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. Recognizing these hazards and their associated risks is essential for implementing effective health & safety controls.
Understanding Biological Hazards
To ensure the safety of people, the environment, and the public, it’s crucial to have proper biosafety measures in place. Certain workplace safety laws require employers that are exposed to transmissible infectious pathogens to have effective written safety plans and controls in place. Laboratories that perform procedures with biohazardous materials that contain transmissible pathogens are likely to have occupational exposure to these agents.
Here are some common biohazard examples found in laboratories:
- Blood and Other Potentially Infectious Materials (OPIM): Human and animal blood, along with other bodily fluids, can transmit various pathogens.
- Laboratory Cultures and Samples:Working with cultured microorganisms and biological research materials carries the risk of exposure to infectious agents.
- Contaminated Sharps: Used syringes, needles, and other sharp instruments contaminated with biohazardous materials pose a significant risk of puncture wounds and potential infection.
- Fungal Growth: Mold and yeast can thrive in laboratory environments, causing respiratory problems and allergic reactions.
- Waste from Animals: Animal waste or contaminated bedding can harbor harmful pathogens.
Risk Groups and Biohazard Safety Levels
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 (1-4).
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. See our Biosafety Guidelines guide for more information on these risk groups and BSLs.
5 Opportunities to Prevent Biohazards Through Effective Biosafety and Biosecurity Governance
1. A single, centralized system for biological registration approvals
There's a growing demand for stricter regulations regarding oversight. Organizations in the US receiving federal funding have to comply with NIH Guidelines, and the White House OSTP recently introduced a comprehensive Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC), effective from May 6, 2025. Similarly, the EU has its own directives concerning exposure to biological agents.
The emphasis is shifting from considering robust registration and approval systems for work involving biological agents as optional to regarding them as essential. Having a single, centralized system for biological registration approval ensures an organization adheres to high standards for biosafety, regulatory compliance, and internal processes with efficient oversight of projects, biological materials, and potential exposures.
2. Biosecurity - Who is working on what? Where?
Understanding who is working on what and where within a biomedical lab presents a pivotal opportunity for enhancing overall biohazard prevention strategies. By implementing comprehensive biological registration and authorization systems, organizations can gain real-time visibility into project activities, including tracking material, personnel, and space exposure levels.
Streamlining registration management processes reduces approval times and facilitates efficient communication, ensuring robust oversight and risk management throughout the project lifecycle.
Furthermore, driving consistency in materials management through standardized biomaterials libraries enables organizations to establish controls over materials usage, personnel, and locations, thereby enhancing biosecurity and internal compliance processes. This holistic approach to understanding lab activities fosters a culture of accountability and transparency, ultimately mitigating risks associated with biohazard incidents and safeguarding the well-being of personnel and the broader community.
3. Institutional Biosafety Committee Oversight for Biologicals Projects
Expanding the requirement for institutional biosafety committees to encompass all institutions engaged in high-containment laboratory activities presents a significant opportunity to enhance effective biosafety and biosecurity governance. Currently, only federally funded institutions conducting recombinant or synthetic nucleic acid research are mandated to have such committees, leaving privately funded institutions exempt from compliance. This discrepancy in regulatory oversight underscores the need for a level playing field, ensuring that all institutions conducting similar high-risk activities adhere to standardized review processes and oversight mechanisms.
By mandating a universal requirement for local oversight bodies, potential risks associated with laboratory-acquired infections and biological incidents can be mitigated. This approach not only ensures a consistent level of review and approval across all institutions but also addresses public concerns regarding the oversight and input of risky research conducted within communities. While there are challenges such as additional bureaucracy for non-compliant organizations and the need to establish and operate biosafety committees, the benefits of standardized oversight outweigh the disadvantages, promoting transparency, safety, and community trust in biosafety practices.
4. De-risking the Organization and Personnel with Training and Assessment of Biohazards
In high-containment laboratories like BSL-3 and BSL-4 facilities, personnel handle indigenous or exotic agents capable of causing severe or fatal diseases. Training in the safe handling of such pathogens is crucial for personnel, who must be supervised by knowledgeable scientists. However, the consistency and rigor of this training vary across institutions, highlighting the need for standardized assessment and guidance to ensure personnel proficiency and risk awareness.
Establishing minimum education and training requirements for personnel in high-containment laboratories offers several benefits for effective biosafety governance. It fosters confidence in the competence of individuals working with hazardous pathogens, promoting trust within the community. Moreover, by ensuring that personnel understand and can manage risks effectively, such standards enhance overall laboratory safety. However, implementing new requirements may pose challenges, particularly in adapting regulations across diverse research operations and ensuring compliance among existing workforce members. Despite these obstacles, standardized training protocols are essential for safeguarding personnel, institutions, and the wider community from biohazard risks.
5. Inspections and Medical Surveillance
By implementing robust biosafety management protocols with software such as SciShield, organizations can identify personnel handling biological agents and mitigate exposure risks effectively. Leveraging Learning Management Systems (LMS) presents an opportunity to automate training assignments tailored to individual staff members' risk exposures, ensuring they receive necessary medical clearances, vaccinations, and skill enhancements. Simultaneously, optimizing equipment management processes ensures the availability and functionality of safety gear, bolstering biosecurity measures.
Strategic biosafety inspections of laboratory spaces provide organizations with a chance to ensure compliance with safety protocols, promptly addressing vulnerabilities. Embracing medical surveillance systems enables proactive tracking and management of personnel health, facilitating timely interventions such as medical clearances and vaccinations. By capitalizing on these opportunities, organizations can fortify their biosafety and biosecurity frameworks, creating safer environments for personnel and the wider community.
Managing Biological Hazards with Software
Implementing a robust biosafety program is essential to protect yourself, your colleagues, and the environment from biohazards. Investing in biological software solutions can significantly enhance your biohazard management practices, promoting safety, regulatory compliance, and overall lab hazard awareness.
