FDA CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals

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Draft – Not for Implementation Guidance for Industry Regulation of Intentionally Altered Genomic DNA in Animals This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction and Background FDA is issuing this draft revised Guidance for Industry to clarify its approach to the regulation of intentionally altered genomic DNA in animals. This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or 1,2,3

other technologies that introduce specific changes to the genome of the animal. This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration. Recombinant DNA (rDNA) technology has been used for the past 40 years to intentionally alter traits in microorganisms, plants, and animals (Cohen and Boyer 1973). Various agencies across the US government (USG) have provided guidance and regulation to affected stakeholders 1

FDA used the term “genetically engineered” (GE) to describe the animals within the scope of current Guidance for Industry #187. The term “GE” does not suit the discussion in this revised draft guidance because this draft guidance’s scope includes animals whose genomes have been intentionally altered with new technologies. The term “transgenic” is also not used for the same reason, except for citation of earlier documents. 2

In Draft Guidance for Industry #236, “Regulation of Mosquito-Related Products,” FDA has proposed to clarify that the phrase “articles (other than food) intended to affect the structure or any function of the body of man or other animals” does not include articles intended to prevent, destroy, repel, or mitigate mosquitoes for population control purposes. Instead, such products are pesticides regulated by the Environmental Protection Agency (EPA) http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM53

(

3600.pdf). 3

The term “modern molecular technologies” does not include selective breeding or other assisted reproductive technologies, including random mutagenesis followed by phenotypic selection.

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