GAO, Inspector General testify on biosecurity of select agents

Marcia Crosse, director of healthcare for the Government Accountability Office | Government Accountability Office

The House Committee on Energy and Commerce’s Oversight and Investigation Subcommittee heard testimony on Tuesday on continuing concerns over shipments of live anthrax and other dangerous substances.

In May, the Army’s Dugway Proving Ground in Utah shipped a sample of live anthrax to commercial laboratories, including one in Maryland. This, the Department of Defense concluded, was part of a larger trend; 86 facilities in 20 states and seven other countries received live anthrax over the past 10 years, leaving 21 people on post-exposure prophylaxis.

Transfer of these hazardous pathogens, called ‘select agents’, is overseen by the Federal Select Agent Program at the Centers for Disease Control (FSAP). Tuesday's hearing aimed to address the weaknesses in FSAP that allowed the Dugway incident and others like it to take place.

“DOD and CDC had existing policies and procedures that addressed biosafety and biosecurity within their high-containment labs at the time the safety lapses occurred in 2014 and 2015,” said Marcia Crosse, director of healthcare for the U.S. Government Accountability Office, in written testimony. However, she added, those lapses exposed weaknesses in those procedures.

Crosse said that while the CDC and DOD continue to develop new policies and procedures to tighten safety on high-contaminant labs, more oversight from the government is needed.

“The safety lapses of 2014 and 2015 continue to raise questions about the adequacy of federal biosafety and biosecurity policies and procedures and department and agency monitoring and evaluation activities, including appropriate levels of senior management involvement,” concluded Crosse.

When a violation of the FSAP practices leads to a lapse in safety, the Department of Health and Human Services Office of the Inspector General (OIG) coordinates with the CDC to gather facts and presents its findings to the appropriate agency. Because of this involvement, OIG testified about ways to improve FSAP.

“On the basis of our enforcement work, OIG has identified opportunities to strengthen FSAP that CDC should consider as it reviews how FSAP can be improved,” testified Greg Demske, chief counsel to the Inspector General at the U.S. Department of Health and Human Services. “In addition, OIG will continue to provide oversight through audits and evaluations of FSAP and use our CMP (Civil Money Penalty) authority to take enforcement actions.”

These suggestions include saving documents longer, keeping records of more parts of the process of dealing with dangerous substances like anthrax and prohibiting the destruction of those documents. Additionally, OIG suggested considering using third parties to test the select agents for their viability to pose harm.