[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79623-79624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2672]


Amended Environmental Assessment for Production of AquAdvantage 
Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward 
Island, Canada; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a document entitled ``Amended 
Environmental Assessment for Production of AquAdvantage Salmon at the 
Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.'' 
This amended environmental assessment (EA) has been prepared by FDA in 
support of the approved new animal drug application (NADA 141-454) 
concerning AquAdvantage Salmon (AAS), in response to an order by the 
U.S. District Court, Northern District of California.

FOR FURTHER INFORMATION CONTACT: Holly Zahner, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 240-402-0834, <a href="/cdn-cgi/l/email-protection#2c444340405502564d4442495e6c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="82eaedeeeefbacf8e3eaece7f0c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
document entitled ``Amended Environmental Assessment for Production of 
AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on 
Prince Edward Island, Canada.'' This amended EA has been prepared by 
FDA in support of the approved application (NADA 141-454) concerning 
AAS, in response to an order by the U.S. District Court, Northern 
District of California, issued on November 5, 2020; Inst. for Fisheries 
Res. v. United States Food and Drug Adm'n, 499 F. Supp. 3d 657, 660 
(N.D. Cal. 2020) and is available in the docket.
    On November 19, 2015, FDA approved NADA 141-454 concerning AAS, 
owned by AquaBounty Technologies (ABT). AAS are triploid, hemizygous, 
all-female Atlantic salmon

[[Page 79624]]

(Salmo salar) bearing a single copy of the [alpha]-form of the opAFP-
GHc2 recombinant DNA (rDNA) construct at the [alpha]-locus in the E.O.-
1[alpha] lineage. AAS is designed to exhibit a rapid-growth phenotype. 
The November 19, 2015, NADA approval allowed for the AAS to be produced 
at a facility on Prince Edward Island (PEI), Canada, and grown at a 
facility in Panama (that has subsequently closed) and allowed for sale 
of food harvested from AAS in the United States.
    As part of the NADA review process under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, et seq.) and consistent with the 
mandates in the National Environmental Policy Act of 1969 (NEPA) (42 
U.S.C. 4321, et seq.) and FDA's environmental impact considerations 
regulations (21 CFR part 25), FDA's Center for Veterinary Medicine 
prepared an EA dated November 12, 2015, for the original approval of 
the rDNA construct as integrated in the genome of AAS. Based on the 
2015 EA and the specific conditions that were established in the NADA, 
FDA determined the action would not individually or cumulatively have a 
significant effect on the quality of the human environment in the 
United States. Therefore, FDA prepared a finding of no significant 
impact (FONSI). Based on the findings in the 2015 EA, FDA also made a 
``no effect'' determination under the Endangered Species Act (ESA) (16 
U.S.C. 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, FDA's evaluations under NEPA and the ESA for the 2015 NADA 
approval. On November 5, 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 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, 660 (N.D. Cal. 2020). However, the Court did not vacate the 
approval; the approval remains in effect.
    To address the November 5, 2020, Court opinion, we 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.'' We requested that the 
public review that draft amended EA and submit comments to the docket 
(87 FR 69032, November 17, 2022). We also held a virtual public meeting 
on December 15, 2022, at which we solicited comment on the draft 
amended EA (87 FR 69030, November 17, 2022).
    In that draft amended EA, we expanded our assessment beyond that in 
the 2015 EA to include an exhaustive analysis of the likelihood and 
severity of harms that could occur if AAS and AquAdvantage broodstock 
(collectively referred to in the amended EA as ABT Salmon) are assumed 
to be present in the U.S. aquatic environment. We outlined the pathways 
necessary for ABT Salmon to escape confinement from the PEI facilities 
and migrate to and establish a persistent population in the United 
States. We also evaluated the potential pathways for disease (including 
pathogen and parasite) transmission from ABT Salmon and from the 
production of ABT Salmon at facilities on PEI to wild fish populations. 
In addition, we identified and evaluated the potential harms 
(consequences) to the U.S. environment and the endangered Atlantic 
salmon of the Gulf of Maine Distinct Population Segment if these highly 
unlikely scenarios were to occur. Finally, we revisited whether there 
is a potential for significant impacts on the U.S. environment under 
NEPA, and whether the action could result in effects on threatened and 
endangered Atlantic salmon and their critical habitat in the United 
States under the ESA.
    We note that the information and analyses in the draft amended EA 
reflected comments and input received from the National Marine 
Fisheries Service and the Fish and Wildlife Service during an ESA 
technical assistance review.
    We received 1,728 comment submissions on the draft amended EA. 
Please refer to ``Summary Responses to Public Comments on the November 
2022 AAS Draft Amended Environmental Assessment'' (https://www.fda.gov/media/181568/download?attachment) for a summary and FDA review of these 
comments.
    FDA is announcing the availability of an EA entitled ``Amended 
Environmental Assessment for Production of AquAdvantage Salmon at the 
Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.'' 
This document can be found at https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141-454#eaid.
    We have also prepared and are making available a FONSI and, based 
on the findings in the EA, have made a ``no effect'' determination 
under the ESA, concluding that AAS, when produced and reared under the 
conditions as described in the EA, will 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. This document can be found at https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141-454#eaid.

    Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22308 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P


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