21 CFR § 528.1092 - opAFP-GHc2 recombinant deoxyribonucleic acid construct.

---
identifier: "/us/cfr/t21/s528.1092"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 528.1092 - opAFP-GHc2 recombinant deoxyribonucleic acid construct."
title_number: 21
title_name: "Food and Drugs"
section_number: "528.1092"
section_name: "opAFP-GHc2 recombinant deoxyribonucleic acid construct."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "528"
part_name: "INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "74 FR 6823, Feb. 11, 2009, unless otherwise noted."
cfr_part: "528"
---


# 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.

[80 FR 73104, Nov. 24, 2015]