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Design the workflow around the exact material, procedures, people, equipment, and facility—not the pathogen name alone. Before work begins, document where exposure or release could occur, assess the likelihood and consequences, select layered controls, and have the plan reviewed by the appropriate institutional biosafety experts. Reassess whenever the work or its operating conditions change.
Start with the work you will actually do
A safe workflow begins with a protocol-specific risk assessment. The CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), sixth edition, describes this as its core principle: one document cannot anticipate every combination of risks and mitigations. CDC identifies the BMBL as advisory guidance, not a regulatory document, so use it to inform—not replace—your institution’s review and applicable local requirements.
Describe the full lifecycle of the work, from receipt through processing, storage, transport, and disposal. Include:
- The material or agent, what is known about its hazards, and any relevant uncertainty.
- The research objective and each activity or procedure step, including how material is handled and moved.
- The people involved, their roles and demonstrated competencies.
- The instruments and equipment used, and the facility conditions in which the work will occur.
- How materials, samples, and waste move between people, equipment, rooms, and storage locations.
The assessment should describe actual operating conditions, not just the intended method on paper. A change in procedure, personnel, equipment, or facility can alter the risk.
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Map hazards and exposure opportunities by workflow step
For each activity, ask what could go wrong, who or what could be exposed, and how material could escape its intended containment. CDC’s biological risk-assessment guidance highlights several routes to examine:
- Mucous-membrane exposure: sprays, splashes, or droplets that reach the eyes, nose, or mouth.
- Inhalation: aerosols generated during activities such as mixing or centrifugation.
- Percutaneous exposure: inoculation through sharps or needlesticks, or contact with non-intact skin.
Use these as prompts, not as a complete hazard list. Consider the specific steps and conditions in your own workflow, including foreseeable incidents and how materials are handled before and after the main procedure.
Evaluate risk before choosing controls
For each identified hazard, assess both the likelihood of an undesirable incident and its potential consequences, including the likelihood and consequences of infection where relevant. Biological laboratory assessments are generally qualitative: their purpose is to make risks explicit, prioritize them, and guide decisions about mitigation. Record what is uncertain rather than treating missing information as proof of safety.
When comparing proposed workflows, compare the hazards and exposure routes created by each procedure, the likelihood and consequences of incidents, and how much the proposed controls reduce the remaining risk. Also consider whether the controls can be implemented, maintained, and evaluated in the actual facility. Do not assign a containment level from an organism’s name alone; procedure and facility context matter.
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Choose practices, safety equipment, and facility safeguards in response to the assessment. The BMBL describes a hierarchy that starts with eliminating or reducing hazards, then uses engineering and administrative controls to address residual risk, with personal protective equipment (PPE) where needed. The right combination is context-dependent; this topic does not establish a universal biosafety level or fixed PPE set.
Document why each selected control is appropriate to the identified risks and how protections overlap. A control that depends on equipment or a particular practice also depends on that equipment functioning and people being able to follow the practice. Record foreseeable gaps and how the institution will address them. Have the assessment and proposed safeguards reviewed by the appropriate biosafety professional, relevant subject-matter experts, and institutional biosafety committee or equivalent, as applicable.
Prepare people, equipment, and incident procedures
Before work starts, confirm that staff understand and can perform the required practices, that equipment is suitable and functioning, and that procedures cover routine work as well as foreseeable incidents. The BMBL risk-management discussion calls for evaluating staff proficiency and safety-equipment integrity, then addressing training or competency gaps.
Make responsibilities clear: who is authorized to perform each activity, who verifies readiness, and who should be contacted if a control fails or an incident occurs. The assessment should connect these operational responsibilities to the institution’s procedures and review process rather than relying on informal assumptions.
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Check whether controls work and reassess changes
Risk management continues after approval. Evaluate whether the selected controls are effective in practice and update the documented assessment when the work or its conditions change. CDC advises completing formal assessments before work begins and repeating them when changes are introduced.
Use a change in any of the following as a prompt to check whether the assessment remains valid:
- Procedures or the sequence of activities.
- Personnel, roles, or demonstrated proficiency.
- Instruments, safety equipment, or their condition.
- Facility conditions or how materials move through the facility.
- Other operating conditions that could affect exposure, containment, or response.
Record the change, decide whether it alters hazards or controls, and route the revised assessment through the appropriate institutional review before proceeding when required by local processes.
Address biosecurity separately when it applies
Biosafety focuses on preventing exposure and release; biosecurity focuses on preventing loss, theft, misuse, or unauthorized access. The risks can intersect, but they are not interchangeable. For high-consequence work, assess biosecurity alongside worker and environmental exposure risks, using institutional and national oversight processes as applicable.
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WHO’s 2024 laboratory biosecurity guidance addresses assessment and management of risks involving high-consequence research. It includes a laboratory biosecurity risk-assessment template and describes a risk- and list-based approach to oversight. Consider biosecurity controls and oversight implications when comparing proposed workflows involving relevant materials.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Use guidance as a framework, not a substitute for local review
The CDC/NIH BMBL sixth edition is the central U.S. best-practice reference described here; CDC’s edition page, dated March 18, 2026, states that it is advisory rather than regulatory. WHO’s Laboratory Biosafety Manual fourth-edition materials provide an international risk-based reference: WHO describes a core document and seven subject-specific monographs, with its risk-assessment publication dated 2020.
Neither reference can decide every protocol-specific control for a particular laboratory. Confirm current institutional requirements and applicable local rules with your biosafety professional and institutional review body before beginning work, and use their processes to resolve uncertainties about the proposed workflow.
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