The famous faster-growing transgenic salmon AquAdvantage, produced by the biotechnology company AquaBounty Technologies (Maynard, MA, USA), might see eventually its path cleared to the US market in year 2013, 24 years after it was originally generated (in 1989) and 18 years after the company initiated its application for commercialization (in 1995). This long-awaited green light will come after many debates, studies and investigations, and after having been declared by the US Food and Drug Administration (FDA) a safe food product, “as safe as food from conventional Atlantic salmon” (on 20 September 2010), and with no significant impact to the environment (on 4 May 2012). The last FDA report on environmental safety of the AquAdvantage salmon, prepared more than seven months ago, was eventually made public last week (on 21 December 2012), after an article published in Slate.com suggested political interference of the AquAdvantage’s FDA approval process . Subsequently, several newspapers reported on this FDA’s new report (e.g., Los Angeles Times, Washington Post, The Independent) which appears to be, probably, one of the last steps (still pending the mandatory 60 day period for public comments) before the eventual approval for commercialization of this transgenic fish, after being passed the FDA’s Food Safety and Environmental Safety assessments. If this finally becomes a reality, the AquAdvantage salmon would be the first genetically-modified animal authorised as food for human consumption. These are not only good news for the producing company itself but for the Animal Biotechnology field as a whole.
The AquAdvantage salmon, is a genetically-modified Atlantic salmon (Salmo salar) [termed transgenic line EO-1alpha] carrying an “all-fish” transgene (opAFP-GHc2) which contains the coding sequence of the growth hormone gene from the Pacific Chinook salmon (Oncorhynchus tshawytscha) under the control of 5’ UTR, promoter and 3’ UTR sequences of the type III anti-freeze protein OP5a gene from the ocean pout (Macrozoarces americanus). The transgenic EO-1alpha line grows considerably more rapidly than non-transgenic Atlantic salmon. This genetic modification provides AquAdvantage salmon with the potential to reach market size (4-6 kg) in about half the time required by conventional Atlantic salmon (3 years) cultured commercially in sea cages. This genetically-modified salmon has been described and characterized in several scientific publications (e.g., Du et al. 1992; Yaskowiak et al. 2006; Hobbs and Fletcher 2008; Levesque et al. 2008).
As described in the FDA’s last report, the AquAdvantage salmon would be produced as triploid (and therefore sterile), all-female (and therefore monosex) populations with eyed-eggs as the product for commercial sale and distribution. These eggs would be generated in the AquaBounty Technologies facility on Prince Edward Island (Canada) and thereafter shipped to a grow-out land-based facility in Panama, where they would be reared to market size and harvested for processing (e.g., preparation of fish fillets, steaks, etc.) prior to retail sale in the US. AquAdvantage salmon would not be produced or grown in the US, or in net pens or cages, and no live fish would be imported for processing.
To date, only one single product originated in transgenic animals (ATryn) has been approved by the FDA (in February 2009). ATryn is a recombinant human antithrombin produced by GTC Biotherapeutics in the milk of transgenic goats, indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. The use of ATryn had been first approved by the EMEA (European Medicines Agency) in July 2006 under exceptional circumstances for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. In Europe, a second product produced in transgenic animals (Ruconest) has been already authorised by the EMEA (in October 2010). Ruconest is a recombinant form of human C1 esterase inhibitor, produced by Pharming Group N.V. in the milk of transgenic rabbits and indicated for the treatment of patients with hereditary angioedema caused by mutations in the gene encoding the C1 esterase inhibitor.
