Health and Safety
Executive / Commission
Infections at work and GMOs
This page provides answers to some of the more commonly asked questions about the new arrangements for SAPO and plans for the regulation of work involving pathogens. If you have a query that isn't listed below, please telephone HSE’s Infoline on 0845 345 0055 and ask to be put through to the Biological Agents Duty Inspector or e-mail HSE's Callaghan Implementation Team at callaghan@hse.gsi.gov.uk.
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.
No. Currently, HSE is involved only if you are applying for a licence for work in a facility in England. To fit in with the way that HSE operates its inspection programme, a robust process has been built in to the Memorandum of Understanding (MoU) that exists between Defra and HSE. In effect, upon being notified by Defra of an application, HSE will take a maximum of 50 working days to make its recommendations to Defra about the issue of a licence (see sections 4.2 and 4.3 of the MoU).
If you are working in a facility in England, inspection of SAPO facilities has been incorporated into HSE’s national rolling inspection programme. Defra has provided HSE with details of licences so that HSE is aware when licences are due for renewal and its inspectors are planning visits accordingly. As part of the arrangements under the MoU, HSE will meet with Defra on a regular basis to inform Defra of the outcome of SAPO inspections.
If you are working in a facility in Scotland, Wales or Northern Ireland, the existing arrangements continue to apply, and you should contact the relevant Authority for licence renewal information and advice.
Currently, Defra still issues SAPO licences for work in facilities in England, on HSE’s recommendations following inspection. This will continue until any new legislation comes into force.
In the event of an outbreak of animal disease resulting from a loss of containment at a research facility in England:
The existing system remains in place for GM work. This may change when the new legislation comes in, but GM centres will be included in the consultation on proposals for change.
No decisions about the new framework have been made. However, the regulation of work with GMOs seems to work well and so may be seen as a good model for future legislation.
This was recognised as an issue early on and a working group from the Advisory Committee on Dangerous Pathogens has been established to produce a simplified set of common containment measures. Members from the Scientific Advisory Committee on Genetic Modification (Contained Use) have been co-opted onto this working group.
Government policy is to recover costs wherever possible. 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. And we will of course seek the views of those affected before proposals are made to Ministers. We plan to consult in 2009 and it is not likely that the new regime will be in operation before April 2010.
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
You will need to submit a fresh SAPO licence application for the site, i.e. the facility at which the work will take place. Subsequent to the receipt of your new licence, you will also need to apply to Defra for a domestic transfer licence before you can move and therefore commence any work involving materials containing the specified animal pathogen.
If the recipient facility is in England, it will need to undergo an inspection by an HSE specialist inspector before the new licence can be issued by Defra. However, if the facility has been inspected recently by an HSE specialist inspector, then HSE may use its discretion to waive the need for this requirement.