C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION › Subpart B—Enzyme Preparations and Microorganisms

21 C.F.R. § 173.170

Aminoglycoside 3′-phosphotransferase II

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The food additive aminoglycoside 3′-phosphotransferase II may be safely used in the development of genetically modified cotton, oilseed rape, and tomatoes in accordance with the following prescribed conditions:

(a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin.

(b) Aminoglycoside 3′-phosphotransferase II is encoded by the kanr gene originally isolated from transposon Tn5 of the bacterium Escherichia coli.

(c) The level of the additive does not exceed the amount reasonably required for selection of plant cells carrying the kanr gene along with the genetic material of interest.

[59 FR 26711, May 23, 1994]
Notes of Decisions
Cited in 1 case, 2000–2000 · leading case: All. for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000).
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All. for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000). “See 21 C.F.R. §§ 173.170 , 573.130 (recognizing as safe the food additive aminoglycoside 3'-phospotransferase II, the additive used to genetically modify the Flavr Savr tomato); AR at 37832-33; 37836; 39947-48.”
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