Annex 13

CHAPTER 1.11.

APPLICATION FOR OFFICIAL RECOGNITION BY WOAH OF FREE STATUS FOR FOOT AND MOUTH DISEASE

Article 1.11.1.

Country free from infection with foot and mouth disease virus where vaccination is not practised

The following information should be provided by WOAH Member Countries to support applications for official recognition of status as a country where *vaccination*is not practised that is free from *infection*with foot and mouth disease (FMD) virus in accordance with Chapter 8.8. of the *Terrestrial Code*.

The dossier provided to WOAH should address concisely all the following topics under the headings provided to describe the actual situation in the country and procedures currently applied, explaining how these comply with the *Terrestrial Code*.

The terminology defined in the WOAH *Terrestrial Code*and *Terrestrial Manual*should be referred to and used in compiling the dossier.

National legislation, regulations and *Veterinary Authority*directives may be referred to and annexed as appropriate in one of the WOAH official languages. Weblinks to supporting documents in one of the official languages of WOAH may also be provided, where they exist.

All annexes should be provided in one of the WOAH official languages.

The Delegate of the Member Country applying for recognition of FMD freedom for a country where *vaccination*is not practised must demonstrate compliance with the *Terrestrial Code*. That is, the Delegate should submit documentary evidence that the provisions of Article 8.8.2. have been properly implemented and supervised.

In addition, the Delegate of the Member Country must submit a declaration indicating ~~that~~ for at least the past 12 months:

1)	there has been no *~~case~~*~~of~~*infection* with FMDV~~during the past 12 months~~;

2)there has been no ~~evidence of FMDV~~ transmission of FMDV in previously vaccinated animal *populations*;

3)*surveillance* in accordance with Articles 8.8.40. to 8.8.42. is in operation, and that regulatory measures for the prevention and control of FMD have been implemented;

~~2~~4)	~~no~~*vaccination* against FMD has been prohibited and the prohibition has been effectively implemented and supervised~~carried out during the past 12 months~~.

In addition, the Delegate of the Member Country applying for recognition of historical freedom must also submit documentary evidence that the provisions in Article 1.4.6. of the *Terrestrial Code*have been properly implemented and supervised.

# 1. Introduction

a) Geographical features (rivers, mountain ranges, etc.). Provide a general description of the country and, where relevant, of the region, including physical, geographical and other factors that are relevant to introduction of *infection*and spread of FMD virus, taking into account the countries or *zones*sharing common borders and other epidemiologic pathways for the potential introduction of the *infection*. Provide maps identifying the features above. Specify whether the application includes any noncontiguous territories.

b) Livestock demographics. Describe the composition of the livestock industry in the country. In particular, describe:

i) the susceptible animal *population*by species and types of production systems;

ii) the number of *herds*or *flocks*, etc. of each susceptible species;

iii) their geographical distribution;

iv) *herd*or *flock*density;

v) the degree of integration and role of producer organisations in the different production systems;

vi) any recent significant changes observed in the production (attach relevant documents if available). Provide tables and maps.

c) *Wildlife*demographics. What susceptible *captive wild*, *wild*or *feral*species are present in the country? Provide estimates of *population*sizes, ~~and~~ geographic distribution and a summary description of their habitat. What are the measures in place to prevent contact between domestic and susceptible *wildlife*species?

d) *Slaughterhouses/abattoirs*, markets and events associated with the congregation of susceptible livestock (e.g. fairs, shows, competitions). Where are the major livestock marketing or collection centres? What are the patterns of movement of susceptible domestic species for marketing within the country? How are the susceptible animals sourced, transported and handled during these transactions? Provide maps as appropriate.

# 2. Veterinary system

a) Legislation. Provide a table (and when available a weblink) listing all relevant veterinary legislation, regulations and *Veterinary Authority*directives in relation to FMD and a brief description of the relevance of each. The table should include, but not be limited to, the legislation on disease control measures and compensation systems.

b) *Veterinary Services*. Describe how the *Veterinary Services*of the country comply with Chapters 1.1., 3.2. and 3.3. of the *Terrestrial Code*. Describe how the *Veterinary Services*supervise, control, enforce and monitor all FMD-related activities. Provide maps, figures and tables wherever possible.

c) Provide information on any PVS evaluation conducted in the country and follow-up steps within the PVS Pathway and highlight the results relevant to FMD and the susceptible species.

d) Provide a description of the involvement and the participation of industry, producers, farmers, including subsistence and small-scale producers, keepers, *veterinary paraprofessionals*including community animal health workers, and other relevant groups in FMD *surveillance*and control. Provide a description of the role and structure of the private veterinary sector, including the number of *veterinarians*and their distribution, in FMD *surveillance*and control. Include a description of continuing education and awareness programmes on FMD at all relevant levels.

e) *Animal identification*, registration, traceability and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the traceability system, including methods of *animal identification*and *establishment*or *herd*or *flock*registration, applicable to all susceptible species. How are movements of all susceptible species controlled in the country? Provide evidence of the effectiveness of *animal identification*and movement controls and a table describing the number, species, origin and destination of the animals and their products moved within the country in the past 24 months. Provide information on pastoralism, transhumance and related paths of movement.

Describe the *risk management*strategy for uncontrolled movements of susceptible species (e.g. seasonal migration).

Describe the actions available under national legislation. Provide information on illegal movements detected in the past 24 months and the action taken.

# 3. FMD eradication

a) History. If *infection*has never occurred in the country, or has not occurred within the past 25 years, state explicitly whether or not the country is applying for recognition of historical freedom according to Article 1.4.6. of the *Terrestrial Code*.

If *infection*has occurred in the country within the past 25 years, provide a description of the FMD history in the country, with emphasis on recent years. If applicable, provide tables and maps showing the date of first detection, the sources and routes of introduction of *infection*, the temporal and spatial distribution (number and location of *outbreaks*per year), the susceptible species involved, the date of last *case*or *eradication*, and the types and strains in the country.

b) Strategy. Describe how FMD was controlled and eradicated (e.g. *stamping-out policy*, zoning, *vaccination*, movement control). Provide the time frame for *eradication*. Describe and justify the corrective actions that have been implemented to prevent future *outbreaks*of FMD in response to any past incursions of FMD virus.

c) Vaccines and *vaccination*. Briefly answer the following:

i) Is there any legislation that prohibits *vaccination*? If so:

· Provide the date when *vaccination*was formally prohibited;

· Provide information on cases of detection of illegal *vaccination*during the reporting period and actions taken in response to the detection.

ii) Was *vaccination*ever used in the country? If so:

· Provide the date when the last *vaccination*was carried out;

· What type of vaccine was used?

· What species were vaccinated?

· How were vaccinated animals identified?

· What was the fate of those animals?

iii) In addition, if *vaccination*was applied during the past 24 months, provide a description and justification of the *vaccination*strategy and programme, including the following:

· the vaccine strains;

· potency and formulation, purity, details of any vaccine matching performed;

· the species vaccinated;

· identification of vaccinated animals;

· the way in which the *vaccination*of animals was certified or reported and the records maintained;

· evidence that the vaccine used complies with Chapter 3.1.8. of the *Terrestrial Manual*.

d) Provide a description of the legislation, organisation and implementation of the *eradication*campaign. Outline the legislation applicable to the *eradication*and how the campaign was organised at different levels. Indicate if detailed operational guidelines exist and give a brief summary.

# 4. FMD diagnosis

Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 3.1.8. of the *Terrestrial Manual*are applied. The following points should be addressed:

a) Is FMD *laboratory*diagnosis carried out in the country? If so, provide an overview of the FMD-approved *laboratories*in the country, including the following:

i) How the work is shared between different *laboratories*, logistics for shipment of samples, the follow-up procedures and the time frame for reporting results;

ii) Details of test capability and the types of tests undertaken and their performance for their applied use (specificity and sensitivity per type of test). Provide details of the number of FMD tests performed in the last 24 months in national *laboratories*and in *laboratories*in other countries, if relevant;

iii) Procedures for quality assurance and for the official accreditation of *laboratories*. Give details of formal internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the *laboratory*system;

iv) Provide details of performance in inter-*laboratory*validation tests (ring trials), including the most recent results and, if applicable, the corrective measures applied;

v) Provide details of the handling of live pathogenic agent, including a description of the biosecurity and biosafety measures applied;

vi) Provide a table identifying the tests carried out by each of the *laboratories*where they are performed, the quality accreditation and biosecurity standards followed and the proficiency tests carried out.

b) If FMD *laboratory*diagnosis is not carried out in the country, provide the names of the *laboratories*in other countries providing the service as well as the arrangements in place, including logistics for shipment of samples and the time frame for reporting results.

# 5. FMD surveillance

Provide documentary evidence that *surveillance*for FMD in the country complies with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*, and Chapter 3.1.8. of the *Terrestrial Manual*. The following information should be included:

a)	What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what incentives are there for reporting and what penalties are involved for failure to report?

b)	Describe how clinical *surveillance*is conducted, including which sectors of the livestock production system are included in clinical *surveillance*, such as *establishments*, markets, fairs, *slaughterhouses/abattoirs*, check points, etc.

Provide a summary table indicating, for the past 24 months, the number of suspected *cases*, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide an indication of the timelines of the response including completion of testing to confirm or exclude FMD. Provide details of follow-up actions taken on all suspicious and positive results.

c)	Serological or virological *surveillance*. Are serological or virological surveys conducted? If so, provide detailed information on the target population, design prevalence, confidence level, sample size, stratification, sampling methods and diagnostic tests used in accordance with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*. How frequently are surveys conducted? Are susceptible *wildlife*species included in serological or virological surveys? If not, explain the rationale. Describe how previously vaccinated or newly introduced vaccinated animal *populations* are considered in the strategy and design of the *surveillance* programme, if applicable.

Provide a summary table indicating, for the past 24 months, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide details of follow-up actions taken on all suspicious and positive results and on how these findings are acted upon. Provide criteria for selection of *populations*for targeted surveillance based on the risk and numbers of animals examined and samples tested in diagnostic *laboratories*. Provide details of the methods selected and applied for monitoring the performance of the *surveillance*programme including indicators.

d)	Provide information on risks in different husbandry systems, and provide evidence that targeted studies are implemented to address gaps (e.g. targeted serological surveys, active *surveillance*, participatory epidemiology studies, *risk assessments*, etc.). Provide evidence of how the knowledge acquired through these activities assisted in more effective implementation of control measures.

e)	Provide details of the oversight of *surveillance*programmes by the *Veterinary Services*including training programmes for personnel involved in clinical, serological and virological *surveillance*, and the approaches used to increase community involvement in FMD *surveillance*programmes.

# 6. FMD prevention

Describe the procedures in place to prevent the introduction of FMD into the country, including details of:

a) Coordination with other countries. Describe any relevant factors in neighbouring countries that should be taken into account (e.g. size, distance from the border to affected *herds*, *flocks*or animals). Describe coordination, collaboration and information-sharing activities with other countries in the same region or ecosystem.

Are *protection zones*in place? If so, provide details of the measures that are applied (e.g. *vaccination*, intensified *surveillance*, density control of susceptible species), and provide a geo-referenced map of the *zones*.

b) Describe the measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Describe the measures implemented to prevent the spread of the pathogenic agent within the country or *zone*. Provide evidence that measures to reduce transmission of FMD are in place at markets, such as enhancing awareness of FMD transmission mechanisms and human behaviour that can interrupt transmission, and implementation of good *biosecurity*, hygiene and *disinfection*routines at critical points all along the production and marketing networks (typically where animals are being moved and marketed through the country or region).

c) What measures are taken to limit access of susceptible domestic, *feral*and *wild*animals to waste products of animal origin? Is the feeding of swill to pigs regulated? If so, provide information on the extent of the practice, and describe controls and *surveillance*measures.

d) Import control procedures

Provide information on countries, *zones*or *compartments*from which the country authorises the import of susceptible animals or their products into the country. Describe the criteria applied to approve such countries, *zones*or *compartments*, the controls applied to entry of such animals and products, and subsequent internal movement. Describe the import measures (e.g. quarantine) and test procedures required. Advise whether imported animals of susceptible species are required to undergo a quarantine or isolation period and, if so, the duration and location of quarantine. Advise whether import permits and *international veterinary certificates*are required.

Describe any other procedures used for assessing the *risks*posed by import of susceptible animals or their products. Provide summary statistics on imports of susceptible animals and their products for at least the past 24 months, including temporary import and re-entry, specifying countries, *zones*or *compartments*of origin, species, vaccination status, and the quantity or volume and eventual destination in the country. Provide information on whether or not *outbreaks*have been related to imports or transboundary movements of domestic animals.

i) Provide a map with the number and location of all ports, airports and land border crossings. Describe the management structure, staffing levels and resources of the service responsible for import controls and its accountability to the central *Veterinary Services*. Describe the communication systems between the central authorities and the *border posts*, and between *border posts*.

ii) Provide a description of the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 24 months, of the quantity disposed of and the disposal locations. What are the biosecurity measures in place at waste disposal sites?

iii) Cite the regulations and describe procedures, type and frequency of checks, and management of noncompliance at the points of entry into the country or their final destination, concerning the import and follow-up of the following:

· animals;

· genetic material (semen, oocytes and embryos);

· animal products;

· *veterinary medicinal products*;

· other materials at risk of being contaminated with FMD virus, including bedding, litter and *feed*.

# 7. Control measures and contingency planning

a) List any written guidelines, including contingency plans, available to the *Veterinary Services*for dealing with suspected or confirmed *outbreaks*of FMD. The contingency plan should be attached as an annex in one of the WOAH official languages. If not available, provide a brief summary of what is covered. Provide information on any simulation exercise for FMD that was conducted in the country in the past five years.

b) In the event of a suspected or confirmed FMD *outbreak*:

i) Are quarantine measures imposed on *establishments*with suspected *cases*, pending final diagnosis? What other procedures are followed with respect to suspected *cases*(e.g. livestock standstills)?

ii) Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;

iii) Describe the actions that would be taken to control the disease situation in and around the

*establishments*where the *outbreak*is confirmed;

iv) Provide a detailed description of the control or *eradication*procedures (e.g. forward and backward tracing, movement control, *disinfection*of *establishments*, *vehicles*and equipment, including verification methods, *vaccination*including vaccine delivery and cold chain, *stamping-out policy*, methods of disposal of carcasses and other contaminated products or materials, decontamination, campaigns to promote awareness of farmers) that would be taken. In the case of emergency *vaccination*, indicate the source and type of vaccine and provide details of any vaccine supply scheme and stocks;

v) Describe the criteria and procedures that would be used to confirm that an *outbreak*has been successfully controlled or eradicated, including restocking strategies, use of sentinel animals, serological *surveillance*programmes, etc.;

vi) Give details of any compensation that would be made available to owners, farmers, etc. when animals are slaughtered for disease control or *eradication*purposes and the prescribed timetable for payments;

vii) Describe how control efforts, including *vaccination*and *biosecurity*, would target critical risk control points.

# 8. Recovery of free status

Member Countries applying for recognition of recovery of free status for a country should comply with the provisions of Article 8.8.7. and points 4, 5 and 6~~1, 3 and 4~~ of Article 8.8.2. of the *Terrestrial Code*and provide detailed information as specified in Sections 3, 5 and 6~~1-7 (inclusive)~~ of this questionnaire.

Article 1.11.2.

Country free from infection with foot and mouth disease virus where vaccination is practised

The following information should be provided by WOAH Member Countries to support applications for official recognition of status as a country where *vaccination*is practised that is free from *infection*with foot and mouth disease (FMD) virus in accordance with Chapter 8.8. of the *Terrestrial Code*.

The dossier provided to WOAH should address concisely all the following topics under the headings provided to describe the actual situation in the country and procedures currently applied, explaining how these comply with the *Terrestrial Code*.

The terminology defined in the WOAH *Terrestrial Code*and *Terrestrial Manual*should be referred to and used in compiling the dossier.

National legislation, regulations and *Veterinary Authority*directives may be referred to and annexed as appropriate in one of the WOAH official languages. Weblinks to supporting documents in one of the official languages of WOAH may also be provided, where they exist.

All annexes should be provided in one of the WOAH official languages.

The Delegate of the Member Country applying for recognition of FMD freedom for a country where *vaccination*is practised must demonstrate compliance with the *Terrestrial Code*. That is, the Delegate should submit documentary evidence that the provisions of Article 8.8.3. have been properly implemented and supervised.

In addition, the Delegate of the Member Country must submit a declaration indicating ~~that~~ for at least the past 12 months:

1)	there has been no *~~case~~*~~of~~*infection* with FMDV~~for the past 24 months~~;

2)	no ~~evidence of FMDV~~ transmission of FMDV ~~for the past 12 months~~;

~~3)~~*~~surveillance~~*~~for FMD and FMDV transmission in accordance with Articles 8.8.40. to 8.8.42. and is in operation, and that regulatory measures for the prevention and control of FMD have been implemented;~~

~~4~~3~~)	routine~~compulsory systematic *vaccination*is carried out in the target population ~~for the purposes of the prevention of FMD~~;

~~5~~4)	the vaccine used complies with the standards described in the *Terrestrial Manual*.

And, for at least the past 24 months, *surveillance* in accordance with Articles 8.8.40. to 8.8.42. is in operation, and regulatory measures for the prevention and control of FMD have been implemented.

In addition, the Delegate of the Member Country applying for recognition of historical freedom must also submit documentary evidence that the provisions in Article 1.4.6. of the *Terrestrial Code*have been properly implemented and supervised.

# 1. Introduction

a) Geographical features (rivers, mountain ranges, etc.). Provide a general description of the country and, where relevant, of the region, including physical, geographical and other factors that are relevant to introduction of *infection*and spread of FMD virus, taking into account the countries or *zones*sharing common borders and other epidemiologic pathways for the potential introduction of the *infection*. Provide maps identifying the features above. Specify whether the application includes any noncontiguous territories.

b) Livestock demographics. Describe the composition of the livestock industry in the country. In particular, describe:

i) the susceptible animal *population*by species and types of production systems;

ii) the number of *herds*or *flocks*, etc. of each susceptible species;

iii) their geographical distribution;

iv) *herd*or *flock*density;

v) the degree of integration and role of producer organisations in the different production systems;

vi) any recent significant changes observed in the production (attach relevant documents if available). Provide tables and maps.

c) *Wildlife*demographics. What susceptible *captive wild*, *wild*or *feral*species are present in the country? Provide estimates of *population*sizes, ~~and~~ geographic distribution and a summary description of their habitat. What are the measures in place to prevent contact between domestic and susceptible *wildlife*species?

d) *Slaughterhouses/abattoirs*, markets and events associated with the congregation of susceptible livestock (e.g. fairs, shows, competitions). Where are the major livestock marketing or collection centres? What are the patterns of movement of susceptible domestic species for marketing within the country? How are the susceptible animals sourced, transported and handled during these transactions? Provide maps as appropriate.

# 2. Veterinary system

a) Legislation. Provide a table (and when available a weblink) listing all relevant veterinary legislation, regulations and *Veterinary Authority*directives in relation to FMD and a brief description of the relevance of each. The table should include, but not be limited to, the legislation on disease control measures and compensation systems.

b) *Veterinary Services*. Describe how the *Veterinary Services*of the country comply with Chapters 1.1., 3.2. and

3.3. of the *Terrestrial Code*. Describe how the *Veterinary Services*supervise, control, enforce and monitor all FMD-related activities. Provide maps, figures and tables wherever possible.

c) Provide information on any PVS evaluation conducted in the country and follow-up steps within the PVS Pathway and highlight the results relevant to FMD and the susceptible species.

d) Provide a description of the involvement and the participation of industry, producers, farmers, including subsistence and small-scale producers, keepers, *veterinary paraprofessionals*including community animal health workers, and other relevant groups in FMD *surveillance*and control. Provide a description of the role and structure of the private veterinary sector, including the number of *veterinarians*and their distribution, in FMD *surveillance*and control. Include a description of continuing education and awareness programmes on FMD at all relevant levels.

e) *Animal identification*, registration, traceability and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the traceability system, including methods of *animal identification*and *establishment*or *herd*or *flock*registration, applicable to all susceptible species. How are movements of all susceptible species controlled in the country? Provide evidence of the effectiveness of *animal identification*and movement controls and a table describing the number, species, origin and destination of the animals and their products moved within the country in the past 24 months. Provide information on pastoralism, transhumance and related paths of movement.

Describe the *risk management*strategy for uncontrolled movements of susceptible species (e.g. seasonal migration).

Describe the actions available under national legislation. Provide information on illegal movements detected in the past 24 months and the action taken.

# 3. FMD eradication

a) History. Provide a description of the FMD history in the country, with emphasis on recent years. If applicable, provide tables and maps showing the date of first detection, the sources and routes of introduction of *infection*, the temporal and spatial distribution (number and location of *outbreaks*per year), the susceptible species involved, the date of last *case*or *eradication*, and the types and strains in the country.

b) Strategy. Describe how FMD was controlled and eradicated (e.g. *stamping-out policy*, modified stamping-out policy, zoning, *vaccination*, movement control). Provide the time frame for *eradication*. Describe and justify the corrective actions that have been implemented to prevent future *outbreaks*of FMD in response to any past incursions of FMD virus.

c) Vaccines and *vaccination*. Describe any legislation regulating *vaccination*. Provide a description and justification of the *vaccination*strategy and programme, including the following:

i) the vaccine strains;

ii) potency and formulation, purity, details of any vaccine matching performed;

iii) the species vaccinated;

iv) identification of vaccinated animals;

v) the way in which the *vaccination*of animals was certified or reported and the records maintained;

vi) the date on which the last *vaccination*was performed;

vii) evidence that the vaccine used complies with Chapter 3.1.8. of the *Terrestrial Manual*.

d) Provide detailed evidence of *vaccination*coverage and population immunity as follows:

Describe how the number of animals intended for *vaccination*and the number of vaccinated animals are estimated.

For serological surveys to estimate population immunity, provide detailed information on the sampling frame (target population, age, species and *vaccination*status) and survey design (expected prevalence, acceptable error, confidence level, sample size, stratification, sampling methods and diagnostic tests used). How long after *vaccination*are samples collected? Describe how the threshold for protective immunity has been established.

Provide the results of the *vaccination*coverage and population immunity by year, serotype, species, as relevant.

Provide details of any additional methods applied for monitoring the performance of *vaccination*.

e) Provide a description of the legislation, organisation and implementation of the *eradication*campaign. Outline the legislation applicable to the *eradication*and how the campaign was organised at different levels. Indicate if detailed operational guidelines exist and give a brief summary.

# 4. FMD diagnosis

Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 3.1.8. of the *Terrestrial Manual*are applied. The following points should be addressed:

a) Is FMD *laboratory*diagnosis carried out in the country? If so, provide an overview of the FMD-approved

*laboratories*in the country, including the following:

i) How the work is shared between different *laboratories*, logistics for shipment of samples, the follow-up procedures and the time frame for reporting results;

ii) Details of test capability and the types of tests undertaken and their performance for their applied use (specificity and sensitivity per type of test). Provide details of the number of FMD tests performed in the last 24 months in national *laboratories*and in *laboratories*in other countries, if relevant;

iii) Procedures for quality assurance and for the official accreditation of *laboratories*. Give details of formal internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the *laboratory*system;

iv) Provide details of performance in inter-*laboratory*validation tests (ring trials), including the most recent results and, if applicable, the corrective measures applied;

v) Provide details of the handling of live pathogenic agent, including a description of the biosecurity and biosafety measures applied;

vi) Provide a table identifying the tests carried out by each of the *laboratories*where they are performed, the quality accreditation and biosecurity standards followed and the proficiency tests carried out.

b) If FMD *laboratory*diagnosis is not carried out in the country, provide the names of the *laboratories*in other countries providing the service as well as the arrangements in place, including logistics for shipment of samples and the time frame for reporting results.

# 5. FMD surveillance

Provide documentary evidence that *surveillance*for FMD in the country complies with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*, and Chapter 3.1.8. of the *Terrestrial Manual*. The following information should be included:

a) What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what incentives are there for reporting and what penalties are involved for failure to report?

b) Describe how clinical *surveillance*is conducted, including which sectors of the livestock production system are included in clinical *surveillance*, such as *establishments*, markets, fairs, *slaughterhouses/abattoirs*, check points, etc.

Provide a summary table indicating, for the past 24 months, the number of suspected *cases*, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide an indication of the timelines of the response including completion of testing to confirm or exclude FMD. Provide details of follow-up actions taken on all suspicious and positive results.

c) Serological or virological *surveillance*. Are serological or virological surveys conducted? If so, provide detailed information on the target population, design prevalence, confidence level, sample size, stratification, sampling methods and diagnostic tests used in accordance with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*. How frequently are surveys conducted? Are susceptible *wildlife*species included in serological or virological surveys? If not, explain the rationale.

Provide a summary table indicating, for the past 24 months, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide details of follow-up actions taken on all suspicious and positive results and how these findings are acted upon. Provide criteria for selection of *populations*for targeted surveillance based on the risk and numbers of animals examined and samples tested in diagnostic *laboratories*. Provide details of the methods selected and applied for monitoring the performance of the *surveillance*programme including indicators.

d) Provide information on risks in different husbandry systems, and provide evidence that targeted studies are implemented to address gaps (e.g. targeted serological surveys, active *surveillance*, participatory epidemiology studies, *risk assessments*, etc.). Provide evidence of how the knowledge acquired through these activities assisted in more effective implementation of control measures.

e) Provide details of the oversight of *surveillance*programmes by the *Veterinary Services*including training programmes for personnel involved in clinical, serological and virological *surveillance*, and the approaches used to increase community involvement in FMD *surveillance*programmes.

f) Provide evidence that surveys are carried out to assess *vaccination*coverage and population immunity of the target *populations*, show laboratory evidence that the vaccine strains used is appropriate.

# 6. FMD prevention

Describe the procedures in place to prevent the introduction of FMD into the country, including details of:

a) Coordination with other countries. Describe any relevant factors in neighbouring countries that should be taken into account (e.g. size, distance from the border to affected *herds*, *flocks*or animals). Describe coordination, collaboration and information-sharing activities with other countries in the same region or ecosystem.

Are *protection zones*in place? If so, provide details of the measures that are applied (e.g. *vaccination*, intensified *surveillance*, density control of susceptible species), and provide a geo-referenced map of the *zones*.

b) Describe the measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Describe the measures implemented to prevent the spread of the pathogenic agent within the country or *zone*. Provide evidence that measures to reduce transmission of FMD are in place at markets, such as enhancing awareness of FMD transmission mechanisms and human behaviour that can interrupt transmission, and implementation of good *biosecurity*, hygiene and *disinfection*routines at critical points all along the production and marketing networks (typically where animals are being moved and marketed through the country or region).

c) What measures are taken to limit access of susceptible domestic, *feral*and *wild*animals to waste products of animal origin? Is the feeding of swill to pigs regulated? If so, provide information on the extent of the practice, and describe controls and *surveillance*measures.

d) Import control procedures

Provide information on countries, *zones*or *compartments*from which the country authorises the import of susceptible animals or their products into the country. Describe the criteria applied to approve such countries, *zones*or *compartments*, the controls applied to entry of such animals and products, and subsequent internal movement. Describe the import measures (e.g. quarantine) and test procedures required. Advise whether imported animals of susceptible species are required to undergo a quarantine or isolation period and, if so, the duration and location of quarantine. Advise whether import permits and *international veterinary certificates*are required.

Describe any other procedures used for assessing the *risks*posed by import of susceptible animals or their products. Provide summary statistics on imports of susceptible animals and their products for at least the past 24 months, including temporary import and re-entry, specifying countries, *zones*or *compartments*of origin, species and the quantity or volume and eventual destination in the country. Provide information on whether or not *outbreaks*have been related to imports or transboundary movements of domestic animals.

i) Provide a map with the number and location of all ports, airports and land border crossings. Describe the management structure, staffing levels and resources of the service responsible for import controls and its accountability to the central *Veterinary Services*. Describe the communication systems between the central authorities and the *border posts*, and between *border posts*.

ii) Provide a description of the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 24 months, of the quantity disposed of and the disposal locations. What are the biosecurity measures in place at waste disposal sites?

iii) Cite the regulations and describe procedures, type and frequency of checks, and management of noncompliance at the points of entry into the country or their final destination, concerning the import and follow-up of the following:

· animals;

· genetic material (semen, oocytes and embryos);

· animal products;

· *veterinary medicinal products*;

· other materials at risk of being contaminated with FMD virus, including bedding, litter and *feed*.

# 7. Control measures and contingency planning

a) List any written guidelines, including contingency plans, available to the *Veterinary Services*for dealing with suspected or confirmed *outbreaks*of FMD. The contingency plan should be attached as an annex in one of the WOAH official languages. If not available, provide a brief summary of what is covered. Provide information on any simulation exercise for FMD that was conducted in the country in the past five years.

b) In the event of a suspected or confirmed FMD *outbreak*:

i) Are quarantine measures imposed on *establishments*with suspected *cases*, pending final diagnosis? What other procedures are followed with respect to suspected *cases*(e.g. livestock standstills)?

ii) Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;

iii) Describe the actions that would be taken to control the disease situation in and around the

*establishments*where the *outbreak*is confirmed;

iv) Provide a detailed description of the control or *eradication*procedures (e.g. forward and backward tracing, movement control, *disinfection*of *establishments*, *vehicles*and equipment, including verification methods, *vaccination*including vaccine delivery and cold chain, *stamping-out policy*, methods of disposal of carcasses and other contaminated products or materials, decontamination, campaigns to promote awareness of farmers) that would be taken. In the case of emergency *vaccination*, indicate the source and type of vaccine and provide details of any vaccine supply scheme and stocks;

v) Describe the criteria and procedures that would be used to confirm that an *outbreak*has been successfully controlled or eradicated, including restocking strategies, use of sentinel animals, serological *surveillance*programmes, etc.;

vi) Give details of any compensation that would be made available to owners, farmers, etc. when animals are slaughtered for disease control or *eradication*purposes and the prescribed timetable for payments;

vii) Describe how control efforts, including *vaccination*and *biosecurity*, would target critical risk control points.

# 8. Recovery of free status

Member Countries applying for recognition of recovery of free status for a country should comply with the provisions of Article 8.8.7. and points 1 e), f), g) and 2~~, 3 and 4~~ of Article 8.8.3. of the *Terrestrial Code*and provide detailed information as specified in Sections 3, 5 and 6~~1-7 (inclusive)~~ of this questionnaire.

Article 1.11.3.

Zone free from infection with foot and mouth disease virus where vaccination is not practised

The following information should be provided by WOAH Member Countries to support applications for official recognition of status as a *zone*where *vaccination*is not practised that is free from *infection*with foot and mouth disease (FMD) virus in accordance with Chapter 8.8. of the *Terrestrial Code*.

The dossier provided to WOAH should address concisely all the following topics under the headings provided to describe the actual situation in the country and procedures currently applied, explaining how these comply with the *Terrestrial Code*.

The terminology defined in the WOAH *Terrestrial Code*and *Terrestrial Manual*should be referred to and used in compiling the dossier.

National legislation, regulations and *Veterinary Authority*directives may be referred to and annexed as appropriate in one of the WOAH official languages. Weblinks to supporting documents in one of the official languages of WOAH may also be provided, where they exist.

All annexes should be provided in one of the WOAH official languages.

The Delegate of the Member Country applying for recognition of FMD zonal freedom must demonstrate compliance with the *Terrestrial Code*. That is, the Delegate should submit documentary evidence that the provisions of Article 8.8.2. have been properly implemented and supervised.

In addition, the Delegate of the Member Country must submit a declaration indicating~~that~~ for at least the past 12 months:

1) there has been no *~~case~~*~~of~~*infection* with FMDV~~during the past 12 months~~;

2)	there has been no ~~evidence of FMDV~~ transmission of FMDV in previously vaccinated animal~~s~~*populations*;

3)	*surveillance*~~for FMD and FMDV transmission~~in accordance with Articles 8.8.40. to 8.8.42. is in operation, and that regulatory measures for the prevention and control of FMD have been implemented;

4)	~~no~~*vaccination* against FMD has been prohibited and the prohibition has been effectively implemented and supervised~~carried out during the past 12 months~~.

In addition, the Delegate of the Member Country applying for recognition of historical zonal freedom must also submit documentary evidence that the provisions in Article 1.4.6. of the *Terrestrial Code* have been properly implemented and supervised.

# 1. Introduction

a) Geographical features (rivers, mountain ranges, etc.). Provide a general description of the country and the *zone*, and where relevant of the region, including physical, geographical and other factors that are relevant to introduction of *infection*and spread of FMD virus, taking into account the countries or *zones*sharing common borders and other epidemiologic pathways for the potential introduction of the *infection*.

The boundaries of the *zone*must be clearly defined, including a *protection zone*if applied. Provide maps identifying the features above, including a digitalised, geo-referenced map with a precise text description of the geographical boundaries of the *zone*.

b) Livestock demographics. Describe the composition of the livestock industry in the country and the *zone*. In particular, describe:

i) the susceptible animal *population*by species and types of production systems in the country and the *zone*;

ii) the number of *herds*or *flocks*, etc. of each susceptible species;

iii) their geographical distribution;

iv) *herd*or *flock*density;

v) the degree of integration and role of producer organisations in the different production systems;

vi) any recent significant changes observed in the production (attach relevant documents if available). 

Provide tables and maps.

c) *Wildlife*demographics. What susceptible *captive wild*, *wild*or *feral*species are present in the country and the *zone*? Provide estimates of *population*sizes, ~~and~~ geographic distribution and a summary description of their habitat. What are the measures in place to prevent contact between domestic and susceptible *wildlife*species?

d) *Slaughterhouses/abattoirs*, markets and events associated with the congregation of susceptible livestock (e.g. fairs, shows, competitions). Where are the major livestock marketing or collection centres? What are the patterns of movement of susceptible domestic species for marketing within the country or *zone*, and between *zones*of the same or different status? How are the susceptible animals sourced, transported and handled during these transactions? Provide maps as appropriate.

# 2. Veterinary system

a) Legislation. Provide a table (and when available a weblink) listing all relevant veterinary legislation, regulations and *Veterinary Authority*directives in relation to FMD and a brief description of the relevance of each. The table should include, but not be limited to, the legislation on disease control measures and compensation systems.

b) *Veterinary Services*. Describe how the *Veterinary Services*of the country comply with Chapters 1.1., 3.2. and 3.3. of the *Terrestrial Code*. Describe how the *Veterinary Services*supervise, control, enforce and monitor all FMD-related activities. Provide maps, figures and tables wherever possible.

c) Provide information on any PVS evaluation conducted in the country and follow-up steps within the PVS Pathway and highlight the results relevant to FMD and the susceptible species.

d) Provide a description of the involvement and the participation of industry, producers, farmers, including subsistence and small-scale producers, keepers, *veterinary paraprofessionals*including community animal health workers, and other relevant groups in FMD *surveillance*and control. Provide a description of the role and structure of the private veterinary sector, including the number of *veterinarians*and their distribution, in FMD *surveillance*and control. Include a description of continuing education and awareness programmes on FMD at all relevant levels.

e) *Animal identification*, registration, traceability and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the traceability system, including methods of *animal identification*and *establishment*or *herd*or *flock*registration, applicable to all susceptible species. How are movements of all susceptible species controlled in and between *zones*of the same or different status for all production systems? Provide evidence of the effectiveness of *animal identification*and movement controls and a table describing the number, species, origin and destination of the animals and their products moved within the country in the past 24 months. Provide information on pastoralism, transhumance and related paths of movement.

Describe the *risk management*strategy for uncontrolled movements of susceptible species (e.g. seasonal migration).

Describe the actions available under national legislation. Provide information on illegal movements detected in the past 24 months and the action taken.

# 3. FMD eradication

a) History. If *infection*has never occurred in the country, or has not occurred within the last 25 years, state explicitly whether or not the *zone*is applying for recognition of historical freedom according to Article 1.4.6. of the *Terrestrial Code*.

If *infection*has occurred in the *zone*within the past 25 years, provide a description of the FMD history in the country and *zone*, with emphasis on recent years. If applicable, provide tables and maps showing the date of first detection, the sources and routes of introduction of *infection*, the temporal and spatial distribution (number and location of *outbreaks*per year), the susceptible species involved, the date of last *case*or *eradication*and the types and strains in the country.

b) Strategy. Describe how FMD was controlled and eradicated in the *zone*(e.g. *stamping-out policy*, modified stamping-out policy, zoning, *vaccination*, movement control). Provide the time frame for *eradication*. Describe and justify the corrective actions that have been implemented to prevent future *outbreaks*of FMD in response to any past incursions of FMD virus.

c) Vaccines and *vaccination*. Briefly answer the following:

i) Is there any legislation that prohibits *vaccination*? If so:

· Provide the date when *vaccination*was formally prohibited;

· Provide information on cases of detection of illegal *vaccination*during the reporting period and actions taken in response to the detection.

ii) Was *vaccination*ever used in the *zone*? If so:

· Provide the date when the last *vaccination*was carried out;

· What type of vaccine was used?

· What species were vaccinated?

· How were vaccinated animals identified?

· What was the fate of those animals?

iii) In addition, if *vaccination*was applied during the past 24 months, provide a description and justification of the *vaccination*strategy and programme, including the following:

· the vaccine strains;

· potency and formulation, purity, details of any vaccine matching performed;

· the species vaccinated;

· identification of vaccinated animals;

· the way in which the *vaccination*of animals was certified or reported and the records maintained;

· evidence that the vaccine used complies with Chapter 3.1.8. of the *Terrestrial Manual*.

iv) If *vaccination*continues to be used in the rest of the country, give details of the species vaccinated and on the post-*vaccination*monitoring programme.

d) Provide a description of the legislation, organisation and implementation of the *eradication*campaign. Outline the legislation applicable to the *eradication*and how the campaign was organised at different levels. Indicate if detailed operational guidelines exist and give a brief summary.

# 4. FMD diagnosis

Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 3.1.8. of the *Terrestrial Manual*are applied. The following points should be addressed:

a) Is FMD *laboratory*diagnosis carried out in the country? If so, provide an overview of the FMD-approved *laboratories*in the country. Indicate the *laboratories*where samples originating from the *zone*are diagnosed. Address the following points:

i) How the work is shared between different *laboratories*, logistics for shipment of samples, the follow-up procedures and the time frame for reporting results;

ii) Details of test capability and the types of tests undertaken and their performance for their applied use (specificity and sensitivity per type of test). Provide details of the number of FMD tests performed in the last 24 months in national *laboratories*and in *laboratories*in other countries, if relevant;

iii) Procedures for quality assurance and for the official accreditation of *laboratories*. Give details of formal internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the *laboratory*system;

iv) Provide details of performance in inter-*laboratory*validation tests (ring trials), including the most recent results and, if applicable, the corrective measures applied;

v) Provide details of the handling of live pathogenic agent, including a description of the biosecurity and biosafety measures applied;

vi) Provide a table identifying the tests carried out by each of the *laboratories*where they are performed, the quality accreditation and biosecurity standards followed and the proficiency tests carried out.

b) If FMD *laboratory*diagnosis is not carried out in the country, provide the names of the *laboratories*in other countries providing the service as well as the arrangements in place, including logistics for shipment of samples and the time frame for reporting results.

# 5. FMD surveillance

Provide documentary evidence that *surveillance*for FMD in the *zone*complies with Articles 8.8.40. to 8.8.42. of the

*Terrestrial Code*, and Chapter 3.1.8. of the *Terrestrial Manual*. The following information should be included:

a) What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what incentives are there for reporting and what penalties are involved for failure to report?

b) Describe how clinical *surveillance*is conducted, including which sectors of the livestock production system are included in clinical *surveillance*, such as *establishments*, markets, fairs, *slaughterhouses/abattoirs*, check points, etc.

Provide a summary table indicating, for the past 24 months, the number of suspected *cases*, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide an indication of the timelines of the response including completion of testing to confirm or exclude FMD. Provide details of follow-up actions taken on all suspicious and positive results.

c) Serological or virological *surveillance*. Are serological or virological surveys conducted? If so, provide detailed information on the target population, design prevalence, confidence level, sample size, stratification, sampling methods and diagnostic tests used in accordance with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*. How frequently are surveys conducted? Are susceptible *wildlife*species included in serological or virological surveys? If not, explain the rationale. Describe how previously vaccinated or newly introduced vaccinated animal~~s~~*populations* are considered in the strategy and design of the surveillance programme, if applicable.

Provide a summary table indicating, for the past 24 months, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide details of follow-up actions taken on all suspicious and positive results and how these findings are acted upon. Provide criteria for selection of *populations*for targeted surveillance based on the risk and numbers of animals examined and samples tested in diagnostic *laboratories*. Provide details of the methods selected and applied for monitoring the performance of the *surveillance*programme including indicators.

d) Provide information on risks in different husbandry systems, and provide evidence that targeted studies are implemented to address gaps (e.g. targeted serological surveys, active *surveillance*, participatory epidemiology studies, *risk assessments*, etc.). Provide evidence of how the knowledge acquired through these activities assisted in more effective implementation of control measures.

e) Provide details of the oversight of *surveillance*programmes by the *Veterinary Services*including training programmes for personnel involved in clinical, serological and virological *surveillance*, and the approaches used to increase community involvement in FMD *surveillance*programmes.

# 6. FMD prevention

Describe the procedures in place to prevent the introduction of FMD into the country or *zone*, including details of:

a) Coordination with other countries. Describe any relevant factors in neighbouring countries and *zones*that should be taken into account (e.g. size, distance from the border to affected *herds*, *flocks*or animals). Describe coordination, collaboration and information-sharing activities with other countries and *zones*in the same region or ecosystem. If the FMD free *zone*without *vaccination*is established in a FMD infected country or borders an infected country or *zone*, describe the animal health measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Are *protection zones*in place? If so, indicate whether or not the *protection zone*are included in the proposed FMD free *zones*. Provide details of the measures that are applied (e.g. *vaccination*, intensified *surveillance*, density control of susceptible species), and provide a geo-referenced map of the *zones*.

b) Describe the measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Describe the measures implemented to prevent the spread of the pathogenic agent within the country or *zone*. Provide evidence that measures to reduce transmission of FMD are in place at markets, such as enhancing awareness of FMD transmission mechanisms and human behaviour that can interrupt transmission, and implementation of good *biosecurity*, hygiene and *disinfection*routines at critical points all along the production and marketing networks (typically where animals are being moved and marketed through the country or region).

c) What measures are taken to limit access of susceptible domestic, *feral*and *wild*animals to waste products of animal origin? Is the feeding of swill to pigs regulated? If so, provide information on the extent of the practice, and describe controls and *surveillance*measures.

d) Import control procedures

Provide information on countries, *zones*or *compartments*from which the country authorises the import of susceptible animals or their products into the *zone*. Describe the criteria applied to approve such countries, *zones*or *compartments*, the controls applied to entry of such animals and products, and subsequent internal movement. Describe the import measures (e.g. quarantine) and test procedures required. Advise whether imported animals of susceptible species are required to undergo a quarantine or isolation period and, if so, the duration and location of quarantine. Advise whether import permits and *international veterinary certificates*are required.

Describe any other procedures used for assessing the *risks*posed by import of susceptible animals or their products. Provide summary statistics on imports of susceptible animals and their products for at least the past 24 months, including temporary import and re-entry, specifying countries, *zones*or *compartments*of origin, species, vaccination status, and the quantity or volume and eventual destination in the country. Provide information on whether or not *outbreaks*have been related to imports or transboundary movements of domestic animals.

i) Provide a map with the number and location of all ports, airports and land border crossings. Describe the management structure, staffing levels and resources of the service responsible for import controls and its accountability to the central *Veterinary Services*. Describe the communication systems between the central authorities and the *border posts*, and between *border posts*.

ii) Provide a description of the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 24 months, of the quantity disposed of and the disposal locations. What are the biosecurity measures in place at waste disposal sites?

iii) Cite the regulations and describe procedures, type and frequency of checks, and management of noncompliance at the points of entry into the *zone*or their final destination, concerning the import and follow-up of the following:

· animals;

· genetic material (semen, oocytes and embryos);

· animal products;

· *veterinary medicinal products*;

· other materials at risk of being contaminated with FMD virus, including bedding, litter and *feed*.

# 7. Control measures and contingency planning

a) List any written guidelines, including contingency plans, available to the *Veterinary Services*for dealing with suspected or confirmed *outbreaks*of FMD. The contingency plan should be attached as an annex in one of the WOAH official languages. If not available, provide a brief summary of what is covered. Provide information on any simulation exercise for FMD that was conducted in the country in the past five years.

b) In the event of a suspected or confirmed FMD *outbreak*:

i) Are quarantine measures imposed on *establishments*with suspected *cases*, pending final diagnosis? What other procedures are followed with respect to suspected *cases*(e.g. livestock standstills)?

ii) Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;

iii) Describe the actions that would be taken to control the disease situation in and around the

*establishments*where the *outbreak*is confirmed;

iv) Provide a detailed description of the control or *eradication*procedures (e.g. forward and backward tracing, movement control, *disinfection*of *establishments*, *vehicles*and equipment, including verification methods, *vaccination*including vaccine delivery and cold chain, *stamping-out policy*, methods of disposal of carcasses and other contaminated products or materials, decontamination, campaigns to promote awareness of farmers) that would be taken. In the case of emergency *vaccination*, indicate the source and type of vaccine and provide details of any vaccine supply scheme and stocks;

v) Describe the criteria and procedures that would be used to confirm that an *outbreak*has been successfully controlled or eradicated, including restocking strategies, use of sentinel animals, serological *surveillance*programmes, etc.;

vi) Give details of any compensation that would be made available to owners, farmers, etc. when animals are slaughtered for disease control or *eradication*purposes and the prescribed timetable for payments;

vii) Describe how control efforts, including *vaccination*and *biosecurity*, would target critical risk control points.

# 8. Recovery of free status

Member Countries applying for recognition of recovery of free status for a *zone* where *vaccination* is not practised should comply with the provisions of Article 8.8.7. and points 4, 5 and 6~~1, 3 and 4~~ of Article 8.8.2. of the *Terrestrial Code* and provide detailed information as specified in Sections 3, 5 and 6~~1-7 (inclusive)~~ of this questionnaire.

Article 1.11.4.

Zone free from infection with foot and mouth disease virus where vaccination is practised

The following information should be provided by WOAH Member Countries to support applications for official recognition of status as a *zone*where *vaccination*is practised that is free from *infection*with foot and mouth disease (FMD) virus in accordance with Chapter 8.8. of the *Terrestrial Code*.

The dossier provided to WOAH should address concisely all the following topics under the headings provided to describe the actual situation in the country and procedures currently applied, explaining how these comply with the *Terrestrial Code*.

The terminology defined in the WOAH *Terrestrial Code*and *Terrestrial Manual*should be referred to and used in compiling the dossier.

National legislation, regulations and *Veterinary Authority*directives may be referred to and annexed as appropriate in one of the WOAH official languages. Weblinks to supporting documents in one of the official languages of WOAH may also be provided, where they exist.

All annexes should be provided in one of the WOAH official languages.

The Delegate of the Member Country applying for recognition of FMD zonal freedom must demonstrate compliance with the *Terrestrial Code*. That is, the Delegate should submit documentary evidence that the provisions of Article 8.8.3. have been properly implemented and supervised.

In addition, the Delegate of the Member Country must submit a declaration indicating ~~that~~ for at least the past 12 months:

1)	there has been no *~~case~~*~~of~~*infection* with FMDV~~for the past 24 months~~;

2)	no ~~evidence of FMDV~~ transmission of FMDV ~~for the past 12 months~~;

~~3)	*surveillance*for FMD and FMDV transmission in accordance with Articles 8.8.40. to 8.8.42. and is in operation, and that regulatory measures for the prevention and control of FMD have been implemented;~~

~~4~~3)	~~routine~~compulsory systematic *vaccination*is carried out in the target population ~~for the purposes of the prevention of FMD~~;

~~5~~4)	the vaccine used complies with the standards described in the *Terrestrial Manual*.

And, for at least the past 24 months, *surveillance* in accordance with Articles 8.8.40. to 8.8.42. is in operation, and regulatory measures for the prevention and control of FMD have been implemented. 

In addition, the Delegate of the Member Country applying for recognition of historical zonal freedom must also submit documentary evidence that the provisions in Article 1.4.6. of the *Terrestrial Code*have been properly implemented and supervised.

# 1. Introduction

a) Geographical features (rivers, mountain ranges, etc.). Provide a general description of the country and the *zone*, and where relevant of the region, including physical, geographical and other factors that are relevant to introduction of *infection*and spread of FMD virus, taking into account the countries or *zones*sharing common borders and other epidemiologic pathways for the potential introduction of the *infection*.

The boundaries of the *zone*must be clearly defined, including a *protection zone*if applied. Provide maps identifying the features above, including a digitalised, geo-referenced map with a description of the geographical boundaries of the *zone*.

b) Livestock demographics. Describe the composition of the livestock industry in the country and the *zone*. In particular, describe:

i) the susceptible animal *population*by species and types of production systems in the country and the *zone*;

ii) the number of *herds*or *flocks*, etc. of each susceptible species;

iii) their geographical distribution;

iv) *herd*or *flock*density;

v) the degree of integration and role of producer organisations in the different production systems;

vi) any recent significant changes observed in the production (attach relevant documents if available). 

Provide tables and maps.

c) *Wildlife*demographics. What susceptible *captive wild*, *wild*or *feral*species are present in the country and the *zone*? Provide estimates of *population*sizes, ~~and~~ geographic distribution and a summary description of their habitat. What are the measures in place to prevent contact between domestic and susceptible *wildlife*species?

d) *Slaughterhouses/abattoirs*, markets and events associated with the congregation of susceptible livestock (e.g. fairs, shows, competitions). Where are the major livestock marketing or collection centres? What are the patterns of movement of susceptible domestic species for marketing within the country or *zone*, and between *zones*of the same or different status? How are the susceptible animals sourced, transported and handled during these transactions? Provide maps as appropriate.

# 2. Veterinary system

a) Legislation. Provide a table (and when available a weblink) listing all relevant veterinary legislation, regulations and *Veterinary Authority*directives in relation to FMD and a brief description of the relevance of each. The table should include, but not be limited to, the legislation on disease control measures and compensation systems.

b) *Veterinary Services*. Describe how the *Veterinary Services*of the country comply with Chapters 1.1., 3.2. and 3.3. of the *Terrestrial Code*. Describe how the *Veterinary Services*supervise, control, enforce and monitor all FMD-related activities. Provide maps, figures and tables wherever possible.

c) Provide information on any PVS evaluation conducted in the country and follow-up steps within the PVS Pathway and highlight the results relevant to FMD and the susceptible species.

d) Provide a description of the involvement and the participation of industry, producers, farmers, including subsistence and small-scale producers, keepers, *veterinary paraprofessionals*including community animal health workers, and other relevant groups in FMD *surveillance*and control. Provide a description of the role and structure of the private veterinary sector, including the number of *veterinarians*and their distribution, in FMD *surveillance*and control. Include a description of continuing education and awareness programmes on FMD at all relevant levels.

e) *Animal identification*, registration, traceability and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the traceability system, including methods of *animal identification*and *establishment*or *herd*or *flock*registration, applicable to all susceptible species. How are movements of all susceptible species controlled in and between *zones*of the same or different status? Provide evidence of the effectiveness of *animal identification*and movement controls and a table describing the number, species, origin and destination of the animals and their products moved within the country in the past 24 months. Provide information on pastoralism, transhumance and related paths of movement.

Describe the *risk management*strategy for uncontrolled movements of susceptible species (e.g. seasonal migration).

Describe the actions available under national legislation. Provide information on illegal movements detected in the past 24 months and the action taken.

# 3. FMD eradication

a) History. Provide a description of the FMD history in the country and *zone*, with emphasis on recent years. If applicable, provide tables and maps showing the date of first detection, the sources and routes of introduction of *infection*, the temporal and spatial distribution (number and location of *outbreaks*per year), the susceptible species involved, the date of last *case*or *eradication*and the types and strains in the country.

b) Strategy. Describe how FMD was controlled and eradicated in the *zone*(e.g. *stamping-out policy*, zoning, *vaccination*, movement control). Provide the time frame for *eradication*. Describe and justify the corrective actions that have been implemented to prevent future *outbreaks*of FMD in response to any past incursions of FMD virus.

c) Vaccines and *vaccination*. Describe any legislation regulating *vaccination*. Provide a description and justification of the *vaccination*strategy and programme, including the following:

i) the vaccine strains;

ii) potency and formulation, purity, details of any vaccine matching performed;

iii) the species vaccinated;

iv) identification of vaccinated animals;

v) the way in which the *vaccination*of animals was certified or reported and the records maintained;

vi) the date on which the last *vaccination*was performed;

vii) evidence that the vaccine used complies with Chapter 3.1.8. of the *Terrestrial Manual*.

d) Provide detailed evidence of *vaccination*coverage and population immunity as follows:

Describe how the number of animals intended for *vaccination*and the number of vaccinated animals are estimated.

For serological surveys to estimate population immunity, provide detailed information on the sampling frame (target population, age, species and *vaccination*status) and survey design (expected prevalence, acceptable error, confidence level, sample size, stratification, sampling methods and diagnostic tests used). How long after *vaccination*are samples collected? Describe how the threshold for protective immunity has been established.

Provide the results of the *vaccination*coverage and population immunity by year, serotype, species, as relevant.

Provide details of any additional methods applied for monitoring the performance of *vaccination*.

e) Provide a description of the legislation, organisation and implementation of the *eradication*campaign. Outline the legislation applicable to the *eradication*and how the campaign was organised at different levels. Indicate if detailed operational guidelines exist and give a brief summary.

# 4. FMD diagnosis

Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 3.1.8. of the *Terrestrial Manual*are applied. The following points should be addressed:

a) Is FMD *laboratory*diagnosis carried out in the country? If so, provide an overview of the FMD-approved *laboratories*in the country. Indicate the *laboratories*where samples originating from the *zone*are diagnosed. Address the following points:

i) How the work is shared between different *laboratories*, logistics for shipment of samples, the follow-up procedures and the time frame for reporting results;

ii) Details of test capability and the types of tests undertaken and their performance for their applied use (specificity and sensitivity per type of test). Provide details of the number of FMD tests performed in the last 24 months in national *laboratories*and in *laboratories*in other countries, if relevant;

iii) Procedures for quality assurance and for the official accreditation of *laboratories*. Give details of formal internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the *laboratory*system;

iv) Provide details of performance in inter-*laboratory*validation tests (ring trials), including the most recent results and, if applicable, the corrective measures applied;

v) Provide details of the handling of live pathogenic agent, including a description of the biosecurity and biosafety measures applied;

vi) Provide a table identifying the tests carried out by each of the *laboratories*where they are performed, the quality accreditation and biosecurity standards followed and the proficiency tests carried out.

b) If FMD *laboratory*diagnosis is not carried out in the country, provide the names of the *laboratories*in other countries providing the service as well as the arrangements in place, including logistics for shipment of samples and the time frame for reporting results.

# 5. FMD surveillance

Provide documentary evidence that *surveillance*for FMD in the *zone*complies with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*, and Chapter 3.1.8. of the *Terrestrial Manual*. The following information should be included:

a) What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what incentives are there for reporting and what penalties are involved for failure to report?

b) Describe how clinical *surveillance*is conducted, including which sectors of the livestock production system are included in clinical *surveillance*, such as *establishments*, markets, fairs, *slaughterhouses/abattoirs*, check points, etc.

Provide a summary table indicating, for the past 24 months, the number of suspected *cases*, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide an indication of the timelines of the response including completion of testing to confirm or exclude FMD. Provide details of follow-up actions taken on all suspicious and positive results.

c) Serological or virological *surveillance*. Are serological or virological surveys conducted? If so, provide detailed information on the target population, design prevalence, confidence level, sample size, stratification, sampling methods and diagnostic tests used in accordance with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*. How frequently are surveys conducted? Are susceptible *wildlife*species included in serological or virological surveys? If not, explain the rationale.

Provide a summary table indicating, for the past 24 months, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide details of follow-up actions taken on all suspicious and positive results and how these findings are acted upon. Provide criteria for selection of *populations*for targeted surveillance based on the risk and numbers of animals examined and samples tested in diagnostic *laboratories*. Provide details of the methods selected and applied for monitoring the performance of the *surveillance*programme including indicators.

d) Provide information on risks in different husbandry systems, and provide evidence that targeted studies are implemented to address gaps (e.g. targeted serological surveys, active *surveillance*, participatory epidemiology studies, *risk assessments*, etc.). Provide evidence of how the knowledge acquired through these activities assisted in more effective implementation of control measures.

e) Provide details of the oversight of *surveillance*programmes by the *Veterinary Services*including training programmes for personnel involved in clinical, serological and virological *surveillance*, and the approaches used to increase community involvement in FMD *surveillance*programmes.

f) Provide evidence that surveys are carried out to assess *vaccination*coverage and population immunity of the target *populations*, show laboratory evidence that the vaccine strains used is appropriate.

# 6. FMD prevention

Describe the procedures in place to prevent the introduction of FMD into the country, including details of:

a) Coordination with other countries. Describe any relevant factors in neighbouring countries and *zones*that should be taken into account (e.g. size, distance from the border to affected *herds*or *flocks*or animals). Describe coordination, collaboration and information-sharing activities with other countries and *zones*in the same region or ecosystem.

If the FMD free *zone*with *vaccination*is established in a FMD infected country or borders an infected country or *zone*, describe the animal health measures implemented to effectively prevent the introduction of the agent, taking into consideration physical or geographical barriers.

Are *protection zones*in place? If so, indicate whether or not the *protection zone*are included in the proposed FMD free *zones*. Provide details of the measures that are applied (e.g. *vaccination*, intensified *surveillance*, density control of susceptible species) and provide a geo-referenced map of the *zones*.

b) Describe the measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Describe the measures implemented to prevent the spread of the pathogenic agent within the country or *zone*. Provide evidence that measures to reduce transmission of FMD are in place at markets, such as enhancing awareness of FMD transmission mechanisms and human behaviour that can interrupt transmission, and implementation of good *biosecurity*, hygiene and *disinfection*routines at critical points all along the production and marketing networks (typically where animals are being moved and marketed through the country or region).

c) What measures are taken to limit access of susceptible domestic, *feral*and *wild*animals to waste products of animal origin? Is the feeding of swill to pigs regulated? If so, provide information on the extent of the practice, and describe controls and *surveillance*measures.

d) Import control procedures

Provide information on countries, *zones*or *compartments*from which the country authorises the import of susceptible animals or their products into the country or *zone*. Describe the criteria applied to approve such countries, *zones*or *compartments*, the controls applied to entry of such animals and products, and subsequent internal movement. Describe the import measures (e.g. quarantine) and test procedures required. Advise whether imported animals of susceptible species are required to undergo a quarantine or isolation period and if so, the duration and location of quarantine. Advise whether import permits and *international veterinary certificates*are required.

Describe any other procedures used for assessing the *risks*posed by import of susceptible animals or their products. Provide summary statistics on imports of susceptible animals and their products for at least the past 24 months, including temporary import and re-entry, specifying countries, *zones*or *compartments*of origin, species and the quantity or volume and eventual destination in the country. Provide information on whether or not *outbreaks*have been related to imports or transboundary movements of domestic animals.

i) Provide a map with the number and location of all ports, airports and land border crossings. Describe the management structure, staffing levels and resources of the service responsible for import controls and its accountability to the central *Veterinary Services*. Describe the communication systems between the central authorities and the *border posts*, and between *border posts*.

ii) Provide a description of the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 24 months, of the quantity disposed of and the disposal locations. What are the biosecurity measures in place at waste disposal sites?

iii) Cite the regulations and describe procedures, type and frequency of checks, and management of noncompliance at the points of entry into the *zone*or their final destination, concerning the import and follow-up of the following:

· animals;

· genetic material (semen, oocytes and embryos);

· animal products;

· *veterinary medicinal products*;

· other materials at risk of being contaminated with FMD virus, including bedding, litter and *feed*.

# 7. Control measures and contingency planning

a) List any written guidelines, including contingency plans, available to the *Veterinary Services*for dealing with suspected or confirmed *outbreaks*of FMD. The contingency plan should be attached as an annex in one of the WOAH official languages. If not available, provide a brief summary of what is covered. Provide information on any simulation exercise for FMD that was conducted in the country in the past five years.

b) In the event of a suspected or confirmed FMD *outbreak*:

i) Are quarantine measures imposed on *establishments*with suspected *cases*, pending final diagnosis? What other procedures are followed with respect to suspected *cases*(e.g. livestock standstills)?

ii) Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;

iii) Describe the actions that would be taken to control the disease situation in and around the *establishments*where the *outbreak*is confirmed;

iv) Provide a detailed description of the control or *eradication*procedures (e.g. forward and backward tracing, movement control, *disinfection*of *establishments*, *vehicles*and equipment, including verification methods, *vaccination*including vaccine delivery and cold chain, *stamping-out policy*, methods of disposal of carcasses and other contaminated products or materials, decontamination, campaigns to promote awareness of farmers) that would be taken. In the case of emergency *vaccination*, indicate the source and type of vaccine and provide details of any vaccine supply scheme and stocks;

v) Describe the criteria and procedures that would be used to confirm that an *outbreak*has been successfully controlled or eradicated, including restocking strategies, use of sentinel animals, serological *surveillance*programmes, etc.;

vi) Give details of any compensation that would be made available to owners, farmers, etc. when animals are slaughtered for disease control or *eradication*purposes and the prescribed timetable for payments;

vii) Describe how control efforts, including *vaccination*and *biosecurity*, would target critical risk control points.

# 8. Recovery of free status

Member Countries applying for recognition of recovery of free status for a *zone*where *vaccination*is practised should comply with the provisions of Article 8.8.7. and points 1 e), f), g) and 2~~, 3 and 4~~ of Article 8.8.3. of the *Terrestrial Code*and provide detailed information as specified in Sections 3, 5 and 6~~1-7 (inclusive)~~ of this questionnaire.

Article 1.11.5.

Application for endorsement by WOAH of an official control programme for foot and mouth disease

The following information should be provided by WOAH Member Countries to support applications for endorsement by WOAH of an *official control programme*for foot and mouth disease (FMD) in accordance with Chapter 8.8. of the *Terrestrial Code*.

The dossier provided to WOAH should address concisely all the topics under the headings provided in Sections 1 to 4 to describe the actual situation in the country and the procedures currently applied, explaining how these comply with the *Terrestrial Code*.

In Sections 3 f) to 3 i) describe concisely the work plan and timelines of the control programme for the next five years.

The terminology defined in the WOAH *Terrestrial Code*and *Terrestrial Manual*should be referred to and used in compiling the dossier.

National legislation, regulations and *Veterinary Authority*directives may be referred to and annexed as appropriate in one of the WOAH official languages. Weblinks to supporting documents in one of the official languages of WOAH may also be provided, where they exist.

All annexes should be provided in one of the WOAH official languages.

The Delegate of the Member Country applying for endorsement of the *official control programme*should submit documentary evidence that the provisions of Article 8.8.39. have been properly implemented and supervised. In addition, the Delegate of the Member Country must submit the detailed national official control programme for FMD.

# 1. Introduction

a) Geographical features (rivers, mountain ranges, etc.). Provide a general description of the country and *zones*, and where relevant of the region, including physical, geographical and other factors that are relevant to introduction of *infection*and spread of FMD virus, taking into account the countries or *zones*sharing common borders and other epidemiologic pathways for the potential introduction of *infection*. Provide maps identifying the features above. Specify whether the application includes any noncontiguous territories.

b) If the endorsed plan is implemented in stages to specific parts of the country, the boundaries of the *zones*should be clearly defined, including the *protection zone*if applied. Provide a digitalised, geo-referenced map with a description of the geographical boundaries of the *zones*.

c) Livestock demographics. Describe the composition of the livestock industry in the country and any *zones*. In particular, describe:

i) the susceptible animal *population*by species and types of production systems;

ii) the number of *herds*or *flocks*, etc. of each susceptible species;

iii) their geographical distribution;

iv) *herd*or *flock*density;

v) the degree of integration and role of producer organisations in the different production systems;

vi) any recent significant changes observed in the production (attach relevant documents if available). Provide tables and maps.

d) *Wildlife*demographics. What susceptible *captive wild*, *wild*or *feral*species are present in the country and any *zones*? Provide estimates of *population*sizes, ~~and~~ geographic distribution and a summary description of their habitat. What are the measures in place to prevent contact between domestic and susceptible *wildlife*species?

e) *Slaughterhouses/abattoirs*, markets and events associated with the congregation of susceptible livestock (e.g. fairs, shows, competitions). Where are the major livestock marketing or collection centres? What are the patterns of movement of susceptible domestic species for marketing within the country? How are the susceptible animals sourced, transported and handled during these transactions? Provide maps as appropriate.

# 2. Veterinary system

a) Legislation. Provide a table (and when available a weblink) listing all relevant veterinary legislation, regulations and *Veterinary Authority*directives in relation to FMD and a brief description of the relevance of each. The table should include, but not be limited to, the legislation on disease control measures and compensation systems.

b) *Veterinary Services*. Describe how the *Veterinary Services*of the country comply with Chapters 1.1., 3.2. and 3.3. of the *Terrestrial Code*. Describe how the *Veterinary Services*supervise, control, enforce and monitor all FMD-related activities. Provide maps, figures and tables wherever possible.

c) Provide information on any PVS evaluation conducted in the country and follow-up steps within the PVS Pathway and highlight the results relevant to FMD and the susceptible species.

d) Provide a description of the involvement and the participation of industry, producers, farmers, including subsistence and small-scale producers, keepers, *veterinary paraprofessionals*including community animal health workers, and other relevant groups in FMD *surveillance*and control. Provide a description of the role and structure of the private veterinary sector, including the number of *veterinarians*and their distribution, in FMD *surveillance*and control. Include a description of continuing education and awareness programmes on FMD at all relevant levels.

e) *Animal identification*, registration, traceability and movement control. Are susceptible animals identified (individually or at a group level)? Provide a description of the traceability system, including methods of *animal identification*and *establishment*or *herd*or *flock*registration, applicable to all susceptible species. How are animal movements controlled in the country for all susceptible species? Provide evidence of the effectiveness of *animal identification*and movement controls and a table describing the number, species, origin and destination of the animals and their products moved within the country in the past 24 months. Provide information on pastoralism, transhumance and related paths of movement.

Describe the *risk management*strategy for uncontrolled movements of susceptible species (e.g. seasonal migration).

Describe the actions available under national legislation. Provide information on illegal movements detected in the past 24 months and the action taken.

# 3. Official control programme for FMD submitted for WOAH endorsement

Submit a concise plan of the measures for the control and eventual *eradication*of FMD in the country, including:

a) Epidemiology

i) Describe the FMD history in the country, with emphasis on recent years. Provide tables and maps showing the date of first detection, the number and location of *outbreaks*per year, the sources and routes of introduction of *infection*, the types and strains present, the susceptible species involved and the date of implementation of the control programme in the country.

ii) Describe the epidemiological situation of FMD in the country and the surrounding countries or *zones*highlighting the current knowledge and gaps. Provide maps of:

· the geography of the country with the relevant information concerning FMD situation;

· livestock density and movements and estimated FMD prevalence.

b) FMD surveillance

Provide documentary evidence that *surveillance*for FMD in the country complies with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*, and Chapter 3.1.8. of the *Terrestrial Manual*. The following information should be included:

i) What are the criteria for raising a suspicion of FMD? What is the procedure to notify (by whom and to whom) and what incentives are there for reporting and what penalties are involved for failure to report?

ii) Describe how clinical *surveillance*is conducted, including which sectors of the livestock production system are included in clinical *surveillance*, such as *establishments*, markets, fairs, *slaughterhouses/abattoirs*, check points, etc. Provide details of follow-up actions taken on clinical suspicions.

iii) Serological or virological *surveillance*. Explain whether or not serological or virological surveys are conducted and, if so, how frequently and for what purpose. Provide detailed information on the target population, design prevalence, confidence level, sample size, stratification, sampling methods and diagnostic tests used in accordance with Articles 8.8.40. to 8.8.42. of the *Terrestrial Code*. Are susceptible *wildlife*species included in serological or virological surveys? If not, explain the rationale.

Provide a summary table indicating, for at least the past 24 months, the number of suspected *cases*, the number of samples tested for FMD, species, type of sample, testing methods and results (including differential diagnosis). Provide procedural details of follow-up actions taken on suspicious and positive results and on how these findings are interpreted and acted upon.

Provide criteria for selection of *populations*for targeted surveillance and numbers of animals examined and samples tested in diagnostic *laboratories*. Provide details of the methods selected and applied for monitoring the performance of the *surveillance*programme including indicators.

iv) Provide information on circulating strains and the level of *risk*in different husbandry systems, and provide evidence that targeted studies are implemented to address gaps (e.g. targeted serological surveys, active *surveillance*, participatory epidemiology studies, *risk assessments*, etc.) and that the acquired knowledge assists in more effective implementation of control measures.

v) Provide details of the oversight of *surveillance*programmes by the *Veterinary Services*including training programmes for personnel involved in clinical, serological and virological *surveillance*, and the approaches used to increase community involvement in FMD *surveillance*programmes.

vi) Provide evidence that surveys are carried out to assess *vaccination*coverage and population immunity of the target *populations*, show laboratory evidence that the vaccine used is appropriate for circulating strains of virus, show analysis of *surveillance*data to assess the change in FMD prevalence over time in the target *populations*, assess the control measures (cost effectiveness, degree of implementation, impact). Provide information on outcomes of *outbreak*investigations including *outbreaks*that have occurred despite control measures, documented inspections showing compliance with biosecurity and hygiene requirements.

c) FMD diagnosis

Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 3.1.8. of the *Terrestrial Manual*are applied. The following points should be addressed:

i) Is FMD *laboratory*diagnosis carried out in the country? If so, provide an overview of the FMD-approved *laboratories*in the country, including the following:

· How the work is shared between different *laboratories*, logistics for shipment of samples, the follow-up procedures and the time frame for reporting results;

· Details of test capability and the types of tests undertaken and their performance for their applied use (specificity and sensitivity per type of test). Provide details of the number of FMD tests performed in the past 24 months in national *laboratories*and in *laboratories*in other countries, if relevant;

· Procedures for quality assurance and, if available, the official accreditation of *laboratories*. Give details of formal internal quality management systems, e.g. Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the *laboratory*system;

· Provide details of performance in inter-*laboratory*validation tests (ring trials), including the most recent results and, if applicable, the corrective measures applied;

· Provide details of the handling of live pathogenic agent, including a description of the biosecurity and biosafety measures applied;

· Provide a table identifying the tests carried out by each of the *laboratories*where they are performed, the quality accreditation and biosecurity standards followed and the proficiency tests carried out.

ii) If FMD *laboratory*diagnosis is not carried out in the country, provide the names of the *laboratories*in other countries providing the service as well as the arrangements in place, including logistics for shipment of samples and the time frame for reporting results.

d) Strategies

i) Provide a description of the legislation, organisation and implementation of the current FMD control programme. Outline the legislation applicable to the control programme and how its implementation is organised at different levels. Indicate if detailed operational guidelines exist and give a brief summary.

ii) Describe FMD control strategies in the country or any *zones*, including in terms of animal movement control, fate of infected and in-contact animals and *vaccination*. Strategies should be based on the assessment of the FMD situation in the *zones*, country and region.

iii) Provide information on what types of vaccines are used and which species are vaccinated. Provide information on the licensing process for the vaccines used. Describe the *vaccination*programme in the country and any *zones*, including records kept, and provide evidence to show its effectiveness, such as *vaccination*coverage, population immunity, etc. Provide details of the studies carried out to determine the *vaccination*coverage and the population immunity, including the study designs and the results.

iv) Describe how the *stamping-out policy*is implemented in the country or any *zones*and under which circumstances.

v) In the event of *outbreaks*, provide evidence of the impact of the control measures already implemented on the reduction in number of *outbreaks*and their distribution. If possible, provide information on primary and secondary *outbreaks*.

e) FMD prevention

Describe the procedures in place to prevent the introduction of FMD into the country, including details of:

i) Coordination with other countries. Describe any relevant factors in neighbouring countries and *zones*that should be taken into account (e.g. size, distance from the border to affected *herds*or *flocks*or animals). Describe coordination, collaboration and information-sharing activities with other countries and *zones*in the same region or ecosystem.

Are *protection zones*in place? If so, provide details of the measures that are applied (e.g. *vaccination*, intensified *surveillance*, density control of susceptible species), and provide a geo-referenced map of the *zones*.

ii) Describe the measures implemented to effectively prevent the introduction of the pathogenic agent, taking into consideration physical or geographical barriers. Describe the measures implemented to prevent the spread of the pathogenic agent within the country or *zone*. Provide evidence that measures to reduce transmission of FMD are in place at markets, such as enhancing awareness of FMD transmission mechanisms and human behaviour that can interrupt transmission, and implementation of good *biosecurity*, hygiene and *disinfection*routines at critical points all along the production and marketing networks (typically where animals are being moved and marketed through the country or region).

iii) What measures are taken to limit access of susceptible domestic, *feral*and *wild*animals to waste products of animal origin? Is the feeding of swill to pigs regulated? If so, provide information on the extent of the practice, and describe controls and *surveillance*measures.

iv) Import control procedures

Provide information on countries, *zones*or *compartments*from which the country authorises the import of susceptible animals or their products into the country or any *zones*. Describe the criteria applied to approve such countries, *zones*or *compartments*, the controls applied to entry of such animals and products and subsequent internal movement. Describe the import measures (e.g. quarantine) and test procedures required. Advise whether imported animals of susceptible species are required to undergo a quarantine or isolation period and, if so, the duration and location of quarantine. Advise whether import permits and *international veterinary certificates*are required.

Describe any other procedures used for assessing the *risks*posed by import of susceptible animals or their products. Provide summary statistics on imports of susceptible animals and their products for at least the past 24 months, including temporary import and re-entry, specifying countries, *zones*or *compartments*of origin, species and the quantity or volume and eventual destination in the country. Provide information on whether or not *outbreaks*have been related to imports or transboundary movements of domestic animals.

· Provide a map showing the number and location of all ports, airports and land border crossings. Describe the management structure, staffing levels and resources of the service responsible for import controls and its accountability to the central *Veterinary Services*. Describe the communication systems between the central authorities and the *border posts*, and between *border posts*.

· Provide a description of the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past 24 months, of the quantity disposed of and the disposal locations. What *biosecurity*is in place at waste disposal sites? 

· Cite the regulations and describe procedures, type and frequency of checks, and management of noncompliance at the points of entry into the country or their final destination, concerning the import and follow-up of the following:

· animals;

· genetic material (semen, oocytes and embryos);

· animal products;

· *veterinary medicinal products*;

· other materials at risk of being contaminated with FMD virus, including bedding, litter and *feed*.

v) Describe the actions available under legislation when an illegal import is detected. Provide information on illegal imports detected and the action taken.

f) Work plan and timelines of the control programme for the next five years, including cessation of *vaccination*. Describe the progressive objectives including expected status to be achieved in the next five years: for *zones*(if applicable) and for the whole country.

g) Performance indicators and timeline. The performance indicators should relate to the most important areas and steps where improvements in the programme are needed. These may include, but are not restricted to, strengthening *Veterinary Services*, legislation, reporting, availability and quality of vaccines, *animal identification*systems, *vaccination*coverage, population immunity, movement control, disease awareness, livestock owners' participatory perception on the effectiveness of the programme, etc. The progressive reduction of *outbreak*incidence towards elimination of FMD virus transmission in all susceptible livestock in at least one *zone*of the country should also be measured and monitored.

h) Assessment of the evolution of the *official control programme*since the first date of implementation. This should include documented evidence demonstrating that the control programme has been implemented and that the first results are favourable. Measurable evidence of success such as the performance indicators should include, but not be limited to, *vaccination*data, decreased prevalence, successfully implemented import measures, control of animal movements and finally decrease or elimination of FMD *outbreaks*in the whole country or selected *zones*as described in the programme. Where relevant, the transition to the use of vaccines, which are fully compliant with the *Terrestrial Manual*in order to enable demonstration of no evidence of FMD virus transmission, should be included in the timeline. This should include documented evidence of the effective implementation of Sections 3 d) and 3 e) above.

i) Describe the funding for the control programme and annual budgets for its duration.

# 4. Control measures and emergency response

a) List any written guidelines, including contingency plans, available to the *Veterinary Services*for dealing with suspected or confirmed *outbreaks*of FMD. The contingency plan should be attached as an annex in one of the WOAH official languages. If not available, provide a brief summary of what is covered. Provide information on any simulation exercise for FMD that was conducted in the country in the last five years.

b) In the event of a suspected or confirmed FMD *outbreak*:

i) Are quarantine measures imposed on *establishments*with suspected *cases*, pending final diagnosis? What other procedures are followed regarding suspected *cases*(e.g. livestock standstills)?

ii) Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;

iii) Describe the actions that would be taken to control the disease situation in and around the *establishments*where the *outbreak*is confirmed;

iv) Describe in detail the control or *eradication*procedures (e.g. forward and backward tracing, *disinfection*of *establishments*, *vehicles*and equipment, including verification methods, *vaccination*including *vaccination*delivery and cold chain, *stamping-out policy*, movement control, control of *wildlife*, pastured livestock and livestock as pets, methods of disposal of carcasses and other contaminated products or materials, decontamination, campaigns to promote awareness of farmers) that would be taken. In the case of emergency *vaccination*, indicate the source and type of vaccine and provide details of any vaccine supply scheme and stocks;

v) Describe the criteria and procedures that would be used to confirm that an *outbreak*has been successfully controlled or eradicated, including restocking strategies, use of sentinel animals, serological *surveillance*programmes, etc.;

vi) Provide details of any compensation that would be made available to owners, farmers, etc. when animals are slaughtered for disease control or *eradication*purposes and the prescribed timetable for payments;

vii) Describe how control efforts, including *vaccination*and *biosecurity*, would target critical risk control points.

2

Report of the Meeting of the WOAH Terrestrial Animal Health Standards Commission/February 2024	1