Materials that are hazardous due to their biological or infectious properties are called biohazardous materials or simply biohazards. Research laboratories work with a variety of biological agents including recombinant or synthetically derived nucleic acid, blood, tissues, body fluids, cell lines, bacteria, viruses, viral vectors, plasmids, fungi, prions, or parasites that cause disease in humans, animals, or plants. The primary purpose of biosafety is to protect individuals and the environment from unintentional exposure to biological agents and biohazards.
Biosecurity is equally as important as biosafety. The primary purpose of biosecurity is to prevent unauthorized access, theft, misuse, or intentional release of biohazardous materials such as pathogens and toxins. This involves securing these materials to mitigate the potential risks associated with their malicious use.
What is Biosafety?
Within research laboratories, biosafety encompasses the control measures, regulations, containment principles, and administrative controls like safe work practices that are used to manage risks associated with working with the handling and use of biological agents. As stated above, these agents can represent a wide variety of potentially hazardous materials.
Goals of Biosafety:
- Minimize the risk of exposure: Protect individuals such as laboratory researchers from biological agent exposure.
- Containment of biohazards: Implement robust biosafety containment measures to prevent the inadvertent release of infectious agents from affecting personnel, the environment, or community.
- Standard Operating Procedures: Establish biosafety protocols to ensure safe handling and disposal of biological materials.
To evaluate biohazard risks, biosafety risk assessments should be conducted to determine the 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.
What is Biosecurity?
Biosecurity involves the comprehensive set of measures implemented to securely handle and store biological materials. It focuses on preventing unauthorized access, theft, misuse, or intentional release of these materials, which could have catastrophic consequences if used for malicious purposes such as bioterrorism or biological warfare.
Goals of Biosecurity:
- Prevent malicious use: Prevent the intentional misuse of biological agents that threaten public health, ecosystems, agriculture, and national and global security.
- Secure research activities and materials: Ensure the integrity of research activities and safeguard the biological materials utilized throughout the research process.
Measures and Practices:
Biosafety:
- Biological Risk Group (Risk Groups 1 – 4): Biological agents are classified according to their risk level when considering infectivity, pathogenicity and availability of preventive measures and treatments for the corresponding disease. The National Institute of Health has established classification of biological agents into four risk groups.
- Biosafety Levels (BSL-1 to BSL-4): Based on the biosafety risk assessment and biological agents, specific biosafety levels (BSL-1 to BSL-4) are designated, each with increasingly stringent containment requirements.
- Biological Safety Cabinets (BSCs): These cabinets are designed to reduce the escape of research materials and agents in the room environment, and they’re used to remove contaminants from the research work zone. There are different classes of BSCs and the selection of the class is dependent on the types of biological agents being handled. BSCs must be tested and certified.
- Safe Work Practices, Training, and Procedures: Hazard awareness training and risk specific training should be required. Safe work practices and SOPs that include general safety rules and techniques, inventory control, and minimization of aerosols are especially important.
- Personal Protective Equipment (PPE): Utilizing appropriate PPE, such as gloves, gowns, respirators, and eye protection are also used to reduce potential exposure.
Biosecurity:
- Physical Security: Securing access points to facilities that handle biological agents such as fencing, gates, locks, surveillance cameras, and access control systems that prevent unauthorized access.
- Personnel Security: This includes background checks, security clearances, data access and permissions, and training.
- Inventory Control: Records of biological agents including quantity, location, authorized users which helps with tracking usage and traceability. This is important for biosafety, as well.
- Cybersecurity and Data Management: Cybersecurity and data management infrastructure intend to protect sensitive information associated with research activities and biological materials. Breaches in these systems can warn of potential biosecurity threats.
- Dual-Use Research Assessments: These evaluate intended beneficial applications and potential for misuse of biological materials.
Regulatory Compliance:
Both biosafety and biosecurity are subject to regulations established at the local, national, and international level. Organizations should have up-to-date compliance registers to ensure they’re meeting the requirements that relate to biosafety such as handling and storing materials, managing biohazardous waste including transportation, protecting workers from bloodborne pathogens or other potentially infectious materials, and installed biosecurity controls.
Risk Assessment:
- Biosafety Risk Assessment: A risk assessment that involves hazard identification, hazard assessment and risk evaluation, risk management, documentation & communication, and review & update. Learn more about Biosafety Risk Assessments.
- Biosecurity Risk Assessment: This assessment identifies potential biological threats and assesses vulnerabilities in the measures and practices listed above. The outcomes of a biosecurity assessment can include emergency preparedness and response drills, training, communication, and coordination plans.
The purpose of both biosafety and biosecurity risk assessments is to identify risks or weaknesses and implement corrective and preventive actions (CAPAs) to mitigate the gaps. These types of assessments are interminable, meaning they should be periodically reviewed and updated to reflect new processes, controls procedures, or changes to the organization that could affect the biosafety and biosecurity risk levels.
Education and Training:
Comprehensive biosafety and biosecurity training are essential for the protection of people and the environment. This training equips individuals with the necessary knowledge and skills to ensure safe and secure research practices.
- Biosafety Training – Biosafety training is a general term that captures multiple programs that target biohazard risk reduction such as emergency preparedness and response training or bloodborne pathogens training. Topics should cover basic requirements including but not limited to: relevant regulations, modes of transmission of pathogens, the importance of standard precaution measures, vaccine information (e.g., Hepatitis B), containment with BSCs, safe handling practices, PPE requirements and their limitations, decontamination of waste, incident reporting, and what to do during an emergency.
- Biosecurity Training – Biosecurity training should cover topics such as incident reporting, dual-use research considerations, ethical and legal aspects, security policies and procedures such as access control measures, data management practices, and specific security measures.
Biosafety and biosecurity are distinct in their objectives, but they mutually reinforce aspects of responsible laboratory management. Biosafety focuses on preventing unintentional exposure to biological agents and ensuring the safety of people and the environment. Biosecurity addresses intentional misuse by implementing measures to safeguard biological materials from unauthorized access, theft, or malicious use. Focus on robust biosafety and biosecurity programs can create a safe and secure environment for organizations, minimizing the risk of both accidental and intentional harm.
