Safety and Security: Questions and Answers for the Community
Why do we need to conduct research on influenza?
Influenza is one of the world’s most important diseases, affecting millions of people each year. To effectively improve treatments for flu and develop new strategies to contain the disease when it occurs in human populations, scientists worldwide are actively exploring the basic biology of flu viruses. In particular, there is a pressing need to better understand the biology of flu viruses that infect both people and animals, such as avian or "bird" flu. By elevating our basic understanding of the flu virus and how it works, lives will be saved and the human and economic toll of the disease will be greatly reduced.
What hazardous materials will be handled in this facility?
This research group studies several strains of influenza virus. Some of the strains have circulated recently in the population and cause common flu-like symptoms. The bird flu, H5N1, also is studied. This strain causes significant mortality in birds and is a big concern to the poultry industry. It also causes mortality in some wild birds. The H5N1 virus has caused human deaths and is of great concern as an emerging pandemic strain. To date, the H5N1 virus has not evolved to transmit efficiently from human to human.
Do the university and this research group have the appropriate experience to work with these pathogens?
Yes. Professor Yoshihiro Kawaoka’s research group at UW-Madison has been conducting this work since 1997. The group understands the risks posed by the influenza virus, and takes a conservative and cautious approach.
How do researchers avoid getting the flu when they work with it in the lab and avoid bringing it home to their families?
The researchers use several ways to protect themselves, their families and other immediate contacts. Head-to-toe personal protective equipment, including respiratory protection, is worn whenever employees work in the high-containment areas. The virus is handled in a biological safety cabinet, which is specialized equipment that prevents release of the virus into the room and protects both the worker and the environment. For work with the H5N1 virus, the workers are required to fully change out of street clothes into laboratory coveralls, and to take a full shower when they exit the high-containment area. The employees participate in a medical surveillance program. They are trained to recognize and report any suspected flu-like illness. A clinical test distinguishes the source of the virus.
When people get sick from H5N1, are the symptoms different from regular flu?
According to the Centers for Disease and Prevention (CDC), symptoms range from typical human influenza-like symptoms (fever, cough, sore throat and muscle aches) to eye infections, pneumonia, severe respiratory diseases and other severe complications. Bird flu viruses do not usually infect humans. Most cases to date have resulted from direct or close contact with infected poultry.
Will the flu vaccine protect me?
The seasonal flu vaccine provides protection against the influenza virus strains that commonly circulate in the population. It will not provide protection against the bird flu, which only rarely infects humans.
Will animals be involved in the work?
Yes. The research will include use of animals to allow the effectiveness of candidate vaccines to be tested. Animal studies also are important to understand how the virus causes disease, so that targeted therapies like vaccines and antiviral drugs can be developed.
Could the genetic engineering techniques create a more virulent virus?
The reverse genetics technique pioneered by Professor Kawaoka is very precise in recombining specific genes. A fundamental safeguard among the procedures is to test the strains periodically to ensure that they retain susceptibility to antiviral drugs.
What is a high-containment facility?
A high-containment lab is designed to allow researchers to safely study microbes that could cause significant harm to humans, animals or plants. Safety and security are foremost concerns, both in the design and construction, as well as the day-to-day operations. This facility will be designed to meet or exceed federal standards for biosafety level 3 containment (see explanation below).
How do you keep the pathogens from getting out of the facility and into the community?
The facility will be built to ensure a high level of safety. Specialized equipment prevents escape of the pathogens. Strict procedures for handling the pathogens are followed. No virus is allowed outside the facility in the air or sewage system. All waste will be treated before it leaves the building.
Are there any dangers from the lab to the community?
The people working and living near the new facility will not be in danger. The facility will be constructed to provide the necessary safeguards for the surrounding community.
What if the virus escapes from the lab?
An incident-response plan is in place and personnel are trained to deal with incidents. It is unlikely that an escape would make people sick. The H5N1 influenza strain has had only limited ability for transmission among humans. The response would trigger the Campus Crisis Response Plan, based on the incident command system, and involve community emergency response.
Why was the University Research Park location selected for the lab?
We have an immediate need to expand Professor Kawaoka’s research space. His expertise is in high demand, and the current space in the School of Veterinary Medicine is inadequate to meet the research needs. Space was not available to expand the facility on the main campus. The refurbished facility at University Research Park fits well with existing research facilities located there, and a vacant building was available to be remodeled.
Is University Research Park a safe location for a high-containment facility?
The university’s experience with other research labs already located at University Research Park has shown that this is an excellent location where work with biohazardous materials (BSL-2 and BSL-3, see explanation below) can be conducted safely. The remodeling will create a state-of-the-art research facility. The architects and engineers are experienced in designing these specialized facilities.
Who decides what standards the facility must meet?
The facility design is based on a thorough understanding of the characteristics of the influenza virus pathogen and the experimental procedures to be used. The standards that must be met are set by federal agencies, specifically Centers for Disease Control and Prevention (CDC) and Animal and Plant Health Inspection Service (APHIS). These agencies will be involved throughout the process, starting with the early planning stages. Before work with the H5N1 virus begins at the facility, the operations must be approved by CDC. This review will involve a thorough assessment of every aspect of the facility.
How will you know that the containment systems are doing their jobs?
Containment will be assured by systems that are designed with redundancy and backups and to fail to a safe condition. If one system fails, the backup system kicks in. Even though power failures are relatively rare in this part of Madison, there will be backup power. Frequent inspections will be conducted to verify that the systems are working. For example, the air-handling system will not allow the room to pressurize and blow contaminated air out. Furthermore, the systems will have alarms to notify personnel when there is a problem so that corrective action can be taken. The facility will be inspected and certified regularly to verify the proper function of the containment systems.
Tornadoes happen in the Midwest. Will this facility withstand one?
The high-containment portion of the facility will be constructed with reinforced concrete. It has to be able to maintain a strong air-pressure differential, somewhat like a submarine. The building is designed to a higher specification of reinforcement than typical Midwestern research facilities.
How can you protect the facility from break-ins?
A sophisticated security system will be used to protect against entry by unauthorized individuals. The building will be locked at all times. The interior doors to the high-containment rooms will have high-security locks with biometric readers and video surveillance. The specifications for the security system are the same as those currently in use for select-agent facilities on the main campus. Security services will be provided by the UW Police Department in coordination with the Madison Police Department.
What is a select agent?
The federal government has designated certain microbes and toxins that have a potential to be used as biological weapons as select agents. This facility will develop vaccines to protect the public and agriculture against one of these agents. Stringent oversight applies to these materials to ensure safety and security. The H5N1 influenza virus is a select agent. Personnel who work with a select agent are screened to eliminate anyone with a criminal background (per the USA Patriot Act) and are required to undergo a federal background check.
Who provides oversight for the daily operations?
Local oversight is provided by UW-Madison staff of the School of Veterinary Medicine, the Office of Biological Safety and the UW Police Department. Detailed containment procedures are reviewed by the Institutional Biosafety Committee.
What is meant by biosafety levels?
Biosafety levels refer to standards for safe conduct of research with biohazardous materials. The levels correspond to increasing risk, where biosafety level 1 (BSL-1) is relevant for biological agents that do not cause disease or impact the environment, and at the upper end, biosafety level 4 is used for pathogens that cause high mortality, such as smallpox virus. The standards for facility specifications and containment procedures are described in documents from the National Institutes of Health and Centers for Disease Control and Prevention. This facility will have laboratories that provide BSL-2 and BSL-3 containment.
What is biosafety level 2 (BSL-2)?
BSL-2 containment is suitable for work with pathogens that cause diseases that rarely are serious and for which preventive or therapeutic interventions are often available. Pathogens handled under BSL-2 containment cause common diseases, including the commonly circulating influenza virus strains that infect the general population. This level of biosafety builds on a foundation of good microbiological practices, especially good hygiene. Access to the laboratory is restricted to those who need to be present. Activities that produce aerosols or splatters of infectious agent or that involve high concentrations or large volumes are done in a manner that protects personnel and the environment. Signs are posted to indicate the potential presence of biohazards. Personnel receive training to handle the materials safely.
What is biosafety level 3 (BSL-3)?
BSL-3 containment is appropriate for work with pathogens that are associated with serious or potentially lethal human disease, often as a result of exposure by inhalation. This level of biosafety builds on the foundation of BSL-2 practices. BSL-3 laboratories are designed to have secondary barriers to set labs apart from one another. All work with infectious agent is done using containment equipment, such as a biological safety cabinet that protects the worker and the environment. Procedures are in place to prevent exposure of personnel or escape of the pathogen to the environment. Workers participate in a medical surveillance program. Special attention is paid to controlling contamination of air, such as having workers use respiratory protection and filtering the exhaust air.
The H5N1 influenza virus requires enhanced BSL-3 containment, termed BL3-Ag. Additional requirements include redundant containment systems, filtering incoming air, showering when personnel leave the laboratory and prohibiting contact with birds outside the facility.