C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 528—INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS

21 C.F.R. § 528.1092

opAFP-GHc2 recombinant deoxyribonucleic acid construct

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(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]
Notes of Decisions
Cited in 1 case, 2019–2019 · leading case: Inst. for Fisheries Resources v. Hahn (N.D. Cal. 2019).
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Inst. for Fisheries Resources v. Hahn (N.D. Cal. 2019). “” 21 C.F.R. § 528.1092 (a). The regulation memorializing the FDA’s approval limits the production of these fish to “physically-contained, freshwater culture facilities specified in an FDA-approved application.”
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