RELATED RESOURCES:
Original records from Texas A&M
Update: E-mails received from Texas A&M, 25 Jun e 2007The Sunshine Project
News Release
12 April 2007Texas A&M University Violates Federal Law in Biodefense Lab Infection
- Student climbs into dirty bioaerosol chamber and contracts brucellosis
- A&M failed to report the incident to federal authorities
- May lose federal funding and owe $750,000 or more in fines.
- Urgent need for mandatory federal accident and near-miss reporting system that publishes institution-level data on mishaps to provide missing lab public accountability.
UPDATE (27 June 2007): An additional set of e-mails were received by the Sunshine Project from Texas A&M on 25 June 2007. Some of these pertain to the accident described below, providing additional details. The e-mails have been scanned into a PDF file and are available here.
12 April 2007 - An aerosol chamber mishap at Texas A&M University in February 2006 caused a researcher to be infected with the bioweapons agent brucella. Texas A&M University then violated federal law by not reporting the brucellosis case to the Centers for Disease Control (CDC) and now faces severe penalties. This information has only come to light as a result of persistent Texas Public Information Act requests by the Sunshine Project.
Overdue records obtained by the Sunshine Project in the last two days confirm that A&M officials discussed the fact that the federal Select Agent Rule required reporting the brucella infection; but they chose not to do so. A&M is still holding back additional documentation of crime. The scandal points to the urgent need for a mandatory federal accident and near-miss reporting system that publishes institution-level data on mishaps and creates public accountability for biodefense lab accidents.
For federal violations, Texas A&M may be fined $500,000, plus up to $250,000 for individual(s) that failed to report the incident. In refusing to produce information about the infection, A&M officials also flouted the Texas Public Information Act. The Sunshine Project is filing a complaint with Texas Attorney General Greg Abbott that may result in other fines and/or jail sentences if A&M officials are found guilty of hiding documents.
What Happened: The infection incident occurred on 9 February 2006. Several A&M researchers, including Principal Investigator Thomas Ficht, were in a BSL-3 lab training in the use of the Madison Aerosol Chamber. Supervising was David McMurray, an A&M professor and self-described inventor of the chamber, who has characterized it as "foolproof".
Following a "hot" run that blew aerosolized brucella into the chamber to expose mice, researchers began clean up procedures. Using what Texas A&M now admits were inappropriate protocols, a researcher "cleaned the unit by climbing partially into the chamber to disinfect it." A&M officials later concluded that the brucella bacteria likely entered her body via her eyes as a result of this improper procedure. (This is the third instance of lab-acquired infections related to the Madison chamber that the Sunshine Project has uncovered. The others were in Seattle and New York City.)
By April 2006, the researcher had "been home sick for several weeks." Nobody apparently suspected brucellosis, despite the occupational exposure and, presumably, familiarity with its symptoms. Eventually, the researcher's personal physician ordered blood tests and made the diagnosis on about April 10. On 15 April, the infected researcher began a heavy treatment course reflecting the severity of the situation. She received a week of intravenous antibiotics followed by a 45-day course of two additional antibiotic drugs. Just over a month later, new blood tests indicated that the infection had passed.
Failure to Report: E-mails that Texas A&M finally released to the Sunshine Project late on Tuesday night reveal that the University broke federal law by not reporting the infection. The Select Agent Rule required A&M to report the infection immediately upon its discovery and for the school to file a formal report, called APHIS/CDC Form 3, within 7 days.
According to A&M records, the sick researcher told Thomas Ficht of the diagnosis on Monday or Tuesday, April 10 or 11, 2006. Based on the records A&M has released, Ficht does not appear to have told A&M administrators until ten days later. On 21 April, a Friday afternoon, Ficht informed other A&M officials, including Angela Raines, the Responsible Official under the Select Agent Rule and Brent Maddox, the A&M biosafety director, in an e-mail titled "Workmen's Compensation".
Texas A&M has also released a partial e-mail sequence involving discussions during the following week between Ficht, the sick researcher, and Maddox (the safety director). On Tuesday April 25, Ficht noted "according to the select agent guidelines [sic] we are required to report any laboratory exposures to the CDC." Yet no report was filed.
Ficht is the Research Standards Officer of Texas A&M University, a member of the NIH bacterial biodefense and bacterial pathogenesis study groups, and is funded to study bioweapons agents by the Department of Homeland Security and National Institutes of Health. Notably, Ficht is one of only a few US researchers who were studying Brucella before the post-9/11 biodefense boom.
A&M has yet to release any of Maddox or Raines' records about the incident, despite having been obligated to do so by Texas law for almost six months. These undoubtedly would shed more light on A&M's violation of the Select Agent Rule.
A Year Too Late: There is no reason to suspect that A&M would have admitted the truth without pressure. It has taken six months for the Sunshine Project to convince A&M to reveal this incident to the limited extent known today. This week, as the Project was closing in on details in a series of tense e-mails with the Texas A&M General Counsel (including a threat to take the matter to law enforcement), A&M officials apparently decided that they could no longer stonewall.
While A&M was refusing to answer Sunshine Project requests, on Tuesday (10 April), A&M e-mailed CDC to inform it of the incident - a full year after the infection should have been reported. Yesterday (11 April), A&M's Angela Raines filed the required APHIS/CDC Form 3 document, 51 weeks after A&M was required to submit it.
Penalties: The Sunshine Project is calling for maximum penalties to be levied. Says Sunshine Project Director Edward Hammond, "The evidence released to us indicates that Texas A&M officials discussed the federal requirement to report the incident, yet they did not do so. They chose to ignore the law, and that irresponsible decision to endanger public health and security should be swiftly and severely punished with maximum fines and loss of federal research funding."
An Ongoing Problem: For years, watchdogs have pointed to the lack of effective regulation of BSL-3 and BSL-4 labs in the United States, and particularly the need for improved (and transparent) accident reporting. Those calls have grown louder after a series of accidents in recent years that labs tried to hide from the public, including tularemia infections at Boston University, a plague problem in Newark, New Jersey, and a genetically-engineered bird flu incident in Austin, Texas.
The Sunshine Project has gathered data (in press) documenting nearly a score more BSL-3 and BSL-4 accidents, including select agent incidents, almost none of which have been reported to the public. Due to the absence of effective federal regulation, there are, undoubtedly, many more accidents that have been successfully buried, like the Texas A&M brucella incident almost was.
"It is common knowledge in the biodefense business that lab accidents with bioweapons agents are routinely buried in order to avoid negative publicity and endangering funding," says Hammond, "It is only through the power of the Texas Public Information Act that Texas A&M's criminal failures have been revealed."
The Sunshine Project is calling for a mandatory national accident and near-miss reporting system to be established. "When accidents are buried, nobody learns from past mistakes, and communities are kept in the dark about accidents and sloppy labs in their midst." says Hammond, "It's time for biodefense labs to stop talking down to the public with false safety claims and to start being transparent. All BSL-3 and BSL-4 labs should be required to report all significant accidents and near-accidents, and that information should be published by the federal government, with details of every incident, including the name of the lab and the agent involved."
DOCUMENTS FROM TEXAS A&M UNIVERSITY
1. Initial Public Information Act Reply (PDF) with one page, claiming it was the entirety of records concerning the incident.
2. E-mails released on the evening of 10 April 2007 (PDF).
3. Sunshine Project letter to Texas A&M on the morning of 11 April (PDF).
4. Belatedly submitted APHIS/CDC Form 3 (PDF), released on the evening of 11 April.