21 CFR 573.130 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 590-599) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 590-599) — Animal Drugs, Feeds, And Related Products (Subpart A To Parts 590-599) — Food Additives Permitted In Feed And Drinking Water Of Animals (Subpart A To § 573.1020) — Food Additive Listing (§ 573.120 To § 573.1020) — Aminoglycoside 3′-phospho- transferase 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.