March 15, 2017


 FDA addresses modern genome editing technologies in animals

Posted March 1, 2017

To address the use of modern genome editing technologies in animals, the Food and Drug Administration has drafted an update to existing guidance regarding genome editing in animals. The existing guidance focuses on recombinant DNA.

According to a Jan. 18 post in the FDA Voice blog, “When animals are produced using genome editing, FDA has determined that, unless otherwise excluded, the portion of an animal’s genome that has been intentionally altered, whether mediated by rDNA or modern genome editing technologies, is a drug because it is intended to alter the structure or function of the animal and, thus, subject to regulation under our provisions for new animal drugs.”

Individuals or groups should submit comments on the draft guidance by April 19 to ensure consideration before the FDA begins work on the final version of the guidance.

The agency is seeking input on two major categories of questions:

  • How should the FDA refer to these animals?
  • Is there any existing empirical evidence demonstrating that certain types of genome editing might pose minimal risk?
Details are available here.  

Related JAVMA content:

Editing Animals (March 15, 2016)