The report by the Government Accountability Office to Congress
followed a series of mishaps in which dangerous pathogens were
inadvertently released. The report, seen by Reuters, concluded that
the Federal Select Agent Program needs an overhaul.
The GAO audited laboratory safety oversight following errors that
could have exposed dozens of people to live anthrax bacteria and the
deadly toxin ricin. Its report will guide questioning of officials
before the House Energy and Commerce Committee’s oversight
subcommittee on Thursday.
The Federal Select Agent Program is jointly run by the U.S. Centers
for Disease Control and Prevention (CDC) and the Animal and Plant
Health Inspection Service (APHIS) of the U.S. Department of
According to the report, a chief concern is that the program is too
focused on physical security measures, such as preventing theft from
labs, and needs to focus more on biosafety issues that could protect
researchers and the wider public from errors.
The GAO report also noted that many of the labs using high-risk
pathogens for research belong to either CDC or the USDA, and
recommended that Congress consider setting up a fully independent
oversight body to remove potential conflicts of interest.
"The Select Agent Program does not fully meet our key elements of
effective oversight," the report stated.
Safety lapses in CDC labs captured headlines in 2014 when scientists
at a high-level biosecurity lab did not properly inactivate anthrax
bacteria before sending the material to labs with fewer safeguards.
More than 80 scientists were exposed to potentially live anthrax,
though no one fell ill.
In the months that followed, the Food and Drug Administration
disclosed the discovery of decades-old vials of smallpox in a
storage closet, while a U.S. Army lab erroneously shipped live
anthrax to nearly 200 labs worldwide.
To address concerns of conflict of interest, CDC and APHIS have made
structural changes to increase the program's independence, but
according to the GAO report, the program has not undergone a
comprehensive risk management review, even as problems with lab
safety continue to come to light.
As recently as last November, the Department of Homeland Security
found a private lab inadvertently shipped ricin - a lethal poison -
to one of its training centers on multiple occasions in 2011.
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"Considering the type of research we're talking about, we should
have a much more robust, systematic oversight approach. That seems
to be lacking," said an aide to the House committee who declined to
To avoid conflicts of interest, inspections of APHIS laboratories
are supposed to be carried out by the CDC, and inspections of CDC
labs are to be carried out by APHIS. But the report revealed that at
least three times in 2015, APHIS inspected its own laboratories,
partly because there is no process in place to ensure compliance.
The report also cited excessive workloads for inspectors, which
delay inspection reports and make it harder to retain personnel. In
some cases, inspectors have been assigned to tasks outside of their
expertise. For example, the GAO found that an APHIS physical
security expert was asked to inspect ventilation systems - a
critical protection against the accidental release of dangerous
Short of a move by Congress to create an independent oversight
agency, GAO recommended that CDC and APHIS officials conduct a risk
assessment of the Select Agent Program and how it handles conflicts
of interest. It also recommended that program officials shift
inspection priorities to focus on high-risk activities in labs and
develop a joint plan to train and hire inspectors.
The Health and Human Services Department, which oversees CDC, and
the USDA, which runs APHIS, agreed with many of these
recommendations, according to the report. Officials from the CDC and
APHIS will testify at the Thursday hearing.
(Reporting by Julie Steenhuysen; Editing by Michele Gershberg)
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