NIH Blue Ribbon Panel March 13, 2008 Building 1, Wilson Hall National Institutes of Health Campus

1. Risk Assessment of the National Emerging Infectious Diseases Laboratories at the Boston University Medical Center NIH Blue Ribbon Panel March 13, 2008 Building 1, Wilson Hall National Institutes of Health Campus

2. NIH Blue Ribbon Panel: Purpose • To provide scientific and technical advice to the NIH regarding the construction and operation of a national biocontainment laboratory at Boston University Medical Center. • Comments and concerns have been voiced by: • Courts • Local community • General public

3. NIH Blue Ribbon Panel: Major Task • The Blue Ribbon Panel will provide independent scientific advice regarding: • The scope of any additional risk assessments that might be necessary; • Effective risk communication. • The Panel will be especially mindful of issues related to National Environmental Policy Act requirements, environmental justice, community liaison, and risk communication.

4. Specific Tasks • Review judicial materials and public concerns; • Consult with technical experts, including NRC committee; • Evaluate the adequacy of the scenarios, organisms, methodologies, and assumptions in the supplementary risk assessments. • Propose additional risk assessments as appropriate; • Provide ongoing advice regarding the conduct of such studies; • Advise on final report.

5. Membership and Structure • The Blue Ribbon Panel is established as a Working Group of the standing Advisory Committee to the Director (ACD), NIH. • http://www.nih.gov/about/director/acd/index.htm • The Panel’s recommendations will be conveyed to the NIH Director through the ACD. • The Panel members provide expertise in: • Infectious diseases • Public health • Epidemiology • Risk assessment • Infectious disease modeling • Risk communications • Biosafety • Bioethics • Environmental justice.

6. Today’s Topics • Background on Overarching Aims and Scope of the Research • NIH biodefense and emerging infectious diseases research • Biomedical research portfolio of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center • Overview of Federal, State, and Municipal Requirements: • National Environmental Policy Act (NEPA) • Massachusetts Environmental Policy Act (MEPA) • Boston municipal requirements and safeguards for biocontainment laboratories

7. Today’s Topics • Overview of Legal Proceedings • Federal litigation • State litigation • Overview of Draft Supplementary Environmental Risk Assessments • Purpose, models, and methodology • Perspectives from members of the National Research Council Committee • Public Comment

8. NIH BioDefense & EmergingInfectious Diseases:Strategic Overview Michael G Kurilla, MD-PhD Director, Office of BioDefense Research Affairs Division of Microbiology & Infectious Diseases Associate Director, BioDefense Product Development National Institute of Allergy and Infectious Diseases March 13, 2008

9. Not with a bang, but with a whimper

10. SARS: A New Global Health Challenge

11. Homeland Security Presidential Directives • HSPD-10 “Biodefense for the 21st Century” (4/2004) • Four Pillars (Threat Awareness, Prevention & Protection, Surveillance & Detection, Response & Recovery) • HSPD-18 “Medical Countermeasures against Weapons of Mass Destruction” (1/2007) • Inclusion of enhanced (XDR-TB) and emerging disease (SARS) agents • Move towards broad spectrum solutions • HSPD-21 “Public Health and Medical Preparedness” (10/2007) • “establishes a National Strategy for Public Health and Medical Preparedness” • “…applicable to a broad array of natural and manmade public health and medical challenges”

12. Inputs and Outputs

13. Strategic Plans and Agendas

14. 2002 Blue Ribbon Panel: Bioterrorism and Its Implications for Biomedical Research • Research with potentially deadly Category A agents must be conducted in appropriate containment facilities • Access to biosafety level (BSL) 3 and 4 facilities, … is limited and must be expanded • NIAID’s research agenda will include . . . the physical infrastructure within which to conduct this research

15. Extramural Construction Program: National Biocontainment Laboratories (NBLs) & Regional Biocontainment Laboratories (RBLs) • Funding to build comprehensive, state-of-the-art BSL-2, BSL-3 and BSL-4 laboratories • Designed and built using the strictest federal standards (protect the public & lab workers) • Complement and support biodefense and emerging infectious disease research AND assist national, state and local public health efforts in the event of a bioterrorism or infectious disease emergency.

16. Expansion of BiodefenseResearch Capacity

17. Timeline for Biocontainment Construction Program August 2002 Public Briefing on proposed BAA for Biocontainment Labs October 2002 BAA issued for Regional (BSL3) and National Labs (BSL4) February 2003 Omnibus Spending Bill--$375M for extramural construction grants September 2003 Following Peer Review, NIAID awards Cooperative Agreements (UC06): 2 NBLs (BU NEIDL and UTMB GNL) 9 RBLs

18. January 2004 Design & Environmental Impact Statement prep begins December 2005 Design completion January 2006 Record of Decision (ROD) issued March 2006 Construction begins March 2008 77% construction completion October 2008 Estimated completion 2009 Ongoing commissioning Occupancy to commence Post Award NEIDL Milestones

19. Project: 185,670 GSF building located on the UTMB campus, consisting of ABSL-4 and ABSL-3 vivarium, BSL-4, BSL-3 and BSL-2 laboratories, animal support and building support facilities. Schedule: Current: 85% construction complete Building Completion: July, 2008 The Other BSL-4:University of Texas Medical Branch NBLGalveston National Laboratory – Galveston, TX

20. RBL Completions: 2007 University of Pittsburgh Colorado State University Duke University

21. Selected Public Health& BioDefense Advances • Influenza • Pre-pandemic vaccines; antivirals • Anthrax • rPA vaccine (2nd gen); post-exposure vaccination; therapeutics (antitoxins) • Ebola • 2nd gen vaccines; novel RNAi therapeutic

22. National Emerging Infectious Diseases Laboratories at Boston University Mark S. Klempner, MD Associate Provost for Research Director, National Emerging Infectious Diseases Laboratories Institute Boston University

23. Daniel Wheeland Director, Office of Research Facilities Development and Operations National Institutes of Health Federal Environmental Policy Requirements Under the National Environmental Policy Act (NEPA)

24. National Environmental Policy Act (NEPA) National Environmental Policy .. to create and maintain conditions under which man and nature can exist in productive harmony, and fulfill the social, economic, and other requirements of present and future generations of Americans. National Environmental Policy Act (NEPA) .. is our basic national charter for protection of the environment. It establishes policy, sets goals and provides means for carrying out the policy. The purpose of NEPA is to ensure that Federal agencies understand the potential impacts of their actions, mitigate them where possible, and make informed decisions.

25. National Environmental Policy Act What federal agency actions are subject to NEPA? • Actions that could have environmental effects, such as federal construction projects, plans to manage and develop federally owned lands, and federal approvals of non-federal activities, e.g., grants, licenses, and permits. • NIH’s action is the partial funding of the construction of the NEIDL. Environmental Impact Statement (EIS) • A written statement drawing conclusions on how a course of action is likely to affect the environment and analyzing the potential impacts of an action. • NIH conducted an EIS that analyzed potential impacts and mitigation measures associated with the partial funding of the NEIDL. Record of Decision (ROD) • A concise written record of the Agency’s decision based upon the EIS. • The NIH determined on 1/26/06 in its ROD that the NEIDL posed a negligible risk to the community and that the NEIDL would not have a disproportionate impact on low-income and minority populations.

26. Areas Studied As Part Of The NEIDL EIS • Social Resources • Economic Resources • Environmental Justice • Visual Quality • Wastewater and Water Resources • Biological Resources • Air Quality • Noise • Transportation • Historic and Cultural Resources • Land Use • Cumulative Impacts • Human Health and Safety • Appendix 9: “Hazard and Risk Assessment NEIDL” Evaluated the aerosol release of anthrax spores. (Conducted by RWDI) • Appendix 11: “Executive Summary Threat and Risk Assessment”, Four-step vulnerability assessment. (Conducted by Applied Risk Management) • Appendix 12: “BUMC/NEIDL Risk Assessment”, Maximum possible risk with an aerosol release of anthrax spores. (Conducted by CDIC, Inc.)

27. NEIDL NEPA Chronology • 01/09/04: Notice of Intent to Prepare EIS • 02/17/04: EIS Scoping Meeting • 10/22/04: Draft EIS Notice of Availability • 11/10/04: Draft EIS Public Comment Meeting • 04/01/05: Supplemental DEIS Notice of Availability • 04/25/05: Supplemental DEIS Public Comment Meeting • 12/09/05: Final EIS Notice of Availability • 01/26/06: Record of Decision (ROD) Approved

28. NEPA and MEPA

29. Massachusetts Environmental Policy Act Deerin Babb-Brott Director Executive Office of Environmental Affairs Massachusetts Environmental Policy Act Office

30. Boston Municipal Requirements and Safeguards for Biocontainment Laboratories M. Anita Barry, MD, MPH Director, Communicable Disease Control Boston Public Health Commission Roger Swartz, MPH Director, Community Initiatives Bureau Boston Public Health Commission

31. Federal Litigation David Lankford, JD Senior Attorney, HHS Office of the General Counsel Public Health Division, NIH Branch

32. Three Legal Actions Filed Three lawsuits have been filed related to funding/construction of NEIDL: • Federal NEPA lawsuit; • Complaint with the DHHS Office of Civil Rights (OCR), with subsequent lawsuit; • State lawsuit under the Massachusetts Environmental Protection Act (MEPA).

33. NEPA Lawsuit May 16, 2006: • Several Boston residents and two public interest groups, the Conservation Law Foundation and the Lawyers’ Committee for Civil Rights, sued the NIH under NEPA. • BU joined the lawsuit as a co-defendant.

34. NEPA Lawsuit Plaintiffs asked the court to: 1) Declare that NIH violated NEPA, and 2) Stop the NIH’s funding of the NEIDL.

35. NEPA Lawsuit • Plaintiffs allege that NIH failed to properly assess potential risks of the NEIDL on the public health and failed to consider alternative locations, including less populated areas. • The crux of the plaintiffs’ claims is that infectious agents will be released from the NEIDL and harm the community. • The focus of the NEPA lawsuit is BSL-4 agents in the NEIDL; plaintiffs have tried to broaden scope to BSL-3 and below, but the court has limited the case to BSL-4 agents.

36. NEPA Lawsuit • Plaintiffs have also raised an Environmental Justice claim, arguing that the NEIDL’s location will have a disproportionate impact on low-income and minority populations.

37. NEPA Lawsuit September 6, 2006: • At a Federal court hearing, the judge asked NIH to further assess the possible impacts of release of BSL-4 agents, particularly Ebola, into the community. • NIH agreed to provide the court with a supplementary risk assessment. • The court deferred ruling on halting NIH’s funding of the NEIDL, pending completion of this supplemental review, allowing construction to continue.

38. NEPA Lawsuit August 23, 2007: • NIH released its draft supplementary risk assessments for public comment. December 20, 2007: • After receiving comments on the draft supplementary risk assessments, including the NRC report, NIH informed the court that it would perform additional analyses of the potential risks of the NEIDL.

39. NEPA Lawsuit • Although construction on the NEIDL has continued, BSL-4 research will not be conducted until the court decides whether the NIH has complied with NEPA. • If the court determines that NIH did not comply with NEPA, the court could deny the conduct of BSL-4 research in the NEIDL pending further environmental review by the NIH. • Although much less likely, the court could also enjoin use of the rest of the NEIDL.

40. Office of Civil Rights Complaint July 11, 2005: • Several Boston residents filed an administrative complaint with the DHHS OCR, alleging that Boston University’s decision to build the NEIDL at its current location was discriminatory under Title VI of the Civil Rights Act of 1964. • The complainants argued that release of pathogens from the NEIDL would have a disproportionate impact on minority residents. • OCR postponed investigating the complaint pending completion of the NIH’s supplementary assessments and NEPA lawsuit, reasoning that the NIH’s analyses of the risks posed by the NEIDL were relevant to the discrimination complaint. • The complainants filed a lawsuit to compel OCR to investigate the complaint before NIH completed its investigation, but the Federal court has agreed with OCR’s position that the NIH’s supplementary review is relevant to the discrimination complaint and that OCR’s investigation can await the completion of the NIH’s supplementary review.

41. State Legal Proceedings Seth D. Jaffe, JD, MPP Foley Hoag LLP, Boston Outside Counsel to Boston University and Boston Medical Center

42. National Emerging Infectious Diseases Laboratories (NEIDL): Overview Draft Supplementary Risk Assessments and Additional Site Suitability Analyses (DSRASSA) Deborah E. Wilson, DrPH, SM (NRM), CBSP Director Division of Occupational Health and Safety National Institutes of Health

43. Why were the additional studies initiated? The Federal Judge presiding over the NEPA lawsuit requested information regarding impact on the community should an agent, like Ebola, be released from the Maximum Containment Laboratory (BSL-4) in Boston.

44. Purpose of the Study • Additional evaluations of the alternative sites to further ensure that equal consideration was given to each. • Perform risk assessments: a. To investigate the extent to which an exotic disease agent, if accidentally released from a BSL-4 laboratory, may spread into communities in which the NEIDL may be sited; b. To compare the impacts on the three sites; c. To determine if there would be disproportionate health impacts on Environmental Justice Communities surrounding the Albany Street NEIDL site.

45. Why weren’t agents assigned to BSL-3 laboratories included in the additional risk assessments? From October 20, 2006 Federal Court Order: “At the hearing, plaintiffs also challenged the building of a level-2 and level-3 lab under NEPA, but the record does not support a showing of a likelihood of success on a NEPA violation or irreparable harm from these kinds of laboratories which exist elsewhere in Boston.”* *Saris U.S.D.J., Case 1:06-cv-10877-PBS Document 36, Klare Allen et al. v National Institutes of Health

46. The DSRASSA Has Two Main Parts • The Additional Site Analyses • Qualitative • The Risk Assessments • Evaluation of complex infectious disease scenarios • Quantitative

47. The Additional Site Analyses • Sites selected for further analysis • BU-Albany Street Site Boston, Massachusetts • Boston University Corporate Education Center Tyngsborough, Massachusetts • Boston University Sargent Center for Outdoor Education Hancock/Peterborough, New Hampshire

48. Facility Location Visual Quality of the Site Historic Resources Noise Impacts Utility Availability and Impacts Transportation and Access Air Quality Impacts Economics, Income and Demographics Availability of and Impacts on Healthcare Facilities, Social Assistance and Emergency Response Presence of Floodplains Wetlands, Riparian Areas and Surface Waters Impacts on Habitat, Wildlife and Vegetation Impacts on Threatened or Endangered Species Impacts on Agriculture and Livestock Results from the additional risk analyses The additional site analyses included consideration of the following:

49. Risk assessment data were derived for three simulated “synthetic” communities: • Boston, MA • Urban environment • Environmental Justice Communities present • Tyngsborough, MA • Suburban environment • No Environmental Justice Communities present • Peterborough, NH • Rural environment • No Environmental Justice Communities present

50. Data for Use in the Additional Site Analyses Were Collected Through: • Site visits • Review of public documents • Master plans, local regulations or covenants, environmental testing results (where available) • Interviews • Visits to the healthcare facilities and staff interviews • Site plan reviews • Utility reviews • Other literature and information