Leaders of Committee that Oversees CDC and Biomedical Research Question “Breach in Safety Protocol”
Washington, DC- Following a recent incident at the Centers for Disease Control and Prevention (CDC) in which upwards of 75 staff may have been exposed to live anthrax, members of the Senate Health, Education, Labor, and Pensions (HELP) Committee today requested information from the agency about the lapse in safety protocols that led to the potential exposure, and asked for steps the CDC is taking to prevent future incidents. In a letter sent to CDC Director Tom Frieden, U.S. Senator Bob Casey (D-PA), along with Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and Senator Richard Burr (R-NC), said they have “serious concerns and questions with respect to the protocols and procedures that were followed at the biosafety labs” and were also concerned that the Committee, which oversees the CDC and biomedical research, was not informed promptly of the incident.
“We are writing with concerns and questions about the Centers for Disease Control and Prevention’s (CDC) recent report that approximately 75 Atlanta-based staff may have been unintentionally exposed to live Bacillus anthracis (anthrax). This raises serious concerns about the events that led to this exposure and what can be done to ensure such an incident does not happen in the future,” the senators wrote. “We request a detailed explanation of what happened, why established safety protocols were not followed or were insufficient to prevent such an incident, and what is being done both to resolve this issue and to prevent such an incident in the future.
Casey, Harkin, Alexander and Burr worked together on the successful passage of the Pandemic and All-Hazards Preparedness Reauthorization Act, a law that strengthens our nation’s preparedness for and ability to respond to medical and public health emergencies, optimizes state and local all-hazards preparedness and response efforts and collaboration, enhances medical countermeasure activities, and reauthorizes key medical and public health programs. It was signed into law by the President in March 2013.
The text of the letter can be found below:
Tom Frieden, MD, MPH
Director
Centers for Disease Control and Prevention
Dear Dr. Frieden:
As members of the Senate Health, Education, Labor, and Pensions (HELP) Committee with jurisdiction over public health and biomedical research, we are writing with concerns and questions about the Centers for Disease Control and Prevention’s (CDC) recent report that approximately 75 Atlanta-based staff may have been unintentionally exposed to live Bacillus anthracis (anthrax). This raises serious concerns about the events that led to this exposure and what can be done to ensure such an incident does not happen in the future. We request a detailed explanation of what happened, why established safety protocols were not followed or were insufficient to prevent such an incident, and what is being done both to resolve this issue and to prevent such an incident in the future.
On Thursday, June 19th, we learned that bioterrorism researchers at the CDC discovered that on June 6th they had mistakenly sent live anthrax specimens to two labs at lower biosafety levels at the agency, instead of what they thought were deactivated – and therefore harmless – samples. According to reports, researchers were “trying out a new protocol” to inactivate the anthrax samples. The samples were then moved to other CDC laboratories not equipped to handle live anthrax samples. A week later, the scientists discovered anthrax growth on one of the samples, and realized that all the samples may have exposed workers to anthrax. Further, these procedures in the labs may have aerosolized the spores.
This breach in safety protocol threatened the health and safety of CDC staff and raises serious concerns and questions with respect to the protocols and procedures that were followed at the biosafety labs. Of additional concern is the fact that the HELP Committee, which has jurisdiction over the CDC, the select agent program, and biomedical research generally, did not learn of this incident until nearly a week after it was detected. To address these concerns, we request a briefing and written explanation that addresses the following questions:
1. What were the exact events that led to this incident, including the procedures used to attempt to inactivate the specimen?
2. What are the relevant security and safety protocols that are currently in place for the biosafety laboratories involved in this incident?
3. Has the CDC initiated a review of its safety measures and protocols to identify what happened, what changes may need to be made in order to ensure the safety of CDC staff, and any additional steps that should be taken to ensure that such an incident does not occur in the future? If not, please explain why.
4. Were there any measures in place that would have detected the anthrax had it not been discovered by the researcher who was attempting to dispose of it?
5. Are additional measures necessary to detect initial lapses in the adherence to laboratory safety and/or security protocols for CDC’s laboratories engaged in research involving the agents that present the most lethal characteristics? If so, what measures do you believe are necessary?
We look forward to your prompt response and working with CDC to ensure the security and safety of our nation’s laboratories engaged in research that supports our nation’s medical countermeasures.
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