What is biosecurity?

Biosecurity refers to the protections against deliberate release of pathogens.

Biosecurity controls include:

engineering controls (entrance controls, video surveillance, video archiving)

operational controls (2-person rule)

management controls (registration and inspection, personnel reliability,

assurance, personnel training, inventory monitoring, incident reporting)

What are the current biosecurity protections in the US?

There are US biosecurity regulations with force of law for 68 human, livestock, and crop pathogens and biological toxins deemed to have high potential for use as bioweapons (“select agents”; regulated under the Select Agent Rule).

Specified administrative controls include: lab registration, lab inspection, operational planning, personnel reliability assurance, personnel training, inventory monitoring, incident reporting

But there are gaps that need to be addressed:

There are no specified engineering controls other than entrance controls. (For example, there is no requirement for video monitoring or video archiving.)

There are no specified operational controls. (For example, there is no requirement for the 2-person rule.)

Most decisions on engineering controls, and all decisions on operational controls, are left to discretion of researchers and researchers’ institutions.

The Select Agent Program is administered by the CDC and the USDA. Because these agencies perform research and fund research, there are inherent conflicts of interest.

What are the major problems with current system?

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

Existing regulations with force of law for biosecurity do not specify minimum required engineering controls, other than entrance controls, and do not specify minimum required operational controls.

There are no regulations with force of law–and not even guidelines–for biosecurity of research with pathogens not listed as Select Agents.

What should be done to ensure rigorous biosecurity protections?

Oversight of biosecurity 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 biosecurity of research with all pathogens. These regulations should be universal, independent of funding source, independent of classification status, specific, monitored, and enforced.  

If possible, oversight of biosecurity should be harmonized internationally, and oversight of biosecurity 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.)

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

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