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Local Recombinant DNA Oversight Mass Biotech Council Series

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”

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Local Recombinant DNA Oversight Mass Biotech Council Series

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

  2. Local Recombinant DNA OversightThe 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

  3. Local Recombinant DNA OversightPublic 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

  4. 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

  5. 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

  6. Local Recombinant DNA OversightBiological 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

  7. Local Recombinant DNA OversightBiosafety 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 ….

  8. Local Recombinant DNA OversightRisk 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 oftenavailable • 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)

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

  10. Local Recombinant DNA OversightLocal 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

  11. Local Recombinant DNA OversightRequired 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

  12. 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

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