A Look at the Proposed Cambridge Biosafety Regulation
Posted on Tue, Aug 04, 2009 @ 08:03 AM
by Kimberly Parker, Account Manager, Life Sciences
The Cambridge Department of Public Health (DPH) has been regulating rDNA research since 1977. The regulation was developed in response to public concern about activities in academic research laboratories at the Biosafety Level 3 (BSL3), which at the time was called "P3". At the same time that Cambridge began discussing the regulation of work with rDNA molecules, the NIH Guidelines on Research Involving Recombinant DNA Molecules (NIH Guidelines) were also created. These Guidelines were included in the Cambridge rDNA regulation, making them enforceable in Cambridge. Later, the Cambridge Biosafety Committee (CBC) was also created to provide oversight of biosafety and rDNA work in the city.
Current public concern about work with high risk biological agents in Cambridge has led the CBC/Cambridge DPH to draft a new proposed version of the Cambridge Biosafety Regulation. This draft was out for public comment until July 31, 2009.
So what's the difference you ask? Well, in a nutshell...
- The new regulation will require covered facilities to follow both the NIH Guidelines and the "BMBL" (Biosafety in Microbiological and Biomedical Laboratories 5th edition).
- Rather than obtaining an rDNA permit, covered facilities will be issued a Cambridge "Biosafety" permit similar to the rDNA permit but including other ‘high risk' activities. These activities are work at the BSL3 level, with Risk Group 3 or 4 agents (defined by NIH Guidelines) or work with Select Agents. (There are no BSL4 labs in Cambridge and this activity is banned in the city).
Many labs that work with Select Agents or at the BSL3 level also work with rDNA, so a significant increase in the number of permit holders is unlikely. However, these changes are an indication of the continued commitment in Cambridge to ensure that proper Biosafety practices are used when working with high risk, potentially infectious agents.