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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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Bphc oversight high maximum security labs

BPHC OversightHigh & Maximum Security Labs

NIH Blue Ribbon Panel Teleconference

September 09, 2008


High maximum security laboratories bphc oversight purpose

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


High maximum security laboratories permitting

High & Maximum Security LaboratoriesPermitting

  • Permit type

    • Provisional

    • Unconditional (6)

      • Select agent (2)

    • Conditional (1)

      • Additional reports

      • More frequent inspections


High maximum security laboratories permit review

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


High maximum security laboratories permit requirements

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


High maximum security laboratories oversight activities

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


High maximum security laboratories bphc oversight structures

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


High maximum security laboratories bphc oversight structures1

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.


High maximum security laboratories bphc oversight structures2

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


High maximum security laboratories boston biosafety committee

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


High maximum security laboratories boston biosafety committee1

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


High maximum security laboratories boston biosafety committee2

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


High maximum security laboratories institutional requirements

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


High maximum security laboratories oversight structures

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


High maximum security laboratories reporting to bphc

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


High maximum security laboratories bphc enforcement

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


High maximum security laboratories quality transparency misc

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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