Regulatory roadblocks to AquaBounty's GE salmon ‘seriously damage the global credibility of FDA and its objective, science-based approval process’, warn scientists

By Elaine Watson contact

- Last updated on GMT

Scientists to Obama: AquaBounty's experience gives 'credence to those who publicly contend FDA regulation is based on politics and public opinion rather than science'
Scientists to Obama: AquaBounty's experience gives 'credence to those who publicly contend FDA regulation is based on politics and public opinion rather than science'

Related tags: Salmon

90 scientists have written to President Obama urging him to press the FDA into making a decision, one way or another, on whether AquaBounty Technologies should be allowed to introduce the first genetically engineered (GE) animal to the human food supply.

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.

trader-joes-florida cropped
Trader Joe's is one of several food retailers to say it will not sell GE seafood, even if the FDA gives it the seal of approval

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.

Related news

Show more

Related products

Kikkoman

Asian Flavors Adapt to Fit New Applications

Kikkoman Sales USA, Inc. | 07-Aug-2018 | Technical / White Paper

For close to four centuries, Kikkoman has built its heritage on mastering the techniques—and applying the leading-edge technologies—that maximize flavor....

Plant-based alternatives to thrill your tastebuds

Plant-based alternatives to thrill your tastebuds

Tereos Starch & Sweeteners Europe | 25-May-2018 | Technical / White Paper

Tereos has launched a range of delicious, 100% plant-based solutions for the food industry. Sauté Végétal is the first example of this new range of high-protein...

Related suppliers

1 comment

The FDA has scientific credibility?

Posted by Jennifer Christiano,

The implication of the article is that the FDA has much scientific credibility to begin with. Who do the geniuses who penned/signed the letter think they're fooling? The public knows that FDA is about as committed to "objective science" as are the profit-hungry companies that the FDA effectively works for.

Report abuse

Follow us

Featured Events

View more

Products

View more

Webinars