Friday, March 5, 2010
EXTENSIVE, MULTILAYERED APPROVAL PROCESS REQUIRED FOR K-STATE'S BIOSECURITY RESEARCH INSTITUTE TO SAFELY STUDY SELECT AGENT PATHOGENS
MANHATTAN -- Through stacks of documentation and months of preparation, the Biosecurity Research Institute is undergoing the extensive, multilayered process of gaining approval to study federally regulated select agent pathogens that threaten human and animal health as well as the food supply.
"There's a misperception that regulators will just come in and give a blanket OK, and that's not true," said Scott Rusk, director of Pat Roberts Hall, which houses the laboratory. "The inspectors don't come in and then leave us with the whole building and all possible research projects approved."
The Biosecurity Research Institute is a biosafety level-3 facility for research on animal and plant diseases that threaten human and animal health and food safety. The ability to possess and use some of these pathogens in research requires approval from multiple agencies like the U.S. Department of Agriculture and the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention.
Both groups collaboratively regulate the use and security of select agent pathogens. he listing of pathogens as select agents is subject to change, with new ones being added over time, and it doesn't necessarily correlate to how dangerous an agent is to people, said Beth Montelone, the institute's interim director. Rather, a pathogen's status depends on what threat the government thinks it poses.
The Biosecurity Research Institute is currently seeking approval for six bacterial pathogens and one virus that are considered select agents.
"The regulators' upcoming site visit is just the first step of what we'll be doing in terms of getting the building fully ready for all of the projects that have been proposed for the next two years," Montelone said. "The select agent registration is the brass ring, but there are layers below that."
Even if the Centers for Disease Control and Prevention gives the OK for work with the seven pathogens, the laboratory and scientists will still have to get permits from the U.S. Department of Agriculture to use them. So from the day the regulators perform the initial inspection, it could be another six months before researchers can actually start the project.
"It's good that there's scrutiny, but it does have a price," Montelone said. "It costs time and effort, and it means that research is slowed down. There's only part of the process that we can control."
To become approved to study select agents, the Biosecurity Research Institute is being scrutinized from top to bottom. This includes understanding how the infrastructure at Pat Roberts Hall works, reviewing the laboratory's safety, security, operations and maintenance, medical surveillance, training and incident response programs, standard operating procedures, and interviewing laboratory workers and laboratory support staff.
"Each application is project-specific, so if we get approval to do these seven pathogens and want to add new research projects with the same pathogens, additional pathogens or more personnel, we have to prepare an amendment and resubmit it for approval," Rusk said.
Going through a lengthy and extensive authorization process is vital to keeping the laboratory safe. Moreover, when a lab doesn't adhere to standards, its authorization to work with agents can get yanked for years. It could also face significant monetary fines -- recently an institution was fined nearly $1 million -- and people could lose their jobs and even face criminal penalties.
Because of the extensive process, some research organizations have decided not to study select agents. But Rusk and Montelone said that the Biosecurity Research Institute was created for exactly this type of research.
"We have long-term relationships and plan to work with collaborators at the National Bio and Agro-defense Facility and the U.S. Department of Agriculture Arthropod-Borne Animal Disease Research Unit," Rusk said. "If confidence is lost in our ability to do this type of work, those relationships and collaborations may be impacted as well. That's the reason this all takes a long time. The stakes are high, and you have to get it right. The ultimate goal is to facilitate the high quality of science that goes on in the building."
While the process to become approved for select agents and materials requiring U.S. Department of Agriculture permits is ongoing, the Biosecurity Research Institute has had several other projects under way. In November 2009, a study of the wheat blast fungus began and a study was completed on two pig diseases, porcine circovirus and porcine reproductive and respiratory syndrome virus.
And since August 2008, the laboratory has housed a project in which researchers are using lower level agents as a first phase of a research project that will eventually include select agents when the Biosecurity Research Institute obtains approval to do that next phase of work."Having researchers in the building but not doing highly regulated work is a huge benefit because it helps test our operations so that we are fully prepared when higher risk work begins." Rusk said.