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 § 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 .

86 FR 4079