Reports warn of lax inspections, bioterror lab risks

Alison Young, USA TODAY | USATODAY

The United States is at increased risk for accidents at laboratories conducting research on potential bioterror germs, such as anthrax, because federal officials have failed to develop national standards for lab design, construction and operation, according to a report to be released Monday by the Government Accountability Office. The GAO called for the standards more than three years ago.

Meanwhile, another recent government audit has found significant failures by federal officials to detect security and safety violations during inspections of bioterror labs. The undetected issues included the transfer of anthrax and plague to an unauthorized facility, and allowing workers at multiple research facilities to remain on the job with expired security risk assessments.

"As a result, there is increased risk of the misuse of select agents and the potential for serious security violations going undetected," says the November2012 report by inspector general auditors at the U.S. Department of Agriculture.

Security at bioterror labs has been an issue of particular concern since the 2001 anthrax letter attacks that killed five and sickened 17; a scientist at an Army biodefense lab was later implicated.

USDA inspection program officials disputed many of the auditors' findings, called the report's language "unduly alarming," and refused to adopt many of the auditors' recommendations, the report says.

Officials in USDA's Animal and Plant Health Inspection Service declined to be interviewed. In a statement issued Friday, spokeswoman Lyndsay Cole said that in January the inspection program agreed to take actions to address all of the auditors' concerns. Cole said "our inspections are effective at identifying deficiencies."

The USDA and the Centers for Disease Control and Prevention (CDC) share responsibility for inspecting numerous individual labs at about 350 government, academic and commercial organizations registered to work with dangerous germs and toxins that have bioterror potential.

The USDA was put in charge of inspecting labs operated by the CDC last summer, in the wake of USA TODAY's reports about safety and security problems at CDC labs in Atlanta.

U.S. Rep. Fred Upton, chairman of the House Committee on Energy and Commerce, called the USDA inspector general's findings "very troubling" and said they show the need for oversight. He said the committee will be investigating.

"The inadequate and lax inspection practices of USDA raise additional concerns about their ability and independence to conduct effective inspections of CDC's labs to ensure safety," said Upton, R-Mich.

U.S. Rep. Henry Waxman of California, the committee's ranking Democrat, said: "It is troubling that safety and security risks that were identified years ago have still not been fixed, and that the USDA IG has identified additional new vulnerabilities."

Safety experts also expressed concerns.

Najmedin Meshkati, an engineering professor at the University of Southern California, said the USDA lab inspection program "may be suffering from a serious safety-culture problem," based on his quick review of the audit report.

Richard Ebright, a biosafety expert at Rutgers university in New Jersey, said the repeated failures by USDA inspectors to detect problems is "significant" and it "erodes confidence" that regulations are being effectively monitored and enforced. Ebright noted that the USDA "rebuffed" auditors' recommendations. "This is one of the most striking parts of the report," he said.

CDC officials declined to be interviewed or to discuss audits of their inspection program. In a statement, the CDC said: "The record stands for itself," noting that the agency has performed more than 1,500 inspections over the past 10 years. "The public should be confident that the critical research and development work to treat and prevent disease associated with select agents in the U.S. is done in a safe and secure manner."

The USDA generally oversees about 50 organizations with labs that work with pathogens that primarily pose a risk to livestock and crops, and the CDC has primary responsibility for inspecting those at about 300 entities that work with germs that are dangerous to people.

It's unclear what government auditors have found recently in similar audits of the effectiveness of CDC's inspection program. The CDC is audited by the U.S. Department of Health and Human Services inspector general, which is still processing USA TODAY's Freedom of Information Act request for the reports.

Incidents involving bioterror agents are rare, according to a CDC report last year in the journal Applied Biosafety. Between 2004 and 2010, there were no reports of thefts and only one confirmed loss, which occurred during the shipment of a fungus that can cause a type of pneumonia called Valley Fever. An FBI investigation of the lost fungus package concluded it was "apparently destroyed during processing at a commercial shipping facility," the CDC researchers' article said.

The CDC report said there were 11 laboratory-acquired infections among 639 potential release incidents reported to the agency during those years among more than 10,000 people with approved access at organizations working with "select agents," the government's term for germs and toxins that have the potential to be used as bioweapons. None of the infections was fatal or involved the disease spreading to others.

USA TODAY reported last month that the HHS inspector general has repeatedly cited the CDC for safety and security problems in the operation of its own labs in Atlanta and Fort Collins, Colo., including failing to secure potential bioterror agents and not properly training employees who work with them. At the time of those reports, issued in 2008 through 2010, the CDC was responsible for inspecting its own labs.

CDC officials have said nobody has been endangered by the lapses because their labs have redundant layers of safety and security to protect employees and the public. When issues arise, they are fixed immediately, the agency says.

Other incidents have also caused concern, including power outages at CDC labs in Atlanta in 2007 and 2008. In 2007, a leaky drainage system was suspected in the release of foot-and-mouth disease virus — a highly infectious livestock disease that can have significant economic consequences — from a vaccine research facility in the United Kingdom and an outbreak on nearby farms, according to the GAO, the investigative arm of Congress.

In 2009, the GAO examined the potential risks posed by the proliferation of "high-containment labs" experimenting with dangerous germs, including bioterror agents, in the wake of the 2001 terrorist attacks and increased biodefense funding. The labs' research focuses on such things as developing treatments, vaccines, diagnostic tests and other countermeasures. The GAO concluded that a national oversight strategy was needed, including a periodic assessment of the nation's need for the labs. The report also said national construction, operation and maintenance standards were needed.

But federal security and science officials in the Executive Office of the President have not acted on the recommendations, the GAO said in its new report scheduled to be released Monday. "There is still no one agency or group that knows the nation's need for all U.S. high-containment laboratories," the report said, noting that budget constraints make the need for a national strategy and prioritization "more critical today than 3years ago."

The GAO said it remains concerned that there continue to be no national standards for lab design, construction and operation. "This will make it difficult to be able to assess and guarantee safety," the report said.

According to the report, officials in the president's Office of Science and Technology Policy disagreed with the GAO's conclusion that there is an increased risk associated with the increased number of labs and said several actions have been taken since 2009 to strengthen lab security, including the creation of new regulations and committees focused on managing risks. White House officials did not respond to USA TODAY's requests for interviews or comment.

Upton said the lack of action is "not acceptable" and that the "GAO recommendations merit action and engagement by the administration."