Notification of Work with Genetically Modified Organisms

GMOCU requires HSE to be notified of premises and certain higher risk activities in advance of commencement of the work. Activity class 2 and 3 genetically modified organism activities have to be notified in advance to the HSE on an individual basis and specific consent obtained to carry out the work. HSE produces a CU2 notification form to provide the information and request consent for the activity. A copy of the GM risk assessment for the work has to be provided as part of the notification. A single notification may be made under of a connected programme of work at one site or a single activity carried out by the same person at more than one site. HSE will send acknowledgement of the notification and there are then various notification periods before work can start depending on the particular activity and whether that activity class of work has been done at the premises previously. HSE examines notifications and may request additional information, impose conditions and time limits to consents and revoke or vary them. Note that HSE charges fees for processing GMOCU notifications. Work may not start until HSE has given written acknowledgement or consent depending on the activity. HSE must also be notified of any subsequent significant changes in activities or new information which may have a bearing on the GM risk assessment. HSE must be informed of any changes to processes, procedures or agents that are of importance to health and safety and which render the original notification invalid. You can modify a GM risk assessment which has been notified under GMOCU but you must first reassess the risks of the project and make the appropriate changes to the GM risk assessment. If the modification is within the scope of the original notified project and there is no significant increase in the risks of the work, then you only need to make the changes to the risk assessment and obtain the relevant approval and no further action is required. If the modification is within the scope of the original notified project but will significantly increase the risks of the work, then you must not carry out the work until consent for these changes has been obtained from the HSE. This will require making changes to the GM risk assessment and sending the modified risk assessment and an updated CU2 form to the HSE. Note that you cannot change the scope of the original notified project. If the modification is outside the scope of the original notified project, whether or not it changes the risks, then you must not carry out the work until consent has been obtained from the HSE. This will require a new request for consent for this project to the HSE. This will require a separate new GM risk assessment and CU2 form. HSE must be notified when the project has ceased and all of the genetically modified organisms have been destroyed. Information submitted to HSE as part of a notification is placed on the public register on the HSE website. However in certain circumstances it is possible to claim confidentiality and exemption from public disclosure for some information but any claim has to be fully justified against stringent criteria and is subject to agreement by HSE.

GMOCU requires all genetically modified organism activities including all GM risk assessments, controls, notifications and all changes to be advised on and approved by the GM Safety Committee. The GMBSO chairs the GMSC and is the point of contact for all managers and principal investigators on all matters relating to work with genetically modified organisms, GM risk assessments and controls. The GMSC must be informed of all proposed GM risk assessments for all activity classes and will advise the principal investigator and issue approval for the work. The GMSC must be informed of all proposed changes to GM risk assessments for all activity classes. The GMSC must be informed of all proposed changes to GM risk assessments and notified projects and will decide whether these are significant and will deal with the HSE. The GMBSO will advise principal investigators and will deal with all notifications to HSE, provide feedback and issue the relevant approvals and consents.

Many animal and plant pathogens and pests are covered by specific animal and plant health and environmental laws and in certain cases require licences from the Scottish Government, DEFRA or related agencies for possession, use, consignment, importation and exportation. , The Scottish Government and DEFRA specify specific containment and control conditions for licensed pathogens and pests. The COSHH, SAPO and other relevant animal or plant health or environmental classifications are not complementary and the requirements are very different for the containment and control of human and animal pathogens, plant pathogens and pests. Compliance with one does not absolve managers, principal investigators and their workers from responsibilities under the other and in all cases where there is any discrepancy between GMOCU, COSHH, SAPO or other relevant requirements then you must comply with all of the requirements for containment and control although the higher control requirements must be the minimum standard which must be followed.

Managers and principal investigators must keep a list of workers exposed to activity class 3 or 4 genetically modified organisms, including details of the type of work involved, the agents to which they have been exposed and records of exposures, accidents or incidents. There is an exemption to this requirement if the risk assessment indicates the activity does not involve a deliberate intention to work with or use the agent or that there is no significant health risk to exposed workers. The list must be kept for at least 40 years from the last known exposure. HSE must be notified of any accident involving a significant and unintended release of genetically modified organisms which present an immediate or delayed hazard to either human health and safety or the environment. This requirement is in addition to any notification requirements under Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR). The HSE notification must provide information on the circumstances of the incident, identity and quantity of genetically modified organisms concerned information necessary to assess the risk and any measures taken to deal with the accident. Note that all incident reports should be made to the Safety and Environmental Protection Service which makes RIDDOR and other reports to HSE.