BiolabsConcerns grow over repeated safety failures at U.S. BioLabs

According to a report that was released by the Government Accountability Office (GAO) late last month, the United States is at a high risk for accidents at laboratories which conduct research on potential bioterror germs such as anthrax because federal officials have failed to develop national standards for lab design, construction, and operation.

USA Todayreports that  the GAO called for new standards more than three years ago.

A second government audit found that federal officials have failed to detect security and safety violations during inspections of bioterror labs. The issues in the audit include multiple facilities which allowed workers to remain on the job with expired security risk assessments, and the transfer of anthrax and plague pathogens to an unauthorized facility.

“As a result, there is increased risk of the misuse of select agents and the potential for serious security violations going undetected,” the November 2012 report, conducted by inspector general auditors at the U.S. Department of Agriculture (USDA) states.

USDA inspection officials rejected the auditor’s findings, calling the report’s language “unduly alarming,” and refusing to adopt many of the auditor’s recommendations.

Officials who work in the USDA’s Animal and Plant Health Inspection Service refused an interview with the USA Today, but spokeswoman Lyndsay Cole released a statement in January saying that the inspection program agreed to take actions to address all of the auditor’s concerns.

“Our inspections are effective at identifying deficiencies.”

Representative Fred Upton (R-Michigan) the chairman of the House Committee on Energy and Commerce, said the USDA inspector general’s findings were “very troubling” and said they show the need for oversight and that 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 Center for Disease Control’s (CDC) labs to ensure safety,” Upton told USA Today.

Representative Henry Waxman (D-California) who is also on the committee is just as upset. 

“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.”

Richard Ebright, a biosafety expert at Rutgers University, said the repeated failures by USDA inspectors to detect problems are “significant” and “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,” Ebright told USA Today.

CDC officials refused to comment but did release a statement.

“The record stands for itself,” noting that the agency has performed more than 1,500 inspections over the past ten 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.”

According to a CDC report last year, which was published in the journal Applied Biosafety, between 2004 and 2010 there was not one single report of theft and only one confirmed loss, which took place during the shipment of a fungus that can cause a type of pneumonia called Valley Fever and an FBI investigation of the lost package concluded the package was “apparently destroyed during processing at a commercial shipping facility,” the CDC researchers’ article stated.

Incidents between those years did cause concern however. In 2007 a substandard drainage system was suspected in the release of foot-and-mouth disease virus from a research facility in the United Kingdom according to the GAO.

The disease is a highly infectious livestock disease that can have significant economic consequences.

Agency officials also said that no one has been endangered by the lapses due to the labs having many layers of safety and security to protect employees and the public and when issues do arise, they are solved immediately.

The GAO however said it is still concerned about the fact that there are still no national standards.

“This will make it difficult to be able to assess and guarantee safety,” the report stated.

Officials in the president’s Office of Science and Technology have disputed the GAO’s conclusion and said that actions have been takes since 2009 to strengthen lab security, including new regulations and committees which are focused on managing risks.

Upton was not convinced, however, saying the lack of action is “not acceptable” and that the “GAO recommendations merit action and engagement by the administration.”