Cambridge is a global center for biotechnology research and manufacturing, with more than 50 biotechnology and pharmaceutical laboratories located within city limits.
In 1977, Cambridge became the first city in the world to regulate the manipulation of genetic material. The Cambridge Recombinant DNA Technology Ordinance establishes strict oversight of university and commercial laboratories that engage in recombinant DNA research. The requirements set forth in the city ordinance are based on the widely employed National Institutes of Health (NIH) Guidelines for Research Involving DNA Molecules.
In 2009, the Cambridge Public Health Department extended the authority of the Cambridge Biosafety Committee through promulgation of the Cambridge Biosafety Regulation. This regulation adds non-recombinant high risk research and manufacturing (BSL-3 using Risk Group 3 or 4 agents) and Select Agents (as defined by federal law) to the purview of the committee. Furthermore, BSL-4 laboratories not already prohibited by the rDNA Ordinance are prohibited under this regulation.
Enforcement of the city's Recombinant DNA Technology Ordinance and Cambridge Biosafety Regulation is carried out by the Cambridge Biosafety Committee. One unified application is required and only one Biosafety permit will be issued. The Procedures of the committee apply to both the regulation and the ordinance.
The committee is comprised of Cambridge residents with no ties to the industry and it is staffed by the Cambridge Public Health Department. The committee strives to quickly guide Cambridge laboratories through the regulatory process, while continuing to work on behalf of Cambridge residents to ensure that biological work in Cambridge meets the highest standards of biosafety.
Permits are issued year-round, and are renewed every January.