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GMO / GMM Licence

GMO / GMM Licence

Obtaining a Licence to Work with Genetically Modified (GM) Materials

Work with GM materials requires a consent from the EPA, which are given to named PI's for all work that their group may carry out. It is not possible to use another PI's consent for your work, unless the aforementioned PI has a substantial role in the work.

The Guide to the Use of Genetically Modified Organisms in UCD provides legislative guidance on the contained use of GM’s, as well as definitions as to what constitutes GM work / organisms.

Visit the Biosafety section for further relevant information

First establish if the material in use / the processes undertaken constitute GM work under the legislative definitions. A consent is required whether the researcher modifies the agent themselves or obtains it in an already modified state.

Researchers should establish if the GM consent they require is for Genetically Modified Microorganisms (GMMs) (includes cell lines, viruses, bacteria, etc.) or Genetically Modified Organisms (GMOs) (whole plant or animals). In some cases both may be required.

  1. Carry out a risk assessment to establish what Class of GMM is in use. As a rule as long as the modification does not increase the virulence or pathogenicity of the organism or cell line then the wild type classification can be used.
  2. There are sample risk assessments on the EPA website for Class 1 and Class 2 GMM's. When completing the risk assessment researchers must adhere to the layout and numbering system of these sample risk assessments.
  3. Once complete the risk assessments can be sent to sirc@ucd.ie for review. This is required before the EPA will consider the risk assessment.
  4. SIRC Office will review the risk assessment and if necessary seek additional advice on same (usually only required for the use of higher risk materials).
  5. Once comments made / risk assessment approved, it can be submitted to the EPA along with the required fee and a completed Additional Information Document.
  6. Note that if the fee is not paid in advance then the EPA will not review the submission.
  7. The EPA will review the submission and if happy will issue a consent. They have 45 days in which to do so. If they seek further information the clock will stop. Note that if a quicker turnaround time is required this can be requested. 
  8. If you are planning on modifying a Class 3 microorganism you are advised to contact the SIRC Office as early as possible for advice at sirc@ucd.ie

  1. Carry out a risk assessment using a UCD template (EPA approved).
  2. Once complete the risk assessments can be sent to sirc@ucd.ie for review. This is required before the EPA will consider the risk assessment.
  3. SIRC Office will review the risk assessment and if necessary seek additional advice on same (usually only required for the use of higher risk materials).
  4. Once comments made / risk assessment approved, it can be submitted to the EPA along with a completed Additional Information Document.
  5. There is no fee for a GMO consent submission.
  6. Work with the GMO can begin 45 days after the submission has been made as at this time consent can be assumed. Note that if a quicker turnaround time is required this can be requested.

  1. A separate consent is required for every strain of GMO.
  2. If you already have a Class 1 or Class 2 GMM consent then you can use other Class 1 GMMs under that consent as long as you have a risk assessment on file and you update the EPA by sending them said risk assessment. There is no charge for this.
  3. If you already have a Class 2 GMM consent then you can use another Class 2 GMM under that consent as long as you make a full submission to the EPA as outlined above and pay the required fee. Work can begin ten days after the notification.
  4. All users are required to submit an annual report to the EPA for the preceding calendar year by March of the following year. 

Contact UCD SIRC Office

University SIRC Office, Roebuck Castle, University College Dublin, Belfield, Dublin 4, Ireland.
T: +353 1 716 8771 | E: sirc@ucd.ie