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BPHC Oversight High & Maximum Security Labs

BPHC Oversight High & Maximum Security Labs. NIH Blue Ribbon Panel Teleconference September 09, 2008. High & Maximum Security Laboratories BPHC Oversight Purpose. Protect the safety and health of the public and lab workers

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BPHC Oversight High & Maximum Security Labs

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  1. BPHC OversightHigh & Maximum Security Labs NIH Blue Ribbon Panel Teleconference September 09, 2008

  2. High & Maximum Security LaboratoriesBPHC Oversight Purpose • Protect the safety and health of the public and lab workers • Increase public confidence and awareness about lab safety procedures and regulations

  3. High & Maximum Security LaboratoriesPermitting • Permit type • Provisional • Unconditional (6) • Select agent (2) • Conditional (1) • Additional reports • More frequent inspections

  4. High & Maximum Security LaboratoriesPermit Review Permit timelines: • BSL3 initial/renewal – 4/3 months advance • BSL4 initial/renewal – 6/4 months advance • Permit valid for 3 years • New projects – submit ≥30 days advance

  5. High & Maximum Security LaboratoriesPermit Requirements • Required for all BSL3 & BSL4 research laboratories • Application process includes: • Document review • Biosafety/Lab safety manual • Disease surveillance plan • Evacuation and emergency response plans • Waste disposal plan • Security plan • Transportation plan • Chemical hygiene plan • Strain verification policy/procedure • Risk management program description • IBC roster • Key staff list

  6. High & Maximum Security LaboratoriesOversight Activities • Inspections • BSL3 – one per year minimum • BSL4 – two per year minimum • Inspection components • Review of policies, procedures and documents • Staff interviews • Observation and assessment of facility and practices • Results available to public

  7. High & Maximum Security LaboratoriesBPHC Oversight Structures • BPHC Internal • BPHC Board • BPHC Executive Director • Boston Biosafety Committee (BBC) • BPHC Staff – Biosafety Program Director; General Council • External • City of Boston • City Working Group • Independent consultants

  8. High & Maximum Security LaboratoriesBPHC Oversight Structures • Boston Biosafety Committee (BBC) • At least 7 members • Appointed by BPHC Executive Director (BBC Chair) • Scientific and community representatives • 2 neighborhood residents • 1 - RDNA expertise • 3 from: public health, occupational health, infectious diseases, biosafety, environmental quality. • Other members with qualifications determined to be necessary by the ED.

  9. High & Maximum Security LaboratoriesBPHC Oversight Structures • Boston Biosafety Committee (cont.) • Special Municipal Employee status • Conflict of interest • Gifts • Contracts • 2 year term; removal for cause; reappointment eligibility • Replaces Boston RDNA Advisory Committee • Not subject to open meeting laws

  10. High & Maximum Security LaboratoriesBoston Biosafety Committee Duties & Responsibilities • Review effectiveness of regulations; consider changes & amendments • Provide TA/advise Board & ED • Review & recommend: • Literature & emerging science • Permit & project applications • Policies & procedures • Manuals & programs • Violations & appeals • Conduct inspections

  11. High & Maximum Security LaboratoriesBoston Biosafety Committee Operations • Meet with sufficient frequency… • Staffed by EHO & CDC of BPHC • Notice posted on BPHC website 48 hours prior to meeting or ASAP for emergency • Minutes maintained

  12. High & Maximum Security LaboratoriesBoston Biosafety Committee Current Status: • Applicants nominated • Applicants recruited • Representation from all required categories • High degree of expertise • Under review; appointment made by ED

  13. High & Maximum Security LaboratoriesInstitutional Requirements • IBC for all BSL3-4 • Annual IBC report with all meeting minutes • Annual public meeting with public disclosure of research • Chair reports to RO • BPHC approves 1 community member

  14. High & Maximum Security LaboratoriesOversight Structures • NEIDL Structures – not required by BPHC • External Scientific Advisory Committee • BPHC Representative • “… will review … for scientific merit, quality and relevance … ” • “...advise & report regularly to the EC & to the leadership of BU, to the NIAID, CDC & other agencies … on safety procedures … including verification that safety procedures are followed.” • Community Oversight Committee

  15. High & Maximum Security LaboratoriesReporting to BPHC • Incident reporting – upon discovery, not > 24 hours • Disease Surveillance and Reporting Regulation • Mechanical or security system • Containment systems and practices • Anything reported to IBC, NIH, CDC • Executive Director informs Board and/or BBC members as deemed appropriate

  16. High & Maximum Security LaboratoriesBPHC Enforcement • Monetary fines • Permit may be issued with conditions, revoked, suspended, modified or not renewed • Immediate closure of laboratory • Process for appeal of citation

  17. High & Maximum Security LaboratoriesQuality & Transparency (misc.) • Annual Report to BPHC Board • Annual public meeting by BPHC • Whistleblower provisions for anonymous reporting of health and safety violations • Professional standards of best practice – City-wide drills, training, documents, etc. • Education and training

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