You are currently viewing archive.bio.org. Head to our home page to check out our fresh new look!

BIO Applauds FDA Action on GE Salmon

<p>
Today, as part of its rigorous, scientific regulatory review governing genetically engineered (GE) animal technologies, the U.S. Food and Drug Administration (FDA) has released its draft Environmental Assessment of the genetically engineered (GE) AquAdvantage Salmon.</p>

WASHINGTON, D.C. (December 21, 2012) – Today, as part of its rigorous, scientific regulatory review governing genetically engineered (GE) animal technologies, the U.S. Food and Drug Administration (FDA) has released its draft Environmental Assessment of the genetically engineered (GE) AquAdvantage Salmon. 

The FDA is expected to formally publish the 140+ page notice in the December 26, 2012 Federal Register, and it will be subject to a 60 day comment period.  

In response to the AquAdvantage Salmon Draft Environmental Assessment and FDA’s Preliminary Finding of No Significant Impact of the AquAdvantage Salmon, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement: 

“Today’s FDA action, as a part of the broader Administration – though long overdue – is an indication to the animal biotechnology community that the review process is moving forward, and that the United States can be a leader for innovation in this growing, dynamic and important field of science. 

“The development of AquAdvantage salmon is based on more than two decades of scientific research, making it the most studied line of Atlantic salmon. This action is a significant milestone in the approval process for the first food application from a genetically engineered animal.  

 “Over the years, innovations in agricultural biotechnology have helped improve farmers’ lives, lessen agriculture’s impact on the environment and contributed to a more sustainable food supply for a growing world population. 

“The rigorous FDA approval process assures the safety and efficacy of genetically engineered animal products.  We look forward to the FDA’s final decision soon.” 

The AquAdvantage salmon is genetically engineered to reach its market weight in half the time of conventionally raised salmon thus contributing to more sustainable aquaculture systems.  It was developed by Massachusetts-based AquaBounty Technologies, a Biotechnology Industry Organization (BIO) member. 

For More Information:
The AquAdvantage Salmon Draft Environmental Assessmentand
FDA’s Preliminary Finding of No Significant Impact of the AquAdvantage Salmon

are posted online.