“Small mistakes in biosafety could have terrible global consequences” – Thomas Ingelsby, Center for Biosecurity at the University of Pittsburgh 

On May 28, 2015, media coverage revealed ongoing and serious flaws in the safety and security of biodefense research facilities, including the shipment of live Bacillus anthracis originating from the Utah-based U.S. Army’s West Desert Test Center-Dugway Proving Ground, to 24 laboratories contracted to conduct research, development and testing involving select agent biodetection systems and biomedical countermeasures. The 22 live bacterial shipments were sent to 11 states, and were also sent to the Joint United States Forces Korea Portal and Integrated Threat Reduction Program at Osan Air Base in South Korea, with an additional shipment to an Australian facility. In what has emerged as an intense and broad military and homeland security investigation, U.S. Army and Pentagon officials have reported that shipments of live, active Bacillus anthracis may have been shipped unwittingly to Australia as far back as 2008 or 2009.

Frank 1In the U.S., lapses in biosafety and biosecurity occurred at several Federal and contractual biodefense laboratories, including the Centers for Disease Control and Prevention (CDC) and Department of Defense (DoD) related laboratories, began in the Summer of 2014, and perhaps before, as biodefense assets have had prior breaches in both biosafety and biosecurity. In the past, worst-case scenarios of environmental releases of pathogens and other hazardous materials have occurred at facilities such as the USDA-DHS Plum Island Animal Disease Research Center, where during a severe storm several hundred gallons of highly pathogenic microbial agents present in untreated sewage flowed into the waters of Long Island Sound in New York. Many hazardous materials are shipped via commercial transport systems, such as Fed -Ex or UPS – including several of the errant live Bacillus anthracis shipments delivered promptly and on time to various biodefense establishments.

In terms of preventive medical countermeasures, four U.S. and 22 overseas personnel were provided with medical examinations, prophylactic antibiotics and even anthrax vaccinations. While none of the exposed personnel had developed symptomatology or signs of anthrax infection, the potential for a major public health crisis via accidental, or even intentional dissemination of live Bacillus anthracis spores, or other lethal select agents, is becoming increasingly probable in the high stakes game of biodefense R&D.
Normally, samples that have been rendered inactive via an irradiation sterilization process are shipped to various biodefense laboratories, and are first determined to be non-pathogenic as per standard biosafety and biosecurity protocols and procedures. Recently, newer chemical deactivation methods have been developed to replace irradiation of Bacillus anthracis spores, however, the protocol has not been adequately validated by the CDC, resulting in potentially live agent employee exposures and biosafety-security breaches.

The U.S. Centers for Disease Control and Prevention (CDC), in a collaborative effort with the U.S. Department of Defense (DoD), other state and federal stakeholders have undertaken an ongoing investigation involving various recipient laboratories. These egregious lapses in biosafety and biosecurity have led to intense review of laboratory procedures, protocols, inventories of live agent stocks, employee occupational safety and health, decontamination aspects, handling of biohazardous laboratory waste and relevant epidemiological consultation.

Because of the serious nature of the Summer 2014 lapses in biosafety practices at several Federal laboratories, the Assistant to the President for Homeland Security and Counterterrorism Lisa Monaco and Assistant to the President for Science and Technology John Holdren issued a memorandum, titled “Enhancing Biosafety and Biosecurity in the Frank 3United States”, which urged all U.S. Government departments and agencies that work with, possess, use, transfer, or store human, animal, or plant infectious agents or biotoxins were urged to perform a Safety Stand Down. This down-regulation of activities superseded by elaborate biosafety and biosecurity checks, included an immediate sweep of their facilities to verify that all Biological Select Agents and Toxins (BSAT) in their possession were appropriately registered, stored, and disposed of with strict adherence to applicable regulations and protocols. This operation entailed the participation of over 4,000 facilities across the U.S. and in U.S facilities abroad, with the intention of improving overall biosafety and biosecurity oversight. The U.S. Federal Bureau of Investigation (FBI) which leads crisis management and investigative efforts for CBRN events, also had an important role to play to ensure that the biosafety and security deficiencies found and reported during the Safety Stand Down had no connections to malevolent or nefarious activities.

In addition to the disclosures that governmental and contract biodefense laboratories mishandled Bacillus anthracis, Variola major (smallpox), various strains of avian influenza virus, and other select biothreat agents, including Ebola hemorrhagic fever, have also been carelessly mishandled in presumably high security containment facilities. Due to the perceived threats of bioterrorism and emerging and exotic infectious disease outbreaks, the U.S. has tripled its biodefense R&D laboratory capacity to 1,500 laboratories, many having lax oversight in biosafety and biosecurity. Several watchdogs and government officials have called for a decrease in the amount of active biodefense facilities. Many, including concerned citizen groups, feel that the complex of biodefense research facilities peppered among academic, industrial and governmental institutions and agencies are a prelude to biological catastrophe.

In fact, several domestic and international biodefense laboratories have been found to be inherently unsafe due to serious flaws in design and biosafety/biosecurity procedures and protocols. For example, the CDC’s Building 18 in Atlanta, Georgia, harbored safety hazards ranging from defective air filtration systems to severe deficiencies in laminar air flow and inadequate pressurization of biocontainment areas. Improper access to containment areas and unsafe removal of highly infectious and pathogenic select agents at the CDC’s Special Pathogens Branch maximum biocontainment facility has also been observed and documented. Several laboratory personnel, at various facilities, have been found with their “PPE down”, as in respirators, safety goggles or face shields, gloves and other safety equipment. As a former Chemical and Biosafety Officer for a large biomedical research complex and academic medical complex, this author has actually witnessed recombinant DNA material being indiscriminately poured down a sink drain, lab workers utilizing non-operational exhaust hoods and, of course, the proverbial absence of personal protective equipment and/or personal hygienic practices, e.g. proper handwashing and unsafe storage or handling of biologicals or chemicals.

Need we look to sophisticated biodefense operations to trigger an outbreak of an infectious disease? The answer is “No”.

Frank 2How many on -site and off-site medical diagnostic laboratories receive blood and bodily fluids hourly for laboratory examination? How many health care facilities place their collected specimens in flimsy collection boxes for pick up by courier? How about tons of untreated medical and biohazardous waste being generated daily from routine health care operations globally? Do these facilities engage in best practices for biosafety and biosecurity? Can a series of unsecured and contaminated syringes be used to inflict a biocrime or other contaminated items to cultivate a bacterial or viral agent knowingly present to commit an act of bioterror? Can a professor or a graduate student abscond with a live culture of Shigella, hog cholera, wheat rust, monkeypox or a vial of a concentrated neurotoxin?

Indeed, the possibilities and prospects are endless, which leads us back to the risk vs. benefit equation.

In an age of tactical and strategic uncertainties and past events threatening or actually utilizing select agents such as Bacillus anthracis and ricin toxin, and the evolving threat of emerging infectious diseases such as Ebola hemorrhagic fever, chickungunya viral disease, Middle Eastern Respiratory Syndrome (MERS), highly pathogenic avian influenza, are we willing to accept the inherent risks associated with biodefense research and development versus the consequences of a bioterror attack or pandemic?

As with any scientific or technological venture, we must continue to weigh risk versus benefit, and seek innovation and improvements so that safety and security will never take a rear seat but be tightly interwoven into all of our noble, but risky efforts to protect public health and global security and safety.

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Frank G. Rando possesses over 30 years of real world experience as a public safety professional,clinician, educator ,emergency and crisis manager ,author and consultant in the areas of tactical ,disaster and operational medicine, weapons and tactics, law enforcement /criminal investigations ,counterterrorism, hazardous materials management and emergency response ,toxicology, environmental safety and health,and health care and public health emergency management .