How to apply for consent for a GMO/GMM

Notification Requirements for the contained use of Genetically Modified Micro-organisms (GMMs)

The following links set out the notification requirements for the first time use of premises for and the subsequent contained use of

Class 1 GMMs

Class 2 GMMs

Class 3 and Class 4 GMMs

Notification Requirements for the contained use of Genetically Modified Organisms other than Genetically Modified Micro-organisms (GMMs)

The following links set out the notification requirements for the first time use of premises for and the subsequent contained use of GMOs i.e. GM plants and/or GM animals

Note the following points

  • A premises shall not be used for the first time, unless, a notification relating to the first time use has been submitted to the Agency and the Agency has issued a consent in respect of it.
  • A consent for the first time use of the premises for a particular class of activity shall apply to that class and any lower class of activity.
    For example, a consent issued in respect of a Class 2 GMM contained use activity will also permit the user to use Class 1 GMMs. The user will not be required to submit a separate or new notification in respect of the Class 1 GMM use.
  • Where a user has obtained consent for a particular class of activity, the user will be required to submit a notification and obtain consent in respect of any higher class of activity.
    For example, a Class 2 GMM user will be required to submit a notification to the Agency and obtain consent in respect of any Class 3 GMM use not previously notified. 

Submitting a notification to the Agency

Notifications for GMM/GMO contained use activities should be forwarded by e-mail to licensing@epa.ie.

Fees

With regard to fees, the Agency does not issue invoices.

If required, the Agency will issue a letter on EPA headed paper stating the fees involved.

Class of Activity

 

First-time use of a premises

Subsequent contained use

Class 1 GMM 250 0
Class 2 GMM 1875 625
Class 3 GMM 4500 1500
Class 4 GMM 22500 7500
GMO (GM plants / GM animals) 0 0

Role of the Agency

Once the Agency has received a notification for first time use of the premises or the subsequent contained use of a GMM and corresponding fee, the Agency will acknowledge receipt of the notification citing the date on which the notification was received.

The Agency will issue the user with a GMO Register number (G0XXX-01)

The Agency will review the notification and grant consent with or without conditions or refuse consent.

The flowchart provides an overview of the procedure involved in obtaining a consent for the contained use of a GMM / GMO in accordance with the GMO (Contained Use) Regulations 2001-2010.

Class 1 GMMs

Notification requirements for the first time use of a premises for a Class 1 GMM 

  • An assessment of the risks to human health and the environment associated with the Class 2 GMM contained use activity
  • Information relating to waste management (i.e. GMM contaminated liquid and solid waste)
  • Information as set out under Part A of the 5th Schedule of the Regulations
  • Fee: €250. A notification is not valid until the fee has been received by the Agency

Agency review period

The Agency has a 45-day review period from the date of receipt of the notification by the Agency. This does not include any period during which the Agency is awaiting receipt of any additional information it may have requested i.e. the clock is stopped until all requested additional information is received.

Notification requirements for the subsequent contained use of a Class 1 GMM

Where the user has been issued with a consent for the first time use of the premises and wishes to use a new Class 1 GMM (not previously notified to the Agency), the user must submit a risk assessment to the Agency prior to commencement of any work involving its use.

The user should also provide the GMO Register Number relating to the first time use of the premises.

Agency review period

The user may proceed directly once the ERA has been submitted. There is no requirement to await Agency approval / acknowledgement.

Class 2 GMMs

Notification requirements for the first time use of a premises for a Class 2 GMM/h4>

  • An assessment of the risks to human health and the environment associated with the Class 2 GMM contained use activity
  • Information relating to waste management (i.e. GMM contaminated liquid and solid waste)
  • Information as set out under Part A of the 5th Schedule of the Regulations
  • Fee: €1,875.  A notification is not valid until the fee has been received by the Agency

Agency review period

The Agency has a 45-day review period from the date of receipt of the notification by the Agency. This does not include any period during which the Agency is awaiting receipt of any additional information it may have requested i.e. the clock is stopped until all requested additional information is received

Notification requirements for the subsequent contained use of a Class 2 GMM

(Where the user has been issued with a consent for the first time use of the premises and wishes to use a new Class 2 GMM not previously notified to the Agency).

  • An assessment of the risks to human health and the environment associated with the Class 2 GMM contained use activity
  • Information relating to waste management (i.e. GMM contaminated liquid and solid waste)
  • Fee: €625.  A notification is not valid until the fee has been received by the Agency

In addition to the above, the user should provide the GMO Register Number relating to the first time use of the premises.

Agency review period

The Agency has a 10-day review period. If the user has not been notified of the Agency’s decision within that 10-day period, the user may proceed with the contained use activity in accordance with the requirements of their existing consent.

Class 3 and Class 4 GMMs

Notification requirements for the first time use of a premises for a Class 3 or a Class 4 GMM

  • An assessment of the risks to human health and the environment associated with the Class 3 GMM/ Class 4 GMM contained use activity. The ERA should contain the information required under Part C of the 5th Schedule of the GMO (Contained Use) Regulations 2001-2010
  • Information relating to waste management (i.e. GMM contaminated liquid and solid waste);
  • Information as set out under Part A of the 5th Schedule of the Regulations
  • Fee: €4,500 – Class 3 GMM, €22,500 – Class 4 GMM.  A notification is not valid until the fee has been received by the Agency

Within 7 days of receipt of the notification by the Agency, the notifier must publish a notice in a newspaper ‘circulating in the district’ in which the proposed contained use activity will take place. The purpose of this notice is to inform the public of the proposed GMO contained use activity and the submission of the notification to the Agency. It will also invite members of the public to make representations to the Agency on the notification. In drafting the notice for publication, the format as set out under Article 22 of the GMO (Contained Use) Regulations, 2001-2010, should be followed.

Agency review period

The Agency has a 90-day review period. This does not include any period during which the Agency is awaiting receipt of any additional information it may have requested from the notifier i.e. the clock is stopped until all requested additional information is received.The notifier cannot proceed with the contained use activity without the prior agreement of the Agency.

Notification requirements for the subsequent contained use of a Class 3 / Class 4 GMM

(Where the user has been issued with a consent for the first time use of the premises for a Class 3 GMM or Class 4 GMM contained use activity and wishes to use a new Class 3 GMM or Class 4 GMM not previously notified to the Agency).

  • An assessment of the risks to human health and the environment associated with the Class 3 GMM/ Class 4 GMM contained use activity. The risk assessment should contain the information required under Part C of the 5th Schedule of the GMO (Contained Use) Regulations, 2001-2010
  • Information relating to waste management, (i.e. GMM contaminated liquid and solid waste)
  • Information as set out under Part A of the 5th Schedule of the Regulations
  • Fee:  €1,500 – Class 3 GMM, €7,500 – Class 4 GMM

Agency review period

The Agency has a 45-day review period. This does not include any period during which the Agency is awaiting receipt of any additional information it may have requested from the notifier i.e. the clock is stopped until all requested additional information is received.

The notifier cannot proceed with the contained use activity without the prior agreement of the Agency.

GMOs (GM plants and/or GM animals)

Notification requirements for the first time use of a premises for GMOs (GM plants and/or GM animals)

Agency review period

The Agency has a 45 day review period. This does not include any period during which the Agency is awaiting receipt of any additional information it may have requested from the notifier i.e. the clock is stopped until all requested additional information is received.

Notification requirements for the subsequent contained use of a GMO

Where the user has been issued with a consent for the first time use of the premises and wishes to use a new GM plant or GM animal not previously notified to the Agency, the user must submit an assessment of the risks to human health and the environment associated with the new GMO use to the Agency prior to commencement of any work involving its use. The user should also provide the GMO Register Number relating to the first time use of the premises.

Agency review period

The user may proceed directly once the risk assessment has been submitted. There is no requirement to await Agency approval / acknowledgement.

Note

GMO related waste should address the inactivation of the following where applicable:

  • GM animal carcasses;
  • GM / non-GM animal carcasses where GMMs (specify class) have been administered to the animal;
  • Animal cages and bedding where GMMs (specify class) administered to the animal have been shed;
  • GM plants, seeds, tissue culture waste, pots, trays, compost, soil, run-off.