[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 3987-3988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00774]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / 
Notices  

[[Page 3987]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

 [Docket No. APHIS-2020-0094]


Notice of Availability of a Draft Federal Select Agent Program 
Policy Statement for Biosafety for Large Animal Study-Related 
Activities With Brucella abortus and Brucella suis Using Outdoor 
Containment Spaces

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) is making a draft Federal Select Agent 
Program (FSAP) policy statement related to brucella available. This 
policy statement will aid individuals and entities on how to develop 
biosafety plans for outdoor host animal studies involving swine, elk, 
bison, and cattle to further brucellosis research in accordance with 
the select agent and toxin regulations, as well as how to submit such 
plans to FSAP (administered jointly by the Centers for Disease Control 
and Prevention (CDC) and APHIS) for approval. We are making this draft 
policy statement available to the public for review and comment. This 
notice is being issued as a companion to a notice issued by CDC, which 
is also published in today's Federal Register.

DATES: We will consider all comments that we receive on or before 
February 16, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0094.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0094, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The draft policy statement and any comments we receive may be 
viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0094 
or in our reading room, which is located in room 1620 of the USDA South 
Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.
    The draft policy statement is also available at the following 
internet address: https://www.selectagents.gov/regulations/policy/animalstudy.htm.

FOR FURTHER INFORMATION CONTACT: Dr. Jacek Taniewski, DVM, Director, 
Division of Agricultural Select Agents and Toxins, ERCS, APHIS, 4700 
River Road, Riverdale, MD 20737; (301) 851-3352; 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (42 U.S.C. 262a) and the Agricultural Bioterrorism 
Protection Act of 2002 (7 U.S.C. 8401) provide for the regulation of 
certain biological agents and toxins that have the potential to pose a 
severe threat to human, 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 
Agricultural Bioterrorism Protection Act of 2002 within the U.S. 
Department of Agriculture (USDA). The Centers for Disease Control and 
Prevention (CDC) has the primary responsibility for implementing the 
provisions of The Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 within the Department of Health and Human 
Services (HHS). Together, APHIS and CDC comprise the Federal Select 
Agent Program (FSAP) and oversee the possession, use, and transfer of 
biological agents and toxins, referred to as select agents and toxins. 
In accordance with the referenced Acts, APHIS and CDC promulgated the 
select agent and toxin regulations found in 7 CFR part 331, 9 CFR part 
121, and 42 CFR part 73. Overlap select agents and toxins, listed in 9 
CFR 121.4 and 42 CFR 73.4, are those select agents and toxins that have 
been determined to pose a severe threat to public health and safety, to 
animal health, or to animal products. Overlap select agents and toxins 
are subject to regulation by both APHIS and CDC.
    Brucellosis, also known as contagious abortion or Bang's disease, 
is a contagious, costly disease that has significant animal health, 
public health, and international trade consequences. While most often 
found in ruminant animals (e.g., cattle, bison, cervids, and swine), 
brucellosis can affect other animals and is transmissible to humans. 
Brucellosis is caused by a group of bacteria known scientifically as 
the genus Brucella. Two species of Brucella are of particular concern 
in the United States: B. abortus, principally affecting cattle, bison, 
and cervids, and B. suis, principally affecting swine and reindeer, but 
also cattle and bison.
    Brucellosis can be costly to agriculture production. In 1952, prior 
to established efforts to eradicate the disease, agriculture production 
losses due to brucellosis exceeded $400 million. A cautionary indicator 
of the need for greater understanding of the disease is the expanding 
range of endemic B. abortus in the Greater Yellowstone Area and B. suis 
in feral swine populations throughout various areas of the United 
States. This disease expansion emphasizes the critical need for 
improved diagnostics, along with vaccine development for both Brucella 
species, which could be furthered by outdoor research studies.
    Both B. abortus and B. suis are currently listed as overlap select 
agents in APHIS' and CDC's select agent and toxin regulations (9 CFR 
121.4(b) and 42 CFR 73.4(b), respectively). Accordingly, any outdoor 
research studies must comport with the select agent and toxin 
regulations. Therefore, APHIS and CDC are issuing a draft FSAP policy 
statement on biosafety for large animal outdoor containment studies 
with B. abortus and B. suis to aid individuals and entities in the 
development of biosafety plans for such studies that meet the 
requirements of the select agent and toxin regulations. We are making 
this draft policy statement available to the public for review and 
comment on regulations.gov (see ADDRESSES above) and at https://
www.selectagents.gov/regulations/

[[Page 3988]]

policy/animalstudy.htm. We will consider all comments that we receive 
on or before the date listed under the DATES section at the beginning 
of this notice.
    Copies of the draft policy statement are also available for public 
inspection at USDA, room 1620, South Building, 14th Street and 
Independence Avenue SW, Washington, DC, between 8 a.m. and 4:30 p.m., 
Monday through Friday, except holidays. Persons wishing to inspect 
copies are requested to call ahead on (202) 799-7039 to facilitate 
entry into the reading room. In addition, copies may be obtained by 
calling or writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 371.3, and 371.4.

    Done in Washington, DC, this 11th day of January 2021.
Mark Davidson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-00774 Filed 1-14-21; 8:45 am]
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