[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Inspection Service (APHIS) has withdrawn the select agent regulatory 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withdrawn.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