Briefing for the NIH Director September 12, 2008

1. Update: NIH Blue Ribbon Panel on Risk Assessment of the BUMC National Emerging Infectious Diseases Laboratories Briefing for the NIH Director September 12, 2008

2. Topics • Brief Update re Risk Assessment • Community Engagement Plan • Boston municipal prohibition on use of rDNA in BSL-4 lab

3. Risk Assessment Studies • Scope • 12 infectious agents • 12 archetypal scenarios • Analyses to include impact of: • Risk mitigation measures • Municipal emergency response plans • Contract with Tetra Tech • Add in cost • Administered by Army • Statement of Work finalized • Detailed work plan review by Blue Ribbon Pnael and NIH , and BU • Ongoing oversight • Blue Ribbon Panel • NIH Coordinating Committee • Timeline: Fix dates • Target RA completion date: February 2009 • Public Comment: March –April 2009 • Court Filings: May 2009

4. Boston Community Consultations √ May 16th Blue Ribbon Panel meeting in Boston √ July 16th BRP meeting on community engagement • October 14 BRP meeting to present draft principles underpinning ???????: • “Fix Title”

5. Court asked us to address the community plan • List citation • 2 citations

6. BRP Draft Report onEarning and Sustaining Public Trust in High Containment Labs Intending to Serve as a National Resource • Scope: • Specific to BU/BUMC NEIDL • Also, applicable to NIH funded BSL-3 and BSL-4 facilities intended to serve as national resources • Approach: • Articulate fundamental principles • Recommend best practices and proposed strategies • Specific implementation mechanisms left up to local jurisdiction

7. Fundamental Principles • Rigorous local review of BSL3 and BSL-4 research • Including scientific expert not affiliated with the institution • Inclusion of the local public health authorities • Maximal transparency regarding facility operation, nature of research, and oversight of research • Community representation • Appropriate technical expertise • Ongoing oversight

8. Strategies • Transparent local review and oversight of research • Phase-in of research operations • Community liaison activities

9. Current Scope of Local Review • Current IBC review embodies these principles • However, currently IBC review mandated only for rDNA and Select Agent research • Review includes: • Community representatives • Biosafety and scientific expertise • Authority to approve/disapprove rDNA protocols • Ongoing oversight throughout life of research project • Meetings 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

10. BRP 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 operational • Institutional implementation: all infectious disease research in high or maximum containment ought have review and oversight by a local review body • For the BUMC NEIDL this body would optimally include: • Independent Chair, 2 community reps, 2 BU reps, 2 public health commission representative experts, 2 independent scientists • BPHC act as secretariat for the body

11. Local Review: Independent Outside expert • Add lagauge from paper – Allan’s new bullet

12. Phase-in of Research Operations • Standard practice for launching high and maximum containment labs entails phasing in operations • Training • Systems assessment • Local 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

13. Community Liaison Activities • Institutions with maximum containment laboratories should develop community liaison activities to foster: • Input from community about impact of lab on community • Can help further inform community representatives on local independent review body • Communication to the community about operation of the lab • Education about research and health targeted at adults and children

14. Potential BRP Meeting In Boston (Update this Slide) • Location: Community venue • Date: Mid-September • Time: 7:00 – 10:00 PM • Purposes: • Present draft report: “High and Maximum Containment Laboratories: Fundamental Principles and Proposed Strategies For Earning and Sustaining Public Trust” • Hear from community • Presentation from Boston Public Health Commission on plans for review and oversight of research at the NEIDL

15. Update 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 RESTRICTIONS • 3.01. 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 [1] 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) [1] In a June 11, 2008 telephone conversation with NIH OBA staff.

16. Boston 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 research • What 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

17. Discussion

18. Backpocket Slides

19. Preliminary Analysis rDNA manipulation (cannot be done at NEIDL) Wild type Risk Group 4 Agent (e.g., Yersinia pestis) Recombinant Y. pestis Biosafety Assessment of appropriate containment BSL-4 BSL-3 or below Cannot be used at NEIDL Can be used at NEIDL

20. NIH 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.”

21. Tetra 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 scope • Has ~ 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.

22. Tetra 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.

23. Tetra Tech’sRelevant 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 Laboratory • Environmental 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