FDA to put AquaBounty’s sustainable salmon through additional environmental assessment

The U.S. Food and Drug Administration (FDA) is putting AquaBounty’s AquAdvantage salmon through an additional environmental assessment (EA) following a lawsuit from multiple organizations that resulted in a court order calling for additional analysis, The Fish Site reports.

AquaBounty is a member of the Biotechnology Innovation Organization (BIO).

Although the FDA greenlit the genetically engineered salmon in 2015, a judge ruled in 2020 that the agency must do an additional examination of the salmon and the risk of it being a potential danger to wild salmon populations if it is accidentally released in the wild.

“The FDA did not, however, meaningfully analyze what might happen to normal salmon in the event the engineered salmon did survive and establish themselves in the wild,” wrote U.S. District Court of Northern California Judge Vince Chhabria. “Even if this scenario was unlikely, the FDA was still required to assess the consequences of it coming to pass.”

Although the court criticized the FDA, the approval is still in place, and the salmon can still be sold.

FDA prepares new draft amended environmental assessment (EA)

The FDA now brings back the spotlight to the AquAdvantage salmon by preparing a draft amended EA, titled “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.”

“In this draft amended EA, the FDA has expanded its assessment beyond that in the 2015 EA to include an exhaustive analysis of the likelihood and severity of harms that could occur in the highly unlikely event that AAS or their broodstock were to escape confinement, migrate from Canada to the U.S., and be present in the U.S. aquatic environment,” FDA writes.

The FDA is seeking public comment on the draft amended EA and is accepting public comments through 11:59 p.m. Eastern Time on January 17, 2023.

“The likelihood of our salmon escaping our land-based farms, surviving and establishing a population in the wild is ‘extremely low’. Those are FDA’s words in its first review issued in 2015, and in the amended environmental assessment released on 16 November,” AquaBounty’s CEO Sylvia Wulf said in a statement. Wulf is a member of BIO’s Agriculture & Environment Governing Board of the Board of Directors.

“We are continuing to review FDA’s amended environmental assessment and are confident this process will affirm the extremely low likelihood that our salmon could successfully establish a population in the wild. We look forward to having this matter quickly settled and, in the meantime, we will continue to focus on sharing our sustainable, nutritious salmon with our customers,” adds Wulf.

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