U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Development & Approval Process
  4. Biotechnology Products at CVM: Animals and Animal Food
  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, that are used 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 Prior to this release, FDA published the FDA’s Response to Public Comments on Draft Guidance for Industry #187; this response was released on September 19, 2008.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. 

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 Assessment Summaries for Low Risk IGAs in Animals


Enforcement Discretion

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

Related Information

If you have questions about a process or product, please email [email protected]

If you would like to provide feedback regarding CVM’s regulation of biotechnology products, please email [email protected]


Back to Top