February 2004

An Integrated Research Facility
at Fort Detrick, Maryland

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, Maryland, and in Hamilton, Montana.

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, NIH plans to construct a new Integrated Research Facility for NIAID's biodefense program on the grounds of Fort Detrick in Frederick, Maryland. 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. Similar agents have been studied for decades at facilities of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick. 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 Integrated Research Facility.

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. More details will be available once the design phase begins.

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	Good microbiological practice Hand washing No eating, drinking or gum chewing in the laboratory	Pipeting devices- mouth pipeting is prohibited
BSL-2	These agents are associated with human disease	Limited lab access Most work may be performed on a bench top Biohazard warning signs "Sharps" precautions Biosafety manual defining any needed waste decontamination or medical surveillance policies	Class I or II Biological Safety Cabinets (BSCs) or other physical containment devices Lab coats, gloves, face protection, as needed	Open bench-top sink for hand washing is required Autoclave available
BSL-3	These agents: Are associated with human disease and cause illness by spreading through the air (aerosol) Cause diseases that may have serious or lethal consequences	BSL-2 practice plus Controlled access Decontamination of all waste Decontamination of lab clothing before laundering	Class I or II Biological Safety Cabinets (BSCs) or other physical containment devices Protective lab clothing, gloves, respiratory protection as needed	BSL-2 plus Physical separation from access corridors Self-closing, double-door access Exhaust air is not recirculated Negative airflow into laboratory Design includes back-up/redundant systems
BSL-4	These agents: Are associated with human disease and cause illness by spreading through the air (aerosol) or have an unknown cause of transmission; Cause diseases that are usually life-threatening;	BSL-3 practices plus Clothing change before entering Shower on exit All material decontaminated on exit from facility	All 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 Separate building or isolated zone Dedicated supply and exhaust, vacuum, and decontamination systems Design includes back-up/redundant systems Other requirements outlined in NIH/CDC publication "Biosafety in Microbiological and Biomedical Laboratories"*

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

Most facilities in the U.S. 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; 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.

4. 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 proposed Integrated Research Facility at Fort Detrick was approved specifically for these reasons.

5. 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 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.

6. 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.

7. 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.

8. Has there ever been an 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.

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

A properly constructed and properly operated BSL-3 and BSL-4 facility poses no threat to the local community. There are no recorded incidents involving community contamination from any of the existing BSL-3 and BSL-4 facilities.

10. 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. Potentially, some of these microbes also could be used as agents of bioterrorism. Examples of diseases caused by these agents include plague, Lyme disease, rabies, tick-borne encephalitis, West Nile virus disease, influenza, anthrax infection, Ebola virus hemorrhagic fever, HIV, tuberculosis, transmissible spongiform encephalopathies, and Q fever. All of this work has been carried out in either the Maryland or Montana laboratories with required safety measures in place.

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

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.

12. When will construction of the new facility be completed?

Preliminary planning for the facility has been completed; the project is now in design development. An Environmental Impact Statement (EIS) is being prepared to address possible environmental impacts of the project. The design should be finished within one year.

No construction can begin until the EIS process is completed. Groundbreaking is estimated to occur in mid to late 2004. Construction may take up to two years.

13. How much will the new facility cost?

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

14. How many people will work in the facility?

Until the design process is complete, it is not known exactly how many persons will work in the facility. It is estimated that approximately 100 people will staff the facility.

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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