Do We Need to Re-Define Process Safety?

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The COVID-19 crisis has clearly shown how vulnerable humankind is to new, infectious micro-organisms and is prompting serious reflection on how we can best prepare for and respond to this type of threat. Process safety, originally developed to address and mitigate risks related to hazardous materials and energy sources in an industrial context, can prove useful against biological agents as well, especially as biomanufacturing expands its applications beyond its traditional niche. Faced with new challenges, the process safety framework is sufficiently robust to accommodate the necessary modifications and confront emerging risks.

If we should decide to expand the definition of process safety to include a reference to risks related to biomanufacturing, what changes will occur in process safety? In particular, what aspects of current practices will need to be supplemented or modified?

Current circumstances have made us acutely aware of the need to confront growing risk. New bioengineering technologies are increasingly applied to manufacture a range of goods, even beyond food and pharmaceuticals. Genetically modified micro-organisms are also purposefully dispersed into the environment to help clean up chemical or oil spills. At the same time, the COVID-19 pandemic is demonstrating that human exposure to new microorganisms (including engineered ones) can turn into a global catastrophe with unprecedented consequences.

We must remember, however, that risk of exposure to new hazards has always existed. In fact, humans developed process safety as a way to identify, assess and manage risks caused by hazardous materials, whether from familiar substances such as flammable dusts (sugar, flour) or those linked with hazardous industrial chemical reactions and new chemicals. Managing risk through technological and organizational means is the domain of process safety.

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