posted
CDC suspends work at Texas A&M biodefense lab
Lisa Schnirring * Staff Writer
Jul 3, 2007 (CIDRAP News) - The US Centers for Disease Control and Prevention (CDC) on Jun 30 ordered a biodefense research laboratory at Texas A&M University to stop all work on select agents and toxins while the CDC investigates reports of lab workers infected with the category B bioterror agents Brucella and Coxiella burnetti.
The alleged lab accidents, along with related alleged violations of federal law, were recently reported by the Sunshine Project, an Austin, Texas, nonprofit group that monitors biodefense research safety. The group used Texas freedom-of-information requests to obtain documents about the lab incidents.
In April, the Sunshine Project reported that a Texas A&M researcher had been infected with Brucella after a February 2006 aerosol chamber mishap and that the school did not immediately notify the CDC as required by federal law. Five days ago, the watchdog group reported that the exposure of three other Texas A&M workers to C burnetti, which causes Q fever, was confirmed in April 2006 but also was not reported to the CDC.
The Sunshine Project said its investigation of Texas A&M came about through its review of select-agent labs that are vying to host the federal government's planned new national biodefense facility, according to a Jun 27 report in the Dallas Morning News.
The laboratory is affiliated with the Foreign Animal and Zoonotic Disease Defense Center, a US Department of Homeland Security (DHS) center of excellence that focuses on the study of foot-and-mouth disease, avian influenza, and Rift Valley fever, according to the center's Web site. The center is funded by an $18 million DHS grant, according to an Associated Press report yesterday.
According to the Sunshine Project, Texas A&M notified the CDC about the Brucella infection in April 2007, a year after the worker's illness was confirmed.
Shortly after Texas A&M reported the Brucella infection, representatives from the CDC's Select Agents and Toxins Division inspected the laboratory and, in a Jun 30 memo, obtained and released by the Sunshine Project, ordered the lab to stop its work on all select agents and toxins until further notice.
Von Roebuck, a CDC spokesman, told CIDRAP News that the agency has never issued such a broad suspension order to a lab before. He said the Jun 30 order applies to every agent the lab works with. The list of affected agents is not public information because of security concerns, Roebuck said.
In the Jun 30 letter, the CDC outlined the concerns it has about the lab, which include the adequacy of biosafety plans, security of the facility from unauthorized visitors, occupational safety protocols, authorization from the CDC to work with certain agents, and compliance with federal select agent regulations.
Roebuck said CDC officials will visit the Texas laboratory again in the next few weeks to gather more information about its procedures and protocols. "Then the agency will move forward with any recommendations to get them under compliance," he said.
In a statement sent to Texas A&M faculty and staff yesterday, the school's interim president, Eddie J. Davis, said the laboratory incidents did not pose a threat to anyone on or off campus, but conceded that the university should have reported the worker's Brucella exposure in a more timely manner. (The university provided CIDRAP News with a copy of the statement.)
Davis said none of the workers who were exposed to the Q fever agent got sick and that Texas A&M was going beyond health monitoring standards at other select-agent labs by monitoring workers' blood for the organism. He said the university believed that the threshold for reporting worker exposure was a confirmed illness.
"We are unequivocally committed to taking all appropriate steps to ensure we are in full compliance with all CDC and any other relevant policies and regulations," he said.
The university has asked an independent expert and an environmental health and safety group from the University of Texas Health Science Center in Houston to advise Texas A&M on how it can "expeditiously redeploy a fully compliant select agent research program," Davis said.
The Sunshine Project, in a statement e-mailed to journalists today, said the problems it found at Texas A&M show that the US government needs to reduce the number of people and facilities that handle bioweapons agents and bring a hodgepodge of federal lab rules into a unified, mandatory, and enforceable system to ensure lab safety and accountability.
In its statement, the group released details about nine other accidents at Biosafety Level 3 labs throughout the United States, four of which involved worker exposure. The information was gleaned from the Sunshine Project's review of publicly accessible biosafety committee meeting minutes at the facilities. "There is no reason not to presume that many more similar accidents have occurred but have yet to come to light," the group said.
Coxiella burnetii causes a flulike disease in humans that is rarely fatal, according to the CDC. However, it is highly infectious when it becomes airborne and is inhaled by humans. The agent has previously been weaponized and is considered a potential terrorist threat.
Brucella infections cause prolonged fever and a wide range of other possible manifestations, such as arthritis, hepatitis, and meningitis. Symptoms can be prolonged, but the disease is rarely fatal. In livestock, brucellosis causes infertility and abortions. As bioterrorism agents, Brucella strains are inexpensive to produce and disperse, according to an August 2005 article in the CDC journal Emerging Infectious Diseases (EID).
Some Statistics About the US Biodefense Program and Public Health
NIAID Competitive Awards, Change Over 3 Years Three Year Sums, adjusted to constant 2005 USD using the NIH Biomedical Research and Development Price Index
Source: CRISPER (http://www.cbwtransparency.org/crisper), 4 March 05
The NIAID Newbies: How Expert are They? One Measure of Pathogen-Handling Experience
Pathogen Total Number of Principal Investigators 2001-2005 YTD Number of those PIs that received NIAID funding for agent before 2001 Percentage never before funded by NIAID for agent Anthrax 219 6 97.3% (213) Brucellosis 6 0 100% (6) Glanders 10 1 90% (9) Plague 107 6 94.4% (101) Melioidosis 16 0 100% (16) Tularemia 81 2 98% (79) TOTAL 439 15 96.6% (424)
--------------
Side-by-Side Comparison: NIAID's Biodefense Program vs. Infectious Disease Public Health Problems
NIAID Priority Total Reported US Cases (2003) Tularemia 129 Brucellosis 104 Plague 1 Anthrax 0
Melioidosis� None indicated, CDC estimates zero to five US cases per year.
Glanders� None indicated, CDC reports no US cases since the 1940s, except lab-acquired.
Source: CDC MMWR Weekly 53(30);687 (5 Aug 2004). Notice to Readers: Final 2003 Reports of Notifiable Diseases � A keyword search of MMWR revealed no US reports of these diseases in 2003.
Public Health Problem Total Reported US Cases (2003) Gonorrhea 335,104
AIDS 44,232
Syphilis 34,270
Lyme Disease 21,273
Acute Viral Hepatitis A/B/C 16,281
Tuberculosis 14,883
Whooping Cough 11,647
Drug-Resistant Streptococcus 2,356
Legionnaire's Disease 2,232
Rocky Mountain Spotted Fever 2,077
Disease Likelihood of a person in the United States being diagnosed, 2003:
Gonorrhea 1:859
AIDS 1:6,511
Syphilis (all) 1:8,403
Lyme Disease 1:13,537
Acute Viral Hepatitis A/B/C 1:17,688 Tuberculosis 1:19,349 ----- - Tularemia 1:2,232,357 Brucellosis 1:2,768,981 Plague 1:287,974,000 Anthrax, Glanders, Melioidosis 0 (no cases reported) ----- - Likelihood of diagnosis of infection with any of the 6 NIAID priority bioweapons agents (i.e. combined): 1:1,230,658 Likelihood for the 6 non-bioweapons infectious diseases listed above, combined: 1:617 Likelihood of diagnosis with one of the 6 public health diseases vs. NIAID priority bioweapons agents: 2000 times more likely. (1995.6x) ----- - Total number of reported US infections with anthrax, glanders, tularemia, brucellosis, melioidosis, and plague in 2003: 234
Texas A&M Bioweapons Accidents More the Norm than an Exception
* From anthrax in Albuquerque to tuberculosis in New York, the public is kept in the dark about many biolab incidents
* It is unclear if the government is aware of the extent, the danger continues to grow with mushrooming biodefense research
* Need for stronger federal biolab oversight, reduced and rationalized biolab system
* "Instead of a 'culture of responsibility', the federal government has instilled a culture of denial... so labs hide problems, and think that accident reporting is for masochists... "
Far more accidents have happened in biodefense and other high containment labs in recent years than the public knows about. It is not clear if the federal government is even aware of the extent of the problems. The rash of biolab accidents is a result of the massive expansion of the biodefense program, which has brought research on bioweapons agents to scores of new labs in recent years.
What is needed, according to the Sunshine Project, is to reduce the number of facilities and people handing bioweapons agents in the United States and to bring the fragmented and frequently unenforced hodgepodge of federal biolab rules and suggestions together into a unified, mandatory, and enforced system that ensures laboratory safety and public accountability.
The Sunshine Project has recently released information about unreported accidents with biological weapons agents that resulted in an order from the US Centers for Disease Control (CDC) for Texas A&M University to cease and desist all research with "select agents", as bioweapons agents are called in federal regulations.
Here, the Sunshine Project releases information on other accidents that it has confirmed involving select agents and/or biosafety level three (BSL-3) labs. None of these accidents, to the Project's knowlege, have been made public before:
- In mid-2003, a University of New Mexico (UNM) researcher was jabbed with an anthrax-laden needle. The following year, another UNM researcher experienced a needle stick with an unidentifed (redacted) pathogenic agent that had been genetically engineered;
- At the Medical University of Ohio, in late 2004 a researcher was infected with Valley Fever (C. immitis), a BSL-3 biological weapons agent.
The following summer (2005), a serious lab accident occurred that resulted in exposure of one or more workers to an aerosol of the same agent;
- In mid-2005, a lab worker at the University of Chicago punctured his or her skin with an infected instrument bearing a BSL-3 select agent. It was likely a needle contaminated with either anthrax or plague;
- In October and November of 2005, the University of California at Berkeley received dozens of samples of what it thought was a relatively harmless organism. In fact, the samples contained Rocky Mountain Spotted Fever, classified as a BSL-3 bioweapons agents because of its transmission by aerosol. As a result, the samples were handled without adequate safety precautions, until the mistake was discovered. Unlike nearby Oakland Children's Hospital, which previously experienced an anthrax mixup, UC Berkeley never told the community;
In addition to lab-acquired infections and exposures, other types of dangerous problems have occurred, such as unauthorized research, equipment malfunction, and disregard for safety protocols:
- In February 2005 at the University of Iowa, researchers performed genetic engineering experiments with the select agent tularemia without permission. They included mixing genes from tularemia species and introducing antibiotic resistance. The University reported the incident to the National Institutes of Health, but public disclosure was (to our knowlege) never made;
- In September 2004 at the University of Illinois at Chicago, lab workers at a BSL-3 facility propped open doors of the lab and its anteroom, a major violation of safety procedeures. A alarm that should have sounded did not;
- In March 2005 at the University of North Carolina at Chapel Hill, lab workers were exposed to tuberculosis when the BSL-3 lab's exhaust fan failed. Due to deficiences in the lab, a blower continued to operate, pushing disease-laden air out of a safety cabinet and into the room. An alarm, which would have warned of the problem, had been turned off. The lab had been inspected and approved by the US Army one month earlier;
- In December 2005 at the Albert Einstein College of Medicine at Yeshiva University in New York City, three lab workers were exposed (converted) to tuberculosis following experiments in a BSL-3 lab. The experiments involved a Madison Aerosol Chamber, the same device used in the February 2006 experiments that resulted in the Texas A&M brucella case;
- In mid-2004, a steam valve from the biological waste treatment tanks failed at Building 41A on the NIH Campus in Bethesda, Maryland. The building houses BSL-3 and BSL-4 labs. Major damage was caused, and the building was closed for repairs;
It is very important to note that these and other examples of lab accidents are drawn from biosafety committee meeting minutes of institutions that actually record such incidents in records that are (at least nominally) available to the public. Often, this is not the case, such as that of Texas A&M, which only released accident information under extreme pressure. Thus, the sample of institutions named above is skewed toward those that have been more open about their accidents than others.
There is no reason not to presume that many more similar accidents have occurred but have yet to come to light.
"One can see in Texas A&M's statements and actions an ingrained resistance to transparency about accidents," says Sunshine Project Director Edward Hammond, "this is the result of an irrational and ineffective federal system in which incentives are tilted against reporting and transparency."
Add Hammond, "Instead of a 'culture of responsibility', the federal government has instilled a culture of denial. Reporting requirements, to the extent that they exist, are not well-enforced unless NGOs or the press make a stir, so labs hide problems, and think that accident reporting is for masochists, an attitude clearly reflected by A&M's President, who says that he now regrets reporting the the Q Fever infections."
[ 15. July 2007, 06:04 PM: Message edited by: Neil M Martin ]
-------------------- Neil Posts: 697 | From Tucson, AZ USA | Registered: Apr 2002
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