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How do I make my application?

This page provides you with guidance on the practical elements of applying for a SAPO licence. It is important that applicants ensure a valid application is submitted to HSE which means that all relevant sections are completed. Consideration should be given as to whether additional notification is required under the Genetically Modified Organisms (Contained Use) Regulations 2014 or the Control of Substances Hazardous to Health Regulations 2002.

Ways to notify?

There are several ways to apply for a SAPO licence - using an online form, an electronic form or by post

The options for submitting an application

Online forms

When submitting an online notification, it is not possible to save the information as you go along. 

Before you start, please ensure you have the relevant information that you will need for completing the online form to enter and/or copy and paste into the form.

There is an option to print your completed online application form before submitting to HSE or receive a copy of the form by email after submitting.

Electronic forms

This is a MS word version of the form that you can save to your computer and input the information.  This form can be submitted by email to
bioagents@hse.gov.uk

Post

This option is only really used for information that is of a sensitive nature and can delay your approval, so please bear this in mind.  Please send completed notifications to: SAPO Applications Officer, Health and Safety Executive, Hazardous Installations Directorate, Biological Agents Unit, 5S2 Redgrave Court, Merton Road, Bootle, Merseyside, L20 7HS

General information on making an application

Which form should I use to apply for a licence?

A SAPO form should be completed. You can identify on the form if you are applying for a new or renewal licence or notifying a significant change to an existing licence.

The use of application forms is not a legal requirement but they have been designed to ensure that the necessary information is submitted. Failure to submit all the necessary information will delay the time taken to issue a licence and may necessitate HSE requesting additional information.

What information do I need available for completing the online application?

Given the range of different information that needs to be compiled for a licence application, it is not recommended that text is typed directly into an online form. Online forms cannot be saved during the drafting process. It is, therefore, a good idea to draft in a format that can be saved and then cut and paste into the online form. The information you will need to have ready is outlined below.

  • Addresses of all the premises where work involving specified animal pathogens will be conducted.
  • Details of the specified animal pathogen(s) for which the application is being made.
  • A copy of the risk assessment for work involving specified animal pathogens
  • Details of the person or safety committee with expertise in risk assessment relating to work involving specified animal pathogens, and their comments on the risk assessment.
  • Details of the waste management measures.
  • Details of the management arrangements.
  • If applying for derogation, details of the measures and justification.
  • Details of any arrangements for transporting the specified animal pathogen off the premises (if applicable).
  • Name and training qualifications of the person responsible for supervision and possession of the specified animal pathogen(s), and the name of the Biological Safety Officer and any other relevant contacts.

An application that does not include the above information will be deemed not to be valid and returned to the applicant to complete in full.

Will HSE acknowledge receipt of my application?

HSE will acknowledge receipt of a completed application form within 10 working days of receipt. No activities, to which the application relates, can commence until HSE issues the applicant with a valid SAPO licence.

What type of further information am I likely to have to provide and will an inspector visit?

Most requests for further information occur because the applicant has not included the relevant information in the application or because the information provided is not clear.

For novel or complex work, where the evidence of risk is not well established, an HSE inspector may ask you about how you have used evidence in your risk assessment.

HSE will check compliance before issuing a new licence as follows:

  • SAPO 2 licences - Desk based assessment of application form, risk assessment and associated information.
  • 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).
  • SAPO4 as part of the annual intervention plan.

What constitutes a significant change to a licence?

A significant change which increases or presents different risks from the licensed activities requires notifying to the licensing authority. This may relate to a proposed change to the ongoing work or where new information emerges that changes the rationale upon which the risk assessment is based. These changes are significant if they lead to a change to the way you work (eg containment or control measures) or if they present different or increased hazards/risks from the work (eg addition of a different specified animal pathogen). For more information about significant changes to licences see Guidance for licence holders on the containment and control measures for specified animal pathogens.

To notify a significant change, you will need to complete a licence application form and indicate on the form that you are notifying a significant change to an existing licence and provide the relevant details including a revised risk assessment for the work.

How do I make a renewal application for a licence?

HSE will contact licence holders prior to their existing licence expiring to advise of this and where the licence holder wishes to continue to use the specified animal pathogen, a completed application form should be submitted to HSE in advance of the expiry of the existing licence. However, licence holders should not rely upon being reminded. It is the responsibility of those possessing specified animal pathogens to ensure they hold a valid licence for that pathogen.

How do I apply for a derogation?

At the time of making a new licence application, it is possible to seek agreement from the licensing authority to not apply a measure(s) indicated as required in the containment level corresponding to the categorisation of the specified animal pathogen. Such requests must be justified by the risk assessment. HSE will inform the applicant whether the derogation has been agreed when responding to the application.

Licence holders can also request derogation from a specific containment measure after the licence has been issued. This would be classed as a significant change to a licence and this option should be selected when completing the application form.

The justification for not applying a specific measure should:

  1. Provide the reasons why the measure is not necessary.
  2. Provide the alternative measures to be implemented to provide equally effective protection.

How do I obtain a licence for transferring specified animal pathogens between sites?

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.

How do I obtain a licence for importing specified animal pathogens or carriers from outside of the EU?

This does not fall within the remit of HSE. A separate licence is required under the Importation of Animal Pathogens Order (IAPO) 1980. These licences are issued by the Animal Plant Health Agency Imports Team. An IAPO licence will only be issued if the applicant holds a SAPO licence to hold/work with the specified animal pathogen concerned.

If I am not happy with the decision made about my licence?

If you disagree with any licensing decision, you should contact HSE and raise the matter with the licensing team. This should be done via email.

If you are unhappy about how HSE has dealt with you, we want to know and you can contact us. HSE has in place a procedure to investigate and resolve any instances where concerns are raised in relation to the way HSE has performed.

Can I appeal against a licensing or enforcement notice?

There is a formal appeal process for any SAPO licence holder who is aggrieved by decisions made by the licensing authority. The appeal should be made to Defra, Scottish Government or Welsh Government depending on the premises location. However, you are advised to discuss the matter with HSE in the first instance to ascertain whether it can be resolved before lodging a formal appeal.

Who can I contact if I need help?

You can get advice on administrative matters relating to making an application or any other query relating to your SAPO licence by contacting the SAPO Application Officer.

This is also the address for submission of MS word applications:

SAPO Application Officer
Health and Safety Executive
Biological Agents
Unit 5S.2 Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS

Updated 2015-06-15