How do I notify?

A CU1 should be attached for premises notifications and/or a CU2 for GM contained use notifications.

The use of notification forms is not a legal requirement but they have been designed to ensure that the necessary information is submitted and to clearly indicate any confidential material.

Given the range of different information that needs to be put together for a notification it is not recommended that text is typed directly into an online form.

Online forms cannot be saved during the drafting process. It is, therefore, a good idea to draft in a format that can be saved and then cut and paste into the online form.  The information you will need to have ready is outlined below.

• Premises notification (CU1):
  • Addresses of all the premises where contained use will be conducted
  • A summary of the risk assessment for class 1 contained use involving GMMs or non-notifiable contained use involving larger GMOs
  • Details of the person or Genetic Modification Safety Committee and comments with expertise in risk assessments relating to contained use
  • Details of the waste management measures
  • If applying for derogation, details of the measures and justification;
  • Name and training qualifications of both the person responsible for supervision and safety of GM contained use at the premises, and the Biological Safety Officer, and any other contacts; and
  • Any information in relation to non-disclosure of information for the public register
• Contained use notification (CU2)
  • Date of premises notification and the reference provided from HSE;
  • Details of the purpose of the contained use. In providing this information the scope of the work covered by the notification should be established. This is particularly important for a connected programme. When preparing a notification that covers a broad programme of research it is important to include an overview that sets boundaries on the extent of the work
  • Characteristics of the GMO's, including
    • Recipient or parental organism
    • Host/vector system; and
    • Origins and intended functions of the inserted genetic material
  • In situations where a number of different GMOs are being constructed it is particularly important that there is detailed risk assessment of the most hazardous GMO that will be made. Once this is set out, it may enable you to provide less detail on other GMOs by cross referencing
  • Evaluation of the foreseeable effects of the modifications (including a judgement as to whether the GMM will any more hazardous than the parental organism or vector)
  • Containment and control measures for larger GMOs (eg animals and plants
  • Maximum culture volumes per experiment (for GMMs only)
  • If applying for derogation, details of the measures and justification
  • Details of the waste management measures
  • A copy of the emergency plan, if required under regulation 21
  • The risk assessment and comments from the Genetic Modification Safety Committee on that risk assessment
  • Name and training qualifications of both the person responsible for supervision and safety of GM contained use at the premises
  • Any information in relation to non-disclosure of information for the public register

• Most requests for further information occur because the applicant has not included the relevant information in the notification or because the information provided is not clear. 
• For novel work, where the evidence of risk is not well established, an HSE inspector may ask you about how you have used evidence in your risk assessment.
• A notification will not necessarily lead to an inspector's visit, but for more complex or higher risk contained use the inspector may arrange a visit to ensure they have the information they require to assess the notification.

The Genetically Modified Organisms (Contained Use) Regulations 2014 requires the competent authority to maintain a public register of information about all notifications concerning contained use. 

Personal details will not be published on HSE's public register of information about GMO notifications.  All personal details will be handled in accordance with the Data Protection Act 1998. 

For information, HSE handles notifications in accordance with the Freedom of Information Act 2000 and information may be disclosed, unless there is a valid reason for not releasing it.  You must make a claim of confidentiality to the competent authority if you wish for information submitted as part of a notification to not be disclosed.  This claim is subject to approval by the competent authority so you should not commence the contained use until you have received this approval. 

More information about claiming confidentiality

Where it is necessary to refer to confidential material in order to provide the information that is sought in any section of the form, the confidential information should be provided in section 12 of the CU1 and section 17 of the CU2.   If it is necessary to provide confidential information to describe the purpose of the contained use (usually provided in Section 6) in section 12 (CU1) or 17 (CU2) under a heading such as 'Full response to section 6 which contains confidential information'.  At the same time a more general response must be provided in section 6, which gives some indication of the purpose of the work without revealing the specific confidential information.

In cases where the submission of a full risk assessment requires the use of confidential information, the confidential information needs to be clearly identified.  Although there is no set procedure for this, it is easiest for all concerned if you supply two separate risk assessments – one with the confidential information and one without.  If this is done, sending out the version of the risk assessment that does not contain confidential information can readily satisfy any request for information from the public under Open Government provisions. 

At the time of notifying, it is possible to seek agreement from the competent authority to not apply a measure(s) in the containment level corresponding to the class of contained use.  Such requests must be justified by the risk assessment.  HSE will inform the notifier whether the derogation has been agreed when responding to the notification.  Unless, or until, written agreement has been received the full containment level must be applied. 

Notifiers can also request derogation from a specific containment measure after the contained use has been notified.  However, a subsequent request for derogation could be subject to a further notification fee, as it is likely to constitute a significant change to the notified activity. 

Section 6 of the CU1 form and section 12 of the CU2 form require information about waste management to be provided.  This information is important, as correct handling of waste is one of the key ways to limit contact between GMMs and the environment and so ensure the health and safety of humans and the environment.  The information provided in these sections is placed on the Public Register. Further guidance on waste management can be found in the guide to the regulations (L29).

• Are all boxes in the first section (1-8 of the CU1 and 1-15 of the CU2 form) of the form, marked with 'Public Register' down the margin or next to the section title, completed?
• Are the personal and contact details (9, 10, 11 & 13 of the CU1 and 16 & 18 of the CU2) fully completed?  Please note that personal details are confidential under the Data Protection Act, therefore you do not need to claim confidentiality
• If a confidentiality claim has been made at section 12 of CU1 or section 17 of CU2, have 'disclosable' details been provided in the 'Public Register' sections of the form 
• Have the comments from the person or Genetic Modification Safety Committee (GMSC) with expertise on risk assessments relating to contained use been completed for all notifications
• Have you attached a summary or full risk assessment (as required)
• Have you paid the appropriate fee

If you are unhappy about how HSE has dealt with you, we want to know and you can contact us.

There is a formal appeal process for any person responsible for contained use who is aggrieved by decisions made by the competent authority but you are advised to discuss this with HSE before lodging a formal appeal.

An appeal can be made for any of the following:

• Not permitting a class 3 or 4 contained use to take place
• Imposing conditions, suspending, terminating or time limiting any contained use
• Revoking or varying a consent for a class 3 or 4 contained use
• Not allowing derogation from the full containment
• Revoking an exemption certificate
• Placing conditions or a time limit on an exemption certificate
• Requiring additional information about a premises or contained use notification, and any instructions (such as stopping, destroying or storing the GMOs) associated with the request for additional information

The decision of the competent authority will not be suspended pending the appeal (except that information will not be made public until an appeal on that issue has been heard).

You can get advice on administrative matters relating to the submission of notifications under the Genetically Modified Organisms (Contained Use) Regulations by contacting the Notifications Officer on [email protected]. This is also the address for submission of notifications:

The Notifications Officer
Health and Safety Executive
Biological Agents Unit
Bld 5S.2 Redgrave Court
Merton Road
Bootle
Merseyside L20 7HS