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CLCAC

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1. What is a containment lab?

A containment laboratory employs engineering controls for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate the risk of exposure to laboratory workers, other persons and the outside environment to potentially hazardous agents. Other equally important principles in containment labs are Biosafety, Biosurety and proper personnel training. There are four designated levels of containment, each with increasing levels of control. Sources:

http://orf.od.nih.gov/
Glossary of definitions: http://www.frontlinefoundation.org

2. What do the Bio-safety level designations mean?

There are four biosafety containment levels (BSLs) that define proper laboratory techniques, safety equipment, and design, depending on the types of microbes or agents being studied. Where a microbe is confined is based on the degree of hazard posed by the microbe:

• BSL-1 labs are used to study microbes that don’t normally cause disease in healthy adults. They follow basic safety procedures and require no special equipment or design features.

• BSL-2 labs are used to study microbes that can infect humans if accidentally inhaled, swallowed, or enter the skin, but don’t usually cause serious disease. All of these diseases can be cured because there is an existing vaccine or treatment. Safety measures include the use of gloves and eyewear as well as hand washing sinks and waste decontamination equipment like autoclaves (sophisticated pressure cookers).

• BSL-3 labs are used to study microbes that can be transmitted through the air and can cause serious disease or death if untreated. These diseases are treatable with existing vaccines or treatments. Researchers perform lab work in a gas-tight room within boxes that filter the air. Other safety features include clothing decontamination, sealed windows and rooms, and specialized ventilation systems with HEPA filters. Most facilities and Universities in the US with infectious disease research programs have BSL-3 labs, and many hospitals have BSL-3 areas for isolating patients with highly contagious diseases. BSL-3 labs work with pathogens such as anthrax and plague. Access to BSL-3 labs is tightly controlled.

• BSL-4 labs are used to study microbes that can cause serious illness or death and for which no vaccine or therapy is commonly available. Lab personnel are required to wear full-body sealed suits with their own air supply and to shower when exiting the facility. The labs incorporate all BSL 3 features and occupy safe, isolated zones within a larger building. Those zones are at negative atmospheric pressure to keep all air within the lab and filtered. BSL-4 labs work with pathogens such as ebola and other hemorrhagic fevers. Access to BSL-4 labs is tightly controlled, physically and procedurally.

Sources:

http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PublicMedia/pages/faqs.aspx
www.selectagents.gov
www.cdc.gov
www.usda.gov
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm 
http://www.bordeninstitute.army.mil/published_volumes/biological_warfare/BW-ch22.pdf 
http://www.nems.nih.gov/Pages/default.aspx 

 

3. What Containment labs operate in Frederick County?

In Frederick County, Biosafety level 3 and 4 (BSL-3 and BSL-4) labs are located within the perimeter of Fort Detrick. Two private BSL-3 labs are located outside of Fort Detrick. There are no BSL-4 laboratories operating in Frederick County outside of the perimeter of Fort Detrick. Inside Fort Detrick are laboratory facilities operated by: •Army (US Army Medical Research Institute of Infectious Diseases, or USAMRIID), •Dept. of Homeland Security (National Biodefense Analysis and Countermeasures Center, or NBACC), •National Institute of Allergies and Infectious Disease or NIAID (Integrated Research Facility, or IRF), and •US Dept. of Agriculture Agricultural Research Service (Foreign Disease-Weed Science Research Unit) As of December 2011, the existing USAMRIID lab, the USDA labs and portions of the Homeland Security labs are in operation. The portion of the Homeland security laboratory that is operational was certified by Centers for Disease Control & Prevention (CDC) and the United States Department of Agriculture (USDA), as of September 2011. The remaining portion is anticipated to be certified and become operational in late 2012. The NIAID facility is under construction, and is expected to be certified and become operational in 2012-13. Another Army laboratory, the Medical Countermeasures Medical Countermeasures Test & Evaluation (MCT&E) facility is still in the planning stages. A new USAMRIID facility is under construction, with estimated completion reported for 2015. Outside of Fort Detrick, there are two privately-operated containment (biosafety level 3, or ‘BSL-3’) labs in Frederick County. The State of Maryland holds information on the locations and operators of these labs. Maryland law defines who this information can be shared with and that includes emergency planners and responders but not the general public. The State of Maryland requires any individual with access to the most dangerous microbes to be registered with the Maryland Biological Agent Registry program. Sources: www.cdc.gov 

Annotated Code of Maryland, Title 10 Department of Health and Mental Hygiene, Subtitle 10 Laboratories, Chapter 11, Biological Agents Registry Program.   

• www.selectagents.govwww.usda.gov 
•  http://www.nap.edu/catalog.php?record_id=13265
• https://health.maryland.gov/laboratories/Pages/BAR-Program.aspx
• http://www.ars.usda.gov/main/site_main.htm?modecode=19-20-00-00
• https://bnbi.org

4. What is the National Interagency Biodefense Campus (NIBC)?

The NIBC is a campus of research facilities located on the premises of Fort Detrick, including biological labs run by the Army, National Institutes of Health, United States Department of Agriculture, and Department of Homeland Security. Each of the labs comprising the NIBC are operated and maintained independently. The US Army Garrison at Fort Detrick is responsible for operation and maintenance of infrastructure for the NIBC, including power, water, sewer, post security, waste disposal, and emergency response. Source: www.detrick.army.mil/nibc

5. What disease-causing organisms do the labs in Frederick County work on?

The list of microbes (pathogens) under research by all the labs in Frederick County are too long to list, but the following Select Agents (see “What is a select agent?”) and other microbes have been reported as being present in one or more labs located at Fort Detrick:
• Bacillus anthracis (anthrax bacterium)
• Clostridium botulinum (makes the toxin responsible for botulism)
• Yersinia pestis (plague bacterium)
• Francisella tularensis (tularemia bacterium)
• A variety of viruses including Lassa, Ebola, Marburg, Equine Encephalitis, Crimean-Congo Hemorrhagic Fever, Yellow Fever, influenza
• Coxiella burnetti (causes Q fever)
• Burkholderia pseudomallei (melioidosis bacterium and B. mallei (glanders bacterium)
• Brucella species (causes brucellosis)
• Hanta virus
• Rift Valley fever
• Toxins including Ricin and Staph enterotoxin B

The labs have reported that the types of microbes/pathogens and toxins being worked on at any one time changes based on what research is active. They have also reported that there are no programs designed for large scale production; only a small number of microbes/pathogens are needed to conduct the research conducted at these labs.

Source:
Presentation by USAMRIID to the Containment Lab Community Advisory Committee, 2012

6. What is a select agent and how are they controlled?

Some of the microbes/pathogens under research have been specially designated by the US Government as ‘Select Agents’ because of their potential for causing severe public harm or being used as a threat against the public. See www.selectagents.gov for a list of these controlled pathogens.

The US Government now tightly controls who has access to Select Agents via each laboratory’s Personnel Reliability Program and the National Select Agent Registry.

The Federal Government empowered the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) to ensure compliance with internationally-recognized standard practices for biological safety & security; for safety & security practices surrounding Select Agents, it is a Federal crime to deviate from these standards punishable by fines and jail time.

Source:

http://www.selectagents.gov/

7. Do the labs in Frederick County conduct research on ‘weaponized’ pathogens and/or conduct classified research?

Since 1969 when President Nixon officially ended the Biowarfare Research & Development Program, it is illegal to conduct offensive biowarfare DEVELOPMENT research. American scientists such as those working at Fort Detrick are authorized to conduct research with biowarfare pathogens only for defensive purposes. Each of the labs reports that their research is defensive and/or focused on development of new vaccines, antibiotics, antivirals, and other therapeutics and diagnostic tests. Each of the labs reports developing modeling systems such as aerosolizing small amounts of pathogens in sealed biosafety cabinets in order to test the efficacy of countermeasures and treatments. However, "weaponized" agents may be present in some research laboratories at Fort Detrick. The National Biodefense Analysis and Countermeasures Center (NBACC) at Fort Detrick may receive evidence from a bio-crime or terrorist attack including ‘weaponized’ microbes /pathogens, and conduct diagnostic tests to detect the microbes, or in the pursuit of medicines and vaccines. The Army lab (US Army Medical Research Institute of Infectious Disease, or USAMRIID), reports that none of the research they do is classified at this time. The Homeland Security Lab (NBACC) reports that 10 to 15% of its research is classified, as of December 2011. Two private Biosafety level 3 research laboratories in Frederick County are involved in research and development of pharmaceutical drugs (vaccines and treatments) work on non-classified research with select agents (see “What is a select agent?”). Information about these laboratories is not open to the public for security reasons, as specified in the Maryland Biological Agent Registry regulations. Private BSL-3 laboratories may be protected by various laws around trade secrets and patent laws but are still subject to Federal and State regulations regarding safe handling of infectious diseases, registration of workers with access to dangerous microbes, and inspection of their facilities by Federal agencies (Centers for Disease Control & Prevention, or CDC, and the US Department of Agriculture, or USDA). Source: Textbook of Military Medicine: Part 1, Medical Aspects of Chemical and Biological Warfare. Office of The Surgeon General, Department of the Army, USA. Zajtchuk R, Bellamy RF, (Eds.) 1997.

Textbook of Military Medicine: Part 1, Medical Aspects of Biological Warfare. Office of The Surgeon General, Department of the Army, USA. Lenhart M, Lounsbury DE, Martin JW (Eds.) 2007.

For a summary of the history of biowarfare and bioterrorism, a good online resource includes the Arizona Department of Health Services’ Bureau of Emergency Preparedness and Response at the link below: 

http://www.azdhs.gov/phs/edc/edrp/es/bthistor2.htmhttp://www.nems.nih.gov/Pages/default.aspxhttp://bnbi.org/https://www.ars.usda.gov/https://www.usamriid.army.mil

Maryland Biological Agent Registry regulations: http://dhmh.maryland.gov/labs/html/emergency_prep.html 

8. Why would any laboratory choose to work with select agents?

At Fort Detrick, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has as a core mission element research to “develop medical solutions – vaccines, drugs, diagnostics, and information – to protect our military service members from biological threats.” Also at Fort Detrick, the Department of Homeland Security’s National Biodefense Analysis and Countermeasures Center (NBACC) has been established to be “a national resource to understand the scientific basis of the risks posed by biological threats and to attribute their use in bioterrorism or biocrime events." The President and Congress charged NBACC with “research and development of technologies to protect the American public from bioterrorism.” Also at Fort Detrick, the National Institute of Allergy and Infectious Diseases (NIAID, part of the National Institutes of Health) has the Integrated Research Facility (IRF) including BSL-2, -3, and -4 labs. The mission of the NIAID IRF is "to manage, coordinate, and facilitate the conduct of emerging infectious disease and biodefense research to develop vaccines, countermeasures, and improved medical outcomes for patients." The NIAID IRF was created "to carry out biodefense research needed to understand the clinical disease processes which correlate with the severity of microbial-induced disease." Also at Fort Detrick, the USDA Agriculture Research Service (ARS) maintains a research greenhouse operated at BSL-3 in order to conduct important research on microbes that can kill crops. Without the ability to test possible treatments safely, and to examine the processes that cause plant disease, no treatments will become available. These laboratories are all located at Fort Detrick in order for their researchers to work closely together with the other experts in biodefense and emerging infectious diseases. Sources: https://www.usamriid.army.mil  http://www.bnbi.org  http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PublicMedia/pages/faqs.aspx  http://www.nems.nih.gov/Pages/default.aspx  https://www.ars.usda.gov

Textbook of Military Medicine: Part 1, Medical Aspects of Chemical and Biological Warfare. Office of The Surgeon General, Department of the Army, USA. Zajtchuk R, Bellamy RF, (Eds.) 1997.

Textbook of Military Medicine: Part 1, Medical Aspects of Biological Warfare. Office of The Surgeon General, Department of the Army, USA. Lenhart M, Lounsbury DE, Martin JW (Eds.) 2007.

9. Who operates the labs?

Labs at Fort Detrick are operated by the US Government through its departments or contractors. The National Institutes of Health operates the Integrated Research Facility (IRF), while the Army operates the US Army Medical Research Institute of Infectious Diseases (USAMRIID). T The National Biodefense Analysis and Countermeasures Center (NBACC) is managed and operated for the Department of Homeland Security as a Federally-Funded Research and Development Center by the Battelle National Biodefense Instittue, LLC. Each of the labs employs contract employees from a variety of sources including Batelle Memorial Institute, SAIC, and others. Source: www.saic.com  http://www.bnbi.org

10. Where are the BSL-3 and BSL-4 containment labs located in Frederick County?

The biodefense laboratories located at Fort Detrick in Frederick are collectively called the National Interagency Biodefense Campus (NIBC). These include the Integrated Research Facility (IRF, the National Institutes of Health lab), the US Department of Agriculture research lab, US Army Medical Research Institute of Infectious Diseases (USAMRIID), and the National Biodefense Analysis and Countermeasures Center (NBACC). Two privately-owned Bio-safety level 3 laboratories also operate in Frederick County and are registered with the State of Maryland. Source: http://www.usamriid.army.mil  http://www.bnbi.org  http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PublicMedia/pages/faqs.aspx  http://nems.nih.gov/home/frederick.cfmhttps://www.ars.usda.gov

11. Why are these labs in Frederick County and not somewhere else?

The first US biowarfare research facility was started in April 1943 at Camp Detrick. Later, in 1956, the US Army Medical Unit (USAMU) was created at the site to develop the means to diagnose, treat, and prevent diseases caused by biological warfare agents. In 1969, USAMU was re-named USAMRIID and remains on site at Fort Detrick. Other research facilities were developed at Fort Detrick to capitalize on the facilities, expertise, and knowledge developed there through USAMRIID. The security of the site, and the ability for experts to collaborate easily in a secure and safe area, are reported as some of the reasons for the labs to be located in close proximity. Source: http://www.usamriid.army.mil  http://www.bnbi.org  http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PublicMedia/pages/faqs.aspx  http://nems.nih.gov/home/frederick.cfm  https://www.ars.usda.gov

Department of Health Services’ Bureau of Emergency Preparedness and Response at the link below:  http://www.azdhs.gov/phs/edc/edrp/es/bthistor2.htm

12. What are the potential ways for microbes to escape from a lab, and how do the labs prevent this from happening?

Microbes (e.g., viruses, bacteria, fungi) could potentially escape from a lab in a variety of ways. These include: •Fomites: Inanimate objects capable of carrying microbes in a way that allows them to continue to be infectious – these can include clothing, stethoscopes, doorknobs, writing instruments, table tops, etc. Lab workers wear surgical scrubs and special suits that are decontaminated after use, and nothing leaves a containment lab without it being autoclaved or treated with microbicidal chemicals. •Through the air: Microbes can survive the harsh environment outside a warm, moist body for a little while in the droplets formed when we cough or sneeze, and a few, like anthrax, can form tough outer coatings to form ‘spores’ that can survive outside the host for years. Air filters in labs and ultraviolet lights eliminate microbes before they escape. Containment labs are maintained at negative pressure so that air only flows inward through HEPA filters, thus preventing any lab air from ever escaping into another area. •Insects: Mosquitos are common carriers [‘vectors’] of parasites like malaria, while fleas can pick up plague bacteria from infected rodents and transmit them to humans. Ticks transmit the bacterium that causes Lyme disease between deer and human. Containment labs are maintained at negative pressure so that air only flows inward through HEPA filters – this also prevents a flying insect like a mosquito or fly from exiting a room. Doors of containment labs also have seals. •Water/food: Foodborne illness can be caused by poor manufacturing processes, poor food preparation practices, drinking from river or lake water contaminated by untreated waste, and even swimming pools and water parks. Containment labs do have sinks where water runs into pipes into huge steel tanks where the liquids mingle with powerful chemicals and are also ‘pressure cooked’ for hours before being allowed to exit the facility. •By infecting a lab worker: Laboratory-acquired infections (LAIs) can occur if a lab worker accidentally infects himself. Because lab workers are so well protected by multiple gloves and respiratory protection and special suits, the vast majority of these LAIs occur from accidental needle stick injuries. Any lab worker who accidentally pokes himself or herself is not immediately infectious: it takes time for any microbe to replicate inside the body and cause disease, so there is time for the worker to leave the lab and begin the appropriate treatment. If the situation warrants, the worker may be quarantined during treatment. Sometimes an infected worker has not been aware of the exposure and returns to the community. Lab workers are trained to immediately report any suspicious illness. •By malevolent intent: A worker intent on removing a pathogen from the laboratory could possibly do so, as the FBI reports occurred in 2001 during the Anthrax letter attacks. In order to address this concern a complex system of personnel reliability, security, and training has been put in place, along with regulations and security cameras, designed to prevent such an occurrence. Each of the containment labs in Frederick County operate under mandated biological safety & security regimes defined by a variety of internationally-accepted standards. These standards have been designed to prevent spread of microbes including the accidental or intentional release from a containment lab. The standards are laid out in detail in a publication called “Biosafety in Microbiological and Biomedical Laboratories” (see reference). These practices are in agreement with the World Health Organization’s “Laboratory Biosafety Manual” (see reference). Federally-appointed responsibility for enforcing and monitoring lab compliance with these regulations is given to the Centers for Disease Control & Prevention (CDC) and to the United States Department of Agriculture (USDA). For labs using the most dangerous microbes, additional security measures are mandated by the Federal and State governments. Laboratory practices are scrutinized and any person with access to the microbes is required to be actively cleared in a Personnel Reliability Program, and register with the State of Maryland. These measures are taken to ensure that the individuals with access are trustworthy. All of Fort Detrick’s National Interagency Biodefense Campus (NIBC) labs have "biosurety" programs in place that focus on four main areas: 1)safety – biosafety involves enforcing proper procedures for handling dangerous pathogens; 2)security – biosecurity includes physical systems like locks and alarms, guards, and procedures to prevent theft or unauthorized activities; 3)inventory and access – microbes are inventoried and access is controlled; and 4) Personnel reliability – starting in the middle of the last decade, people with access to dangerous microbes must undergo extensive background checks and psychological evaluations, as well as frequent monitoring, to ensure they meet very high standards for reliability and trustworthiness. The Federal Government mandates this for the most dangerous organisms (all BSL-4 microbes and many BSL-3 microbes) as part of a Personnel Reliability Program. The privately-owned laboratories are subject to the same Federal laws regulating access and handling to the most dangerous organisms. The Centers for Disease Control & Prevention (CDC) and the US Department of Agriculture (USDA) have jurisdiction and conduct inspections and, if necessary, can institute a cessation of operations if the situation warrants such action. In addition, the State of Maryland maintains a Registry of all individuals who are authorized to work with the most dangerous microbes. This list of individuals is not available to the public in order to protect the individuals. Sources: Annotated Code of Maryland, Title 10 Department of Health and Mental Hygiene, Subtitle 10 Laboratories, Chapter 11, Biological Agents Registry Program.  http://dhmh.maryland.gov/labs/html/emergency_prep.html 

www.cdc.gov 

www.selectagents.gov

Safety and informational presentations by Army to CLCAC:    http://www.cityoffrederick.com/DocumentView.aspx?DID=1090  http://www.cityoffrederick.com/DocumentView.aspx?DID=1088 

http://www.niaid.nih.gov/topics/microbes/understanding/transmission/Pages/transmissionWays.aspx 

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm 

www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf 

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm 

http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf 

13. What agencies oversee operations to ensure safety?

All of the laboratories are subject to certification and inspection from the Centers for Disease Control (CDC) and the US Department of Agriculture (USDA), in addition to biological safety & security (BS&S) oversight from within their operating organizations. Laboratories themselves are subject to direct oversight from the State of Maryland if they handle the most dangerous microbes; in that case, they are subject to Maryland’s Biological Agents Registry Program, and also to the Federally-mandated Select Agent Registry. Ancillary operations, such as incinerator operation and sewer water sanitization, are subject to oversight by Maryland Department of the Environment. Sources: www.cdc.gov  www.usda.gov Annotated Code of Maryland, Title 10 Department of Health and Mental Hygiene, Subtitle 10 Laboratories, Chapter 11, Biological Agents Registry Program.   

www.selectagents.gov

14. How often are the labs inspected?

The Army lab (US Army Medical Research Institute of Infectious Diseases) is inspected approximately once per year by the Centers for Disease Control & Prevention (CDC), every 4 years by US Department of Agriculture (USDA), and every year by the Army Inspector General, in addition to other internal Army functions. Other laboratories at Fort Detrick are inspected yearly by CDC if they handle the most dangerous microbes and by USDA if they handle agricultural microbes. Other laboratories in Frederick County are subject to inspection by CDC if they handle the most dangerous microbes, and the USDA if they handle dangerous agricultural microbes.

All labs working with the most dangerous microbes are regulated by the CDC Select Agent Program, which regulates the possession, use and transfer of biological agents and toxins that pose serious public health threat. The Program promotes lab safety and security by:

1) Developing, implementing, and enforcing select agent regulations
2) Providing guidance to the regulated community, and
3) Inspecting facilities working with select agents.

The Program works with the USDA and the Department of Justice. The CDC and the USDA maintain the National Select Agent Registry which details regulations, guidance documents, FAQs, links, and other information.

Source:

www.cdc.gov/phpr/dsat.htm 
www.selectagents.gov

15. How did the presentations at the CLCAC Meeting by Emergency and Health Services personnel relate to the charted mission of the CLCAC regarding public health and safety of the Frederick community?

The presentations during this forum on October 10, 2017 served to support the purpose of the CLCAC By-laws/mission (see http://www.cityoffrederick.com/DocumentCenter/View/5396).  In accordance with our By-Laws published October 13, 2015, “The Containment Laboratory Community Advisory Committee (“Committee”) serves to foster and facilitate two-way communication between the Frederick County community and the operators of the high and maximum containment laboratories (Biosafety Level 3 and 4) operating at Fort Detrick and elsewhere in Frederick County.  The Committee shall seek information about issues of public concern and ways to address those concerns, including the implications of laboratory operations on the safety and health of the community.  The Committee shall advise and make recommendations on behalf of the public regarding opportunities to improve any laboratory-related matters that could impact public safety and health.”  

At this forum, Frederick’s Emergency Management, First Responder and Public Health officials talked about what happens in case of an emergency involving pathogens from the laboratories located at Fort Detrick or private labs in the county.  Each laboratory facility at Fort Detrick has an Emergency Response Plan that is shared with Frederick County Emergency Management officials.  At this October 10, 2017 CLCAC meeting, Emergency Response Plans were addressed and discussed by the CLCAC and Emergency Response personnel.  A video transcript of these discussions can be viewed at http://cityoffrederick.granicus.com/MediaPlayer.php?view_id=12&clip_id=3430.   

 The CLCAC, emergency responders and Health Officials presented the facts regarding Fort Detrick potential risks and how these potential risks would be managed.  These policies and procedures are robust, and serve to mitigate any potential risks to the Frederick community by the Fort Detrick laboratories.

16. What is the time-line for Fort Detrick Officials to notify Frederick County first-responders when there is an abnormal event or incident on the Fort Detrick campus?

At Department of Defense facilities, a biological mishap is defined as an event in which the failure of laboratory facilities, equipment, or procedures appropriate to the level of potential pathogenicity of an infectious agent or toxin may allow the unintentional, potential exposure of humans or the laboratory environment to that agent.  All mishaps involving biological select agents and toxins (BSAT) will be reported to CDC or APHIS (Animal and Plant Health Inspection Service of the USDA and will be reported concurrently to the first general officer (or equivalent) in the mishap reporting chain. If the facility is a tenant on an installation, the mishap will also be reported to the garrison commander. The first general officer (or equivalent) receiving the report will forward it up the chain of command to the Office of the Director of Army Safety (ODASAF).  Upon discovery of a non-BSAT occupational exposure or release of a non-BSAT outside of the laboratory, an individual or entity must immediately notify the first general officer (or equivalent) in the mishap reporting chain (DA PAM 395-69).  There is no information or policy regarding release of any of the mishap information to the community.

17. What is the County action plan for public notification and potential evacuation when Fort Detrick reports the release of an infectious material/toxin/contaminated animal or specimen into the Community

The risk of any potential release of biological material(s) to the community is low to negligible.  There is an extreme amount of redundancy of safety equipment at these facilities that would preclude any potential release of material(s).  For instance, the reference Biosafety in Microbiological and Biomedical Laboratories [BMBL] (which is an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective, and is not intended as a regulatory document) states that all procedures involving the manipulation of infectious materials must be conducted within a biological safety cabinet or other physical containment devices.  Thus, a barrier is placed at the immediate level of a hazard.  In addition, a ducted air ventilation system is required. This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed.  The BMBL can be accessed at https://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf. 

For biosafety level 3 (BSL-3) laboratories (appropriate for agents with a known potential for aerosol transmission, for agents that may cause serious and potentially lethal infections and that are indigenous or exotic in origin), a ducted air ventilation system is required. This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed (redundancy). The laboratory exhaust air must not re-circulate to any other area of the building and the laboratory building exhaust air should be dispersed away from occupied areas and from building air intake locations or the exhaust air must be filtered through a high efficiency particulate air (HEPA) filter.  A HEPA filter is defined by the United States Department of Energy (DOE) standard adopted by most American industries to remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter. 

To the best of our knowledge, all air exhausted from biosafety level 3 laboratories at Fort Detrick is HEPA-filtered. Notably this level of engineering exceeds the recommendations of the BMBL publication for BSL-3 laboratories. 

For biosafety level 4 (BSL-4) laboratories (appropriate for dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission).  There are two models for BSL-4 laboratories:  (1) A cabinet laboratory - manipulation of agents must be performed in a Class III BSC (the Class III cabinet must have a HEPA filter on the supply air intake and two HEPA filters in series on the exhaust outlet of the unit); and (2) a suit laboratory - personnel must wear a positive pressure supplied air protective suit (the suit is supplied with HEPA-filtered breathing air).  In addition to the criteria listed for BSL-3 laboratories, all exhaust air from both the suit laboratory and cabinet laboratory, decontamination shower and fumigation or decontamination chambers must pass through two HEPA filters in series before discharge to the outside environment.

The Code of Federal Regulations (CFR) defines a maximum credible event (MCE) as a hypothesized worst-case accidental explosion, fire, or agent release that is likely to occur from a given quantity and disposition of explosives, chemical agents, or reactive material.  One example of an MCE at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) follows: 

“The first MCE scenario for a BSL-3 laboratory accident occurs during the processing of 1 liter (0.26 gallons) of slurry containing Coxiella burnetii, the causative agent of Q fever, to prepare an experimental vaccine.  The infective dose for this species of bacteria ranges from 1 to 10 organisms.  During this process, a centrifuge rotor holding six 250-milliliter (8.45-fluid ounce) polypropylene centrifuge tubes is fitted with O-rings; each tube contains 165 milliliters (5.58 fluid ounces) of slurry.  The 990 milliliters (33.46 fluid ounces) of slurry contain a total of 9.9 x 10¹² (9.9 trillion) human infective doses (HID50) of the organism.  One HID50 is the dose that infects 50% of exposed humans.  In this scenario, a laboratory worker fails to use rubber O-rings to seal the centrifuge tubes and fails to properly tighten the safety centrifuge caps designed to prevent leakage into the centrifuge compartment that houses the rotor.  All six tubes spill slurry into the rotor cups, and some of this slurry leaks into the rotor compartment, which is not sealed against the release of organisms in a small-particle aerosol.  It is assumed that 10% of the slurry spills, of which 1% leaks into the rotor compartment, where 0.1% of the leakage is aerosolized.  It is further assumed that 90% of the aerosol settles as liquid droplets inside the chamber.  Thus, 10% (spilled from tubes) x 1% (leaked from rotor cups) x 0.1% (aerosolized) x 10% (did not settle out) = 0.00001% of the original slurry placed in the centrifuge tubes for processing would be released into the room.  The most serious consequence of this laboratory accident would be the release of enough concentrated aerosol to override the air filter system, allowing the subsequent release of a significant number of infectious doses into the surrounding community.  Following the assumptions above, 9.9 x 10⁵ HID50 are presented to the filter.  Further assuming that the air filter system is 95% efficient, approximately 5 x 10⁴ HID50 (5% not removed x 9.9 x 10⁵ HID50) would be released to the atmosphere from the exhaust stack.  Using a simple Gaussian plume dispersion model in HPAC [Hazard Prediction and Assessment Capability (HPAC) modeling system developed by the Defense Threat Reduction Agency] with weather condition parameters of USAMRIID for each calendar month, the worst-case total exposure of a person breathing ground-level air would be less than 1 HID50 of Coxiella burnetii at a distance less than 2 meters (6.56 feet) from the stack.  This concentration of organisms would pose no risk to human health.”

Additional scenarios of a maximum credible event are contained within the document Programmatic Environmental Impact Statement - Chemical Biological Defense Program, March 2006, Appendix C, Hazard Analyses, and can be viewed at

 http://mrmc.amedd.army.mil/assets/docs/sse/appendixC.pdf

18. What are the notification procedures in the event of a release of an infectious material(s) or toxin or contaminated animal or specimen (“materials") at a Fort Detrick facility?

Army Regulation (AR) 385-10, The Army Safety Program, Chapter 20, Infectious Agents and Toxins (see http://www.wsmr.army.mil/gar/dir/Safety/Documents/References/r385-10.pdf) establishes Department of the Army safety policies and procedures for the use, handling, transportation, transfer, storage, and disposal of infectious agents and toxins (IAT) rated at BSL-2 and above used in microbiological activities in permanent or temporary clinical laboratories, biomedical and biological research settings, microbiology teaching laboratories, and veterinary reference laboratories.  These policies and procedures apply to all U.S. Army activities and facilities in which IAT are used, produced, stored, handled, transported, transferred, or disposed. 

Chapter 19 of AR 385-10 describes Emergency Planning and Response.  The facility emergency response plan will be reviewed at least annually and, as necessary, be amended to keep current with new or changing facility conditions or information. Senior commanders and local, regional, State, and Federal emergency support and coordinating agencies (for example, law enforcement, fire departments, and health departments) will be informed of CBRN defense activities at Government-owned facilities. Agreements will be made with these agencies to identify and ensure the availability of support, including equipment and training, necessary to provide effective emergency response and to ensure compliance with applicable statutes and regulations and the facility emergency response plan. Agreements must be in writing and agreements will be reviewed annually or upon a change in operations that could affect existing emergency response plans and updated as necessary. The emergency response plan will be compatible and integrated with the disaster, fire, and/or emergency response plans of the installation and local, state, and Federal agencies. An employee alarm system will be installed according to 29 CFR 1910.165 (see https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=9819) to notify employees of any necessary emergency action. Emergency response plans will be exercised prior to adoption and at least annually thereafter to ensure the adequacy of response plans and responder training, responder familiarity with response procedures and equipment, the adequacy of support agreements, and the availability and adequacy of emergency equipment and medical support. Emergency response drills and exercises for biological operations will be conducted according to Department of the Army Pamphlet (DA PAM) 385–69 (see http://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p385_69.pdf).

DA PAM 385–69, Safety Standards for Microbiological and Biomedical Laboratories, Chapter 11, Emergency Planning and Response, states that all IAT biological laboratories will establish specific emergency plans for their facilities. Plans will include liaison through proper channels with local emergency groups and with community officials. These plans will include both the building and the individual laboratories.

 Therefore, based on these documents, there is in-place a comprehensive Fort Detrick-Frederick County notification protocol if an incident results in release of an IAT into the Frederick community

19. Is there a permanent real-time meteorological monitoring station on the Fort Detrick campus which supports an abnormal event or incident on the Fort Detrick campus?

To the best of our knowledge, there is no permanent real-time meteorological monitoring station on the Fort Detrick campus which would serve to detect an event that would warrant evacuation of any surrounding areas.  Realistically, it is assumed that the decision not to monitor is not only risk-based, but also considering the fact of extensive redundancy in facility infrastructure (filtration of BSL-3 laboratory exhaust air) and research operation policies and procedures.  As stated in the BMBL and practiced, all procedures involving the manipulation of infectious or toxin-containing materials must be conducted within a biological safety cabinet or other physical containment devices.

20. What is the difference between biological material and nuclear material?

There is a profound distinction between biological material(s) and nuclear material(s).  The former are replicating entities (with the exception of toxins) and when introduced into susceptible hosts usually reveal their variable effects after 24 hours.  Realistically, evidence of exposure is usually seen in days or weeks (this period is known as the incubation period).  For certain pathogens and toxins, real-time detection and identification is not immediate - the minimum time may be 30 minutes.  On the contrary, nuclear material(s) is non-replicating and may reveal their effects in a susceptible host immediately upon exposure of the host to the nuclear material.  There are methodologies available to detect nuclear material(s) in real-time, unlike for biological material(s).

21. How did the presentations at the CLCAC Meeting by Emergency Management and Health Services personnel relate to the charted mission of the CLCAC regarding County Public Health and Safety?

The presentations during this forum on October 10, 2017 served to support the purpose of the CLCAC By-laws/mission (see http://www.cityoffrederick.com/DocumentCenter/View/5396).  In accordance with our By-Laws published October 13, 2015, “The Containment Laboratory Community Advisory Committee (“Committee”) serves to foster and facilitate two-way communication between the Frederick County community and the operators of the high and maximum containment laboratories (Biosafety Level 3 and 4) operating at Fort Detrick and elsewhere in Frederick County.  The Committee shall seek information about issues of public concern and ways to address those concerns, including the implications of laboratory operations on the safety and health of the community.  The Committee shall advise and make recommendations on behalf of the public regarding opportunities to improve any laboratory-related matters that could impact public safety and health.”