The current Coronavirus outbreak in Wuhan, SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and the need for stringent, risk-proof ways of handling them.

A biorisk management system is a key step towards enabling an organisation to effectively identify, control and manage the biosafety or biosecurity risks related to its activities.

ISO 35001, Biorisk management for laboratories and other related organisations, is the first International Standard for a biorisk management system. It defines the requirements and guidance for laboratories or any other organisation that works with biological agents to control and reduce any risks associated with their use.

Patty Olinger, Convenor of the working group that developed the standard, said that while there are a number of regional or national standards that help organisations manage their risks and meet regulatory requirements, ISO 35001 is the first that harmonises them to deliver international best practice that is recognisable everywhere.

“ISO 35001 provides organisations and individuals with a roadmap of how to organise and systematically manage and structure their biological risk programmes,” she adds. "This is increasingly important to protect our global public health infrastructure as our world becomes more and more integrated.”

According to the US Department of Health and Human Services, "Biorisk management” is the effective management of risks posed by working with infectious agents and toxins in laboratories; it includes a range of practices and procedures to ensure the biosecurity, biosafety, and biocontainment of those infectious agents and toxins. Biorisk management includes the full spectrum of safety and security measures for laboratories, from standard operating procedures to physical measures to individual practices in the laboratory. In this sec tion, you will find information on biosafety, biosecurity, biocontainment and how all three concepts relate to each other."

Physical security comes within this remit under the heading of biosecurity, and includes the physical barriers and other methods used to keep unauthorised personnel out of laboratories, such as fences and key coded locks on laboratory doors or refrigerators. Information security focuses on preventing unauthorised access to the information gathered about infectious agents and toxins. And personnel reliability measures ensure that all workers allowed access to high containment biological laboratories are trustworthy and reliable. Assessments of personnel reliability have evolved to focus on the whole person, not just a resume or a simple background check.

A biosecurity risk assessment determines procedures and practices to ensure that biological materials remain secure. The risk assessment includes a thorough review of the building and premises, the laboratories, and biological material storage areas. Physical security elements should be implemented, as needed, based upon the risk assessment process.