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 UK CA provides the mechanism by which agreement on policies related GMO(CU)-related business will be sought for response to the European Commission (EC) by UK representatives and 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:

  • Receive any reports, directions or outcomes from the EC or the EU Member State competent authority meetings (on contained use of GMOs);
  • Agree policies to be put forward by UK representatives in responding to the EC;
  • 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

It is anticipated that the UK CA will meet once per year at a time that is convenient for members and when there is adequate items for discussion.  These meetings will be held face-to-face and the location is to be rotated.

Reports and other correspondence from the EC (eg three yearly implementation reports, EU competent authority meetings, annual report on class 3 and 4 activities, accident notifications) are communicated to the CA. Where lines to take are required for EU committees, in relation to routine issues, these can be cleared by correspondence, unless significant issues are raised. It will be the responsibility for the UK lead to initiate the correspondence. They will need to use their judgement to decide which issues are technical or minor issues, which can be agreed between relevant experts as necessary, and which give rise to policy issues on which the formal agreement of UK departments and the devolved administrations are necessary through the CA.

Where timing permits, more significant issues may be discussed at the CA meetings. In such cases, where the meeting is expected to reach a decision, 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.

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

A brief note of each CA meeting will be published on the HSE GMO website.

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.

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Updated 2021-08-02