Notice2024-10770
Notice of Withdrawal of Select Agent Regulatory Exclusion for African Swine Fever Virus-G-ΔI177L
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Published
May 16, 2024
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has withdrawn the select agent regulatory exclusion for African swine fever virus (ASFV) strain, ASFV-G- [Delta]I177L.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.
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[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Page 42834]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10770]
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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.
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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Inspection Service (APHIS) has withdrawn the select agent regulatory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withdrawn.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: <a href="/cdn-cgi/l/email-protection#2943484a4c42075d4847404c5e5a4240695c5a4d48074e465f"><span class="__cf_email__" data-cfemail="1379727076783d67727d7a766460787a53666077723d747c65">[email protected]</span></a>.
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 <a href="https://www.selectagents.gov">https://www.selectagents.gov</a>.
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
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