PI's Step by Step guide to GM risk assessments and HSE notifications

(updated 03/12/18)

1.You decide to create or acquire a new GM Microorganism/Organism.

2.You email SLS Safety with a summary of what you plan to do and ask for advice on completing the risk assessment.

3.SLS Safety supplies you with relevant worked examples, if any are avilable, and instructions on how to access the Risk Assessment Database and create your own GMM risk assessment.

4.You complete the risk assessment with assistance from a Biological Safety Adviser and/or SLS Safety, if required.

5.Once finalised, you submit the assessment, via the database, to SLS Safety. SLS Safety check the assessment, then forward it on to the University Biological Agents Committee for review.

6. The Committee members are given 1 week to comment.

7. If the the Committee members agree with the classification, the assessor will receive an email confirming this and approval details will be entered into the database. The assessor will then be asked to ensure all personnel involved in the work read the assessment and register their name against it in the GMM Risk Assessment Database to confirm that they have read and understood the assessment and that any queries about it have been answered. If the Committee members do not agree with the initial classification, the assessor will receive an email detailing why. The assessor can then submit additional information in support of the initial classification or revise their assessment in light of the Committee members' comments.

8. The assessor will receive an annual reminder asking them to confirm that their assessment is still current and, if it is not, asking them to update it and, if the changes are significant, resubmit it to the Biological Agents Committee.

9. SLS Safety must be informed when a GM project ceases. This information will be passed to the Biological Agents Committee and, if necessary, the HSE.

10. In the case of all Class 3 projects and any Class 2 projects not covered by the existing HSE notifications/authorisations, HSE notification is required. A separate form must be completed. SLS Safety will assist with this.

11. The completed notification form is sent to the HSE by SLS Safety. The notification fee is covered by the School's safety budget. Note: notifications submitted to HSE are published on a public register. Opportunity is given to make a case for withholding highly sensitive information.

12. The HSE endeavor to acknowledge receipt of the notification within 10 days. Once HSE acknowledgement is received by SLS Safety, the letter is copied to the assessor and the Head of Safety Services. In the case of Class 2 projects, work can now begin. A letter of consent must be received before a Class 3 project can begin and this can take up to 45 days from the acknowledgement date.

13. The HSE will scrutinise the notification after acknowledging receipt and may ask for additional information or clarification on specific points.