21 CFR 528.2010
§ 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 528.2010, § 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87679
- Permanent ID
ys:prov:87679@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.