Biosafety

Biosafety refers to the controls and standards that protect against the accidental release of pathogens.

Biosafety controls:

engineering controls (infrastructure, “containment”)

operational controls (personal protective equipment, procedures)

management controls (planning, training, incident reporting)

Biosafety standards:

biosafety level 2 (BSL-2): lockable door, screened windows, uncarpeted floor, sink, eyewash, decontamination/sterilization device, gown, gloves

biosafety level 3 (BSL-3): BSL-2 plus negative air pressure, tandem self-closing doors, sealed windows, biosafety cabinet, rear-closing gown

biosafety level 4 (BSL-4): BSL-3 plus pass-through decontamination/sterilization device, exit shower, donning/doffing room and shower, positive-pressure suit, independent air supply

There are no US regulations with force of law–only guidelines–for biosafety controls and biosafety standards for research with pathogens other than smallpox virus.

All US decisions on biosafety controls and biosafety standards for research on pathogen other than smallpox virus are left to the discretion of researchers and researchers’ institutions. Biosafety guidelines apply only to federally funded research and only to unclassified research.

Biosafety guidelines are administered by agencies that perform research and fund research (NIH and CDC; inherent conflicts of interest).

Oversight of biosafety is performed by federal agencies that perform research and fund research, which presents inherent conflicts of interest.

There are no regulations with force of law on biosafety controls and biosafety standards for pathogens other than smallpox virus.

Oversight of biosafety should be assigned to an independent national agency–an agency that does not perform research and does not fund research. (The Nuclear Regulatory Commission provides a model.)

Regulations with force of law should be enacted for biosafety with all pathogens. These regulations should be universal, independent of funding source, independent of classification status, specific, monitored, and enforced.   

Enhanced mandatory engineering controls, operational controls, and administrative controls should be implemented.

Assignments of pathogens to biosafety levels should be tightened (e.g., re-assignment of SARS-related and MERS-related coronaviruses from BSL-2 to BSL-3).

If possible, oversight of biosafety should be harmonized internationally, and oversight of biosafety for the highest-risk subset of research with dangerous pathogens should be assigned to an international agency. (The WHO Advisory Committee on Variola Virus Research, which currently oversees research on smallpox virus, provides a potential model.)