Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability, 79623-79624 [2024-22308]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect the reorganization of
CVM OM and ONADE.
The reorganization of OM merged the
Budget Planning and Evaluation Staff
(BPES) and the Program and Resource
Management Staff (PRMS) and retitled
the PRMS to the Financial Management
Staff (FMS) and abolished BPES. The
reorganization retitled ONADE to the
Office of New Animal Product
Evaluation (ONAPE), established the
Regulatory Counsel Staff and the
Administrative Staff, established
branches within the Division of Food
Animal Drugs, the Division of
Companion Animal Drugs, the Division
of Human Food Safety, the Division of
Manufacturing Technologies, the
Division of Business Information
Science and Management, the Division
of Animal Bioengineering and Cellular
Therapies (DABCT), and the Division of
Scientific Support (DSS). The
reorganization retitled DABCT to the
Division of Biotechnology and retitled
DSS to the Division of Statistical and
Biological Sciences. The reorganization
established the Office of Generic Animal
Drugs (OGAD), established the Business
Management and Operations Staff and
the Division of Manufacturing
Technologies (DMT) under OGAD,
realigned the Division of Generic
Animal Drugs (DGAD) from ONADE to
OGAD, and established branches under
DGAD and DMT.
DCGB. ORGANIZATION. CVM’s OM
is headed by the Associate Director for
Management, and includes the
following:
Financial Management Staff (DCGB1)
Human Capital Management Staff
(DCGB2)
Talent Development Staff (DCGB3)
Business Informatics Staff (DCGB5)
DCGC. ORGANIZATION. CVM’s
ONAPE is headed by the Director, and
includes the following:
Office of New Animal Product
Evaluation (DCGC)
Regulatory Counsel Staff (DCGC1)
Administrative Staff (DCGC2)
Division of Food Animal Drugs
(DCGCA)
Food Animal Branch 1 (DCGCA1)
Food Animal Branch 2 (DCGCA2)
Division of Companion Animal Drugs
(DCGCC)
Companion Animal Branch 1 (DCGCC1)
Companion Animal Branch 2 (DCGCC2)
Companion Animal Branch 3 (DCGCC3)
Division of Human Food Safety
(DCGCD)
Human Food Safety Branch 1 (DCGCD1)
VerDate Sep<11>2014
17:51 Sep 27, 2024
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Human Food Safety Branch 2 (DCGCD2)
Division of Manufacturing Technologies
(DCGCE)
Feed and Topical Branch (DCGCE1)
Sterile Drugs Branch (DCGCE2)
Biotherapeutics Branch (DCGCE3)
Chemotherapeutics Branch (DCGCE4)
Drug Substance Branch (DCGCE5)
Division of Statistical and Biological
Sciences (DCGCF)
Environmental Branch (DCGCF1)
Biostatistics Branch 1 (DCGCF2)
Biostatistics Branch 2 (DCGCF3)
Clinical Pharmacology Branch
(DCGCF4)
Division of Business Information
Science and Management (DCGCH)
Business Informatics Branch (DCGCH1)
Quality Assurance Branch (DCGCH2)
Project Management Branch (DCGCH3)
Division of Biotechnology (DCGCI)
Animal Biotechnology Branch (DCGCI1)
Biologic Products Branch (DCGCI2)
DCGG. ORGANIZATION. CVM’s
OGAD is headed by the Director, and
includes the following:
Office of Generic Animal Drugs (DCGG)
Business Management and Operations
Staff (DCGG1)
Division of Generic Animal Drugs
(DCGGA)
Generics Review Branch 1 (DCGGA1)
Generics Review Branch 2 (DCGGA2)
Generics Review Branch 3 (DCGGA3)
Generics Review Branch 4 (DCGGA4)
Generics Review Branch 5 (DCGGA5)
Division of Manufacturing Technologies
(DCGGB)
Generic Drug Manufacturing Branch 1
(DCGGB1)
Generic Drug Manufacturing Branch 2
(DCGGB2)
Generic Drug Manufacturing Branch 3
(DCGGB3)
Generic Drug Substances and Facilities
Assessment Branch (DCGGB4)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
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79623
(Authority: 44 U.S.C. 3101)
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–22147 Filed 9–26–24; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2672]
Amended Environmental Assessment
for Production of AquAdvantage
Salmon at the Bay Fortune and Rollo
Bay Facilities on Prince Edward Island,
Canada; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
document entitled ‘‘Amended
Environmental Assessment for
Production of AquAdvantage Salmon at
the Bay Fortune and Rollo Bay Facilities
on Prince Edward Island, Canada.’’ This
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.
FOR FURTHER INFORMATION CONTACT:
Holly Zahner, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0834,
holly.zahner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the availability of a
document entitled ‘‘Amended
Environmental Assessment for
Production of AquAdvantage Salmon at
the Bay Fortune and Rollo Bay Facilities
on Prince Edward Island, Canada.’’ This
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. United States Food and
Drug Adm’n, 499 F. Supp. 3d 657, 660
(N.D. Cal. 2020) and is available in the
docket.
On November 19, 2015, FDA
approved NADA 141–454 concerning
AAS, owned by AquaBounty
Technologies (ABT). AAS are triploid,
hemizygous, all-female Atlantic salmon
SUMMARY:
E:\FR\FM\30SEN1.SGM
30SEN1
ddrumheller on DSK120RN23PROD with NOTICES1
79624
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
(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 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 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. United States
Food and Drug Adm’n, 499 F. Supp. 3d
657, 660 (N.D. Cal. 2020). However, the
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
Court did not vacate the approval; the
approval remains in effect.
To address the November 5, 2020,
Court opinion, we prepared a draft
amended EA, titled ‘‘Draft Amended
Environmental Assessment for
Production of AquAdvantage Salmon at
the Bay Fortune and Rollo Bay Facilities
on Prince Edward Island, Canada.’’ We
requested that the public review that
draft amended EA and submit
comments to the docket (87 FR 69032,
November 17, 2022). We also held a
virtual public meeting on December 15,
2022, at which we solicited comment on
the draft amended EA (87 FR 69030,
November 17, 2022).
In that draft amended EA, we
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 ABT
Salmon) are assumed to be present in
the U.S. aquatic environment. We
outlined 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 evaluated 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 identified
and evaluated 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
revisited 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.
We note that the information and
analyses in the draft amended EA
reflected comments and input received
from the National Marine Fisheries
Service and the Fish and Wildlife
Service during an ESA technical
assistance review.
We received 1,728 comment
submissions on the draft amended EA.
Please refer to ‘‘Summary Responses to
Public Comments on the November
2022 AAS Draft Amended
Environmental Assessment’’ (https://
www.fda.gov/media/181568/download?
attachment) for a summary and FDA
review of these comments.
FDA is announcing the availability of
an EA entitled ‘‘Amended
Environmental Assessment for
PO 00000
Frm 00124
Fmt 4703
Sfmt 4703
Production of AquAdvantage Salmon at
the Bay Fortune and Rollo Bay Facilities
on Prince Edward Island, Canada.’’ This
document can be found at https://
animaldrugsatfda.fda.gov/adafda/
views/#/home/previewsearch/141454#eaid.
We have also prepared and are
making available a FONSI and, based on
the findings in the EA, have made a ‘‘no
effect’’ determination under the ESA,
concluding that AAS, when produced
and reared under the conditions as
described in the EA, will 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. This document can
be found at https://animaldrugsatfda.
fda.gov/adafda/views/#/home/
previewsearch/141-454#eaid.
Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22308 Filed 9–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4115]
Clarification of Radiation Control
Regulations for Manufacturers of
Diagnostic X-Ray Equipment;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Clarification of
Radiation Control Regulations for
Manufacturers of Diagnostic X-Ray
Equipment.’’ This guidance provides
clarification to industry and FDA staff of
the Federal regulations that relate to
diagnostic x-ray equipment. These
regulations pertain to the recordkeeping,
reporting, manufacturing, importing,
and installation of an ‘‘electronic
product’’ as defined in FDA regulations.
This guidance supersedes FDA’s 1989
guidance entitled ‘‘Clarification of
Radiation Control Regulations for
Diagnostic X-Ray Equipment.’’
DATES: The announcement of the
guidance is published in the Federal
Register on September 30, 2024.
ADDRESSES: You may submit either
electronic or written comments on
SUMMARY:
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79623-79624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22308]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2672]
Amended Environmental Assessment for Production of AquAdvantage
Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward
Island, Canada; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a document entitled ``Amended
Environmental Assessment for Production of AquAdvantage Salmon at the
Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.''
This 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.
FOR FURTHER INFORMATION CONTACT: Holly Zahner, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-0834, [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
document entitled ``Amended Environmental Assessment for Production of
AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on
Prince Edward Island, Canada.'' This 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. United States Food and Drug Adm'n, 499 F. Supp. 3d 657, 660
(N.D. Cal. 2020) and is available in the docket.
On November 19, 2015, FDA approved NADA 141-454 concerning AAS,
owned by AquaBounty Technologies (ABT). AAS are triploid, hemizygous,
all-female Atlantic salmon
[[Page 79624]]
(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 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. United States Food and Drug Adm'n, 499 F. Supp. 3d
657, 660 (N.D. Cal. 2020). However, the Court did not vacate the
approval; the approval remains in effect.
To address the November 5, 2020, Court opinion, we prepared a draft
amended EA, titled ``Draft Amended Environmental Assessment for
Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay
Facilities on Prince Edward Island, Canada.'' We requested that the
public review that draft amended EA and submit comments to the docket
(87 FR 69032, November 17, 2022). We also held a virtual public meeting
on December 15, 2022, at which we solicited comment on the draft
amended EA (87 FR 69030, November 17, 2022).
In that draft amended EA, we 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 ABT Salmon) are assumed
to be present in the U.S. aquatic environment. We outlined 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 evaluated 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 identified and evaluated 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 revisited 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.
We note that the information and analyses in the draft amended EA
reflected comments and input received from the National Marine
Fisheries Service and the Fish and Wildlife Service during an ESA
technical assistance review.
We received 1,728 comment submissions on the draft amended EA.
Please refer to ``Summary Responses to Public Comments on the November
2022 AAS Draft Amended Environmental Assessment'' (https://www.fda.gov/media/181568/download?attachment) for a summary and FDA review of these
comments.
FDA is announcing the availability of an EA entitled ``Amended
Environmental Assessment for Production of AquAdvantage Salmon at the
Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.''
This document can be found at https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141-454#eaid.
We have also prepared and are making available a FONSI and, based
on the findings in the EA, have made a ``no effect'' determination
under the ESA, concluding that AAS, when produced and reared under the
conditions as described in the EA, will 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. This document can be found at https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141-454#eaid.
Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22308 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P
