[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69032-69034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a document entitled ``Draft Amended 
Environmental Assessment for Production of AquAdvantage Salmon at the 
Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.'' 
This draft 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.

DATES: Submit either electronic or written comments on the draft 
amended EA by January 17, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 17, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

[[Page 69033]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the 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,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments, and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-492-7500.

FOR FURTHER INFORMATION CONTACT: Holly Zahner, Center for Veterinary 
Medicine (HFV-162), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0834, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    FDA is announcing the availability of a document entitled ``Draft 
Amended Environmental Assessment for Production of AquAdvantage Salmon 
at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, 
Canada.'' This draft 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. U.S. Food and 
Drug Admin, 499 F. Supp. 3d 657, 660 (N.D. Cal. 2020) and is available 
in the docket or at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022.
    On November 19, 2015, FDA approved NADA 141-454 concerning AAS, 
owned by AquaBounty Technologies (ABT). AAS are triploid, hemizygous, 
all-female Atlantic salmon (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 a 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

[[Page 69034]]

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. U.S. Food and Drug Admin, 
499 F. Supp. 3d 657, 660. However, the Court did not vacate the 
approval; the approval is still in effect.
    To address the November 5, 2020, Court opinion, we have prepared a 
draft amended EA, entitled ``Draft Amended Environmental Assessment for 
Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay 
Facilities on Prince Edward Island, Canada.'' We request that the 
public review the draft amended EA and submit comments to the docket.
    In this draft amended EA, we have 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 AquaBounty 
Technology (ABT) Salmon) are assumed to be present in the U.S. aquatic 
environment. We outline 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 evaluate 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 identify 
and evaluate 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 revisit 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. 
Ultimately, this analysis will aid the Agency in the decision of 
whether to prepare a FONSI or an environmental impact statement.
    We note that the information and analyses in the draft amended EA 
reflect comments and input received from the National Marine Fisheries 
Service and the Fish and Wildlife Service during a recent ESA technical 
assistance review initiated in June 2022 with initial discussions 
beginning in March 2021. 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.
    Elsewhere in this issue of the Federal Register, we are providing 
notice of a virtual public meeting on December 15, 2022. Further 
information, including the time the meeting will start, the agenda, and 
how to register to attend the meeting, can be found at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022.

II. Topics for Comment Regarding the Draft Amended EA

    The Agency is placing the draft amended EA on public display at the 
Dockets Management Staff (see DATES and ADDRESSES) and at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022 for public review and comment for 60 days.
    Comments 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 such as AquAdvantage Salmon generally or the 
approved application. Given that FDA must comply with a court order and 
that the public can comment both by submitting comments to the docket 
and by participating in the public meeting, FDA believes that a 60-day 
comment period is appropriate and does not intend to grant requests for 
extension of the comment period.
    We are particularly interested in receiving comments from the 
public on the following:
    1. Is the expanded conceptual model for risk assessment (Figure 4-
1) in the draft amended EA complete?
    2. Are the risk-related questions (Section 4.4) appropriate given 
the new expanded conceptual model?
    3. Are there any exposure pathways to the U.S. environment that 
were not identified or evaluated in the draft amended EA?
    4. Are there any potential harms (adverse consequences, effects, or 
impacts) to the U.S. environment from ABT Salmon that were not 
identified or evaluated in the draft amended EA?
    5. Are there any potential environmental impacts on endangered 
Atlantic salmon or their critical habitat in the United States that 
were not identified or evaluated in the draft amended EA?

    Dated: November 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25001 Filed 11-16-22; 8:45 am]
BILLING CODE 4164-01-P