Guidance Notes for the Templates

Below is further extensive information and guidance for each of the sections within the Biological Risk Assessment template. If you click on the ‘Q’, then the information hidden underneath will become visible.

  • A Biological Risk Assessment is required not only for work with biological agents but also with materials that may contain these. The Biological RA template can be used to undertake a risk assessment as required by COSHH.

  • The Control of Substances Hazardous to Health Regulations 2002 (COSHH) requires employers to identify substances in the workplace that may be hazardous to human health, to assess the risk of exposure to these substances and to take steps to prevent or control exposure. Most people are aware that hazardous chemicals are covered in COSHH, but, it also includes ‘biological agents’.
  • Biological agents are defined as any micro-organism, cell culture, prion or human endoparasite which may cause infection, allergy and toxicity or otherwise create a hazard to human health.  We extend this definition to include materials that may contain these biological agents.
  • This BRA has primarily been designed to fulfil the requirements of COSHH. However, certain biological materials are also subject to a number of other statutory regulations and compliance, including, but limited to, work with human tissues, specified animal pathogens, animal by-products and biological agents that are subject to robust national security measures.  This BRA aims to help the person undertaking the risk assessment to think about and identify such materials and to ensure that appropriate action, such as the application for a licence, is undertaken prior to materials being received, handled, and stored.

 

  • Contact your departmental BSO. The earlier the BSO knows about the project, the faster the project will be reviewed and approved by the departmental H&S committee where required. The BSO will also advise whether the work might need to be ‘registered’ with certain agencies/government bodies (eg notification) or a licence be obtained.

 

  • A risk assessment must be carried out for all micro-organisms/biological material being used deliberately in departments irrespective of their hazard group. The completion of the risk assessment will document the level and nature of the risk and will finally allow the risk assessor to specify the final classification/containment level for the project.

  • The use of the new Bio RA template is not mandatory, however the Safety Office strongly recommends the adoption and use of this new template to BSOs. It might be particularly useful in non-biological departments. The Safety Office is not proposing that all RAs are put into the new format immediately but that if a RA has a substantial update it could be an opportunity to use the new template.

  • The use of a consistent universal Bio RA template is of benefit to all researchers within the University, especially when reviewing documents across multiple departments, when auditing documents and when working on collaborative projects.

  • The template covers some aspects of the Human Tissue Act. Where it is clear that the department will never work with human specimen of any kind, we allow departments to ‘delete’ this dedicated section to make the template more specific for their department. However, the BSO must be aware that when this changes and the department wants to start working with human specimen, that the relevant section is re-inserted into their risk assessment.

  • This template is the University’s minimum standard and has been designed to reflect the large variety of biological research being carried out in the University.

  • The BSO, in consultation with the departmental biological Health & Safety committee, will have the final decision what containment level is given to a project.

  • Further advice is available from either the Schools’ Safety Officers in the first instance or the Biological Safety team in the Safety Office.

  • The approval and signing off procedure is not the sole decision of the PI/researcher, in particular when it comes to working with ‘biohazards’ requiring Containment level 2 and above. It is strongly recommended that the departmental BSO is consulted during the planning stage as he/she can advise what type of information is required and whether it requires notification to enforcement agencies. It will save valuable research time and money in the long-term if both sides are aware of what is required.

 

  • The BSO can also advise whether other risk assessments need to be completed, eg if the work involves the use of GMMs, GMOs or animals.

     

  • The sign-off documentation has the purpose of documenting that all relevant parties (who need to see the risk assessment for administrative, logistical or legal purposes) have indeed been consulted, are aware of the risks and have given their approval for the work to go ahead.

 

  • The RA also requires the naming of the reviewer accepting the overall responsibility for this activity.

 

  • Approval and signing off. All new biological risk assessments, or existing ones that require substantial amendment, must be seen and approved by the BSO. If the initial RA indicates that the activity may be CL2 or higher, the departmental biological safety committee is usually consulted. Some departments go a step further and require the Head of Department to approve the RA, in particular if the project requires notification. The departmental BSO will be able to advise.

 

  • Projects requiring the use of CL3/derogated CL3 facilities. It is expected that BSOs inform their School’s Safety Officer (Safety Officer for the School of Clinical Medicine; Safety Officer for the School of Biological Sciences) of all projects requiring CL3 facilities. For departments which are outside those two Schools, the BSO should contact the University Biological Governance and Compliance Officer in the Safety Office for the risk assessment to be assessed by the University’s CL3 Working Group. Further information regarding working with a new Hazard Group 3 biological agent requiring CL3 can be found in the ‘Containment Level 3 Laboratory Policy’  https://www.safety.admin.cam.ac.uk/subjects/biologicals/cl3-policy.

     

  • For risk assessment review: see comments for Section 12.

 

  • Compliance matters. There is a dedicated area/box for BSOs to document whether the project requires any registration, notification or licence. This greyed out box is for the sole use of the BSO and not for the risk assessor.

  • It is important that all locations are listed in which the activities (or part of the activities) are carried out. This ensures that other personnel responsible for certain lab/facilities are informed of the risks and have given their approval for the work being carried out in the facilities under their control.

 

  • All Departments/facilities involved with this activity must be provided with the RA. Persons responsible in other departments/facilities must sign it to indicate that they approve and comply with the planned control measures of the activities (see Section 7).

 

  • In case of collaborative projects between separate departments/institutes, it must be made clear who the person responsible is in both locations. Representatives of both sides must have seen the risk assessment and must sign it off. It might be useful to use the terms ‘Home’ and ‘Host’ departments, whereby the ‘Home’ department is the department where the PI/researcher, who is responsible for the project, usually works. The ‘Host’ department would be the department where some of the activity is carried out.

  • It is important that all questions are completed.

  • The questions are aimed to gather information regarding the activity from the point of arrival of new pathogens/biohazards, the use and storage of the biological material including further transportation and transfer inside/outside the department, through to final waste disposal.

  • The HSE document ‘Management and operation of microbiological containment laboratories’ contains a comprehensive set of recommendations and advice for working safely in containment labs (including transport, waste handling and storage) and will be useful for BSOs, risk assessor and workers. The document is available via the HSE website: https://www.hse.gov.uk/biosafety/management-containment-labs.pdf).

  • General. This section is the most important part of the Bio RA and the risk assessor is asked to determine the possible effects on humans as well as the environment (eg live-stock, plants, aquatic life, etc).

 

  • General. For those researchers who want to work with biological material, but do not have a background in biological sciences, a good starting point to gather information for this section are:

 

  • Hazard Identification – how to complete the table. The risk assessor must list potential hazardous micro-organisms that could be present in the biological samples being used. The origin of samples plays an important role as certain pathogens/hazards are either more prevalent in certain sample donors or are endemic in some regions of the world. Hence it is essential to describe where samples are coming from.
  • If a micro-organism is listed on the Specified Animal Pathogen Order (SAPO) list - and hence the SAPO tick-box is selected, please consult the Safety Office as it will require a separate SAPO licence. The HSE website provides guidance and specifies the legalities at: https://www.hse.gov.uk/biosafety/app-process.htm. Please be aware that the law states ‘SAPO prohibits any person from having in their possession: (i) any specified animal pathogen listed in Part 1 of Schedule 1 of SAPO or (ii) any carrier in which they know such a pathogen is present. Similarly, in the absence of a licence, it also prohibits the introduction into any animal or bird of any pathogen listed in Parts 1 and 2 of Schedule 1 of SAPO. SAPO also requires any person who has in their possession anything in which they have reasonable grounds for suspecting that a specified animal pathogen in Part 1 of Schedule 1 of SAPO is present, and who does not have a licence in respect of that pathogen’ to immediately contact the University Safety Office.
     

Examples are given below to illustrate how the table should be completed:

Description of biological material

(eg microbiological cultures human saliva, mouse urine, soil samples from abroad/polio endemic regions etc)

Micro-organism(s)

 

(list actual or potential hazardous micro-organisms that could be present in the biological samples) 

 

ACDP Hazard Group (1-4)

SAPO agent?

Schedule 5?

Human saliva samples from unscreened patients

Mycobacterium tuberculosis

Respiratory syncytial virus (RSV)

Sars-CoV-2

3

2

3

☐

☐

☐

☐

☐

☐

Unscreened sheep placenta from farms

Brucella melitensis

3

☒

☒

Soil samples

Clostridium tetani

2

☐

☐

Cultures of Herpes virus

Herpes simplex virus

2

☐

☐
  • Working with human/animal blood and tissues. If the project involves the use of human or animal blood/tissues, the Safety Office has two new guidance documents on its intranet, which highlights the risks when working with this type of material. The documents can be found here: https://www.safety.admin.cam.ac.uk/subjects/biologicals/blood.

 

  • Use of live animals. If the research project involves the use of live animals, then the following applies:
    • When using laboratory animals, in particular those used in biomedical facilities, then a separate and dedicated Biological RA must be completed. A Biological Risk Assessment for Working with Animals is being developed and will be available in due course. At the present time, please continue to assess animal work on the available general biological RA template.
    • For other animals such as flies (eg drosophila, soldier flies), worms etc, the completion of a specific (when made available) Animal Bio RA template is not required. The general biological RA  template can be used.
    • Where the work involves genetically modified animals (ie the generation or use of GM animals), then the GM(B) template must be used: (https://www.safety.admin.cam.ac.uk/subjects/biologicals/gm-gmo-gmm-gm-plants/risk-assessment-proformas ).
    • Please contact your BSO in the first instance. Further advice about the Biological RA template can be sought from the Safety Officer of the School of Biological Sciences.
  • For animal research that falls within the scope of the Animal (Scientific Procedures) Act (e.g. the breeding of genetically altered animals), there is an additional requirement to obtain Home Office licences and complete Home Office mandated training before the research can start.  Most but not all procedures undertaken on animals for a scientific purpose require Home Office authority. Failure to obtain the necessary authorities can lead to a criminal prosecution.  Advice about the training and licences required for animal research should be sought from your BSO in the first instance. If the work is to be done at University Biomedical Services then your enquiry can also be submitted to: ubsenquiries@admin.cam.ac.uk.

 

 

  • Section 4a – Risk to outside environment. The risk of accidental escape into the environment of the biological agent/pathogen or the micro-organism(s) contained within it must be considered and assessed. Such accidental escape could occur during waste handling and transportation/transfer from site to site.  
     
    • The movement of biological materials, including those identified as biohazardous, within and/or between University buildings, and their subsequent transport by road/air/sea, must be appropriately risk assessed to ensure they are moved safely and in a manner that does not cause unnecessary public concern. Biohazardous materials transported by road/air/sea must be packed, marked and labelled to standards defined by national and international transport of dangerous goods regulations. As a general rule, biohazardous materials or material of a sensitive nature must not be transported by public transport eg bus, train, taxi or by higher risk transport means e.g. bicycle. Personal cars may be used if the owner has (appropriate) personal business insurance. It is preferable to use either an approved courier, a works vehicle, or where an approved taxi service is assessed as acceptable, material is still to be supervised during the journey by a member of staff. Contact your department’s dangerous goods trained contact for advice. The Safety Office has additional information on transport and waste management at: https://www.safety.admin.cam.ac.uk/subjects/biologicals/transportation and https://www.safety.admin.cam.ac.uk/subjects/biologicals/waste-biological.

 

  • Section 4c - Describe any disease that may be caused. It is important to provide the main clinical symptoms for any serious disease that could arise if the worker were to become exposed to biological agents. This is of particular importance when working with Hazard Group 2 and 3 agents. All staff/students should be familiar with these clinical symptoms so that they can report these immediately to their line manager, project leader, First Aider, BSO and Occupational Health.

 

 

  • Section 4g - Are there any other non-biological hazards which might increase the risk when working with this biological material? The use of sharps, needles, scalpels, glass Pasteur pipettes pose an additional risk factor and should be avoided as much as possible, especially if the biological agent is in a ‘concentrated’ form (eg during viral transduction, resuspension of pellets, processing of clinical samples).

 

  • If needles are used, then the use of ‘blunt’ needles must be used for the work. If the use of ‘sharp’ needles or other sharps is absolutely necessary, then the reasons for their use must be explained and the risk must be assessed and controlled for within the Biological RA. The risk is further increased by tiredness, lack of concentration or inexperience. Therefore steps must be taken to consider workloads in this context and also to ensure that adequate training, support and supervision is given to trainees/students. It might take several hours, days and weeks to train a person but only a second for that person to sustain serious injuries if left unsupervised. Another significant risk is lone working – PIs must ensure that it is safe for staff/students to undertake work without the availability of support or supervision. Hence adequate training must be given before staff/students are permitted to work unsupervised or on their own. Lone working alarms, security cameras, buddy systems, etc are some possible control measures. The manual handling aspect must also be considered: extended periods of tissue dissection and intense tissue culture periods could pose a manual handling or other musculo-skeletal health hazard (lack of available leg space, etc).

  • General. Working with certain human specimens falls under the remit of the Human Tissue Act (HTA) and might require the department to have a HTA licence, and for individuals involved to complete an HTA training before any such work can commence. If the department has not done this type of work before, it is advisable to check with the departmental BSO and/or the HTA compliance officer within the Safety Office: hta@admin.cam.ac.uk. It is imperative to check the licencing and consent status of the human tissue samples prior to bringing them into the University.

  • Working with human blood and tissues. If the project involves the use of human or animal blood/tissues, the Safety Office has two guidance documents which highlight the risks when working with these types of materials. The documents can be found here: https://www.safety.admin.cam.ac.uk/subjects/biologicals/blood.

  • Section 5b - What is the country of origin (source) of the human samples? Certain countries have a higher incidence rate for serious diseases caused by bacteria and viruses, often well above countries in the EU or the UK. Problems can arise if researchers, who don’t have a biological science background, want to work with certain type of human tissue in an area that is not well equipped to do so: shared equipment, lack of knowledge about diseases and ‘infection control’ can increase the risk further by unknowingly contaminating equipment with pathogens through handling and touch points, thereby putting others at risk.

 

  • Polio. It is worth noting that there are still countries where the polio virus is still endemic (Afghanistan, Pakistan) and faecal/stool samples, blood and lymphatic tissue could be a concern. For more information, see: https://www.who.int/health-topics/poliomyelitis and https://www.safety.admin.cam.ac.uk/subjects/biologicals/polio-eradication

  • Tuberculosis. The same applies to tuberculosis, in particular the multi-drug resistant strains are becoming increasingly a problem due to global travel and migration. The WHO produces an annual report on Tuberculosis (https://www.who.int/teams/global-tuberculosis-programme/data). Sputum samples and bronchial lavages could be a concern.

  • HIV. There are some countries where the incidence rate of HIV is often up to 40-50 % of the population in certain age categories. The WHO has an up-to-date list of HIV prevalence on their website: https://www.who.int/health-topics/hiv-aids#tab=tab_1 . HIV can be present in various body fluids, hence the assessor should take into consideration the type of material being worked on.

  • Hepatitis B and C (HBV and HCV). The same principles apply as for HIV. To assess the risk, check the prevalence for the disease, the study population (if applicable) and the human ‘tissue’ being used.

 

  • Section 5c - Have the sample donors been pre-screened for infectious diseases? Unless there is a test certificate available, all human blood samples should be treated as potentially infectious and be handled under CL2 conditions. It is often assumed that blood from the NHS Blood Bank Service is ‘pre-screened’ and therefore ‘safe’ to use, however we have been informed that often bloods are released before the test result becomes available. The Safety Office has generated a new guidance leaflet on the safe use of human blood/tissues, which is available via the ‘Biologicals’ section of the intranet: https://www.safety.admin.cam.ac.uk/subjects/biologicals/blood

 

  • Section 5d - What was/will be the collection date/source of the human samples? Since the start of the Sars-CoV-2 pandemic (causing Covid-19), there is now a new disease/pathogen which we need to consider in biological risk assessments. Currently Sars-CoV-2 is not on the ‘Schedule 5’ list, but it is possible that this might change once the disease is under control. Hence we recommend that human samples should be categorised as ‘before/after Covid-19’ to allow departments to segregate those samples from their other holdings to meet legal requirements. This cut-off period for the ‘Covid-19-safe’ sample threshold might be the autumn of 2019. Question 5d is currently mainly aimed at Sars-CoV-2, but could also include other pathogens in future. 

 

  • Section 5g:
    • Samples obtained under a current NHS REC approval are exempt from HTA licencing.
    • However, if samples are obtained with the University’s Human Biology Research Ethics Committee (HBREC) approval only, then this is not recognised by the HTA and thus will require HTA licencing.
    • Commercially obtained samples still require HTA licencing in order to be stored on University Departmental premises.
    • Samples obtained from a Tissue bank may or may not require the Department to be HTA licenced depending on the type of NHS ethical approval granted to the Tissue Bank.
    • Please see the ‘Frequently Asked Questions’ section of the Safety Office intranet for further information: https://www.safety.admin.cam.ac.uk/subjects/biologicals/human-tissue-act/frequently-asked-questions.

  • There is a generic list of emergency procedures in the Appendix. This generic list in the Appendix can be modified and amended to suit the proposed activity. Sometimes the hazard requires special procedures, which should be listed in this section. These could include:

 

  • The requirement of how and who to contact in an emergency

  • Having to switch off certain pieces of equipment

  • Having to wear breathing apparatus in case of accidental spills

  • What to do if the normal disposal route goes down (eg failure of autoclave, etc)

  • Working with certain pathogens may require checks of safety equipment and testing of control measures before they are used. These could be the checking of differential pressure gauges before entering certain lab areas, use of anemometers before using a MSC II or the inclusion of bio-indicators during autoclaving of waste.

 

 

  • It is University policy that all biological waste materials must be inactivated prior to final disposal.  This can be achieved by different means and is dependent on the pathogen, the type of biological material and whether other hazardous components are present (eg solvents, cytotoxic or toxic compounds).

 

  • Information must be provided what the back-up solutions are in case of autoclave failure, unavailability of incineration or delays in waste removal by contractors. If certain types of waste require the temporary storage of waste in freezers or cold rooms, then back-up solutions for failure of freezers and cold rooms must be considered as well.

 

  • Some departments are embedded in hospitals, which have their own local rules which the department has to comply with. Enquire with the DSO and BSO if necessary to find out what the required local waste procedures are.

 

 

  • It is University policy that all staff/students working with certain hazardous materials should complete a Job Hazard Evaluation form (Form OHF29, https://www.oh.admin.cam.ac.uk/oh-forms ). This includes work with biological and non-biological materials. If the risk(s) can’t be adequately controlled using the control measures listed in this risk assessment, then Occupational Health (OH) should be consulted.

 

  • All staff and students working with animals or working with hazard group 3 pathogens must be seen by OH prior to work commencing and must complete Form OHF35, (https://www.oh.admin.cam.ac.uk/oh-forms ) when working with HG3 pathogens.

 

  • All staff/students should be familiar with the clinical symptoms which could be the result from infection with the biological agent they are working with. This will be of particular importance when working with Hazard Group 2 and 3 agents.

 

  • It is advisable that Standard Operating Procedures (SOPs) or Safe Systems of Work (SSOW) documents are written for high-risk activities involving biological agents in order to safeguard the health of staff and others.

 

  • All workers should be signed-off when undergoing training for high-risk activities to indicate competency for doing the work.

     

  • If there are SOPs, SSOW and other risk assessments relating to this activity, these should be mentioned in this section.

  • The HSE document ‘Management and Operation of microbiological containment laboratories’, available at: https://www.hse.gov.uk/biosafety/management-containment-labs.pdf gives a good rationale regarding the selection of the containment level, which will depend on the implemented control measures of the risk assessment.

 

  • The completed risk assessment and the ACDP category will determine the containment level.

 

  • It will be up to the departmental BSO and for higher risk activities, the Biological Safety Committee to make the final decision about the classification for the proposed activity.

  • Biological risk assessments must be reviewed on a regular basis. It is the responsibility of the BSO to verify that PIs are reviewing their risk assessments. The Safety Office recommends that biological RAs are reviewed annually and after any accident/incident occurring during the duration of the project/activity.