Presentation on theme: "Briefing for the NIH Director September 12, 2008"— Presentation transcript:
1Briefing for the NIH Director September 12, 2008 Update: NIH Blue Ribbon Panel on Risk Assessment of the BUMC National Emerging Infectious Diseases LaboratoriesBriefing for the NIH DirectorSeptember 12, 2008
2Topics Brief Update re Risk Assessment Community Engagement Plan Boston municipal prohibition on use of rDNA in BSL-4 lab
3Risk Assessment Studies Scope12 infectious agents12 archetypal scenariosAnalyses to include impact of:Risk mitigation measuresMunicipal emergency response plansContract with Tetra TechAdd in costAdministered by ArmyStatement of Work finalizedDetailed work plan review by Blue Ribbon Pnael and NIH , and BUOngoing oversightBlue Ribbon PanelNIH Coordinating CommitteeTimeline: Fix datesTarget RA completion date: February 2009Public Comment: March –April 2009Court Filings: May 2009
4Boston Community Consultations √ May 16th Blue Ribbon Panel meeting in Boston√ July 16th BRP meeting on community engagementOctober 14 BRP meeting to present draft principles underpinning ???????:“Fix Title”
5Court asked us to address the community plan List citation 2 citations
6BRP Draft Report on Earning and Sustaining Public Trust in High Containment Labs Intending to Serve as a National ResourceScope:Specific to BU/BUMC NEIDLAlso, applicable to NIH funded BSL-3 and BSL-4 facilities intended to serve as national resourcesApproach:Articulate fundamental principlesRecommend best practices and proposed strategiesSpecific implementation mechanisms left up to local jurisdiction
7Fundamental Principles Rigorous local review of BSL3 and BSL-4 researchIncluding scientific expert not affiliated with the institutionInclusion of the local public health authoritiesMaximal transparency regarding facility operation, nature of research, and oversight of researchCommunity representationAppropriate technical expertiseOngoing oversight
8Strategies Transparent local review and oversight of research Phase-in of research operationsCommunity liaison activities
9Current Scope of Local Review Current IBC review embodies these principlesHowever, currently IBC review mandated only for rDNA and Select Agent researchReview includes:Community representativesBiosafety and scientific expertiseAuthority to approve/disapprove rDNA protocolsOngoing oversight throughout life of research projectMeetings and minutes open to public (Note: details pertaining to security or commercial confidential may be redacted)No such review and oversight mandated for work with non-recombinant infectious agents or non-Select Agents
10BRP Recommendation: Expanded Scope of Local Review BRP recommends local review body to review and provide ongoing oversight all BSL-3 and BSL-4 research (ADD IN NIH Funded National Resources)Note: Panel currently receiving input from the Boston Public Health Commission and Boston University regarding the scope and process of the local review process envisioned of the BUMC NEIDL if it becomes operationalInstitutional implementation: all infectious disease research in high or maximum containment ought have review and oversight by a local review bodyFor the BUMC NEIDL this body would optimally include:Independent Chair, 2 community reps, 2 BU reps, 2 public health commission representative experts, 2 independent scientistsBPHC act as secretariat for the body
11Local Review: Independent Outside expert Add lagauge from paper – Allan’s new bullet
12Phase-in of Research Operations Standard practice for launching high and maximum containment labs entails phasing in operationsTrainingSystems assessmentLocal review of research protocols proposing to initiate BSL-3 or BSL-4 research includes an assessment of the institutional and investigator safety record for prior research with infectious agents
13Community Liaison Activities Institutions with maximum containment laboratories should develop community liaison activities to foster:Input from community about impact of lab on communityCan help further inform community representatives on local independent review bodyCommunication to the community about operation of the labEducation about research and health targeted at adults and children
14Potential BRP Meeting In Boston (Update this Slide) Location: Community venueDate: Mid-SeptemberTime: 7:00 – 10:00 PMPurposes:Present draft report: “High and Maximum Containment Laboratories: Fundamental Principles and Proposed Strategies For Earning and Sustaining Public Trust”Hear from communityPresentation from Boston Public Health Commission on plans for review and oversight of research at the NEIDL
15Update re Update this slide for Amy to review Since 1994 the City of Boston has an ordinance that prohibits use of rDNA under BL-4 conditions.SECTION 3.00 RESTRICTIONS3.01. RDNA use requiring containment defined by the [NIH Guidelines for Research Involving Recombinant DNA Molecules] as "BL4" shall not be permitted in the City of Boston.The Boston Public Health Commissioner has confirmed  that the restriction applies not only construction of agents that must be done under BL-4 conditions, but to their subsequent use in research, as well.Note: In the event of a public health emergency, the BPH Commissioner has the authority to override this prohibition and allow such work at the BSL-4 level (e.g., diagnostic analyses of patient samples) In a June 11, 2008 telephone conversation with NIH OBA staff.
16Boston rDNA BSL-4 Prohibition: Clarifying Scope and Implications Developing a set of Q/As, to be reviewed by Boston Public Health Commission, NIH and BUMC, regarding scope and implications of Boston prohibition on rDNA BSL-4 researchWhat is the prohibition?What was the impetus for its enactment?What rDNA can be done? What rDNA cannot be done?What are the implications of this restriction on the NEIDL fulfilling its mission as a National Biocontainment Lab?Q/A’s will provide factual basis for incorporation into court filings
19Preliminary Analysis Wild type Risk Group 4 Agent rDNA manipulation(cannot be done at NEIDL)Wild typeRisk Group 4 Agent(e.g., Yersinia pestis)Recombinant Y. pestisBiosafety Assessment ofappropriate containmentBSL-4BSL-3 or belowCannotbe used at NEIDLCanbe used at NEIDL
20NIH Guidelines: RG-4 Agents and BSL-4 Containment Under the NIH Guidelines, organisms are classified according to Risk Groups (1-4) that provide a starting point in the risk assessment process.Risk Group 4 agents (e.g., Ebola virus, Herpes B virus) are typically worked with under BL-4 conditions, unless there are mitigating circumstances.Section III-D-2-a states experiments utilizing DNA from Risk Group 4 agents may be performed under BL-2 conditions only after “demonstration that only a totally and irreversibly defective fraction of the agent’s genome is present in a given recombinant.”
21Tetra Tech, Inc.Founded in 1966 to provide engineering services related to waterways, harbors and coastal areas.Over the past 40 years, substantially increased size and scopeHas ~ 8,500 employees in more 275 offices worldwide.Provides environmental services, water/wastewater management, infrastructure services, security design, and outsourced technical services.Based in Pasadena, California.
22Tetra Tech, Inc.: History 1966: Tetra Tech's predecessor is founded.1969: A wave lab is opened.1973: Tetra Tech launches the first remote control submarine for exploration and military applications.1979: Tetra Tech analyzes data and explores Alaska's North Slope for oil.1980: Tetra Tech is acquired by Honeywell.1985Tetra Tech is awarded its first national water quality program.1988: Through a leveraged buy-out, the company's management team purchases Tetra Tech from Honeywell. The company has about 300 personnel.1989: Tetra Tech expands its groundwater capability.1991: Tetra Tech completes its initial public offering. The company primarily provides services in the Resource Management business area.1992: U.S. Department of Energy awards Tetra Tech a nuclear weapons configuration contract.1993: U.S. Air Force awards Tetra Tech a nationwide National Environmental Policy Act (NEPA) contract.1994: U.S. Navy awards Tetra Tech a CLEAN II 10-year, $330 million contract.1995: Tetra Tech establishes its Infrastructure Services business segment.1997: Tetra Tech establishes its Communications Services business segment.1999: Tetra Tech's research and development group creates U.S. Environmental Protection Agency (EPA) BASINS model to enable watershed management approach.2003: Tetra Tech establishes its Systems Support and Security business to apply its skills to the growing homeland security concern.2007: Tetra Tech expands its alternative energy capabilities.
23Tetra Tech’s Relevant Risk Assessment Projects: Examples Supplemental and Final Environmental Impact Statements for the Rocky Mountain Laboratories (NIAID)Final Environmental Impact Statements for the Galveston National Laboratory for Biodefense and Emerging Infectious Diseases Research Facility (NIAID)Final Environmental Impact Statements for National Bio- and Agro-Defense Facility (DHS)Environmental Assessment for University of Missouri-Columbia Regional Biological LaboratoryEnvironmental Assessment for Construction and operations of BSL_3 facility at Los Alamos NAtioanl Laboratory (DoE)Environmental Assessment for George Mason University regional Biocontainment Laboratory (NIAID)~10+ other examples