Biosafety Regulations (BMBL) and their relevance for AI

By stepanlos @ 2023-06-29T19:20 (+7)

AI regulations could draw inspiration from the field of biosafety regulation, specifically the CDC's guidelines for Biosafety in Microbiological & Biomedical Laboratories (BMBL), which outline the necessary precautions for working with dangerous biological agents and recommend a systematic approach for assessing their risks.

The remainder of this report will describe the structure and mission of BMBL, outline its key principles and recommendations and indicate relevant takeaways for the field of AI regulation. 

Epistemic status: I am not an expert in biosafety. However, I think a summary document which highlights concrete safety steps undertaken in an adjacent field to AI and highlights some actionable steps for AI labs to increase safety could be potentially useful. All construcive feedback and suggestions for improvements are welcome!

Structure and Mission

BMBL is an advisory document protecting laboratory staff, the public and the environment from exposure to dangerous microorganisms and hazardous materials (e.g. radioactive agents). While many organizations and agencies use BMBL for regulations, it is primarily an advisory document to help with a comprehensive protocol which helps laboratories identify risks and ensure safe conduct when working with dangerous microorganisms and hazardous materials. It provides guidelines for protecting laboratory staff, the public and the environment. 


BMBL is a set of biosafety guidelines compiled by experts and members of the public. To produce BMBL, the Office of Laboratory Science and Safety (OLSS) works with the National Health Institute (NIH) to recruit over 200 expert contributors from scientific societies, federal agencies (NIH, CDC, FBI, and many more), and the public.

Key Principles and Procedures

Containment of dangerous microorganisms is key to biosafety. Containment refers to the principle that the laboratory staff, the public and the environment should be protected from exposure to dangerous microorganisms being manipulated in the laboratory. 


Risk assessment is key to preventing laboratory-associated-infections. Risk assessment is the process that outlines the correct procedure of handling dangerous samples in order to prevent laboratory-associated-infections (LAI) both for laboratory staff and the public.


Protective measures are taken relative to the degree of risk posed by concrete organisms. BMBL employs a risk-based approach to biosafety, where rigidity of protective measures is relative to the degree of risk posed by concrete microorganisms (labeled agents) in order to ensure effective distribution of resources.


“Err on the side of caution”. BMBL works under the precautionary principle of “imposing safeguards more rigorous than needed” where there is an insufficient amount of data to determine risk.


Degree of risk determines the degree of containment. Each level of containment describes the microbiological practices, safety equipment, and facility safeguards for the corresponding level of risk associated with handling an agent. The risk criteria are: Infectivity, Severity of disease, Transmissibility, Nature of the work being conducted and Origin of agent. 


Four levels of containment based on the risk criteria: 

BSL-1: appropriate for agents that do not cause disease to immunocompetent adult humans, 

BSL-2: moderate-risk agents that do not transmit through aerosol and are of varying (but not lethal) severity, 

BSL-3: agents with known potential for aerosol transmission and causing potentially lethal infections, 

BSL-4: agents with high risk of causing life-threatening disease by aerosol for which there is no known treatment.


BMBL provides detailed risk-assessments for concrete known agents. Agent Summary Statements are written based on the levels above for agents known to present a risk to the laboratory personnel and to public health. Statements prepared by scientists, clinicians and biosafety professionals who contributed to BMBL.


BMBL recommends an ongoing six-step risk-assessment procedure to mitigate risks. Laboratories are instructed to engage in ongoing risk-assessment for particular agents and procedures, especially prior to working with a new agent. 

1) Identify hazards characteristic for the agent and assess inherent risk. 

2) Identify procedural hazards of working with the agent. 

3) Determine Biosafety level. 

4) Consult a third-party professional, expert or expert-body. 

5) Assess proficiency of staff regarding safety practices. 

6) Continually review risk-management strategies in the lab.


Thanks to Jakub Kraus for valuable comments. Cross posted on LW: