Session #1: Paths From Assessments to Functional Labs

1. Session #1: Paths From Assessments to Functional Labs • Examples of how countries and companies construct labs in three regions • Activities at those labs • Effectiveness of the labs to meet their original objective • Lessons learned during lab operation Rapporteurs: Fran Sharples, Ben Rusek, and Alison Hottes

2. Breakout #1: Eastern Asia Fran Sharples NAS Staff

3. Mahidol Oxford Tropical Medicine Research Unit (MORU) • Major labs in Bangkok, Vientiane • MORU funding imperative is to follow BMBL5, US Select Agent rules, Thai law • Requires full time biosafety administrator, registered biosafety professional, 7 biosafety site representatives • Requires robust induction procedure and documented competency; dual use awareness; training by experts with regular refreshers • Had to create baseline inventory, have catalogued 20,000 samples from freezers over last 3 years • Need to rethink some aspects, e.g., in tropical climate, wasteful to pump cool, dry air outside • Engineering and technology choices should be based on risk assessments: Is BSL3 really needed? Could BSL2 with some upgrades work instead?

4. International Vaccine Institute, South Korea • Non-profit international with HQ in Seoul under UN Develop Program • Subject to Korean law on highly dangerous pathogens • Construction began 2007, certified by Korean CDC in 2009, opened in 2010, has operated for one year • Operates under internal regulations in BSL3 manual and 19 SOPs • Internal approval system: Institutional Biosafety Committee for research and General Manager for access • Training to create and nurture biosafety culture for both lab workers aqnd maintenance staff • Maintenance: daily/weekly/monthly/annual inspections • Alarm system to detect malfunction emergencies • Annual revalidation in 2011

5. Central Biocontainment Laboratory, Bangkok, Thailand • Supported by University medical centers and Thai Red Cross • Need to provide safe environment for working with bioagents (SARS, bird flu, swine flu) • Operated since 2008 • Working group of 5 experienced members, one full time staff for facility and equipment, regular maintenance • Efforts to sustain and improve • Obstacles: costs very high, supported by faculty of medicine so far

6. Conclusion • East Asia a hotbed of emerging and re-emerging infectious diseases • At least 45 BSL3 LABS in southeast Asia • Many east Asian countries low resource settings: Laos, Cambodia, Vietnam, Thailand • For many labs in these countries, are questions about standards, management, training, security, lack of biosafety professionals, etc. • Many also lack national legislation or have laws that are poorly enforced and/or understood. (Does not apply to Singapore, Korea, some Thai law). • Money to build labs is easy, money for maintenance is hard to come by.

7. Breakout #2: Africa Ben Rusek NAS Staff

8. Veterinary Serum and Vaccine Research Institute (VSVRI) • Located in Cairo, Egypt • Vaccine production facility for avian flu, FMD, sera and diagnostic reagents and research in these areas • Part of the response to the Egyptian avian flu outbreak • Created BSL3 lab out of existing lab due to the difficulty of getting a license for a new site, construction will be complete in three months • Will be a fully functional BSL3 facility when online • Currently developing biosafety training program for lab workers

9. Morocco Biopharma Research Lab • State lab created in 1984. Used for bacterial fermentation, diagnostics and animal disease surveillance, vaccine production, and culture collection. • Has helped keep Morocco free from FMD since 1998 although FMD is endemic in the region (maintains 2 million doses as concentrated inactivated antigen that could be manufactured within two days). • Plans to upgrade to GMP standards to improve production and quality control and expand the facilities at the current location • This would include an upgrade to the lab buildings from centralized to terminal HEPA filters and improve fluid distribution and waste treatment. • Eventually build a new laboratory according to international standards away from the current residential area location.

10. The International Centre of Medical Research of Franceville Gabon: CIRMF • Primarily gov funded lab has isolated 16 of 18 strains of Ebola • CIRMF remote location is close to emerging infections (500 km from capital, all facilities onsite) • Emergency BSL3+ took 2 years to build in 1997 after Ebola outbreak in Gabon, BSL4 completed in 2011 and took 7 years • Today operates BSL3, ABSL3 and primate facility and BSL4 glovebox • Remote location makes maintenance a problem

11. Conclusion • North Africa is an international crossroads and Central Africa is a hotbed of emerging infectious diseases so the location of containment labs in the region is especially important • Although the three labs presented in Egypt, Morocco and Gabon would be considered to be in “developing” countries all are well funded • For these labs partnership with other countries and federal sponsorship are important for sustainment • These labs are fulfilling their research and public health goals but require good leadership to implement projects and programs in the future. • Again largest issues are funding for maintenance and training. Important to design the maintenance plan for a facility as it is being designed and built • Might be useful to have a group that certifies BSL3 equipment in Africa

12. Breakout #3: Eastern Europe and Western Asia Alison Hottes NAS Staff

13. Pendik Veterinary Control and Research Institute (Turkey) • Founded in 1894 and moved to current location in 1912 • Started by producing cattle plague serum • Currently national reference lab for some animal diseases and has responsibility for animal diseases in local region • Produces vaccines, serums, antigens • In response to avian influenza in domestic and wild poultry, Turkey assessed needs • Decided to add BSL3 capabilities to Pendik • Currently waiting for equipment placement and personnel training

14. Chumakov Institute of Poliomyelitis & Viral Encephalitides of Russian Academy of Medical Sciences • Founded 1955 to combat poliomyelitis • Produced vaccines that lead to successful eradiation of poliomyelitis in Russia (since reintroduced) • Focus changing to match current public health threats such as hepatitis B and hemorrhagic fever with renal syndrome • Recently removed old infrastructure and updated virus collections • Currently holds Containment BSL2 Certification (Russian system)—need to pay to maintain certification • 6 workers, including presenter, have been infected by a hantavirus or an arenavirus during laboratory research

15. Georgian Central Public Health Reference Laboratory • U.S. supporting as part of Biological Threat Reduction Program and will maintain long-term presence • Will serve as regional reference lab • Promote public and animal health through infectious disease detection, epidemiological surveillance, and research for the benefit of Georgia, the Caucasus region, and the global community. • Half BSL3-capable, half BSL2-capable • Animal and human wings • Currently training Georgian locals • Expect certification by end of the year

16. Planned Kyrgyz Republic Lab • Canada committed $1 billion to Global Partnership including $100 million for biological non-proliferation • Searched for projects in former Soviet Union with large impact • Kyrgyz Republic has endemic diseases of terrorist concern (e.g., FMD, anthrax), large pathogen collections, and decaying facilities • Designed lab • Animal and human facilities • Central reference lab • Attempt to use local markets and trades • Involved scientists, government, community, and designers from the beginning • Lab currently on hold due to Krygyz Republic politics

17. Lessons Learned • Uncertainty leads to overdesign do full needs assessment first and expect things to evolve • Involve and inform everyone from the start including community, local and national government, collaborators, scientists, designers, engineers, contractors, and certifiers • Only accept contractors and sub-contractors with containment lab experience

18. Issues Raised • When should pathogen collections be destroyed? Preserved? • Should the decision to build a lab be a national or international decision? • Is there a way to certify workers as BSL3-competent? • Should animal and human work be combined in a single lab? • Cost effective • Groups historically are separate, but forced interactions can be productive (One Health)