Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs. Final Guidance

摘要

Since its first demonstration as proof of principle by Cohen and Boyer in 1973, recombinant DNA (rDNA) technology has been applied to microorganisms, plants, and animals. Various agencies across the US government (USG) have provided guidance and regulations to affected stakeholders describing the regulation of these recombinant DNA (rDNA), or genetically engineered (GE), plants and microorganisms and of products produced by them. GE animals have been produced since the early 1980s when Brinster et al. (1982) and Palmiter et al. (1982) reported on the development of GE mice. Not long thereafter, Hammer et al. (1985) demonstrated that rabbits and pigs could also be genetically engineered. Now, more than two decades later, many different species, including those traditionally consumed as food, have been genetically engineered with various rDNA constructs. For the purpose of this guidance, FDA defines genetically engineered (GE) animals as those animals modified by rDNA techniques, including the entire lineage of animals that contain the modification. The term GE animal can refer to both animals with heritable rDNA constructs and animals with non-heritable rDNA constructs (e.g., those modifications intended to be used as gene therapy). Although much of this guidance will be relevant to non-heritable rDNA constructs, and FDA intends to regulate non-heritable constructs in much the same way as described in this guidance for heritable constructs, this guidance only pertains to GE animals containing heritable rDNA constructs. We may issue a separate guidance on the regulation of GE animals bearing non-heritable constructs to discuss when those constructs would be under FDA jurisdiction and the kinds of information that would be relevant for FDAs review. In this guidance, we will use the term GE animal to refer to GE animals with heritable rDNA constructs.