[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4079-4080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00877]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0003]


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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of availability and request for comment.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) is opening a public 
docket to obtain comment on a draft Brucella policy statement. This 
draft policy statement, when finalized, will aid individuals and 
entities in the development of biosafety plans for outdoor large animal 
studies involving swine, elk, bison, and cattle to further brucellosis 
research in a manner that complies with the HHS and U.S. Department of 
Agriculture (USDA) select agent regulations. In a companion document 
published in this issue of the Federal Register, USDA has proposed the 
same policy for comment.

DATES: Submit written or electronic comments by March 16, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0003 by either of the methods listed below. Do not submit comments by 
email. CDC does not accept acomments by email.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Select Agents and Toxins, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-7, 
Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket No. CDC-2021-0003 for this rulemaking. All relevant comments 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided.
    Docket Access: For access to the docket to read background 
documents or comments received, or to download an electronic version of 
the draft policy statement, go to http://www.regulations.gov. Please be 
aware that comments and other submissions from members of the public 
are made available for public viewing without changes.

FOR FURTHER INFORMATION CONTACT: Samuel S. Edwin Ph.D., Director, 
Division of Select Agents and Toxins, Centers for Disease Control and

[[Page 4080]]

Prevention, 1600 Clifton Road NE, Mailstop H21-7, Atlanta, Georgia 
30329. Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION:

A. Legal Authority

    HHS/CDC is promulgating this policy under the authority of sections 
201-204 and 221 of Title II of Public Law 107-188, 116 Stat 637 (42 
U.S.C. 262a).

B. Background

    Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Bioterrorism Response Act) (42 U.S.C. 
262a(a)(1)), the HHS Secretary regulates a list of biological agents 
and toxins that have the potential to pose a severe threat to public 
health and safety. The biological agents and toxins listed in 42 CFR 
73.3 (HHS select agents and toxins) have the potential to pose a severe 
threat to human health and safety and are regulated only by HHS/CDC. 
The biological agents listed in Sec.  73.4 (overlap select agents and 
toxins) have not only the potential to pose a severe threat to human 
health and safety; but have been determined by the USDA, pursuant to 
USDA's authority under the Agriculture Bioterrorism Protection Act of 
2002 (7 U.S.C. 8401), to have the potential to pose a severe threat to 
animals and animal products. Accordingly, these biological agents are 
jointly regulated by HHS/CDC and USDA as ``overlap'' select agents. The 
Bioterrorism Response Act defines the term ``overlap agent or toxin'' 
to mean a biological agent or toxin that is listed pursuant to 42 
U.S.C. 262a and is listed pursuant to 7 U.S.C. 8401. See 7 U.S.C. 8411.
    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 found 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 select agent regulations (42 CFR 73.4 and 9 CFR 121.4). 
Accordingly, any outdoor research studies must comport with the select 
agent and toxin regulations. Therefore, HHS/CDC and USDA are issuing a 
FSAP draft 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 regulations. We are making 
this policy document available to the public at the Supporting & 
Related Materials tab of the docket and at https://www.selectagents.gov/regulations/policy/animalstudy.htm for review and 
comment.
    Copies of the policy document 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.

Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-00877 Filed 1-14-21; 8:45 am]
BILLING CODE 4163-18-P