1. Briefing for the NIH Director September 12, 2008
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 on Earning 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 Wild type Risk Group 4 Agent
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’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 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