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Who is responsible for the GMO (CU) Regulations?

Background

The UK competent authority (CA) for the Genetically Modified Organisms (Contained Use) Regulations (GMO(CU)) comprises representatives of the four responsible authorities for GMO(CU) in the UK. The GMO(CU) 2014 Regulations apply to England, Scotland and Wales. The GMO(CU) (Northern Ireland) 2015 Regulations apply to Northern Ireland.

In England and Wales, the Health and Safety Executive (HSE) and the Secretary of State for the Department for Environment, Food and Rural Affairs (DEFRA) acting jointly form the competent authority. The functions are delegated to HSE and DEFRA officials. Officials from Welsh Government are included in any matters relating to Wales.

In Scotland, the competent authority comprises Scottish Ministers and HSE acting jointly and similarly these functions are delegated to HSE and Scottish Government officials.

In Northern Ireland, the competent authority is the Health and Safety Executive for Northern Ireland (HSENI) and the Department of the Environment, acting jointly. HSENI officials are provided with technical support from HSE, under an Agency Agreement.

HSE and HSENI take the lead on behalf of the other parts of the CA for administering the respective Regulations and act as the point of contact for notifications, enquiries and inspections in Great Britain and Northern Ireland respectively.

The UKCA provides the mechanism by which they will advise, support and oversee the HSE and the HSENI in the discharge of the functions and responsibilities required to effectively implement the Regulations in Great Britain and Northern Ireland.

The Terms of Reference are set out below

The competent authority will:

  • consider reports and performance of the enforcing authorities (HSE and HSENI) on their regulatory activities in relation to the GMO(CU) regulations including operation of the notification scheme, inspection regime and any relevant accident information and outcomes
  • consider the performance and effectiveness of the Scientific Advisory Committee for Genetic Modification (Contained Use)
  • consider the effectiveness of the procedure for appeals under the GMO(CU) Regulations and amend accordingly

Working methods

The UKCA will meet when there are adequate items for discussion and at time that is convenient for members.

Meetings of the CA will discuss routine performance of the regulatory regimes, the organisation and management of the CA and the annual performance report of the Scientific Advisory Committee for Genetic Modification (SACGM(CU)).

Where more significant issues are to be discussed and the CA is expected to reach a decision at the meeting, proposals should be circulated to all members at least two weeks in advance. Members of the CA should consider whether such decisions need to be referred to their Ministers, and should do so before the meeting where necessary. Similarly, two weeks should be allowed for agreement by correspondence, and Departments should clear with Ministers where necessary.

Composition

Composition of the CA is representatives from:

  • Department for the Environment Food and Rural Affairs
  • The Health and Safety Executive
  • The Health and Safety Executive Northern Ireland
  • The Scottish Government

The Welsh Government will be included in all matters relating to contained use in Wales. Other government departments, agencies, non-departmental public bodies, representatives of local government and Chair of SACGM(CU) may attend CA meetings as observers, by invitation of the CA.

Link URLs in this page

  1. Biosafetyhttps://www.hse.gov.uk/biosafety/index.htm
  2. Safety noticeshttps://www.hse.gov.uk/biosafety/notices/index.htm
  3. Overview - The regulation of specified animal pathogenshttps://www.hse.gov.uk/biosafety/sapo.htm
  4. Background on the regulation of specified animal pathogenshttps://www.hse.gov.uk/biosafety/background.htm
  5. SAPO Application processhttps://www.hse.gov.uk/biosafety/app-process.htm
  6. How do I make my application?https://www.hse.gov.uk/biosafety/how-do-i.htm
  7. Notifying accidents and dangerous occurrencehttps://www.hse.gov.uk/biosafety/notify.htm
  8. Guidance on Appeals for Notices issued under SAPOhttps://www.hse.gov.uk/biosafety/guidance-appeals-sapo.htm
  9. Overview - Infections at workhttps://www.hse.gov.uk/biosafety/infection.htm
  10. Preventing infections at workhttps://www.hse.gov.uk/biosafety/about.htm
  11. HSE and infectionshttps://www.hse.gov.uk/biosafety/hseandinfection.htm
  12. Overview - Are you at risk?https://www.hse.gov.uk/biosafety/microorganisms.htm
  13. Laboratory workhttps://www.hse.gov.uk/biosafety/laboratories.htm
  14. Healthcarehttps://www.hse.gov.uk/biosafety/healthcare.htm
  15. Overview - Specific infectionshttps://www.hse.gov.uk/biosafety/diseases/index.htm
  16. Overview - Influenzahttps://www.hse.gov.uk/biosafety/diseases/influenza.htm
  17. Avian influenzahttps://www.hse.gov.uk/biosafety/diseases/avianflu.htm
  18. Pandemic influenzahttps://www.hse.gov.uk/biosafety/diseases/pandemic.htm
  19. Workplace guidancehttps://www.hse.gov.uk/biosafety/diseases/pandflu.htm
  20. Anthraxhttps://www.hse.gov.uk/biosafety/diseases/anthrax.htm
  21. Zoonoseshttps://www.hse.gov.uk/biosafety/diseases/zoonoses.htm
  22. Bovine spongiform encephalopathy (BSE)https://www.hse.gov.uk/biosafety/diseases/bovine.htm
  23. Handling the deceased with suspected or confirmed COVIDhttps://www.hse.gov.uk/biosafety/handling-the-deceased.htm
  24. What the Law says about Biosafetyhttps://www.hse.gov.uk/biosafety/law.htm
  25. Biosafety Resourceshttps://www.hse.gov.uk/biosafety/information.htm
  26. Useful linkshttps://www.hse.gov.uk/biosafety/links.htm
  27. Blood-borne viruseshttps://www.hse.gov.uk/biosafety/blood-borne-viruses/index.htm
  28. Overview - GMOhttps://www.hse.gov.uk/biosafety/gmo/index.htm
  29. What are GMOs?https://www.hse.gov.uk/biosafety/gmo/whatare.htm
  30. Who is responsible for GMO (CU) Regulations?https://www.hse.gov.uk/biosafety/gmo/whos-responsible.htm
  31. GMOs and the lawhttps://www.hse.gov.uk/biosafety/gmo/law.htm
  32. GMO Notificationshttps://www.hse.gov.uk/biosafety/gmo/notifications/index.htm
  33. What do I notify?https://www.hse.gov.uk/biosafety/gmo/notifications/what.htm
  34. How do I notify?https://www.hse.gov.uk/biosafety/gmo/notifications/process.htm
  35. Feeshttps://www.hse.gov.uk/biosafety/gmo/notifications/fees.htm
  36. Appealshttps://www.hse.gov.uk/biosafety/gmo/notifications/appeals.htm
  37. Confidentiality and disclosure of notified datahttps://www.hse.gov.uk/biosafety/gmo/notifications/confid.htm
  38. Description of the Public Registerhttps://www.hse.gov.uk/biosafety/gmo/notifications/publicregister.htm
  39. Overview - Resourceshttps://www.hse.gov.uk/biosafety/gmo/information.htm
  40. The SACGM Compendium of Guidancehttps://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm
  41. Risk assessment guidancehttps://www.hse.gov.uk/biosafety/gmo/acgm/index.htm
  42. Department for Environment, Food and Rural Affairs https://www.gov.uk/government/organisations/department-for-environment-food-rural-affairs
  43. Department of Health https://www.gov.uk/government/organisations/department-of-health
  44. Food Standards Agencyhttp://www.food.gov.uk/
  45. COSHHhttps://www.hse.gov.uk/coshh/index.htm
  46. RIDDORhttps://www.hse.gov.uk/riddor/index.htm
  47. Skinhttps://www.hse.gov.uk/skin/index.htm
  48. Health and social carehttps://www.hse.gov.uk/healthservices/index.htm

Glossary of abbreviations/acronyms on this page

GMO
Genetically modified organisms

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Updated 2024-01-19