While this wasn’t exactly a redo, a federal court ordered the Food and Drug Administration to conduct additional analysis and reconsider its 2015 “no effect” decision on AquaBounty salmon.
The FDA announced this week that it has completed its work and that a draft revised Environmental Assessment (EA) for approval of the AquaBounty application, Atlantic salmon with intentionally altered genomes, is now available. .
The agency also announced a virtual public meeting to obtain public comment on the revised draft EA.
The FDA is the first to approve AquAdvantage Salmon (AAS), an Atlantic salmon containing intentional genomic alterations (IGAs). This allows AAS to grow more rapidly than conventional farmed Atlantic salmon without IGA. November 19, 2015.
As part of its evaluation of the application, and in accordance with the requirements of the National Environmental Policy Act (NEPA), FDA evaluated whether approval of the application would have a material impact on the quality of the human environment in the United States.
EA focused on approved conditions, including AAS egg production at the Bay Fortune facility in Prince Edward Island, Canada, and growth at the now-closed Panama facility. The FDA issued an Environmental Assessment and No Significant Impact Certification (FONSI) upon approval.
Based on the findings of the 2015 EA, FDA also made a “no effect” determination under the Endangered Species Act (ESA) and AAS listed in the 2015 EA under the terms of the petition. endanger the continued existence of threatened or endangered U.S. populations of Atlantic salmon, or destroy their critical habitat or It will not cause any adverse changes.
Several organizations have since filed lawsuits in the U.S. District Court for the Northern District of California, challenging the FDA’s evaluation under NEPA and ESA for 2015 approval. On December 19, 2019, a court ruled that the FDA has legal authority under the Food, Drug, and Cosmetic Act to approve and regulate genomic modifications of AAS. On November 15, 2020, the court ordered FDA to conduct additional analysis and reconsider the ESA’s “no effect” determination along with his revised NEPA assessment. The court did not revoke the approval, it remains valid.
In response to the Court’s opinion, FDA has prepared a revised draft EA, entitled “Proposed Amendments to the Environmental Assessment for AquaAdvantage Salmon Production at the Bay Fortune and Loro Bay Facilities, Prince Edward Island, Prince Edward Island, Canada,” which is currently open for public comment. are accepting In this revised draft EA, FDA expands its assessment beyond that of the 2015 EA to assess harm that can occur when AAS or their broodstock escape confinement and are highly unlikely to migrate from there. We have included a thorough analysis of the likelihood and severity of From Canada to the United States and to be present in the aquatic environment of the United States.
The revised draft EA assessed the potential risks to the U.S. environment from the production of AAS eggs at all currently operating facilities on Prince Edward Island, Canada, including the Bay Fortune and Rollo Bay facilities. I’m here. It also takes into account the potential for future expansion at the Loro Bay facility. The FDA is seeking public comment on the revised draft EA and is accepting public comments until January 17, 2023 at 11:59 PM EST.
Information and analysis for the revised draft EA was received from the National Marine Fisheries Service (NMFS) and Fish and Wildlife Service (FWS) (collectively referred to as the Service) during ESA’s Technical Assistance Review beginning in June 2022. It reflects your comments and input. If the current conclusions regarding the ESA remain unchanged, FDA plans to initiate informal consultations with the service after the public comment period ends.
FDA will also hold a public meeting on December 15, 2022 from 1:00 p.m. to 5:00 p.m. ET “Public Meeting on Proposed Amendments to Environmental Assessments for AquaAdvantage Salmon Production at Prince’s Bay Fortune and Loro Bay Facilities. We are announcing that we will hold a virtual public meeting titled “. Canada, Edward Island. The virtual public meeting will focus only on the revised EA draft and will not include discussion of the AAS in general or approved applications.
Registration for the Virtual Public Meeting closes on December 9, 2022 at 11:59 PM ET. Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Submissions of all comments received should be submitted to Docket No. FDA-2022-N-2672 should be referenced. Using Aqua Advantage Salmon at the Bay Fortune and Loro Bay facilities in Prince Edward Island, Canada.
To register for the conference, request an oral presentation, or submit written or electronic comments, please visit FDA’s conference webpage for more information.
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