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, 69030-69032 [2022-25002]
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Federal Register / Vol. 87, No. 221 / Thursday, November 17, 2022 / Notices
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you, if any.
HISTORY:
86 FR 72245 (Dec. 21, 2021).
[FR Doc. 2022–25017 Filed 11–16–22; 8:45 am]
BILLING CODE 4184–42–P
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of public meeting;
request for comments.
AGENCY:
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.
SUMMARY:
CONTESTING RECORD PROCEDURES:
To request correction of a record
about you in this system of records,
submit a written amendment request to
the System Manager identified in the
‘‘System Manager’’ section of this
SORN, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the same
information required for an access
request and include verification of your
identity in the same manner required for
an access request. In addition, the
request must reasonably identify the
record and specify the information
contested, the corrective action sought,
and the reasons for requesting the
correction; and should include
supporting information to show how the
record is inaccurate, incomplete,
untimely, or irrelevant.
lotter on DSK11XQN23PROD with NOTICES1
NOTIFICATION PROCEDURES:
To find out if the system of records
contains a record about you, submit a
written notification request to the
System Manager identified in the
‘‘System Manager’’ section of this
SORN, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must identify this system of
records, contain the same information
required for an access request, and
include verification of your identity in
the same manner required for an access
request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
VerDate Sep<11>2014
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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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
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Federal Register / Vol. 87, No. 221 / Thursday, November 17, 2022 / Notices
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-201509-18/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,
CVMamendedEA@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:26 Nov 16, 2022
Jkt 259001
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-aquadvantagesalmon-draft-amended-environmentalassessment-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 a-form of the opAFP–GHc2
recombinant DNA (rDNA) construct at
the a-locus in the E.O.-1a 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,
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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.
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Federal Register / Vol. 87, No. 221 / Thursday, November 17, 2022 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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/workshopsconferences-meetings/virtual-publicmeeting-aquadvantage-salmon-draftamended-environmental-assessment12152022 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 60day 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?
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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-aquadvantagesalmon-draft-amended-environmentalassessment-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
CVMamendedEA@fda.hhs.gov 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 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.
Transcripts: A transcript of the public
meeting will be accessible at https://
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www.regulations.gov and on the FDA
website at: https://www.fda.gov/animalveterinary/workshops-conferencesmeetings/virtual-public-meetingaquadvantage-salmon-draft-amendedenvironmental-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
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability; request
for comments.
AGENCY:
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.
SUMMARY:
E:\FR\FM\17NON1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
