2016 Gets its Very Own Bio-lapse

In mid-December, USA Today published an article by Alison Young entitled Emergency trainees mistakenly exposed to deadly ricin. In it, she reports that more than 9,600 trainees at the Federal Emergency Management Agency’s (FEMA) Center for Domestic Preparedness (CDP) located in Anniston, Alabama had been unintentionally exposed to a lethal form of ricin during a series of training exercises spanning a five year period. In response to this revelation, FEMA administrator Craig Fugate has already called for an investigation by DHS’s inspector general, and CDP has suspended all trainings involving toxic exposures.

Most importantly, there is no indication that anyone became ill following exposure to the ricin used during training, and students wearing proper personal protective equipment while working with the toxin. That’s the good news. It would have been a cruel irony for anyone to be harmed simply while honing their skills for this rewarding but uniquely dangerous calling. What follows are some initial reactions to this story.

Some background is in order. CDP is where the nation’s police officers, firefighters, emergency medical services providers, emergency managers, and healthcare workers gain the particular knowledge and experience needed to respond to a range of crises, including those of a CBRN nature. State and local responding agencies can send staff to Anniston for highly specialized training courses, such as the infection control and clinical course offered to US-based healthcare providers who deployed to West Africa to contribute to the Ebola response effort in 2014-15.

Second, a few observations about ricin. From the Center’s fact sheet:

Ricin toxin or ricin, as it is more commonly known, is a protein that consists of A and B subunits that can be extracted from the beans of the castor plant, Ricinus communis…The toxic effects of ricin are caused by its ability to inhibit protein synthesis. Ricin can be introduced to the body through inhalation of an aerosol, or through ingestion, injection, or infusion.

The mosaic nature of ricin’s composition is important to understanding what had apparently been going on at Anniston for the past 5 years. Per FEMA’s statements in the USA Today article, they thought their students were working with a powdered preparation of ricin’s A chain protein, which would have been much safer to work with while still generating positive results by environmental detection assays. Here is where things get (semi) interesting.

There are actually two chemically distinct lectins produced in castor beans, ricin and Ricinus communis Agglutinin (abbreviated “RCA”), which is significantly less toxic than ricin. To add to the confusion, at least one naming convention designates the whole ricin toxin “RCA60”. One might wonder whether CDP staff saw that they were receiving a product labeled “RCA” and interpreted that to mean “Ricin Chain A.”

Needless to say, there should be a thorough investigation in this case, as the question of responsibility appears to have devolved into a finger pointing exercise between FEMA and the contractors responsible for providing the agency with the product they ordered.

Regardless of confusion over names, labels, purchase orders, and intentions, many people may quite reasonably be wondering why first responders should have anything to do with ricin toxin in the first place. The answer relates to a worrisome but under-appreciated trend in the post 9/11 era: the skyrocketing occurrence of white powder incidents. First responders are called to thousands of these events per year, the vast majority of which events turn out to be hoaxes. But, every once in a while, a bored college student, romantic rival, or would-be assassin figures out how to formulate and use at least a crude preparation of the real thing. As a result, every suspect powder has to be treated as potentially harmful until field-based detectors, confirmed by laboratory diagnostic tests, indicate otherwise.  Make no mistake, the high frequency of these white powder incidence makes bio-detection as vital for some local first responders as CPR.

In order to be sure that responders can handle these white powder incidents safely, there is no substitute for rigorous training. To protect themselves and the public, local first responders have to be able to discriminate fake threats from real ones. The myriad detection technologies available to first responders vary significantly in their ease of use, sensitivity, specificity and turn-around-time. In other words, they can be difficult to use properly, and thus the need for training with live agents – to ensure that equipment works properly and first responders can accurately run them and interpret the results.

Unavoidably, there is the issue of optics. Ms. Young understandably links the Anniston incident with prior examples of biosafety lapses by federal biodefense programs. Let’s review. Last year it was live samples of anthrax inadvertently mailed by a Department of Defense lab (a story that may actually say as much about the incredibly hardy biology of B. anthracis as it does the sufficiency of inactivation protocols). The year before that, it was the unexpected discovery of viable variola virus in an FDA freezer on NIH’s campus in Bethesda, MD. In that same year, CDC made headlines with an unexpected exposure of staff to B. anthracis. So… not great. And now, 2016 has a bio-lapse of its very own.

Once you get past the headlines though, it’s less clear what should be done about that less-than-stellar track record. In each instance, the value of the underlying program to national and global health security is beyond question. What’s more, each of those incidents took place in very different operational and organizational contexts, so a one-size-fits-all policy fix isn’t likely to materialize. Finally, because of the amount of agent CDP was working with (reportedly less than 70mg), they were not recognized as a regulated entity under the CDC’s Select Agent Program, this instance should not be interpreted as a regulatory failure.

That said, it is not my intention to downplay the significance of this unusually long running event. Had a health impact occurred resulting from exposure to a pathogen or toxin, the results could have been tragic. Additionally, should the public or their legislative representatives begin to perceive more risk than benefit from federal biodefense programs, their continued existence could be called into question, to the detriment of our national health security.

What this series of unfortunate events underlines is the need for continued, systemic commitment to - and flawless execution of - biosafety and biosecurity practice at every governmental agency engaged in these efforts. In addition, the field could probably benefit from an increased level of scientific inquiry into how to enhance biosafety at the institutional and national levels. Whether or not those steps are taken before the next lapse takes place is an open question.