Secret sanctions revealed against university hosting $1.25 billion biolab

Alison Young | USA TODAY

Kansas State University — where a controversial $1.25 billion biosecurity lab facility is under construction — secretly faced federal sanctions last year after repeatedly violating safety regulations during its research with bioterror pathogens, records obtained by USA TODAY show.

Kansas State’s “history of non-compliance” during four consecutive inspections over two years shows a “systemic problem” and has “raised serious concerns” about the university’s ability to put safeguards in place to ensure safety and containment of dangerous pathogens, according to a March 2014 letter to the university from federal lab regulators.

University officials said Tuesday they were surprised by the letter’s harsh tone and language because nearly all of the violations involved administrative paperwork issues that posed no safety or security threat. Yet in the letter, regulators threatened to suspend or revoke the university’s permits to do research with bioterror pathogens if it didn’t agree to enter a federal performance improvement program.

The regulatory action against Kansas State is of particular importance because the university’s campus in Manhattan is the site of the federal government’s new National Bio and Agro-Defense Facility (NBAF), which held a groundbreaking ceremony in May. Construction of the 570,000-square-foot facility has faced years of delays and controversy because of concerns about whether research on some of the world’s most dangerous agricultural diseases can be done safely in farm country and near herds of livestock.

Although the NBAF will be an independently run Department of Homeland Security facility when it opens around 2022, the university has publicized on its website that Kansas State’s labs already are being used to “jump-start” research that “will eventually transition” to the new federal facility. Transition research underway includes studies of Rift Valley fever, a mosquito-borne disease that can cause abortions in livestock and fatal infections in people; Japanese encephalitis, another mosquito-borne disease that can cause reproductive problems in pigs and serious and sometimes fatal brain infections in people; and Classical swine fever, a potentially deadly pig disease.

“If I read that letter, I would think it sounds horrible, too,” said Julie Johnson, biosecurity officer of the university’s Biosecurity Research Institute, about the March 2014 enforcement letter. She said the university has a strong record of safety and the letter is primarily a reflection of the rigorous oversight provided by federal officials.

Lab regulators at the Federal Select Agent Program did not grant interviews or answer specific questions posed since Friday afternoon about Kansas State’s regulatory history. The university has completed its performance improvement plan, and inspectors "will continue to ensure they are able to demonstrate longterm compliance before lengthening their registration period,” said a general statement issued Tuesday evening by regulators from the U.S. Department of Agriculture, which jointly runs the program with the Centers for Disease Control and Prevention.

Johnson said the violations have been corrected and the university was released from the federal performance improvement program in April.

Select agent is the government's term for a list of 65 viruses, bacteria and toxins that could be used as bioweapons or that pose severe threats to health or agriculture.

Officials at the Department of Homeland Security said Tuesday that any regulatory issues at Kansas State’s labs have no impact on the work that will be done at the new federal facility. “It doesn’t reflect on the NBAF. It’s a totally separate entity,” said James Johnson, executive director of the NBAF program. The federal lab, once built, will have its own accreditation process and federal permits for doing research.

Leaders of some cattle industry groups said the violation letter fuels their concerns about building the massive federal lab in America’s farm country where a release of an animal pathogen could spread to nearby livestock herds.

“The fact that they are not currently capable of meeting necessary safety standards reinforces our concern that there will likely be an inadvertent release of one of these dangerous pathogens from that site,” said Bill Bullard, CEO of R-CALF USA, a trade association for cattle producers. “This entire proposal is irresponsible and reckless, particularly given that we have a safe location where this research has been conducted since the 1950s.”

The NBAF is being built to replace the federal government’s aging Plum Island Animal Disease Center, which is located off the coast of New York’s Long Island and is the only lab in the country allowed to work with live foot-and-mouth disease virus — which is highly contagious and considered one of the most economically devastating livestock diseases in the world.

When NBAF opens in about seven years, foot-and-mouth disease research will move from the island location to the Kansas facility. Foot-and-mouth research will occur only in the federal facility, not in the university’s labs, according to information on Kansas State’s website.

After a series of high-profile accidents at federal labs, an ongoing USA TODAY Media Network investigation has uncovered hundreds of incidents at public and private research facilities across the country and revealed how the secrecy that surrounds the oversight of biological and select agent research shields failures by labs and regulators from public scrutiny.

Federal regulators have refused USA TODAY’s repeated requests for the names of more than 100 research facilities that have faced enforcement actions since 2003. They have cited secrecy provisions in a bioterrorism law as justification for redacting lab names from enforcement letters they released to the newspaper under the federal Freedom of Information Act. USA TODAY, through its reporting, has obtained names of sanctioned labs such as Kansas State University.

In the March 2014 letter to Kansas State, federal lab regulators wrote that “it is our determination that the failure of the KSU select agent program to comply with the select agent and toxin regulations continues to be a systemic problem unrelated to any one particular Principal Investigator, location, or project.”

A chart in the letter illustrates how the university failed to comply with nine of 10 types of safety and security requirements on each of its four previous inspections since January 2012, including biosafety and containment practices, incident response and security plan requirements and training of staff.

“Why can you fail nine of 10 inspection points and still be operating?” asked Tyler Dupy, executive director of the Kansas Cattlemen’s Association. “There’s a need for the research, but can we trust that the safeguards are in place to keep this stuff in place? One little mistake and it’s all over.”

The letter said issues at the university’s labs included:

Failing repeatedly to develop written biosafety plans commensurate with the risk of its registered select agent pathogens.

Repeatedly failing to have safeguards sufficient to ensure biosafety and biocontainment of select agent pathogens.

Continuously failing to provide appropriate training and ensure personnel understood the training provided and failing to document the training claimed to have been performed.

Repeatedly failing to implement the requirements of the university’s security plan to ensure select agents are protected against unauthorized access, theft, loss or release.

The records show that KSU was cited for the same types of failings in January 2012, August 2012, February 2013 and December 2013.

The issues behind the violations, to hear Kansas State officials describe them, involve administrative minutia.

For example, Johnson said inspectors took issue with the university’s incident response plan saying only that a top official would be notified of an incident but not specifying how it would be done. The violation was corrected by adding words to specify that the official would be notified by phone, fax or e-mail, she said.

Violations related to failing to ensure staff understood training involved another kind of documentation issue, she said. The university kept copies of quizzes given to staff after training sessions and attached them to a dated sign-in sheet. The inspectors didn’t consider the documentation adequate because each quiz wasn’t individually dated, she said.

The university says these kinds of bureaucratic issues are typical of nearly all the violations that precipitated the March 2014 enforcement letter. The only issue that wasn’t administrative, the university says, involves a 2012 citation for select agent research done in an unregistered area. Johnson said research on a rice plant pathogen was conducted in a space where it had been worked with long before the pathogen was added by federal officials to their list of select agents. The university said it immediately ceased the work and has since required all select agent work occur only in their Biosecurity Research Institute.

USA TODAY asked Kansas State for copies of its select agent inspection reports. University officials said they would consider the request but noted that the reports and the university’s response letters are voluminous and would need to be redacted for security issues, which might take some time.

The March 2014 enforcement letter gives no indication that the violations involve minutia.

“Since 2011, KSU has expanded its select agent research program with the addition of new registered areas, select agents and work objectives, but KSU repeatedly failed to develop and implement plans to address this expanded scope of work,” said the letter, which is jointly signed by officials from the USDA and CDC.

Though regulators noted the university’s researchers were cooperative and eager to comply, they “had not been provided adequate guidance from KSU leadership to enable them to do so.”

The CDC, in a statement, referred questions about Kansas State to the USDA, which it said is the lead agency that inspects the university’s labs. The USDA did not grant interviews or provide any response to USA TODAY’s questions submitted last Friday about its oversight of the university’s labs and why it took failures on four consecutive inspections before enforcement action was taken. The USDA also didn’t respond to Kansas State’s characterization of the violations as primarily involving administrative issues.

Kansas State University was part of a coalition of Kansas state leaders that campaigned for the NBAF to be located on their campus. U.S. Sen. Pat Roberts, R-Kan., a key ally of the project, said the federal lab will create as many as 500 high-paying federal jobs and bring additional research jobs to the state. Over a 20-year-period, he said, the facility is estimated to have a $3.5 billion impact on the Kansas economy.

As part of the Kansas bid for the federal lab, Kansas State University offered the use of its biosafety level 3 labs at its Biosecurity Research Institute until the adjacent NBAF was completed. Roberts helped secure state funding for the university’s lab in 2002, according to his news releases. The university named the lab’s building “Pat Roberts Hall.”

Roberts did not respond to interview requests about the university’s inspection history.

The NBAF has been dogged by years of controversy and questions about whether the Department of Homeland Security downplayed the risks of putting the massive research facility in the center of the country’s agricultural heartland.

The potential risks posed by the NBAF — which will for the first time in decades bring foot-and-mouth disease virus research to the U.S. mainland — have been the subject of much study and controversy.

In 2012, the Department of Homeland Security estimated the risk of a foot-and-mouth disease release is tiny — less than 0.11% over 50 years. Independent scientific experts convened by the National Research Council concluded in 2010 that the risk was as high as 70% over 50 years, and in 2012, they said the DHS was not adequately assessing the risks based on “overly optimistic” assessments of the potential for human error.

In its 2010 report, the National Research Council expert panel said the economic impact of a lab release of foot-and-mouth virus from the NBAF could be as much as $50 billion. Because of the risks posed by human error, the experts said staff at the new facility will need “adequate ongoing training, education, and evaluation of skills. Furthermore, there will need to be zero tolerance of deviations from biosafety standards and practices recommended by the CDC and USDA.”

Documents obtained by USA TODAY show the CDC and USDA have in the transition period allowed Kansas State’s select agent researchers to have what the letter says are serious violations on inspection after inspection, including with training and biosafety — threatening to put the university on a performance improvement plan only after problems on four consecutive inspections.

Last month, the CDC launched a comprehensive review of how it regulates safety and security at select agent labs in the wake of USA TODAY’s investigation, which revealed the agency’s inspectors allowed labs to keep experimenting with bioterror pathogens despite failing marks on inspections for years. USDA officials have not responded to USA TODAY’s questions since July 20 about whether that agency is conducting a similar self-review of its oversight performance.

Bipartisan members of Congress have expressed concerns about whether the oversight of labs is adequate. In the wake of questions asked by USA TODAY, committees in the House and Senate have told the Federal Select Agent Program they want the names of labs that have faced enforcement actions.

The CDC has provided the information requested by the Senate Committee on Homeland Security and Governmental Affairs, said Melinda Schnell, a spokesperson for committee chairman Ron Johnson, R-Wis. The committee is not publicly releasing the information at this time, she said.

“We will continue to do oversight of the program and are very concerned about the repeated failures on the part of Kansas State to safely manage its Select Agent research program,” Schnell said in an email.

Officials with the House Energy and Commerce Committee, which also has requested information about labs that have faced enforcement action, were not available for comment Tuesday.

Read full coverage of USA TODAY's ongoing investigation of lab safety and security issues: biolabs.usatoday.com

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