21 CFR 173.170 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 170.3 To Parts 191-199) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Parts 170 To 199) (§ 170.3 To Parts 191-199) — Food For Human Consumption (Continued) (§ 170.3 To Parts 191-199) — Secondary Direct Food Additives Permitted In Food For Human Consumption (§ 173.5 To § 173.405) — Enzyme Preparations And Microorganisms (§ 173.110 To § 173.170) — Aminoglycoside 3′-phosphotransferase II.

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 kan ^r 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 kan ^r gene along with the genetic material of interest.