Preview of the FSAP Draft Policy Statement:
Biosafety for Large Animal Study-Related Activities with B. abortus and B. suis Using Outdoor Containment Spaces
Below, the Federal Select Agent Program (FSAP) wishes to provide a preview of the FSAP Draft Policy Statement, Biosafety for Large Animal Study-Related Activities with Brucella abortus and B. suis Using Outdoor Containment Spaces, that soon will be published in the Federal Register for public comment. FSAP received Office of Management and Budget approval to share the draft policy in advance in order to allow the public to view it prior to submitting comments through the Federal Register process. The draft policy will be officially published in the Federal Register in the coming weeks.
Draft Policy Statement from the Federal Select Agent Program
Biosafety for Large Animal Study-Related Activities with Brucella abortus and B. suis Using Outdoor Containment Spaces
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, and 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. Both Brucella species are listed as overlap select agents under the select agent and toxin regulations. 9 C.F.R. § 121.4(b), 42 C.F.R. § 73.4(b). FSAP regulates the possession, use, and transfer of select agents, which includes any animals that have intentionally been introduced to the agents.
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.
FSAP recognizes the need to conduct host animal studies involving swine, bovine, and cervid species to further brucellosis research. Multiple research needs involving both B. abortus and B. suis have been identified and communicated to FSAP. Previous brucellosis transmission and pathogenesis outdoor studies with large animals were not conducted in compliance with the select agent and toxin regulations and were subsequently terminated. Due to the intentional introduction of the agent during the studies, the studies did not meet the requirements for exclusion from the select agent and toxin regulations in 9 C.F.R. §121.4(d)(1), and 42 C.F.R. §§ 73.4(d)(1)). As a result, FSAP issued an August 18, 2017 Policy Statement entitled “Non-Exclusion of Study-Related Activities Involving Naturally Infected Animals.”external icon
Proper containment of B. abortus and B. suis, including containment of the animals that have intentionally been introduced to the select agents, is of paramount importance to protect researchers and all study personnel, the public, and the environment. Proper containment is also essential to comply with the select agent and toxin regulatory requirements. FSAP recognizes that large animal outdoor containment studies with B. abortus and B. suis cannot be conducted under the normally applicable Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines. However, FSAP anticipates that such outdoor studies can be conducted in compliance with the select agent and toxin regulations with the institution of other biosafety and containment procedures.
FSAP is issuing the following policy statement on large animal outdoor containment studies with B. abortus and B. suis to aid individuals and entities in the development of biosafety plans that meet the requirements of the select agent and toxin regulations. This policy statement emphasizes research needs related to cattle, bison, elk, and feral swine and the accompanying difficulty of limited indoor large animal containment facilities to conduct such host animal studies on a larger scale and appropriately handle the wildlife species.
B. abortus and B. suis are listed as overlap select agents and toxins (9 C.F.R. § 121.4(b), 42 C.F.R. § 73.4(b)) and therefore, their possession, use, and transfer must comply with the select agent and toxin regulations. Under section 12(a) of the select agent and toxin regulations,
[a]n individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent.
Under section 12(b), “[t]he biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).”
Biosafety plans for large animal B. abortus or B. suis outdoor containment studies within endemic areas of the agents should contain sufficient information for FSAP to determine that the study can be safely conducted in compliance with the select agent and toxin regulations. Factors and procedures that FSAP will look for in the biosafety plan include:
- Details of the biosafety level plan containment procedures for the animals as well as the agent(s). FSAP recognizes that unique containment procedures will be relevant and may need to be employed for work with species such as bison, elk, and feral swine;
- Appropriate animal containment and handling procedures that ensure animals enrolled in the study will always be confined and have no direct contact with susceptible animals not enrolled in the study that are present in the vicinity of the study site. Such containment and handling procedures need to prevent the accidental exposure or infection of animals (domestic and wildlife) not enrolled in the study with the agent both during and after conclusion of the study; including where appropriate, but not limited to: double penned enclosures, fence heights appropriate to species and netting and other safeguards to prevent inadvertent inter-species transfer, indoor facilities, and incineration or other organism-destroying deactivation of waste.
- Safeguards and protocols for ensuring the safety of the study personnel based upon risk assessments, including, but not limited to: personal protective equipment, animal restraint equipment, and animal handling protocols;
- Protocols for animal euthanasia and the processing of animal samples, tissues, and infectious waste; and
- Information about the endemic prevalence of the select agent under study (either abortus or B. suis) to the region (as defined by the State or Federal Veterinary Health Officials) of the study site. Such information will be considered in assessing the risk associated with the proposed study.
Specific study protocols, which may not be contained in detail within the biosafety plan, but are related to biosafety, will also be reviewed. Examples of protocols specific to the following study factors should be readily available for FSAP review if not included in the biosafety plan:
- Animal transport, handling, and quarantine plans;
- Personnel occupational health and surveillance and exposure plans with associated risk assessments;
- Transmission/challenge procedures;
- Animal sample collection, sample transport and security, sample processing, and sample disposition procedures;
- Animal disposition procedures at study completion;
- Animal holding pen disinfection; and
- Waste collection and disposal management plan.
Non-registered entities should contact AgSAS for additional information and guidance for FSAP registration and subsequent study review. Registered entities can submit registration amendment requests through the electronic FSAP (eFSAP) information system as is customarily done. An entity will also have the option of providing the amendment request and accompanying documentation to AgSAS prior to an eFSAP registration amendment submission. This option is provided to allow the entity to work directly with AgSAS and obtain technical assistance and guidance prior to submitting the amendment request through eFSAP.