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  6. Intentional Genomic Alterations in Animals: Enforcement Discretion
  1. Animals with Intentional Genomic Alterations

Intentional Genomic Alterations in Animals: Enforcement Discretion

FDA’s Center for Veterinary Medicine’s (CVM) oversight of Intentional Genomic Alterations (IGAs) in animals includes an evaluation of safety and effectiveness, with a particular focus on safety, and is based on risk. What this means in practice is that, while sponsors are generally required to have an approved application for IGAs in animals prior to marketing, as described below, for those alterations that are low risk, the Agency may not expect sponsors to seek approval of these IGAs.

For IGAs in animals that are in non-food producing species and that are either under other government oversight or are raised in contained and controlled laboratory conditions for research (e.g. mice), CVM has said that it will exercise enforcement discretion without a prior review of data. For other IGAs in animals, CVM has said that it may exercise enforcement discretion on a case-by-case basis if, after a review of appropriate risk factors, it determines that the product or category of products is low risk.

Below is a list of those IGAs in animals that, following a review of risk factors, FDA has determined are low-risk and for which we do not intend to take action. This is not a determination of “safety” under the Federal Food, Drug, and Cosmetic Act but is instead a determination that, based on risk, FDA does not believe it would be a good use of its limited resources to take action against sponsors for the marketing and distribution of these unapproved products. If FDA becomes aware of new information about risk, it may revisit these decisions.

IGAs in aquarium fish, intended to cause the fish to fluoresce

GloFish Red Danio RZF2005 RDNA construct in Danio rerio
GloFish Purple Danio PZF2010 RDNA construct in Danio rerio
GloFish Blue Danio BZF2010 RDNA construct in Danio rerio
GloFish Orange Danio YZF2010 RDNA construct in Danio rerio
GloFish Green Danio GD2006 RDNA construct in Danio rerio

GloFish Orange Tetra YT2012 RDNA construct in Gymnocorymbus ternetzi
GloFish Green Tetra GT2011 RDNA construct in Gymnocorymbus ternetzi
GloFish Pink Tetra RT2012A RDNA construct in Gymnocorymbus ternetzi
GloFish Red Tetra RT2013 RDNA construct in Gymnocorymbus ternetzi
GloFish Purple Tetra PT2013 RDNA construct in Gymnocorymbus ternetzi
GloFish Blue Tetra BT2014 RDNA construct in Gymnocorymbus ternetzi

GloFish Green Barb GB2011 RDNA construct in Puntius tetrazona
GloFish Red Barb RB2015 RDNA construct in Puntius tetrazona

GloFish Orange Shark OS2016 RDNA construct in Epalzeorhynchos frenatus
GloFish Purple Shark PS2016 RDNA construct in Epalzeorhynchos frenatus
GloFish Blue Shark BS2017 RDNA construct in Epalzeorhynchos frenatus
GloFish Green Shark GS2017 RDNA construct in Epalzeorhynchos frenatus

GloFish Green Betta GBS2019 RDNA construct in Betta splendens

IGAs in animals of food-producing species intended for use as models of disease

Exemplar Genetics, ExeGen ATM miniswine ATM-NEO RDNA construct in Yucatan Miniature Swine
Exemplar Genetics, ExeGen LDLR miniswine LDLR-NEO RDNA construct in Yucatan Miniature Swine
Exemplar Genetics, ExeGen SCN5A miniswine SCN5A-NEO RDNA construct in Yucatan Miniature Swine

Recombinetics, OssaPig-FH-PCSK9 Miniature Swine PCSK9-D374Y RDNA construct in Ossabaw Miniature Swine
Recombinetics, OssaPig-NF-NF1(FS41) Miniature Swine (Sus scrofa (g.(NC_010454.4)43530892C>T + 43530890_43530889insAGCTT in Ossabaw Miniature Swine)