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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[42], The Specified Animal Pathogens (Wales) Order 2008[43] and The Specified Animal Pathogens (Scotland) Order 2009 (SAPO[44]), are made under the Animal Health Act 1981[45].

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 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[46] and complete an application form for a SAPO licence[47]. This application should be sent to HSE at bioagents@hse.gov.uk.

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.

Link URLs in this page

  1. Biosafetyhttps://www.hse.gov.uk/biosafety/index.htm
  2. Safety noticeshttps://www.hse.gov.uk/biosafety/notices/index.htm
  3. Overview - The regulation of specified animal pathogenshttps://www.hse.gov.uk/biosafety/sapo.htm
  4. Background on the regulation of specified animal pathogenshttps://www.hse.gov.uk/biosafety/background.htm
  5. SAPO Application processhttps://www.hse.gov.uk/biosafety/app-process.htm
  6. How do I make my application?https://www.hse.gov.uk/biosafety/how-do-i.htm
  7. Notifying accidents and dangerous occurrencehttps://www.hse.gov.uk/biosafety/notify.htm
  8. Guidance on Appeals for Notices issued under SAPOhttps://www.hse.gov.uk/biosafety/guidance-appeals-sapo.htm
  9. Overview - Infections at workhttps://www.hse.gov.uk/biosafety/infection.htm
  10. Preventing infections at workhttps://www.hse.gov.uk/biosafety/about.htm
  11. HSE and infectionshttps://www.hse.gov.uk/biosafety/hseandinfection.htm
  12. Overview - Are you at risk?https://www.hse.gov.uk/biosafety/microorganisms.htm
  13. Laboratory workhttps://www.hse.gov.uk/biosafety/laboratories.htm
  14. Healthcarehttps://www.hse.gov.uk/biosafety/healthcare.htm
  15. Overview - Specific infectionshttps://www.hse.gov.uk/biosafety/diseases/index.htm
  16. Overview - Influenzahttps://www.hse.gov.uk/biosafety/diseases/influenza.htm
  17. Avian influenzahttps://www.hse.gov.uk/biosafety/diseases/avianflu.htm
  18. Pandemic influenzahttps://www.hse.gov.uk/biosafety/diseases/pandemic.htm
  19. Workplace guidancehttps://www.hse.gov.uk/biosafety/diseases/pandflu.htm
  20. Anthraxhttps://www.hse.gov.uk/biosafety/diseases/anthrax.htm
  21. Zoonoseshttps://www.hse.gov.uk/biosafety/diseases/zoonoses.htm
  22. Bovine spongiform encephalopathy (BSE)https://www.hse.gov.uk/biosafety/diseases/bovine.htm
  23. Handling the deceased with suspected or confirmed COVIDhttps://www.hse.gov.uk/biosafety/handling-the-deceased.htm
  24. What the Law says about Biosafetyhttps://www.hse.gov.uk/biosafety/law.htm
  25. Biosafety Resourceshttps://www.hse.gov.uk/biosafety/information.htm
  26. Useful linkshttps://www.hse.gov.uk/biosafety/links.htm
  27. Blood-borne viruseshttps://www.hse.gov.uk/biosafety/blood-borne-viruses/index.htm
  28. Overview - GMOhttps://www.hse.gov.uk/biosafety/gmo/index.htm
  29. What are GMOs?https://www.hse.gov.uk/biosafety/gmo/whatare.htm
  30. Who is responsible for GMO (CU) Regulations?https://www.hse.gov.uk/biosafety/gmo/whos-responsible.htm
  31. GMOs and the lawhttps://www.hse.gov.uk/biosafety/gmo/law.htm
  32. GMO Notificationshttps://www.hse.gov.uk/biosafety/gmo/notifications/index.htm
  33. What do I notify?https://www.hse.gov.uk/biosafety/gmo/notifications/what.htm
  34. How do I notify?https://www.hse.gov.uk/biosafety/gmo/notifications/process.htm
  35. Feeshttps://www.hse.gov.uk/biosafety/gmo/notifications/fees.htm
  36. Appealshttps://www.hse.gov.uk/biosafety/gmo/notifications/appeals.htm
  37. Confidentiality and disclosure of notified datahttps://www.hse.gov.uk/biosafety/gmo/notifications/confid.htm
  38. Description of the Public Registerhttps://www.hse.gov.uk/biosafety/gmo/notifications/publicregister.htm
  39. Overview - Resourceshttps://www.hse.gov.uk/biosafety/gmo/information.htm
  40. The SACGM Compendium of Guidancehttps://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm
  41. Risk assessment guidancehttps://www.hse.gov.uk/biosafety/gmo/acgm/index.htm
  42. The Specified Animal Pathogens Order 2008http://www.legislation.gov.uk/uksi/2008/944/contents/made
  43. The Specified Animal Pathogens (Wales) Order 2008http://www.legislation.gov.uk/wsi/2008/1270/contents/made
  44. The Specified Animal Pathogens (Scotland) Order 2009 (SAPOhttp://www.legislation.gov.uk/ssi/2009/45/contents/made
  45. Animal Health Act 1981http://www.legislation.gov.uk/ukpga/1981/22/contents
  46. Guidance for licence holders on the containment and control of specified animal pathogenshttps://www.hse.gov.uk/pubns/books/hsg280.htm
  47. SAPO licencehttps://www.hse.gov.uk/biosafety/app-process.htm
  48. CD230 - Consultation on the Legislative Reform Order to amend the Health and Safety at Work etc. Act (1974)https://consultations.hse.gov.uk/
  49. Department for Environment, Food and Rural Affairshttps://www.gov.uk/government/organisations/department-for-environment-food-rural-affairs
  50. Department of Healthhttps://www.gov.uk/government/organisations/department-of-health
  51. Food Standards Agencyhttp://www.food.gov.uk/

Glossary of abbreviations/acronyms on this page

GMO
Genetically modified organisms

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Updated 2024-07-30