What work with GMOs requires notification?
HSE needs to be made aware of all premises undertaking contained use and must also be specifically notified before certain contained uses commence.
What is meant by contained use
Contained use means the process of making or using GMOs where barriers are used to limit contact with and provide protection for people and the environment. The barriers can be physical, chemical or biological.
The question of whether a particular contained use requires notification depends on the classification of the work. This classification is based on a risk assessment; which determines the containment measures required to adequately control the identified risks. In other words, the risk assessment determines which level of containment is appropriate which in turn determines the risk class.
|Level of risk
|Appropriate Containment Level required to protect human health and the environment
Contained uses of no or negligible risk
Containment Level 1
Contained uses of low risk
Containment Level 2
Contained uses of moderate risk
Containment Level 3
Contained uses of high risk
Containment Level 4
Notification of work with larger GMOs is required if the genetic modification increases the risk of harm to human health. This work is not further classified.
Notifying premises to be used for contained use and contained use notifications
Premises notifications (CU1)
You need to make a premises notification if you are going to undertake contained use with genetically modified organisms for the first time.
If you are going to construct or use a GMO for the first time at a premises you will need to notify HSE. You must submit a premises notification before you begin the contained use. HSE will check that you have sent the correct information and will contact you within 10 days to acknowledge receipt. You may begin work at this stage. You will then receive final clearance within 45 days.
If you are undertaking the first GMO project in a building or Department that is part of a university, hospital or company, you should consider whether GMO's are already being used elsewhere in the organisation. If contained use activities have already been notified elsewhere on the site or campus, your project may be covered under the existing premises notification.
Contained use notifications
Whilst a large proportion of contained use work is class 1 and does not require notification, any contained use classified as class 2, class 3, and class 4 must be notified. The period before which the work can commence may vary depending on the type and circumstances related to a specific contained use notification (see notification and consent requirements below). During this time HSE may contact you to require that the work does not proceed. For higher risk work (class 3 and class 4) you will require consent before you can begin work.
A contained use notification should contain the information necessary for the competent authority to achieve a general understanding of the different types of GMOs that will be used or constructed. However, it is permissible to provide varying levels of detail on the risk assessment of these GMOs. Commonly used types of construct, such as those described in Part 2.3 of the SACGM Compendium of Guidance, need much less detailed consideration than novel constructs. Examples of novel constructs which would need to be described in detail are those where insertion of the foreign DNA may be expected to bring about a significant alteration in the properties of the recipient such as alteration of host range, tissue tropism, immune response etc. Further information is available in Part 2 of the SACGM Compendium of Guidance.
Overview of notification and consent requirements
|Notification of first contained use at relevant classification
|Notification requirements for subsequent contained uses
|Included in premises notification. Work can begin once acknowledgement is received.
|Notification not required
Consent not required.
Work can begin 45 days after acknowledgment of the notification has been received unless HSE require that work does not begin.
Consent not required.
Work can begin once acknowledgment of the notification has been received.
|Class 3 & Class 4
HSE will grant or refuse consent within 90 days after acknowledgment of the notification.
HSE will grant or refuse consent within 45 days after acknowledgement of the notification.
|Larger GMOs (modified plants and animals)
|Notification required for any contained use where the modification increases risk of harm to human health.
Consent not required.
Work can begin 45 days after notification unless HSE require that work does not begin.
Notifying contained uses as part of a connected programme
The regulations require dutyholders to notify any significant change affecting the risks associated with an ongoing contained use. Changes are deemed to be 'significant' when they increase or present different risks compared to the originally notified work. Such changes thus alter the rationale upon which the original risk assessment was based. For example, any changes that lead to the user having to change the way they work (eg containment or control measures) will certainly be significant.
Further guidance related to connected programmes can be found in the guide to the regulations (L29).
Notifying significant changes
The regulations require dutyholders to notify any significant change affecting the risks associated with an ongoing contained use. Significant means where the changes increase or present different risks compared to the originally notified work and lead to the user having to change the way they work (eg containment or control measures).
Further guidance related to significant changes can be found in the guide to the regulations (L29) and ISTR guidance provides examples of significant changes.
Notifying administrative changes
You must notify changes to administrative details that have been previously notified. Adminstrative details do not affect the output of the risk assessment. Updating such information can be done by e-mail or letter.
You need to inform the competent authority when changes occur to such notified information as:
- The premises names, address, telephone, fax and email address
- Details of the Genetic Modification Safety Committee
- Address of the premises where the work is to be carried out and general description of those premises. If you move to a new premises you will need to submit a new premises notification
- Any new building, including where it is covered by existing premises address
- Where the premises are no longer being used for GM work
- Where an individual contained use (or connected programme) has ceased for the time being
- Where an individual contained use (or connected programme) has ceased entirely
- Where GM work is recommencing, having been previously suspended
- Changes in the person named in a notification as being responsible for the supervision and safety of contained use and their training/qualifications
- When claims for confidentiality are no longer valid (for instance, the work has been published)
Notifying an accident involving a genetically modified organism
There is a requirement to notify accidents under the GMO (Contained Use) Regulations. This does not include all unintended incidents, only those which result in a significant and unintended release of the GMO and which presents an immediate or delayed risk to human health or the environment. This requirement is in addition to the requirements under RIDDOR to report accidents and dangerous occurrences in relation to the risks to human health and safety.
Notifying transfer of contained use
You must notify HSE if you are transferring a contained use from one premises to another. This can be done using a CU4 form, if the contained use will cease completely at the original GM centre. Otherwise, a new contained use notification will be required. If the project was notified under the transitional provisions of the GMO (Contained Use) Regulations 2000 then a new contained use notification must be submitted by the new notifier.