Dataset Information

Biosafety and Biosecurity in Containment: A Regulatory Overview.

ABSTRACT: When biosafety for contained use is addressed in international fora and discussions, often the topic is limited to working with genetically modified organisms (GMOs) in facilities such as laboratories, animal facilities, and greenhouses. However, the scope of biosafety in containment encompasses many other types of biological materials, such as human, animal and plant pathogens, nucleic acids, proteins, human samples, animals or plants, or by-products thereof, and overlaps often with the topic of biosecurity. This is also reflected in the regulations that apply for activities with biological materials in contained facilities. The common denominator of these regulations is the focus on protection of people and environment, while applying the key principles of risk assessment and risk management. This review provides an overview of regulatory frameworks for biosafety and biosecurity in containment around the globe, as well as points out overlap with other regulatory frameworks, such as the Nagoya Protocol, or Plant and Animal Health regulations.

SUBMITTER: Beeckman DSA

PROVIDER: S-EPMC7348994 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Biosafety and Biosecurity in Containment: A Regulatory Overview.

Beeckman Delphine S A DSA Rüdelsheim Patrick P

Frontiers in bioengineering and biotechnology 20200630

When biosafety for contained use is addressed in international fora and discussions, often the topic is limited to working with genetically modified organisms (GMOs) in facilities such as laboratories, animal facilities, and greenhouses. However, the scope of biosafety in containment encompasses many other types of biological materials, such as human, animal and plant pathogens, nucleic acids, proteins, human samples, animals or plants, or by-products thereof, and overlaps often with the topic o ...[more]

PMID: 32719780

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Project description:Following the global-level Ebola virus disease (EVD) outbreak during 2014-2016, international collaboration with multiorganizational participation has rapidly increased. Given the greater priorities for research and development (R&D) outcomes despite the quantitative and qualitative lack of high-containment laboratory facilities in low- and middle-income countries (LMICs), where biological targets for investigation are located near their natural habitats, occupational readiness for health workers' safety has not been well-addressed, where limited global expert human resources are being deployed to high-containment laboratories including biosafety level 4 (BSL-4) facilities for case management and medical investigations. Pursuing scientific and managerial success to make laboratories efficient and productive, most laboratory safety policies have focused on the functionality of technical skills or performance, procedural methodologies, and supervision over the employees to collaborate in LMICs. The experts dispatched from advanced countries bring a long list of scientific tasks with high-tech devices, supplies, and training programs to introduce their collaboration with local partners in LMICs. However, the dispatched experts would subsequently realize their list becomes endless to establish their basic functions required in high-containment laboratories to ensure qualified scientific outcomes in LMICs. Under such circumstances where dual or multiple policies and standards accommodated pose dilemmas for operational procedures to ensure biosafety and biosecurity, all the frontline experts from both LMICs and advanced countries may be exposed to significant risks of life-threating infection of highly pathogenic agents like EVD, without any pragmatic measures or road maps to establish valued international collaboration, pursuing its sustainability. Given the fact mentioned above, we conducted a quick review of the key biosafety and biosecurity management documents, relevant policy analyses, and research to understand the current status and, if any, measures to dissolve critical dilemmas mentioned above. As a result, we found that occupational safety and health (OSH) aspects had not been sufficiently addressed, particularly in the context of international BSL-4 collaboration in LMICs. Moreover, consideration of OSH can be one of the key drivers to make such collaborative interventions more pragmatic, safer to reorient, harness disease-based vertical approaches, and harmonize policies of biosafety and biosecurity, particularly for collaborations organized in resource-limited settings.

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Dataset Information

Biosafety and Biosecurity in Containment: A Regulatory Overview.

Publications

Biosafety and Biosecurity in Containment: A Regulatory Overview.

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