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Disease surveillance & control: Animal Pathogens

This site contains guidance on the controls on animal pathogens that Defra administers under the Importation of Animal Pathogens Order 1980 as amended and the Specified Animal Pathogens Order 2008. Sir Bill Callaghan’s review of the regulatory framework for animal pathogens recommended a three phased approach to implement a number  of changes to strengthen this framework in the UK. Further information is available on the Investigations and reviews into the FMD outbreak page.

31 March 2010 – HSE consultation: Amendments to the Genetically Modified Organisms (Contained Use) Regulations 2000.

1 February 2010 - HSE consultation: Proposed Legislative Reform Order that will extend HSE’s powers under The Health and Safety at Work etc. Act to cover the protection of animal health arising from work with animal pathogens.

4 September 2009 - Consultation: Amendment to the specified animal pathogens order (SAPO) 2008

Contents

Importing an animal pathogen or carrier from a country outside the European Communities under the Importation of Animal Pathogens Order 1980 (IAPO)

The Importation of Animal Pathogens Order 1980 (IAPO) prohibits the importation into England from a third country (i.e. a country that is not a Member State of the European Communities) of any animal pathogen or carrier except under the authority of a licence in writing issued by the Secretary of State for Environment, Food and Rural Affairs and in accordance with the conditions of that licence.

The Order also requires anyone who has in their possession an animal pathogen or carrier which they know to have been imported in contravention of the provisions of the Order to report the fact to a veterinary inspector as quickly as possible. If you need to make such a report, you should contact the nearest Animal Health Divisional Office. This will be listed in your local telephone directory.

The Order does not apply to any animal pathogen or carrier contained in a licensed medicinal product, the importation of which is permitted under the Medicines Act 1968, or to importations made from other Member States of the European Communities.

Licences under IAPO

Licences usually stipulate the manner in which the animal pathogen or carrier must be prepared, treated and packed prior to importation, the containment conditions under which it must be handled while it is in England and the method by which it and its derivatives must be disposed of, if it is not re-exported. The purpose of imposing these conditions is to protect the British livestock and poultry industries from infection by animal pathogens imported into Great Britain from outside the EC. Licences are normally valid for two years, to provide for the importation of the material and the completion of work on the material in the laboratory, following importation.

Definitions under IAPO

Under the Importation of Animal Pathogens Order 1980:

  • an “animal pathogen” means any collection or culture of organisms or any derivative either on its own or in recombinant form of such collection or culture of organisms which may cause disease in animals or poultry.
  • a “carrier” means “any living creature except man which may carry or transmit an animal pathogen or the tissue, cell culture, body fluid, excreta, carcase or part of a carcase of such creature by or by means of which an animal pathogen may be transmitted.

For the purposes of the Order, “animals” means cattle, sheep, goats and all other ruminating animals, horses and swine, and “poultry” means domestic fowls, turkeys, geese, ducks, guinea-fowls, pigeons, pheasants, partridges and quail.

Applying for an import licence under IAPO

If your laboratory is located in England and you wish to apply for a licence to import an animal pathogen or carrier from a country outside the EC an application form for a licence under the Importation of Animal Pathogens Order 1980 (IAPO) can be downloaded from the Defra website. This form can be printed but cannot be completed electronically. Forms completed in manuscript and signed should be sent to the Pathogens Licensing Team at Defra. An application form may be faxed to us but the signed original must also be provided. Forms that may be completed electronically are available on request. An electronically-completed form may be emailed to us but the signed original must also be provided.

We aim to issue an IAPO licence within 15 working days of receipt of the application, provided that it has been signed and completed correctly and we do not need to seek additional information from the applicant.

The contact point for applicants who wish to import animal pathogens or carriers into England is:

The Pathogens Licensing Team,
Defra,
Area 5A,
17 Smith Square,
London,
SW1P 3JR

Telephone: 020 7238 6211/6150
Fax: 020 7238 6105
Email: pathogens@defra.gsi.gov.uk

If you wish to apply for a licence to import an animal pathogen or carrier from a country outside the EC into Scotland or Wales, please contact the relevant licensing authority at the address below.

Scotland

Scottish Executive Environment and Rural Affairs Department
Animal Health and Welfare
Saughton House
Broomhouse Drive
P Spur, Edinburgh
EH11 3XD
Telephone: 0300 244 9794
E-mail: animal.health@scotland.gsi.gov.uk

Wales

Welsh Assembly Government
Department for Rural Affairs
Cathays Park
Cardiff
CF1 3NQ
Telephone: 02920 823592
Facsimile: 02920 826120
Email: AnimalHealth@wales.gsi.gov.uk

Applying for a licence to transfer material imported under an IAPO licence

Licences issued under the Importation of Animal Pathogens Order 1980 contain conditions prohibiting any transfer of the imported animal pathogen and/or carrier and its derivatives to any other person or laboratory without the prior authority of the Secretary of State. Transfer licences must be obtained to authorise all movements of licensed, imported material or derivatives of imported material, including movements to ports or airports.

There is no application form for an IAPO transfer licence and a short request letter giving the relevant details is all that is needed. Such letters should be signed by the holder of the licence under which the animal pathogen or carrier was imported and give the number of that licence. Full details of the proposed transfer should also be provided (e. g. the pathogen/carrier to be transferred, with quantities and number of containers, the name and address of the person to whom the material is to be transferred, and the approximate transfer date). Where a number of different strains of an animal pathogen are included in one transfer these should be separately listed. Requests for transfer licences may be faxed or emailed in the first instance but a signed letter of request should also be provided.

Importing animals, animal products or products of animal origin under other Defra legislation

Other controls apply to animals, animal products or products of animal origin that are subject to EC trade rules. If you are planning to undertake such an import and are unsure whether a licence under the Importation of Animal Pathogens Order or under animal products’ legislation is needed, please read International trade pages.

Contact point for advice on importation of animals, animal products and products of animal origin subject to EC trade rules:

Animal Health Import Team
Animal Health Divisional Office
Beeches Road
Chelmsford
Essex CM1 2RU

Tel: 01245 358383
Fax: 01245 351162
Email: AHITChelmsford@animalhealth.gsi.gov.uk

Importing an animal pathogen or carrier from another member state of the European Communities

An IAPO licence is not required to import an animal pathogen or carrier from another Member State of the European Communities. However, if the material to be imported is a specified animal pathogen or a carrier of a specified animal pathogen a licence under the Specified Animal Pathogens Order 2008 will need to be obtained prior to importation to authorise the movement of the material from the port of entry to the laboratory for which it is destined in England (see below). Such licences will only be issued where the laboratory of destination is already licensed under the Specified Animal Pathogens Order 2008 to hold or work with the specified animal pathogens concerned.

Controls on specified animal pathogens under the Specified Animal Pathogens Order 2008 (SAPO)

The Specified Animal Pathogens Order 2008 prohibits any person from having in their possession any specified animal pathogen listed in Part I of the Schedule to the Order or any carrier in which they know such a pathogen is present. It also prohibits the introduction into any animal or bird of any pathogen listed in the Schedule to the Order (Parts I and II).

The Order requires any person who has in their possession any thing in which they have reasonable grounds for suspecting that a specified animal pathogen in Part 1 of the Schedule to the Order is present, and who does not have a licence in respect of that pathogen, to notify a veterinary inspector immediately. If you need to make such a notification, you should contact the nearest Animal Health Divisional Office. This will be listed in your local telephone directory.

The purpose of the Order is to prevent the introduction and spread into Great Britain of specified animal pathogens which, if introduced, could cause serious disease and economic loss to the British livestock and poultry industries.

The Order has no application to any animal pathogen or carrier contained in licensed veterinary or human medicines.

Licences under SAPO

Licences under the Specified Animal Pathogens Order 2008 stipulate the way in which the specified animal pathogens covered by the licence must be handled to ensure their safe containment and disposal, the areas of the laboratory in which various types of work may be done and the persons responsible for supervising the work. Licences are usually valid for 5 years. Re-inspections of laboratories licensed under the Specified Animal Pathogens Order may be carried out at any time to ensure full compliance with licence conditions.

Definitions under SAPO

Under the Specified Animal Pathogens Order 2008:

"specified animal pathogen" means an animal pathogen listed in the schedule to the Specified animal Pathogens Order 2008, including-

  1. intact pathogens;
  2. pathogens which have been attenuated or genetically modified by any means, and
  3. any nucleic acid derived from an animal pathogen listed in the Schedule which could produce that pathogen when introduced into a biological system in which the nucleic acid is capable of replicating.

“carrier” means any living creature except man which may carry or transmit a specified animal pathogen or the tissue, cell culture, body fluid, excreta, carcase or part of a carcase of such creature by or by means of which a specified animal pathogen may be transmitted.

Applying for a licence under SAPO

If you wish to hold or work with a specified animal pathogen or a carrier of a specified animal pathogen at a laboratory in England, an application form for a licence under the Specified Animal Pathogens Order 2008 can be downloaded from the Defra website. An electronically-completed form may be e-mailed to us but the signed original must also be provided. Forms completed in manuscript and signed should be sent to the Pathogens Licensing Team at Defra. You may fax your application form to us but the signed original must also be provided.

Contact point for applicants who wish to hold and work with a specified animal pathogen in England:

The Pathogens Licensing Team,
Defra,
Area 5A,
17 Smith Square,
London,
SW1P 3JR

Telephone: 020 7238 6211/6150
Fax: 020 7238 6105
Email: pathogens@defra.gsi.gov.uk

If you wish to hold or work with a specified animal pathogen or carrier in Scotland or Wales please contact the relevant licensing authority at the address below.

Scotland

Scottish Executive Environment and Rural Affairs Department
Animal Health and Welfare
Saughton House
Broomhouse Drive
P Spur, Edinburgh
EH11 3XD
Telephone: 0300 244 9794
E-mail: animal.health@scotland.gsi.gov.uk

Wales

Welsh Assembly Government
Department for Rural Affairs
Cathays Park
Cardiff
CF1 3NQ
Telephone: 02920 823592
Facsimile: 02920 826120
Email: AnimalHealth@wales.gsi.gov.uk

The SAPO licensing process takes several months as applicants’ laboratories are inspected. Inspections are not arranged until satisfactory documentation has been provided. This documentation must detail all the operating procedures for work with the specified animal pathogens for which application has been made. Laboratories are advised to carry out their own risk assessment and put in place appropriate containment measures before they apply. This will speed up the process. Laboratories must have the necessary trained staff, documented operating procedures and facilities to ensure the safe containment, handling and disposal of the specified animal pathogens concerned. Laboratory inspections will be carried out to assess this.

Specified animal pathogens are classified into four categories by Defra. There are no specified animal pathogens in category 1. Category 4 pathogens (including Foot-and Mouth Disease virus), rabies virus and all viruses of the genus Lyssavirus are subject to particularly stringent controls.

For the containment requirements for categories 2, 3 and 4 click on the appropriate link. There are separate containment requirements for handling rabies virus and all viruses of the genus Lyssavirus, and arthropods. There are also Minimum Standards for laboratories handling Foot-and-Mouth Disease virus and links to these are also provided.

These containment requirements are intended only as a guide, as decisions on the facilities and procedures required to contain specified animal pathogens safely at individual establishments are made on a case by case basis.

There are separate containment requirements for laboratories that wish to apply to the European Commission to test blood samples from pet cats and dogs under the Pet Travel Scheme.

Applying for a transfer licence under SAPO to transfer a specified animal pathogen

Licences issued under the Specified Animal Pathogens Order 2008 contain conditions prohibiting any transfer of specified animal pathogens and/or carriers and their derivatives to any other people or laboratories without the prior authority of the Secretary of State. Transfer licences must be obtained to authorise all movements of such material, including movements to ports or airports.

There is no application form for a SAPO transfer licence and a short request letter giving the relevant details is all that is needed. Such letters should be signed by the SAPO licence holder (or a person deputised to take action on the licence holder’s behalf such as the institution’s Biological Safety Officer) and give the number of the licence. Full details of the proposed transfer should also be provided (e.g. the specified animal pathogens/carriers to be transferred, with quantities and number of containers, the name and address of the person to whom the material is to be transferred and the approximate transfer date). Where different strains of a specified animal pathogen are included in one transfer these should be separately listed. Requests for transfer licences may be faxed or emailed to us in the first instance but a signed letter should also be provided.

We aim to issue SAPO transfer licences within 15 working days of receipt of the transfer request letter, provided that we do not have to seek additional information from the applicant.

A SAPO transfer licence will not be issued to authorise a domestic movement of a specified animal pathogen or carrier to another laboratory unless the laboratory for which it is destined holds a current SAPO licence for the specified animal pathogen concerned.

Importing specified animal pathogens

When a specified animal pathogen or carrier is being obtained from a country outside the EC, a licence under the Importation of Animal Pathogens Order (IAPO) will be required to authorise the importation. In this case a separate SAPO licence to authorise the movement of the specified animal pathogen from the port of entry to the licence holder’s laboratory will not be necessary, as the IAPO licence will authorise this. An IAPO licence authorising the importation of a specified animal pathogen or carrier will only be issued if the applicant holds a licence under the Specified Animal Pathogens Order to hold /work with the specified animal pathogen concerned at their laboratory.

If a specified animal pathogen or carrier is being sourced from another EC Member State the SAPO licence holder at the receiving laboratory will need to obtain a transfer licence under SAPO to authorise the movement of the specified animal pathogen from the port of entry in England to the licensed laboratory.

List of specified animal pathogens

Specified animal pathogens listed in Part I of the Schedule to the Specified Animal Pathogens Order 2008 (as amended) are:

African horse sickness virus
African swine fever virus
Aujeszky’s disease virus
Avian influenza viruses which are:
(a) uncharacterised; or
(b) Type A viruses which have an intravenous pathogenicity index in six week old chickens of greater than 1.2; or
(c) Type A viruses H5 or H7 subtype for which nucleotide sequencing has demonstrated multiple basic amino acids at the cleavage site of haemagglutinin
Babesia bovis, B. bigemina and B. caballi
Bacillus anthracis
Bluetongue virus
Bovine leukosis virus
Brucella abortus
Brucella melitensis
Brucella ovis
Brucella suis
Burkholderia mallei
Classical swine fever virus
Cochliomyia hominivorax
Eastern and Western equine encephalomyelitis viruses
Echinococcus multilocularis and Echincoccus granulosus
Ehrlichia ruminantium
Equine infectious anaemia virus
Foot and mouth disease virus
Hendra disease virus
Histoplasma farciminosum
Japanese encephalitis virus
Lumpy skin disease virus
Mycoplasma agalactiae
Mycoplasma capricolum sub species capripneumoniae
Mycoplasma mycoides sub species mycoides SC and mycoides LC variants
Mycoplasma mycoides var capri
Newcastle disease (avian paramyxovirus type 1) viruses which are –
(a) uncharacterised, or
(b) have an intracerebral pathogenicity index in one-day-old chicks of 0.4 or more, when not less than 10 million 50% egg infectious doses (EID50) are administered to each bird in the test.
Nipah disease virus
Peste des petits ruminants virus
Porcine Reproductive and Respiratory Syndrome virus (genotype 2)
Rabies virus and all viruses of the genus Lyssavirus
Rift Valley Fever virus
Rinderpest virus
St Louis equine encephalomyelitis virus
Sheep and goat pox virus
Swine vesicular disease virus
Teschen disease virus
Theileria annulata
Theileria equi
Theileria parva
Trichinella spiralis
Trypanosoma brucei, T. congolense, T. equiperdum, T. evansi, T. simiae, and T. vivax
Venezuelan equine encephalomyelitis virus
Vesicular stomatitis virus
West Nile virus

The specified animal pathogen listed in Part II of the Schedule to the Order is:

The live virus causing viral haemorrhagic disease of rabbits.

Customer Service Standards

Service standards – Import licensing of animal pathogens and carriers, licensing of laboratories to hold and work with specified animal pathogens

We are committed to providing a responsive and consistently high quality service. We will ensure that we respond to all queries courteously and helpfully and we are dedicated to greater openness in our dealings with our customers. The following paragraphs set out the standards of service that we aim to provide you.

Licences

The Importation of Animal Pathogens Order 1980 (IAPO): We aim to issue IAPO licences within 15 working days of receipt of a correctly completed and signed application. If we request additional information from you in support of your application, processing will be suspended until the date on which we receive the information requested. The 15 working days will re-commence from the date on which we receive all information to support the application. If, following such a request, we do not hear from you within a month, we will consider your application to have been withdrawn and will write to you to confirm this. If our work on the processing of the licence is likely to delay the issue of the licence beyond 15 days, we will keep you fully informed of progress. If the issue of a licence has not been agreed by our veterinary advisers, we will write to you to explain the reasons for this within 15 working days of receipt of your application or any additional information we have requested. Application forms are available.

The Specified Animal Pathogens Order 2008 (SAPO): The consideration of an application for a licence under SAPO is likely to take several months. In almost every case it will be necessary for Health and Safety Executive (HSE) to inspect the laboratory where the work with specified animal pathogens is intended to be done and your application will not be considered until and unless we are satisfied that the management, facilities and documented operating procedures comply fully with Defra standards for the safe containment of the category of pathogen concerned.

We will acknowledge your SAPO application within 15 working days of receipt and either ask for more information or inform you that an inspector will be in touch to arrange an inspection date. If we request additional information from you in support of your application, processing will be suspended until the date on which we receive the information requested. We will respond to any correspondence about SAPO applications that are being processed within 15 working days or write to you to explain why we cannot do so.

Once we have all the information we need to consider your application, HSE aim to arrange a laboratory inspection within 3 months. Following the inspection and receipt of confirmation from HSE inspectors that any follow-up action required has been completed to Defra’s satisfaction, we will aim to complete our consideration of the licence application and notify the applicant of the outcome within 15 working days. Application forms are available.

Answering your telephone calls

We will answer your telephone calls promptly or provide a customer friendly answering service for those calls we are unable to answer. We will return all calls within 1 working day. If the person you are calling is out of the office for more than 1 day, a voicemail message will provide an alternative contact name and telephone number. If it is necessary to transfer your call to another section, we will tell you what is happening and we will give you the name and extension number of the person to whom you are being transferred. When we answer the telephone or make calls to you, we will give you our name and the name of the section within which we work.

Dealing with your correspondence

We aim to provide a full reply to letters within 15 working days, or if this is not possible we will explain to you the reason for the delay. Where the 15 day deadline cannot be met, we will send a holding reply within 5 working days explaining the reason for the delay. When we write to you we will be clear, concise and courteous.

Answering your e-mailed enquiries

We will acknowledge e-mailed correspondence within 1 working day. As with written correspondence, we will send you a reply within 15 working days. Where the 15 day deadline cannot be met, we will send a holding reply within 5 working days explaining the reason for the delay. If the person you have e-mailed is out of the office for more than 1 day, an out of office message will provide an alternative contact name, e-mail address and telephone number. We will use electronic services to communicate with you quickly and effectively.

Availability of information

Where possible we will offer a choice in the way you can access our services and we will ensure that the information we provide is readily understandable. We will use our pages on the Defra website, to provide up-to-date application forms and guidance. Application forms and guidance can also be obtained from the Pathogens Licensing Team at the address provided below.

Meetings

We will be on time for any pre-arranged meetings.

Constructive Feedback

We value and welcome feedback on the services we provide as this helps us to improve our service to you. If you are dissatisfied about the way in which we have dealt with your application, please contact the Pathogens Licensing Team. You can do this by e-mail, letter, fax, or telephone using the details provided at the end of this document. If you feel that your case has not been fully resolved you may then write to:

Defra,
Head of Pathogens Licensing Team,
Exotic Disease Policy
Area 5A,
17 Smith Square,
London,
SW1P 3JR

Email: pathogens@defra.gsi.gov.uk

It will help us to investigate your case if you set out the facts as fully as possible. Your case will be thoroughly investigated and you will normally receive a full response within 15 working days.

If you remain dissatisfied about the outcome of your complaint or you feel that your complaint has not been fully resolved, you can write to Trevor Cook, the Department’s impartial Complaint Adjudicator in respect of standards of service at Defra, Area 7D, Nobel House, 17 Smith Square, London, SW1P 3JR. Email: service-standards.adjudicator@defra.gsi.gov.uk.

Trevor Cook will investigate your complaint and report back to you within 15 working days. If it is not possible to complete investigations within that timescale, he will write to you explaining why and letting you know when you may expect a full response. (Please note that this procedure only covers complaints which relate specifically to Defra’s standards of service. Any complaints regarding the Department’s policies or the interpretation of EC Regulations or other legislation fall outside the Complaints Adjudicator’s remit, and should be addressed to the Head of the relevant Defra Policy Section).

If you are not satisfied with the adjudicator’s decision, you may write to a Member of Parliament who may agree to refer your complaint to the Parliamentary and Health Service Ombudsman at: OPCA, Millbank Tower, 21-24 Millbank, London SW1P 4QP.

Monitoring and improving standards

We are dedicated to identifying and serving the needs of our customers. We will consult with our customers on issues that affect them and will ensure customer responses are relayed back to our managers and operational staff so that action can be taken to improve our quality of service. Defra monitors responses to all forms of communications: letters, faxes, telephone calls and e-mails against Departmental standards.

Compliance

We may investigate the accuracy of information provided on licence applications and prosecute any contravention of the Importation of Animal Pathogens Order 1980 or the Specified Animal Pathogens Order 2008 or the conditions laid down in licences issued under those Orders.

We may undertake visits to check compliance with the conditions of licences under the Importation of Animal Pathogens Order 1980 and the Specified Animal Pathogens Order 2008.

Where we can, we will give some prior notification of our intention to inspect laboratories or other premises.

The Pathogens Licensing Team,
Defra,
Area 5A,
17 Smith Square,
London,
SW1P 3JR

Telephone: 020 7238 6211/6150
Fax: 020 7238 6105
Email: pathogens@defra.gsi.gov.uk

Page last modified: February 14, 2011