The biotechnological company seeking to obtain Food and Drug Administration approval to sell genetically modified salmon in the US was notified Wednesday that its application has progressed to the next, and near-final, stage in the approval process.
The FDA’s Centre for Veterinary Medicine informed AquaBounty Technologies of its intention to discuss and make a recommendation regarding the approval of the GM salmon at a meeting of the Veterinary Medicine Advisory Committee (VMAC) to be held at Rockville, Maryland, on 19-20 September 2010.
Furthermore, the FDA will hold a public hearing on September 21 on the application of its food labelling requirements and how they might apply to the company’s genetically modified Atlantic salmon called AquAdvantage Salmon.
It has been a long process for AquaBounty Technologies. The company claims that the research conducted in the United States and Canada to produce the genetically modified salmon has taken nearly 20 years. AquaBounty sent in an original application to the FDA to have the GM fish approved for human consumption in 1995; however, it was not until 2009 that the company had completed all the information and submissions requested by the FDA.
According to AquaBounty’s press release, the company’s president and CEO Dr. Ronald Stotish commented: “This is welcome and exciting news for the Company as we near the end of the detailed and necessary process to receive regulatory approval for our AquAdvantage Salmon. The meeting will provide an opportunity for the public to understand how the application of our technology will enable the safe and sustainable production of high quality fish. We believe the economic and environmental benefits of our salmon will very effectively help to meet the demand for food from the growing world population.”
The transgenic construct of AquAdvantage Salmon is known as opAFPGHc and consist of chinook salmon (Oncorhynchus tshawytscha) growth hormone fused to ocean pout (Zoarces americanus) antifreeze protein gene promoter. The inserted “hybrid gene” allows the modified Atlantic salmon to grow to market size in about half the time and makes it more disease resistant and cold tolerant. According to the company, the aquaculture production of the AquAdvantage GM salmon should not result in environmental risk to wild Atlantic salmon or other salmonid species since the genetically modified fish are to be reared in secure enclosures and they are all-female, sterile fish.
Photo courtesy of AquaBounty
Size comparison of an AquAdvantage® Salmon (background) vs. a non-transgenic Atlantic salmon sibling (foreground) of the same age.
Currently, there are several genetically modified plants sold on the US and global markets; however there are no GM animal food products available. If authorized, this fish would be the first transgenic animal approved by the FDA for human consumption. The first transgenic non-food fish in the market was the ornamental fluorescent zebra fish (Danio rerio) also known as Glofish.