February 2004

An Integrated Research Facility at
Rocky Mountain Laboratories

Questions and Answers

Overview

One of the oldest research components of the U.S. National Institutes of Health (NIH), Rocky Mountain Laboratories (RML) in Hamilton, Montana, plays a key role in the nation's biomedical research program. Although it began in an abandoned school nearly 100 years ago, RML today is a state-of-the-art research facility occupied by world-class scientists with a mission to study infectious microbes that cause disease in humans and animals. Because of its long history and expertise in infectious disease research, RML is now poised to play a leading role in the nation's fight against bioterrorism and emerging infections. Along with its parent organization, the National Institute of Allergy and Infectious Diseases (NIAID), RML will expand its studies to help develop new diagnostics, vaccines, and treatments for diseases caused by emerging infections and the intentional release of infectious agents into a civilian population.

For that research to be carried out safely for both the scientists and the community, NIAID plans to construct an additional research facility on the RML campus. 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. The 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 research facilities and biocontainment.

1. What type of additional facility is being planned for the RML campus?

The 100,000-square-foot building will be an Integrated Research Facility housing laboratories, offices, conference rooms, a lunch room, animal quarters, mechanical space, and a waste-handling area. There will be BSL-2 and BSL-3 laboratory suites similar to those already on the RML campus. In addition, there will be a suite of laboratories designed to operate at Biosafety Level 4 (BSL-4).

The BSL-4 research laboratories and animal quarters will comprise only 6,800 net square feet of the building.

2. What is a Biosafety Level 4 (BSL-4) laboratory?

BSL-4 laboratories are designed to prevent infectious microbes from being released into the environment and to provide the highest possible level of safety to scientists carrying out experiments with infectious microbes. BSL-4 facilities may contain clinical components and/or those where animal experiments can be safely carried out.

BSL-4 uses several measures to ensure infectious agents are properly contained or destroyed. They include microfiltration of air, air-lock buffer zones, "space suits" with positive-pressure air supply, chemical decontamination, and decontamination at high temperature for long periods of all materials produced in the facility.

See list of safety requirements and policies at http://bmbl.od.nih.gov/sect3bsl4.htm.

3. Why does RML need BSL-4 laboratories?

President Bush has tasked NIAID, the parent institute of the RML, with a leadership role in carrying out research on microbial agents that may be used as agents of bioterrorism, agents directed at our civilian population. In addition to bioterrorism, some of these same agents are the causes of newly 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 this facility. RML is world renowned for expertise in research on infectious microbes. Because some of the microbes studied at RML are naturally newly emerging in the United States or may jump from animals to humans, they share characteristics with potential agents of bioterrorism. RML researchers have long-term experience in studying such organisms. These scientists are uniquely qualified to apply their knowledge and skills to investigate these diseases and to develop strategies and products to counter the threats they pose.

Currently, there is no BSL-4 facility to serve the northwestern United States.

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

The BSL-4 facility will be constructed within the secured perimeter. In addition, there will be extra security for the BSL-4 lab building. New lighting, observation cameras, and card reader systems are being installed for the entire campus and additional measures will be implemented in the BSL-4 facility. Multi-levels of security devices will be installed throughout the new facility.

5. What precautions are in place for transporting infectious materials to and from the lab?

There are specific Government regulations for transportation of infectious materials. Infectious materials are safely transported worldwide on a daily basis under these regulations. See http://bmbl.od.nih.gov/appendc.htm.

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

The Division of Safety, National Institutes of Health, will oversee all efforts related to the planning and design of the facility. In addition, this organization will review and approve all proposed protocols and standard operating procedures for the BSL 4 laboratory prior to its use. A stringent approval process will take place before each and any experiment begins in the facility. In addition, RML has active in-house programs in biosafety, radiation safety, occupational safety, and hazardous material safety.

7. Why can't the research be carried out in the BSL-3 facility already operating at RML?

A BSL-4 facility expands the capability of the RML researchers to conduct research on highly infectious agents. The use of BSL-4 is required for research of certain agents and for certain experiments, such as the testing of vaccines for emerging infectious microbial agents that are normally ranked at BSL-3. BSL-3 and BSL-4 facilities use stringent safeguards to keep any pathogens from escaping into the environment. In addition, BSL-4 is designed to prevent physical contact between pathogens and lab personnel inside the workspace. To meet this goal, people working in a BSL-4 laboratory wear special protective suits with filtered air supply. A BSL-4 facility also requires increased security to control access. In addition, all personnel must receive rigorous and detailed instruction and certification before they are allowed to work in high- containment laboratory suites

8. Will this additional facility pose any threat to the local community?

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

9. Are RML scientists already studying potential agents of bioterrorism?

Even before the current emphasis on biodefense, RML 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 these diseases include plague, Lyme disease, rabies, HIV, tuberculosis, transmissible spongiform encephalopathies and Q fever. All of this work has been carried out with required safety measures in place.

10. How many other research facilities in the United States have BSL-4 laboratories?

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.

11. 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. Criteria for inclusion on this list includes their potential for use as agents of bioterrorism. (http://www.bt.cdc.gov/Agent/Agentlist.asp). Presently, RML scientists conduct basic research on infectious agents at BSL-2 and BSL-3 levels of containment. The new facility will expand the opportunities to work at those levels, and also will provide the opportunity to work at the BSL-4 level.

12. When will construction of the building 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. No construction can begin until the EIS process is completed. The design should be finished within one year; construction may take up to two years. BSL-4 laboratories also must undergo a stringent certification process before they can be used.

13. How much will the project cost?

The budget allows $66.5 million for planning, construction and related costs.

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 anticipated that current staff members will expand their research efforts to include experiments at the BSL-4 level. In addition, new staff members with expertise in biocontainment procedures will be recruited.

15. Has there ever been an accident at a BSL-3 or BSL-4 facility that caused release of micro-organisms into the environment?

No. A number of 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.

16. Will the research be secret?

The ultimate goal of this research program is to provide information and to translate this information into diagnostics, treatments and vaccines that will combat 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 research at the NIH.

Rocky Mountain Laboratories is a component of the NIAID, part of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press 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

U.S. Department of Health and Human Services

Department of Health and Human Services

National Institutes of Health (NIH) Bethesda, Maryland 20892

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