 |
Image:P Paul Keim, CDC EID, via Wikipedia |
The select agent program, created in 1996 and strengthened significantly in the wake of the 2001 terrorist attacks, regulates the people and institutions that use potentially dangerous bioagents. Approximately 12,000 people at about 400 facilities in the country have clearance to study the 82 agents on the list. Breaking the rules means potential fines and even criminal penalties.
The number of labs working with select agents has increased dramatically since 2001. That spells trouble, some say, citing highly publicized breaches in security (such as the recent discovery of unrecorded vials at an army laboratory)and safety (for example, the 2006 infections of three workers in high-containment labs at Texas A&M University). "We need to sharply reduce the number of institutions and scientists that have access" to these dangerous pathogens, said chemist Richard Ebright of Rutgers University in New Jersey.
The Congressional bill, currently under discussion in several committees, calls for an evaluation of oversight of high-containment laboratories, mandates safety training for laboratory personnel, and establishes a reporting system to track accidents. But more legislation may create more bureaucracy, which some say is already impeding needed research. "Protection of the public is not being done if we in the trenches are going to decide it's not worth the effort," said virologist Edward Dubovi of Cornell University.
One possibility to lessen the bureaucracy, recommended by the National Science Advisory Board for Biosecurity (NSABB) in a report last May, is to shorten or stratify the select agent list. Attenuated strains, for example, may not require the highest security measures allotted to their virulent cousins. But in requesting that a weak strain be exempted, scientists must prove it's not dangerous -- creating a catch-22 since researchers would need select agent clearance to amass such proof, said James Roth, a veterinary microbiologist at Iowa State University in Ames and NSABB member.
How to improve security is another key issue, particularly in light of last year's announcement that Bruce Ivins, a long-time researcher at the US Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Md., was allegedly responsible for the 2001 anthrax letters. Some have suggested measures such as requiring people to work in pairs, hosting unannounced inspections, and putting up video cameras. "Had there been video monitoring [in the army lab], the person in all likelihood would not have been inclined to prepare the material," said Ebright.
Others have suggested putting the spotlight on individuals with measures such as psychological testing and credit histories on top of the routine background checks. But the NSABB found no evidence that these techniques would ferret out potential miscreants. "It's really hard to tell whether someone's going to go on to do something bad," said Michael Imperiale of the University of Michigan in Ann Arbor, a member of the NSABB.
Current rules to track materials may also not be sufficient for keeping select agent stocks secure. In June, USAMRIID announced it had discovered 9,220 unlogged samples -- some decades old and stashed in the freezer well before the select agent rules came into play. But scientists say simply keeping count, while appropriate for nuclear and chemical weapons programs, is nearly pointless with reproducing organisms. "It creates a false sense of security," said NSABB member Paul Keim, a microbiologist at Northern Arizona University and the Translational Genomics Research Institute in Flagstaff. "If somebody really wanted to steal something... the inventory system wouldn't catch them."
Ultimately, the best way to avoid breaking the rules is not to play the game at all. "Many of my own students don't want to get involved," said Peter Palese, a virologist at the Mount Sinai School of Medicine in New York City. "We are preventing some of the young, very imaginative and hardworking people from working in these areas because they just don't want to be bothered."
Related stories:
[16th October 2008]
[25th September 2007]
[31th January 2005]
