NIH Blue Ribbon Panel to Advise on the Risk Assessment of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center

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The National Emerging Infectious Diseases Laboratories at Boston University Medical Center

1. What is the purpose of this facility?
2. Why did NIH support the construction of this facility in downtown Boston?
3. What studies have been done to evaluate the safety and siting of this facility?

The NIH Blue Ribbon Panel to Advise on the Risk Assessment of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center

1. What is the purpose of the NIH Blue Ribbon Panel?
2. Who serves on the Blue Ribbon Panel?
3. How were members of the Blue Ribbon Panel selected?
4. Are meetings of the Blue Ribbon Panel open to the public?

NIH supplementary risk assessment process

1. What is the timeline for completion of the final supplementary risk assessment?
2. What is the role of the NRC committee in the Blue Ribbon Panel’s process?
3. How will the NIH and the Blue Ribbon Panel communicate to the public during the supplementary risk assessment process?
4. What is the expected outcome of this process?

Community input and engagement

1. How have public comments been considered throughout the review processes?
2. Why has the Panel also developed recommendations on community engagement and communications?
3. Will the public have the opportunity to review and offer comments on the draft supplementary risk assessment?
4. How can I be involved now?

Background information on research into emerging infectious diseases and related safety requirements

1. What are emerging infections?
2. Why is it important to have laboratories that can safely study these diseases?
3. What is a biosafety level (BSL)?
4. How many BSL levels are there?

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The National Emerging Infectious Diseases Laboratories at Boston University Medical Center

What is the purpose of this facility?

The National Emerging Infectious Diseases Laboratories, or NEIDL, at Boston University Medical Center (BUMC) is intended to provide a safe and secure facility for conducting critical research on emerging and re-emerging infectious diseases. The facility would provide a needed research resource. It would enable researchers to develop vaccines and treatments for infectious diseases that threaten public health. Scientists must study the viruses and bacteria that cause these diseases in order to develop ways to diagnose, prevent, and treat them.

Why did NIH support the construction of this facility in downtown Boston?

NIH provided partial funding for the construction of the NEIDL based on the project’s scientific and technical merits. The decision to fund the project was made after a rigorous scientific review that evaluated several factors. These factors included the technical merit of the BUMC application; the scientific expertise of the proposed NEIDL staff; BUMC’s commitment to regional research collaborations; and the institution’s financial commitment to the project. A key strength of the BUMC application was that the NEIDL would be close to a large and renowned community of infectious disease researchers. The specific site for the laboratory was proposed by BUMC.

What studies have been done to evaluate the safety and siting of this facility?

NIH and BUMC have conducted several studies on the safety and siting of this facility. NIH began by preparing a report evaluating all potential environmental impacts of the NEIDL. The report was prepared in accord with the National Environmental Policy Act (NEPA). Public input was sought and considered multiple times before the report was finalized (the Final Environmental Impact Study for the NEIDL can be viewed at http://www.bu.edu/neidl/data/pdf/SAFETY_FEIS.pdf.). These analyses determined that the facility posed a negligible risk to the surrounding community.

Some members of the public, however, continued to have concerns about the safety and environmental impact of the facility. Several citizens and public interest groups filed lawsuits in Federal and State courts. In the Federal court, specific questions were raised about the potential risks of the biosafety level 4 (BSL-4) laboratory. To address the concerns raised in the Federal court, NIH prepared a Draft Supplementary Risk Assessments and Site Suitability Analyses report.

At the same time, a similar risk assessment process was under way at the State level. BUMC was preparing analyses to comply with the Massachusetts Environmental Policy Act. To assist in its review of the BUMC analyses, the Massachusetts Executive Office of Energy and Environmental Affairs asked the National Research Council (NRC) to assemble a committee to analyze the NIH Draft Supplementary Risk Assessments report. The state agency viewed that report as potentially relevant to its own decision-making process. In November 2007, the NRC committee issued a report that was critical of the NIH Draft Supplementary Risk Assessments and Site Suitability Analyses report.

The NIH Blue Ribbon Panel to Advise on the Risk Assessment of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center

What is the purpose of the NIH Blue Ribbon Panel?

On March 6, 2008, NIH announced the establishment of the Blue Ribbon Panel as a working group of the Advisory Committee to the Director. The Blue Ribbon Panel has been charged with advising NIH on the issues and concerns voiced by the courts, the local community, the NRC committee, and the general public regarding the BUMC NEIDL. As part of this charge, the Panel is providing independent scientific advice on a new supplementary risk assessment now under way, including questions to be addressed, as well as on scenarios and specific infectious agents to consider. Throughout this process, the Panel has been mindful of issues related to NEPA requirements, environmental justice, risk assessment, and risk communications. The Panel also has been charged with advising on best practices regarding community relations and communications. The Panel process is designed to be transparent and to ensure that NIH has done its best to evaluate public concerns. The Panel has and will continue to seek and consider input from the Boston community.

Who serves on the Blue Ribbon Panel?

The Panel is chaired by Adel Mahmoud, M.D., Ph.D., of Princeton University, an expert in infectious diseases and international health. The Panel also includes experts in public health and epidemiology, risk assessment, environmental justice, risk communications, biodefense, biosafety, and infectious disease modeling. Read the full roster of Panel members.

How were members of the Blue Ribbon Panel selected?

Members of the Blue Ribbon Panel were selected on the basis of their standing as nationally recognized experts in a variety of fields. These fields include infectious diseases, public health, epidemiology, risk assessment, infectious disease modeling, risk communications, biodefense, biosafety, and environmental justice. Geographic and demographic diversity of members were also taken into account. Individuals who might have a conflict of interest by virtue of having any personal interest in the NEIDL or being vested in the conclusions of any other pertinent analyses that may have been done were excluded from consideration.

Are meetings of the Blue Ribbon Panel open to the public?

Yes. The Panel’s process is transparent, and its meetings routinely involve opportunity for public comment. All meetings are Webcast and can be accessed via the NIH Blue Ribbon Panel Web site. Video recordings of these meetings also can be viewed on the Web site after the meeting takes place. The Panel is a Working Group of the standing Advisory Committee to the Director, NIH (ACD). The ACD meets in public session twice a year to advise the NIH Director on important matters affecting the agency. The Working Group reports periodically to the ACD at the Committee’s public meetings. The final work products of the Panel will be reviewed by the ACD as well.

NIH supplementary risk assessment process

What is the timeline for completion of the final supplementary risk assessment?

The NIH is committed to ensuring that the supplementary risk assessment is as rigorous and comprehensive as possible. This aim requires obtaining advice and commentary from many sources throughout the risk assessment process, and hence the timeframe for conducting and completing the supplementary risk assessment is a best estimate.

The NIH anticipates that, by the winter of 2009–2010, a draft version of the full report will be completed. At that time, the NIH will seek and consider additional comments from the public before it is finalized. The estimated date of completion of the final report is Summer 2010.

Throughout the supplementary risk assessment process, the NIH will post periodic updates online as more information becomes available.

What is the role of the NRC committee in the Blue Ribbon Panel’s process?

The NRC committee has important perspectives to share with the Blue Ribbon Panel as it pursues its task. NIH asked the NRC committee to make recommendations regarding the characteristics of the risk assessment that NIH is conducting. The NRC shared its recommendations with the Panel at its May 2, 2008 meeting, and the Blue Ribbon Panel carefully considered the views expressed by the NRC committee. NIH also will ask the NRC to offer its views on the supplementary risk assessment report now being drafted at different stages of its development.

How will the NIH and the Blue Ribbon Panel communicate to the public during the supplementary risk assessment process?

The NIH will provide updates about the ongoing supplementary risk assessment and the Blue Ribbon Panel’s activities on the Panel’s Web site. Members of the public may sign up for automatic updates by subscribing to the Web site’s email list.

After the draft supplementary risk assessment has been completed, NIH will also post a notice in the Federal Register and place ads in Boston newspapers to solicit public comment.

Throughout the entire process, meetings of the Panel are open to the public. Individuals may attend the meetings in person or view the proceedings online, via live or archived Webcasts.

What is the expected outcome of this process?

NIH reviewed and accepted the Blue Ribbon Panel’s initial advice, and in June 2008 decided to conduct an additional supplementary risk assessment that evaluates potential risks posed by the NEIDL. Development of the supplementary risk assessment is under way. The risk assessment will consider the questions and concerns raised by the public, the NRC committee, and the Federal and State courts with respect to potential risks. NIH will solicit public comment on the draft supplementary risk assessment before finalizing the report. The BRP will also make recommendations on community relations and communications applicable to the NIH-supported Regional and National Biocontainment Laboratories.

Community input and engagement

How have public comments been considered throughout the review processes?

The Blue Ribbon Panel values public comments and has taken them under careful consideration from the start of its deliberations in Spring 2008. The Panel began its work with a thorough analysis of comments from the public regarding drafts of the Environmental Impact Statement for the NEIDL and scheduled public meetings in Boston to hear from the community directly. The Panel also considered comments from the courts, as well as input from the National Research Council on the NIH’s Draft Supplementary Risk Assessments and Site Suitability Analyses. In response to all of these comments, the Panel recommended that the current supplementary risk assessment process take into account scenarios and specific infectious disease agents that were of concern to these groups. These scenarios and agents have since been incorporated into the supplementary risk assessment now under way.

The National Research Council will be reviewing and providing input on drafts of the supplementary risk assessment. The Panel will discuss the NRC’s commentary at open meetings, and members of the public will have opportunities to offer their own comments on drafts of the report during this process. In addition, the Panel welcomes public comments at any time, which may be sent to NIH_BRP@od.nih.gov

Why has the Panel also developed recommendations on community engagement and communications?

The Panel believes that the successful operation of biocontainment laboratories relies on establishing and preserving the public trust. Accordingly, the Panel’s recommendations are designed to prompt further reflection and conversation within institutions about principles, best practices, and lessons learned regarding biocontainment laboratories and community engagement.

The Panel has created these recommendations for consideration by the Advisory Committee to the Director, NIH. They are directed to all NIH-funded Regional and National Biocontainment Laboratories, and would therefore apply to the NEIDL if the outcome of the ongoing supplementary risk assessment study and court cases leads to a decision to conduct research under high- or maximum-containment conditions.

Will the public have the opportunity to review and offer comments on the draft supplementary risk assessment?

Yes. A draft of the supplementary risk assessment will be made available online for public review and comment. These comments will be considered by the NIH and the BRP before the supplementary risk assessment is finalized.

How can I be involved now?

The Blue Ribbon Panel welcomes public input. You may submit questions or comments at the BRP’s meetings, or at any time via email (NIH_BRP@od.nih.gov) or post:

ATTN: Blue Ribbon Panel
Office of Biotechnology Activities
National Institutes of Health
6705 Rockledge Drive, Suite 750, MSC 7985
Bethesda, MD 20892-7985

(For non-U.S. Postal Service mail, please use ZIP code 20817.)

To stay informed about the Panel’s activities, visit the BRP Web site for periodic announcements. You can also receive automatic updates by subscribing to the BRP’s email list.

Background information on research into emerging infectious diseases and related safety requirements

What are emerging infections?

Emerging infections are new diseases, or existing diseases showing up in new ways, in new places, or with new resistance against antibiotic treatment.

Why is it important to have laboratories that can safely study these diseases?

To protect the public health, particularly during an outbreak or epidemic, medical researchers must develop new medical tools for emerging infections, whether they arise naturally or are deliberately released. These tools include diagnostic tests, treatments, and vaccines. Medical tools such as these can only be developed with a solid understanding of the biology of the disease-causing agents. Such research sometimes requires working with the actual microbes or their toxins. This research must be conducted in special biosafety laboratories and in accord with the many laws, regulations, policies, and well-established guidelines that govern research on these microbes and the design, management, and operation of these laboratories.

What is a biosafety level (BSL)?

Scientists use biosafety labs to study infectious materials safely and effectively. A BSL, or biosafety level, defines the different safety and security precautions that must be taken to isolate and work with biological agents within a laboratory. The primary goal of the BSL standards is to protect laboratory workers and individuals in the surrounding community from accidental exposure to these agents.

How many BSL levels are there?

There are four biosafety levels. The levels define proper laboratory techniques, safety equipment, and laboratory design, all of which depend on the type of infectious agent being studied. The lowest level, BSL-1, describes the minimum precautions required for handling agents that generally do not cause disease in healthy humans. The highest level, BSL-4, describes the extensive precautions required for handling certain new agents and those known to cause serious disease for which there are no treatments or vaccines. For example, BSL-4 lab personnel are required to wear full-body, air-supplied suits and to undergo a decontamination shower whenever they exit the laboratory. Many U.S. institutions and companies with infectious disease research programs have BSL-3 laboratories. In addition, some hospital have small laboratory or clinical areas that can operate at the BSL-3 level, including space for isolating patients suspected or known to have certain highly contagious diseases.

Thus, the levels are defined by the risk of potential harm to the individuals who would potentially become infected. BSL-4 agents generally are not the most contagious: they may cause serious disease, but usually the infection is not easy to transmit from person to person.

The biosafety and containment practices pertinent to each biosafety level are described in the manual Biosafety in Microbiological and Biomedical Laboratories. Biosafety and containment practices for research involving recombinant DNA are described in the NIH Guidelines for Research Involving Recombinant DNA Molecules.