The regulation of specified animal pathogens
What is a specified animal pathogen?
Specified animal pathogens are infectious agents, such as viruses, bacteria, parasites, including:
- Intact pathogens;
- Pathogens which have been attenuated or genetically modified by any means; and
- Any nucleic acid derived from an animal pathogen listed in Schedule 1 of SAPO which could produce that pathogen when introduced into a biological system in which the nucleic acid is capable of replicating.
What is the Specified Animal Pathogens Order (SAPO)?
The primary legislation that applies to contained use of specified animal pathogens is The Specified Animal Pathogens Order 2008, The Specified Animal Pathogens (Wales) Order 2008 and The Specified Animal Pathogens (Scotland) Order 2009 (SAPO), are made under the Animal Health Act 1981.
SAPO prohibits any person from having in their possession:
- any specified animal pathogen listed in Part 1 of Schedule 1 of SAPO; or
- any carrier in which they know such a pathogen is present.
Similarly, in the absence of a licence, it also prohibits the introduction into any animal or bird of any pathogen listed in Parts 1 and 2 of Schedule 1 of SAPO.
SAPO also requires any person who has in their possession anything in which they have reasonable grounds for suspecting that a specified animal pathogen in Part 1 of Schedule 1 of SAPO is present, and who does not have a licence in respect of that pathogen, to immediately notify the Secretary of State via the licensing authority (HSE).
SAPO has no application to any animal pathogen or carrier contained in veterinary or human medicines, which have market authorisation in accordance with the relevant legislation for use in the UK.
What is the purpose of SAPO?
The purpose of the Order is to prevent the introduction and spread into Great Britain of specified animal pathogens which are not endemic and which, if introduced, would cause serious disease and economic loss to the livestock industry.
What are the new SAPO arrangements?
With effect from 1 April 2015, HSE will be responsible for regulation of activities involving specified animal pathogens through the administration, licensing, inspection and enforcement of SAPO in England, Scotland and Wales.
The new approach means:
- The transfer of licensing, inspection and enforcement responsibilities to HSE.
- Revision of licence conditions and associated guidance to make them more risk based and goal setting.
- Providing a single user/regulator interface for contained use of biological agents (including genetically modified microorganisms, human and animal pathogens).
- Retention of the policy lead for SAPO by Defra and the Devolved Governments (DGs). These functions are carried out by HSE under Agency Agreements with Defra and the DGs.
Consequently, HSE is the point of contact for all enquires related to licensing and inspection of activities involving specified animal pathogens, as well as regulation of contained use of human pathogens and genetically modified organisms.
How will the transition to the new regime happen?
By September 2016, all existing licence holders will be moved to a new licence with revised licence conditions. HSE has developed transitional arrangements, which sets out how existing SAPO licence holders will achieve this.
HSE will write to all existing licence holders in April 2015, explaining the process and setting out the time period to permit licence holders to become compliant with the requirements of their new licences. This time period will be at least 6 months and will reflect the scale and complexity of the SAPO activities.
How do I obtain a SAPO licence?
Those who wish to possess or work with a specified animal pathogen or a carrier (in which a specified animal pathogen may be present) in England, Scotland or Wales need to consider Guidance for licence holders on the containment and control of specified animal pathogens and complete an application form for a SAPO licence. This application should be sent to HSE.
As the licensing process can take up to 3 months to complete, and may require a pre-licensing inspection, applicants should allow sufficient time before work with the specified animal pathogen is proposed to start.