The FDA has announced the availability of a draft amended Environmental Assessment (EA) for an approved application concerning Atlantic salmon with an intentionally altered genome, and a subsequent virtual public meeting, entitled “Public Meeting on Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada,” to obtain public input on the draft amended EA.  

The FDA will hold this virtual public meeting from 1:00-5:00 pm ET on December 15, 2022. The virtual public meeting will focus on the draft amended EA only and will not include discussion about AquAdvantage Salmon generally or the approved application. Registration for the virtual public meeting closes at 11:59 p.m. Eastern Time on December 9, 2022. Requests for oral presentations must be made by November 28, 2022.  

The FDA is seeking public comment on the draft amended EA and is accepting public comments through 11:59 p.m. Eastern Time on January 17, 2023. Public comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to:

Dockets Management Staff (HFA-305)

Food and Drug Administration’

5630 Fishers Lane, Rm 1061

Rockville, MD 20952.

All comment submissions received must reference Docket No. FDA-2022-N-2672 for “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.”   

For more information, please see FDA’s CVM Update and public meeting webpage.