Terrestrial Animal Health Code
Terrestrial Animal Health Code |
Application for official recognition by the OIE of free status for foot and mouth disease
Country free from infection with foot
and mouth disease virus where vaccination is not practised
The following information should be provided by OIE 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 the OIE 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 OIE 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 OIE
official languages. Weblinks to supporting documents in one of the
official languages of the OIE may also be provided, where they exist.
All annexes should be provided in one of the
OIE 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:
there has been no case of FMD during the past 12 months;
no vaccination against FMD has been 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 of point 1 a) of Article 1.4.6. of the Terrestrial Code have been properly implemented and supervised.
Introduction
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.
Livestock demographics. Describe the composition of the livestock industry in the country. In particular, describe:
the susceptible animal population by species and types of production systems;
the number of herds or flocks, etc. of each susceptible species;
their geographical distribution;
the degree of integration and role of producer organisations in the different production systems;
any recent significant changes observed in the production (attach relevant documents if available).
Provide tables and maps.
Wildlife demographics. What susceptible captive wild, wild or feral species are present in the country? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and susceptible wildlife species?
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.
Veterinary system
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.
Veterinary Services. Describe how the Veterinary Services of the country comply with Chapters 1.1., 3.1. and 3.2. 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.
Provide information on any OIE 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.
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.
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.
FMD eradication
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 point 1 a) of 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.
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.
Vaccines and vaccination. Briefly answer the following:
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.
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?
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 2.1.8. of the Terrestrial Manual.
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.
FMD diagnosis
Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 2.1.8. of the Terrestrial Manual are applied. The following points should be addressed:
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 last 24 months in national laboratories and in laboratories in other countries, if relevant;
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;
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.
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.
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 2.1.8. of the Terrestrial Manual. The following information should be included:
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?
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.
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 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.
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.
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.
FMD prevention
Describe the procedures in place to prevent the introduction of FMD into the country, including details of:
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 zone 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.
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).
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.
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.
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.
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?
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;
other materials at risk of being contaminated with FMD virus, including bedding, litter and feed.
Control measures and contingency planning
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 OIE 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.
In the event of a suspected or confirmed FMD outbreak:
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)?
Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;
Describe the actions that would be taken to control the disease situation in and around the establishments where the outbreak is confirmed;
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;
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.;
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;
Describe how control efforts, including vaccination and biosecurity, would target critical risk control points.
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, 3 and 4 of Article 8.8.2. of the Terrestrial Code and provide detailed information as specified in Sections 1-7 (inclusive) of this questionnaire. Information in relation to other sections need only be supplied if relevant.
Country free from infection with foot and mouth disease virus where vaccination is practised
The following information should be provided by OIE 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 the OIE 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 OIE 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 OIE official languages. Weblinks to supporting documents in one of the official languages of the OIE may also be provided, where they exist.
All annexes should be provided in one of the OIE 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:
there has been no case of FMD for the past 24 months;
no evidence of FMDV transmission for the past 12 months;
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;
routine vaccination is carried out for the purposes of the prevention of FMD;
the vaccine used complies with the standards described in the Terrestrial Manual.
In addition, the Delegate of the Member Country applying for recognition of historical freedom must also submit documentary evidence that the provisions of point 1 a) of Article 1.4.6. of the Terrestrial Code have been properly implemented and supervised.
Introduction
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.
Livestock demographics. Describe the composition of the livestock industry in the country. In particular, describe:
the susceptible animal population by species and types of production systems;
the number of herds or flocks, etc. of each susceptible species;
their geographical distribution;
the degree of integration and role of producer organisations in the different production systems;
any recent significant changes observed in the production (attach relevant documents if available).
Provide tables and maps.
Wildlife demographics. What susceptible captive wild, wild or feral species are present in the country? Provide estimates of population sizes and geographic distribution. What are the measures in place to prevent contact between domestic and susceptible wildlife species?
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.
Veterinary system
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.
Veterinary Services. Describe how the Veterinary Services of the country comply with Chapters 1.1., 3.1. and 3.2. 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.
Provide information on any OIE 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.
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.
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.
FMD eradication
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.
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.
Vaccines and vaccination. Describe any legislation regulating vaccination. 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;
the date on which the last vaccination was performed;
evidence that the vaccine used complies with Chapter 2.1.8. of the Terrestrial Manual.
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.
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.
FMD diagnosis
Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 2.1.8. of the Terrestrial Manual are applied. The following points should be addressed:
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 last 24 months in national laboratories and in laboratories in other countries, if relevant;
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;
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.
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.
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 2.1.8. of the Terrestrial Manual. The following information should be included:
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?
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.
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.
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.
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.
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.
FMD prevention
Describe the procedures in place to prevent the introduction of FMD into the country, including details of:
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 zone 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.
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).
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.
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.
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.
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?
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;
other materials at risk of being contaminated with FMD virus, including bedding, litter and feed.
Control measures and contingency planning
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 OIE 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.
In the event of a suspected or confirmed FMD outbreak:
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)?
Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;
Describe the actions that would be taken to control the disease situation in and around the establishments where the outbreak is confirmed;
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;
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.;
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;
Describe how control efforts, including vaccination and biosecurity, would target critical risk control points.
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, 3 and 4 of Article 8.8.3. of the Terrestrial Code and provide detailed information as specified in Sections 1-7 (inclusive) of this questionnaire. Information in relation to other sections need only be supplied if relevant.
Zone free from infection with foot and mouth disease virus where vaccination is not practised
The following information should be provided
by OIE 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 the OIE 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 OIE 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 OIE official languages. Weblinks to supporting documents in one of the official languages of the OIE may also be provided, where they exist.
All annexes should be provided in one of the
OIE 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:
there has been no case of FMD during the past 12 months;
no vaccination against FMD has been 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 of point 1 a) of Article 1.4.6. of the Terrestrial Code have been properly implemented and supervised.
Introduction
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.
Livestock demographics. Describe the composition of the livestock industry in the country and the zone. In particular, describe:
the susceptible animal population by species and types of production systems in the country and the zone;
the number of herds or flocks, etc. of each susceptible species;
their geographical distribution;
the degree of integration and role of producer organisations in the different production systems;
any recent significant changes observed in the production (attach relevant documents if available).
Provide tables and maps.
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. What are the measures in place to prevent contact between domestic and susceptible wildlife species?
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.
Veterinary system
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.
Veterinary Services. Describe how the Veterinary Services of the country comply with Chapters 1.1., 3.1. and 3.2. 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.
Provide information on any OIE 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.
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.
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.
FMD eradication
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 point
1 a) of 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.
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.
Vaccines and vaccination. Briefly
answer the following:
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.
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?
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 2.1.8. of the Terrestrial Manual.
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.
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.
FMD diagnosis
Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 2.1.8. of the Terrestrial Manual are applied. The following points should be addressed:
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:
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 last 24 months in national laboratories and in laboratories in other countries, if relevant;
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;
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.
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.
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 2.1.8. of the Terrestrial Manual. The following information should be included:
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?
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.
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.
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.
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.
FMD prevention
Describe the procedures in place to prevent the introduction of FMD into the country or zone, including details of:
Coordination with other countries. Describe any relevant factors about 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 zone 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.
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).
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.
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 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 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.
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?
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;
other materials at risk of being contaminated with FMD virus, including bedding, litter and feed.
Control measures and contingency planning
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 OIE 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.
In the event of a suspected or confirmed FMD outbreak:
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)?
Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;
Describe the actions that would be taken to control the disease situation in and around the establishments where the outbreak is confirmed;
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;
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.;
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;
Describe how control efforts, including vaccination and biosecurity, would target critical risk control points.
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 1, 3 and 4 of Article 8.8.2. of the Terrestrial Code and provide detailed information as specified in Sections 1-7 (inclusive) of this questionnaire. Information in relation to other sections need only be supplied if relevant.
Zone free from infection with foot and mouth disease virus where vaccination is practised
The following information should be provided by OIE Member Countries to support applications for official recognition of status as a zone where vaccination is practised that is free from infection with food and mouth disease (FMD) virus in accordance with Chapter 8.8. of the Terrestrial Code.
The dossier provided to the OIE 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 OIE 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 OIE official languages. Weblinks to supporting documents in one of the official languages of the OIE may also be provided, where they exist.
All annexes should be provided in one of the OIE 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:
there has been no case of FMD for the past 24 months;
no evidence of FMDV transmission for the past 12 months;
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;
routine vaccination is carried out for the purposes of the prevention of FMD;
the vaccine used complies with the standards described in the Terrestrial Manual.
In addition, the Delegate of the Member Country applying for recognition of historical zonal freedom must also submit documentary evidence that the provisions of point 1 a) of Article 1.4.6. of the Terrestrial Code have been properly implemented and supervised.
Introduction
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.
Livestock demographics. Describe the composition of the livestock industry in the country and the zone. In particular, describe:
the susceptible animal population by species and types of production systems in the country and the zone;
the number of herds or flocks, etc. of each susceptible species;
their geographical distribution;
the degree of integration and role of producer organisations in the different production systems;
any recent significant changes observed in the production (attach relevant documents if available).
Provide tables and maps.
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. What are the measures in place to prevent contact between domestic and susceptible wildlife species?
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.
Veterinary system
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.
Veterinary Services. Describe how the Veterinary Services of the country comply with Chapters 1.1., 3.1. and 3.2. 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.
Provide information on any OIE 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.
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.
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.
FMD eradication
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.
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.
Vaccines and vaccination. Describe any legislation regulating vaccination. 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;
the date on which the last vaccination was performed;
evidence that the vaccine used complies with Chapter 2.1.8. of the Terrestrial Manual.
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.
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.
FMD diagnosis
Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 2.1.8. of the Terrestrial Manual are applied. The following points should be addressed:
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:
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 last 24 months in national laboratories and in laboratories in other countries, if relevant;
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;
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.
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.
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 2.1.8. of the Terrestrial Manual. The following information should be included:
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?
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.
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.
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.
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.
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.
FMD prevention
Describe the procedures in place to prevent the
introduction of FMD into the country, including details of:
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 zone 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.
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).
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.
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.
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.
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?
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;
other materials at risk of being contaminated with FMD virus, including bedding, litter and feed.
Control measures and contingency planning
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 OIE 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.
In the event of a suspected or confirmed FMD outbreak:
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)?
Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;
Describe the actions that would be taken to control the disease situation in and around the establishments where the outbreak is confirmed;
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;
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.;
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;
Describe how control efforts, including vaccination and biosecurity, would target critical risk control points.
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, 3 and 4 of Article 8.8.3. of the Terrestrial Code and provide detailed information as specified in Sections 1-7 (inclusive) of this questionnaire. Information in relation to other sections need only be supplied if relevant.
Application for endorsement by the OIE of an official control programme for foot and mouth disease
The following information should be provided by OIE Member Countries to support applications for endorsement by the OIE 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 the OIE 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 OIE 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 OIE official languages. Weblinks to supporting documents in one of the official languages of the OIE may also be provided, where they exist.
All annexes should be provided in one of the OIE 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.
Introduction
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.
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.
Livestock demographics. Describe the composition of the livestock industry in the country and any zones. In particular, describe:
the susceptible animal population by species and types of production systems;
the number of herds or flocks, etc. of each susceptible species;
their geographical distribution;
the degree of integration and role of producer organisations in the different production systems;
any recent significant changes observed in the production (attach relevant documents if available).
Provide tables and maps.
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. What are the measures in place to prevent contact between domestic and susceptible wildlife species?
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.
Veterinary system
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.
Veterinary Services. Describe how the Veterinary Services of the country comply with Chapters 1.1., 3.1. and 3.2. 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.
Provide information on any OIE 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.
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.
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.
Official control programme for FMD submitted for OIE endorsement
Submit a concise plan of the measures for the control and eventual eradication of FMD in the country, including:
Epidemiology
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.
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.
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 2.1.8. of the Terrestrial Manual.
The following information should be included:
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?
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.
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.
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.
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.
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.
FMD diagnosis
Provide documentary evidence that the relevant provisions of Chapters 1.1.2., 1.1.3. and 2.1.8. of the Terrestrial Manual are applied. The following points should be addressed:
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.
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.
Strategies
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.
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.
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.
Describe how the stamping-out policy is implemented in the country or any zones and under which circumstances.
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.
FMD prevention
Describe the procedures in place to prevent the introduction of FMD into the country, including details of:
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 zone 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.
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).
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.
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;
other materials at risk of being contaminated with FMD virus, including bedding, litter and feed.
Describe the actions available under legislation
when an illegal import is detected. Provide information on illegal
imports detected and the action taken.
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.
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.
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.
Describe the funding for the control programme
and annual budgets for its duration.
Control measures and emergency response
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 OIE 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.
In the event of a suspected or confirmed FMD outbreak:
Are quarantine measures imposed on establishments with suspected cases, pending final diagnosis? What other procedures are followed regarding suspected cases (e.g. livestock standstills)?
Indicate the sampling, dispatch and testing procedures that would be used to identify and confirm presence of the pathogenic agent;
Describe the actions that would be taken to control the disease situation in and around the establishments where the outbreak is confirmed;
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;
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.;
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;
Describe how control efforts, including vaccination and biosecurity, would target critical risk control points.
nb: first adopted in 2009; most recent update adopted in 2018.
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