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  5. Intentional Genomic Alterations (IGAs) in Animals
  1. Biotechnology Products at CVM: Animals and Animal Food

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) #187A and #187B

In May 2024, FDA CVM released GFI #187A “Heritable intentional Genomic Alterations in Animals: Risk Based Approach” and draft GFI #187B “Heritable Intentional Genomic Alterations in Animals: The Approval Process.” GFI #187A describes FDA’s risk-based regulatory approach to the oversight of heritable IGAs in animals and draft GFI #187B describes how the approval process applies to heritable IGAs in animals. FDA CVM plans to finalize GFI #187B in the future based on feedback from stakeholders.

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. 

Information About Marketed Products


AquAdvantage® Salmon, opAFP-GHc2 rDNA Construct in the EO-1α Lineage of Atlantic Salmon

pPL657 rDNA Construct in Domestic Pigs

Bc2371 rDNA Construct in R69 New Zealand White Rabbits

hLAL rDNA Construct in SBC LAL-C Chickens

Bc6 rDNA Construct in GTC 155-92 Goats

    Risk-Reviewed IGAs

    CVM provides a list of those IGAs in animals for which the agency has reached a determination that it understands the product’s risks for the specified intended use and it has no safety concerns following a review of product-specific information.

    Risk Assessment Summaries for IGAs in Animals

    PRLR-SLICK cattle


    CVM Publications Related to IGAs in Animals

    Related Information

    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


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