Rao Venkat, Bordelon Emily
Parsons Government Services, Health Programs, Washington, DC, USA.
Summer Intern, USA.
Appl Biosaf. 2019 Mar 1;24(1):20-29. doi: 10.1177/1535676018818563.
Existing biosafety guidelines and biosecurity policies do not adequately address the Increased deployment of mobile high-containment biological laboratories (MBSLs) to manage disease outbreak response demonstrates potentials for rapid diagnosis of risk group 3 and 4 pathogens and allows for research under the biosafety level (BSL)-4/3 environment.
The primary objective of this study was to evaluate limitations in current biosafety and biosecurity guidelines to address the unique operational environment and new and varied international stakeholders involved in these deployments.
Current biosafety best practices guidelines and biosecurity policy and regulatory directives are crafted mostly toward conventional high-containment biological facilities and may not be readily applicable to the MBSLs. Although the pilot MBSLs reported in published literature have adopted multiple safety precautions to reduce exposure risks and have modified process flows in the constrained space to basically meet the proximate requirements for epidemic response, there are no systematic risk assessments for these sophisticated BSL-4/3 mobile laboratory infrastructure-deployed in locations with poor public health infrastructure backup and security problems and handling highly pathogenic agents in constrained environments-with potentials for failure, the nature and extent of which are yet to be determined. The probability of potential occupational exposure and risks to the local general environment may require a reassessment of the biosafety best practice management procedures for MBSLs to deal with these contingencies.
现有的生物安全指南和生物安保政策未能充分应对移动高等级生物实验室（MBSL）部署增加的情况。MBSL用于应对疾病爆发，展现出对3级和4级风险病原体进行快速诊断的潜力，并允许在生物安全4级/3级环境下开展研究。
本研究的主要目的是评估当前生物安全和生物安保指南在应对这些部署所涉及的独特操作环境以及新的、多样的国际利益相关者方面存在的局限性。
当前的生物安全最佳实践指南以及生物安保政策和监管指令大多是针对传统的高等级生物设施制定的，可能无法直接应用于移动高等级生物实验室。尽管已发表文献中报道的试点移动高等级生物实验室采取了多种安全预防措施以降低暴露风险，并在有限空间内修改了工艺流程，基本满足了应急反应的近期要求，但对于这些部署在公共卫生基础设施薄弱且存在安全问题地区的复杂生物安全4级/3级移动实验室基础设施，以及在有限环境中处理高致病性病原体的情况，尚无系统的风险评估——其存在失败的可能性，失败的性质和程度尚待确定。潜在的职业暴露概率以及对当地总体环境的风险可能需要重新评估移动高等级生物实验室的生物安全最佳实践管理程序，以应对这些意外情况。
