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  1. Biotechnology Products at CVM: Animals and Animal Food

Intentional Genomic Alterations in Animals: Enforcement Discretion

Intentional Genomic Alterations in Animals: Enforcement Discretion

For certain Intentional Genomic Alterations (IGAs) in animals that FDA’s Center for Veterinary Medicine (CVM) has determined are low risk, the Agency may exercise enforcement discretion over approval requirements, i.e., the Agency does not enforce the requirement that they get an FDA approval before going to market.

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 and not enforce approval requirements 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 enforce approval requirements. 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 enforce approval requirements for these products. If FDA becomes aware of new information about risk, it may revisit this decision.

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

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

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)