Inspection Shows Bedford Biotech Companies Meet Biosafety Regulations

There are 10 Bedford businesses whose work with regulated biological agents requires periodic inspection of facilities, procedures, and practices for compliance with the town’s biosafety regulations.

Rebecca Caruso, a scientist who has handled these specialized inspections for the Health Department for the past four years, told the Board of Health Monday that although she found some deficiencies, none was “glaring.”

The Board of Health enforces regulations for “businesses who use recombinant DNA or biological agents to file an annual permit and explanation of their current projects,” Health and Human Services Director Heidi Porter explained after the meeting. “As a follow-up to that permit application, our contracted inspector conducts an annual inspection.”

Caruso, director of Harvard Medical School’s Committee on Microbiological Safety, said she conducted the inspections virtually and made verbal recommendations during the “walk-through.”

There are 16 categories in the workplace subject to local inspection. The necessary improvements identified ranged from the condition of cabinets and waste management to training materials and required meetings and records of each firm’s in-house biosafety committee.

She told the board that the 10 companies are the same ones she inspected last year and that all displayed excellent Covid safety compliance.

The local regulations conform to guidelines from the National Institutes of Health and the Centers for Disease Control and Prevention.

The local permitting requirements include detailed emergency planning; a list of all organisms used; decontamination processes; a plan for treatment or management of biological waste; protocol for strain verification of potentially pathogenic organisms; and health monitoring, health surveillance, and training manuals.


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