OVERVIEW

During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State’s Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The attendees included laboratory directors, scientists, engineers, and members of governmental and nongovernmental organizations. The participants were active in the fields of biosafety, biosecurity, scientific research, disease surveillance, and public health. Some came from countries with a long history of operating multiple laboratories while others were from countries that had only recently opened their first biological containment (biocontainment) lab. Many were affiliated with groups contemplating the construction of new laboratories or interested in improving their existing facilities.

The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories—equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks.

During the course of the meeting, participants discussed many aspects of the topic including:

•   Technological options to meet diagnostic, research, and other goals;

•   Laboratory construction and commissioning;

•   Operational maintenance to provide sustainable capabilities, safety, and security; and

•   Measures for encouraging a culture of responsible conduct.

To develop a sense of the current norms in the world, workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.

DETERMINING AND ADOPTING APPROPIRATE SAFEGUARDS

Participants described many examples where, in their opinion, biosafety and biosecurity precautions were not proportional to the risks. In some labs, poorly trained workers perform aerosol-generating procedures without the benefit of personal protective equipment and functional, certified biosafety cabinets. In contrast, other labs invest in cutting-edge air-handling engineering and adhere to all recommendations of a standard biosafety level, regardless of the particulars of their mission or setting (e.g., disease endemicity, local population immunity, and local risk tolerance). One participant argued that given the high costs of an accidental or deliberate pathogen release, not using all possible safeguards could be considered irresponsible and was likely to upset communities in which laboratories reside. Others argued that regulations have not kept pace with evolving practices and engineering options and that the ensemble of options used today is both unnecessarily expensive and does not provide the



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OVERVIEW During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State’s Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The attendees included laboratory directors, scientists, engineers, and members of governmental and non- governmental organizations. The participants were active in the fields of biosafety, biosecurity, scientific research, disease surveillance, and public health. Some came from countries with a long history of operating multiple laboratories while others were from countries that had only recently opened their first biological containment (biocontainment) lab. Many were affiliated with groups contemplating the construction of new laboratories or interested in improving their existing facilities. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories— equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks. During the course of the meeting, participants discussed many aspects of the topic including: • Technological options to meet diagnostic, research, and other goals; • Laboratory construction and commissioning; • Operational maintenance to provide sustainable capabilities, safety, and security; and • Measures for encouraging a culture of responsible conduct. To develop a sense of the current norms in the world, workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action. DETERMINING AND ADOPTING APPROPIRATE SAFEGUARDS Participants described many examples where, in their opinion, biosafety and biosecurity precautions were not proportional to the risks. In some labs, poorly trained workers perform aerosol-generating procedures without the benefit of personal protective equipment and functional, certified biosafety cabinets. In contrast, other labs invest in cutting-edge air-handling engineering and adhere to all recommendations of a standard biosafety level, regardless of the particulars of their mission or setting (e.g., disease endemicity, local population immunity, and local risk tolerance). One participant argued that given the high costs of an accidental or deliberate pathogen release, not using all possible safeguards could be considered irresponsible and was likely to upset communities in which laboratories reside. Others argued that regulations have not kept pace with evolving practices and engineering options and that the ensemble of options used today is both unnecessarily expensive and does not provide the 1

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2 Biosecurity Challenges maximum risk reduction. Accordingly, some workshop attendees urged that more applied biosafety research be funded. Yet others suggested that in view of limited resources and competing funding priorities, labs and the communities in which they reside should define an acceptable level of risk and select their precautions accordingly using a qualitative and/or quantitative risk analysis. SAMPLE AND STRAIN TRANSPORT Participants also discussed the need to balance the risks and intellectual property concerns of transporting strains and diagnostic samples with the costs of maintaining additional biocontainment labs and pathogen collections. Numerous participants expressed frustration with what they perceived as unnecessarily restrictive transport, import, and export regulations. Individuals also complained about burdensome paperwork, precautions perceived as out of proportion to the risk, long delays to obtain permission, and multiple levels of officials who could block a transfer. To ameliorate some of these problems, several participants suggested continuing to engage the International Air Transport Association, the United Nations Committee on Dangerous Goods Transport, and national governments in dialogs to better define the requirements for safe transport and to accurately characterize the associated risks. NATIONAL REGULATIONS Many workshop attendees expressed the need for regulatory frameworks that support safe and secure research without adding undue burdens. Currently, some laboratories work under a limited or poorly enforced national regulatory framework, while others must comply with multiple sets of regulations to satisfy donor and national requirements. Similarly, a lack of national and international guidance and accreditation standards frustrates some laboratories seeking formal accreditation or certification. While most felt that implementing national regulatory frameworks and certification procedures was largely a responsibility of individual countries, many suggested that international assistance could facilitate the process. Others urged donors to simplify their regulatory requirements. LABORATORY PLANNING Numerous discussions emphasized the importance of the planning (needs assessment) phase that precedes facility construction and upgrades. Many workshop attendees stressed the benefits of involving everyone (e.g., the community, architects, the lab director, scientists, regulators, designers, contractors, and certifiers) from the very beginning and keeping them involved throughout the process. Some participants suggested that the planning phase might consider provisions for surge capacity (temporary increases in capacity of a needed containment level) in response to disease outbreaks; ways a new laboratory might expand and complement existing national and regional capabilities; and how emerging technologies, such as molecular diagnostics, affect containment requirements. Preparations for long-term sustainability including planning for maintenance and operational funds, obtaining equipment and reagents, and recruiting or training people with the needed expertise (e.g., engineers, technicians, biosafety professionals, craftspeople, and lab workers) can also start during the planning phase. Many participants identified the Biological and Toxin Weapons Convention review conference in December of 2011 and the subsequent annual "experts meetings," the International Health Regulations update in 2014, and the next revision of the World Health Organization’s Laboratory Biosafety Manual as places the biosafety, biosecurity, and public health communities might try to make changes. Biosafety associations could assist by providing

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3 Overview neutral, national and regional platforms for discussions among stakeholders from multiple agencies and encouraging the adoption of a biosafety culture. Additionally, individual “champions” could take up the cause and spread the message in their countries and regions.

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