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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
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

local recombinant dna oversight the debate
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
local recombinant dna oversight public perception of risk
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
local recombinant dna oversight benefits of cambridge nih rules
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
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
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

local recombinant dna oversight biosafety levels
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 ….
local recombinant dna oversight risk group levels
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)
slide9
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

local recombinant dna oversight local enforcement agencies
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
local recombinant dna oversight required presentation to the cbc
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
local recombinant dna oversight laboratory site visit
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