Management of Biological Safety Policy

Policy statement

The University of Dundee is committed to ensuring risks from biological materials are managed effectively by carrying out risk assessments that are comprehensive, proportionate to the level of harm, involve staff and are communicated clearly to staff and students so that they understand their responsibilities.

Arrangements

Reporting lines are detailed in the University Health & Safety policy. Specific responsibilities for managing biological risks are outlined below.

Head of Division (HoD) must have arrangements in place to ensure:

• risk assessments are carried out
• laboratory facilities are adequate
• local rules are drawn up, and implemented
• appropriate waste disposal procedures are used
• necessary licences are obtained
• emergency plans are drawn up if required
• microbiological safety cabinets and autoclaves are tested at least annually
• staff and students receive vaccination and health surveillance if required
• records of an individual’s work with Hazard Group 3 and 4 micro-organisms are kept
• appropriate training is in place
• accidents and spillages involving micro-organisms are investigated and reported to University Biological Safety Adviser (UBSA)
• accident report recommendations are implemented
• spillages of genetically modified micro-organisms (GMM) and escape of genetically modified organisms (GMO) are recorded, investigated and reported to UBSA
• biological safety inspections are carried out at least once a year
• inspection report recommendations are implemented
• notifications are made to the Health and Safety Executive (HSE) if required
• competent Biological Safety Advisers (BSA) are appointed
• these arrangements are reviewed at least annually

Principal Investigator (PI) or other delegated competent member of staff must

• carry out risk assessments by completing appropriate forms issued by Safety Services or equivalent forms
• inform staff and students of risks when working with biological agents and control measures to minimise risks
• formulate and implement local rules appropriate for the work being undertaken and facilities available
• ensure staff and students comply with local rules
• obtaining licence to work with animal and plant pathogens if required
• notify and obtain consent from HSE to work with genetically modified organisms if required
• keep records of an individual’s work with Hazard Group 3 and 4 micro-organisms
• draw up emergency plan if required, and instruct staff in contents
• report accidents and spillages of GMM and escape of GMO to BSA
• report accidents and spillages of pathogens to BSA
• train staff

Staff and students must:

• follow local rules as instructed
• dispose of waste as instructed
• report accidents and spillages of GMO and pathogens to PI and BSA
• report shortcomings in working procedures to PI and BSA

Biological Safety Adviser (BSA) will:

• advise on risk assessments
• advise on local rules
• advise on licences required
• advise on disinfection and waste disposal
• provide list of pathogens to UBSA annually
• ensure microbiological safety cabinets and autoclaves are tested when required
• monitor compliance with local rules on a regular basis, and reporting non-compliance to PI, and if necessary HoS and UBSA
• perform formal biological safety inspections at least once a year as part of an inspection team
• investigate accidents, spillages of GMM and pathogens, and escape of GMO reported by staff and students, and notify HoD and UBSA of findings and recommendations

University Biological Safety Adviser (UBSA) will:

• draw up policies to ensure all university employees fulfil their statutory duties
• keep copies of genetic modification risk assessments
• ensure risk assessments are reviewed by Genetic Modification Safety Committee if required
• ensure work is notified to HSE if required
• report accidents to HSE if required
• report spillages of GMM and escape of GMO to HSE if required
• keep register of pathogens used in research
• give advice to BSA on any issue
• train BSA in risk assessment
• organise and take minute of Committee meetings

Biological and Genetic Modification Safety Committees will:

• comprise Convener, BSA’s and UBSA
• meet twice a year
• report to Health and Safety Sub-committee on risks posed to people and the environment by biological hazards created by the University
• give advice on risk assessments carried out under Genetically Modified Organisms (Contained Use) Regulations 2000
• review accident/incident reports concerning GMO and request a revised risk assessments if required
• review inspection reports.
• authorise work involving genetically modified organisms to proceed after consideration of:
  • the risk assessment
  • laboratory facilities
  • staff and student training and supervision
  • local rules
  • arrangements for testing control measures such as microbiological safety cabinets and autoclaves
  • statutory notification and consent requirements.

Companies working with genetically modified organisms within University premises must:

• receive authorisation for the work to commence from the City Campus Biological Safety and Genetic Modification Safety Committee or the Ninewells Genetic Modification and Biological Safety Committee
• submit a risk assessment to the Committee via the UBSA. The risk assessment must document the containment facilities, procedures, and competence of staff to control risks to human health and the environment. Authorisation will only be given if the committee consider risks to human health and the environment are controlled adequately
• cease work immediately if requested by the UBSA or other member of the City Campus Genetic Modification Safety Committee or Ninewells Genetic Modification and Biological Safety Committee.
• comply with Local Rules issued by the University.
• notify accidents involving genetically modified organisms to the UBSA
• notify escape of genetically modified organisms to the UBSA.
• appoint a competent BSA from senior management. The BSA will be responsible for ensuring compliance with Items 1-5 above, and will liaise with the UBSA

Guidance note on management of biological safety

Competence, training and supervision

Staff and students working with biological agents must be competent to work safely. Previous work experience in another laboratory or holding a paper qualification does not mean a person is competent to work safely. Competence must be assessed for everyone working in the laboratory and if judged to be inadequate training and a high level of supervision must be given. Training programmes should be tailored for each individual taking into account their level of knowledge, experience and the type of work undertaken. Training should include the following:

• information regarding hazards and safeguards to prevent exposure/infection
• knowledge and understanding of local rules
• knowledge and understanding of disinfection policy
• knowledge and understanding of waste disposal procedures
• knowledge and understanding of emergency spillage procedures
• technical competence for all aspects of the work, for example, use of microbiological safety cabinet, centrifuges, automatic pipette aids
• securing and sealing microbiological safety cabinet following spill within cabinet, and fumigation procedures
• safe evacuation and sealing of Containment Level 3 laboratory following spill outside cabinet, and fumigation procedures
• safe transport and storage of micro-organisms and genetically modified organisms
• accident/incident reporting including personal injury, near misses, spillages and breakages, escape of GMO, non-compliance with local rules, for example, wrongly packaged or labelled containers

Written records of training should be kept.

All members of staff and students must be continually supervised until they can demonstrate:

• a satisfactory level of technical competence
• a full understanding of local rules
• correct response to spillage, accident, or another emergency

Inspection

At least once a year as part of the formal inspection of laboratories the inspection team must consider biological safety. The inspection team should include the BSA, School Safety Adviser and Laboratory Manager. The UBSA will be invited to participate in these inspections, and typically will attend six such inspections throughout the year. A typical inspection checklist for a laboratory where biological research is carried out is available on the Safety Services Sharepoint site. The inspection team should give a short verbal report to the Head of Division on the inspection day, and also prepare a formal report with a time-scale for remedial actions. This report should be kept in Divisional Safety Files and discussed at the Divisional Safety Meeting.

Handbooks

The following handbooks on the Safety Services Sharepoint website should be consulted as appropriate before completing a risk assessment:

• Working Safely with Micro-organisms
• Working Safely with Human Blood, Tissues and other Specimens in a Research Laboratory
• Working safely with Genetically Modified Organisms in a Research Laboratory
• Safe Disposal of Biological/Clinical Waste
• Safe use of a Microbiological Safety Cabinet

Risk assessment forms

Risk assessment forms listed below are available on the Safety Services Sharepoint website.

• Biological Research Laboratory Inspection Report
• USS/Fast Track Genetically Modified Micro-organisms
• USS/Genetically Modified Micro-organisms
• USS/Gene Therapy
• USS/Genetically Modified Animals
• USS/Micro-organisms
• USS/Human Samples

Document information