Share thisThe potential threat of avian flu and the need for appropriate facilities to work with strains of HPAI raise design issues of protection and timely development.
We, like everyone else, have become increasingly concerned about the potential threat of an influenza pandemic over the next few years and the impact it could have on the world’s health and economy. There seems to be a perception of difficulty in the design of appropriate laboratory scale and small animal facilities for work with HPAI caused by the lack of shared knowledge available on the real design issues related to containment. There is also a wide variety of responses in facilities that are currently working with various strains of HPAI. We have been working with CDC, NIH, the British Government, and others on new HPAI facilities and have been reviewing HPAI facilities in the U.S. and Asia. We find that there is not a great deal of consensus on what to do related to design issues, particularly the enhancements to BSL-3 (or ABSL-3) required for environmental protection. We felt that it would be important to share lessons learned from these experiences to assist the scientific and laboratory design community to get these facilities up and running as quickly as possible. In addition to facility development and operations, appropriate security programs must also be implemented.
It is important to note that “one size does not fit all” in biocontainment and that the information provided does not substitute for a risk assessment of the work to be undertaken and the specific facility requirements required to mitigate the risk. In particular, this should be undertaken in light of any local regulations regarding biosecurity and biocontainment. In addition, this column is focusing on HPAI facilities; requirements may be more stringent if other highly pathogenic influenzas such as the 1918 influenza virus construct are utilized. It must be clearly noted that in working with an easily transmitted, high consequence agent such as HPAI, careful attention to appropriate biosafety practices and procedures is critical, no matter how well the facility is designed and operated.
The impetus for this discussion was the ambiguity of when, where, and how to apply the regulations that govern the design of these types of spaces, particularly those designed to work with small animals housed in primary containment. Recognizing this lack of clarity in the design guidelines, the CDC is in the process of developing guidelines to address this issue. These standards will be incorporated into the 5th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) publication, which is due to be available to the general public in the spring of 2006. As this column is not intended to replace the guidance from BMBL, it would be wise to consult this document, when available, for additional guidance on facility design criteria and appropriate procedures for HPAI laboratories.
In the U.S., the Animal and Plant Health Inspection Service (APHIS), a department of the United States Department of Agriculture (USDA), is the governing body which regulates the transport and possession of pathogens having a potential to dramatically impact the country’s plant and livestock resources, including HPAI. APHIS is also the governing body that establishes and enforces the requirements for the facilities that house HPAI. The Centers for Disease Control, through their select agent program, may be the inspecting agency in lieu of APHIS. Prior to construction planning on a facility for HPAI, the risk assessment and the containment strategy should be discussed with the agency assigned to review and inspect your facility.