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. Armys 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.

In 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

United 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 CDCs
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 CDCs 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.

How 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.