Biosafety Guidelines: What you Need to Know to Maintain Safety and Compliance

Biomedical research is critical in advancing healthcare and understanding biological processes. This work often involves handling potentially hazardous biological agents, making biosafety a critical aspect of laboratory operations. As research continues to innovate and explore new frontiers, the need for robust biosafety programs remains a priority.

Understanding Biosafety Levels (BSLs)

The Centers for Disease Control and Prevention (CDC) define biosafety levels through the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines. The BSL framework is intended to categorize laboratories based on the risk posed by the biological agents they handle. This framework outlines four biosafety levels (BSL-1 to BSL-4) with increasing stringency in safety practices and containment measures.

• BSL-1: This is the basic level for handling minimal risk agents, suitable for work involving well-characterized agents not known to cause disease consistently in immunocompetent adult humans. Basic practices such as hand washing, the use of personal protective equipment like lab coats and gloves, and good laboratory hygiene are typically sufficient.
• BSL-2: This level applies to laboratories working with moderate-risk agents that can cause human disease but are typically spread through direct contact. Additional precautions beyond BSL-1 include controlled access to the laboratory, specific training for personnel, and the use of appropriate personal protective equipment.
• BSL-3: This level is for handling high-risk agents that can cause serious or fatal diseases via inhalation or exposure to bodily fluids. In addition to BSL-2 controls, BSL-3 facilities have additional engineering controls such as specialized ventilation systems to prevent the release of infectious aerosols.
• BSL-4: This is the highest biosafety level for laboratories working with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted infections and life-threatening disease that are frequently fatal and for which there are no vaccines or treatments. This level is required for related agents with unknown risk or route of transmission. Most stringent safety and containment measures including complete isolation from the outside environment through multiple airlocks and highly specialized ventilation systems.

Key Components of Biosafety

Effective biosafety controls include several key components:

• Facility Design: The laboratory design itself plays a critical role in biosafety. Well-designed facilities incorporate physical barriers like self-closing doors, airlocks, sealed walls, and HEPA-filtered ventilation systems to control airflow and prevent the escape of pathogens. The layout of the lab should also minimize the risk of contamination by separating areas with different biosafety levels.
• Engineered Equipment: Safety equipment plays a critical role in biosafety. Primary barriers in biosafety are physical containment measures (e.g., biological safety cabinets (BSCs), centrifuge safety cups) that protect laboratory personnel and the environment from exposure to infectious agents. They are the first line of defense against splashes, spills, and aerosols that can contain harmful biological agents.
• Safe Work Practices, Training, and Procedures: Safe lab practices minimize the risk of exposure to infectious agents by ensuring aseptic techniques, having established protocols for handling biological materials, and ensuring proper disposal of biohazardous waste.
• Risk Assessment: A biosafety risk assessment is a systematic process that identifies, evaluates, and mitigates risks associated with the use of biological agents. It aims to:
  • Identify procedural hazards and hazardous characteristics of biological agents that are handled.
  • Classifies biological agents into risk groups according to their degree of risk of infectivity, virulence, pathogenicity, availability of preventive measures and effective treatments, and potential damage to the environment.
  • Determine the appropriate biosafety level for controls and restriction understanding.
  • Consider biosecurity which focuses on the prevention of theft, loss, and misuse of hazardous biological agents and toxins, equipment, and/or valuable information.
  • Identify and implement controls to minimize the risk of exposure to biological agents for workers, the environment, and the community.
  • Ensure regulatory compliance with local and national biosafety regulations.

Learn how to create your own biosafety risk assessments in our guide.

• Personal Protective Equipment: Personal protective equipment (PPE) like gloves, gowns, and respirators are the last line of defense and provide additional protection. This combination minimizes the risk of exposure to infectious agents during laboratory procedures.

Maintaining Biosafety in the Workplace

Improving biosafety hazard identification, evaluation and control can be attained by doing the following:

• Form a Biosafety Committee: A dedicated committee with expertise in biosafety and laboratory operations should oversee the implementation and monitoring of biosafety research and operations. This committee, composed of laboratory personnel, EHS professionals, and operational stakeholders should oversee all aspects of biosafety within the facility.  Their responsibilities include reviewing proposed research activities for EHS concerns, approving the use of biological agents, and ensuring compliance with biosafety requirements.
• Conduct Regular Risk Assessments: Employers must conduct biosafety risk assessments to determine which employees have exposures from work activities or conditions that are reasonably anticipated to elevate risk of contracting a disease caused by an infectious agent. Laboratories that perform procedures with biohazardous materials that contain transmissible pathogens are likely to have occupational exposure to these agents. A biosafety risk assessment evaluates risks, so the appropriate control measures are implemented to prevent illness. Regularly assess the risks associated with the biological agents being handled and adjust protocols as needed.
• Develop Emergency Preparedness and Response Plans: Emergency preparedness and response plans must cover procedures to handle spills and exposures, an exposure control plan, accessing emergency contact information, and how to report an incident involving biohazards. Facilities where human blood or other potentially infectious materials (OPIM) exist as an occupational hazard should have a specific exposure control plan. The purpose of the exposure control plan is to describe practices to prevent or minimize exposure to human blood, bloodborne pathogens (BBP), or other potentially infectious materials (OPIM).
• Training and Competency: The priority of biosafety training is to reduce the risks of biological agents through awareness and work practices. Do the following in biosafety training: 
  • Communicate containment measures associated with biological risk groups and biosafety levels. 
  • Educate laboratory personnel on safe practices for handling biological materials and the prevention of laboratory acquired infections.
  • Ensure compliance with regulations.

Challenges and Solutions in Biosafety Management

Challenges to managing effective biosafety programs include:

• Keeping Up with Emerging Threats: New and emerging infectious diseases can pose unforeseen risks.
  • Regular biosafety program reviews and updates are critical to address evolving threats. Design biosafety programs with the ability to adapt to new threats.   
  • Encourage collaboration and information sharing between researchers, institutions, and public health agencies to stay informed about emerging pathogens. 
  • Regularly review risk assessments to categorize biological agents and adjust biosafety levels as needed.

• Resource Limitations: Implementing and maintaining stringent biosafety measures can be resource-intensive, especially for smaller labs. Biosafety programs require investment in proper facilities, equipment, training, and qualified personnel.
  • Explore grant opportunities and public-private partnerships to secure funding for biosafety infrastructure and training.
  • Focus resources on areas with the highest risk profiles.
  • Technology like hazardous substance inventory software can help address some of these challenges by streamlining processes, improving data management, and facilitating regulatory compliance.
• Training Needs: Ensuring continuous training for all laboratory personnel requires ongoing commitment and resources.
  • Implement training programs to keep staff up-to-date on the latest biosafety protocols and techniques. 
  • Conduct regular assessments to evaluate staff proficiency in biosafety procedures.
  • Best practices like sharing resources and collaborating with institutions or industry groups can optimize training programs and cost-effectiveness.

Biosafety Regulatory Bodies and International Standards

Organizations like the CDC, NIH, and WHO play a crucial role in establishing and promoting global biosafety standards. Their guidelines offer a framework for national regulations and promote international collaboration in research.

• Centers for Disease Control and Prevention (CDC) - In collaboration with the National Institutes of Health (NIH), the CDC publishes the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines.  This document serves as the primary reference for safe laboratory practices in the US, outlining recommendations for containment measures, biosafety levels, and safe work practices for various biological agents.

• National Institutes of Health (NIH) – In addition to the BMBL guidelines mentioned above, the NIH sets biosafety requirements for institutions that receive NIH funding for research involving biological agents.

• World Health Organization (WHO) - The WHO issues biosafety guidelines that provide recommendations for laboratory practices in resource-limited settings and other international contexts.

Conclusion

In conclusion, biosafety controls are crucial during the design of laboratories and operational stages. Engineering controls, safe work practices, risk assessments, biosafety stakeholder engagement, and PPE will assist in mitigating risks to as low as reasonably achievable. By proactively identifying potential and emerging hazards associated with biological agents – including storage, use, and modification – and including the appropriate cross-functional interested parties in management of biosafety, organizations can establish a strong foundation for continual improvement of biosafety programs.