Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories Summary of a Workshop (2012) / Chapter Skim
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1 Introduction
1 Introduction
Pages 5-16
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Containment labs are no longer solely the province of "high resource" or developed countries. Low resource countries are also investing in labs to produce livestock vaccines matched to local strains, perform research on endemic diseases, and combat local human and animal disease outbreaks.
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WORKSHOP STRUCTURE A number of international organizations have encouraged countries to improve their laboratory biosafety and biosecurity,1 and workshop participants were asked to examine the growing number of high biocontainment labs in the context of the full biosafety and biosecurity spectrum (see Box 1-2)
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, which entered into force in 1975, bans the development, production, and stockpiling of biological agents and toxins for all but "prophylactic, protective, or other peaceful" purposes,c concerns remain. Examples of recent threats include an attempted theft of a lab's pathogen collection by an external groupd and a purported biological attack by a rogue biocontainment lab employee.e Concerns about the possibility of events of this nature following the breakup of the Soviet Union led to the creation of the United States Department of Defense's Biological Threat Reduction Program (BTRP)
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Participants also discussed the need for national regulatory frameworks whose enforcement increases safety and security without imposing undue burdens on scientists. Guidance regarding these matters is increasingly available, not just from national and international legal frameworks, but also from national and regional biosafety associations (BSA)
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During IFBA's conference, participants developed an agenda for advancing global biosafety and biosecurity that emphasizes raising awareness, education, and development and implementation of regulatory frameworks.4 Table 1-1 Biosafety Associations That Are Members or Observers of IFBA as of September 2011. Association Date Founded Afghan Biorisk Association (ABA)
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The second set of breakout sessions (Chapter 6) examined the present and future role of containment labs in human and animal disease diagnostics.
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THE FUNCTION AND EVOLUTION OF BIOCONTAINMENT LABS In the late 1800s, soon after scientists began isolating and studying microorganisms that cause infectious diseases, reports of workers suffering from laboratory-acquired infections (LAIs) started to appear (Table 1-2)
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reduce aerosol exposure, and Class III BSCs and full-body, positive pressure suit technologies can fully-isolate workers from pathogens. In some cases, immunizations against specific pathogens are available, which provide a measurable decrease in LAIs compared to the use of personal protective equipment and BSCs alone, particularly for agents with low infective doses (NRC, 2011c, Rusnak et al., 2004)
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, each of which includes a combination of practices, safety equipment, and laboratory features that are summarized in .8 BSL levels roughly correlate with, but do not directly correspond to, risk group assignments. The workshop focused on laboratories that operate at the two most stringent BSL levels, BSL-3 and BSL-4, which are referred to as high and maximum containment, respectively.9 According to the BMBL, BSL-3 and BSL-4 are intended for: 8 WHO also describes four standard biosafety levels (WHO, 2004)
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Laboratory bench and sink required 1 practices PPE: laboratory coats and gloves; eye, face protection, as needed BSL-1 practice plus: Primary barriers: BSCs or other BSL-1 plus: Limited access, biohazard physical containment devices Autoclave available warning signs, "sharps" used for all manipulations of precautions, biosafety agents that cause splashes or 2 manual defining any aerosols of infectious materials needed waste PPE: Laboratory coats, gloves, decontamination or face and eye protection, as medical surveillance needed policies BSL-2 practice plus: Primary barriers: BSCs or other BSL-2 plus: Controlled access, physical containment devices Physical separation from access decontamination of all used for all open manipulations of corridors; self-closing, double-door waste, decontamination of agents access; exhausted air not 3 laboratory clothing before PPE: Protective laboratory recirculated; negative airflow into laundering clothing, gloves, face, eye and laboratory; entry through airlock or respiratory protection, as needed anteroom; hand washing sink near laboratory exit BSL-3 practices plus: Primary barriers: all procedures BSL-3 plus: Clothing change before conducted in Class III BSCs or Separate building or isolated zone, entering, shower on exit, all Class I or II BSCs in combination dedicated supply and exhaust, 4 material decontaminated with full-body, air-supplied, vacuum, decontamination systems, on exit from facility positive pressure suit and other requirements outlined in BMBL SOURCE: United States HHS, 2009; see page 59. (PPE: personal protective equipment)
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voluntary Laboratory Biorisk Management standard CWA (CEN workshop agreement) 15793:2008,10 which describes a system management approach to laboratory risk reduction centered on the principle of continual improvement, are growing in popularity.
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