Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 29 January 2016 | By Michael Mezher
The US Food and Drug Administration (FDA) has issued an alert banning the import of genetically engineered (GE) salmon, months after approving the first such animal as safe to eat.
The import alert helps the agency comply with the FY 2016 omnibus spending bill President Obama signed into law in December. The law ordered FDA to block imports of GE salmon until the agency issues final guidance requiring food derived from GE salmon to be labeled as such.
The law also requires FDA to allocate at least $150,000 of its funding towards developing and implementing guidance to "disclose to consumers whether salmon [is] genetically engineered."
In November, FDA approved AquaBounty Technologies' AquAdvantage salmon after two decades of deliberation. The genetically engineered salmon is modified to grow faster than non-GE Atlantic salmon and come to market in 18 months rather than the typical three years.
"After rigorous scrutiny, FDA determined that food from AquAdvantage salmon is as safe and nutritious to eat as food from non-GE Atlantic salmon," said Dr. Bernadette Dunham, director of the Center for Veterinary Medicine at FDA. As part of the approval, AquaBounty is only authorized to produce the salmon at two facilities, a breeding facility in Canada and a growing facility in Panama.
The agency also conducted an environmental assessment to ensure there would be no significant environmental consequences of approving AquAdvantage salmon.
Alongside the approval, FDA also released a draft guidance that would make labeling foods derived from genetically modified salmon a voluntary matter for companies. This follows the agency's longstanding policy for labeling foods derived from genetically engineered plants.
However, the approval and guidance were highly controversial, drawing criticism from several politicians and anti-GMO advocates. Among them, Sen. Lisa Murkowski (R-AK), placed a hold on confirmation proceedings to nominate Robert Califf to be the next FDA Commissioner unless FDA reversed its stance on labeling the products as such.
Murkowski called the import alert "a huge step" in the fight against "Frankenfish," a term coined by opponents of GE salmon.
AquaBounty CEO Ronald Stotish said the alert will not affect the company's operations, as they are not yet importing the salmon into the US, noting that "FDA is working to complete the guidelines" as mandated by the spending package.
Under the import alert, all shipments suspected to contain GE salmon are to be held and forwarded to the local FDA District Compliance Branch.
FDA previously issued the same import alert for all Aquaculture seafood products that use unapproved new animal drugs from various companies in China, India, Indonesia, Malaysia, Mexico, Taiwan and Vietnam.
Import Alert 99-40
Import Alert 16-124
Tags: AqaAdvantage salmon, Genetically engineered salmon, GE salmon, AquaBounty
Regulatory Focus newsletters
All the biggest regulatory news and happenings.