Last modified: Friday, August 7, 2009
Questions & answers
IU's select agent laboratory
1) What is a "select agent"?
A select agent is a pathogen (or potential pathogen) that could pose a threat to public health and safety. After the terrorist attacks of September 11, 2001, Congress passed new laws that gave the Centers for Disease Control and Prevention funds to establish the Select Agent Program. The Select Agent Program of the CDC regulates the use of pathogenic species in industry, education and research by only authorizing use in ways and facilities that have been demonstrated to be safe. Anyone who wishes to use select agents must first pass a background check by the U.S. Department of Justice. Labs containing select agents are initially inspected and must be approved by the CDC before use of the select agents can begin and the facility must pass rigorous inspection standards. All users agree to follow the standards described in the Code of Federal Regulations Title 42 Part 73 "Possession, Use, and Transfer of Select Agents and Toxins; Final Rule," and participate in regular CDC inspections.
2) What is Yersinia pestis?
Yersinia pestis is a gram-negative bacterium colloquially known as "plague." Its natural habitat is a limited variety of rodent species.
3) How common is Yersinia pestis in the U.S.?
According to the Centers for Disease Control and Prevention, plague is occasionally found in non-human animals in the southwestern U.S. Transmission from these animals to humans is exceedingly rare. Plague has been documented in the Grand Canyon's wildlife population, a popular site that attracts 276 million visitors annually.
4) How dangerous is it?
While Yersinia pestis is famously known for causing a population dip in 14th-century Europe, outbreaks of infection are practically negligible in the U.S., thanks to the limitation of contact between humans and rodent carriers, general inclination toward cleanliness in modern societies, and the effectiveness of modern diagnostic and treatment procedures. Infections can be treated with antibiotics.
5) How many Americans die each year from Yersinia pestis infections?
Since the CDC began keeping records, there have been zero plague deaths in the state of Indiana. Plague infections in the southwestern U.S. fluctuate between about 10 and 20 reported cases per year. The mortality rate is fairly low -- 14 percent -- meaning only two or three Americans die each year from Yersinia pestis infection, all from exposure to infected rodents.
6) What makes the Select Agent Lab different from other labs on campus?
This is the only IU lab that uses the security risk assessment process of screening and approval to determine who may work in the lab. No other laboratory on campus has been as thoroughly evaluated and tested by the federal government for safety and security. The security procedures and systems now in effect for the Select Agent Lab have no equivalent on any IU campus.
7) Can anyone visit the lab?
Absolutely not. In fact, the only true visitors to the lab will be CDC inspectors.
8) Are scientists who work in the lab automatically contaminated?
Lab protocols are such that researchers should never come into contact with the bacteria directly. But just to be safe, scientists wear scrubs and footwear under protective suits. Their clothes and gear are sterilized thoroughly upon exiting the laboratory. The clothing and protective suits are sterilized a second time after removal.
9) What other precautions have you taken to prevent Yersinia pestis's escape?
The work is done inside of multiple layers of containment. The plague bacteria are only handled inside a biosafety cabinet (which protects the laboratory workers and the laboratory). As an additional precaution, the laboratory has a separate air handling system that is designed to prevent lab air from flowing out of the facility and into the surrounding areas, the air is filtered before being exhausted from the building, and the exhausted air is not drawn back into the building with supply air. Finally, laboratory workers are wearing protective gear. All items that enter the lab are decontaminated or sterilized before being removed. Equipment is tested and re-certified regularly.
10) OK, OK. It won't get out. But let's just say it did -- hypothetically. What would happen?
Probably nothing. Yersinia pestis needs a host to stay alive, so it would need to come into contact with a potential carrier almost immediately. Even if it did find a host -- such as a rodent -- direct human contact with feral rodents is so uncommon that transmission to humans is extremely unlikely.
11) Are there other labs like this in the state of Indiana?
IU's Select Agent Laboratory is the first academic lab of its type in state history.
12) What are the benefits of this lab to the research community, to the university as a whole, and to the state?
A better understanding of Yersinia pestis can help researchers understand the pathways of infection for Yersinia pestis and other bacteria. The system used by the bacteria to attack or infect host cells is not unique to Yersinia pestis -- the "type III secretion system" is also used by other bacterial species, some of which don't attack animals at all, but plants. IU Bloomington biologist Melanie Marketon's research could therefore aid (human) medical researchers and agricultural scientists alike. The existence of the select agent lab is likely to attract top research faculty to Indiana University, and also make it easier for pathogen researchers to acquire monetary support from the National Institutes of Health and other funding agencies.
13) Will this lab be used for bioweapons research?
No. International treaties prohibit bioweapons research. This activity, which is funded by the National Institute of Allergy and Infectious Diseases, is being performed to better understand the microbiological aspects of how the plague acts to infect cells. Ultimately, by giving scientists a better understanding of the cellular interaction when the plague infects cells, eventually this research could lead to better treatments for any number of infectious diseases. Detailed protocols describing both research and safety procedures for work inside the lab must be approved by the Indiana University Institutional Biosafety Committee and the CDC Select Agent Program.