Local Recombinant DNA Oversight Mass Biotech Council Series Enforcement of the Cambridge Recombinant DNA Technology Ordinance Cambridge Biosafety Committee and Cambridge Public Health Department July 9th, 2009

Local Recombinant DNA Oversight The Debate 1970s and the “Gene Scare” Asilomar Conference (1975) Cambridge debates gene splicing NIH develops biosafety standards Recombinant DNA Technology ordinance Other communities weigh in Amendments & Enforcement

Local Recombinant DNA Oversight Public Perception of Risk Public health alarm has dissipated vs. 1970s Biotech as a clean, low-impact industry New focus of public concern: Biological/Chemical/Radiological terrorism Pandemic flu CDC-funded biocontainment labs (e.g. BU lab) Public concern has also shifted to the applications of genetic technology GM foods Gene therapy Pharmaceutical safety, efficacy and value

Local Recombinant DNA Oversight Benefits of Cambridge/NIH Rules Labs commit to public/worker safety via Institutional Biosafety Committees (IBCs): safe lab practices, training, containment Companies and researchers get more predictable regulatory oversight; goodwill Public gains accountability and transparency Public participation on these IBCs improves their public credibility and informs residents

Local Recombinant DNA Oversight RDNA Permit Holder Responsibilities Ensure compliance with NIH Guidelines and local rDNA regulation Establish an IBC with full membership Appoint a Biosafety Officer (BSO) Ensure IBC has expertise in all reviewed work and that members are trained Establish a medical surveillance program Report accidents to the NIH and local BOH Submit Annual Reports to NIH & BOH

Local Recombinant DNA Oversight Biological Safety … is achieved through a combination of containment principles operating at different levels: Biological Containment Environmental stability, growth factors, routes of infection, attenuated strains, media requirements Primary Containment Safety cabinets, good microbiological practices, PPE Secondary Containment Barriers, decontamination, air flow, gas-tight (BSL3) 6

Local Recombinant DNA Oversight Biosafety Levels … describe a hierarchy of procedures, practices, equipment and lab design which achieve containment for the organism in question and the procedures to be used Biosafety levels are ranked from 1- 4, BSL-4 being the most stringent. Cambridge does not allow BSL-4 labs under the rDNA ordinance. Biosafety level assignment for a project is the result of a Comprehensive Risk Assessment based on procedures and the Risk Group for that agent ….

Local Recombinant DNA Oversight Risk Group Levels Risk Group 1: Agents that are not associated with disease in healthy adult humans Risk Group 2: Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available Risk Group 3: Agents associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high worker risk but low community risk) Risk Group 4: Agents likely to cause serious lethal human disease for which preventive or therapeutic interventions are not usually available (high worker & community risk)

Pathogenicity Infectious dose Concentration Environmental Stability Transmission route Host Range Training & Skill Level Vaccination Availability Population Risk Factors Medical Interventions Disease Outcomes Local Recombinant DNA Oversight Lab Worker vs. Community Risk

Local Recombinant DNA Oversight Local Enforcement Agencies Cambridge Biosafety Committee (CBC) CBC Meetings IBC Representatives Presentation to CBC Laboratory Site Visits Fire Department & LEPC Chemical hygiene plans, flammables, hazmat response, advanced 911 compatibility

Local Recombinant DNA Oversight Required Presentation to the CBC Mission of Research Overview of rDNA Procedures & Vectors Floor Plans: BL level & Access Control Employee Medical Surveillance Permits received and pending (local, state) Service Contracts: Bio, Chem, Rad, Pests Submit Biosafety Manual & IBC Reps

Local Recombinant DNA Oversight Laboratory Site Visit General Lab Hygiene Wastewater Treatment/Backflow Prevention Signage Access Controls HVAC Systems/Air Balance/Filtration Biological/Chemical Waste Systems Ergonomics and Safety