On June 27-28, 2018, the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) convened an international workshop in Amsterdam, the Netherlands, on developing norms for provision of laboratories in low-resource contexts, at the request of the U.S. Department of State’s Biosecurity Engagement Program (BEP). The purpose of the workshop was to engage an international group of organizations that provide funding for construction, upgrades, and maintenance of biological laboratories in countries that could not otherwise afford them to discuss what considerations should factor into decisions whether to pursue particular partnerships and projects. The intent was to advance the conversation about the identification and application of guiding principles and common norms for use by these organizations in supporting laboratories that work with pathogens that are particularly dangerous and require special handling, equipment, and facilities—biological safety level “2 plus” and above-for public and animal health. The statement of task is presented in Appendix A. The agenda is in Appendix B. The biographical sketches for the 21 participants from 19 organization is in Appendix C.
This proceedings has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. The planning committee’s role was limited to planning and convening the workshop. The views contained in the proceedings are those of individual workshop participants and do not necessarily represent the views of all workshop participants, the planning committee, or the National Academies.
Dr. Ann Arvin, chair of the planning committee, made welcoming remarks and explained that the participants were convened to advance the discussion on best practices toward a common approach and perhaps even common criteria or “norms” for deciding whether to provide support for specific laboratories.
Why is this discussion necessary? For some time, funders have provided this kind of assistance to developing countries with mixed results. Laboratories have been built in localities with insufficient need for them, limited funds for continued operation and maintenance, or inadequate infrastructure and availability of supplies. Lacking sufficient financial support, the laboratories have become degraded, disused, and unsafe and unsecure. In addition, some laboratories may have received financial support but lacked the ability to train personnel, again leading to problems with safety, quality, and security. These problems are not unique to laboratories in low-income countries. Laboratories have been built in the United States without sufficient consideration of the true need for them or appreciation of the expense and effort needed to sustain them. However, other challenges and risks arise in developing countries. In addition, the number of such degraded or inoperable laboratories appears to be rising, although there has not be a proper accounting of the laboratories built and by whom.
In 2011, the Academies convened an international workshop in Istanbul, Turkey, that focused on the safety and security challenges associated with the spread of high-containment laboratories. Dr. Arvin noted that multiple efforts have made progress to improve the situation. For example, the U.S. State Department issued a white paper for the 2015 Biological Weapons and Toxins Convention (BWC) Meeting of Experts that described the U.S. policy for guiding decisions on whether to fund such laboratories. Canada, which in 2018 had the chair of the G7 and the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction (see www.gpwmd.com), has worked with Chatham House, the World Organisation for Animal Health (OIE), and others to develop decision tools and engineering options applicable to such laboratory projects. This has resulted in Chatham House’s Sustainable Laboratories Initiative and the OIE Consultation on Sustainable Laboratories, insights from which were shared with the workshop participants by the respective leads of the two activities. Although Chatham House and OIE follow slightly different approaches, their findings have many common elements to draw on and discuss.
Dr. Arvin’s introductory remarks were followed by a summary of the 2011 workshop and presentations and discussions about funder goals; the need for laboratories; practical considerations for conducting the work; efforts to update guidance on laboratory safety and security; data on what we know about the location and status of existing labs; and new technological developments to replace live culture work. Because the main workshop goal was to foster productive discussions among the
participants, discussions were emphasized over presentations. Throughout this proceedings, attribution is provided only for formal presentations.
Dr. Frances Sharples, Director of the National Academies’ Board on Life Sciences, presented an overview of the July 2011 workshop in Istanbul, Turkey (hereafter the 2011 workshop), which was also held at the request of the State Department’s BEP. The 2011 workshop in some ways amounted to a precursor to the current workshop. Many of the issues addressed in 2011 were the same as those to be discussed from the funding perspective in the 2018 workshop.
On July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul for the workshop on Anticipating Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories.1 The meeting workshop held in partnership with the Turkish Academy of Sciences. The participants included laboratory directors, scientists, engineers, and members of governmental and nongovernmental organizations. They were active in the fields of biosafety, biosecurity, scientific research, disease surveillance, and public health. Some were from countries with a long history of operating multiple laboratories, while others were from countries that had only recently opened their first biological containment lab. Many were affiliated with groups contemplating the construction of new laboratories or interested in improving their existing facilities.
The workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories equivalent to the U.S. Centers for Disease Control and Prevention’s high-containment (BSL-3+) laboratories. Although these laboratories enable the characterization of highly dangerous human and animal pathogens, assist in disease surveillance, and serve as resources for the production of vaccines, they are complex facilities and building and operating them entails some risks.
During the course of the meeting, Sharples reported that the 2011 workshop participants discussed many aspects of the workshop topic, including:
1 The report summarizing the results of the 2011 workshop is titled Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop and is available on the National Academies Press website at https://www.nap.edu/catalog/13315.
- 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 status of biocontainment laboratories around the world, participants described the history and challenges they face in their individual laboratories. Speakers described steps being taken to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many spoke about physical security, access controls, and monitoring of pathogen inventories. The 2011 workshop participants also identified tensions in the field and suggested possible remedies.
According to Sharples, the 2011 workshop participants cited many examples of inadequate (in their opinion) implementation of biosafety and biosecurity precautions. For example, in some labs, poorly trained workers were performing aerosol-generating procedures without the benefit of personal protective equipment. Many biosafety cabinets were neither functional nor regularly inspected. For some labs, the availability of electricity and water was severely limited. Many countries have few or no regulations covering biocontainment laboratories and little or no government involvement in their operation and maintenance. In contrast, laboratories in some countries invest in cutting-edge air-handling systems and adhere to the standards for all biosafety levels regardless of the mission or setting.
On the topic of safeguards, participants made the following observations and suggestions:
- Failure to implement and use all possible safety and security measures could be considered irresponsible because it imposes the risk of accidental or deliberate pathogen release on surrounding communities.
- Regulations have not kept pace with evolving practices and engineering options, and the options available in were unnecessarily expensive and did not provide maximum risk reduction.
- There is a need to fund more applied biosafety research.
- Because of limited resources and competing funding priorities, laboratories and the communities in which they reside should define an acceptable level of risk and then select their precautions accordingly using a qualitative and/or quantitative risk analysis.
Sample and Strain Transport
The 2011 workshop participants discussed the need to balance the risks and intellectual property concerns of transporting strains and diagnostic samples to regional or other analytical facilities with the costs and risks of constructing, operating, and maintaining additional biocontainment labs and pathogen collections in situ. Numerous participants expressed frustration with what they perceived to be unnecessarily restrictive transport, import, and export regulations. They also complained about burdensome paperwork, precautions that were disproportionate to the risk, long delays in obtaining transport permission, and the need for approval by multiple officials, any of whom 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 of Experts on the Transport of Dangerous Goods, and national governments in dialog to better define the requirements for safe transport and to accurately characterize the associated risks.
Many 2011 workshop participants expressed the need for regulatory frameworks that support safe and secure research without adding undue burdens. Participants said that some laboratories work under limited or poorly enforced national regulatory frameworks, while others must comply with multiple sets of regulations to satisfy donor and national government requirements. Similarly, a lack of national and international guidance and accreditation standards is a source of frustration for laboratories seeking formal accreditation or certification. Most participants believed that implementing national regulatory frameworks and certification procedures was largely the responsibility of individual countries, but agreed that international assistance could facilitate the process. Others urged donors to simplify their regulatory requirements.
Numerous discussions in the 2011 workshop emphasized the importance of the planning (needs assessment) phase that precedes facility design and construction or upgrade. Many participants stressed the
benefits of involving all stakeholders (the local community, architects, lab directors, scientists, regulators, designers, contractors, and certifiers) in this phase as well as the design and construction phase. Some participants suggested that the planning phase consider provisions for surge capacity (i.e., temporary increases in analytical capacity in response to disease outbreaks; ways in which a new laboratory might expand and complement existing national and regional capabilities; and how emerging technologies, such as molecular diagnostics, could affect containment requirements and reduce the need for labs with the highest containment levels). Preparations for long-term sustainability, including ensuring the availability of operation and maintenance funds, equipment and reagents, and adequately trained workers with the appropriate expertise (e.g., engineers, technicians, biosafety professionals, craftspeople, and lab workers) can also begin during the planning phase.
Dr. Sharples concluded her remarks by noting that many participants identified the BWC review conference in December 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 Manual2 as opportunities for the biosafety, biosecurity, and public health communities to make changes. Biosafety associations could also assist by providing neutral national and/or 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.