A search of National Institutes of Health (NIH) laboratories for forgotten infectious agents has turned up a handful of dangerous bacteria and toxins in labs not approved to handle them, according toThe Washington Post, which broke the story late Friday.
The samples included two vials of plague bacteria (Yersinia pestis); two vials of Burkholderia pseudomallei, which causes the tropical disease melioidosis; three vials of tularemia bacteria; two vials of botulinum toxin; and a sample of deadly ricin in an old collection dating to 1914. These agents and toxins are all on the federal select agent list, which means they must be registered and handled only by approved labs.
The Post also reported that in July, the Food and Drug Administration (FDA) found samples of staphylococcal enterotoxin, which can cause food poisoning, in an unapproved lab. The finds came as part of a sweep for select agents at NIH and other federal agencies launched after six vials of live smallpox dated 1954 were found in July in a cold storage room in an FDA lab on the NIH campus.
A 5 September memo from NIH Director Francis Collins to staff (see below) says that the bacteria samples were all stored at NIH’s Clinical Center. The Burkholderia pseudomallei samples were an isolate from a patient; the others were testing samples. Ricin, a substance derived from castor beans that has been used in bioterror attacks, “has legitimate lab uses in very small quantities,” but was not in use in this lab, the memo says. As for botulinum toxin, the public may know it best as Botox, the substance injected in foreheads to erase wrinkles.
Collins describes the discoveries as “a small number of instances where select agents were improperly stored.” Nobody was exposed to the agents and toxins, which were in sealed containers. Still, “[t]he finding of these agents and toxins highlights the need for constant vigilance in monitoring laboratory materials in compliance with federal regulations on biosafety,” Collins wrote. NIH expects to issue a status report on its campuswide inventory in early October.
THE FULL TEXT OF THE NIH MEMO:
From: Exec Sec1 (NIH/OD)
Sent: Friday, September 05, 2014 12:43 PM
Subject: Interim Update on Comprehensive Sweep at the NIH from the Director, NIH
Dear NIH Colleagues:
As we recognize National Biosafety Stewardship Month, I thought this would be a good opportunity to provide you with an interim update on the progress of our comprehensive search underway at NIH facilities for improperly stored select agents, toxins, or hazardous biological materials. Two weeks ago, Lisa Monaco, Assistant to the President for Homeland Security and Counterterrorism, and John Holdren, Assistant to the President for Science and Technology, sent a joint memo (http://www.whitehouse.gov/blog/2014/08/28/ensuring-biosafety-and-biosecurity-us-laboratories) to all federal departments and agencies involved in life-sciences research to conduct a "Safety Stand-Down" in the near-term, during which senior leaders would review laboratory biosafety and biosecurity best practices and protocols, and would develop and implement plans for sustained inventory monitoring.
In fact, we had a head start and initiated our sweep back in July, shortly after smallpox was found at an Food and Drug Administration lab located on the NIH campus. So far, we have found a small number of instances where select agents were improperly stored.
Importantly, all of the agents found were in sealed and intact containers and there were no personnel exposures associated with the storage or discovery of these vials or samples. All of these agents have been reported to the Centers for Disease Control and Prevention and destroyed in compliance with select agent regulations.
Three select agents were found at the NIH Clinical Center Department of Laboratory Medicine, which as you are probably aware, has thousands of microbial isolates from a historical collection. This department also stores microorganisms for the purpose of proficiency testing of laboratory clinical operations as well as libraries of samples collected for scientific purposes. The select agents found in this laboratory were:
* Burkholderia pseudomallei, a patient microbial isolate. B. pseudomallei causes melioidosis, which is an uncommon bacterial infection usually found in tropical or sub-tropical areas.
* Francisella tularensis, the cause of tularemia also known as Rabbit Fever, that was a College of American Pathologists (CAP) proficiency testing samples.
* Two small lab vials of Yersinia pestis, the cause of plague, is an acute bacterial infection transmitted to humans and some domestic animals by fleas that come from infected rodents. There have not been any human-to-human transmissions of plague in the United States since around 1925. This was also a CAP proficiency testing sample.
Two additional agents were found in other NIH laboratories:
* One bottle of ricin of unknown quantity, but labeled 5 grams. Ricin is very poisonous if inhaled, injected, or ingested; it acts as a toxin by inhibiting protein synthesis. This sample was found in a historical collection dating from 1914 and is thought to be 85-100 years old. Ricin has legitimate lab uses in very small quantities.
* Botulinum neurotoxin in individual quantities below the regulatory limits, but in aggregate quantities above the allowable limit. This neurotoxin is the cause of botulism, which is a rare, but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum.
As of this interim update, there have been no other improperly stored hazardous materials identified.
I want to reiterate there were no personnel exposures associated with the storage or discovery of these vials or samples. And there is no evidence to suggest there was a safety risk to anyone in the lab, the surrounding areas, or the community. The finding of these agents and toxins highlights the need for constant vigilance in monitoring laboratory materials in compliance with federal regulations on biosafety. The safety of NIH employees and the public is of paramount importance and we ask for your continued diligence in review of your laboratories during this search.
I encourage you to review the Biosafety Stewardship Month materials on the NIH website: http://www.nih.gov/science/index.html#safety. I will update you again in early October, when a preliminary status report is expected. Thank you for helping to protect the health and well-being of NIH staff, patients, and the public.
Francis S. Collins, M.D., Ph.D.