Essentials of GM Risk Assessments

GM risk assessments are required before work commences for all work involving the possession or use of genetically modified organisms. Managers and principal investigators are responsible for ensuring that the risk assessment and controls are carried out, adequate for the work, regularly monitored and that the assessment and controls are reviewed and revised. GM risk assessments must be carried out by competent persons. The work must be categorised on the basis of risks taking into account the genetically modified organisms, the type of activity, appropriate activity class, containment level and all necessary controls to ensure that the work can be done safely while protecting people, animals, plants and other aspects of the environment. GM risk assessments must address all aspects of the work including routine and non-routine work and what to do in emergencies. All workers including staff, students and visitors must be adequately informed, trained and supervised to enable them to safely and competently perform the work. There is a legal requirement for GM risk assessments to be reviewed and advised on by a Genetic Modification Safety Committee (GMSC). Genetically modified organisms must not be brought into the University, obtained or any work conducted until GMSC permission is given for the GM risk assessment. To help you carry out your GM risk assessments here are some of the essential steps which you need to follow to protect humans, animals, plants and other aspects of the environment from risks associated with genetically modified organisms.

  1. GM risk assessment is used to assess and control risks to humans, animals, plants and other aspects of the environment arising from the use of the genetically modified organisms in the work.
  2. GM risk assessments must be done in advance and by competent persons.
  3. Consult and communicate with managers, workers and safety coordinators and advisers.
  4. GM risk assessments and controls must be suitable and sufficient and proportionate to the risks.
  5. Consider the genetically modified organisms and the work activity.
  6. Decide who or what might be harmed and how.
  7. Assess risks relating to hosts, vectors, genetic materials and final genetically modified organisms.
  8. Decide on the activity class (1 - 3).
  9. Decide on the containment level (1 - 3).
  10. Decide what control measures are necessary to prevent or adequately control exposure and minimise the risks.
  11. Control measures must be implemented, monitored and maintained.
  12. Decide whether health surveillance and monitoring of exposure is required.
  13. Ensure genetically modified organisms are safely handled, stored, transported, inactivated and disposed.
  14. Ensure there are plans and procedures to deal with emergencies.
  15. Ensure workers are properly informed, trained and supervised to enable them to safely and competently perform the work.
  16. GM Safety Committee advice and permission is required for all Class 1, 2 and 3 genetically modified organisms.
  17. HSE notification is required for Class 2 and 3 activities.
  18. HSE consent required for Class 3 activities.
  19. Scottish Government Animal Health licences and Plant Health licences are required for work with certain animal pathogens and plant pathogens and pests.
  20. GM risk assessments and other relevant records must be kept by the relevant managers and principal investigators.
  21. GM risk assessments must be reviewed and revised where they are no longer valid or where there are significant changes to the activity or risks.

GM risk assessments should be of a high standard particularly in respect to clarity, justification of statements on hazards and risks and the selection of control measures. The risk assessment will enable valid decisions to be made about what needs to be done to prevent or control adequately exposure to genetically modified organisms. GM risk assessments need to be sufficiently specific but should be understood by non-experts such as colleagues, workers, safety advisers or HSE inspectors. It is important that the risk assessment is clear and statements about risks and controls are properly justified. Avoid being unnecessarily restrictive and try to anticipate future changes and incorporate these into the risk assessment. The information should be kept as brief as possible and focused on what is needed to understand the risk assessment. Remember that you are writing a risk assessment not a grant application so you do not have to justify doing the work only that it will be done safely. Statements about risks should be explicitly justified. Probably the easiest way to justify most statements is to either cite an appropriate reference or provide sufficient information and explanation. Appropriate references can include scientific publications, official guidance documents which are very useful but please specify section and paragraph numbers and commercial catalogues.