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)

• An assessment of the risks to human health and the environment associated with the GMO contained use activity. The risk assessment should contain the information required under Part II of the 7th Schedule of the GMO (Contained Use) Regulations, 2001-2010
• Information as set out under Part I of the 7^th Schedule
• Information relating to the inactivation and disposal of GMO related waste (see note below)
• There is no fee for the contained use of GMOs

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.