Notice2022-25001
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
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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 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.
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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 69032-69034]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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.
[[Page 69033]]
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 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 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#83c0d5cee2eee6ede7e6e7c6c2c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="4605100b272b2328222322030706202227682e2e3568212930">[email protected]</span></a>.
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 <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>.
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 <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>.
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 <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 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
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