Biolabs in your backyard

Sloppy biosafety practices and contaminated worker clothing led to a dangerous bioterror bacteria release last year at the Tulane National Primate Research Center and sparked a nationwide USA Today investigation into biomedical labs, public safety and risks.

The incident in 2014 resulted in at least eight monkeys, and possibly a person, becoming exposed to the bacteria that somehow got outside the lab at the Tulane National Primate Research Center about 35 miles north of New Orleans.

Interactive: Biolabs in your backyard

USA Today's investigation found more than 200 "high containment" laboratories across the United States, working with dangerous bacteria, viruses and toxins that require special biosafety level 3 and level 4 precautions to prevent their release. The USA Today investigation also included examination of safety records, including lapses that have put scientists, lab workers and the public at risk with little public scrutiny.

Facilities that include BSL-3 or BSL-4 labs identified by USA Today's research are LSU Health Sciences Center in Shreveport, LSU Health Sciences Center in New Orleans, Louisiana State University AgCenter in Baton Rouge and the Tulane National Primate Research Center in Covington.

The Government Accountability Office, which is the investigative arm of Congress, has warned for years that no single federal entity is responsible for oversight of high-containment labs, and there are no national standards for their design or operation. It isn't even known how many high-containment labs are in operation nationwide because those working with dangerous pathogens that aren't on the federal "select agent" list — such as tuberculosis and some potentially deadly bird flu strains — aren't required to register with the CDC-USDA program.

The Tulane National Primate Research Center became the focus of federal and state investigations in December 2014 after tests showed two rhesus macaque monkeys — which were not part of any experiments — were sickened by a strain of bioterror bacteria being studied in a BSL-3 lab elsewhere on the 500-acre campus. Later tests showed additional monkeys had been exposed.

Focus of the BSL-3 work at the primate research center is developing vaccines, diagnostics and therapeutics for a variety of infectious agents, including tuberculosis, Burkholderia, ricin toxin and chikungunya virus.

USA Today's investigation, and review of hundreds of pages of records obtained through Freedom of Information requests, found the lab incident was particularly concerning because some monkeys exposed to the bacteria were kept in a huge, outdoor breeding colony on the facility's south campus.

As a result of the release of the bacteria, federal regulators ordered Tulane's primate center to halt all research involving select agents until the cause of the accident was identified and corrections were made.

Sloppy biosafety practices and contaminated worker clothing are the likely ways the bacteria got out of Tulane's lab, according to findings by federal investigators released in March 2015.

Tests are underway to determine if the deadly bioterror bacterium hasn't colonized the soil and water around the primate center. Tulane will test for the next five years on its outdoor monkey colony as well as wildlife and feral cats around the 500-acre facility to ensure the bacteria haven't contaminated the environment. The CDC and Tulane say they think the bacteria spread only inside the center's buildings, and so far tests outdoors have not detected the bacterium,

Matthew Woolard, assistant professor for the department of microbiology and immunology at LSU Health Sciences Center in Shreveport said the university's Shreveport campus is home to an ABSL-3 suite with two laboratories and two animal care rooms.

Researchers are working on a vaccine for tularemia, a bacterial disease that can be spread through animals and is deadly to humans without treatment. Infected patients can show symptoms from skin lesions to coughing and chest pain, similar to pneumonia, according to the Centers for Disease Control and Prevention.

The bacteria is classified as a tier 1 select agent because of its ability to be used in bioterrorism.

Researchers are working to identify ways to effectively treat people infected by a pathogen used in a bioterrorist attack.

"If we understand the biology — how the stuff works, how it makes us sick, why it makes us sick, we can hopefully develop a vaccine or ways to treat infection," Woolard said.

USA Today's research found no incidents at the Shreveport biolab, which Woolard credits to its smaller scale, level of safety measures and surveillance by the research team.

With any research, there are risks, Woolard said.

"We do everything we can to mitigate those risks, and it is actually safer than a lot of other lab work because of the level of restrictions of people who come into the area, and those allowed to get to the pathogen," Woolard said.

Equipment and apparel used by researchers provide an extra level of protection not only for the researchers involved, but layers of protection against any possible spill.

"We are so contained it is nearly impossible to have it get to a point where it would affect the community. The agents we work on, by and large, are found in the environment, and the manner in which we work and the level of surveillance, the likelihood of any lab outbreak causing severe damage is less than the natural occurrence of these pathogens in the environment," Woolard said.

Mike Durham, director of Environmental Health and Safety at LSU told USA Today the LSU AgCenter has two BSL-3 laboratories, but he declined to say what kinds of pathogens are studied in the labs.

The USA Today investigation found the LSU AgCenter is the unnamed university that lab regulators from the Federal Select Agent Program claimed in a June 2009 report to Congress had been fined $425,000 – which if true would be among the largest fines imposed in the program's history.

Records obtained with state and federal open records requests show the fine was never imposed, even though federal investigators documented serious violations at LSU. Violations included the release of a dangerous bacterium from an LSU research facility that resulted in the infection of a cow in an adjacent disease-free herd. After the experiments, 27 cows infected with the bacteria were sent to an unapproved slaughter facility and their meat was sold commercially for human consumption.

According to a Centers for Disease Control and Prevention fact sheet on the bacterium, people are most at risk of exposure from consuming raw or unpasteurized dairy products, but the agency advises against eating undercooked meat.

The bacterium involved in the violations was Brucella abortus, which causes a contagious disease called brucellosis that can be economically devastating to the cattle industry. The disease, which is primarily a threat to cattle, bison, elk and deer, can cause pregnant animals to abort fetuses and result in reduced milk production, weight loss, infertility and lameness, according to the U.S. Department of Agriculture. Brucella can also sicken people, causing fever, fatigue, muscle and joint pain and other symptoms that may last "for prolonged periods of time," according to the CDC.

The discovery of the Brucella-infected cow at LSU's Baton Rouge facility caused significant concern among state officials, who mobilized to stop a potential outbreak. They began tracing animals sold out of the LSU herd during the previous year, identifying all cattle herds within a mile of the LSU facility and creating plans to increase testing, records show.

Despite investigations by LSU, the USDA, as well as state agriculture and wildlife officials, it was never determined how the cow became exposed to the research strain of the bacterium.

While investigating the infected Brahman in the breeding herd, the USDA discovered that cattle exposed to and infected with Brucella abortus in the research program had repeatedly been sent to a slaughter plant in Plaquemine that was not registered with the Federal Select Agent Program to accept experimental animals exposed to the highly regulated pathogen. "The resulting meat product from the slaughter of these animals was sold for human consumption," the USDA's investigation report says.

In July 2008, the USDA notified LSU that the federal investigation had found the university violated select-agent regulations by transferring cattle infected with Brucella abortus to the slaughter plant and by failing to have biosafety procedures that could contain the bacteria, "causing infection of" the Brahman cow. The letter, signed by the chief of enforcement operations, told LSU it could settle the matter by paying a $425,000 penalty.

The fine came as a surprise to the university, said Phil Elzer, the scientist running the Brucella research when the incident happened and who now is an associate vice chancellor at the LSU AgCenter. "We went back to them and basically said: We had no release, no one proved a release, no one proved it was our strain. We challenged them," Elzer said in an interview with USA Today. Elzer said LSU had for years routinely sent to slaughter the program's research cattle, which were tagged as being "suspect" or having brucellosis. This practice was declared in the research program's operating procedures that were reviewed and signed off on at each inspection by Federal Select Agent Program regulators, he said. "To all of a sudden say we were doing it wrong was very surprising," Elzer said.

In initial written statements to USA Today and in interviews, Elzer indicated that federal and state investigators never concluded the university's experiments were at fault. "The incident was not found to be caused by a violation of federal regulations; no fines were imposed upon LSU, and the regulatory agencies had uncertainty as to whether the strain of bacteria in the affected cow was the same strain that was being used in the LSU research," he said in a November 2014 email to USA Today.

Yet, in early December 2014, when USA Today received copies of the USDA and Louisiana agriculture departments' investigative reports in response to public records requests, the documents showed no uncertainty. An LSU spokeswoman sent an email clarifying that the "uncertainty" expressed by Elzer involved a USDA test result showing the bacteria in the infected animal didn't produce a substance called H2S, "while the lab organism being used in Dr. Elzer's research did produce H2S." This distinction is not flagged or discussed in the released federal or state records as raising any concerns about a bacteria mismatch.

USDA officials declined requests for interviews about the LSU incident, why Congress was told the fine had been imposed when it wasn't and why none of the later reports to Congress sought to correct the enforcement record. In a written statement, Freeda Isaac, the USDA's director of Agriculture Select Agent Services, said the 2008 report "should have stated that we were proposing a fine, instead of stating we issued a fine. In the end, there was no fine."

USA Today reporters contributed to this report.