Date: April 12, 2007
Source: Sunshine Project
Abstract: 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" (Sunshine Project, 2007).
Title: Plague-Infested Mice, Anthrax Missing From N.J. Labs
Date: April 26, 2006
Source: Fox News
Abstract: In the past year, two New Jersey laboratories have been unable to account for plague-infested mice and vials of deadly anthrax spores, and top state officials are scrambling to devise better ways to safeguard deadly material.
In both cases, authorities say they think the items in question were not actually lost, but were simply unaccounted for due to clerical errors.
They cannot say for sure — and that has a Rutgers University microbiologist predicting more trouble if such substances are not kept at a central location secured by the federal government.
"The fact that they don't know the answer means they're not running a properly secured facility," professor Richard Ebright said of both cases. "The odds are that it was an accounting error, but it is very possible that one of the persons with access to the lab has removed that material."
Last week, state health officials said they could not account for two vials of anthrax bacteria once thought to have been stored at a government laboratory in Trenton. In September, a Newark health research lab lost track of three mice infected with the bacteria responsible for bubonic plague.
The mice were never located, and officials said the rodents might have been stolen, eaten by other lab animals or just misplaced in a paperwork error.
While the FBI and state authorities are investigating the possibility that the anthrax and mice were removed from the labs, they believe that no crimes have been committed. The state Health Department plans to tell federal authorities on Wednesday it believes the anthrax case is the result of a counting error.
Samples of anthrax have been stored at the Trenton lab since shortly after the October 2001 anthrax mailings that went through a Hamilton, New Jersey, post office, killing four people across the country and sickening 17.
"I think the genesis was that they were inundated with samples," Canas said. "What I would like to see is bringing this number down. Let's at least cull these down into something more manageable."
Richard Canas, New Jersey's Homeland Security director, said it does appear an accounting error is to blame for the latest case. But he wants better safeguards put in place, including disposing of some of the samples.
Ebright, who has been critical of the nation's bioterrorism safety efforts since the anthrax attacks, said more than 300 institutions nationwide and 16,500 individuals received government clearance to possess deadly bio-agents such as anthrax as part of a plan to study and protect the specimens.
"After the mailings in 2001, the logical approach was to tightly restrict the number of institutions and officials with access to the materials," he said. "Precisely the opposite has happened, unfortunately. This is a case when we've spent money to put ourselves at greater risk."
That is not to say facilities have not taken stronger steps on their own. The Trenton lab where the anthrax spores were stored has multiple layers of security, including a padlocked containment area requiring two different sets of identification for access. Only 11 people have such clearance, and all have been questioned, authorities said.
The lab also has video monitoring and 24-hour security guards.
The Newark lab that lost track of the plague-infested mice conducts bioterrorism research for the federal government. After the incident, the facility improved its video surveillance and stopped using contracted animal handlers. Before the incident, the center relied on a single security guard.
Ebright said the U.S. should store all its hazardous bio-agents at a single, secure location rather than having them scattered across the country.
"If an adversary of the United States, such as al-Qaida, wanted to obtain this material, the most effective, simple procedure to do so is to plant a person in one of those numerous institutions that the administration has put in place working with this material," he said. "Because the number of those institutions has increased and because it happened without an increase in effective security, the risk to the United States has dramatically increased" (Fox News, 2006).