Terms of Reference and Constitution
Document owner: Biological Health and Safety Manager
1. Origin
- To assist the University of Southampton in effectively discharging its responsibilities with regard to regulation 8 of The Genetically Modified Organisms (Contained Use) Regulations 2014 and schedule 3 of the Control of Substances Hazardous to Health Regulations 2002 (as amended).
2. Purpose
- To give advice on risk assessment for all University activities involving biological agents defined as any microbiological entity, cellular or non-cellular, naturally occurring or engineered, capable of replication or of transferring genetic material that may be able to provoke infection, allergy, toxicity or other adverse effects in humans, animals, or plants.
- To give advice on risk assessment for all University activities involving biological materials defined as any material comprised of, containing, or that may contain biological agents and/or their harmful products such as toxins or allergens.
- To give advice on risk assessment for all University activities involving toxins defined as substances produced by plants, animals, protists, fungi, bacteria, or viruses, which in small amounts produce an adverse effect in humans, animals, or plants.
- To provide consent in relation to items above such that work may commence, subject to any further consent from enforcement agencies as may be required.
- The Chair is responsible for ensuring that any equality impacts have been considered as part of the decision-making process.
3. Responsibilities and activity
- To receive for review and to provide advice on risk assessments for all contained use activities in relation to the Genetically Modified Organisms (Contained Use) Regulations 2014.
- To receive for review and to provide advice on risk assessments for all hazard group 3 contained use activities in relation to the Control of Substances Hazardous to Health (as amended) Regulations 2002, Regulation 7(10) Schedule 3.
- To receive for review and to provide advice on risk assessments for all activities involving animal pathogens under Schedule 1 of the Specified Animal Pathogens Order 2008.
- To receive for review and to provide advice on risk assessments for all activities involving agents under Part 7, Schedule 5 of the Anti-Terrorism, Crime and Security Act 2001.
- To review GM risk assessments on behalf of University Hospital Southampton Foundation Trust to allow them to effectively discharge their responsibilities with regard to regulation 8 of The Genetically Modified Organisms (Contained Use) Regulations 2014. Until such date that they implement their own Committee.
- To receive notification of Genetically Modified Organisms (Deliberate Release) trials undertaken by the University of Southampton or the University Hospital Southampton, with regard to section 12, (4), (c) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002.
- To delegate consent for commencement of GM Activity Class 1 projects to the Biological Health and Safety Manager ahead of formal review by the Committee.
- To delegate consent for commencement of Control of Substances Hazardous to Health Hazard group 2 contained use activities to the Biological Health and Safety Manager.
- To delegate consent for the use of biological toxins to the Biological Health and Safety Manager.
- To have oversight of all Biological Risk Management System audit findings and to check that all major non-conformities resulting from these audits are completed within the required timescales.
- To review the minutes of the Containment level 3 Management Committee for all hazard group 3 contained use activities in relation to the Control of Substances Hazardous to Health (as amended) Regulations 2002, Regulation 7(10) Schedule 3.
- To review all Biological Risk Management System audit findings and to check that all major non-conformities resulting from these audits are completed within the required timescales.
- To review the effectiveness of the University Biological Risk Management System, policies and procedures.
4. Reporting arrangements
- This Committee reports to the University Health and Safety Committee.
5. Constitution
Chair (appointed by UHSC for a maximum of three terms, each term not exceeding 3 years)
Deputy Chair – University Biological Health and Safety Manager (permanent member)
Representatives of Academic staff (one from each School working with biological agents. Appointed for a maximum of three terms, each term not exceeding 3 years)
- Biological Sciences
- Ocean and Earth Sciences
- Chemistry
- Cancer Sciences
- Human Development and Health
- Clinical and Experimental Sciences
- Health Sciences
Representatives of technical staff (one each from the Faculties working with biological agents. Appointed for a maximum of three terms, each term not exceeding 3 years)
- Faculty of Medicine
- Faculty of Environmental and Life Sciences
A representative of the Health, Safety and Risk Directorate (permanent member)
Representatives of Postgraduate Students (one each from the Highfield campus and Southampton General Hospital campus Appointed for 1 term, not exceeding 2 years)
- Highfield
- Southampton General Hospital
Representatives with specialist expertise (Appointed for a maximum of three terms, each term not exceeding 3 years)
1. Clinical trial expert
The Committee may co-opt additional members (whether members of the University or not) for a period of up to one year to provide specialist skills, knowledge or experience. Co-opted members will have a right to speak, but not vote. Co-opted members will not be included in any calculation of the quorum.
6. Quorum and frequency
6.1 Quorum
- Quoracy is a minimum attendance of half the current Committee members plus one present at each meeting or half the current Committee members plus one must respond before an online decision can be made.
6.2 Frequency of meetings
- Meetings to be held triannually.
7. Resources
- Provision of secretariat support
8. Terms of Reference review
Date of last review: 2 May 2023
Date of next review: 7 May 2024