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

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 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

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 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)

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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 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 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 OversightLab Worker vs. Community Risk

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 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

General Lab Hygiene Wastewater Treatment/Backflow

Prevention Signage Access Controls HVAC Systems/Air Balance/Filtration Biological/Chemical Waste Systems Ergonomics and Safety