Notice of Withdrawal of Select Agent Regulatory Exclusions for Two Strains of African Swine Fever Virus, 65023 [2022-23446]
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65023
Notices
Federal Register
Vol. 87, No. 207
Thursday, October 27, 2022
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.
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of withdrawal of select
agent regulatory exclusions.
AGENCY:
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withdrawn the select agent regulatory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–DMGF and
ASFV–G–D9GL/DMGF. 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.
SUMMARY:
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select agent exclusions were withdrawn.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:
Randy.T.Capsel@usda.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
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
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
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
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 § 121.3(b) of
the select agent and toxin regulations.
APHIS approved the initial select agent
regulatory exclusions of two ASFV
strains, ASFV–G–DMGF and ASFV–G–
D9GL/DMGF, 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 § 121.3(e)(1), APHIS listed
the exclusions on the National Select
Agent Registry website at https://
www.selectagents.gov.
On January 7, 2022, APHIS withdrew
the previously approved select agent
regulatory exclusions for the ASFV–G–
DMGF and ASFV–G–D9GL/DMGF
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
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
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–DMGF and ASFV–G–
D9GL/DMGF 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
DEPARTMENT OF AGRICULTURE
Foreign Agricultural Service
Notice of Request for Approval of an
Existing Information Collection in Use
Without an Office of Management and
Budget Control Number
Foreign Agricultural Service,
USDA.
ACTION: Notice of Information
Collection; request for comments.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the intention of the
Foreign Agricultural Service (FAS) to
request approval for an existing
collection in use without an Office of
Management and Budget (OMB) control
number for the International
Agricultural Education Fellowship
Program.
DATES: Comments on this notice must be
received by December 27, 2022 to be
assured of consideration.
ADDRESSES: You may send comments,
identified by OMB Control Number
0551-New, by any of the following
methods:
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Page 65023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23446]
========================================================================
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. 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.
-----------------------------------------------------------------------
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: [email protected].
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 https://www.selectagents.gov.
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
