By John Williamson
In February 2005, the University of Cincinnati opened a microbiological research laboratory to train researchers in the study of infectious agents and examine pathogens falling within the Bio Safety Level 3 (BSL3) category.
BSL3 pathogens have high potential to cause human disease or death. Examples include Y. pestis, R. rickettsii, hanta virus, West Nile virus and yellow fever. This contrasts to BSL4 pathogens, which have extreme potential to cause disease or death. Lower-risk infectious agents fall into the BSL1 and BSL2 categories.
“BSL3 labs are highly regulated,” says the facility’s director, Neal Wolfe. “Protective measures apply to personnel training, personnel protective equipment, and facility design and operation. Typically, they are independently certified prior to U.S. Department of Agriculture (USDA) or the Centers for Disease Control and Prevention (CDC) inspections,” he explains. “The pathogens being worked upon determine the inspecting agency. Reinspections are conducted on a regular basis.”
“Our first year was a success,” says Wolfe. “Most research was healthcare- and vaccine-related. Now we are expanding to bio-defense work, again with a focus on vaccines. We worked on three major projects in 2005 and expect three more this year. To date, 10 researchers have completed training, and that should also double this year.”
At 3200 square feet, the facility comprises four research labs, two animal rooms and an animal procedure room. These were designed in-house by the university and constructed primarily by local companies, Wolfe reports.
Construction and operational guidelines follow the 4th edition of the manual “Bio Safety in Microbiological and Biomedical Laboratories” (BMBL; http://bmbl.od.nih.gov/) and the federal government’s Code of Federal Regulations (CFR) Sections 7, 9 and 42 relating to agriculture, animal and animal products, and interstate shipments. Other local, state and federal regulations apply, along with those by the Institutional Animal Care and Use Committees (IACUC) and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
The ‘Three Bs’ of protection
“Comprehensive protective measures, an intense training regimen and multiple safety operating procedures describe the university’s biosafety program, one of the ‘Three Bs’ at the facility,” Wolfe says. “Biosafety is achieved with personal protective equipment. Examples are double-gloving, protective outer garments and goggles. N95 respirators and Powered Air Purifying Respirators (PAPR) provide respiratory protection.
“Biocontainment, the second B, keeps pathogens under control and inside,” Wolfe says. The entire facility is under cascading negative air pressure controlled by a redundant HEPA-filtered heating, ventilating and air conditioning (HVAC) system. “With 15 air changes per hour, we are well above the minimum required. Entry and exit is via airlocks; there is an autoclave, and work is conducted in eight biosafety cabinets and a high-aerosolization glove box,” says Wolfe.
“The third B, biosecurity, addresses the requirement to keep these agents out of the wrong hands.” For this, there is a multilayered security system, regular agent inventories and audits, personnel background checks through the FBI, and coordination and training with emergency personnel. Noting that there are extensive federal regulations regarding lab security operations and procedures, Wolfe adds, “We have gone above and beyond what these require.”
According to K. John Morrow, Jr., PhD, president of Newport Biotech Consultants (Newport, Ky.; www.newportbiotech.com), changes in the world security landscape have sparked advancements in protection against unwanted intrusion. “Newer facilities such as those at the University of Cincinnati tend toward higher-tech security equipment, with more sophisticated electronic identification procedures, such as palm print ID and retinal scans, to guard against break-ins,” he says. “While foreign terrorists are always a concern, domestic terrorists and animal rights activists must also be considered. There is no high-tech solution to a mole or infiltrator gaining a position in a facility. That means there is no substitute for thorough security checks, common sense, alertness and monitoring in a biosecurity program.”