BiolabsCDC to review oversight of bioterror labs as concerns grow over lax supervision

Published 29 July 2015

Tom Frieden, the director of the CDC, has ordered a review of how the agency oversees and implements safety and security measures in bioterror laboratories across the country. Documents obtained through FOIA request show that dozens of labs handling the most dangerous bioterror pathogens have time and again failed to comply with key safety and security measures, but CDC inspectors allowed these labs to operate for years before offering to put them on a “performance improvement” plan. Even when inspectors identified significant violations of safety or security practices in work with “Tier 1” select agents – the deadliest of bioterror weapons — the agency only “strongly recommend[ed]” the labs stop work with the pathogens, but without mandating it.

Tom Frieden, the director of the Center for Disease Control (CDC), has ordered a review of how the agency oversees and implements safety and security measures in bioterror laboratories across the country. The review comes on the heels of several reports by USA Today detailing lax security and repeated violations of essential safety measures in labs which handle even the most toxic pathogens (“select agents,” in CDC terminology).

CDC said the review will be comprehensive, and will be conducted by Stephen reed, director of the CDC Office of Public Health Preparedness and Response.

CBS19 TV reports that USA Today, through a Freedom of Information Act (FOIA) request, obtained documents detailing how labs, despite failing several inspections and not meeting required standards, have continued to experiment with deadly bioterror pathogens. A hearing before the Subcommittee of the House Energy and Commerce committee yesterday (Tuesday) looked into the CDC’s oversight on select agent labs, with one of the main topics being the recent shipments of live anthrax from a DOD facility in Utah (for a background on the anthrax shipment case, see “51 labs in 17 states may have received live anthrax samples: Pentagon,” HSNW, 4 June 2015).

Leaders of the committee earlier this month sent an angry letter to the CDC and the Department of Health and Human Services, demanding a list of the non-compliant laboratories as well as information about select-agent oversight. Select-agents are microbes with potential to be used as bioweapons or widespread adverse effect on agriculture or the public (see “Lawmakers demand answers on labs’ handling of deadly pathogens,” HSNW, 7 July 2015).

The USA Today Media Network conducted a thorough investigation of the state of security at the nations’ biolabs, and discovered that there were numerous accidents and mishaps in labs which worked with select-agents. Many of these accidents were not reported, and corrective measures not taken, thus leaving employees at these facilities, and possibly the public, exposed to risks. The power of regulators is limited in any event, as they are not authorized to enforce standards and other safety regulations (”No government agency oversees handling of deadly pathogens in 1,495 U.S. labs,” HSNW, 9 June 2015).

More than 100 labs working with select agents have been at the receiving end of some enforcement action, with some labs being repeat offenders. USA Today found that in many cases, CDC and the U.S. Department of Agriculture (USDA) have issued Performance Improvement Plan Programs (PIPPs) to these labs, which allowed the labs to continue and experiment with the pathogens. On the documents obtained by USA Today under FOIA, the names of the labs and the list of the pathogens being worked were redacted.

The documents  show that dozens of labs handling the most dangerous bioterror pathogens have time and again failed to comply with key safety and security measures. CDC inspectors, however, continued to allow  these labs to operate for years before offering to put them on PIPPs. CBS19 TV notes that when inspectors identified significant violations of safety or security practices in work with “Tier 1” select agents, the CDC’s letters said only that the agency “strongly recommends” the labs stop work with the pathogens, but without mandating it.

Tier 1 select agents are pathogens that federal officials deem to pose the “the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure or public confidence, and pose a severe threat to public health and safety.” They include pathogens as the Ebola virus, anthrax and botulinum neurotoxin.