Notice2022-23446
Notice of Withdrawal of Select Agent Regulatory Exclusions for Two Strains of African Swine Fever Virus
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Published
October 27, 2022
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We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has withdrawn the select agent regulatory exclusions for two African swine fever virus strains, ASFV-G-[Delta]MGF and ASFV-G-[Delta]9GL/[Delta]MGF. Possession, use, and transfer of these strains must now comply with APHIS' select agent and toxin regulations. APHIS withdrew the select agent regulatory exclusions for these strains because it has evaluated new information and determined that they have the potential to pose a severe threat to animal health or animal products.
Full Text
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[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Page 65023]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23446]
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Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 /
Notices
[[Page 65023]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2022-0016]
Notice of Withdrawal of Select Agent Regulatory Exclusions for
Two Strains of African Swine Fever Virus
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of withdrawal of select agent regulatory exclusions.
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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Inspection Service (APHIS) has withdrawn the select agent regulatory
exclusions for two African swine fever virus strains, ASFV-G-[Delta]MGF
and ASFV-G-[Delta]9GL/[Delta]MGF. Possession, use, and transfer of
these strains must now comply with APHIS' select agent and toxin
regulations. APHIS withdrew the select agent regulatory exclusions for
these strains because it has evaluated new information and determined
that they have the potential to pose a severe threat to animal health
or animal products.
DATES: As of January 7, 2022, the subject select agent exclusions were
withdrawn.
FOR FURTHER INFORMATION CONTACT: Dr. Randy Capsel, Science Officer,
Division of Agricultural Select Agents and Toxins, Emergency and
Regulatory Compliance Services, Animal and Plant Health Inspection
Service, 4700 River Road, Riverdale, Maryland 20737; Telephone: (301)
851-3402; email: <a href="/cdn-cgi/l/email-protection#e2b0838c869bccb6cca1839291878ea297918683cc858d94"><span class="__cf_email__" data-cfemail="aefccfc0cad780fa80edcfdeddcbc2eedbddcacf80c9c1d8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
The Agricultural Bioterrorism Protection Act of 2002 (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 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 this part 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 select agent regulatory exclusions of two ASFV
strains, ASFV-G-[Delta]MGF and ASFV-G-[Delta]9GL/[Delta]MGF, based on
applications 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 meetings on January 27, 2020, and April 8, 2021. Pursuant
to Sec. 121.3(e)(1), APHIS listed the exclusions on the National
Select Agent Registry website at <a href="https://www.selectagents.gov">https://www.selectagents.gov</a>.
On January 7, 2022, APHIS withdrew the previously approved select
agent regulatory exclusions for the ASFV-G-[Delta]MGF and ASFV-G-
[Delta]9GL/[Delta]MGF strains and removed them from the list on the
National Select Agent Registry website. In addition, 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 part 121. APHIS
based the decision to withdraw the exclusions on newly acquired
information regarding safety and genome instability potentially leading
to reversion of virulence that was either unavailable or not provided
to either APHIS or Ag-ISATTAC during either the January 2020 or April
2021 discussions for regulatory exclusion. More specifically, among
other sources, two journal articles published in 2020 and 2021 from
China's Harbin Veterinary Research Institute identified instability
within the MGF genome segments.
With the publication of this notice, we are informing the public
that we withdrew the previously approved select agent regulatory
exclusions for the ASFV-G-[Delta]MGF and ASFV-G-[Delta]9GL/[Delta]MGF
strains, effective on January 7, 2022, and that the possession, use,
and transfer of these ASFV strains must now comply with the select
agent and toxin regulations in part 121. This notice serves as an
official record and public notification of these actions.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this action
as not a major rule, as defined by 5 U.S.C. 804(2).
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 13th day of October 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-23446 Filed 10-26-22; 8:45 am]
BILLING CODE 3410-34-P
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