April 16, 2003

Building 33, an Integrated Research Facility for the NIH Campus

Overview

The National Institute of Allergy and Infectious Diseases (NIAID), the second largest institute at the National Institutes of Health (NIH) in Bethesda, Maryland, plays a key role in the nation's biomedical research program. NIAID conducts and supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten hundreds of millions of people worldwide.

NIAID's Division of Intramural Research is known as a state-of-the-art research enterprise carried out by world-class scientists on campuses in Bethesda and Rockville, Maryland, and in Hamilton, Montana. The Dale and Betty Bumpers Vaccine Research Center on the NIH campus is also an intramural component of NIAID.

Because of NIAID's long-standing expertise in research on emerging infectious diseases, the Institute has been mandated by the President to play a leading role in the nation's fight against bioterrorism. NIAID is expanding its research programs to spearhead the development of new and improved diagnostics, treatments, and vaccines for diseases caused by naturally occurring infectious agents as well as microbes that may be intentionally released into a civilian population.

For that research to be carried out safely, NIAID plans to construct Building 33, a new Integrated Research Facility on the NIH campus. NIAID is committed to ensuring that its employees work in the safest possible laboratories, and that these laboratories also reduce to the maximal extent possible any potential risks to the surrounding community.

Building 33 will employ the highest safety standards recommended for the research proposed to be conducted there, standards known as Biosafety Level 3 (BSL-3). BSL-3 laboratories are expressly designed to prevent scientists and the environment from being exposed to microorganisms. Other laboratories of this same type have been operating on the Bethesda campus for decades without incident. Like these older BSL-3 laboratories, the new BSL-3 laboratories will comply with stringent Federal and state regulations for construction, use, security, inspection, and certification.

Below are answers to some frequently asked questions about the proposed construction and operation of the new Integrated Research Facility on the NIH campus.

1. Are NIH scientists already studying potential agents of bioterrorism?

Even before the current emphasis on biodefense, NIH scientists had been studying organisms that cause a variety of infectious diseases. Some of these microbes also could be used as potential agents of bioterrorism. Examples of diseases caused by these agents include plague, Lyme disease, rabies, tick-borne encephalitis, West Nile virus, influenza, anthrax infection, Ebola virus hemorrhagic fever, and Q fever. All of this work has been carried in either the Maryland or Montana laboratories with required safety measures in place.

2. What type of facility is being planned for the NIH campus?

Known as Building 33, the 85,000-net-square-foot building will be an Integrated Research Facility housing laboratories, offices, conference rooms, animal quarters, mechanical space, and a waste-handling area. In addition to the BSL-3 laboratories, the facility will include a suite of laboratories designed to operate at BSL-2 level. The NIH campus already has many laboratories operating at the BSL-2 and BSL-3 levels.

3. What is a biosafety level 3 (BSL-3) laboratory?

BSL-3 laboratories are designed for research on agents that may cause serious or lethal infection as a result of exposure by the inhalational route. Examples of agents that may be studied in BSL-3 laboratories include Mycobacterium tuberculosis, the cause of tuberculosis, and Coxielli burnetii, the cause of Q fever. BSL-3 laboratories are required to include biosafety cabinets, controlled double-door laboratory access, and special-facility engineering. As necessary, before an individual can begin work in a BSL-3 laboratory, he or she will be required to undergo special training and receive preventive vaccines.

BSL-3 laboratories have several safeguards to ensure that infectious agents are properly contained or destroyed. These measures include maintaining the BSL-3 suites at negative air pressure relative to the surrounding rooms so that all the airflow is directed into the suites and never out into the surrounding rooms; microfiltration of air; air-lock buffer zones; and long-time, high-temperature decontamination of all materials produced in the facility.

For an extensive list of safety requirements and policies, see http://bmbl.od.nih.gov/sect3bsl3.htm.

4. What is a BSL-2 laboratory?

BSL-2 laboratories are used for moderate-risk agents associated with human disease. Should a person become infected, treatment is available, and the risk of spreading the infection to others is low. Samples can be handled at the laboratory bench if the potential for producing splashes or aerosols is low. For example, blood or body fluids of unknown infectivity may be tested for hepatitis B or salmonella. Scientists and technicians must wear splashshields, face protection, gowns, and gloves while using extra care with needles and glass, and they must decontaminate the work area and materials after each procedure. Biosafety cabinets are used to work with concentrated cultures or procedures that generate aerosols.

5. Why does NIH need this new Integrated Research Facility?

The infectious agents likely to be used in bioterrorism are inherently hazardous. Laboratory work involving these kinds of agents requires that they be handled with great care. President Bush mandated that NIAID take a leadership role in carrying out research on microbes that may be used as agents of bioterrorism directed at civilians. In addition to bioterrorism, some of these same agents are the causes of new or re-emerging diseases that pose significant public health risks. The ultimate goal is to develop new diagnostics, vaccines, and treatments against diseases caused by these infectious agents.

Such products can be developed only on a solid understanding of the basic biology of the disease-causing agents and only with the use of specialized, high-containment labs, such as Building 33. NIAID is world renowned for expertise in basic and clinical research on infectious microbes. Because some of the microbes studied at NIH are naturally newly emerging in the United States or may jump from animals to humans, they share characteristics with potential agents of bioterrorism. NIAID scientists and clinicians have long-term experience in studying such organisms. This group of infectious disease experts is uniquely qualified to apply their knowledge and skills to investigate these diseases and to develop strategies and products to counter the threats they pose.

6. Why can't the research be carried out in the BSL-3 facilities already operating at NIH?

There is insufficient existing laboratory space on the campus. The new building is being designed to be a state-of-the art facility including both BSL-2 and BSL-3 laboratories. It will increase the research capacity of NIAID and allow scientists to carry out the President's mandate to vastly expand the Institute's biodefense research agenda and pursue scientific opportunities that have been delayed or deferred because of the lack of adequate high-containment research facilities. The lack of such facilities has also delayed development of vaccines for naturally occurring diseases that threaten our local population, such as that caused by West Nile virus.

7. Why can't this new facility be built some place else?

Having this facility on the NIH campus takes full advantage of the rich infrastructure, both physical and intellectual, present in the NIAID's existing intramural research program. The proximity of basic and clinical researchers with expertise in infectious diseases provides the foundation for the research and development program that is NIAID's mandate. It would take at least 10 years and more than one billion dollars to duplicate this basic and clinical infrastructure elsewhere. The NIH campus minimizes replication of costly support services and allows use of analytic capability in genomics, proteomics, and imaging. Furthermore, the new laboratory helps fulfill NIAID's biodefense mandate, and makes the President's goals for biodefense research attainable within a meaningful timeframe.

8. What precautions are being taken to ensure the facility is safe from intrusion by outsiders?

The facility will be constructed within a secured perimeter, with the required setback distance from any unscreened vehicles. In addition, there will be extra security for the areas of BSL-3 research within the facility. New lighting, observation cameras, and card reader systems are being installed for the entire campus, and additional measures will be implemented in the BSL-3 laboratories. Multiple levels of security devices will be installed throughout the new facility.

9. What precautions will be in place for transporting infectious materials to and from Building 33?

Specific regulations govern the transportation of infectious materials. Infectious materials are safely transported worldwide on a daily basis under these regulations. More information on these regulations can be found at http://bmbl.od.nih.gov/appendc.htm.

10. What certification and oversight systems will be in place?

NIH's Division of Safety will be closely involved in the planning, design, and operation of Building 33. In addition, the Division reviews and approves all proposed protocols and standard operating procedures for any BSL-3 laboratory on the NIH campus prior to its use. A stringent approval process will take place before each and any experiment can begin in the facility. NIAID also has active in-house programs in biosafety, radiation safety, occupational safety, and hazardous material safety.

11. Will Building 33 pose any threat to the local community?

Building 33 will be constructed to ensure that our employees and neighbors are protected to the maximum extent that current technology allows. There is no reason to believe that a properly constructed and properly operated BSL-3 facility such as Building 33 poses any threat to the local community. There are no recorded incidents involving community contamination from any of the extant BSL-3 facilities.

12. If a terrorist bombing were to take place, would the agents being studied be released into the air and prove fatal to NIH neighbors and employees?

No, these kinds of laboratories are designed specifically to eliminate this risk. In the unlikely event that terrorists attacked Building 33, the agents could not survive such a blast. These agents require sensitive conditions to thrive. For example, M. tuberculosis cannot survive in heat or sunlight; and most if not all viruses studied require complex media and cultured mammalian cells for their growth and survival.

13. How many other research facilities in the United States have BSL-3 laboratories?

Most facilities in the United States with infectious disease research programs have BSL-3 laboratories. In addition, many hospitals have areas that can be operated at this level; these areas are used for isolating patients with highly contagious diseases.

14. What kinds of experiments will be carried out in the facility?

The Centers for Disease Control and Prevention (CDC) has categorized infectious agents according to the containment level at which they must be handled (http://www.bt.cdc.gov/Agent/Agentlist.asp). Criteria for inclusion on this list includes their potential for use as agents of bioterrorism, but many agents on this list are also classified as agents of emerging or re-emerging diseases.

Presently, NIAID scientists conduct basic research on infectious agents at BSL-2, BSL-3, and BSL-4 levels. Currently, all BSL-4 level experiments are carried out at non-NIH facilities. All of these laboratories must undergo stringent certification processes before they can be used. Moreover, they are regularly inspected to assure compliance. Finally, each protocol involving use of agents on the CDC list must be approved by safety officials before work can begin.

15. What agents will be studied in the new facility?

The proposed research projects for BSL-3 portion of Building 33 include the following:

16. How will the environmental impacts of the project be assessed?

This project will follow the requirements of the National Environmental Policy Act (NEPA).

17. When will construction of Building 33 be completed?

Preliminary planning for the facility has been completed; the project is now in design development. The design should be finished within one year; construction may take up to two years. Groundbreaking is expected in mid-to late 2003, with completion anticipated in 2005.

18. How much will Building 33 cost?

The budget includes $186.1 million for planning, design, construction, and related costs for the Integrated Research Facility and the associated 1,250-car garage necessary to replace the surface parking at the proposed site.

19. How many people will work in Building 33?

Until the design process is complete, it is not known exactly how many persons will work in Building 33, but it is estimated that the fully operational facility will house more than 200 workers. It is anticipated that current NIAID staff will expand their research and development efforts at the BSL-3 level. In many cases, this will require recruitment of new staff members with expertise in the selected areas of research. In addition to the research staff, the facility will include administrative areas dedicated to offices for the staff of the NIAID Director and for non-laboratory functions, such as informatics.

20. Has there ever been an accident at a BSL-3 facility that caused release of micro-organisms into the environment?

No. A number of BSL-3 facilities have operated safely in the United States for 30 years. Rare accidents such as needlesticks may cause exposure of laboratory staff; immediate treatment of any person so exposed avoids any danger to other workers or to the community.

21. Will the research carried out in Building 33 be kept secret?

The ultimate goal of this research program is to provide information and to translate this information into diagnostics, treatments, and vaccines that will protect civilians against agents of bioterrorism. Although safety concerns will limit access to the facility, it is anticipated that all research carried out in the facility will be published and communicated in the same manner as other NIH research.

22. Why can't the research you're planning for Building 33 be done in Montana or Frederick, where you are also planning to build high-containment laboratories?

The intramural program of NIAID is a large and complex operation with scientists having expertise in different areas located in different sites. In each case, it is proposed to build upon the existing expertise and infrastructure to expand our efforts in basic and translational research on infectious agents. For example, the success of basic scientists at NIAID's Rocky Mountain Laboratories with vector-borne diseases provides the basis to expand work on Yersinia pestis, the flea-borne agent of plague. Similarly, the Bethesda campus has clinical researchers with expertise in tuberculosis and in the development of viral vaccines, making this an ideal place for expansion of work in these areas. There is neither space nor infrastructure to allow consolidation of the entire infectious disease program at any one location. In addition, our successes in developing drugs and vaccines have been fueled by the close proximity of basic and translational researchers. An attempt to dissect our program based on facility requirements would inevitably lead to an inferior research team that would be less capable of carrying out the biodefense research mandate.

NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892

Department of Health and Human Services

National Institutes of Health (NIH) Bethesda, Maryland 20892

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