U.S. laboratory inspectors charged with protecting the public from the release of deadly pathogens were repeatedly criticized by a federal watchdog for overlooking biosafety lapses long before this year's anthrax scare at the Centers for Disease Control and Prevention (CDC).
Newly released federal documents show that oversight gaps at the CDC Division of Select Agents and Toxins (DSAT) may have contributed to biosafety lapses at six laboratories handling pathogens including smallpox, influenza and monkeypox. As a result, the inspectors may have put public safety at risk.
"We found that DSAT did not effectively monitor and enforce certain federal select agent regulations at the laboratories," Daniel Levinson, inspector general for the U.S. Department of Health and Human Services (HHS) said in a July 2011 report sent with a letter to CDC Director Dr. Thomas Frieden.
"These weaknesses may have contributed to the laboratories not being in full compliance with certain federal select agent regulations, which may have put public health and safety at increased risk."
The documents of the HHS inspections of the CDC labs were released on Friday by the House Energy and Commerce Committee and provide insights into a repeating pattern of biosafety problems that date back to 2008 and span both the Obama and Bush administrations.
The inspector general found that in many cases, deadly pathogens wound up in the hands of people who had not been approved to handle them, increasing the risk that they could have been lost or stolen.
CDC officials were not immediately available to comment on the report.
The findings come after the potential exposure of more than 80 CDC workers to live anthrax bacteria in Atlanta and the unauthorized release of a deadly bird flu strain in March.
Outside experts who reviewed the documents provided by Reuters said they were alarmed by the inspector general’s findings on CDC’s DSAT inspectors.
The CDC inspectors “failed to identify even one of the sixteen identifiable deficiencies, and failed because the checklists were defective, because the inspectors were untrained, and because the inspectors were expected to learn while on the job,” said Richard Ebright, a professor of chemistry and chemical biology at Rutgers University. Ebright testified at a hearing last month by a House Energy and Commerce subcommittee on the CDC safety lapses.
DSAT inspectors no longer oversee CDC labs. That job was transferred to a special inspection team at the U.S. Department of Agriculture in 2012.
The CDC's Frieden has described the move as an effort to avoid potential conflicts of interest. The documents show the change occurred after the HHS inspector general became increasingly critical of DSAT's ability to effectively inspect federal labs.
The release of the documents came as U.S. lawmakers consider possible congressional action that could place a single agency in charge of new national laboratory standards and even potentially take inspection duties away from the CDC and USDA, according to congressional aides.
In a letter contained with the 2011 inspector general's report, Frieden concurred with Levinson's criticism of DSAT and assured the inspector general that the unit was undertaking new training and an audit of its procedures to address the problems.