Biological Risk Assessment FAQs

This page covers the frequently asked questions about the specific biological risk assessments.

The specific risk assessment templates in riskNET are set to guide assessors through the significant hazards when working with biological agents. This page does not cover how to use riskNET or how to write a risk assessment. If further advice is required on the content of the risk assessment, please speak to the approver of the risk assessment or the Biological Safety Officer.

What is the difference between Biosafety Level (BSL) and Containment Level (CL)?

Containment Level is the UK term used to describe the combination of design and management measures in place to protect people working and the wider evironment from the pathogens being handled. Biosafety Level is the term used by the rest of the world. Therefore, we avoid its use on official documentation in the UK. For a quick guide for all UK terms and regulations used in biosafety please use the Biosafety glossary.

Why don't we use the term Category (or Cat)? 

This term is used only in the SAPO regulations. It implies that the requirements for additional controls and notifications are not required when just working at containment level 2 or 3 (CL2, CL3) or with Hazard Groups 1, 2 or 3 that do not fall under SAPO.  For a quick guide for all UK terms and regulations used in biosafety please use the Biosafety glossary.

What is the difference between Class II and Class 2?

Arabic numerals (1,2,3) are used for denoting the risk level associated with a biological agent:

• Class 1, 2 or 3 for genetically modified material
• Hazard Group 1, 2 or 3 for wild-type agents
• CL2 or CL3 for the containment level required for a biological hazard

Roman numerals (I, II, III) are used for the level of protection given by equipment:

• the most commonly used at UCL is a Class II microbiological safety cabinet (MSC)

Can I use a Class II MSC for Class 1 / Hazard Group 1 work?

This depends on why. Control measures must be in proportion to the risk. If the work is at Class 1 or Hazard Group 1, why would Class II protection be needed? Remember the risk of work is dependent on the highest level of engineering/isolation required to work within the guidance.
However, you may require the MSC for the protection of the biological agent, e.g. to keep it sterile. If this is the case, it must be clearly explained in the risk assessment, including the fact that Class II protection is not required to provide worker/user protection.

Can I send separate risk assessments (different reference numbers) for my Class 2 / Hazard Group 2 and my GM animal risk assessment?

Yes. This is the preferred process to ensure the assessor is suitable for the specific hazard. However, you must note in the summary that there is a linked risk assessment and supply the reference number.

What should I title my risk assessment?

One line that identifies the work, and risk level and which can be easily searched in riskNET.Only add a title to the background page of the risk assessment. 

Do not change the title of the specific activity risk assessment. This should be left to allow for auditing.

What should my scope cover?

The project that is planned rather than a single experiment. If HSE notification is required, the consent letter will only cover the scope of the activities in that notification. All significant changes require an additional notification.

Careful consideration should be given to the scope of your assessment. If the activity being assessed is part of a larger project or connected programme of work, the whole project/programme can be assessed rather than generating multiple assessments covering individual activities.

Such a risk assessment should contain a summary of why you have chosen the class or hazard group, in addition to background information that puts the work into context. If the HSE require further information, including the literature that you have based the further work on may be helpful. 

Why do I have to include that I am not using sharps / there are no sharps or injection risks?

The use of sharps or injections may change how you or others could be exposed to the biological agent. Being clear that this is not a significant risk enables the approver to be aware that you have a correct risk and containment level for your work.

Also, consider the scope of the risk assessment. If you are producing a genetically modified organism, in many cases this will require injection. If you are working on a genetically modified organism this often requires sharps work to prepare the sample. However, this type of activity may not be done within the activities or individuals specified in the risk assessment (e.g. prepared off-site). This needs to be clear in the risk assessment.

Why is the volume I am producing/ working with important?

Large volumes, which can occur when fermenting, and high concentrations of certain biological agents, can change the level of risk of exposure. This will require robust controls to be implemented. In the class of Genetically Modified Material an increase in scale can potentially move a Class 1 GMO to a Class 2 GMO. A change in the class of a GMO can result in a change in level of containment required. This will be determined by the risk assessment

Supplying this information, even when there is no additional risk, ensures that all the information is present to allow for approval of the risk assessment.

What information is required about my disinfection procedure?

To ensure that the control measures are suitable for your project and biological agent, the concentration of disinfectant and contact time should be recorded. Best practice is to include the Safety Data Sheet (SDS) for the disinfectant as an attachment.

If you are using an autoclave, the temperature, run time and if possible the cycle reference should be included.

All waste needs to be included in the waste procedures including waste associated with LGMO.