Create an Account - Increase your productivity, customize your experience, and engage in information you care about.
Show All Answers
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.
http://orf.od.nih.gov/ Glossary of definitions: http://www.frontlinefoundation.org/glossary
• 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.
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
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.
www.cdc.gov Annotated Code of Maryland, Title 10 Department of Health and Mental Hygiene, Subtitle 10 Laboratories, Chapter 11, Biological Agents Registry Program. http://dhmh.state.md.us/labs/html/about/leprac.html www.selectagents.gov www.usda.gov http://www.nap.edu/catalog.php?record_id=13265 www.dhmh.state.md.us/labs/html/terrorism/BAR_Policy_(2008).pdf http://www.ars.usda.gov/main/site_main.htm?modecode=19-20-00-00 http://www.bnbi.org/index.html
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.
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
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.
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).
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.htm http://www.nems.nih.gov/Pages/default.aspx http://bnbi.org/ http://www.ars.usda.gov/AboutUs/AboutUs.htm?modecode=19-20-00-00 http://www.usamriid.army.mil/ Maryland Biological Agent Registry regulations: http://dhmh.maryland.gov/labs/html/emergency_prep.html
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.
http://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 http://www.ars.usda.gov/AboutUs/AboutUs.htm?modecode=19-20-00-00 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.
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.
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.
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 http://www.ars.usda.gov/AboutUs/AboutUs.htm?modecode=19-20-00-00
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.
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 http://www.ars.usda.gov/AboutUs/AboutUs.htm?modecode=19-20-00-00 Department of Health Services’ Bureau of Emergency Preparedness and Response at the link below: http://www.azdhs.gov/phs/edc/edrp/es/bthistor2.htm
• 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.
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=1089 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 http://dhmh.state.md.us/labs/html/about/leprac.html
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. http://dhmh.state.md.us/labs/html/about/leprac.html www.selectagents.gov
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 regulations2) Providing guidance to the regulated community, and3) 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.