Biosafety

The Biosafety committee has been established to provide advice to the Biosafety Officer. It meets at least 4 times a year and reviews registration forms received. It advises the Biosafety Officer on University policy and procedures relevant to biological safety and oversees the register of activities associated with the use of Hazardous Biological Agents, genetically Modified Microorganisms and Genetically Modified Organisms.

The Biosafety Committee also advise the University on the development and implementation of policies and procedures for biological safety and on the safe use of genetically modified microorganisms (GMM) and genetically modified organisms (GMO) within the University.

The committee oversees the register of activities in the area of Biological safety, GMM and GMO use, use of Human and other tissues, and aid in site inspections where work is to be carried out.

To register the deliberate use of a named Class 2 (or above) biological agent, please complete the following form:

Work with GM materials requires a consent from the EPA, which is 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 UCDprovides legislative guidance on the contained use of GM’s, as well as definitions as to what constitutes GM work/organisms.

• When is EPA Consent Required?

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.

• What Type of Consent is Required?

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.

Important Notes

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 (opens in a new window)EPA for the preceding calendar year by March of the following year. 

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 (opens in a new window)EPA websitefor Class 1 and Class 2 GMMs. 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 (opens in a new window)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 the same (usually only required for the use of higher-risk materials).
5. Once comments are made and/or risk assessment approved, it can be submitted to the EPA along with the (opens in a new window)required feeand a completed(opens in a new window)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 (opens in a new window)sirc@ucd.ie. 

1. Carry out either a GMO Animal Use or GMO Plant Use only risk assessment using the relevant(opens in a new window)UCD template (EPA approved).
2. Once complete the risk assessments can be sent to (opens in a new window)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 the same (usually only required for the use of higher-risk materials).
4. Once comments are made and/or risk assessment approved, it can be submitted to the EPA along with a completed(opens in a new window)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.