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.
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.
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