Summary of Changes to the World Health Organization Laboratory Biosafety Manual 4^th Edition

This Summary of Changes was prepared by the ABSA International Technical and Regulatory Review Committee (TRR) in collaboration with the International Relations Committee. April 2022

This Summary of Changes is not to be used as a substitute for the WHO Laboratory Biosafety Manual 4th Edition.

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Section 4 Heightened control measures (pages 49-58)

The risk assessment process has evolved whereby a laboratory’s risk activities have changed from the 3^rd edition into the 4^th edition of the LBM by WHO. Topics related to BSL-2 and BSL-3 laboratories are covered in the new edition of the LBM as “Heightened control measures” and the BSL-4 as “Maximum containment measures”, respectively. It is important to mention, that in the WHO 3^rd edition of the Biosafety Manual, basic laboratories (biosafety levels 1 and 2) were covered from pages 9-19, containment laboratories (BSL-3) were covered from pages 20-24, and maximum containment laboratories (BSL-4) were covered from pages 25-27. Each one of these sections included a general code of practice, lab design, facilities and some other aspects such as lab equipment, occupational health, training, waste handling and general safety.

In the new edition of the LBM, the topics covered in section 4 and section 5 included several subsections like operational working practices and standard operating procedures; the importance of personnel competence and training; facility design (which is covered as a specific Monograph). In the same way, subject specific monographs were developed for specimen receipt and storage, decontamination and waste management, and personal protective equipment.   

As it is detailed in the 4^th ed., LBM, the operational working practices, and procedures from the core control measures will remain applicable in the heightened and maximum containment measures (including the good microbiological practices and procedures and the use of containment devices such as BSCs). In the same way, biosecurity measures must be considered to prevent the presence of non-authorized personnel, and a system to monitor and record the activities of personnel who is working inside of the facilities.

Another critical aspect that is detailed in this 4^th ed., of the LBM are the emergency/incident response and occupational health surveillance. These topics are case-by-case scenario dependent as well as the availability of the organization/institutional resources. It is important to mention as well, that specific policies that were included in the 3^rd edition of the WHO Biosafety manual (i.e., two-rule person at high containment facilities), continue in this new edition of the LBM.

In terms of personnel competence and training, it is important to provide all the necessary training to develop appropriate competence among the staff/personnel who is going to have access to these facilities but also, who is going to work with biological agents or materials. Training must include specific agent SOPs, and activities related with emergency preparedness, response and recovering from critical situations.

Regarding the facility design, a complete monograph has been assigned to select heightened control measures, and considerations for the maximum containment facilities. This monograph details topics like separation and design features, controlled access, laboratory equipment, directional airflow, and inward airflow, wase disposal and emergency response.  In addition, a complete section was considered for the operation and maintenance as well as the decommissioning process of laboratory facilities.

As it was previously mentioned, part of the new perspective of the heightened and maximum containment control measures are based on the risk assessment and nature of the work that is going to be done. These two control measures will be chosen if the core requirements are not fully covered, or if the organization/institution, and each one of the interested parties require additional control measures and mitigation controls for the identified risks. On the other hand, the risk assessment will be based on the location and availability of resources (technological, material, infrastructure, and human factor) of the involved institutions.  Another interesting aspect of these new regulations is that these documents can be used where national regulations exist, as this will serve to comply with international requirements.

However, independently of the type of control measures (heightened or maximum), everything will require to be evaluated periodically as well as, the effectiveness of the risk control measures every certain time through lab inspections, reports, and external evaluations.

Regarding the specimen receipt and storage, decontamination and waste management and personal protective equipment, specific monographs were created and detailed based on the level and needs from the institution/organization. It has been emphasized that decontamination and waste management should preferably be decontaminated onsite, or close to the laboratory to minimize the risk of exposure during transportation for the heightened and maximum containment facilities. In terms of personal protective equipment, specialized PPE and protocols should be included and after conducting a risk assessment process.

Finally, the new heightened and maximum containment measures present a novel approach that allows to each organization/institution to take a feasible and most effective combination of risk control measures based on their resources, experience, and local context. In addition, this will support and help these institutions to attain a much desired equitable, adequate, and sustainable access to laboratory services (i.e., diagnostic, reference, research) to promote the safe and secure handling of biological materials that require this level of protection under the highest quality and safety standards. 

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Section 5 Maximum containment measures (pages 59-64)

The maximum containment measures section describes two types of containment measures or laboratory designs that can be used when handling biosafety level 4 agents.  One facility is referred to as a Suit Laboratory named after the positive pressure suits worn by the staff.  The other facility is a Line Laboratory (referred to as a Cabinet Laboratory in the BMBL) where all work is performed in a single or a series of interconnected Class III biosafety cabinets or gloveboxes.  In both cases, the laboratory facility must be under negative pressure to its surrounding space.  There are nine subsections and three comparative tables to this chapter.  Each subsection is very brief and can be considered prescriptive requirements with little operational detail.  

Section 5.1 is entitled “operational working practices and procedures.”  This section adds additional measures to the core requirements described in Section 3.

Section 5.2, personnel competence and training is a short paragraph that states only highly-trained and competent individuals should be allowed to work in a maximum containment lab. 

Section 5.3 entitles “facility design,” contains the three comparative tables that show how Suit and Line laboratories differ in design requirements.  The three tables describe & compare Primary Features, Entry & Access features, and HVAC features for the two types of laboratory facilities. 

Section 5.4, “specimen receipt and storage” is a single paragraph containing four (4) requirements that must be implemented.

Section 5.5, decontamination and waste management, describes requirements for laboratory infrastructure such as a double door autoclave and requirements for waste treatment.  

Section 5.6 entitled Personal Protective Equipment describes the need for specific SOPs and PPE maintenance programs within a Suit laboratory.

Section 5.7, Laboratory equipment, specifically requires dedicated equipment and sharps policies.

Section 5.8 is entitled “emergency/incident response” requires a separate manual for emergency response be developed.  Emergency response exercises should be conducted and, in some cases, include local and national authorities.

Section 5.9 is the final section and describes Occupational Health requirements.  Included in these requirements is a requirement for 24-hour medical assistance.  Multiple other requirements are listed.