluation

  • Sponsor: Calgene
  • Food: Tomato
  • Designation: CR3-613, CR3-623, FLAVR SAVR™
  • Trait: Delayed softening due to reduced pectin degradation
  • Gene: Antisense polygalacturonase (PG) gene to suppress the endogenous PG enzyme
  • Memorandum to the file (May 17, 1994)
  • Letter (May 17, 1994) 

Food Additive Petition 3A4364 - Aminoglycoside 3'-phosphotransferase II

  • Sponsor: Calgene
  • For use as a food additive in cotton, oilseed rape (canola), and tomatoes
  • Trait: Catalyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamycin
  • Gene product: Aminoglycoside 3'-phosphotransferase II
  • Source of genetic material: kanr gene originally isolated from transposon Tn5 of the bacterium Escherichia coli
  • 21 CFR 173.170
  • Federal Register - May 23, 1994 

Contact FDA

Office of Food Additive Safety

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