Notice of Withdrawal of Select Agent Regulatory Exclusion for African Swine Fever Virus-G-ΔI177L, 42834 [2024-10770]
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42834
Notices
Federal Register
Vol. 89, No. 96
Thursday, May 16, 2024
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
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section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2024–0010]
Notice of Withdrawal of Select Agent
Regulatory Exclusion for African
Swine Fever Virus–G–ΔI177L
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of withdrawal of select
agent regulatory exclusion.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service (APHIS) has
withdrawn the select agent regulatory
exclusion for African swine fever virus
(ASFV) strain, ASFV–G–DI177L.
Possession, use, and transfer of this
strain must now comply with the select
agent and toxin regulations. APHIS
withdrew the select agent regulatory
exclusion for this strain because it has
evaluated new information and
determined that this strain, when
adapted to cell lines other than that
used for virus development, has the
potential to pose a severe threat to
animal health or animal products.
DATES: As of February 7, 2024, the
subject select agent exclusion was
withdrawn.
SUMMARY:
Dr.
Jacek Taniewski, DVM, Director,
Division of Agricultural Select Agents
and Toxins, Animal and Plant Health
Inspection Service, 4700 River Road,
Riverdale, Maryland 20737; telephone:
(301) 851–2070; email: jacek.taniewski@
usda.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Background
The Agricultural Bioterrorism
Protection Act of 2002, as amended (7
U.S.C. 8401, referred to below as the
Act) provides for the regulation of
certain biological agents and toxins that
VerDate Sep<11>2014
17:50 May 15, 2024
Jkt 262001
have the potential to pose a severe
threat to animal and plant health, or to
animal and plant products. The Animal
and Plant Health Inspection Service
(APHIS) has the primary responsibility
for implementing the provisions of the
Act within the U.S. Department of
Agriculture.
In accordance with the Act, APHIS
promulgated the select agent and toxin
regulations found in 7 CFR part 331 and
9 CFR part 121. Paragraph (e) in § 121.3
of the select agent and toxin regulations
states that an attenuated strain of a
select agent or a select toxin modified to
be less potent or toxic may be excluded
from the requirements of the select
agent and toxin regulations based upon
a determination by the Administrator
that the attenuated strain or modified
toxin does not pose a severe threat to
animal health or animal products.
African swine fever virus (ASFV) is
listed as a select agent in § 121.3(b) of
the select agent and toxin regulations.
APHIS approved the initial regulatory
exclusion for ASFV strain ASFV–G–
DI177L, based on an application
submitted in accordance with the select
agent and toxin regulations and with
review and recommendations from the
Agriculture Interagency Select Agents
and Toxins Technical Advisory
Committee (Ag–ISATTAC) at a meeting
on April 2, 2020. The exclusion became
effective on April 3, 2020. Pursuant to
§ 121.3(e)(1) of the select agent and
toxin regulations, APHIS listed the
exclusion on the National Select Agent
Registry website at https://www.select
agents.gov.
On February 7, 2024, APHIS
withdrew the previously approved
select agent regulatory exclusion for the
ASFV–G–DI177L strain. APHIS will
remove this strain from the list on the
National Select Agency Registry website
concurrent with this notice. APHIS
notified all entities that were known to
have the previously excluded ASFV
strains that possession, use, and transfer
of these ASFV strains must now comply
with the select agent and toxin
regulations in 9 CFR part 121. APHIS
based the decision to withdraw the
exclusion on newly acquired
information obtained in February 2024
regarding safety and genome instability
potentially leading to reversion of
virulence that was unavailable to Ag–
ISATTAC during the April 2020
discussion for regulatory exclusion.
PO 00000
Frm 00001
Fmt 4703
Sfmt 9990
Recent in-vitro and in-vivo studies
conducted for a European Union grant
provided general information that under
certain conditions, the strain can
demonstrate an increase or reversion to
virulence. More specifically, the ASFV–
G–DI177L strain was adapted to growth
on a Zuckermann macrophage (ZMAC)
cell line, which is a porcine macrophage
cell line that supports high levels of
ASFV replication. The resulting virus
used in back passage swine studies and
upon a fifth passage in swine showed
clinical signs and/or gross pathology
that is consistent with ASFV infection.
Due to the development of clinical signs
and associated gross pathology that
resulted from inoculation with the cell
line adapted virus, APHIS determined
that the ASFV–G–DI177L strain
represents an increased risk under
certain conditions. For these reasons,
APHIS further determined that the
ASFV–G–DI177L strain does not
maintain acceptable attenuation to
continue to remain excluded under
§ 121.3(e).
With the publication of this notice,
we are informing the public that we
withdrew the previously approved
select agent regulatory exclusion for the
ASFV–G–DI177L strain, effective on
February 7, 2024, and that the
possession, use, and transfer of this
ASFV strain must now comply with the
select agent and toxin regulations in 9
CFR part 121. This notice serves as an
official record and public notification of
this action.
Authority: 7 U.S.C. 8401; 7 CFR 2.22,
and 2.80.
Done in Washington, DC, this 10th day of
May 2024.
Michael Watson,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2024–10770 Filed 5–15–24; 8:45 am]
BILLING CODE 3410–34–P
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Page 42834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10770]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 89, No. 96 / Thursday, May 16, 2024 /
Notices
[[Page 42834]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2024-0010]
Notice of Withdrawal of Select Agent Regulatory Exclusion for
African Swine Fever Virus-G-[Delta]I177L
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of withdrawal of select agent regulatory exclusion.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service (APHIS) has withdrawn the select agent regulatory
exclusion for African swine fever virus (ASFV) strain, ASFV-G-
[Delta]I177L. Possession, use, and transfer of this strain must now
comply with the select agent and toxin regulations. APHIS withdrew the
select agent regulatory exclusion for this strain because it has
evaluated new information and determined that this strain, when adapted
to cell lines other than that used for virus development, has the
potential to pose a severe threat to animal health or animal products.
DATES: As of February 7, 2024, the subject select agent exclusion was
withdrawn.
FOR FURTHER INFORMATION CONTACT: Dr. Jacek Taniewski, DVM, Director,
Division of Agricultural Select Agents and Toxins, Animal and Plant
Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737;
telephone: (301) 851-2070; email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
The Agricultural Bioterrorism Protection Act of 2002, as amended (7
U.S.C. 8401, referred to below as the Act) provides for the regulation
of certain biological agents and toxins that have the potential to pose
a severe threat to animal and plant health, or to animal and plant
products. The Animal and Plant Health Inspection Service (APHIS) has
the primary responsibility for implementing the provisions of the Act
within the U.S. Department of Agriculture.
In accordance with the Act, APHIS promulgated the select agent and
toxin regulations found in 7 CFR part 331 and 9 CFR part 121. Paragraph
(e) in Sec. 121.3 of the select agent and toxin regulations states
that an attenuated strain of a select agent or a select toxin modified
to be less potent or toxic may be excluded from the requirements of the
select agent and toxin regulations based upon a determination by the
Administrator that the attenuated strain or modified toxin does not
pose a severe threat to animal health or animal products.
African swine fever virus (ASFV) is listed as a select agent in
Sec. 121.3(b) of the select agent and toxin regulations. APHIS
approved the initial regulatory exclusion for ASFV strain ASFV-G-
[Delta]I177L, based on an application submitted in accordance with the
select agent and toxin regulations and with review and recommendations
from the Agriculture Interagency Select Agents and Toxins Technical
Advisory Committee (Ag-ISATTAC) at a meeting on April 2, 2020. The
exclusion became effective on April 3, 2020. Pursuant to Sec.
121.3(e)(1) of the select agent and toxin regulations, APHIS listed the
exclusion on the National Select Agent Registry website at https://www.selectagents.gov.
On February 7, 2024, APHIS withdrew the previously approved select
agent regulatory exclusion for the ASFV-G-[Delta]I177L strain. APHIS
will remove this strain from the list on the National Select Agency
Registry website concurrent with this notice. APHIS notified all
entities that were known to have the previously excluded ASFV strains
that possession, use, and transfer of these ASFV strains must now
comply with the select agent and toxin regulations in 9 CFR part 121.
APHIS based the decision to withdraw the exclusion on newly acquired
information obtained in February 2024 regarding safety and genome
instability potentially leading to reversion of virulence that was
unavailable to Ag-ISATTAC during the April 2020 discussion for
regulatory exclusion. Recent in-vitro and in-vivo studies conducted for
a European Union grant provided general information that under certain
conditions, the strain can demonstrate an increase or reversion to
virulence. More specifically, the ASFV-G-[Delta]I177L strain was
adapted to growth on a Zuckermann macrophage (ZMAC) cell line, which is
a porcine macrophage cell line that supports high levels of ASFV
replication. The resulting virus used in back passage swine studies and
upon a fifth passage in swine showed clinical signs and/or gross
pathology that is consistent with ASFV infection. Due to the
development of clinical signs and associated gross pathology that
resulted from inoculation with the cell line adapted virus, APHIS
determined that the ASFV-G-[Delta]I177L strain represents an increased
risk under certain conditions. For these reasons, APHIS further
determined that the ASFV-G-[Delta]I177L strain does not maintain
acceptable attenuation to continue to remain excluded under Sec.
121.3(e).
With the publication of this notice, we are informing the public
that we withdrew the previously approved select agent regulatory
exclusion for the ASFV-G-[Delta]I177L strain, effective on February 7,
2024, and that the possession, use, and transfer of this ASFV strain
must now comply with the select agent and toxin regulations in 9 CFR
part 121. This notice serves as an official record and public
notification of this action.
Authority: 7 U.S.C. 8401; 7 CFR 2.22, and 2.80.
Done in Washington, DC, this 10th day of May 2024.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2024-10770 Filed 5-15-24; 8:45 am]
BILLING CODE 3410-34-P
