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

Breakout #1: Eastern Asia Fran Sharples NAS Staff

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?

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

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

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.

Breakout #2: Africa Ben Rusek NAS Staff

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

Morocco Biopharma Research Lab State lab created in 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.

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

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

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

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

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

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

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

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

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)