For all activities involving Genetically Modified Organisms (GMOs) it is a legal requirement under The Genetically Modified Organisms (Contained Use) Regulations 2014 to carry out a suitable and sufficient Risk Assessment (RA) and for that RA to be approved by a local Genetic Modification Safety Committee (GMSC).
A Genetically Modified Organism is defined according to the techniques used to create the organism, as detailed in Part 1 of Schedule 2 of the Contained Use regulations. Briefly, a GMO is defined as an organism in which ‘the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. Note that in the European Union and -unless legislation changes- the UK, organisms produced by gene editing techniques are considered GMOs and are, therefore, covered by these regulations.
At St George’s, you cannot start any activity involving GMOs (including storage) until you have received written confirmation by the Biological Safety Officer for Genetic Modification stating that the activity can commence.
3.1 Complete a risk assessment on the appropriate form depending on the type of organism. Your responses must be entered in the forms’ boxes. Please do not modify the original text of the forms. If the project is complex, it may be easier to use more than one form (e.g. for the creation of GM-plants involving plant-associated microorganisms, a GM-plant form and a GMM form should be completed). These forms closely follow the structure of the Scientific Advisory Committee on Genetic Modification (SACGM)'s guidance and have been designed to harmonise with Health and Safety Executive (HSE)’s CU2 application forms.
The risk assessment process will determine whether the activities should be categorised as Class 1, 2, or 3 and their need for notification to, or approval by, the HSE (follow the prompts in the forms). St George’s University has not been authorised by the HSE to carry out Class 4 activities.
3.2 The completed risk assessment must be sent to the University’s Biological Safety Officer for Genetic Modification (email@example.com).
3.3 On receipt, the BSO-GM will give the assessment a reference code -which should be used in all future communications- and distribute it to the GMSC’s members for review and approval. The BSO-GM may suggest changes before sending the assessment to the GMSC in order to facilitate the review and speed up the process.
3.4 The GMSC will review the assessment, usually within two weeks. In some cases, the GMSC may require amendments. If so, the reved copy must be returned to the BSO-GM.
3.5 Once the GMSC has agreed that the risk assessment is suitable and sufficient and that it has been categorised to the correct class, the BSO-GM will notify you in writing stating whether the activity can commence.
This is all that is required for a Class 1 activity to commence.
3.6 If the work is categorised as Class 2 or 3, it will need to be notified to the HSE, which incurs a fee . You will have to provide a project code. The application will be carried out by the BSO-GM who may come back to you to request further details. If another group you work closely with has already notified a similar activity, it is in your interest to make use of the ability to notify a "connected programme", which doesn’t incur in a fee. Discuss this with the BSO-GM. A Class 2 notification takes 10 working days from the moment payment has cleared. The date of payment clearance is not the same as the date of application and it depends of SGUL’s finance department, not the BSO. A Class 3 notification takes 30 to 45 working days from the moment payment has cleared. The activities cannot start until the HSE has acknowledged notification (class 2) or granted consent (class 3).
3.7 You must ensure that all the risk assessment’s details (users, rooms, etc.) are kept up to date by revising the information in the annual self-audit form distributed by the BSO-GM at the start of the academic year and until the project is suspended or terminated.
3.8 Major changes to the risk assessment (e.g. introduction of a new strain) need to be notified to the BSO-GM before taking place. Minor changes (users, rooms, techniques) can be informed during the annual GM-audit.
3.9 Any accidents involving work with GMOs must be reported to the BSO-GM and -if the incident presents an immediate or delayed hazard to human health or the environment- it needs to be reported to the HSE. Such reporting should be done in conjunction with the BSO-GM and the University's SHE Office.
3.10 Storage of GMOs is considered active work in the regulations.
3.11 If you are only storing GMOs, you can request to mark the activity involved as “suspended” in our internal records. In this case SGUL will not require you to send updates every year via the annual audit. However, these projects are still considered active by the competent authority.
3.12 Researchers are responsible for destroying all GMOs registered under their names or transfering them -internally or externally- and informing the BSO-GM before leaving St George’s.
4.1 The Genetically Modified Organisms (Contained Use) Regulations 2014, Environmental Protection Act (EPA) 1990, and related legislation require that suitable and sufficient risk assessments be carried out for activities involving the genetic modification of organisms. The Contained Use Regulations cover hazards to human health and the EPA those to the environment. The primary role of the risk assessment is to determine the appropriate control measures that are needed to afford maximum protection to both human health and the environment. This, in turn, will determine if there are any notification requirements for the proposed work. Note that even if the GMOs are not considered harmful to human health or the environment, their unauthorised release into the environment is considered an offence under The Genetically Modified Organisms (Deliberate Release) Regulations 2002.
4.2 In the case of genetically modified microorganisms, it is a statutory requirement to assign a containment level (1, 2, 3 or 4) to each activity within the project and to categorise the project as a whole into a class that is -at least- numerically equal to the highest Containment Level required. For example: cloning of plasmids into DH5-a E coli can be performed at Containment Level 1 but production of lentiviruses using those plasmids should be carried out at Containment Level 2. Hence, the project as a whole should be categorised as Class 2. If those plasmids were to be used to transform M tuberculosis instead, then some of the work should be carried at Containment Level 3 and the project as a whole categorised as Class 3.
4.3 As a general rule, the containment level required to handle a GMM will be the same containment level as that specified by the ACDP to handle the parental organism from which the GMM was derived. However, the risk assessment may determine that a higher containment level is required (e.g. the GMM has/may have increased pathogenicity). The use of a lower containment level than that required by the parental organism (e.g. in the case of disabling mutations) has to be carefully justified.
4.4 There is no statutory requirement to set a formal containment level for work with larger GMOs (plants and animals). However, it may be helpful to set a containment level that is appropriate for the facility in which the work will be carried out. The list of containment measures for each containment level is described in Schedule 8 of the Contained Use 2014 regulations and Part 3 of the SACGM Compendium of Guidance. If you are not assigning an activity to a particular class, the individual containment measures to be applied should be listed in the RA.
4.5 Note: Containment measures are not only based on the use of physical barriers, but rely on rigorous procedural and management control as well as biological factors which limit the GMO’s ability to survive and disseminate. You are always expected to follow Good Laboratory Practice (GLP) and Good Occupational Safety and Hygiene (GOSH) as detailed on schedule 7 of the Contained Use regulations.
4.6 Completing a risk assessment: hazards, risks, consequences, and likelihoods. During the risk assessment you will be required to identify hazards (e.g. a blade) and will need to determine the likelihood and consequences (likelihood x consequences = risk) of those hazards being realised (e.g. the blade is accessible to children who are likely to play with it and who could suffer injuries, then the risk is high). The greater the likelihood or consequence the greater will be the need to assign control measures to render the risk as low as possible (e.g. if the blade is placed in a secured locker, the hazard will still exist but the risk will become negligible). After control measures have been applied, the overall risk must be low or negligible.
4.7 The HSE recognizes that some information may be confidential, but what may be claimed as confidential is limited. In many cases careful choice of wording will overcome this problem. Justification of statements should be provided (e.g. references to published work).
4.8 Information provided on the form will be treated as confidential by the GMSC, but it should be noted that Class 2 or 3 activities have to be notified to the HSE. The HSE will put much of the information in the public register, although this will exclude personal information. If you are worried about possible damage to your intellectual property rights, please discussed with the BSO-GM before submission.
4.9 The HSE stresses the importance of inactivating waste by validated means. Use of one of the University's specified autoclaves is a validated means of inactivating waste and is the procedure required for Class 2 and 3 waste. In some cases, e.g. for Class 1 GMOs, chemical means of inactivation may be used, if properly validated. Once inactivated, the GMOs can be disposed of via the offensive waste route (tiger striped bags) although, in some cases (e.g. when the insert encodes cytotoxic or oncogenic genes), it may be appropriate to discard them via yellow or purple streams (see University’s Waste Policy.
4.10 Regarding GM animals, note that many of the procedures necessary for their production and identification are covered by The Animals (Scientific Procedures) Act 1986. A project licence that specifies the programme of work must be obtained before any procedures can be carried out. Please discuss this with the BRF.
4.11 The GMO risk assessment needs to be kept for at least 10 years after work ceases and needs to be reviewed by investigators as the work progresses (including using the annual self-audit form to report changes in staff working on the project and completion of the work).
4.12 A separate risk assessment must be made for any transport of GMOs and transport should be in accordance with the University's policy on the Transport & Receipt of Hazardous Materials. GMOs are in Division 6.2 (Infectious substance) of the European ADR regulations and would most likely be classified as Diagnostic Specimens (UN 3373). Further information may be found in the HSE's Carriage of Dangerous Goods manual.