At the heart of the framework is biorisk governance, which the review describes as a structure that enables biorisk assessment and biorisk management activities to take place in a sustainable way within an organization. According to the report, good governance improves decision making, planning and prioritisation, and contributes to more efficient allocation and use of valuable biological materials within a laboratory. The governance process rests on detailed risk assessment, sound decision making, strict and consistent implementation of appropriate risk mitigation measures, and ongoing monitoring and review. Risk assessment is described as the backbone of the practice of biosafety, and it is a legal obligation in many countries that have biosafety regulations, forming part of notification or authorization processes and serving as a basis for determining required containment levels.

The review distinguishes carefully between the two components of biorisk. Biosafety, as defined in the WHO Laboratory Biosafety Manual, covers the containment principles, technologies and practices implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release. Biosecurity is described as more complex because it carries different meanings in different contexts. In the setting of the Biological Weapons Convention it most commonly refers to mechanisms to establish and maintain the security and oversight of pathogenic microorganisms, toxins and relevant resources. Laboratory biosecurity specifically describes the protection, control and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.

On the biosafety side, the report details the practical measures that make up day-to-day laboratory protection. Personal protective equipment is described as an essential element of laboratory safety that institutions must provide to all staff members free of charge, ranging from gloves and impervious laboratory coats to face shields, goggles and respiratory protection such as N95 respirators. At a minimum, laboratory personnel are directed to wear gloves and a laboratory coat whenever handling biological agents, cells and tissues, with additional protection when materials could be splashed in the face. The review also emphasizes that biological safety cabinets, whose primary purpose is to protect laboratory workers and the environment from exposure to potentially infectious agents rather than merely to protect cultures from contamination, must be tested and certified annually by technicians accredited by the National Sanitation Foundation, and recertified whenever they are moved.

Waste handling receives equally detailed treatment. Infectious and potentially infectious non-sharp waste and waste containing recombinant DNA may only be disposed of in designated biological waste boxes lined with two red plastic bags, and boxes that leak liquid or exceed 55 pounds will not be moved for disposal. Liquid biological waste must be rendered non-infectious by steam sterilization or chemical disinfection before sink disposal; where chemical disinfection is chosen, full-strength household bleach may be added so that the final solution concentration is 10 percent, with a contact time of at least 30 minutes. Autoclaving solutions containing bleach is not permitted because of the potential for production of toxic chlorine gas. Sharps, including hypodermic needles, glass Pasteur pipettes and broken glass, must be disposed of separately in rigid, puncture-resistant containers marked with the universal biohazard symbol, and containers should be sealed when three-quarters full.

The review also explains the technical basis of decontamination. Autoclaves work by denaturing biological molecules with superheated steam, and the report notes that steam is far more effective than dry heat: it takes 12 minutes to kill most spores with steam at 121 degrees Celsius, while six hours are required with dry heat at the same temperature. Anything that does not come into contact with steam inside the autoclave may not be adequately decontaminated, a concern that grows when sealed biohazard bags are placed in the chamber. The preferred validation method uses a commercial spore test system with ampoules containing the heat-tolerant bacterium Bacillus stearothermophilus and a color indicator; the ampoules are autoclaved under realistic conditions and then incubated for two days at 56 degrees Celsius, with growth and a color change indicating inadequate sterilization. Autoclave tape, the report cautions, indicates only that a critical temperature was reached, not the duration at that temperature or whether steam was present.

A substantial portion of the article is devoted to the four biosafety levels, which are selected based on the biological agents or organisms involved, work practices, safety equipment and facility design. Biosafety level 1, the lowest, applies to agents that pose a minimal potential threat and do not consistently cause disease in healthy adults, with work generally performed on standard open laboratory benches. Biosafety level 2 covers agents associated with human disease posing a moderate hazard, such as the equine encephalitis viruses and HIV during routine diagnostic procedures, and requires safety equipment including preferably a biosafety cabinet, autoclave and other decontamination equipment, self-closing lockable doors and biohazard warning signs. Diagnostic and health-care laboratories must all be designed for Biosafety Level 2 or above, because no laboratory has complete control over the specimens it receives.

Higher containment levels add progressively stricter requirements. Biosafety level 3 is designed for work with Risk Group 3 microorganisms and with large volumes or high concentrations of Risk Group 2 microorganisms that pose an increased risk of aerosol spread; examples of agents requiring these practices include yellow fever virus, St. Louis encephalitis virus and West Nile virus, and work with them must be registered with all appropriate government agencies. Facility design at this level incorporates self-closing double-door access separated from general building corridors and ducted, directional airflow with no recirculation. Biosafety level 4, the maximum containment level, is designed for work with Risk Group 4 microorganisms such as Ebola virus and Lassa virus, and any agent with unknown risks of pathogenicity and transmission. These facilities add requirements for a complete clothing change before entry, a shower on exit and decontamination of all materials prior to leaving, and they should contain a Class III biological safety cabinet or use a Class I or II cabinet in combination with a positive-pressure, air-supplied full-body suit.

The report also addresses the organizational structures that sustain these practices. Each laboratory organization should have a comprehensive safety policy, a safety manual and supporting programmes, with responsibility normally resting with the director or head of the institute, who may delegate duties to a biosafety officer. Wherever possible a biosafety officer should be appointed to ensure that biosafety policies and programmes are followed consistently, and this person should possess the professional competence to suggest, review and approve specific activities following appropriate biocontainment procedures. A biosafety committee should likewise be constituted to develop institutional biosafety policies, review research protocols involving infectious agents, animal use, recombinant DNA and genetically modified materials, and its membership should reflect the diverse occupational areas of the organization as well as its scientific expertise.

Internationally, the review surveys the roles of the World Health Organization, the Food and Agriculture Organization and the World Organization for Animal Health. The WHO Biosafety and Laboratory Biosecurity Programme is designed to assist member states in understanding, adopting and implementing biorisk management strategies to minimize risks of infection through safe and secure practices in laboratory and transport environments, supported by five WHO biosafety collaborating centres. The FAO has conducted a technical consultation on biological risk management in food and agriculture, created an international portal on food safety, animal and plant health, and established a Working Group on Biosafety. The OIE produces international health standards for animals and animal products, including the Terrestrial Animal Health Code and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, along with quality standards for the accreditation of veterinary testing laboratories. The review concludes that biorisk management programmes, under the ultimate responsibility of laboratory directors, should include identifying valuable biological materials requiring protection, establishing clear roles and responsibilities, promoting a culture of awareness and ethics, providing appropriate training, and strengthening emergency response plans on the assumption that biorisk management systems can only minimize, but never really eliminate, every conceivable threat.

Subject of Research: Laboratory biorisk management frameworks integrating biosafety, biosecurity and governance

Article Title: Global Trends in Biorisk Management

Article References: Bathula, S. R., & Rakhimol, A. (2017). Global Trends in Biorisk Management. BioRisk, 12, 1-23. https://doi.org/10.3897/biorisk.12.12156

Image Credits: AI Generated

DOI: 10.3897/biorisk.12.12156

Keywords: biorisk management, biosafety, biosecurity, laboratory safety, WHO Laboratory Biosafety Manual, biosafety levels, biological safety cabinets, risk assessment, valuable biological materials, CWA 15793, decontamination, pathogen containment