Level 3 – H&S Policy Structure Working with Genetically Modified Organisms BACKGROUND This policy deals with the health and safety, and legal compliance, aspects of work with genetically modified organisms (GMOs). “Genetically modified organism” means any living organism derived from, or containing, a genetically modified cell. It can be a plant, animal or microorganism. Genetic modification (GM), also referred to as genetic manipulation and genetic engineering, has been developing since 1973. GMOs can be used in contained facilities (as at the University) or deliberately released or grown in the environment as GM crops and animals. LEGISLATION The Genetically Modified Organisms (Contained Use) Regulations 2014 These cover the use of all genetically modified organisms (GMOs) used in contained facilities, not released into the environment. “Use” includes the construction, culturing, storage, transportation, work area decontamination, inactivation and disposal of GMOs. In Regulation 4, The Health and Safety at Work etc Act 1974 is modified to ensure students undertaking contained use GM work in an educational establishment, such as a university, are treated as employees for the purposes of the 1974 Act. The University is required to constitute a Genetic Modification Safety Committee (GMSC), to oversee GM work and comment on GM project proposals. All work with GMOs at the University must be authorised by the University GMSC. All people working with GMOs must be registered with, and approved by, the GMSC. The HSE must be notified before the start of any work involving GM projects at Class 2 or above. Control measures must include the general principles of good microbiological practice (GMP) and good occupational safety and health 1 Genetically Modified Organisms Policy September 2015 (GOSH) detailed in Schedule 7 of the GMO (Contained Use) Regulations 2014. UNIVERSITY POLICY The University of Bath aims to achieve the highest working standards that are reasonably practicable for all work with genetically modified organisms in order to safeguard the health and safety of its staff and all persons that might be affected by those activities. It is the commitment of the University to reduce the risk of unintentional release of, or exposure to, genetically modified organisms and toxins, and to protect the environment. RESPONSIBILITIES Employees Will read relevant risk assessments and comply with the required control measures, such as wearing suitable lab coats, conducting work in a safety cabinet, transporting GMOs in secure containers and observing waste disposal protocols. Will report any incident, accident or defect in equipment relating to the handling of GMOs to the specialist adviser via the University Health, Safety and Environment Service. Will seek advice and register with the Genetic Modification Safety Committee to work with genetically modified organisms. Will cooperate with their supervisors, Health & Safety Advisor, Specialist Health & Safety Officers/Advisors or any other person appointed by the University to monitor biological safety. Line Managers Will inform the GMSC via [email protected] prior to working or supervising work with GMOs at the University of Bath. Will ensure that University policy, procedures and safe systems of work are strictly adhered to in order to ensure compliance with all relevant legislation relating to the use of GMOs (including ordering and acquisition, constructing, growth, transport, storage and disposal). Will ensure that microbiological agents are classified into 1 of 4 hazard groups (defined in ACDP’s Approved List of biological agents), according to their hazard, and are securely stored. 2 Genetically Modified Organisms Policy September 2015 Will assess the risks of GMOs before work starts, considering in particular; (a) The hazard groups of any biological agents that may be present and what form they may be in, e.g. infectious stages or hardy spores; (b) How and where they are present, how they are transmitted and the diseases they cause; and (c) The likelihood of exposure and consequent disease (including the identification of people who may be particularly susceptible, for example because they are immunocompromised), drawing on evidence of the prevalence of infection or other ill effect as experienced within a particular industry sector or workplace. The risks associated with GMOs and contaminated waste material should be assessed at each stage of handling, for example during construction, growth, expression, harvesting and waste disposal. Will ensure that all GMO risk assessments are notified to the GMSC, and that all people planning to work on authorised projects are registered with the GMSC. The GMSC can be contacted at [email protected] Will ensure that any relevant licence (e.g. from DEFRA) is obtained for work with animal or plant GM pathogens. Will ensure that any fees payable to HSE for notification of projects assigned as Class 2 (or above) are paid when the project assessment is sent to the HSE. Will ensure that all workers are competent to work with GMOs, by ensuring they are adequately informed, instructed, trained and supervised. An assessment of competence should be carried out on all persons new to the project and new to a type of work or risk category. Heads of Department Will ensure that their members of staff are aware of, and adhere to, University policy, procedures and safe systems of work in order to ensure compliance with all relevant legislation relating to the use of GMOs. Will ensure sufficient resources are provided to adequately maintain and test controls such as autoclaves and microbiological safety cabinets. Will ensure that biohazard signs (image on right) are displayed and maintained on the doors of facilities housing Class 2 GM projects, and security arrangements are implemented to prevent unauthorised access in areas identified by biohazard signs. Head of University Health, Safety & Environment Service Will ensure a University Genetic Modification Safety Committee is constituted, and relevant employee safety representatives are invited to sit 3 Genetically Modified Organisms Policy September 2015 on it. Will ensure that, under the Management of Health and Safety Regulations 1999, appointments will be made, in writing, of any specialist Health & Safety Officers/Advisers to support the GMSC. Will produce and review this policy biennially or after any significant change whichever is the soonest. Chair of the University Genetic Modification Safety Committee Will ensure that the Committee be comprised of sufficient members to provide expertise on any project coming before the GMSC. Will comment on proposals for work involving GMOs, and authorise such proposals as well as the personnel planning to do GM work. Will identify additional training needs for personnel who cannot demonstrate competence to work with GMOs. Will ensure that Local Rules and protocols for the safe and contained use of GMOs are published. Specialist Health & Safety Advisors/Officers Will advise on the occupational aspects of work with any biological material, as well as liaising with the enforcing authorities for work with Hazard Groups 3 and 4 microorganisms and relevant toxins. Will coordinate the training of personnel needing competence in performing work with biological agents, particularly genetically modified microorganisms. Will check that controls such as autoclaves and microbiological safety cabinets are adequately maintained and tested by departments. Will advise Heads of Departments on matters relating to the containment of biological hazards and the safety of staff, with particular reference to the Genetically Modified Organisms (Contained Use) Regulations 2014 and other relevant legislation and codes issued by the Scientific Advisory Committee on Genetic Modification. Will act as the contact point for GM work with the enforcing authority. Will implement an audit programme to ensure that risk control systems are maintained and remain effective. Will maintain a register of those working in the genetic modification field 4 Genetically Modified Organisms Policy September 2015 and ensure that staff registered to work in this field have suitable training, instruction and supervision. Will monitor the following safety aspects of genetic modification work within the University; o that local rules are followed o that appropriate training in good microbiological practice is given o that accidents are investigated, remedial actions are taken where necessary and appropriate records are kept o that recombinant organisms and pathogenic or potentially pathogenic material are stored in a safe way and that appropriate records are kept o that recombinant organisms are transported in a safe way FURTHER INFORMATION There are guidance notes and further information available on the Staying Safe and Well website with a link to the GM wiki Legislation and official guidance; The Genetically Modified Organisms (Contained Use) Regulations 2014 A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2014 Scientific Advisory Committee on Genetic Modification, Compendium of Guidance The Anti-terrorism, Crime and Security Act 2001 Schedule 5 list of toxins and pathogens 5 Genetically Modified Organisms Policy September 2015
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