GroundRules
21 CFR 528.2010: Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.
Where this section sits in the code
- Title 21—Food and Drugs
- 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
(a) Specifications. A single copy of a human lysosomal acid lipase (hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus), derived from the lineage progenitor XLL 109.
(b) Sponsor. See No. 069334 in § 510.600 of this chapter.
(c) Conditions of use—(1) Intended use. The gene construct directs the expression of that encoding gene such that recombinant, human lysosomal acid lipase (rhLAL) protein intended for the treatment of human disease is present in SBC LAL-C chicken egg whites.
(2) Limitations. Food or feed from XLL 109 chickens is not permitted in the food or feed supply.
Collected 2026-08-27T02:24:47Z. Source file · JSON