Notice2022-25002
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
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Published
November 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 221 (Thursday, November 17, 2022)</title>
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[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69030-69032]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#7e3d28331f131b101a1b1a3b3f3e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="da998c97bbb7bfb4bebfbe9f9b9abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
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 <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022</a>. 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 <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022</a> 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 <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022</a> 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 <a href="/cdn-cgi/l/email-protection#551603183438303b3130311014153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="e2a1b4af838f878c868786a7a3a2848683cc8a8a91cc858d94">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#581b0e1539353d363c3d3c1d19183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="1251445f737f777c7677765753527476733c7a7a613c757d64">[email protected]</span></a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> and on the FDA website at: <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/virtual-public-meeting-aquadvantage-salmon-draft-amended-environmental-assessment-12152022</a> 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
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