[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69030-69032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25002]


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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; Public Meeting; Request for Comments

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

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a virtual public meeting entitled ``Draft Amended Environmental 
Assessment for Production of AquAdvantage Salmon at the Bay Fortune and 
Rollo Bay Facilities on Prince Edward Island, Canada.'' The purpose of 
the public meeting is to obtain public input on a draft amended 
environmental assessment (EA) prepared by FDA in support of an 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: The virtual public meeting will be held on December 15, 2022. 
Either electronic or written comments on this public meeting must be 
submitted by January 17, 2023. See the SUPPLEMENTARY INFORMATION 
section for registration dates and information.

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.

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, those 
filed in a timely manner (see ADDRESSES), 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

[[Page 69031]]

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

    The Agency will be hosting 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,'' to gather 
public comment. In preparation for this meeting, elsewhere in this 
issue of the Federal Register we are providing notice of the 
availability of 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,'' 
and are requesting public comment on questions posed regarding that 
document. 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. The purpose of the virtual 
public meeting is to obtain input from the public on the draft amended 
EA, and whether the information and analysis presented therein is 
accurate and complete.
    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 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. U.S. Food and Drug Admin., 499 F. Supp. 3d 657, 660 
(N.D. Cal. 2020). 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, attend the virtual public meeting 
on December 15, 2022, and submit comments either at the public meeting 
or 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.

[[Page 69032]]

    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 (collectively referred to as 
the Services) 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.

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 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 at the public meeting should be limited to the draft 
amended EA only, as described below. We will not review comments on 
topics outside of the scope of the draft amended EA. 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.
    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:
    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 habit in the United States that were 
not identified or evaluated in the draft amended EA?

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register no later than 11:59 p.m. Eastern Time on December 9, 
2022. Interested persons can register online at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022 and will need to provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone. Early registration is recommended. Registrants will receive 
confirmation when their registration has been accepted and will be 
provided the webcast link.
    If you need special accommodations due to a disability, please 
contact [email protected] no later than December 9, 2022.
    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 [email protected] 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.
    Transcripts: A transcript of the public meeting will be accessible 
at https://www.regulations.gov and on the FDA website at: https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022 approximately 30 days after the meeting. It may be 
viewed at the Dockets Management Staff (see ADDRESSES).

    Dated: November 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25002 Filed 11-16-22; 8:45 am]
BILLING CODE 4164-01-P