Meeting | Virtual

Event Title

Virtual Public Meeting: AquAdvantage Salmon Draft Amended Environmental Assessment

December 15, 2022

Date:: December 15, 2022
Time:: 1:00 p.m. - 5:00 p.m. ET

The U.S. Food and Drug Administration will hold a virtual public meeting on December 15, 2022, entitled “Public Meeting on Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.” The FDA is also announcing the availability of a draft amended environmental assessment (EA) issued by the FDA on November 16, 2022, in support of an approved application concerning AquAdvantage Salmon.

The FDA prepared the 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 response to an order by the U.S. District Court, Northern District of California, issued on November 15, 2020; Inst. for Fisheries Res. v. United States Food and Drug Adm'n, 499 F. Supp. 3d 657 (N.D. Cal. 2020).

The purpose of the public comment period and virtual public meeting is to obtain input from the public on the draft amended EA, and whether the information and analysis presented is accurate and complete.

Background

On November 19, 2015, the FDA announced its approval of an application concerning AquAdvantage Salmon (AAS), an Atlantic salmon which contains an intentional genomic alteration (IGA) that enables the AAS to grow more rapidly than its counterpart, conventional farm-raised Atlantic salmon without the IGA. AAS met the statutory requirements for safety and effectiveness under the Federal Food, Drug & Cosmetic Act. The salmon is safe to eat, the introduced genomic alteration is safe for the fish itself, and the salmon meets the sponsor’s claim about faster growth.

Pursuant to the National Environmental Policy Act (NEPA), the FDA evaluated whether approval of the application would result in significant impacts on the quality of the human environment in the United States. The EA focused on the approved conditions, including production of AAS eggs at the Bay Fortune facility in Prince Edward Island, Canada, and grow-out at a facility, now closed, in Panama. The FDA issued its Environmental Assessment and Finding of No Significant Impact (FONSI) at the time of the approval.

Based on the findings in the 2015 EA, the FDA also made a “no effect” determination under the Endangered Species Act (ESA), 16 USC § 1531, et seq., concluding that AAS, when produced and reared under the conditions in the application, and as described in the 2015 EA, would not jeopardize the continued existence of U.S. populations of threatened or endangered Atlantic salmon or result in the destruction or adverse modification of their critical habitat.

Subsequently, several organizations filed suit in the U.S. District Court, Northern District of California, challenging, among other things, the FDA’s evaluations under NEPA and the ESA for the 2015 approval. On November 15, 2020, the Court found that “FDA did not…meaningfully analyze what might happen to normal salmon in the event the engineered salmon did survive and establish themselves in the wild. Even if this scenario was unlikely, the FDA was still required to assess the consequences of it coming to pass.” The Court ordered the FDA to complete the analysis and reconsider its “no effect” determination under the ESA together with a revised NEPA evaluation. See Inst. for Fisheries Res. v. United States Food and Drug Adm'n, 499 F. Supp. 3d 657 (N.D. Cal. 2020). However, the Court did not vacate the approval, which remains in effect, and in a previous order on December 19, 2019, the Court had already held that the FDA has regulatory authority over the genomic alteration in AAS.

To address the November 15, 2020, Court opinion, the FDA has prepared 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 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. 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. Production of AAS eggs at the Rollo Bay facility was approved in a supplemental application in 2019, which included an EA and FONSI. For more information, see the Federal Register Notice.

Information and analyses in the draft amended EA reflect comments and input received from the National Marine Fisheries Service (NMFS) and the Fish and Wildlife Service (FWS) (collectively referred to as the Services) during an ESA technical assistance review initiated in June 2022 with initial discussions beginning in March 2021. The FDA intends to initiate an Informal Consultation with the Services after the close of the public comment period if the current conclusions with respect to the ESA are not altered.

Public Meeting Information

The virtual public meeting will focus on the draft amended EA only and will not include discussion about AAS generally or the approved application. We are particularly interested in receiving comments from the public on the following:

Is the expanded conceptual model for risk assessment (Figure 5-1) in the draft amended EA complete?
Are the risk-related questions (Section 5.4) appropriate given the new expanded conceptual model?
Are there any exposure pathways to the U.S. environment that were not identified or evaluated in the draft amended EA?
Are there any potential harms (adverse consequences, effects, or impacts) to the U.S. environment from ABT Salmon (collectively includes AAS and their broodstock) that were not identified or evaluated in the draft amended EA?
Are there any potential environmental impacts on endangered Atlantic salmon or their critical habit in the U.S. that were not identified or evaluated in the draft amended EA?

Registration

Stakeholders interested in attending this public meeting must register no later than 11:59 p.m. Eastern Time on December 9, 2022. Interested persons should register online at https://fda.zoomgov.com/webinar/register/WN_dtpIttgWQh-yXR9IeYVQ7A and will need to provide contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if reasonable accommodations due to a disability are needed. Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link. Registrants should ensure they retain the webcast link email and should check their “junk mail” folder if they do not receive an automatic confirmation with the webcast link after registering.

Requests for Oral Presentations

During online registration you may indicate if you wish to make an oral presentation during the public meeting. To facilitate agenda development, registrants requesting to present will be contacted to provide information regarding which topics they intend to address and the title of their presentation. We will do our best to accommodate requests to make an oral presentation.

Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation or submit requests for designated representatives to participate. All requests to make oral presentations must be received by November 28, 2022.

We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and we will notify participants by December 1, 2022. Selected presenters planning to use an electronic slide deck must submit an electronic copy of their PowerPoint presentation to CVMamendedEA@fda.hhs.gov with the subject line “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada” on or before December 8, 2022. If presenters choose not to use a slide deck, they are requested to submit a single slide with their name, affiliation, title of their presentation, and contact information. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Submitting Electronic or Written Comments

Comments to the docket and at the public meeting should be limited to the draft amended EA only, as described below. We will not review comments outside of the scope of the draft amended EA.

Public comments will be accepted through 11:59 p.m. Eastern Time at the end of January 17, 2023.

Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comment submissions received must reference Docket No. FDA-2022-N-2672 for “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions.”

Confidential Submissions –To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. For detailed instructions, refer to the meeting notice.

Recording and Transcript

A recording and the transcript of the public meeting are available here:

U.S. Food and Drug Administration