May 2, 2006

The C.W. Bill Young Center for Biodefense and
Emerging Infectious Diseases

(Building 33)

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.

Since 2001, NIAID has greatly expanded its research programs to spearhead the development of new and improved diagnostics, treatments, and vaccines for emerging and re-emerging diseases caused by naturally occurring infectious agents as well as by microbes that may be intentionally released into a civilian population.

To help carry out that research safely, a new Integrated Research Facility has been constructed on the NIH campus. This facility-the C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases, or Building 33-is dedicated to NIAID's mission in emerging infectious disease research, including the development of medical countermeasures for biodefense. The facility will be staffed by world-class scientists in NIAID's Division of Intramural Research.

Below are answers to some frequently asked questions about the C.W. Bill Young Center on the NIH campus.

1. What is the C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases?

The C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases (Building 33) is an Integrated Research Facility for use by NIAID. The 84,000-net-square-foot building includes laboratories, animal care areas, offices, and conference rooms, and has sophisticated operating systems (for example, mechanical, air filtration, and electrical systems) required to operate this research building safely and securely. The facility includes laboratories and animal care areas designed to operate at either biosafety level 2 (BSL-2) or biosafety level 3 (BSL-3).

2. Who is C.W. Bill Young?

Congressman C.W. Bill Young (R-FL), after whom this building is named, is a long-term member of the House of Representatives and currently serves as Chairman of the House Appropriations Subcommittee on Defense. He has been a stalwart supporter of biomedical research and of the NIH. For more information, see his Web site at http://www.house.gov/young/.

3. How long did it take to construct the building?

Groundbreaking for the Center occurred in November 2003, and construction was completed in December 2005. Since that time, the facility has been undergoing rigorous testing that is required before the facility can be commissioned. The facility is expected to be commissioned in the Summer of 2006.

4. How were the potential environmental impacts of the Center assessed?

Construction of the facility followed the requirements of the National Environmental Policy Act (NEPA).

5. How much did it cost to construct the C.W. Bill Young Center?

The total cost of the project-which includes planning, design, construction, and related costs for the Center and the associated 1,250-car garage necessary to replace the surface parking at the building site-was $182.6 million.

6. How many people will work in the C.W. Bill Young Center?

It is estimated that the fully operational facility will house between 225 and 275 staff. In addition to the research teams, the facility will include administrative staff and those dedicated to non-laboratory functions such as informatics.

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

Prior to the construction of this building, insufficient BSL-3 laboratory space existed on the NIH campus. NIAID had 4,700 net square feet of actively used BSL-3 laboratory space. The C.W. Bill Young Center will give NIAID an additional 14,300 net square feet of BSL-3 laboratory space.

The new Center increases the research capacity of NIAID and enables scientists to greatly expand the Institute's biodefense research agenda and pursue scientific opportunities in emerging infectious diseases that have been delayed or deferred because of the lack of adequate high-containment research facilities. The lack of such facilities has, for example, delayed the development of vaccines for naturally occurring diseases that threaten the United States, such as that caused by West Nile virus.

Laboratory work involving biological agents that might be deliberately released requires that they be handled with great care. Many 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 biosafety labs, such as those in the C.W. Bill Young Center.

8. What types of research will be conducted in the new facility?

The proposed research projects for the BSL-3 laboratories in the Center include expanding and consolidating the following existing NIAID research programs:

• Respiratory viruses such as influenza and avian influenza viruses
• Respiratory bacteria such as multidrug-resistant tuberculosis and anthrax bacteria
• Insect-borne viruses such as West Nile and dengue viruses
• Immunology of infectious diseases
• Development of vaccines for infectious diseases

9. Is the study of potential agents of bioterrorism new to NIAID?

NIAID scientists and clinicians have long-term experience in studying such organisms. Even before the recent expansion of research on biodefense, NIAID scientists had been studying organisms that cause a variety of naturally occurring infectious diseases but that also might be deliberately released into a population. Examples of such infectious threats include plague, rabies, tick-borne encephalitis, West Nile virus, influenza, anthrax, Ebola virus hemorrhagic fever, and Q fever. All of this work has been carried out in NIAID laboratories in Maryland or Montana with required safety measures in place. NIAID's infectious disease experts are uniquely qualified to apply their knowledge and skills to investigate these diseases and to develop strategies and products to counter the public health threats they pose.

10. Why was it necessary to build this facility on the NIH campus in Bethesda, Maryland?

Having this facility on the NIH campus takes full advantage of the rich infrastructure, both physical and intellectual, present in 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 our goals for biodefense and emerging infectious disease research attainable within a meaningful timeframe.

11. What is a biosafety level 3 (BSL-3) laboratory; what is a biosafety level 2 (BSL-2) laboratory?

Presently, NIAID scientists conduct basic research on infectious agents in BSL-2 and BSL-3 laboratories. 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 biological agents on the CDC list must be approved by safety officials before work can begin.

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 comply with stringent federal and state regulations for construction, use, security, inspection, and certification.

BSL-3 laboratories are designed for research on biological agents that may cause serious or lethal infection as a result of exposure by the inhalational route. These laboratories must include biosafety cabinets, controlled double-door laboratory access, and special-facility engineering. Before individuals can begin work in a BSL-3 laboratory, they are 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 laboratory 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.

BSL-2 laboratories are used for research on 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. 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.

For an extensive list of safety requirements and policies, see the manual titled Biosafety in Microbiological and Biomedical Laboratories at http://bmbl.od.nih.gov/sect3bsl3.htm.

12. Does the C.W. Bill Young Center pose any threat to the local community?

Building 33 was constructed to ensure that our employees and neighbors are protected to the maximum extent that current technology allows. A properly constructed and properly operated facility such as the C.W. Bill Young Center poses no threat to the local community. An NIH review of more than 3 million hours of BSL-3 and BSL 2/3 research conducted on the NIH campus between 1982 and 2003 found no recorded incidents involving community contamination from these laboratories.

13. What precautions are being taken to ensure the facility is secure?

The facility is constructed within the secured perimeter of the NIH campus, with the required setback distance from any unscreened vehicles. New lighting, observation cameras, and card reader systems have been installed for the entire NIH campus, and additional measures are implemented in facilities containing BSL-3 laboratories. The laboratories requiring the highest level of security are located in the center of the building. Multiple levels of security devices restrict access throughout the facility.

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

Specific regulations govern the transportation of biological agents to ensure that the public, researchers, and workers in the transportation chain are protected from exposure to any agent during the shipping process. Infectious materials are safely transported worldwide on a daily basis under these regulations. Protection is achieved through 1) packing requirements, 2) appropriate labeling, 3) documentation of contents, and 4) training of personnel in the transportation chain. More information on these regulations can be found at http://bmbl.od.nih.gov/appendc.htm, part of the manual titled Biosafety in Microbiological and Biomedical Laboratories.

15. What certification and oversight systems will be in place at the Center?

NIH's Division of Safety has been closely involved in the planning and design of the facility and will be closely involved in the operation of the Center as well. There is a designated biosafety officer for the Center. 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.

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

No, these kinds of facilities are designed specifically to eliminate release of an agent as a result of an explosion. In the unlikely event that terrorists attacked the C.W. Bill Young Center, the biological agents could not survive such a blast. These agents require sensitive conditions to thrive. For example, Mycobacterium tuberculosis cannot survive in heat or sunlight; and most if not all viruses studied require complex growth media and cultured mammalian cells for their growth and survival.

17. Will any of the research carried out in the Center be kept secret?

Scientists in the Center will conduct fundamental research to facilitate the development of diagnostics, treatments, and vaccines that will protect people against emerging infectious threats that occur naturally or that might be introduced intentionally into a population. Although safety concerns will limit access to the facility, all research carried out in the facility is anticipated to be published and openly communicated in the same manner as other NIH research.

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

Most institutions with infectious disease research programs have BSL-3 laboratories. According to a recent survey, about 275 facilities in the United States have BSL-3 laboratories. See Survey for Determining the Location, Capacity, and Status of Existing and Operational BSL-3 Laboratory Facilities in the United States (http://www3.niaid.nih.gov/Biodefense/PDF/BSL3_survey.PDF).

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

Numerous BSL-3 facilities have operated safely in the United States during the past 30 years. No known accident at a BSL-3 laboratory has caused release of a microorganism into the environment.

20. Can I visit the C.W. Bill Young Center?

The Center is expected to be officially commissioned in the Summer of 2006. Once that happens and research begins, safety and security guidelines require that access to the facility be restricted to those individuals authorized to enter and specifically trained to work in the facility. Photos and video showing typical laboratories and infrastructure in the facility are available on the NIAID Web site at http://www3.niaid.nih.gov/about/organization/dir/building33/default.htm.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)-The Nation's Medical Research Agency-includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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National Institutes of Health (NIH) Bethesda, Maryland 20892

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