Notification of genetic modification activities

Notification of use of premises for the first time

Regulation 9 of GMO Regulations 2000 requires advance notice to the competent authority (HSE) for the first use of premises for genetic modification work. In this case, premises refers to the different laboratories throughout the University undertaking genetic modification activities, allowing only a single notification. A copy of the acknowledgement of receipt is available from the Health and Safety Advisor (Biological Sciences).

Notification of genetic modification activities

The GM Notification Form (HSE) (PDF , 400kb) is used if notification of individual GM activities to the competent authority (HSE) is required. Copies of the form are available directly from the HSE or the HSA(BS) and must be completed by the Project Supervisor and submitted to the GMSC for approval and authorisation. The competent authority (HSE) will then be notified by the GMSC of all activities requiring notification.

Genetically modified micro-organisms (classes 1-4)
Risk assessment of genetic manipulation activities determines the containment measures required to control the risks. The containment measures selected decide the classification of the activity and it is this classification which determines the notification requirements. Table 2 summarises the notification requirements of GMO 2000 Regulations based on classification of genetic manipulation activities.
Genetic modified organisms other than micro-organisms
All activities involving genetically modified organisms other than micro-organisms (e.g. plants and animals) must be notified if the GMO has a greater potential to cause harm to human health than the equivalent non-modified organism. There are no notification requirements in relation to environmental risks.

Examples of harm include:

disease to humans including allergenic or toxic effects
acting as a human disease vector or reservoir
adverse effects to humans arising from change in behaviour or in physical nature
adverse effects arising from the inability to treat human disease or offer effective

Table 2. Notification requirements involving GMOs
Type of Notification	Notification period	HSE Consent Required?
First use of premises	None Work can start on receipt of HSE acknowledgement	No Work can begin after HSE confirms receipt of application
GMMs Class 1	First activity only requires notification	No
GMMs Class 2 (First Activity)	HSE must be notified unless previous work on higher class has already been sanctioned	No Activity can begin 45 days after HSE confirms receipt of application. Work can begin earlier if HSE consents
GMMs Class 2 (Subsequent Activities)	HSE must be notified	No Work can begin after HSE confirmed receipt of application
GMMs Class 3 and 4 (First Activity)	90 days notice before work commences	Yes HSE must give consent or say why consent is refused. This will be 30-90 days after HSE confirms receipt of application
GMMs Class 3 and 4 (Subsequent Activities)	45 days notice before work commences	Yes HSE must give consent or say why consent is refused. This will be 30-45 days after HSE confirms receipt of application
Non-notifiable GMOs (excluding GMMs) Work with plants and animals not likely to harm humans	None, except for first activity	No
Notifiable GMOs (excluding GMMs) Work with plants and animals likely to harm humans	45 days before work commences	No Activity can start 45 days after HSE confirms receipt of application or say why consent is refused

Connected programmes of work

Connected programmes of work undertaken by the same person may be established to assist in managing the notification of genetic modification activities which form a coherent and integrated programme (Regulation 13 of the GMO Regulations 2000). That is, the activities should form part of a specific scientific / research goal. The advantages to users of connected programme notifications include:

only a single notification fee is payable even though the notifications cover several activities
saving of time from not having to duplicate information on separate notifications

However, a full description of each activity along with the risk assessments must be included at the time of notification. A connected programme of work may cover any combination of class 2 – 4 activities and any notifiable activities involving genetically modified organisms which are not micro-organisms (plants and animals). The relevant notification requirements for class 2 – 4 activities (Regulations 10 – 12 of the GMO Regulations 2000) must be complied with for each individual activity within the connected programme.