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Transitional arrangements from the existing SAPO regime to the new SAPO regime

What has changed?

Following the review of SAPO related activities in 2013/14 by HSE, Defra and the Devolved Governments, a non-legislative means of achieving the principles of a common regulatory approach to contained use of biological agents was identified. These new SAPO arrangements will commence from April 2015. The new approach means:

  • The transfer of all licensing, inspection and enforcement responsibilities to HSE.
  • Revision of licence conditions and associated guidance to make them more risk based and goal setting.
  • The development of a single user/regulator interface for all contained use activities.
  • Retention of the policy lead by Defra and Devolved Governments.

What does this mean for existing SAPO licence holders?

Existing licence holders will continue to operate under their existing licence and associated conditions until HSE issues them with a new licence. This will be on a date agreed between HSE and the licence holder that provides sufficient time for the licence holder to comply with the new licence conditions. Before a new licence can be issued, the licence holder must be able to comply with the requirements of the revised licence conditions. These can be found in the Guidance for licence holders on the containment and control of specified animal pathogens.

There are key changes to the new regime which include:

  • A requirement for a risk assessment.
  • A requirement to comply with a set of goal setting licence conditions that include management arrangements to ensure the effective application and maintenance of containment and control measures.

What do you need to do as a current SAPO licence holder?

Existing licence holder should familiarise themselves with Guidance for licence holders on the containment and control of specified animal pathogens.

HSE will be writing to all existing licence holders setting out the new arrangements, the proposed date for transition to a new licence, what is involved and requiring a response from the licence holder. Specifically licence holders will need to:

  • agree to the allotted length of time to comply with the new licence conditions. This will be tailored to individual sites by considering the scale and complexity of the current activities and estimating the gap to be filled between existing and new licence requirements;
  • confirm that they will be compliant with the new licence conditions within the specified timeframe and before the new licence is issued;
  • where necessary, provide a revised date, where the licence holder does not believe the date offered by HSE is realistic to achieve compliance;
  • confirm their licence details (eg current licence holder, specified animal pathogen, site specific details); and
  • confirm whether the licence holder requires any derogations from any of the containment measures set out in the containment tables.

Will the transition to a new licence involve an inspection by HSE?

For those SAPO licences which expire during the transitional period (April 2015 to September 2016), HSE will undertake a compliance check to ascertain whether the licence conditions are being met. This may involve either a desk based review of the risk assessment and relevant documentation or a pre-licensing inspection.

For existing licences that do not expire during the transitional period, the transition to the new licences will be an administrative process and rely upon licence holders to provide confirmation of their conformity with the new licence conditions. Subsequent compliance checks by HSE will be at the time of licence renewal or part of the HSE programme of proactive inspections (based largely on hazard and performance).

What happens to existing SAPO licences?

Licence holders should continue to operate in accordance with their existing licences until HSE issues a new licence, when the existing licence will be revoked. This includes the period between HSE writing to the licence holder and issuing the new licence.

In the interim period should HSE be required to undertake an inspection (eg in relation to a licence amendment) or investigate an accident or dangerous occurrence, this will be checked against the existing licence conditions and current Defra guidance Animal Pathogens – Guidance on Controls.

Amendments to existing SAPO licences

If an amendment to a SAPO licence is required, where possible, licence holders will be transferred onto the new licensing regime. However, where this is not feasible, then HSE will be able to amend existing licences and licence holders can continue to operate in accordance with that licence. This will be assessed by HSE on a case-by-case basis so please contact HSE with details of your amendment who will advise accordingly.

Who will issue the new licence?

HSE will issue new licences. HSE will prepare new licences based on the licence holder’s response and their confirmation of compliance with the new licence conditions. Existing licences will be revoked when the new licence is issued. From April 2015, all licensing and inspection enquiries should be directed to HSE.

How long will a licence be issued for?

In the first instance, the duration of a new licence will vary between licence holders to enable HSE to distribute licence renewal dates in an even manner. Thereafter, it is intended that licences will be issued for a period of five years.

Transfer licences under existing licences

For those licence holders who need to transfer a specified animal pathogen between licence holders and have not moved onto a new licence, then a transfer licence will be required before the specified animal pathogen can be moved. Transfer licences should be obtained by contacting HSE.

Once issued with a new licence, transfer licences will no longer be required. However, licence holders will be required to transport specified animal pathogens safely to comply with their licence condition.

New licence applications from April 2015

For those wishing to use specified animal pathogens and who do not have an existing licence, an application form should be submitted, along with an appropriate risk assessment, to HSE. New licence applications will be processed according to the new SAPO licensing arrangements. Applicants will need to demonstrate compliance with the conditions in the guidance before a SAPO licence is issued.

How do I renew my licence after the transitional period?

All existing licence holders will be issued with a new licence within the transitional period (April 2015 to September 2016). In advance of the expiry of the new licence (and where the licence holder wishes to continue to use the specified animal pathogen), a completed application form should be submitted to HSE. This will be processed according to the new SAPO licensing arrangements. HSE will check compliance before issuing a new licence as follows:

  1. SAPO 2 licences - Desk based assessment of application form, risk assessment and associated information;
  2. SAPO3 licences - Desk based assessment and pre-licensing inspection (there may be circumstances where an inspection is not deemed necessary eg where HSE has inspected the laboratory recently); or
  3. SAPO4 as part of the annual intervention plan.

How do I contact HSE?

If you have a query please email HSE Bioagents.

Updated 2015-04-01