Amid heightened concern over new pandemics, Richard Jones CFIOSH suggests better biohazard management, global standards and effective regulation will be fundamental in keeping us all safe.
The World Health Organization (WHO) has warned that its newly formed advisory group may be its ‘last chance’ to trace the origins of COVID-19, and calls for more data and laboratory audits. This shows how vital it is that laboratory biological hazard management is put under the microscope.
The importance of independent, skilled investigations of laboratories was underlined by the outbreak of foot and mouth disease (FMD) in Pirbright, Surrey, in 2007. Live FMD virus, stored and used for research in an animal health laboratory, escaped via a poorly maintained drainage system. The GB Health and Safety Executive (HSE) confirmed poor risk management and inadequate drain maintenance as causes and recommended a regulatory framework review (Eves, 2010).
Key recommendations from the subsequent independent review included a common framework for regulation and inspection of all laboratories working with animal or human pathogens provided by an ‘arm’s length body’, such as HSE (Spratt, 2007).
So, currently and more generally, it seems clear that sound biorisk management, global standards, effective regulation and appropriate oversight will all be fundamental for future public confidence.
Elements of biorisk management
Biorisk management standards
Pre-dating Pirbright, back in 2004, a group of biosafety professionals recognised the need for standards on this topic, leading, in 2008, to a CEN Workshop Agreement (CWA 15793). Later, given ISO’s extensive role in global management system standards (e.g. ISO 9001, ISO 14001 and ISO 45001) it was decided to develop an ISO standard, with the advantage that organisations with existing management systems could easily integrate one on biorisk management.
So, in 2015, the IOSH representative on the BSI committee on biosafety management also convened the ISO working group that went on to develop ISO 35001: 2019 Biorisk management for laboratories and other related organisations. This work aimed to complement ISO 15190: 2003 (medical laboratories), which was updated and replaced in 2020, by developing a performance-orientated standard on biorisk management systems, using the ‘plan-do-check-act’ cycle, underpinned by continual improvement.
In January 2020, the first-ever international standard on biorisk management, ISO 35001: 2019, was issued just ahead of WHO’s declaration of the COVID-19 pandemic in March 2020. The standard outlines the functions of biorisk management systems, including (in summary) that they:
- Establish the biorisk management principles to achieve biosafety and biosecurity objectives.
- Define the essential components of the system framework to be integrated.
- Describe a comprehensive biorisk management process that mitigates biorisk.
- Provide guidance on implementation and use of the standard.
With the arrival of COVID-19, the committee overseeing ISO 45001 and related standards (ISO TC 283) and liaising with the one on lab safety, has developed new guidance on pandemics:
- ISO PAS 45005: 2020. Occupational health and safety management — General guidelines for safe working during the COVID-19 pandemic. This is free to read online or as a free PDF for registrants.
- The committee is also working on ISO 45006 Occupational health and safety management – preventing and managing infectious diseases at work – guidelines for organizations.
But, what about the genesis of COVID-19 – and why does it matter? People are keen to know how and why this pandemic that has wrought such devastating and ongoing global effects, came about. Did it occur naturally or was it engineered in a lab? Understanding the source is crucial for decision-makers and standard-setters, in order to help prevent future pandemics and inform public policy on biotechnology and biological hazards.
WHO has now named the 26 proposed members of its Scientific Advisory Group on the Origins of Novel Pathogens and its COVID-19 technical lead has highlighted that dozens more studies are needed to determine the animal to human crossover of COVID-19.
Many in the UK will have seen the recent Channel 4 programme (Did COVID leak from a lab in China?, aired in August 2021) on the potential origins of COVID-19, which referred to the genetic alteration of viruses in labs, or ‘gain-of-function’ research and also to the use of ‘humanised mice’.
Many questions about the ethics and wisdom of potentially risky research methods, which can increase the virulence, transmissibility or host-range of viruses, were raised. Similarly, questions were posed about the sufficiency of biosafety levels assigned to such work.
Meanwhile, concerns have also been expressed about the adequacy of current international conventions and national regulatory systems for biotechnology, with a need for ‘existential security’ (Ord, 2020).
For the benefit of all
Given the global growth in high biosafety-level laboratory research work and heightened concerns about pandemic pathogens, I think urgent answers are needed on all questions that could have major impacts on occupational and public health and safety.
Multidisciplinary working and knowledge-sharing are fundamental to biorisk management, requiring ethical practice and international cooperation from policy-makers, scientists, security engineers, regulators, OSH professionals and others across the globe, together with appropriate oversight and civil society involvement.
And, as with all work-related investigations, it is essential that expert investigators can act objectively and gather and analyse data without undue delay, so that they can reach the best-informed, and most well-considered and timely conclusions, for the benefit of all.
Richard Jones MSc CFIOSH is former head of policy and regulatory engagement at IOSH and a contributor to ISO technical committee TC283 (ISO 45001), a liaison committee with TC212 (lab safety)
Spratt BG. (2007) Independent review of the safety of UK facilities handling foot-and-mouth disease virus (accessed 1 November 2021).