Projects involving the use of genetically modified micro-organisms (GMMs) or genetically modified organisms (GMOs) must be adequately risk assessed and reviewed by your local GM Safety Committee in accordance with both College Policy and the Genetically Modified Organisms (Contained Use) Regulations (GM (CU) Regs). In addition, certain work with GMMs and GMOs may require notification to the Health and Safety Executive (HSE) prior to commencement.
Prior to the commencement of projects involving the use of GMMs the following must be undertaken:
- an adequate risk assessment.
- submission of this risk assessment form to the local Genetic Modification Safety Committee and approval of both the risk assessment and identified control measures by that committee.
- the implementation of such control measures.
- if Class 2 or higher, the project has been discussed with the Director of Occupational Health to determine whether health surveillance is appropriate.
HSE
- What happens next?
- Confidentiality claims
- Payment procedures and fees
- When must changes be notified to the HSE?
- How is the HSE notified?
- How much will this cost?
- How long will it take?
- Will I receive confirmation that these changes have been approved?
Following the consideration of your GM project by your local GM Safety Committee, the Administrator for Radiological and Biological Safety will either notify you of the requirement for changes to be made to your application, or alternatively, if the committee has approved the application, notify you as to the next steps. If Class 1, this will be in the form of consent to work (using a Consent Certificate), or if Class 2 or higher details on how the notification to the HSE will be made. Once HSE consent is provided then a Consent Certificate will be provided by the Administrator. Only then can work on this project commence.
Confidentiality may be claimed for certain sections of the risk assessment and CU2 notification form e.g. disclosure of animal experiments. Personal and contact details must be completed in section 16 and 18. Personal details are kept confidential under the Data Protection Act therefore confidentiality does not have to be claimed for this information.
Any information for which confidentiality is claimed must be clearly identified in both the risk assessment and notification form and clear justification must be provided for each claim made. This can be achieved by:
- Providing two separate risk assessment forms - one with the information claimed as confidential and one without. The advantage of this approach is that all of the relevant information is removed from the copy of the risk assessment available for disclosure.
- Providing one risk assessment form, but with all of the information claimed as confidential detailed in an attached document. The disadvantage to this method is that the sections not claimed as confidential will have to refer to the information claimed as confidential, which can cause confusion. The advantage of this method is that the information claimed as confidential will be clearly identifiable and easily removable from the form.
Sections in the CU2 notification form containing confidential information can be removed and inserted into Section 17, with the justification for the confidentiality claim included.
The HSE's preferred method for the payment of charges associated with GM notifications is by BACS. Once you have obtained consent from the Safety Department to make this then please do so by searching 'Health & Safety Executive' on ICIS and raising a purchase order to this account: Notification Officer, Biological Agents Unit, Health & Safety Executive, 5S2 Redgrave Court, Bootle, Liverpool L20 7HS. Under the description, please include the GM Centre, Project Title and PI name. Please email a copy of the purchase order to the Administrator for Radiological and Biological Safety as soon as this payment has been made.
HSE notification fees
Notification Fees (from 1 April 2024)
| Activity | Fee |
|---|---|
| First use of premises |
£538 |
| Class 2 |
£1074 |
| Class 3 |
£1163 |
| Significant change - administrative only |
None |
| Significant change - requiring alteration to risk assessment |
£803 |
| Derogation after normal notification has been submitted |
£803 |
| Derogation as part of a notification |
None |
| Harmful non-GMM activity i.e. transgenic |
£1074 |
| GM Centre Number | Campus |
|---|---|
| GM8 |
South Kensington |
| GM31 |
Hammersmith |
| GM77 | St Mary's |
When any administrative or significant change is made to risk assessments previously notified to the HSE. In other words, this will apply to all Class 2, 3 or 4 projects.
Amendments should be considered as ‘significant’ if these;
- Significantly increases the risks associated with the work; or
- Fall outside of the scope of work described in the original project,
- Address of the premises where the work is to be carried out and general description of those premises. If an additional site is added to the GM centre then the HSE should be informed.
Such notifications must be made prior to the changes being made.
Administrative changes can be notified to the GMSC via Corestream. The HSE will then be informed of such changes in writing by the Safety Department. THE PI OR LOCAL GMSC MUST NOT NOTIFY THE HSE DIRECTLY.
When significant changes are notified to the HSE a new GM risk assessment form must be completed, highlighting the changes from the original notification and including the reference number received from the HSE for the original project.
Administration changes do not incur a fee.
Significant changes to a previously notified project do incur a fee - see the Payment procedures and fees section on how to make a BACS payment to the Health and Safety Executive and the amount you will need to raise the purchase order for.
An acknowledgement receipt of the notification of an administrative or significant change to the HSE should be received by the Administrator within 10 working days.
The Administrator will forward the acknowledgement receipt from the HSE and consent certificate to the PI for their records.