RASTECH Magazine

FDA to amend environmental assessment on AquaBounty

November 17, 2022  By  Nestor Arellano

The United States Food and Drug Administration (FDA) will be holding a virtual public meeting on its draft amendment of its 2015 environmental assessment (EA) AquaBounty’s production of genetically engineered salmon in several recirculating aquaculture facilities in the U.S. and Canada.

The FDA is seeking public comment on the “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada” until  Jan.  17, 2023. It will also hold hold a virtual public meeting from 1-5 p.m. Eastern Standard Time on Dec. 15, 2022.

“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 and their broodstock (collectively referred to in the amended EA as AquaBounty Technology (ABT) Salmon) were to escape confinement, migrate from Canada to the U.S., and be present in the U.S. aquatic environment,” a press release from the FDA said. “The draft amended EA evaluates the potential risk to the U.S. environment from production of AAS eggs at all currently operating facilities on Prince Edward Island, Canada, including the Bay Fortune and Rollo Bay facilities. It also takes into account potential future expansion at the Rollo Bay facility.”

The FDA has not reversed its initial approval of AquaBounty’s GE product branded as AquAdvantage Salmon. However,  the news that the food and drug watchdog has made amendments to its initial EA comes at a time when the Mass-based aquaculture company has been the target of allegations from a former employee of violations of safety protocols at its facility.

Last month, a former AquaBounty employee named Braydon Humphrey shared photos and videos of the alleged unsafe activities at AquaBounty to Block Corporate Salmon, a site run by a network of campus and community-based organizations campaigning for food sovereignty. AquaBounty’s chief executive officer, Sylvia Wulf, dismissed the allegations as inaccurate and maintained that its facilities are regulated by the FDA.

“AquaBounty raises fresh Atlantic salmon in a safe, secure, and sustainable way. 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 Nov. 16, the FDA once again concluded there is a ‘negligible likelihood’ that our product would ’cause significant harms’ or even ANY ‘effects on the environment of the US,’ ” said Wulf in a statement released Nov. 17.

“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.”

In 2015, the FDA made a “no effect” determination from AquAdvantage Salmon. The salmon contains an intentional genomic alteration (IGA). Growth hormone regulating gene from a Chinook salmon and a promoter from an ocean pout was added to the Atlantic salmon’s genes. This enables the AquAdvantage salmon to grow faster than regular salmon.

The FDA evaluated whether approval of the application will have significant impacts on the quality of the human environment in the United States. The EA covered conditions, including the production of AquAdvantage  at the facility in Prince Edward Island, Canada. At that time, the FDA issued a  Environmental Assessment and Finding of No Significant Impact (FONSI).

The FDA also made a  “no effect” determination under the Endangered Species Act (ESA). It concluded that AquAdvantage, when produced under the conditions described in the AquaBounty application, will not jeopardize threatened or endangered Atlantic salmon in the U.S.

In 2020, however, United States federal judge has questioned the FDA’s 2015 decision. U.S. District Judge Vincent Chhabria expressed concerns that the FDA may have moved too quickly in approving the  Massachusetts-based  biotech company’s application.

That same year, the U.S. District Court, Northern District of California, ordered FDA to conduct additional analysis. The court asked the federal body to reconsider its “no effect” determination under the ESA together with a revised National Environmental Policy Act evaluation.

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