April 16 2020
There is no shortage of conspiracy theories when it comes to the current SARS-CoV-2 pandemic. I will state my opinion at the beginning of this post: current pandemic is not a result of conspiracy on the part of any individual, organization or government either in the USA or abroad (including China).
At the same, a brief research of the open-source literature, regulations and actions of the US government agencies reveals multiple well documented accidents related to biosafety, all of them related to a “human factor”.
The Federal Select Agent Program (FSAP) regulates the possession, use, and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. Common examples of select agents and toxins include the organisms that cause anthrax, smallpox, and bubonic plague, as well as the toxin ricin.
The program currently regulates 67 select agents and toxins. The list is reviewed at least every two years to determine if agents or toxins need to be added to or deleted from the list.
Facilities where research with select agents and toxins is conducted must register with FSAP. The majority of entities (86 percent) are registered with CDC/DSAT.
Academic, non-federal government, federal government, commercial, and private non-profit laboratories all work with select agents and toxins. In 2017, 263 entities were registered with FSAP to possess a select agent or toxin.
FSAP history starts in 1995 when a microbiologist was arrested and convicted of mail and wire fraud after misrepresenting the reasons for purchasing three vials of Yersinia pestis (the bacterium that causes plague).
Congress passed Section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 to address concerns about how easy it was to legally obtain biological agents that could cause disease in humans. The Act required HHS to:
Establish a list of biological agents and toxins that could threaten public health and safety (select agents)
Register entities and identify procedures for governing the transfer of those agents
Create safety requirements for registered entities connected to the transfer of those agents
After five people died from the anthrax attacks of 2001, Congress passed:
The USA PATRIOT Act in 2001, which established criteria for those prohibited from having access to select agents and toxins
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which required HHS and USDA to publish regulations to strengthened oversight of select agents and toxins that have the potential to pose a severe threat to public health – as well as animal and plant health, or to animal and plant products
in 2010, President Obama signed Executive Order 13546 , which called for:
A review to prioritize (or “tier”) the riskiest agents and toxins
Consider reducing the number of agents and toxins on the list
Establish physical security standards for select agents and toxins that present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effects on the economy, critical infrastructure, or public confidence
The Select Agents and Toxins list can be found here. It contains 67 agents and toxins, , most notably Ebola virus, SARS-associated coronavirus (SARS-CoV), Hendra virus, Nipah virus, Avian influenza virus, Smallpox virus, etc.
It also determines exclusions from the list: attenuated (weakened) select agent strains or less toxic select toxins that are not subject to the requirements of the select agent regulations. The notable exclusions are:
NATtrolTM treated SARS-CoV molecular controls (effective February 8, 2013)
Ebola ΔVP30 replication incompetent virus (effective 01-02-2013)
Mopeia/Lassa (MOP/LAS) arenavirus construct ML-29 (effective 03-02-2005)
An excluded select agent strain or modified toxin will be subject to the regulations if there is a reintroduction of factor(s) associated with virulence, toxic activity, or other manipulations that modify the attenuation such that virulence or toxic activity is restored or enhanced. In addition, excluded select agent strains or modified toxins are not exempt from the requirements of other applicable regulations or guidelines.
On February 18, 2020, FASP published Clarification on which SARS viruses are regulated referring the “Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group” indicates that SARS-CoV-2 is not a descendent of SARS-CoV, but is genetically closely related.
The select agent regulations currently regulate viruses identified as SARS-CoV and not viruses identified as SARS-CoV-2.
As the Federal Select Agent Program gains more information about the SARS-CoV-2, we will reassess the select agent status as needed. Any changes in the select agent status of SARS-CoV-2 will be published in the Federal Register.
On February 25, 2020, the Federal Select Agent Program (FSAP) sent a notice to clarify that viruses identified as SARS-CoV are regulated by the select agent regulations, while viruses identified as SARS-CoV-2 are not currently regulated.
FSAP wishes to further clarify that the positive strand RNA genome of SARS-COV is also a select agent because this genomic material represents nucleic acids capable of generating infectious virus, SARS-CoV.
In January of 2020, FSAP released The 2018 Annual Report of the Federal Select Agent Program.
The Inspection Findings and Compliance chapter of the report discusses FSAP’s voluntary Corrective Action Plan (CAP) program:
In 2018, one entity agreed to participate in the CAP program, and two entities continued in the CAP program from the previous years (one from 2016 and one from 2017). All three entities successfully completed the CAP program in 2018.
An entity’s registration can be suspended when a departure from the SAR (The Select Agent Regulations) is found to represent a danger to human, animal, and/or plant health, or to public safety.
In 2018, no entities had their registrations entirely suspended. However, FSAP partially suspended five entity registrations (three registered with DSAT [The Division of Select Agents and Toxins], two registered with AgSAS [The Agriculture Select Agent Services]). In 2018, a total of eight entities were partially suspended, including three partial entity registration suspensions that were initially imposed in 2017. Five of the eight partially suspended entities, including the three entities originally suspended in 2017, received approval to resume their work during the year. Three entities remained partially suspended at the end of 2018. The 2018 partial suspensions ranged from a few days to over a year depending on the compliance issue;
The five partial entity registration suspensions imposed in 2018 were for the following reasons:
Failure of the effluent decontamination system that treated waste from their high-containment laboratory. The suspension was lifted once measures were implemented to effectively treat the laboratory waste.
Failure to implement procedures/equipment for decontamination of effluent originating from the containment laboratories. The suspension was lifted once measures were implemented to effectively treat the laboratory waste.
Airflow reversal from the animal containment laboratories. The suspension was lifted once the entity corrected the heating, ventilation, and air conditioning system.
Removal of BSAT (Biological select agents and toxins) that had not been subjected to a validated inactivation procedure from the registered space. Once the inactivation failure was identified, the material was returned to the registered space. The suspension was lifted after the entity validated the inactivation procedures.
Failures with the decontamination systems. The suspension was lifted after the entity fixed the decontamination systems.
FSAP notifies the FBI of any security-related issue identified by either FSAP or a registered entity (for example, allowing an unapproved individual access to BSAT, or a security breach of BSAT storage space) and any report of a loss of a BSAT. This allows FSAP to leverage FBI resources to help determine whether a security issue presents a criminal threat, including whether a loss may represent a theft. FSAP also provides information in support of specific FBI investigations upon request.
In 2018, FSAP notified the FBI of nine matters for investigation. In all nine matters, FBI analysis determined there was no criminal nexus requiring the opening of a case.
Eight matters concerned the loss of BSAT. Inventory accounting errors caused three of the matters, and inadvertent destruction of BSAT accounted for the remaining five matters.
One matter concerned an unsubstantiated complaint about an unregistered entity possessing a select toxin.
FSAP further discusses Theft, Loss, and Release of BSAT.
An entity uses the Report of Theft, Loss, or Release of Select Agents and Toxins (APHIS/CDC Form 3) to report a theft (unauthorized removal of BSAT), loss (failure to account for BSAT), or release [occupational exposure or release of BSAT outside of primary containment, such as a biological safety cabinet (BSC)].
Examples of the causes of a release may include:
Bites or scratches from an infected animal
Equipment or mechanical failure
Spill of BSAT outside of a BSC
Failure or problem with personal protective equipment (PPE)
Needle stick or other percutaneous exposure with contaminated sharp objects
Open bench work involving diagnostic samples (later identified as BSAT) without appropriate PPE
In 2018, FSAP received 193 reports of BSAT release and 8 reports of a BSAT loss. By comparison, FSAP received 237 reports of releases and 9 losses in 2017, 196 reports of releases and 9 losses in 2016, and 233 reports of releases and 12 losses in 2015. As in 2015, 2016, and 2017, there were again no reports of theft of BSAT in 2018.
All eight reports of a loss met the regulatory criteria for a loss. For each report, FSAP was able to identify the cause of the failure to account for the BSAT. None of the losses resulted in a risk to human, animal, or plant health.
Of the 193 reports of a BSAT release, 66 were submitted by registered entities and 127 were from non- registered entities. For registered entities, the most common cause of a release was due to a failure or problem with laboratorian personal protective equipment. For non-registered laboratories, the most common cause of a release was due to manipulation of BSAT outside of a BSC or other type of equipment designed to protect laboratorians from exposure to infectious aerosols. This also was the second most common cause of a release for registered entities.
FSAP reviews each report of a release to determine the potential for an occupational exposure.
For eight of the reported releases, FSAP agreed with the entity that these reports presented a minimal to no risk of occupational exposure.
The remaining 185 reported releases did involve a BSAT occupational exposure.
In 12 of the 185 reports, the entity determined no occupational health services were necessary based on the circumstances of the release.
In the remaining 173 release reports, entities provided 895 individuals (121 individuals from registered entities and 774 from non-registered entities) with occupational health services including medical assessments and, if needed, diagnostic testing and prophylaxis.
None of the reported releases resulted in identified illnesses, deaths, or transmissions among workers or outside of a laboratory into the surrounding environment or community.
The morals of the story: while FSAP denies any serious consequences from the summarized breaches, the sheer number of reported accidents (193 reports of BSAT release and 8 reports of a BSAT loss) and individuals involved (895 individuals) demonstrate plausibility of the incidental spread of deadly viruses, bacteria and toxins causing epidemics due to human error, not conspiracy.
We would be naive fools, if we believe that reported accidents are ALL accidents occurring. I would not venture to say that this is a “tip of the iceberg” but the second law of probability states that “If two possible events, A and B, are independent, then the probability that both A and B will occur is equal to the product of their individual probabilities”, hence it is equally probable that accident will be reported or unreported.
Stay tuned for the next blog on the history of documented biohazard accidents.