The firm - which has been stuck in regulatory limbo for years as the FDA mulls over its technology - deserved an answer, said the scientists, who said AquaBounty’s experience was likely to put off all but the most patient – and fabulously wealthy – investors in GE animals in future, and drive innovative firms to “countries where there is reasonable expectation for rational and predictable regulatory outcomes”.
Inexplicable regulatory bottleneck
The signatories to the letter - including Nobel Prize for Medicine winner Sir Richard J. Roberts, PhD and Dr. Calestous Juma, professor at Harvard University’s Kennedy School of Government - added: “The inexplicable regulatory bottleneck encountered by the AquAdvantage Salmon gives credence to those who publicly contend FDA regulation is based on politics and public opinion rather than science.
“We write to respectfully request FDA issue its final regulatory decision on the AquAdvantage Salmon, developed by AquaBounty Technologies Inc., an application which has been before the agency for 19 years this month.”
The sponsor company has met or exceeded all federal regulatory requirements
AquaBounty first submitted its investigational new animal drug application in 1995 and has still not had a ‘yes’ or a ‘no’ from the FDA, said the scientists.
Its AquAdvantage Atlantic salmon, which includes a gene from the faster-growing Pacific Chinook salmon enabling it to reach maturity twice as quickly as standard Atlantic salmon, will lower carbon emissions as it can be produced closer to market in the US and it consumes less food, claims the firm.
Yet opponents continue to argue that it could present “serious health risks” and “decimate wild salmon populations”, despite all scientific evidence to the contrary, argue the scientists.
“The sponsor company has met or exceeded all federal regulatory requirements and interagency reviews, including unprecedented FDA publication of and solicitation of public comment on the firm’s environmental assessment (EA), the latter action not required by federal law,” they add.
“In December, 2012, FDA released a finding of no significant impact (FONSI), the last step required before the agency may issue its final decision. After an extension of the original EA comment period, the agency has spent an unprecedented 16 months reviewing public comment.”
Regulatory roadblocks seriously damage the global credibility of the FDA
They added: “The obvious regulatory roadblocks AquaBounty is experiencing not only undermine our ability to meet the future food needs of the world, but seriously damage the global credibility of FDA and its objective, science-based approval process, while stifling innovation in this critical field.
“Biotechnology must be a tool available to the scientists working to increase animal protein production if we hope to meet the demand for more high quality protein in an environmentally responsible manner.”
Click HERE for some perspective from supporters and opponents of the technology.