Frequently asked questions

This page provides answers to some of the more commonly asked questions about the new arrangements for a single regulatory framework for contained use work with human and animal pathogens including GMO. This includes work currently done under SAPO.

• If I need a SAPO licence, do I apply to HSE or Defra?
• My SAPO licence is due for renewal, what mechanism is in place to ensure that it doesn’t expire?
• What is Defra/Scottish Government/National assembly for Wales's role?
• I work with genetically modified micro-organisms, will I be affected?
• What will the new regulatory framework look like?
• How will the new regulatory framework affect work with (non GM) human pathogens?
• I have heard that we may have to pay for inspections. Is this true?
• What about importation of animal pathogens?
• How can I found out more about the new regulations and let HSE know my views on them?

If I need a SAPO licence, do I apply to HSE or Defra?

All licence applications, transfers and renewals will be handled:

• In England, licence applications should be made to Defra.
• In Scotland, licence applications should be made to the Scottish Government Rural Directorate.
• In Wales, licence applications should be made to the Welsh Assembly Government.
• In Northern Ireland, licence applications should be made to the Department of Agriculture and Rural Development.

My SAPO licence is due for renewal, what mechanism is in place to ensure that it doesn’t expire?

Inspection of SAPO facilities has been incorporated into HSE’s national rolling inspection programme. HSE is provided with details of licences so that they are aware when licences are due for renewal and its inspectors plan visits accordingly. As part of the arrangements under the MoU with Defra, HSE will meet on a regular basis to inform Defra of the outcome of SAPO inspections.

What is Defra/Scottish Government/National assembly for Wales's role?

Defra/SG/NAW will continue to issue SAPO licences on HSE’s recommendations following inspection.

In the event of an outbreak of animal disease resulting from a loss of containment at a research facility:

• Defra, Scottish Government and National Assembly of Wales will continue to act on animal welfare issues and to prevent the spread of disease.
• HSE investigate the cause of the loss of containment.

I work with genetically modified micro-organisms, will I be affected?

The existing system remains in place for GM work for the time being. This may change to a small extent when the new legislation comes in, but GM centres will be included in the consultation on proposals for change.

What will the new regulatory framework look like?

HSE’s proposal is that the new framework will use the regulatory model that is in place for work with GMOs, i.e., an assessment and risk based classification of contained use activities, notification of premises and activities and application of appropriate containment and control measures.

How will the new regulatory framework affect work with (non GM) human pathogens?

Under the new framework, it is proposed that there will be a need to notify HSE of premises working with human pathogens. This will be similar to the current notification process.

I have heard that we may have to pay for inspections. Is this true?

The Callaghan review recommended that cost recovery be introduced into the new regulatory framework. HSE policy is to recover the cost of work of a ‘permissioning’ nature – for example, licensing, assessing and accepting safety cases, receiving and analysing notifications – as happens now with the GMO(CU) Regulations. We will be investigating options for the establishment of a fair and proportionate cost recovery regime for inspections, investigations and notifications.

What about importation of animal pathogens?

Defra, the Scottish Government and the Welsh Assembly Government remain the licensing authorities for the importation of animal pathogens (IAPO) and will continue to be after the new legislation comes into force

How can I found out more about the new regulations?

Information about the new regulations will be provided through this FAQ page.