CDC suspends biodefense research at Texas A&M
Agency to help university meet safety requirements; no penalties outlinedAUSTIN – Texas A&M won't be allowed to resume biodefense research until federal agents are sure campus labs no longer pose a threat to public health, federal health officials declared in an exhaustive reprimand of the university.
The 21-page report released Tuesday by the Centers for Disease Control and Prevention documents problems ranging from unauthorized access to high-security labs and missing vials of infectious diseases. It follows months of scrutiny over the university's failure to report lab workers being exposed to dangerous biological agents.
The CDC report doesn't indicate whether the university will face a penalty for failing to report one lab worker's infection with Brucella and three others' exposure to Q fever last year.
That news, which could include suspension of funding or up to $500,000 in fines, is expected in a separate report from the U.S. Health and Human Services Department's inspector general.
Congress has also indicated a desire to investigate problems at bioweapons labs.
The ban on "select agent" research at Texas A&M will remain in place, though the report outlines steps for the university to restart its program, which was halted this summer. CDC officials spent a week examining the lab in July.
"Their [research ban] status hasn't changed," said Von Roebuck, a spokesman for the CDC. He would not comment on the details of the report.
The CDC report recommends, among a dozen other improvements, that the university develop and implement a better security plan, keep infectious agents out of the hands of those not authorized to work with them, and overhaul its training policies to ensure that everyone working with a select agent has specific expertise with that disease. Agency officials will help the university improve its record, the report says.
University officials said they are confident Texas A&M will someday be able to resume select agent research, though the CDC gave them no timeline for resuming their work. Select agents are infectious bacteria and viruses that could be used as bioterrorist weapons.
"They pretty much spelled out what we did wrong, and what we've got to fix," A&M Chancellor Mike McKinney said. "We have got to do a better job of documenting, of monitoring what we're doing. We can't always assume we're doing what we're supposed to do."
Dr. McKinney said he hasn't heard anything about a fine, though he said the university wrote a letter to the Health and Human Services inspector general offering to pay a $10,000 penalty. Dr. McKinney said he had not received a response.
From what biological weapons activist Edward Hammond can glean from the CDC report, he said, the punishment will be much more – and could even include criminal penalties.
"The breadth of the problem is so wide – running from issues of physical containment to medical issues to access issues," said Mr. Hammond, director of The Sunshine Project, which first revealed the A&M lab exposures. "It's going to be awhile before they get their permit back, and when they do, I doubt they'll get any major new select agent work for a long time."
Among the shortfalls identified in the university's biodefense program:
• At least seven cases where Texas A&M allowed unauthorized access to select agents, including Brucella and Q fever.
• Several vials of Brucella, an infectious bacteria, were reported missing or unaccounted for.
• Poor record-keeping in logbooks of who came into and out of campus labs.
• Lab workers failing to wear protective respiratory equipment, and wearing coats used for experiments out of the lab setting.
The university "did not sufficiently address the particular needs of the individual, the work they will do, and all of the risks posed by the select agents," the report notes.
Since June, when the news reports of the infection and exposures surfaced, the university has acknowledged failing to properly notify the CDC of the cases, which involved dangerous agents that could be used as bioterrorist weapons.
University officials have also admitted two other mistakes: conducting experiments in labs not approved for them, and allowing unauthorized lab workers to use the agents.
Last month, the university's vice president for research stepped down over the security breaches. A principal investigator supervising the experiments remains on leave, and high-ranking officials close to the case have said other job reassignments could follow the CDC report.
"People may resign over this," Dr. McKinney said.
The university also lost its shot at housing a $450 million national biodefense lab, though federal officials said the decision was not based on the A&M security breaches.
In February 2006, a female lab worker fell seriously ill with Brucella after she leaned into an aerosol chamber to clean it. The university failed to report the case for a year, and records obtained by The Dallas Morning News indicate the woman was not authorized to work with Brucella and should not even have been cleaning up after the experiment.
Around that same time, three other researchers received blood tests that showed they had elevated levels of Q fever antibodies, indicating they had been exposed. A&M officials didn't report this case to the CDC either and insist that, because of the nature of the case, they didn't have the responsibility to do it.
Neither agent is particularly contagious, and there was little public danger from the exposures.
Other documents revealed by The News indicate that a mouse reported missing in December after being infected with Q fever was never found, though investigators believe it must have been thrown out with other biohazard waste. As recently as April, another lab worker reported high levels of Q fever antibodies, though officials don't know whether the researcher was exposed at A&M or at another lab.
Though the recommendations in the latest CDC report seem to address all the security breaches, The Sunshine Project's Mr. Hammond said, what's not clear is how the federal agency missed these problems during past inspections. The most recent, he said, was in February.
"They caught almost nothing," Mr. Hammond said. "People take solace in the fact that we have a stringent permit and inspection program. In reality, it's pretty depressing."
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