Dr. Blacksell started by noting that the world’s population is concentrated in Southeast Asia and that newly emerging diseases (e.g., severe acute respiratory syndrome [SARS] and Nipah), agents of increased virulence (e.g., avian influenza and tuberculosis), and endemic diseases caused by risk group 3 agents drive the region’s diagnostic and research needs.
While Southeast Asia has at least 45 BSL-3 labs, Dr. Blacksell explained that running a facility responsibly requires a huge investment of time, people, facilities, and money, and questions exist about standards, management, training, and security for most labs in the region.
As an example of the challenges, Dr. Blacksell described his experiences with MORU, which maintains a regional network of field sites and BSL-2 and BSL-3 labs. MORU recently built new labs in Bangkok, Thailand and Vientane, Laos and has three additional labs in Thailand as well as labs in Cambodia and Bangladesh.
Historically, the area has lacked a safety culture, so MORU requires a robust induction procedure and documents all training and the resulting competencies of its employees. For its training, MORU utilizes consultants, the United States Department of State Biosecurity Engagement Program (BEP), Sandia National Laboratories, the World Health Organization (WHO), and the Australian Government Overseas Aid Program (AusAID). Training includes dual-use awareness, and labs hold regular refresher training.
MORU employs a full time Biosafety Administrator, a 50 percent time Registered Biosafety Professional, and seven biosafety site representatives. To help address the severe regional lack of biosafety experience and fill the required positions, MORU formed a regional twinning partnership with the Australian Animal Health Laboratory.
Dr. Blacksell stated that security is a concern and that each lab has a site-specific security plan. Because the lab’s funding includes U.S. money, to obtain access, staff must pass a United States Federal Bureau of Investigation security risk assessment and be a United States Department of Justice “registered entity.” Where possible (i.e., Thailand), local police also check all staff using national and international databases.
In additional to personnel checks, the labs have also invested in physical security. BSL-3 freezers require fingerprint access, and access is restricted to three people; incubators with BSL-3 organisms use coded locks. Additionally, MORU has catalogued 20,000 freezer samples, documenting agent, source, intended use, and quantity using software that creates an audit trail. Audits are conducted every three months.
While South Korea and Singapore and to a lesser extent Thailand have well-developed laws governing the safe and secure operation of biocontainment facilities, he observed that most countries in the region either lack national biosafety legislation or have laws that are poorly enforced and understood. MORU is required to follow the host country’s local laws, United Kingdom rules because of their Oxford University affiliation, and Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines and United States Select Agent rules to obtain access to U.S. funds. He elaborated that earning Select Agent qualification turned out to be a bigger task than initially expected but that it was ultimately worthwhile both because of the resulting access to funds and because it gave them added confidence in their operation. The application process, which made them examine everything they did, ultimately resulted in good databases, emergency response procedures, and standard operating procedures (SOP) in both English and Thai.
Other challenges include mismanagement, finding local services and resources, and limited budgets, particularly for maintenance and training. Additionally, the tropical climate makes it very wasteful to cool and dry air only to ultimately pump it back outside; he suggested that regulators consider allowing recirculation of 85 percent of the air with additional high-efficiency particulate air (HEPA) filtration.
Given the complexity of running BSL-3 labs in the area, Dr. Blacksell encouraged people considering new labs to accurately assess their initial expenses, anticipated operational and