Register or view and update details if you will be using:

• genetically modified material
• biological agents that may be harmful to human health, according to COSHH:
  • micro-organisms, defined as microbiological entities, cellular or non-cellular, capable of replication or of transferring genetic material;
  • cell cultures, defined as the growth of cells derived from multicellular organisms in vitro; human endoparasites;
  • agents that cause transmissible spongiform encephalopathies (TSE);
  • parasites, such as malarial parasites, amoebae and trypanosomes;
  • microscopic infectious forms of larger parasites, such as the microscopic ova and infectious larval forms of helminths;
  • oncogenic DNA sequences or other nucleic acids that could create a hazard to human health due to their properties or the way that they are used.
• materials where there is a risk of contamination with biological substances harmful to human health. For example, contamination with blood-borne pathogens such as with primary human tissue.

Using the online registration system:

1. Use the registration system while connected to the UoB network, using a modern internet browser.
2. Create a new registration or edit an existing registration.
3. Complete the form and press submit on the last page. Optionally, print a copy
4. Complete the mandatory biorisk training modules and any applicable optional modules

Risk assessments of activities involving wild-type human or animal pathogens and organisms that have been genetically modified have to be reviewed by the University Biosafety Committee (BGMSC) prior to work commencing. In some cases regulatory notifications and payment of a risk-based fee may be required.

Process:

1. the responsible person (PI) must use the appropriate risk assessment template available from this webpage
2. ask for advice from your school biological safety officer (DBSO)
3. submit completed assessments by email to your DBSO
4. the committee meets quarterly to undertake reviews
   • lower risk work is reviewed between meetings and can be accepted provisionally
5. accepted risk assessments are registered and any regulatory notifications arranged by the University BSO
6. material may be acquired and work may start only after registration and agreement from the regulators
7. PIs must review risk assessments periodically using the online registration system
8. significant changes to work must be reviewed again by BGMSC

Other resources:

• Biosafety committee review flowchart with anticipated timescales
• PIs tailored roadmap of project risk assessment and licensing
• Biosafety committee information and calendar

Purpose: Assessing risks and identifying measures to eliminate or control risks to human health and safety and the environment caused by activities involving deliberate work with biological agents and work with tissue or body fluids that may contain biological agents. This template must not be used for any material that is or will be genetically modified.

Resources: 

• Biological agents and contaminated materials risk assessment template
• Biosafety committee review flowchart with anticipated timescales

Completed by: Researchers planning to carry out work with human pathogens, potentially infectious material or other harmful biological substances. You can ask for assistance from your school biological safety officer (DBSO).

Mandatory registration and review: Please contact your DBSO who will arrange for activity registration and risk assessment review by the biosafety committee, as required by University policy. You may be required to make a notification to the regulator and the University BSO will arrange this with you after the committee review and activity registration. Work may not start and material must not be acquired until this process has been completed.

Related resources:

• Biosafety committee review flowchart with anticipated timescales
• Management and operation of microbiological containment laboratories
• Approved list of biological agents
• Working safely with research animals: management of infection risks
• Infection risks to new and expectant mothers
• Control of Substances Hazardous to Health Regulations ACOP

Purpose: Assessing the risks to human health and environmental safety for work involving genetically modified microorganisms including eukaryotic cell cultures (GMM). The template includes a lentivirus vector information sheet to complete if this vector will be manipulated. This process determines an appropriate containment level for handling the GMM and thereby an activity classification defined in the regulations. This template can also be used to assess work with unmodified biological agents and contaminated material if it is part of the scope of the same activity. Please supplement with the GM plant or GM animal templates if these large GM organisms are used as part of the same activity.

Resources:

• GM microorganisms and cell cultures risk assessment template
• Guidance for completing biorisk assessment template
• Biosafety committee review flowchart with anticipated timescales

Completed by: Principal investigator or responsible person. You can ask for assistance from your school biological safety officer (DBSO).

Mandatory registration and review: Please contact your DBSO who will arrange for activity registration and risk assessment review and classification by the biosafety committee, as required by regulation. You may be required to make a notification to the regulator and the University BSO will arrange this with you after the committee review and activity registration. Work may not start and material must not be acquired until this process has been completed.

Related resources:

• Scientific guidance on GM hazards and risk assessment for laboratories and clinical settings
• Management and operation of microbiological containment laboratories
• Approved list of biological agents

Purpose: Assessing the risks to human health or the environment from work involving genetically modified (transgenic) animals. This must be supplemented with other risk assessment templates if relevant, such as for work with biological agents or genetically modified microorganisms/cell cultures or GM plants.

Resources: 

• GM animals risk assessment template
• Biosafety committee review flowchart with anticipated timescales

Completed by: Principal investigator or responsible person. You can ask for assistance from your school biological safety officer (DBSO).

Mandatory registration and review: Please contact your DBSO who will arrange for activity registration and risk assessment review by the biosafety committee, as required by the UK regulations. You may be required to make a notification to the regulator and the University BSO will arrange this with you after the committee review and activity registration. Work may not start and transgenic animals must not be acquired until this process has been completed.

Related resources:

• Scientific guidance on GM hazards and risk assessment for laboratories and clinical settings
• Management and operation of microbiological containment laboratories
• Approved list of biological agents

Purpose: Assessing the risks to human health or the environment from work involving genetically modified (transgenic) plants. This must be supplemented with other risk assessment templates if relevant, such as for work with biological agents or genetically modified microorgansisms/cell cultures or GM animals.

Resources: 

• GM plants risk assessment template
• Biosafety committee review flowchart with anticipated timescales

Completed by: Principal investigator or responsible person. You can ask for assistance from your school biological safety officer (DBSO).

Mandatory registration and review: Please contact your DBSO who will arrange for activity registration and risk assessment review by the biosafety committee, as required by the UK regulations. You may be required to make a notification to the regulator and the University BSO will arrange this with you after the committee review and activity registration. Work may not start and transgenic plants must not be acquired until this process has been completed.

Related resources:

• Scientific guidance on GM hazards and risk assessment for laboratories and clinical settings
• Management and operation of microbiological containment laboratories
• Approved list of biological agents

Purpose: Online tool for completing biorisk assessment reviews with a built-in monitoring system to periodically identify which activities are due for review.

Resource: Review tool (Biorisk management system)

Completed by: The responsible person for each activity risk assessment must review them as soon as they become invalid and should also schedule reviews every one, two or three years. Refer to the guidance and workflows that are available within the online tool or contact your DBSO for further support.

Related resources:

• Review form guidance
• Review process workflows
• Review process guide for DBSOs 
• GMO(CU) 2014 toolbox talk
• Significant change: guidance by example (ISTR)

Purpose: Guidance for research work with:

• exotic and UK native species of arthropods, such as mosquitoes, biting midges and ticks
• GM insects that are vectors of virus diseases affecting animals, such as bluetongue virus or African horse sickness virus
• GM insects that are vectors of virus diseases affecting humans, such as Zika virus or dengue fever virus

Resource: Arthropods guidance

Produced by: UK biosafety advisors on behalf of HSE and was first published in September 2017.

Purpose: Guidance for using microbiological safety cabinets (MSC), which protect people and the environment from infectious and hazardous material using a combination of airflow and HEPA filtration to contain aerosols generated during your work, covering:

• What a MSC is used for
• The types of MSC (class I, II, III and hybrids) and selection
• Installing and positioning MSCs correctly to ensure they provide protection
• Training and ergonomic use to prevent user fatigue, stresses and strains
• Routine maintenance and testing

Resources:

• ACDP guide to microbiological safety cabinets
• Microbiological safety cabinet selection assessment

Training: The effectiveness of MSCs depends on their correct selection, installation, use and routine maintenance and testing. All users should be trained and have their training recorded, making sure they understand:

• how MSCs work
• how to use MSCs effectively

Selection and purchasing:

• Use the guidance to select the type of MSC you need for your work. This will help you identify if you can use an existing MSC or will need to purchase a new one.
• Use your activity risk assessment to record your MSC type selection.
• Complete the online form if you think you need to purchase a new MSC.
• Your building safety adviser will be emailed with your selection assessment form submission and can help you address any actions needed.
• When purchasing a new MSC, comply with University tender agreements and the Procurement buying guide.

Installation: Before installing the MSC, the supplier must:

• make sure your location is suitable for the MSC selected
• provide a competent installer and test engineer

Maintenance and testing: Once your MSC is installed, you must:

• check your MSC airflows regularly using an anemometer to make sure that users and your work are protected
• ensure your MSC is maintained and operator protection tested at least annually at CL-2 or 6-monthly at CL-3. You can use a University contract for this, which can be arranged by your local safety adviser or technical manager.

Acquisition, storage and use of item on the Schedule 5 list of pathogens and toxin requires:

• notification to the Home Office
• inspection by a police counter-terrorism security adviser
• compliance with more stringent biosecurity requirements

Purpose: Information on using specified pathogens and toxins. is an adapted version of the Anti-terrorism Crime and Security Act, which gives governments the necessary powers to counter the threat of terrorist attacks in the UK, with the Schedule 5 list of specified pathogens and toxins.

How to use: Principal Investigators should contact their SSA and the University Biological Safety Adviser before using any material on this list (or when information they have previously given changes) so that the premises can be inspected and NaCTSO can be notified.

Managers of laboratories and other premises holding stocks of specified disease-causing micro-organisms and toxins are obliged to notify their holdings and comply with reasonable security requirements imposed by a Counter Terrorism Security Adviser (CTSA) based in the local police force. Details of who has access to the dangerous substances held there must also be provided, on request. The Secretary of State is given power to direct that a named individual must not be allowed access to such disease strains or the premises in which they are held.

Pathogens classed as Category A Infectious Substances under carriage of dangerous goods legislation also have elevated biosecurity requirements, which will need to be addressed well in advance of transporting this material to or from a University building.

Resource: Notifiable pathogens and toxins

Audits: The University Biological Safety Adviser audits Schools on their holdings and liaises with the National Counter Terrorism Security Office (NaCTSO) and CTSAs regarding work with and the secure design of premises holding scheduled material.

Please contact your DBSO or the University Biological Safety Adviser for further advice if your work will be affected by these requirements.

Related resources:

• Anti-terrorism, Crime and Security Act 2001
• Anti-terrorism, Crime and Security Act 2001 (Modification) Order 2012
• Transport of biological materials
• Security in transport

Purpose: Guidance for University personnel proposing to work with eukaryotic cell culture systems covering the requirements of COSHH. COSHH includes cell culture in the definition of a biological agent as they may be infected with adventitious biological agents such as mycoplasmas (e.g., Mycoplasma pneumoniae) or viruses. Sometimes they may have also been infected intentionally.

The nature of cell culture systems also means that they are often able to sustain and allow amplification of such agents during use. In addition, cells may also present other hazards to human health, such as the ability to produce toxins or allergens.

How to use: An assessment of the risks must be undertaken before work involving any cell cultures commences.

Resource: Cell culture guidance

Related resources:

• HSE: Management and operation of microbiological containment laboratories
• HSE: Guidance from The Scientific Advisory Committee on Genetic Modification
• Cell culture training
• PHE: Fundamental techniques in cell culture laboratory handbook (4th Ed.)
• CRUK: Guidelines for the use of cell lines in biomedical research
• Biological Agents Risk Assessment Form
• Genetically Modified Biological Agents Risk Assessment Form 

Purpose: Outlining the principals of good microbiological practice and the containment measures for work with biological agents or materials contaminated with such agents required by COSHH. The person responsible for an activity involving biological agents must also consider the requirements for biosecurity and the containment requirements when working with any genetically modified organisms or specified animal pathogens and the most stringent measures identified by risk assessment and required by regulation must be applied. There is additional guidance on GMOs and SAPO under related resources below and on this webpage.

Resources:

• HSE: Management and operation of microbiological containment laboratories

Related resources:

• HSE: The approved list of biological agents
• HSE: Guidance from The Scientific Advisory Committee on Genetic Modification
• Defra/AHVLA: Animal pathogens - guidance on controls
• Pathogen data sheets (Canadian requirements; provided for hazard information only)
• Biorisk management policies, procedures and resources

Purpose: Guidance on risk assessment, sample triage, regulatory clearance and the arrangements required for work involving human tissue. Tissue contamination risk should always be considered, taking into account the source of the tissue, disease prevalence and the likely affected tissues.

All new risk assessments or risk assessments revised due to a significant change, that involve human tissue whatever the source, must be reviewed by the biosafety committee before work commences or changes to ensure a suitable and sufficent assessment and adherence to regulatory permissions. The committee and Biological Safety Advisor are also available for further advice.

Resource: Human tissue research work (SharePoint site)

Related resources:

• Good microbiological practice and containment (guidance on this page)
• HSE: Management and operation of microbiological containment laboratories
• HSE: The approved list of biological agents

Purpose: Guidance on the requirements for decontamination and disposal of biohazardous materials (infectious and/or GM wastes). Waste must be segregated into a number of distinct fractions to satisfy legislative requirements and University environmental policies. Biological research and teaching laboratories generate certain wastes that should or in some cases must be decontaminated before disposal as they contain or might contain substances that are infectious (to humans, animals or plants) and/or because they contain GMOs.

How to use: This guidance supplements the Sustainability hazardous waste disposal charts by providing guidance on how these waste materials from laboratories should be segregated and decontaminated using local procedures prior to disposal or be disposed of directly via incineration.

Resource: Waste decontamination and disposal guidance

Hazardous waste storage, incineration and disposal is also managed by Sustainability under the University's hazardous waste managemtn system.

Related resources:

• Decontamination and disposal charts
• University hazardous waste management system
• Virkon historical efficacy data* and Lanxess Virkon website
• Defra (approved disinfectants for use against animal pathogens)

* Virkon and other disinfectants. The effectiveness of disinfectants is influenced by many factors and disinfectants should be used in accordance with manufacturer's instructions and efficacy data. Virkon is used extensively in the University and so historical efficacy data from the manufacturer is reproduced in this document. The manufacturer should be consulted for up to date data and to obtain specific reports. Other reliable sources of information (eg, research publications) may also be used for determining efficacy in any given situation and be referenced in the activity risk assessment. In all cases, the conditions of use in the laboratory should equate to the validation methods cited in the sources of information used. Where necessary, and proportionate to the risk, in-house experimental data may be required to be confident of effectiveness.

Purpose: Transport of dangerous goods is regulated to prevent, as far as practicable, harm to persons or the environment and damage to property during all stages of the transport chain. The United Nations has developed a harmonised system for hazard classification and risk reduction methods for the different modes of transport (road, rail, sea and air) which are reflected in national and international regulations for the transport of dangerous goods.

How to use: This guidance is concerned with the transport of biological materials including cells, tissues, pathogens, toxins and associated refrigerants such as dry ice. It also covers material that is exempt from the relevant regulations. The guidance should only be used with appropriate training and is not authoritative.

Resource: Transport of biological materials guidance

Relevant for: Trained University staff when classifying biological materials and associated substances for transport to meet the shipping requirements for any that are classed as dangerous goods for transport.

Reviewed periodically to take account of revisions to the modal regulations and guidance.

Animal pathogens that enter the environment could cause serious animal disease.

Biorisk management and containment measures should be in place to prevent:

• misuse
• release
• escape

You must also consider any hazard to human health and any regulated genetic modification.

Using specified animal pathogens on University premises

• Use of certain animal pathogens and any carrier material on University premises is controlled under the Specified Animal Pathogens Order (SAPO).
• The guidance under resources below tells you which pathogens are specified and what the minimum containment and control requirements are.
• The University of Bristol works with specified animal pathogens under a licence issued to it by HSE.
• The Registrar is the signatory to the licence on behalf of the University.

The responsible person (PI) for the work with each pathogen operates under the conditions:

• determined in their risk assessments and
• set by the licence for that pathogen

To obtain or work with specified animal pathogens or change work that is already licensed, contact the University Biological Safety Advisor because this will require:

• BGMSC review
• approval by the Registrar
• application to, and possibly a premises inspection by, the Regulator

Resource: HSE: Specified animal pathogens and requirements for containment and control

When: This process can take several months and should be started well in advance. 

Using non-specified animal pathogens

You must consider any hazards to human health from the work with these pathogens or any genetic modifications that have been or will be made and complete the appropriate biosafety risk assessments and obtain any approvals required.

Importing animal pathogens

You will need a specific licence from the Animal and Plant Health Agency (APHA) to:

• import specified animal pathogen or carriers (you will first need an activity licence from HSE; see above)
• import and use non-specified animal pathogen or carriers

If you need your own import licence for non-specified animal pathogens then you will need to be able to confirm to APHA that you will handle material in CL2 or equivalent laboratories (or higher if required for human health protection), that you will autoclave and/or incinerate waste and that your building is registered as a premises that can handle this type of product with APHA (there is a list of registered premises and material they can handle and the relevant reference number on this page)

Contact the Biological Safety Advisor before obtaining these import licences.

Animal material is called animal products, by-products or products of animal origin in regulations and includes such things as blood components, antibodies, cells, tissues, and organs. There are strict requirements around importing animal material into GB, including for research purposes, and you are likely to require a licence unless there is an existing generic licence provided by Defra that you can follow for import and work with your animal or animal material. You are advised to read the relevant Government webpage and contact the Animal and Plant Health Agency for information about how to import your specific animal or material and the documentation required. Recent enquiries suggest that research material is exempt from the Government's notification of import of products, animals, food and feed system (IPAFFS) but if you are asked to notify by APHA, then please contact the University Governance team in DREI for information about the University's registration on that system.

If you need your own import licence then you will need to be able to confirm to APHA that you will handle material in CL2 or equivalent laboratories, that you will autoclave and/or incinerate related waste and that your building is registered as a premises that can handle this type of product with APHA (there is a list of registered premises and material they can handle and the relevant reference number on this page)

Contact details for the APHA import team are

Centre for International Trade - Carlisle
Eden Bridge House
Lowther Street
Carlisle
CA3 8DX
Email: Imports@apha.gov.uk
Telephone: 03000 200 301

When applying for individual animal material import licences, you will be asked for details of the University premises registration for use of animal by-products (ABPR). The University has registered buildings where it is believed that activities involving animal material take place.

APHA have agreed to group these under two registrations based on geographical location.

Check the following registration documents to ensure that your building and activity type are covered before quoting the reference number from the document (activities are listed first, then buildings included).

• City sites (includes UHB and NB NHS sites)
• Langford sites

Updated on 31 July 2018 to add new and/or remove unused buildings.

If your building or activity needs to be added, contact the University Biological Safety Advisor or the Waste Manager in Sustainability.

• The University of Bristol has registered as a Scientific Institution entitled to the exemption provided by Article VII, paragraph 6, of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).
• This allows for the managed transfer of certain curated herbarium specimens, other preserved, dried or embedded museum specimens, and live plant material covered by the convention between registered institutions for the purposes of non-commercial scientific research.
• This registration is administered on behalf of the University by the Faculty of Life Sciences, please contact the Biological Sciences Technical Manager, Anthony Crawford.
• For all other CITES questions, please contact the Animal and Plant Health Agency's Centre for International Trade in Bristol.
• You must keep a record of all material transfers by contacting your School Safety Advisor.

Purpose: There are many plant pests and diseases which, if they were to become established, could cause serious damage to crops, plants and the environment in the UK. To guard against the spread of harmful organisms official controls apply to the import, movement and keeping of plants, plant pests and other material, such as soil.

Import and licensing controls are in addition to any health and safety requirements under the Control of Substances Hazardous to Health Regulations, the Genetically Modified Organisms (Contained Use) Regulations and University policy.

How to use: Refer to the Animal and Plant Health Agency for guidance and contact them for the latest advice on import controls.

Resource: 

• Information leaflets and licence application forms are available from the Animal and Plant Health Agency (APHA, formerly Fera).
• The UK Plant Health Risk Register is an evolving searchable database of plant pests and any licensing requirements being developed by Defra

Relevant for: University personnel wishing to import and/or work with plants, plant material, plant pests, plant pathogens, soil and growing medium.

Purpose: Template for assessing risk and clearing equipment can be released from a hazardous area for servicing, maintenance, repair or disposal. The permit template covers biological and chemical contamination and incorporates and supersedes the radioactivity clearance certificates RP15 and RP15a.

How to use: The permit must accompany the equipment when leaving the hazardous area. Give suppliers a copy of the permit in advance so any precautionary measures can be discussed and implemented.

Resource: Contaminated item clearance permit

Completed by: This task must be undertaken by or with the person responsible for health and safety within the area housing the equipment (PI, laboratory manager, RPS, etc).

Purpose: Template for determining risks and control measures for clearance of an area previously used to accommodate biological, chemical or radioactive material and associated activities and equipment, with information about decontamination and precautions for the next users of the space.

How to use: This permit template assists with the process of clearing out decommissioned workspaces to allow for maintenance and refurbishment. It can also be used prior to an occupier moving from the area to determine the likelihood of contamination with hazardous biological, chemical or radioactive material. This template complements the contaminated item clearance permit and should be used in conjunction with that form.

Resource: Hazardous area clearance permit

Completed by: The assessment should be undertaken by or with the person responsibility for health and safety within the area, and in the case of radioactive contamination, the appropriate Radiation Protection Supervisor.

Purpose: A form of risk assessment to safely manage the entry of non-laboratory staff into laboratories, where they cannot reasonably be expected to understand or perceive all potential hazards.

Resource: Permit to work

Completed by: Staff member with sufficient knowledge of the laboratory activities undertaken in the areas covered by the permit, on behalf of the school or department. For radiation-controlled areas, the DRPS must also complete Form RP10 and link it to this permit.

Purpose: Template for recording laboratory inspections and action plans. Completed forms may be used as part of an inspection by Safety and Health Services and may also be required as evidence to give to external regulators or insurance inspectors.

How to use: This inspection form could be used for a full inspection and as guidance for other inspections. It has been divided into several sections:

• a general section applicable to all facilities
• optional sections that address particular types of hazards that might be present in a laboratory

The inspection team should decide which of the optional sections are applicable before each inspection or audit takes place. Therefore, although the form appears long, it may not always be necessary to complete all sections.

Resource: Laboratory inspection form

Completed by: The form is also suitable for SSAs to issue to laboratory supervisors or managers for a self-assessment inspection.

When: Full laboratory inspections should take place annually or every six months for high hazard areas. Intermediate inspections should take place regularly in each laboratory by staff.

Completed inspection forms with updated actions should be retained (either in each laboratory or collated by the SSA) for at least 3 years and be available for routine inspections or health and safety audits.