Introduction
Laboratory biosecurity guidance refers to the protection, control, and accountability of high-consequence biological agents and toxins within laboratories to prevent unauthorized possession, loss, theft, misuse, diversion, and accidental or intentional release. It balances traditional laboratory biosafety with broader biosecurity requirements, aiming to strengthen collaboration between the scientific, technical, and security sectors.
Key Components of Laboratory Biosecurity
The essential elements of laboratory biosecurity guidance include:
- Risk Assessments: Determine the level of protection needed for biological materials.
- Clear Chain of Command: Establish authority and responsibility.
- Culture of Responsibility: Promote awareness and accountability.
- Balancing Policy and Progress: Ensure security measures do not hinder research.
- Sector Collaboration: Enhance cooperation between scientific and security sectors.
- Training: Provide appropriate training to all employees.
- Emergency Response: Develop and enhance response and recovery plans.
International Variations in Biosecurity Guidance
Key components of laboratory biosecurity guidance vary internationally due to different regulatory regimes and approaches to biosafety and biosecurity. The World Health Organization (WHO) provides detailed guidance on laboratory biosecurity, while the BMBL focuses on laboratory biosafety but includes some biosecurity principles. The WMD Commission recommends unifying biosafety and biosecurity concepts into a broader risk management framework. Different countries may have varying compliance mechanisms for biosafety and biosecurity education and training. The scope and intended audience of laboratory biosecurity guidance also vary, with a focus on risk assessment and mitigation strategies.
Country-Specific Biosecurity Regulations
France: Reinforced biosafety and biosecurity regulations in containment level 3 (CL-3) laboratories, specific to certain pathogens. However, EU legislation on biological agents and genetically modified microorganisms is not harmonized, leading to implementation difficulties for many laboratories.
United States: Implemented disease surveillance programs, quarantine measures, outbreak management, and enforced regulations related to biosecurity. Focus on domestic regulations, including discussions on biosafety measures regarding gain-of-function (GOF) research.
India: Governed by various ministries, with the proposed Agricultural Biosecurity Bill 2013 aiming to establish an integrated national biosecurity system. India needs a more proactive approach to address biosecurity concerns.
Biosecurity Legislation and Frameworks
Biosecurity regulations work by managing risks, promoting shared responsibility, providing a framework for risk-based decision-making, and facilitating trade by meeting biosecurity requirements in other states. Examples include the Biosecurity Act 2023 in Australia and the Biosecurity Act 1993 in New Zealand, which provide legal frameworks to prevent harmful organisms from entering the country and manage them if they do.
WHO’s Updated Laboratory Biosecurity Guidance
The WHO recently updated its laboratory biosecurity guidance to enhance safety protocols and prevent the misuse of biological agents and toxins. The updates include elements such as risk assessment and management, enhanced security measures, training and competency of personnel, and incident reporting and response procedures. These updates aim to prevent biological threats, strengthen international collaboration, and build public trust in laboratory practices.
Conclusion
Laboratory biosecurity is crucial for protecting public health and safety. By implementing comprehensive biosecurity measures and staying updated with international guidelines, laboratories can minimize risks and ensure the secure handling of dangerous biological materials.
References
A. (2020, March 25). Biosecurity in India: The Way Forward. Bharat Shakti. Retrieved July 7, 2024, from https://bharatshakti.in/biosecurity-in-india-the-way-forward/ and Suryesh K. Namdeo, S. P. (2022, March 26). Why India Needs a National Biosecurity Policy – the Wire Science. Why India Needs a National Biosecurity Policy – The Wire Science. Retrieved July 7, 2024, from https://science.thewire.in/politics/government/india-needs-national-biosecurity-policy-leadership-biological-weapons-convention/ Barden, L. (2020, December 19). Slide 1. Retrieved July 7, 2024, from https://ihvnigeria.org/wp-content/uploads/2020/12/Laboratory-Biosecurity.pdf Biosecurity – an Overview | ScienceDirect Topics. (n.d.). Biosecurity – an overview | ScienceDirect Topics. https://doi.org/10.1016/B978-0-12-814956-0.00003-2 Biosecurity Legislation – Environment, Planning and Sustainable Development Directorate – Environment. (n.d.). Biosecurity legislation – Environment, Planning and Sustainable Development Directorate – Environment. Retrieved July 7, 2024, from https://www.environment.act.gov.au/parks-conservation/plants-and-animals/biosecurity/biosecurity-legislation Biosecurity Overview – National Agricultural Law Center. (n.d.). National Agricultural Law Center. Retrieved July 7, 2024, from https://nationalaglawcenter.org/overview/biosecurity-overview/ Ellis, M. (2015, January 15). Microsoft Word – Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document. Retrieved July 7, 2024, from https://www.aam.org.ar/descarga-archivos/Laboratory-Biosafety-Biosecurity-Guidance.pdf EU CBRN CoE Contributes to Updated WHO Laboratory Biosecurity Guidance. (n.d.). Chemical, Biological, Radiological and Nuclear Risk Mitigation. Retrieved July 7, 2024, from https://cbrn-risk-mitigation.network.europa.eu/news-1/eu-cbrn-coe-contributes-updated-who-laboratory-biosecurity-guidance-2024-07-05_en https://www.gov.uk/guidance/biosecurity-measure-plans-information-and-templates. (n.d.). Retrieved July 7, 2024, from https://www.gov.uk/guidance/biosecurity-measure-plans-information-and-templates https://www.phe.gov/s3/BioriskManagement/biosecurity/Pages/Biosecurity-FAQ.aspx. (2017, April 26). Retrieved July 7, 2024, from https://www.phe.gov/s3/BioriskManagement/biosecurity/Pages/Biosecurity-FAQ.aspx India’s Biosecurity Regulations Face Criticism. (2014, June 30). India’s biosecurity regulations face criticism. https://doi.org/10.1038/nindia.2014.89 Johnson, B., & Casagrande, R. (2016, September 1). Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-of-Function (GOF) Experiments. PubMed Central (PMC). https://doi.org/10.1177/1535676016661772 Pastorino, B., Lamballerie, X. D., & Charrel, R. (2017, May 31). Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements. PubMed Central (PMC). https://doi.org/10.3389/fpubh.2017.00121 Primary Industries, M. F. (2020, November 16). Introduction to Biosecurity Legislation | NZ Government. Introduction to biosecurity legislation | NZ Government. Retrieved July 7, 2024, from https://www.mpi.govt.nz/legal/legislation-standards-and-reviews/biosecurity-legislation/introduction-to-biosecurity-legislation/ Sture, J., Whitby, S., & Perkins, D. (n.d.). Biosafety, Biosecurity and Internationally Mandated Regulatory Regimes: Compliance Mechanisms for Education and Global Health Security. PubMed Central (PMC). https://doi.org/10.1080/13623699.2013.841355 U. (2014, December 16). Fact Sheet: Biosafety and Biosecurity in the United States. Retrieved July 7, 2024, from https://www.nih.gov/sites/default/files/research-training/usg-safety-factsheet-2014.pdf WHO Updates Laboratory Biosecurity Guidance. (2024, July 4). WHO updates laboratory biosecurity guidance. Retrieved July 7, 2024, from https://www.who.int/news/item/04-07-2024-who-updates-laboratory-biosecurity-guidance WHO Updates Laboratory Biosecurity Guidance. (2024, July 5). TISHHA News. Retrieved July 7, 2024, from https://www.tishha.com/news_updates/who-updates-laboratory-biosecurity/