Code of Federal Regulations Title 21. Food and Drugs § 21.528.1092 opAFP–GHc2 recombinant deoxyribonucleic acid construct

(a) Specifications. A single copy of the α-form of the opAFP–GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the α-locus in the EO–1 α lineage of triploid, hemizygous, all-female Atlantic salmon (Salmo salar).

(b) Sponsor. See No. 086053 in § 510.600 of this chapter.

(c) Indications for use. Significantly more of these Atlantic salmon grow to at least 100 grams within 2,700 Celsius degree-days than their comparators.

(d) Limitations. These Atlantic salmon are produced as eyed-eggs and grown-out only in physically-contained, freshwater culture facilities specified in an FDA–approved application.