9

CONCLUDING PLENARY DISCUSSIONS:
MAJOR THEMES AND NEXT STEPS

Chair: Adel Mahmoud

Following brief presentations from rapporteurs on the previous day’s breakout sessions, United States National Research Council (NRC) Committee Chair Adel Mahmoud (Princeton University, United States) led a final discussion on July 13, 2011 to draw attention to the main themes from the workshop, consider the importance of the various issues raised, and identify possible next steps. In the course of the discussion, the group considered the overarching challenges; connections, drivers, and tensions in the field; the areas of greatest concern; and actions with the potential to generate the largest positive impact.

Many participants commented on various aspects of the on-going global expansion of high-containment laboratory capacity. Construction of new labs is continuing, and with the WHO International Health Regulations (IHR) (2005) coming into force, many countries are deciding whether to create their own diagnostic capabilities or to rely on regional neighbors to meet their needs. Laboratory networks are coalescing as countries and regions decide which capabilities they should share and which they need locally. Inadequate transportation infrastructure, restrictive shipping regulations, and intellectual property concerns, however, often hamper multi-national efforts. Many facilities need improved sustainability strategies some participants noted, as donors and national governments often choose to fund new labs rather than maintain on-going operations at older labs. Furthermore, emerging technologies such as molecular diagnostics and high-throughput sequencing, which unlike culture-based assays do not require viable pathogens or containment labs, are expanding diagnostic options and infrastructure is struggling to keep up. Similarly, regulations and guidance have not always kept pace with developments. In some countries, rules exist but are poorly understood and enforced, and many countries lack national guidelines and regulations altogether. Many felt that while these topics are predominantly national issues, international discussions could facilitate progress.

TRANSITIONING FROM BIO SAFETY LEVEL-BASED TO FULLY RISK-BASED PRECAUTIONS

Some speakers drew attention to limitations of the current World Health Organization (WHO) and “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) systems (i.e., BSL-1, 2, 3, or 4) for characterizing labs and practices. While acknowledging the simplicity of systems with a small number of pre-defined levels, they felt the classification methodologies too coarse to describe the wide spectrum of risks that laboratories must address and indicated that the levels are sometimes negatively perceived as a ranking. Others desired minimal standards that could serve as an attainable goal.1 Many argued that while BSL levels were created as specific measures to mitigate particular risks, recently BSL levels have often been used as general-purpose, canned solutions. A common complaint was that by strictly enforcing adherence to one of the standard levels, funders often stop engineers and architects from

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1 Global Laboratory Initiative’s recommendations for tuberculosis procedures (described in Chapter 6), are an example of guidance that could function as a minimum standard.



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9 CONCLUDING PLENARY DISCUSSIONS: MAJOR THEMES AND NEXT STEPS Chair: Adel Mahmoud Following brief presentations from rapporteurs on the previous day’s breakout sessions, United States National Research Council (NRC) Committee Chair Adel Mahmoud (Princeton University, United States) led a final discussion on July 13, 2011 to draw attention to the main themes from the workshop, consider the importance of the various issues raised, and identify possible next steps. In the course of the discussion, the group considered the overarching challenges; connections, drivers, and tensions in the field; the areas of greatest concern; and actions with the potential to generate the largest positive impact. Many participants commented on various aspects of the on-going global expansion of high-containment laboratory capacity. Construction of new labs is continuing, and with the WHO International Health Regulations (IHR) (2005) coming into force, many countries are deciding whether to create their own diagnostic capabilities or to rely on regional neighbors to meet their needs. Laboratory networks are coalescing as countries and regions decide which capabilities they should share and which they need locally. Inadequate transportation infrastructure, restrictive shipping regulations, and intellectual property concerns, however, often hamper multi-national efforts. Many facilities need improved sustainability strategies some participants noted, as donors and national governments often choose to fund new labs rather than maintain on-going operations at older labs. Furthermore, emerging technologies such as molecular diagnostics and high-throughput sequencing, which unlike culture-based assays do not require viable pathogens or containment labs, are expanding diagnostic options and infrastructure is struggling to keep up. Similarly, regulations and guidance have not always kept pace with developments. In some countries, rules exist but are poorly understood and enforced, and many countries lack national guidelines and regulations altogether. Many felt that while these topics are predominantly national issues, international discussions could facilitate progress. TRANSITIONING FROM BIO SAFETY LEVEL-BASED TO FULLY RISK-BASED PRECAUTIONS Some speakers drew attention to limitations of the current World Health Organization (WHO) and “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) systems (i.e., BSL-1, 2, 3, or 4) for characterizing labs and practices. While acknowledging the simplicity of systems with a small number of pre-defined levels, they felt the classification methodologies too coarse to describe the wide spectrum of risks that laboratories must address and indicated that the levels are sometimes negatively perceived as a ranking. Others desired minimal standards that could serve as an attainable goal.1 Many argued that while BSL levels were created as specific measures to mitigate particular risks, recently BSL levels have often been used as general-purpose, canned solutions. A common complaint was that by strictly enforcing adherence to one of the standard levels, funders often stop engineers and architects from 1 Global Laboratory Initiative’s recommendations for tuberculosis procedures (described in Chapter 6), are an example of guidance that could function as a minimum standard. 89

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90 Biosecurity Challenges considering practical, less expensive construction and equipment options that could be sufficient in specific circumstances. Many had similar concerns about systems used to classify pathogens (e.g., risk groups 1-4), indicating that prudent handling practices depend not only on the organism, but also the procedures to be performed and the endemic situation.2 Additionally, one person noted that for precautionary reasons, novel pathogens are usually assumed to be high-risk, and that the initial classification is rarely revisited unless the microbe causes an outbreak that overwhelms the public health system. Hence, the participant said, a systematic reassessment of organisms that downgrades pathogens when appropriate would likely speed research, improve preparedness, and increase the number of potential research collaborators. As an alternative to the current systems, numerous participants proposed starting over and performing a full, situation-specific risk analysis. Several people pointed to the Global Laboratory Initiative’s (GLI) recommendations for tuberculosis (TB) procedures, which are described in Chapter 6, as a good example of the benefits of the risk-based approach. GLI abandoned the traditional BSL framework and instead characterized the risks associated with specific diagnostic and research procedures in detail. Instead of the previous blanket recommendation of BSL-3 labs for most TB work,3 the result is far more nuanced and allows groups to invest in infrastructure and precautions suited to the type of procedures that they actually perform. Multiple attendees acknowledged that moving to a fully risk-based system, although desirable, would require an increase in both data and expertise. Some worried that the lack of funding for applied biosafety research and the paucity of formal accident reporting systems would make obtaining accurate information about how well particular precautions function difficult. Similarly, implementing new recommendations and procedures would require more training specific to the staff and the situation. IMPORTANCE OF COLLABORATION Many participants indicated that in their experience collaboration is the most successful way to transfer knowledge and expertise and that productive collaborations rely on the recruitment and involvement of credible, experience-appropriate individuals from both the donor and recipient countries. For countries that lack sufficient indigenous expertise, activities like WHO’s Train-the-Trainer programs can help fill the gap. Examples of collaborations included individual mentoring programs, such as those offered by many biological safety associations, and laboratory twinning programs like the ones sponsored by the World Organisation for Animal Health (OIE). Several individuals suggested that central (hub) laboratories could use similar mentoring and twinning mechanisms to strengthen the rest of their networks. Such a model would also allow donors and international collaborators to focus their efforts on a small set of hub labs and multiply the return on their investment. Along the same lines, assistance in ‘needs’ decision making in a region or country might consist of a joint analysis of needs rather than a simple declaration of, “Here’s what you need.” Some attendees also suggested drawing on the expertise of individuals in related fields such as those who design or work with hospital isolation rooms or members of the pharmaceutical industry who are familiar with working in a disciplined regulatory environment. 2 The BMBL does augment the classification with specific recommendations for many organisms. 3 See pages 145-147 of the BMBL (United States HHS, 2009) for current guidance on TB work.

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91 Major Themes and Next Steps STRATEGIES TO AFFECT IMPROVEMENTS Many participants identified the Biological and Toxin Weapons Convention (BWC) review in December of 2011 and the subsequent annual "experts meetings," the IHR update in 2014, and the next revision of the WHO Laboratory Biosafety Manual (LBM) as places the biosafety, biosecurity, and public health communities might try to make changes. The IHR, might, for example, add minimum safety and security standards to the current diagnostic capability requirements. The LBM revision might consider adding the GLI TB recommendations as well as rethinking other recommendations on the basis of new risk analyses. Future BWC confidence building measures might consider requesting information about laboratory biosecurity and biosafety for BSL-4 labs and representative BSL-3 labs to help define and baseline this type of research and the current norms in the world. To increase funds for operations and maintenance and support for regulatory changes from national governments and donors, laboratories might increase their efforts to describe containment laboratories in the context of government priorities, national health systems, and local economies. Both labs and their communities benefit when consumables and equipment are available locally, and a quick response during a public health emergency relies on pre- existing bridges between a containment lab and the public health infrastructure. Additionally, biosafety associations could help by educating scientists as well as policymakers and functioning as a catalyst for rewriting national and international standards.

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