Deliberate Releases to the Environment  

There are specific regulations covering deliberate releases into the environment (eg field trials, certain clinical trials), Departments considering undertaking deliberate release activities must contact the University Safety Office at an early stage because formal consent must be obtained from the authorities via notification procedures, which may take some time to complete.

If you have any queries on GMO (DR) regulations, please contact the Safety Office.  Please also see the Defra webpages for details: 'Information about the release of genetically modified organisms (GMOs) for research purposes application, consent and notification process'.

Further Information on GM Contained Use Regulations

Please see the following sites for further information:

• Genetically Modified Organisms (Contained Use) (main source of information from HSE)

​​​​​​

• The Genetically Modified Organisms (Contained Use) Regulations 2014 - this provides guidance on the regulations, and what has changed in this 5th Edition. A free copy can be downloaded.
• There is complementary guidance produced by ISTR on when to notify a significant change

• SACGM Compendium of Guidance

• GMO Information Sources (HSE leaflets/fees/newsletters etc)

• Excel spreadsheet for managing GM notification and associated risk assessments (Cambridge tool for use in departments)

• Risk Assessment Templates and Summary of Legislation (Cambridge University)

• The Safety Office runs an online course on GM Risk Assessment

• For information on Biological agents: Managing the risks in laboratories and healthcare premises (HSE - 2005)

GM Regulations - Principle Changes in 2014

The HSE in October 2014 issued new regulations and guidance for GM contained use. See the HSE update on the regulations and the guidance document.

The principle changes were made to the guidance to:

• reflect the legislative changes to the 2014 Regulations

• simplify and clarify the text

• take account of advances in technology, for example, synthetic biology

• provide clearer distinction between duties on the user and duties on the competent authority

• remove some of the technical advice, which will be updated and included in the SACGM Compendium of Guidance

• remove the appeals process and provide clearer, standalone guidance on the appeals procedure

• improve the advice on significant changes, the genetic modification safety committee, and how the Regulations interact with the Control of Substances Hazardous to Health 2002 (COSHH)

The Scientific Advisory Committee on Genetic Modification (Contained Use), (SACGM(CU)) is expected to issue updated guidance. In the meantime the current information provided on the Safety Office website on GMOs is fit for the purpose of carrying out risk assessments for GMO work in containment, and will be updated in line with HSE and SACGM guidance in due course.