Policy
Management of Biological Safety Policy
How the University manages risks from biological materials.
Updated on 30 September 2024
1 Biological Safety Management
1.1 Purpose
To ensure that academic Schools have appropriate arrangements in place for the management of risk posed by work (including storage, inactivation and transportation) with biological material.
1.2 Objectives
To ensure that School management are aware of their responsibilities regarding:
- General controls necessary to manage the risks of work with biological material
- Work with Genetically Modified Organisms and certain human or plant pathogens
- Storage and transportation of biological material
- Inactivation and disposal of biological material
- Monitoring of compliance with requirements (inspections)
2 Policy Statement
Schools are required to ensure that risks from work with biological material are managed effectively to prevent adverse health and safety events resulting from activities being undertaken. Schools will implement the procedures and practices detailed below and will also comply with other University policies as appropriate to the activities undertaken.
3 Arrangements
3.1 General controls necessary to manage the risks of work with biological material
Definitions of biological material covered by this policy are provided in section 4.1.
Schools within the University Dundee will ensure that only competent individuals, having the appropriate knowledge, experience and skill, undertake work with biological material. Group leaders will be appointed who possess this competence and they will train and supervise more junior staff and students. Only people who have been trained to a high level and demonstrate appropriate competence and understanding of the risks will be allowed to work with material (including micro-organisms) posing serious risk of ill health. See appendix 1 for further details.
Each School working with biological material will appoint a Biological Safety Advisor (BSA) who has appropriate knowledge and expertise to provide general advice on safe working with biological material and act a link to the University Biological Safety Advisor (UBSA). The School BSA also has specific duties with regard to work with genetically modified organisms (see section 3.2 below). Schools where work licensed under the Specified Animal Pathogens Order (SAPO) takes place will also appoint a Biological Safety Officer (BSO) and deputies (if appropriate). The BSO will be a member of management (e.g. a Principal Investigator) and will have executive authority and management responsibility, and will act as the responsible individual for the license holder (University of Dundee).
The duties of all individuals involved in the management of biological safety are provided in Appendix 1.
Each School working with biological material will ensure that appropriately designed and equipped facilities are available for the work, which comply with relevant containment requirements stipulated in Regulations (see section 4.2). Reference should be made to the relevant University safe working handbook and advice sought from the BSA and/or UBSA as necessary.
Each School working with biological material will ensure that appropriate risk assessments are undertaken in relation to the work activities, taking account of the specific hazards posed by the biological material used. Risk assessments will be conducted by researchers and reviewed by the senior research lead (usually Principal Investigator) for the area where work will take place. The BSA and UBSA will be involved as necessary in the risk assessment process and risk assessments will be reviewed by the University Biological Agents Committee (see appendix 2) prior to work commencing, with notifications to HSE and/or relevant licenses obtained as necessary.
Each School working with biological material will provide an annual return to the UBSA containing information about all potentially harmful biological agents and toxins held by the School (whether being actively worked with or stored).
3.2 Work with genetically modified organisms and certain human or plant pathogens
The University Biological Safety Committee fulfils the legal duties of a Genetic Modification Safety Committee (GMSC). The Committee is chaired by the Vice Principal (Research), and has the composition and remit stated in the University Health and Safety Policy.
Schools working with genetically modified organisms will ensure that a BSA with knowledge of genetic modification methods is appointed and advises group leaders on these risks. The BSA will review all GM risk assessments prior to them being provided to the UBSA for consideration by the University Biological Agents Committee. Risk assessments will be notified to HSE as necessary by the UBSA and associated fees paid by the School. Appendix 2 provides details of how the Biological Agents Committee operates.
Schools will obtain, renew, and pay any fees in relation to licenses required for work with certain animal and plant pathogens. The UBSA will be notified of any such work being planned.
3.3 Storage and transportation of biological material
Schools storing biological material will ensure that appropriate storage systems are in place, including the cataloguing of stored material and mechanisms to prevent unauthorised access to stored material.
All transport of biological material will be undertaken in a way that prevents risk of release during transport. Double containment must be used as a minimum for local transportation. Transportation of biological material off campus must be in accordance with relevant road/air transportation regulations. A trained Dangerous Goods Safety Advisor has been appointed by the University and can advise the School if necessary. Specialist courier services will be employed for transportation of hazardous biological material. Appendix 3 provides further guidance on transportation of biological material.
3.4 Inactivation and disposal of biological/clinical material
Biological material that poses a risk of infection will, where possible, be rendered inactive by a validated means prior to leaving University premises. Appropriate physical (e.g. autoclave) or chemical (e.g. treatment with a disinfectant) methods will be used. Treatments must be validated to ensure that inactivation of infectious agents known or suspected to be present has taken place and inactivation details must be included in risk assessments for handling the material. Where biological material posing an infection risk cannot be rendered inactive (or where the nature of the material means that it requires a special final disposal procedure, such as incineration), a suitably licensed and authorised waste contractor must be used. It may also be necessary to seek consent of HSE for such a route to be used and Safety Services must be consulted if disposal without prior inactivation is planned. In most cases it will be necessary to arrange for Safety Services to dispose of the material. Inactivated biological material waste that could be perceived as “offensive” by those encountering it must be placed in “tiger stripe” bags and segregated for final disposal. Biological material (typically “clinical” material) that does not obviously pose a risk of infection must be disposed of via a licensed waste contractor and packaged in an approved type of packaging.
The handbook “Safe Disposal of Biological and Clinical Waste” contains more detail. See also section 3.5 below on autoclaves. Note that Schools operating in NHS-controlled buildings will follow NHS waste management procedures.
3.5 Autoclaves
Autoclaves pose risks directly due to the pressures and temperatures associated with their operation and indirectly due to issues that arise if they fail to inactivate harmful agents in waste. These risks must be controlled through correct selection, use, testing and maintenance in full compliance with legislation and in accordance with best practice. The performance of autoclaves must be verified to ensure that risks from infectious material or micro-organisms are controlled.
Deans must ensure that suitable autoclave facilities are provided and maintained within Schools, that staff and students are competent to use these facilities, and that they follow the approved operating procedures at all times. Specifically, Deans must ensure that autoclave users are trained and fully instructed in correct operating procedures (including selection of appropriate cycles for the type of waste and determining that cycles have completed successfully), the purpose and function of controls and safety devices, and the dangers of bypassing or interfering with safety devices. Users must follow their training and instructions at all times. They must report faults immediately and take steps to prevent use of a faulty autoclave.
Deans must ensure that all autoclaves fulfil standards 1 to 8 below:
- Designed and installed in compliance with BS 2646-1:2021 (or BS EN 285:2015+A1:2021 for steam sterilisers)
- Possess a safety valve to prevent over pressurisation.
- Possess a suitable pressure indicator installed where it can be easily observed.
- Clearly marked with maximum allowable pressure.
- Clearly marked with maximum operating temperature.
- Written operating procedures displayed by the autoclave. These must include daily safety checks for items such as damage to door seal and hinges, smooth operation of door locking mechanism, chamber corrosion and blocked drains, and daily cleaning of chamber.
- Interlock to prevent cycle initiation until the door is securely closed and the chamber sealed.
- Interlock to prevent the door being opened until the temperature is less than 80 deg. C.
Deans will ensure that all new autoclaves of any type are notified to Estates and Campus Services so that they are included in the University register of pressure vessels and subject to statutory inspection as required by the Pressure Systems Safety Regulations 2000 (for autoclaves in areas subject to NHS rules, see below).
Deans will ensure that all infectious waste is rendered non-infectious before disposal by appropriate monitoring depending upon the level of risk. For high-risk waste (e.g. Hazard Group 2 and 3 micro-organisms, and all Class 2 and 3 genetically modified micro-organisms) monitoring must be by a thermocouple placed into the centre of each load, and records must be kept for one year. For low-risk waste (Hazard group 1 micro-organisms and Class 1 genetically modified micro-organisms, potentially infected materials such as human tissues) monitoring can be by other means (e.g. indicator strips placed in the centre of the load), and records should be kept for one year. In both cases, Deans will ensure that the performance of the autoclave is independently validated at least annually by use of a multi-point thermocouple process and that servicing and maintenance is undertaken at appropriate intervals by a competent contractor. Any actions arising from servicing will be implemented.
The Director of Estate and Campus Services will ensure a register of autoclaves operated by University staff and students is kept, and will ensure all these autoclaves are tested by a competent person following a written scheme of examination in compliance with the Pressure Systems Safety Regulations 2000.
At Ninewells Hospital and Dental School
Deans will ensure that new autoclaves are notified to the NHS. The NHS will ensure that autoclaves are tested by a competent person following a written scheme of examination in compliance with the Pressure Systems Safety Regulations 2000.
For guidance on statutory inspections and performance validation, see appendix 4.
3.6 Monitoring of compliance with requirements (inspections)
All areas where work with biological material takes place will be subject to regular inspection by appropriate School staff in conjunction with Safety Services and Union representatives as appropriate, and in accordance with the requirements of University policy “School and Directorate Health and Safety Management”. Deficiencies identified through inspection will be rectified promptly and reports will be discussed locally at appropriate management meetings to ensure actions are completed. The University Biological Agents Committee will also review inspection reports. The University operates a central database for recording inspections and templates suitable for different Containment Level laboratories are available. Further detail is provided in appendix 5.
4 Further Information
4.1 Definitions
Biological materials are:
- cultures and samples of micro-organisms, including genetically modified micro-organisms
- blood, tissue and other specimens, including those that contain or may contain micro-organisms, including genetically modified micro-organisms
- other potentially infectious substances such as viral genomes and prions
4.2 Legislation
Many Acts and Regulations control work with biological material. Not all apply to each type of work, and some are highly specific. Legislation most likely to apply to work within the University is:
- The Control of Substances Hazardous to Health Regulations 2002
- The Importation of Animal Pathogens Order 1980
- The Specified Animal Pathogens Order 2008, The Specified Animal Pathogens (Scotland) Order 2009
- The Plant Health (Scotland) Order 2005, The Plant Health (Official Controls and Miscellaneous Provisions) (Scotland) Regulations 2019
- The Genetically Modified Organisms (Contained Use) Regulations 2014
- The Anti-terrorism, Crime and Security Act 2001
- The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009
- The Special Waste Regulations 1996
4.3 Related University policies and guidance
Related University policies:
- School and Directorate Health and Safety Management
- Control of Substances Hazardous to Health (COSHH)
Related University guidance:
- COSHH Handbook
- Working Safely with Micro-organisms Handbook
- Working Safely with Human Blood, Tissues and other Specimens in Research Laboratories Handbook
- Working Safely with Genetically Modified Organisms in a Research Facility
- Safe Disposal of Biological Waste
- Safe Use of Microbiological Safety Cabinets Handbook
4.4 Appendices
All policy appendices are available on the Safety Services Sharepoint site.
- Appendix 1 - Individuals Involved in Management of Biological Safety
- Appendix 2 - University Biological Agents Committee Role and Operation
- Appendix 3 - Guidance on Transportation of Biological Material
- Appendix 4 - Autoclave Statutory Inspection and Performance Validation
- Appendix 5 - Inspection Database and Templates
5 Document information
5.1 Equality Impact Assessment
This policy has undergone screening for impact on protected characteristics covered under the Equality Act 2010 and no impact has been identified.
5.2 Approvals & Renewals
Document Name | SPA51 - Biological Safety Management |
Status Responsible officer/department/school
Policy owner Date last approved Due for review Authorised and approved for publication Date authorised for publication Information classification: public/internal Location in repository Approval route and history |
Approved People Directorate
Biological Agents Committee 21/08/2024 21/08/2027 Yes 21/08/2024 Public NA Biological Agents Committee 21/08/2024
|
Code | SPA51 |
Safety Services
[email protected]