Intentional Genomic Alterations (IGAs) in Animals
IGAs in animals are changes to an animal's genomic DNA produced using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions. The IGA can be introduced into the animal’s genome using recombinant DNA, genome editing, or other technologies. IGAs in animals have many different intended uses, including applications in human health (e.g., reduced allergenicity; “biopharm” animals that produce substances [generally in their milk or eggs] for use in the production of human therapeutics; animals used to model human disease), in improved animal health, well-being, and husbandry practices (e.g., disease resistance, heat tolerance), and in enhanced production and food quality (e.g., faster growth, feed efficiency, nutritional benefits).
Guidance for Industry (GFI) #187
In January 2017, FDA CVM released draft revised GFI #187 “Regulation of Intentionally Altered Genomic DNA in Animals” for public comment. This draft revised guidance expands the scope of the existing GFI #187 to address animals with intentionally altered genomic DNA developed through use of genome editing technologies, as well as techniques such as recombinant DNA constructs. FDA CVM plans to finalize this document in the future based on feedback from stakeholders.
In January 2009, FDA CVM released final GFI #187, “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs”. Prior to this release, FDA published the FDA’s Response to Public Comments on Draft Guidance for Industry #187; this response was released on September 19, 2008.
Information for Developers and Consumers
CVM is committed to engaging with industry, academia, animal owners/producers, and other stakeholders to increase the transparency of our regulatory process. You can find additional information on the regulation of IGAs in animals below.
- CVM’s FDA-TRACK goals for emerging technologies
- Questions and Answers (Q&A) on FDA regulation of IGAs in animals
- Q&A for Developers of Intentional Genomic Alterations in Animals
- Q&A on Intentional Genomic Alterations in Animals for Consumers
- The Unified Website for Biotechnology Regulation
- FDA CVM Animal Biotechnology Webinar for Developers
- CVM Public Webinar: Genome Editing in Animals
- Animal Biotechnology Products Resource Center
Information About Marketed Products
AquAdvantage® Salmon, opAFP-GHc2 rDNA Construct in the EO-1α Lineage of Atlantic Salmon
pPL657 rDNA Construct in Domestic Pigs
- FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses
- FOI Summary for NADA 141-542 (pPL657 rDNA Construct in Domestic Pigs)
- GalSafe® Pigs Environmental Assessment
- Finding of No Significant Impact for NADA 141-542 (pPL657 rDNA Construct in Domestic Pigs)
Bc2371 rDNA Construct in R69 New Zealand White Rabbits
- FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
- FOI Summary – NADA 141-511 Bc2371 rDNA construct in R69 New Zealand white rabbits
hLAL rDNA Construct in SBC LAL-C Chickens
- FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
- FOI Summary - NADA 141-453
Bc6 rDNA Construct in GTC 155-92 Goats
Low Risk Determination Summaries for Low Risk IGAs in Animals
- FDA Announces Animal Biotechnology Webinar on Low-Risk Intentional Genomic Alterations in Animals for Food Use
CVM provides a list of those IGAs in animals that the agency determined are low risk following a review of product-specific information.
CVM Publications Related to IGAs in Animals
- “Genome editing in animals: why FDA regulation matters”
- “CRISPR, animals, and FDA oversight: Building a path to success”
- “Template plasmid integration in germline genome-edited cattle”
- “Clarifying US regulations on xenotransplantation”
If you have questions about a process or product, please email AskCVM@fda.hhs.gov.
If you would like to provide feedback regarding CVM’s regulation of biotechnology products, please email FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov.