For the purposes of this chapter, the following terms apply: (a) âGene synthesis equipmentâ means equipment needed to produce gene synthesis products that is not readily used for any other purpose. (b) âGene synthesis productâ is double-stranded DNA (dsDNA), double-stranded nucleic acids, RNA, or oligonucleotides, designed and created without an existing DNA template. (c) (1) âGene synthesis providerâ means an entity that does any of the following: (A) An entity that creates gene synthesis products for delivery to a customer. (B) A distributor of gene synthesis products, including, but not limited to, entities who manufacture gene synthesis products for use by other parties, both inside and outside of the entity. (C) A third-party entity that is not the end user of a gene synthesis product and does not make gene synthesis products, but otherwise fills, completes, modifies, or purifies gene synthesis products. (2) âGene synthesis providerâ does not include a research scientist making gene synthesis products for the research scientistâs own use or for use by another research scientist or an entity that manufactures gene synthesis products for the entityâs own use.
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