Local regulation of laboratory biosafety in cambridge, Massachusetts

Cambridge, Massachusetts (pop. 105,000) has emerged within the past 30 years as the most active global center of innovation in biotechnology, genetically-based clinical therapeutics, and pharmaceutical product development. Beyond Harvard and MIT, Cambridge regulates 80+ firms and institutions engaged in biological research and manufacturing that may pose public health risk to employees and neighbors. The current general acceptance of the biotech sector and academic biological research within this community, well known for skepticism towards institutional assurances, only emerged after intense debate over the ethical and public health implications of genetically altered organisms in the 1970s.

Concerns about lab-acquired infections and environmental releases of genetically altered viruses and bacteria were addressed with enactment of local regulations intended to assure residents and workers that all work meets standards established by the National Institutions of Health ("Guidelines for Research Involving Recombinant DNA Molecules"). These locally enforceable guidelines classify microorganisms and their specific gene insertions by Risk Group and impose biosafety containment levels (BSLs) according to the potential risk associated with that work. The Cambridge Public Health Department coordinates a citizens' committee charged with oversight of all laboratories engaged in regulated biological work. Biosafety training workshops are conducted to train residents willing to serve as community representatives on internal biosafety committees for each institution or company, to train public health professionals, and to provide training for biosafety officers within each permitted establishment. This presentation will offer an overview of enforcement and public engagement strategies required for public assurance regarding biological research and manufacturing.