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Biodefense and Emerging Infectious Diseases

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An Integrated Research Facility

Ft. Detrick, MD

Questions and Answers

Overview

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), 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, MD, and in Hamilton, MT.

Because of NIAID's long-standing expertise in research on emerging infectious diseases, the President directed the Institute 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, NIH plans to construct a new Integrated Research Facility (IRF) for NIAID's biodefense program on the grounds of Fort Detrick in Frederick, MD. 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. The laboratories will employ the highest safety standards recommended for the research proposed to be conducted there, standards known as Biosafety Levels 3 and 4 (BSL-3 and BSL-4), to prevent scientists and the environment from being exposed to microorganisms. Researchers at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) facilities at Fort Detrick have studied similar agents for decades.. The new facility 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 this new IRF.


  1. What type of facility is being planned?

    The Integrated Research Facility is a 100,000-square-foot building housing laboratory space for animal research, radiology equipment, mechanical space, and a waste-handling area. There will be BSL-2 and BSL-3 laboratory suites similar to those in existing NIAID laboratories. In addition, there will be a suite of laboratories designed to operate at BSL-4 that will occupy a small portion of the building.

  2. What do the BSL numbers mean?

    See the following table.

    Biosafety Level Agents Practices Safety Equipment Facilities
    BSL-1 These agents are not generally associated with disease in healthy people
  3. Good micro- biological practice
  4. Hand washing
  5. No eating, drinking, or gum chewing in the laboratory
  6. Pipeting devices-mouth pipeting is prohibited
  7.  :
    BSL-2 These agents are associated with human disease
  8. Limited lab access
  9. Most work may be performed on a bench top
  10. Biohazard warning signs
  11. "Sharps" precautions
  12. Biosafety manual defining any needed waste decontamination or medical surveillance policies
  13. Class I or II Biological Safety Cabinets (BSCs) or other physical containment devices
  14. Lab coats, gloves, face protection, as needed
  15. Open bench-top
  16. sink for hand washing is required
  17. Autoclave available
  18. BSL-3

    These agents:

  19. Are associated with human disease and cause illness by spreading through the air (aerosol)
  20. Cause diseases that may have serious or lethal consequences
  21. BSL-2 practice plus

  22. Controlled access
  23. Decontamination of all waste
  24. Decontamination of lab clothing before laundering
  25. Class I or II Biological Safety Cabinets (BSCs) or other physical containment devices
  26. Protective lab clothing, gloves, respiratory protection as needed
  27. BSL-2 plus

  28. Physical separation from access corridors
  29. Self-closing, double-door access
  30. Exhaust air is not recirculated
  31. Negative airflow into laboratory
  32. Design includes back up/redundant systems
  33. BSL-4

    These agents:

  34. Are associated with human disease and cause illness by spreading through the air (aerosol) or have an unknown cause of transmission
  35. Cause diseases that are usually life-threatening
  36. BSL-3 practices plus

  37. Clothing change before entering
  38. Shower on exit
  39. All material decontaminated on exit from facility
  40. Class ll procedures conducted in Class III BSCs or Class I or II BSCs in combination with full-body, air-supplied, positive- pressure personnel suit

    BSL-3 plus

  41. Separate building or isolated zone
  42. Dedicated supply and exhaust, vacuum, and decontamination systems
  43. Design includes back-up/redundant systems
  44. Other requirements outlined in NIH/CDC publication Biosafety in Microbiological and Biomedical Laboratories
  45.  

  46. How many other research facilities in the U.S. have BSL-3 or BSL-4 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.

    BSL-4 labs have the most stringent safety and security requirements. There are currently only four operational BSL-4 laboratory suites in the United States: at the Centers for Disease Control and Prevention in Atlanta, GA; at the United States Army Medical Research Institute for Infectious Diseases at Fort Detrick in Frederick, MD; at the Southwest Foundation for Biomedical Research in San Antonio; and at the University of Texas at Galveston.

    A small BSL-4 facility exists on the NIH campus in Bethesda, MD, but it is currently being operated only at a BSL-3 level for research on important emerging infectious diseases. There is also a small BSL-4 glovebox capability at Georgia State University in Atlanta, GA.

  47. Why is this NIAID facility needed at Fort Detrick?

    Having this facility on Fort Detrick enhances NIAID efforts to expand its biodefense research agenda by capitalizing on the already well-established cooperation between NIAID and USAMRIID scientists. The proximity at Fort Detrick to researchers with expertise in infectious diseases related to biodefense and other emerging infections, as well as the nearby USAMRIID facilities, will provide a critical part of the foundation for the research and development program that is NIAID's mandate. In addition, the location at Fort Detrick will minimize replication of costly support services. The location for the Integrated Research Facility at Fort Detrick was approved specifically for these reasons.

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

    The facility will be constructed within a secured perimeter and with the required setback distance from any unscreened vehicles. In addition, there will be extra security for the areas of BSL-3 and BSL-4 research within the facility. New lighting, observation cameras, and card-reader systems will be installed, and additional measures will be implemented in the BSL-3 and BSL-4 laboratories. Multiple levels of security devices will be installed throughout the new facility.

  49. What precautions are in place for transporting infectious materials to and from the laboratories?

    There are specific government regulations for transportation of infectious materials. Infectious materials are safely transported worldwide on a daily basis under these regulations.

  50. 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 the new facility. In addition, the Division reviews and approves all proposed protocols and standard operating procedures for any BSL-3 or BSL-4 laboratory operated by NIAID prior to its use. A stringent approval process will take place before any experiment can begin in the facility.

  51. Has there ever been consequential accident at a BSL-3 or BSL-4 facility?

    No. A number of BSL-3 and BSL-4 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.

    When appropriate vaccinations are available they are provided to laboratory staff to help prevent disease related to an accidental exposure.

  52. Will the new facility pose any threat to the local community?

    Even before the increased attention to biodefense, NIAID scientists studied organisms that cause a variety of infectious diseases. Examples of diseases caused by these organisms include plague, rabies, tick-borne encephalitis, West Nile virus disease, influenza, anthrax infection, Ebola virus hemorrhagic fever, HIV, tuberculosis, transmissible spongiform encephalopathies, and Q fever. Potentially, some of these microbes also could be used as agents of bioterrorism. All of this work is carried out in either the Maryland or Montana laboratories with required safety measures in place.

  53. Are NIAID scientists already studying potential agents of bioterrorism?

    Even before the current emphasis on biodefense, NIAID scientists had been studying organisms that cause a variety of infectious diseases. Examples of diseases caused by these organisms include plague, rabies, tick-borne encephalitis, West Nile virus disease, influenza, anthrax infection, Ebola virus hemorrhagic fever, HIV, tuberculosis, transmissible spongiform encephalopathies, and Q fever. Potentially, some of these microbes also could be used as agents of bioterrorism. All of this work has been carried out in either the Maryland or Montana laboratories with required safety measures in place. (Modified 12/1/05)

  54. Will the research carried out in the new facility be kept secret?

    No. The ultimate goal of this research program is to provide information that will guide the development of diagnostics, treatments, and vaccines to protect civilians against agents of bioterrorism. Although safety and security regulations will limit access to certain kinds of information, it is anticipated that the results of all research carried out in the facility will be published and communicated in the same manner as other NIH research results.

  55. Is construction of the facility complete?

    Construction of the IRF is now under way.

  56. How much will the new facility cost?

    The budget includes $105 million for planning, design, construction, and related costs for the IRF.

  57. How many people will work in the facility?

    Approximately 100 people will staff the facility.

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Last Updated September 01, 2009