GE salmon for human consumption is expected to be approved by FDA. (Photo: YouTube/linktv/FIS)
AquaBounty still confident its transgenic salmon will be approved
Monday, June 04, 2012, 23:40 (GMT + 9)
AquaBounty Technologies, Inc had a net loss of USD 2.7 million in 2011 compared to a net loss in 2010 of USD 5.3 million. Given its loss, AquaBounty implemented a reorganisation plan to reduce operating costs by 30 per cent, thereby providing sufficient funds until early 2013.
Regarding its transgenic AquAdvantage® Salmon (AAS), on 24 May 2012 the US Senate rejected an amendment demanding further study of the environmental and economic impact of AAS by the National Oceanic and Atmospheric Administration (NOAA), as a pre-requisite for the US Food and Drug Administration (FDA) granting approval. The amendment, which was filed by Senator Lisa Murkowski (R-Alaska) on 17 May 2012, received only 46 of the requisite 60 votes to be adopted.
The Company believes the rejection of this amendment proves the Senate’s support for the FDA and the understanding that Congress should not get in the way of the federal agency's scientific process of approving applications.
“2011 was a frustrating year of waiting for some indication of FDA progress on our application, while continuing our R&D work and preparation for the commercialization phase,” stated Ron Stotish, CEO of AquaBounty.
“We now await the publication of the FDA’s Environmental Assessment, which the FDA commissioner has indicated will be very soon. Following the publication of the Environmental Assessment, we expect to receive final approval of our New Animal Drug Application within the subsequent few months,” he said.
Although the process with AAS has taken considerably longer than expected, the company remains confident that the FDA will approve the genetically engineered (GE) fish for human consumption in the coming months.
The delay in receiving approval to produce and sell AAS eggs has had a strong impact on AquaBounty’s financial condition. The firm ended 2011 with USD 1.6 million of cash, and it has become necessary to raise additional funds as well as cut operating costs.
AquaBounty is up against many opponents when it comes to AAS. In February, three US consumer groups submitted a formal petition to the FDA asking it to classify and evaluate salmon and all of its components as a food additive.
The legal petition of Food & Water Watch, Consumers Union and the Centre for Food argues that the FDA's current review process that treats GE salmon only as a new animal drug is not enough to protect public health, and that the FDA must by law review the GE salmon under a more rigorous process for any new substance added to food. The groups are worried that because the GE salmon may contain increased levels of IGF-1 -- a hormone that helps accelerate the growth of the transgenic fish and is linked to cancer -- consuming it may endanger human health.
Senators Mark Begich (D-AK) and Murkowski last year introduced two amendments for the 2012 agriculture appropriations bill that would ban the GE salmon from entering interstate commerce and the bar FDA from spending federal resource on the salmon's approval, thereby essentially banning the fish.
- Consumer groups petition FDA to classify transgenic fish as food additive
- Struggle over GE salmon approval heats up again
By Natalia Real