Chapter 8.5.

foot and mouth disease

Article 8.5.1.

Introduction

For the purposes of the Terrestrial Code, the incubation period for foot and mouth disease (FMD) shall be 14 days.

For the purposes of this Chapter, ruminants include animals of the family of Camelidae (except Camelus dromedarius).

For the purposes of this Chapter, a case includes an animal infected with FMD virus (FMDV).

For the purposes of international trade, this Chapter deals not only with the occurrence of clinical signs caused by FMDV, but also with the presence of infection with FMDV in the absence of clinical signs.

The following defines the occurrence of FMDV infection:

1. 
   

   FMDV has been isolated and identified as such from an animal or a product derived from that animal; or

   
   
2. 
   

   viral antigen or viral ribonucleic acid (RNA) specific to one or more of the serotypes of FMDV has been identified in samples from one or more animals, whether showing clinical signs consistent with FMD or not, or epidemiologically linked to a confirmed or suspected outbreak of FMD, or giving cause for suspicion of previous association or contact with FMDV; or

   
   
3. 
   

   antibodies to structural or nonstructural proteins of FMDV that are not a consequence of vaccination, have been identified in one or more animals showing clinical signs consistent with FMD, or epidemiologically linked to a confirmed or suspected outbreak of FMD, or giving cause for suspicion of previous association or contact with FMDV.

Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.

Article 8.5.2.

Susceptible animals in the FMD free country where vaccination is not practised should be protected from neighbouring infected countries by the application of animal health measures that effectively prevent the entry of the virus, taking into consideration physical or geographical barriers. These measures may include a protection zone.

To qualify for inclusion in the existing list of FMD free countries where vaccination is not practised, a Member should:

1. 
   

   have a record of regular and prompt animal disease reporting;

   
   
2. 
   

   send a declaration to the OIE stating that:

   
   
   
   
   1. 
      

      there has been no outbreak of FMD during the past 12 months;

      
      
   2. 
      

      no evidence of FMDV infection has been found during the past 12 months;

      
      
   3. 
      

      no vaccination against FMD has been carried out during the past 12 months;

      
      
   4. 
      

      no vaccinated animal has been introduced since the cessation of vaccination;

   
   
3. 
   

   supply documented evidence that:

   
   
   
   
   1. 
      

      surveillance for FMD and FMDV infection in accordance with Articles 8.5.42. to 8.5.48. is in operation;

      
      
   2. 
      

      regulatory measures for the early detection, prevention and control of FMD have been implemented.

   
   
4. 
   

   describe in detail the boundaries and measures of a protection zone, if applicable.

The Member will be included in the list only after the submitted evidence has been accepted by the OIE. Retention on the list requires that the information in points 2, 3 and 4 above be re-submitted annually and changes in the epidemiological situation or other significant events including those relevant to points 3b) and 4 should be reported to the OIE according to the requirements in Chapter 1.1.

Article 8.5.3.

Susceptible animals in the FMD free country where vaccination is practised should be protected from neighbouring infected countries by the application of animal health measures that effectively prevent the entry of the virus, taking into consideration physical or geographical barriers. These measures may include a protection zone.

To qualify for inclusion in the list of FMD free countries where vaccination is practised, a Member should:

1. 
   

   have a record of regular and prompt animal disease reporting;

   
   
2. 
   

   send a declaration to the OIE stating that:

   
   
   
   
   1. 
      

      there has been no outbreak of FMD during the past 2 years;

      
      
   2. 
      

      no evidence of FMDV circulation has been found during the past 12 months;

   
   
3. 
   

   supply documented evidence that:

   
   
   
   
   1. 
      

      surveillance for FMD and FMDV circulation in accordance with Articles 8.5.42. to 8.5.48. is in operation;

      
      
   2. 
      

      regulatory measures for the early detection, prevention and control of FMD have been implemented;

      
      
   3. 
      

      routine vaccination is carried out for the purpose of the prevention of FMD;

      
      
   4. 
      

      the vaccine used complies with the standards described in the Terrestrial Manual and is appropriate for the strains of virus currently circulating;

   
   
4. 
   

   describe in detail the boundaries and measures of a protection zone, if applicable.

The Member will be included in the list only after the submitted evidence has been accepted by the OIE. Retention on the list requires that the information in point 2, 3 and 4 above be re-submitted annually and changes in the epidemiological situation or other significant events including those relevant to points 3b) and 4 should be reported to the OIE according to the requirements in Chapter 1.1.

If a Member that meets the requirements of a FMD free country where vaccination is practised wishes to change its status to FMD free country where vaccination is not practised, the status of this country remains unchanged for a period of at least 12 months after vaccination has ceased. Evidence should also be provided showing that FMDV infection has not occurred during that period.

Article 8.5.4.

An FMD free zone where vaccination is not practised can be established in either an FMD free country where vaccination is practised or in a country of which parts are infected. In defining such zones the principles of Chapter 4.3. should be followed. Susceptible animals in the FMD free zone should be protected from the rest of the country and from neighbouring countries if they are of a different animal health status by the application of animal health measures that effectively prevent the entry of the virus, taking into consideration physical or geographical barriers. These measures may include a protection zone.

To qualify for inclusion in the list of FMD free zones where vaccination is not practised, a Member should:

1. 
   

   have a record of regular and prompt animal disease reporting;

   
   
2. 
   

   send a declaration to the OIE stating that within the proposed FMD free zone:

   
   
   
   
   1. 
      

      there has been no outbreak of FMD during the past 12 months;

      
      
   2. 
      

      no evidence of FMDV infection has been found during the past 12 months;

      
      
   3. 
      

      no vaccination against FMD has been carried out during the past 12 months;

      
      
   4. 
      

      no vaccinated animal has been introduced into the zone since the cessation of vaccination, except in accordance with Article 8.5.10.;

   
   
3. 
   

   supply documented evidence that:

   
   
   
   
   1. 
      

      surveillance for FMD and FMDV infection in accordance with Articles 8.5.42. to 8.5.48. is in operation;

      
      
   2. 
      

      regulatory measures for the early detection, prevention and control of FMD have been implemented;

   
   
4. 
   

   describe in detail and supply documented evidence that these are properly implemented and supervised:

   
   
   
   
   1. 
      

      the boundaries of the proposed FMD free zone,

      
      
   2. 
      

      the boundaries and measures of a protection zone, if applicable,

      
      
   3. 
      

      the system for preventing the entry of the virus (including the control of the movement of susceptible animals) into the proposed FMDV free zone (in particular if the procedure described in Article 8.5.10. is implemented).

The proposed free zone will be included in the list of FMD free zones where vaccination is not practised only after the submitted evidence has been accepted by the OIE.

The information required in points 2, 3 and 4b)-c) above should be re-submitted annually and changes in the epidemiological situation or other significant events including those relevant to points 3b) and 4 should be reported to the OIE according to the requirements in Chapter 1.1.

Article 8.5.5.

An FMD free zone where vaccination is practised can be established in either an FMD free country where vaccination is not practised or in a country of which parts are infected. In defining such zones the principles of Chapter 4.3. should be followed. Susceptible animals in the FMD free zone where vaccination is practised should be protected from neighbouring countries or zones if they are of a lesser animal health status by the application of animal health measures that effectively prevent the entry of the virus, taking into consideration physical or geographical barriers. These measures may include a protection zone.

To qualify for inclusion in the list of FMD free zones where vaccination is practised, a Member should:

1. 
   

   have a record of regular and prompt animal disease reporting;

   
   
2. 
   

   send a declaration to the OIE that within the proposed FMD free zone;

   
   
   
   
   1. 
      

      there has been no outbreak of FMD for the past 2 years;

      
      
   2. 
      

      no evidence of FMDV circulation has been found during the past 12 months;

   
   
3. 
   

   supply documented evidence that:

   
   
   
   
   1. 
      

      surveillance for FMD and FMDV infection in accordance with Articles 8.5.42. to 8.5.48. is in operation;

      
      
   2. 
      

      regulatory measures for the early detection, prevention and control of FMD have been implemented;

      
      
   3. 
      

      routine vaccination is carried out for the purpose of the prevention of FMD;

      
      
   4. 
      

      the vaccine used complies with the standards described in the Terrestrial Manual and is appropriate for the strains of virus currently circulating;

   
   
4. 
   

   describe in detail and supply documented evidence that these are properly implemented and supervised:

   
   
   
   
   1. 
      

      the boundaries of the proposed FMD free zone,

      
      
   2. 
      

      the boundaries and measures of a protection zone, if applicable,

      
      
   3. 
      

      the system for preventing the entry of the virus (including the control of the movement of susceptible animals) into the proposed FMD free zone (in particular if the procedure described in Article 8.5.10. is implemented).

The proposed free zone will be included in the list of FMD free zones where vaccination is practised only after the submitted evidence has been accepted by the OIE. The information required in points 2, 3 and 4 b)-c) above should be re-submitted annually and changes in the epidemiological situation or other significant events including those relevant to points 3 b) and 4 should be reported to the OIE according to the requirements in Chapter 1.1.

If a Member that has a zone which meets the requirements of a FMD free zone where vaccination is practised wishes to change the status of the zone to FMD free zone where vaccination is not practised, the status of this zone remains unchanged for a period of at least 12 months after vaccination has ceased. Evidence should also be provided showing that FMDV infection has not occurred in the said zone during that period.

Article 8.5.6.

A FMD free compartment can be established in either a FMD free country or zone or in an infected country or zone. In defining such a compartment the principles of Chapters 4.3. and 4.4. should be followed. Susceptible animals in the FMD free compartment should be separated from any other susceptible animals by the application of an effective biosecurity management system.

A Member wishing to establish a FMD free compartment should:

1. 
   

   have a record of regular and prompt animal disease reporting and if not FMD free, have an official control programme and a surveillance system for FMD in place according to Articles 8.5.42. to 8.5.44. that allows an accurate knowledge of the prevalence of FMD in the country or zone;

   
   
2. 
   

   declare for the FMD free compartment that:

   
   
   
   
   1. 
      

      there has been no outbreak of FMD during the past 12 months;

      
      
   2. 
      

      no evidence of FMDV infection has been found during the past 12 months;

      
      
   3. 
      

      vaccination against FMD is prohibited;

      
      
   4. 
      

      no animal vaccinated against FMD within the past 12 months is in the compartment;

      
      
   5. 
      

      animals, semen and embryos should only enter the compartment in accordance with relevant Articles in this chapter;

      
      
   6. 
      

      documented evidence shows that surveillance in accordance with Articles 8.5.42. to 8.5.48. is in operation for FMD and FMDV infection;

      
      
   7. 
      

      an animal identification and traceability system in accordance with Chapters 4.1. and 4.2. is in place;

   
   
3. 
   

   describe in detail the animal subpopulation in the compartment and the biosecurity plan for FMD and FMDV infection.

The compartment should be approved by the Veterinary Authority. The first approval should only be granted when no outbreak of FMD has occurred within the zone in which the compartment is situated, during the last 3 months.

Article 8.5.7.

An FMD infected zone is a zone that does not fulfil the requirements to qualify as either an FMD free zone where vaccination is not practised or an FMD free zone where vaccination is practised.

Article 8.5.8.

In the event of limited outbreaks within an FMD free country or zone, including within a protection zone, with or without vaccination, a single containment zone, which includes all cases, can be established for the purpose of minimizing the impact on the entire country or zone. For this to be achieved, the Veterinary Authority should provide documented evidence that:

1. 
   

   the outbreaks are limited based on the following factors:

   
   
   
   
   1. 
      

      immediately on suspicion, a rapid response including notification has been made;

      
      
   2. 
      

      standstill of animal movements has been imposed, and effective controls on the movement of other commodities mentioned in this chapter are in place;

      
      
   3. 
      

      epidemiological investigation (trace-back, trace-forward) has been completed;

      
      
   4. 
      

      the infection has been confirmed;

      
      
   5. 
      

      the primary outbreak and likely source of the outbreak has been identified;

      
      
   6. 
      

      all cases have been shown to be epidemiologically linked;

      
      
   7. 
      

      no new cases have been found in the containment zone within a minimum of two incubation periods as defined in Article 8.5.1. after the stamping-out of the last detected case is completed;

   
   
2. 
   

   a stamping-out policy has been applied;

   
   
3. 
   

   the susceptible animal population within the containment zones should be clearly identifiable as belonging to the containment zone;

   
   
4. 
   

   increased passive and targeted surveillance in accordance with Articles 8.5.42. to 8.5.48. in the rest of the country or zone has been carried out and has not detected any evidence of infection;

   
   
5. 
   

   animal health measures that effectively prevent the spread of the FMDV to the rest of the country or zone, taking into consideration physical and geographical barriers, are in place;

   
   
6. 
   

   ongoing surveillance in the containment zone is in place.

The free status of the areas outside the containment zone would be suspended pending the establishment of the containment zone. The free status of these areas could be reinstated irrespective of the provisions of Article 8.5.9., once the containment zone is clearly established, by complying with points 1 to 6 above. The containment zone should be managed in such a way that it can be demonstrated that commodities for international trade can be shown to have originated outside the containment zone.

The recovery of the FMD free status of the containment zone should follow the provisions of Article 8.5.9.

Article 8.5.9.

1. 
   

   When an FMD outbreak or FMDV infection occurs in an FMD free country or zone where vaccination is not practised, one of the following waiting periods is required to regain the status of FMD free country or zone where vaccination is not practised:

   
   
   
   
   1. 
      

      3 months after the last case where a stamping-out policy and serological surveillance are applied in accordance with Articles 8.5.42. to 8.5.48.; or

      
      
   2. 
      

      3 months after the slaughter of all vaccinated animals where a stamping-out policy, emergency vaccination and serological surveillance are applied in accordance with Articles 8.5.42. to 8.5.48.; or

      
      
   3. 
      

      6 months after the last case or the last vaccination (according to the event that occurs the latest), where a stamping-out policy, emergency vaccination not followed by the slaughtering of all vaccinated animals, and serological surveillance are applied in accordance with Articles 8.5.42. to 8.5.48., provided that a serological survey based on the detection of antibodies to nonstructural proteins of FMDV demonstrates the absence of infection in the remaining vaccinated population.

   
   

   Where a stamping-out policy is not practised, the above waiting periods do not apply, and Article 8.5.2. or 8.5.4. applies.

   
   
2. 
   

   When an FMD outbreak or FMDV infection occurs in an FMD free country or zone where vaccination is practised, one of the following waiting periods is required to regain the status of FMD free country or zone where vaccination is practised:

   
   
   
   
   1. 
      

      6 months after the last case where a stamping-out policy, emergency vaccination and serological surveillance in accordance with Articles 8.5.42. to 8.5.48. are applied, provided that the serological surveillance based on the detection of antibodies to nonstructural proteins of FMDV demonstrates the absence of virus circulation; or

      
      
   2. 
      

      18 months after the last case where a stamping-out policy is not applied, but emergency vaccination and serological surveillance in accordance with Articles 8.5.42. to 8.5.48. are applied, provided that the serological surveillance based on the detection of antibodies to nonstructural proteins of FMDV demonstrates the absence of virus circulation.

   
   
3. 
   

   When a FMD outbreak or FMDV infection occurs in a FMD free compartment, Article 8.5.6. applies.

Article 8.5.10.

In order not to jeopardise the status of a free zone, FMD susceptible animals should only leave the infected zone if moved by mechanised transport directly to slaughter in the nearest designated abattoir under the following conditions:

1. 
   

   no FMD susceptible animal has been introduced into the establishment of origin and no animal in the establishment of origin has shown clinical signs of FMD for at least 30 days prior to movement;

   
   
2. 
   

   the animals were kept in the establishment of origin for at least 3 months prior to movement;

   
   
3. 
   

   FMD has not occurred within a 10-kilometre radius of the establishment of origin for at least 3 months prior to movement;

   
   
4. 
   

   the animals should be transported under the supervision of the Veterinary Authority in a vehicle, which was cleansed and disinfected before loading, directly from the establishment of origin to the abattoir without coming into contact with other susceptible animals;

   
   
5. 
   

   such an abattoir is not approved for the export of fresh meat during the time it is handling the meat of animals from the infected zone;

   
   
6. 
   

   vehicles and the abattoir should be subjected to thorough cleansing and disinfection immediately after use.

The meat should be treated according to Article 8.5.25. or Article 8.5.26. Other products obtained from the animals and any products coming into contact with them should be considered infected, and treated in such a way as to destroy any residual virus in accordance with Articles 8.5.34. to 8.5.41.

Animals moved into a free zone for other purposes should be moved under the supervision of the Veterinary Authority and comply with the conditions in Article 8.5.14.

Article 8.5.11.

In order not to jeopardise the status of a free zone, FMD susceptible animals should only leave the containment zone if moved by mechanised transport directly to slaughter in the nearest designated abattoir under the following conditions:

1. 
   

   the containment zone has been officially established according to the requirements in Article 8.5.8.;

   
   
2. 
   

   the animals should be transported under the supervision of the Veterinary Authority in a vehicle, which was cleansed and disinfected before loading, directly from the establishment of origin to the abattoir without coming into contact with other susceptible animals;

   
   
3. 
   

   such an abattoir is not approved for the export of fresh meat during the time it is handling the meat of animals from the containment zone;

   
   
4. 
   

   vehicles and the abattoir should be subjected to thorough cleansing and disinfection immediately after use.

The meat should be treated according to point  2 of Article 8.5.25. or Article 8.5.26. Other products obtained from the animals and any products coming into contact with them should be treated in such a way as to destroy any residual virus in accordance with Articles 8.5.34. to 8.5.41.

Article 8.5.12.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the animals:

1. 
   

   showed no clinical sign of FMD on the day of shipment;

   
   
2. 
   

   were kept since birth or for at least the past 3 months in a FMD free country or zone where vaccination is not practised or a FMD free compartment;

   
   
3. 
   

   have not been vaccinated;

   
   
4. 
   

   if transiting an infected zone, were not exposed to any source of FMD infection during transportation to the place of shipment.

Article 8.5.13.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the animals:

1. 
   

   showed no clinical sign of FMD on the day of shipment;

   
   
2. 
   

   were kept in an FMD free country or zone since birth or for at least the past 3 months; and

   
   
3. 
   

   have not been vaccinated and were subjected, with negative results, to tests for antibodies against FMD virus, when destined to an FMD free country or zone where vaccination is not practised;

   
   
4. 
   

   if transiting an infected zone, were not exposed to any source of FMD infection during transportation to the place of shipment.

Article 8.5.14.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the animals:

1. 
   

   showed no clinical sign of FMD on the day of shipment;

   
   
2. 
   

   were kept in the establishment of origin since birth, or

   
   
   
   
   1. 
      

      for the past 30 days, if a stamping-out policy is in force in the exporting country, or

      
      
   2. 
      

      for the past 3 months, if a stamping-out policy is not in force in the exporting country,

   
   

   and that FMD has not occurred within a ten-kilometre radius of the establishment of origin for the relevant period as defined in points a) and b) above; and

   
   
3. 
   

   were isolated in an establishment for the 30 days prior to shipment, and all animals in isolation were subjected to diagnostic tests (probang and serology) for evidence of FMDV infection with negative results at the end of that period, and that FMD did not occur within a ten-kilometre radius of the establishment during that period; or

   
   
4. 
   

   were kept in a quarantine station for the 30 days prior to shipment, all animals in quarantine were subjected to diagnostic tests (probang and serology) for evidence of FMDV infection with negative results at the end of that period, and that FMD did not occur within a ten-kilometre radius of the quarantine station during that period;

   
   
5. 
   

   were not exposed to any source of FMD infection during their transportation from the quarantine station to the place of shipment.

Article 8.5.15.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor animals:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD on the day of collection of the semen;

      
      
   2. 
      

      were kept for at least 3 months prior to collection in a FMD free country or zone where vaccination is not practised or a FMD free compartment;

   
   
2. 
   

   the semen was collected, processed and stored in conformity with the provisions of Chapters 4.5. and 4.6.

Article 8.5.16.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor animals:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD on the day of collection of the semen and for the following 30 days;

      
      
   2. 
      

      were kept for at least 3 months prior to collection in an FMD free country or zone where vaccination is not practised or a FMD free compartment;

   
   
2. 
   

   the semen was collected, processed and stored in conformity with the provisions of Chapters 4.5. and 4.6.

Article 8.5.17.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor animals:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD on the day of collection of the semen and for the following 30 days;

      
      
   2. 
      

      were kept for at least 3 months prior to collection in a FMD free country or zone;

      
      
   3. 
      

      if destined to an FMD free country or zone where vaccination is not practised:

      
      
      
      
      1. 
         

         have not been vaccinated and were subjected, not less than 21 days after collection of the semen, to tests for antibodies against FMD virus, with negative results; or

         
         
      2. 
         

         had been vaccinated at least twice, with the last vaccination not more than 12  and not less than one month prior to collection;

   
   
2. 
   

   no other animal present in the artificial insemination centre has been vaccinated within the month prior to collection;

   
   
3. 
   

   the semen:

   
   
   
   
   1. 
      

      was collected, processed and stored in conformity with the provisions of Chapters  4.5. and 4.6.;

      
      
   2. 
      

      was stored in the country of origin for a period of at least one month following collection, and during this period no animal on the establishment where the donor animals were kept showed any sign of FMD.

Article 8.5.18.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor animals:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD on the day of collection of the semen;

      
      
   2. 
      

      were kept in an establishment where no animal had been added in the 30 days before collection, and that FMD has not occurred within 10 kilometres for the 30 days before and after collection;

      
      
   3. 
      

      have not been vaccinated and were subjected, not less than 21 days after collection of the semen, to tests for antibodies against FMD virus, with negative results; or

      
      
   4. 
      

      had been vaccinated at least twice, with the last vaccination not more than 12 and not less than one month prior to collection;

   
   
2. 
   

   no other animal present in the artificial insemination centre has been vaccinated within the month prior to collection;

   
   
3. 
   

   the semen:

   
   
   
   
   1. 
      

      was collected, processed and stored in conformity with the provisions of Chapters  4.5. and 4.6.;

      
      
   2. 
      

      was subjected, with negative results, to a test for FMDV infection if the donor animal has been vaccinated within the 12 months prior to collection;

      
      
   3. 
      

      was stored in the country of origin for a period of at least one month following collection, and during this period no animal on the establishment where the donor animals were kept showed any sign of FMD.

Article 8.5.19.

Irrespective of the FMD status of the exporting country, zone or compartment, Veterinary Authorities should authorise without restriction on account of FMD the import or transit through their territory of in vivo derived embryos of cattle subject to the presentation of an international veterinary certificate attesting that the embryos were collected, processed and stored in conformity with the provisions of Chapters 4.7. and 4.9., as relevant.

Article 8.5.20.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor females:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD at the time of collection of the oocytes;

      
      
   2. 
      

      were kept at the time of collection in a FMD free country or zone where vaccination is not practised or a FMD free compartment;

   
   
2. 
   

   fertilisation was achieved with semen meeting the conditions referred to in Articles 8.5.15.,  8.5.16.,  8.5.17. or  8.5.18., as relevant;

   
   
3. 
   

   the oocytes were collected, and the embryos were processed and stored in conformity with the provisions of Chapters 4.8. and 4.9., as relevant.

Article 8.5.21.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the donor females:

   
   
   
   
   1. 
      

      showed no clinical sign of FMD at the time of collection of the oocytes;

      
      
   2. 
      

      were kept for at least 3 months prior to collection in a FMD free country or zone where vaccination is practised;

      
      
   3. 
      

      if destined for an FMD free country or zone where vaccination is not practised or a FMD free compartment:

      
      
      
      
      1. 
         

         have not been vaccinated and were subjected, with negative results, to tests for antibodies against FMD virus; or

         
         
      2. 
         

         had been vaccinated at least twice, with the last vaccination not less than one month and not more than 12 months prior to collection;

   
   
2. 
   

   no other animal present in the establishment has been vaccinated within the month prior to collection;

   
   
3. 
   

   fertilization was achieved with semen meeting the conditions referred to in Articles 8.5.15., 8.5.16., 8.5.17. or 8.5.18., as relevant;

   
   
4. 
   

   the oocytes were collected, and the embryos were processed and stored in conformity with the provisions of Chapters 4.8. and 4.9., as relevant.

Article 8.5.22.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the entire consignment of meat comes from animals which:

1. 
   

   have been kept in the FMD free country or zone where vaccination is not practised or a FMD free compartment since birth, or which have been imported in accordance with Article 8.5.12., Article 8.5.13. or Article 8.5.14.;

   
   
2. 
   

   have been slaughtered in an approved abattoir and have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results.

Article 8.5.23.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the entire consignment of meat comes from animals which:

1. 
   

   have been kept in the FMD free country or zone where vaccination is practised, or which have been imported in accordance with Article 8.5.12., Article 8.5.13. or Article 8.5.14.;

   
   
2. 
   

   have been slaughtered in an approved abattoir and have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results.

Article 8.5.24.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the entire consignment of meat comes from animals which:

1. 
   

   have been kept in the FMD free country or zone where vaccination is practised, or which have been imported in accordance with Article 8.5.12., Article 8.5.13. or Article 8.5.14.;

   
   
2. 
   

   have been slaughtered in an approved abattoir and have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results.

Article 8.5.25.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the entire consignment of meat:

1. 
   

   comes from animals which:

   
   
   
   
   1. 
      

      have remained in the exporting country for at least 3 months prior to slaughter;

      
      
   2. 
      

      have remained, during this period, in a part of the country where cattle are regularly vaccinated against FMD and where official controls are in operation;

      
      
   3. 
      

      have been vaccinated at least twice with the last vaccination not more than 12 months and not less than one month prior to slaughter;

      
      
   4. 
      

      were kept for the past 30 days in an establishment, and that FMD has not occurred within a ten-kilometre radius of the establishment during that period;

      
      
   5. 
      

      have been transported, in a vehicle which was cleansed and disinfected before the cattle were loaded, directly from the establishment of origin to the approved abattoir without coming into contact with other animals which do not fulfil the required conditions for export;

      
      
   6. 
      

      have been slaughtered in an approved abattoir:

      
      
      
      
      1. 
         

         which is officially designated for export;

         
         
      2. 
         

         in which no FMD has been detected during the period between the last disinfection carried out before slaughter and the shipment for export has been dispatched;

      
      
   7. 
      

      have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results within 24 hours before and after slaughter;

   
   
2. 
   

   comes from deboned carcasses:

   
   
   
   
   1. 
      

      from which the major lymphatic nodes have been removed;

      
      
   2. 
      

      which, prior to deboning, have been submitted to maturation at a temperature above + 2°C for a minimum period of 24 hours following slaughter and in which the pH value was below 6.0 when tested in the middle of both the longissimus dorsi.

Article 8.5.26.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   the entire consignment of meat comes from animals which have been slaughtered in an approved abattoir and have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results;

   
   
2. 
   

   the meat has been processed to ensure the destruction of the FMD virus in conformity with one of the procedures referred to in Article 8.5.34.;

   
   
3. 
   

   the necessary precautions were taken after processing to avoid contact of the meat products with any potential source of FMD virus.

Article 8.5.27.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that these products come from animals which have been kept in a FMD free country, zone or compartment, or which have been imported in accordance with Article 8.5.12.,  Article 8.5.13. or  Article 8.5.14.

Article 8.5.28.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   these products:

   
   
   
   
   1. 
      

      originate from herds or flocks which were not infected or suspected of being infected with FMD at the time of milk collection;

      
      
   2. 
      

      have been processed to ensure the destruction of the FMD virus in conformity with one of the procedures referred to in Article 8.5.38. and in Article 8.5.39.;

   
   
2. 
   

   the necessary precautions were taken after processing to avoid contact of the products with any potential source of FMD virus.

Article 8.5.29.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that the manufacturing method for these products included heating to a minimum core temperature of 70°C for at least 30 minutes.

Article 8.5.30.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that:

1. 
   

   these products have been processed to ensure the destruction of the FMD virus in conformity with one of the procedures referred to in Articles 8.5.35., 8.5.36. and 8.5.37.;

   
   
2. 
   

   the necessary precautions were taken after collection or processing to avoid contact of the products with any potential source of FMD virus.

Veterinary Authorities can authorise, without restriction, the import or transit through their territory of semi-processed hides and skins (limed hides, pickled pelts, and semi-processed leather – e.g. wet blue and crust leather), provided that these products have been submitted to the usual chemical and mechanical processes in use in the tanning industry.

Article 8.5.31.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that these commodities:

1. 
   

   are free of grossly identifiable contamination with material of animal origin;

   
   
2. 
   

   have been subjected to one of the following treatments, which, in the case of material sent in bales, has been shown to penetrate to the centre of the bale:

   
   
   
   
   1. 
      

      either to the action of steam in a closed chamber such that the centre of the bales has reached a minimum temperature of 80°C for at least 10 minutes,

      
      
   2. 
      

      or to the action of formalin fumes (formaldehyde gas) produced by its commercial solution at 35-40% in a chamber kept closed for at least 8 hours and at a minimum temperature of 19°C;

OR

3. 
   

   have been kept in bond for at least 3 months (under study) before being released for export.

Article 8.5.32.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that these products are derived from animals that have been killed in such a country or zone, or which have been imported from a country or zone free of FMD (where vaccination either is or is not practised).

Article 8.5.33.

Veterinary Authorities should require the presentation of an international veterinary certificate attesting that these products have been processed to ensure the destruction of the FMD virus in conformity with the procedures referred to in Article 8.5.40.

Article 8.5.34.

For the inactivation of viruses present in meat, one of the following procedures should be used:

1. 
   

   Canning

   
   

   Meat is subjected to heat treatment in a hermetically sealed container to reach an internal core temperature of at least 70°C for a minimum of 30 minutes or to any equivalent treatment which has been demonstrated to inactivate the FMD virus.

   
   
2. 
   

   Thorough cooking

   
   

   Meat, previously deboned and defatted, shall be subjected to heating so that an internal temperature of 70°C or greater is maintained for a minimum of 30 minutes.

   
   

   After cooking, it shall be packed and handled in such a way that it cannot be exposed to a source of virus.

   
   
3. 
   

   Drying after salting

   
   

   When rigor mortis is complete, the meat must be deboned, salted with cooking salt (NaCl) and completely dried. It must not deteriorate at ambient temperature.

   
   

   ‘Drying’ is defined in terms of the ratio between water and protein which must not be greater than 2.25:1.

Article 8.5.35.

Article 8.5.36.

Article 8.5.37.

Article 8.5.38.

For the inactivation of viruses present in milk and cream for human consumption, one of the following procedures should be used:

1. 
   

   a sterilisation process applying a minimum temperature of 132°C for at least one second (ultra-high temperature [UHT]), or

   
   
2. 
   

   if the milk has a pH less than 7.0, a sterilisation process applying a minimum temperature of 72°C for at least 15 seconds (high temperature – short time pasteurisation [HTST]), or

   
   
3. 
   

   if the milk has a pH of 7.0 or over, the HTST process applied twice.

Article 8.5.39.

For the inactivation of viruses present in milk for animal consumption, one of the following procedures should be used:

1. 
   

   the HTST process applied twice;

   
   
2. 
   

   HTST combined with another physical treatment, e.g. maintaining a pH 6 for at least one hour or additional heating to at least 72°C combined with dessication;

   
   
3. 
   

   UHT combined with another physical treatment referred to in point 2 above.

Article 8.5.40.

For the inactivation of viruses present in skins and trophies from wild animals susceptible to FMD, one of the following procedures should be used prior to complete taxidermal treatment:

1. 
   

   boiling in water for an appropriate time so as to ensure that any matter other than bone, horns, hooves, claws, antlers or teeth is removed;

   
   
2. 
   

   gamma irradiation at a dose of at least 20 kiloGray at room temperature (20°C or higher);

   
   
3. 
   

   soaking, with agitation, in a 4% (w/v) solution of washing soda (sodium carbonate – Na2CO3) maintained at pH 11.5 or above for at least 48 hours;

   
   
4. 
   

   soaking, with agitation, in a formic acid solution (100 kg salt [NaCl] and 12 kg formic acid per 1,000 litres water) maintained at below pH 3.0 for at least 48 hours; wetting and dressing agents may be added;

   
   
5. 
   

   in the case of raw hides, salting for at least 28 days with sea salt containing 2% washing soda (sodium carbonate – Na2CO3).

Article 8.5.41.

Article 8.5.42.

Articles 8.5.42. to 8.5.48. define the principles and provide a guide for the surveillance of FMD in accordance with Chapter 1.4. applicable to Members seeking establishment of freedom from FMD, either with or without the use of vaccination. Guidance is provided for Members seeking reestablishment of freedom from FMD for the entire country or for a zone, either with or without vaccination, or a compartment, following an outbreak and for the maintenance of FMD status.

The impact and epidemiology of FMD differ widely in different regions of the world and therefore it is impossible to provide specific recommendations for all situations. Surveillance strategies employed for demonstrating freedom from FMD at an acceptable level of confidence will need to be adapted to the local situation. For example, the approach to proving freedom from FMD following an outbreak caused by a pig-adapted strain of FMD virus (FMDV) should differ significantly from an application designed to prove freedom from FMD for a country or zone where African buffaloes (Syncerus caffer) provide a potential reservoir of infection. It is incumbent upon the Member to submit a dossier to the OIE in support of its application that not only explains the epidemiology of FMD in the region concerned but also demonstrates how all the risk factors are managed. This should include provision of scientifically-based supporting data. There is therefore considerable latitude available to Members to provide a well-reasoned argument to prove that the absence of FMDV infection (in non-vaccinated populations) or circulation (in vaccinated populations) is assured at an acceptable level of confidence.

Surveillance for FMD should be in the form of a continuing programme designed to establish that the whole territory or part of it is free from FMDV infection/circulation.

For the purposes of this Chapter, virus circulation means transmission of FMDV as demonstrated by clinical signs, serological evidence or virus isolation.

Article 8.5.43.

1. 
   

   A surveillance system in accordance with Chapter 1.4. should be under the responsibility of the Veterinary Authority. A procedure should be in place for the rapid collection and transport of samples from suspect cases of FMD to a laboratory for FMD diagnoses as described in the Terrestrial Manual.

   
   
2. 
   

   The FMD surveillance programme should:

   
   
   
   
   1. 
      

      include an early warning system throughout the production, marketing and processing chain for reporting suspicious cases. Farmers and workers who have day-to-day contact with livestock, as well as diagnosticians, should report promptly any suspicion of FMD. They should be supported directly or indirectly (e.g. through private veterinarians or veterinary para-professionals) by government information programmes and the Veterinary Authority. All suspect cases of FMD should be investigated immediately. Where suspicion cannot be resolved by epidemiological and clinical investigation, samples should be taken and submitted to a laboratory. This requires that sampling kits and other equipment are available for those responsible for surveillance. Personnel responsible for surveillance should be able to call for assistance from a team with expertise in FMD diagnosis and control;

      
      
   2. 
      

      implement, when relevant, regular and frequent clinical inspection and serological testing of high-risk groups of animals, such as those adjacent to an FMD infected country or infected zone (for example, bordering a game park in which infected wildlife are present).

   
   

   An effective surveillance system will periodically identify suspicious cases that require follow-up and investigation to confirm or exclude that the cause of the condition is FMDV. The rate at which such suspicious cases are likely to occur will differ between epidemiological situations and cannot therefore be predicted reliably. Applications for freedom from FMDV infection/circulation should, in consequence, provide details of the occurrence of suspicious cases and how they were investigated and dealt with. This should include the results of laboratory testing and the control measures to which the animals concerned were subjected during the investigation (quarantine, movement stand-still orders, etc.).

Article 8.5.44.

1. 
   

   Introduction

   
   

   The target population for surveillance aimed at identifying disease and infection should cover all the susceptible species within the country, zone or compartment.

   
   

   The design of surveillance programmes to prove the absence of FMDV infection/circulation needs to be carefully followed to avoid producing results that are either insufficiently reliable to be accepted by the OIE or international trading partners, or excessively costly and logistically complicated. The design of any surveillance programme, therefore, requires inputs from professionals competent and experienced in this field.

   
   

   The strategy employed may be based on randomised sampling requiring surveillance consistent with demonstrating the absence of FMDV infection/circulation at an acceptable level of statistical confidence. The frequency of sampling should be dependent on the epidemiological situation. Targeted surveillance (e.g. based on the increased likelihood of infection in particular localities or species) may be an appropriate strategy. The Member should justify the surveillance strategy chosen as adequate to detect the presence of FMDV infection/circulation in accordance with Chapter 1.4. and the epidemiological situation. It may, for example, be appropriate to target clinical surveillance at particular species likely to exhibit clear clinical signs (e.g. cattle and pigs). If a Member wishes to apply for recognition of a specific zone within the country as being free from FMDV infection/circulation, the design of the survey and the basis for the sampling process would need to be aimed at the population within the zone.

   
   

   For random surveys, the design of the sampling strategy will need to incorporate an epidemiologically appropriate design prevalence. The sample size selected for testing will need to be large enough to detect infection/circulation if it were to occur at a predetermined minimum rate. The sample size and expected disease prevalence determine the level of confidence in the results of the survey. The Member must justify the choice of design prevalence and confidence level based on the objectives of surveillance and the epidemiological situation, in accordance with Chapter 1.4. Selection of the design prevalence in particular clearly needs to be based on the prevailing or historical epidemiological situation.

   
   

   Irrespective of the survey design selected, the sensitivity and specificity of the diagnostic tests employed are key factors in the design, sample size determination and interpretation of the results obtained. Ideally, the sensitivity and specificity of the tests used should be validated for the vaccination/infection history and production class of animals in the target population.

   
   

   Irrespective of the testing system employed, surveillance design should anticipate the occurrence of false positive reactions. If the characteristics of the testing system are known, the rate at which these false positives are likely to occur can be calculated in advance. There needs to be an effective procedure for following-up positives to ultimately determine with a high level of confidence, whether they are indicative of infection/circulation or not. This should involve both supplementary tests and follow-up investigation to collect diagnostic material from the original sampling unit as well as herds which may be epidemiologically linked to it.

   
   
2. 
   

   Clinical surveillance

   
   

   Clinical surveillance aims at detecting clinical signs of FMD by close physical examination of susceptible animals. Whereas significant emphasis is placed on the diagnostic value of mass serological screening, surveillance based on clinical inspection should not be underrated. It may be able to provide a high level of confidence of detection of disease if a sufficiently large number of clinically susceptible animals is examined.

   
   

   Clinical surveillance and laboratory testing should always be applied in series to clarify the status of FMD suspects detected by either of these complementary diagnostic approaches. Laboratory testing may confirm clinical suspicion, while clinical surveillance may contribute to confirmation of positive serology. Any sampling unit within which suspicious animals are detected should be classified as infected until contrary evidence is produced.

   
   

   A number of issues must be considered in clinical surveillance for FMD. The often underestimated labour intensity and the logistical difficulties involved in conducting clinical examinations should not be underestimated and should be taken into account.

   
   

   Identification of clinical cases is fundamental to FMD surveillance. Establishment of the molecular, antigenic and other biological characteristics of the causative virus, as well as its source, is dependent upon disclosure of such animals. It is essential that FMDV isolates are sent regularly to the regional reference laboratory for genetic and antigenic characterization.

   
   
3. 
   

   Virological surveillance

   
   

   Virological surveillance using tests described in the Terrestrial Manual should be conducted:

   
   
   
   
   1. 
      

      to monitor at risk populations;

      
      
   2. 
      

      to confirm clinically suspect cases;

      
      
   3. 
      

      to follow up positive serological results;

      
      
   4. 
      

      to test “normal” daily mortality, to ensure early detection of infection in the face of vaccination or in establishments epidemiologically linked to an outbreak.

   
   
4. 
   

   Serological surveillance

   
   

   Serological surveillance aims at detecting antibodies against FMDV. Positive FMDV antibody test results can have four possible causes:

   
   
   
   
   1. 
      

      natural infection with FMDV;

      
      
   2. 
      

      vaccination against FMD;

      
      
   3. 
      

      maternal antibodies derived from an immune dam (maternal antibodies in cattle are usually found only up to 6 months of age but in some individuals and in some species, maternal antibodies can be detected for considerably longer periods);

      
      
   4. 
      

      heterophile (cross) reactions.

   
   

   It is important that serological tests, where applicable, contain antigens appropriate for detecting antibodies against viral variants (types, subtypes, lineages, topotypes, etc.) that have recently occurred in the region concerned. Where the probable identity of FMDVs is unknown or where exotic viruses are suspected to be present, tests able to detect representatives of all serotypes should be employed (e.g. tests based on nonstructural viral proteins – see below).

   
   

   It may be possible to use serum collected for other survey purposes for FMD surveillance. However, the principles of survey design described in this Chapter and the requirement for a statistically valid survey for the presence of FMDV should not be compromised.

   
   

   The discovery of clustering of seropositive reactions should be foreseen. It may reflect any of a series of events, including but not limited to the demographics of the population sampled, vaccinal exposure or the presence of field strain infection. As clustering may signal field strain infection, the investigation of all instances must be incorporated in the survey design. If vaccination cannot be excluded as the cause of positive serological reactions, diagnostic methods should be employed that detect the presence of antibodies to nonstructural proteins (NSPs) of FMDVs as described in the Terrestrial Manual.

   
   

   The results of random or targeted serological surveys are important in providing reliable evidence that FMDV infection is not present in a country, zone or compartment. It is therefore essential that the survey be thoroughly documented.

Article 8.5.45.

In addition to the general conditions described in the above-mentioned articles, a Member applying for recognition of FMD freedom for the country or a zone where vaccination is not practised should provide evidence for the existence of an effective surveillance programme. The strategy and design of the surveillance programme will depend on the prevailing epidemiological circumstances and will be planned and implemented according to general conditions and methods in this Chapter, to demonstrate absence of FMDV infection, during the preceding 12 months in susceptible populations. This requires the support of a national or other laboratory able to undertake identification of FMDV infection through virus/antigen/genome detection and antibody tests described in the Terrestrial Manual.

Article 8.5.46.

In addition to the general conditions described in the above-mentioned articles, a Member applying for recognition of country or zone freedom from FMD with vaccination should show evidence of an effective surveillance programme planned and implemented according to general conditions and methods in this Chapter. Absence of clinical disease in the country or zone for the past 2 years should be demonstrated. Furthermore, surveillance should demonstrate that FMDV has not been circulating in any susceptible population during the past 12 months. This will require serological surveillance incorporating tests able to detect antibodies to NSPs as described in the Terrestrial Manual. Vaccination to prevent the transmission of FMDV may be part of a disease control programme. The level of herd immunity required to prevent transmission will depend on the size, composition (e.g. species) and density of the susceptible population. It is therefore impossible to be prescriptive. However, the aim should, in general, be to vaccinate at least 80% of the susceptible population. The vaccine must comply with the Terrestrial Manual. Based on the epidemiology of FMD in the country or zone, it may be that a decision is reached to vaccinate only certain species or other subsets of the total susceptible population. In that case, the rationale should be contained within the dossier accompanying the application to the OIE for recognition of status.

Evidence to show the effectiveness of the vaccination programme should be provided.

Article 8.5.47.

In addition to the general conditions described in the above-mentioned articles, a country re-applying for country or zone freedom from FMD where vaccination is practised or not practised should show evidence of an active surveillance programme for FMD as well as absence of FMDV infection/circulation. This will require serological surveillance incorporating, in the case of a country or a zone practising vaccination, tests able to detect antibodies to NSPs as described in the Terrestrial Manual.

Four strategies are recognised by the OIE in a programme to eradicate FMDV infection following an outbreak:

1. 
   

   slaughter of all clinically affected and in-contact susceptible animals;

   
   
2. 
   

   slaughter of all clinically affected and in-contact susceptible animals and vaccination of at-risk animals, with subsequent slaughter of vaccinated animals;

   
   
3. 
   

   slaughter of all clinically affected and in-contact susceptible animals and vaccination of at-risk animals, without subsequent slaughter of vaccinated animals;

   
   
4. 
   

   vaccination used without slaughter of affected animals or subsequent slaughter of vaccinated animals.

The time periods before which an application can be made for re-instatement of freedom from FMD depends on which of these alternatives is followed. The time periods are prescribed in Article 8.5.9.

In all circumstances, a Member re-applying for country or zone freedom from FMD with vaccination or without vaccination should report the results of an active surveillance programme implemented according to general conditions and methods in this Chapter.

Article 8.5.48.

The recommended serological tests for FMD surveillance are described in the Terrestrial Manual.

Animals infected with FMDV produce antibodies to both the structural proteins (SP) and the nonstructural proteins (NSP) of the virus. Tests for SP antibodies to include SP-ELISAs and the virus neutralisation test (VNT). The SP tests are serotype specific and for optimal sensitivity should utilise an antigen or virus closely related to the field strain against which antibodies are being sought. Tests for NSP antibodies include NSP I-ELISA 3ABC and the electro-immunotransfer blotting technique (EITB) as recommended in the Terrestrial Manual or equivalent validated tests. In contrast to SP tests, NSP tests can detect antibodies to all serotypes of FMD virus. Animals vaccinated and subsequently infected with FMD virus develop antibodies to NSPs, but in some, the titre may be lower than that found in infected animals that have not been vaccinated. Both the NSP I-ELISA 3ABC and EITB tests have been extensively used in cattle. Validation in other species is ongoing. Vaccines used should comply with the standards of the Terrestrial Manual insofar as purity is concerned to avoid interference with NSP antibody testing.

Serological testing is a suitable tool for FMD surveillance. The choice of a serosurveillance system will depend on, amongst other things, the vaccination status of the country. A country, which is free from FMD without vaccination, may choose serosurveillance of high-risk subpopulations (e.g. based on geographical risk for exposure to FMDV). SP tests may be used in such situations for screening sera for evidence of FMDV infection/circulation if a particular virus of serious threat has been identified and is well characterised. In other cases, NSP testing is recommended in order to cover a broader range of strains and even serotypes. In both cases, serological testing can provide additional support to clinical surveillance. Regardless of whether SP or NSP tests are used in countries that do not vaccinate, a diagnostic follow-up protocol should be in place to resolve any presumptive positive serological test results.

In areas where animals have been vaccinated, SP antibody tests may be used to monitor the serological response to the vaccination. However, NSP antibody tests should be used to monitor for FMDV infection/circulation. NSP-ELISAs may be used for screening sera for evidence of infection/circulation irrespective of the vaccination status of the animal. All herds with seropositive reactors should be investigated. Epidemiological and supplementary laboratory investigation results should document the status of FMDV infection/circulation for each positive herd. Tests used for confirmation should be of high diagnostic specificity to eliminate as many false positive screening test reactors as possible. The diagnostic sensitivity of the confirmatory test should approach that of the screening test. The EITB or another OIE-accepted test should be used for confirmation.

Information should be provided on the protocols, reagents, performance characteristics and validation of all tests used.

1. 
   

   The follow-up procedure in case of positive test results if no vaccination is used in order to establish or re-establish FMD free status without vaccination

   
   

   Any positive test result (regardless of whether SP or NSP tests were used) should be followed up immediately using appropriate clinical, epidemiological, serological and, where possible, virological investigations of the reactor animal at hand, of susceptible animals of the same epidemiological unit and of susceptible animals that have been in contact or otherwise epidemiologically associated with the reactor animal. If the follow-up investigations provide no evidence for FMDV infection, the reactor animal shall be classified as FMD negative. In all other cases, including the absence of such follow-up investigations, the reactor animal should be classified as FMD positive.

   
   
2. 
   

   The follow-up procedure in case of positive test results if vaccination is used in order to establish or re-establish FMD free status with vaccination

   
   

   In case of vaccinated populations, one has to exclude that positive test results are indicative of virus circulation. To this end, the following procedure should be followed in the investigation of positive serological test results derived from surveillance conducted on FMD vaccinated populations.

   
   

   The investigation should examine all evidence that might confirm or refute the hypothesis that the positive results to the serological tests employed in the initial survey were not due to virus circulation. All the epidemiological information should be substantiated, and the results should be collated in the final report.

   
   

   It is suggested that in the primary sampling units where at least one animal reacts positive to the NSP test, the following strategy(ies) should be applied:

   
   
   
   
   1. 
      

      Following clinical examination, a second serum sample should be taken from the animals tested in the initial survey after an adequate interval of time has lapsed, on the condition that they are individually identified, accessible and have not been vaccinated during this period. The number of animals with antibodies against NSP in the population at the time of retest should be statistically either equal to or less than that observed in the initial test if virus is not circulating.

      
      

      The animals sampled should remain in the holding pending test results and should be clearly identifiable. If the three conditions for retesting mentioned above cannot be met, a new serological survey should be carried out in the holding after an adequate period of time, repeating the application of the primary survey design and ensuring that all animals tested are individually identified. These animals should remain in the holding and should not be vaccinated, so that they can be retested after an adequate period of time.

      
      
   2. 
      

      Following clinical examination, serum samples should be collected from representative numbers of susceptible animals that were in physical contact with the primary sampling unit. The magnitude and prevalence of antibody reactivity observed should not differ in a statistically significant manner from that of the primary sample if virus is not circulating.

      
      
   3. 
      

      Following clinical examination, epidemiologically linked herds should be serologically tested and satisfactory results should be achieved if virus is not circulating.

      
      
   4. 
      

      Sentinel animals can also be used. These can be young, unvaccinated animals or animals in which maternally conferred immunity has lapsed and belonging to the same species resident within the positive initial sampling units. They should be serologically negative if virus is not circulating. If other susceptible, unvaccinated animals are present, they could act as sentinels to provide additional serological evidence.

Laboratory results should be examined in the context of the epidemiological situation. Corollary information needed to complement the serological survey and assess the possibility of viral circulation includes but is not limited to:

• 
  

  characterization of the existing production systems;

  
  
• 
  

  results of clinical surveillance of the suspects and their cohorts;

  
  
• 
  

  quantification of vaccinations performed on the affected sites;

  
  
• 
  

  sanitary protocol and history of the establishments with positive reactors;

  
  
• 
  

  control of animal identification and movements;

  
  
• 
  

  other parameters of regional significance in historic FMDV transmission.

The entire investigative process should be documented as standard operating procedure within the surveillance programme.

Fig. 1. Schematic representation of laboratory tests
for determining evidence of FMDV infection
through or following serological surveys

Key:
ELISA	Enzyme-linked immunosorbent assay
VNT	Virus neutralisation test
NSP	Nonstructural protein(s) of foot and mouth disease virus (FMDV)
3ABC	NSP antibody test
EITB	Electro-immuno transfer blotting technique (Western blot for NSP antibodies of FMDV)
SP	Structural protein test
S	No evidence of FMDV