Late last week, a group of nearly 90 independent scientists and biotechnology executives from around the world wrote a letter to United States President Barack Obama urging his administration to expedite the final regulatory decision on AquaBounty Techologies’ controversial genetically modified (GM) farmed Atlantic salmon.
Issued by Steve Kopperud, executive VP for Policy Directions Inc. in Washington, D.C., on behalf of the signatories, the letter to President Obama requested a resolution to the lengthy U.S. Food and Drug Administration (FDA) approval process for AquAdvantage Salmon®.
“September 19 will mark four years since the FDA Center for Veterinary Medicine’s (CVM) Veterinary Medicine Advisory Committee (VMAC) met in Washington, D.C., to review the AquaBounty Technologies application and the underlying scientific submission,” the letter states. “The VMAC formally concluded the scientific data showed the AquaAdvantage Salmon® grew faster than conventional Atlantic salmon, was nutritionally equivalent to conventional Atlantic salmon and the genetic construct did not harm the salmon, among other positive findings.”
The letter, also signed by 1993 Nobel Prize winner Sir Richard J. Roberts, Ph.D., chief scientific officer at New England Biolabs, goes on to say that AquaBounty has met or exceeded all federal regulatory requirements and interagency reviews. The 16 months of public-comment review is “unprecedented,” the letter states.
The regulatory-approval process that AquaBounty has undergone stretches back to 1995, when the company’s founder and CEO, Elliot Entiss, had his “first interaction” with FDA officials; current CEO Ron Stotish took over in 2008. Intrexon Corp. of Blacksburg, Va., USA, owns the majority of AquaBounty shares after establishing an “exclusive channel collaboration” with AquaBounty last year.
