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Biosafety Risk Assessment: What It Is and Why It Is Important

Posted by Amber Poltl on Mar 1, 2024 7:19:26 PM

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.

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. 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. 

What is a Biosafety 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.  
  • Classify 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.

Other factors to consider in a biosafety risk assessment are the possible routes of transmission of infection in the laboratory, the infectious dose, stability in the environment, host range, whether the agent is indigenous or exotic to the local environment, and the genetic characteristics of the agent. If biological agents are genetically modified, ensure that the risk assessment considers how the agent’s hazard characteristics may change, including its infection potential and severity of disease. 

Key Components of a Biosafety Assessment

A comprehensive biosafety risk assessment typically involves five key components:

  1. Hazard Identification: This step involves identifying all the biological agents involved in laboratory activities and the potential hazards associated with the biological agents. Use subject matter experts that are familiar with the hazards to assist with this step. 
  2. Hazard Assessment and Risk Evaluation: After identifying the hazards (i.e., biological agents), determine the risks of these agents by evaluating the likelihood of exposure, and the severity of exposure with the following criteria:
    • Routes of transmission – Understanding a biological agent's natural transmission route helps identify potential risks within a laboratory setting. However, the route of infection and resulting disease can differ in laboratory-acquired infections due to the higher concentrations of agents used in the lab and the potential for aerosolization during procedures, even if the agent isn't naturally transmissible by air.
    • Host range –The variety of different species that a biological agent can infect and potentially cause disease in.  
    • Virulence – The severity of disease that a biological agent can cause in a susceptible host. It essentially reflects the degree of harm the agent can inflict on an infected individual.
    • Infectivity – Ability of a biological agent to establish an infection in a susceptible host. 
    • Pathogenicity – Inherent ability of a biological agent to cause disease in a susceptible host. 
    • Allergenicity – Potential of a biological agent to induce an allergic reaction in a susceptible individual. 
    • Stability – Ability of a biological agent to maintain its physical, chemical, and biological properties over time and under different conditions.
  3. Risk Management: Based on the hazard assessment and risk evaluation, appropriate measures are put in place to minimize or eliminate identified risks. This may involve elimination or substitution of hazards, the implementation of engineering controls, establishment of safe work practices and training, and usage of personal protective equipment. 
  4. Documentation and Communication: Document the risk assessments and findings. All relevant employees and stakeholders should be informed about the risk assessment findings, corrective and preventive actions (CAPAs) to mitigate risks, and CAPA schedule. 
  5. Review and Update: Biosafety risk assessments should be reviewed periodically and when hazards or operations change.

Biological Risk Groups and Biosafety 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: 

  • Risk Group 1 – Agents that are not associated with disease in healthy humans. 
  • Risk Group 2 – Agents that are associated with human disease which is rarely serious or for which preventative or therapeutic interventions are often available. 
  • Risk Group 3 – Agents that are associated with serious or lethal human disease for which preventative or therapeutic interventions may be available (high individual risk but low community risk) 
  • Risk Group 4 - Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk).

The risk groups are not equivalent to the biosafety levels (BSL). The BSL assigned to a laboratory is determined by the risk posed by the biological agents being used. Each BSL has specific EHS requirements for laboratory practices and techniques, equipment and containment measures, and facilities design. The BSLs are: 

  • BSL-1: 
    • Suitable for work involving well-characterized agents not known to cause disease consistently in immunocompetent adult humans. 
    • Agents present minimal potential hazards to personnel and the environment.
    • 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: 
    • Builds upon BSL-1 requirements.
    • Suitable for work involving agents that post moderate hazards to personnel and the environment. 
    • 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: 
    • Builds upon BSL-2 requirements.
    • Applicable to facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.
    • 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: 
    • Builds upon BSL-3 requirements. 
    • Required for work 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. 
    • 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.

How Chemical Safety Improves Biosafety

If your biosafety program is recognized as a weakness and your organization is stronger in chemical safety, harness your strengths and leverage those best good practices to apply to your biosafety program. Maintaining a comprehensive chemical safety program is helpful for biosafety because it supports organizations to:

  • Comply with regulations – As an example, many regulatory agencies require laboratories to maintain accurate chemical inventories as part of compliance with EHS regulations. Having a well-documented inventory aligns with regulatory, emergency preparedness, and auditing requirements. Laboratories should use a similar system for controlling the inventory of infectious agents. 
  • Identify hazards and perform risk assessments – A chemical safety program helps identify and assess the potential hazards associated with the chemicals used in the laboratory. This includes factors like flammability, toxicity, corrosivity, and reactivity. This type of evaluation is important because it highlights taking a risk factor-based approach to manage laboratory hazards, which can be translated over when performing biosafety risk assessments. 
  • Emphasizes safe work practices – Hazardous waste can be chemical or biological. Proper procedures to classify, segregate, and dispose of chemical waste aligns with procedures to reduce contamination to the environment or exposure to personnel, which is similar to biosafety. There are safe handling practices for different classes of chemicals, including proper personal protective equipment usage, labeling, and storage procedures. This ensures that chemicals are handled and stored in a way that minimizes the risk of spills or other incidents. Similar practices and procedures should be developed for biosafety. 

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  • Integrate training and awareness – Biological and chemical agents are frequently handled together (e.g., research processes, decontamination procedures). An integrated approach ensures that both biosafety and chemical safety principles are covered in training programs for laboratory personnel. This training equips personnel with the knowledge and skills to handle both biological agents and chemicals safely, minimizing the risk of accidents or exposures. 

How SciShield Can Standardize Your BioSafety 

With SciShield, you can scale your biosafety management to improve safety, reduce time to approval, eliminate error, streamline communications, and meet compliance regulations.

Request a FREE demo to learn more about Standardizing your Biosafety Management