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

Update: NIH Blue Ribbon Panel on

Risk Assessment of the BUMC National Emerging Infectious

Diseases Laboratories

Briefing for the NIH DirectorSeptember 12, 2008

Topics

Brief Update re Risk Assessment Community Engagement Plan

Boston municipal prohibition on use of rDNA in BSL-4 lab

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

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”

Court asked us to address the community plan

List citation2 citations

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

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

Strategies

Transparent local review and oversight of research

Phase-in of research operations

Community liaison activities

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

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

Local Review: Independent Outside expert

Add lagauge from paper – Allan’s new bullet

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

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

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

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.

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

Discussion

Backpocket Slides

Preliminary Analysis

Biosafety Assessment of appropriate containment

BSL-4 BSL-3 or below

Cannot be used at NEIDL

Can be used at NEIDL

Wild type Risk Group 4 Agent

(e.g., Yersinia pestis)

Recombinant Y. pestis

rDNA manipulation(cannot be done at NEIDL)

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.”

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.

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.

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