Extensive, multilayered approval process for biosafety level-3 laboratory
Through stacks of documentation and months of preparation, Kansas State University’s 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.