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 7th 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.  

EPA review period 

The EPA has a 45-day review period. This does not include any period during which the EPA is awaiting receipt of any additional information it may have requested from the notifier. This means that 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 EPA, the user must submit an assessment of the risks to human health and the environment associated with the new GMO use to the EPA 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.  

EPA review period 

The user may proceed directly once the risk assessment has been submitted. There is no requirement to await EPA approval or 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 and run-off