An outbreak shall be declared where a holding meets one or more of the following criteria:
Foot-and-mouth disease virus has been isolated from an animal, any product derived from that animal, or its environment.
Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species, and the viral antigen or viral ribonucleic acid (RNA) specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from the animal or animals of the same epidemiological group.
Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species and the animal or its cohorts are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity.
Viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from animals of susceptible species and the animals are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that in the case of antibodies to structural proteins previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity.
An epidemiological link has been established to a confirmed foot-and-mouth disease outbreak and at least one of the following conditions applies:
one or more animals are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity;
viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from one or more animals of susceptible species;
serological evidence of active infection with foot-and-mouth disease by detection of seroconversion from negative to positive for antibody to foot-and-mouth disease virus structural or non-structural proteins has been established in one or more animals of susceptible species, and previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity.
Where a previously seronegative status cannot be reasonably expected, this detection of seroconversion is to be carried out in paired samples collected from the same animals on two or more occasions at least 5 days apart, in the case of structural proteins, and at least 21 days apart, in the case of non-structural proteins.
Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species
date of dispatch;
time of dispatch;
country of origin;
name of disease and type of virus, where appropriate;
serial number of outbreak;
type of outbreak;
reference number of outbreak linked to this outbreak;
region and geographical location of the holding;
other region affected by restrictions;
date of confirmation and method used for confirmation;
date of suspicion;
date of estimation of first infection;
origin of disease, as far as can be indicated;
disease control measures taken.
the number of animals of each susceptible species in the outbreak, or premises and means of transport referred to in Article 16;
for each species and type (breeding, fattening, slaughter, etc.), the number of dead animals of susceptible species on the holding, slaughterhouse or means of transport;
for each type (breeding, fattening, slaughter, etc.), the morbidity of the disease and the number of animals of susceptible species in which foot-and-mouth disease has been confirmed;
the number of animals of susceptible species killed in the outbreak, slaughterhouse or means of transport;
the number of carcasses processed and disposed of;
the distance of the outbreak from the nearest holding on which animals of susceptible species are kept;
if foot-and-mouth disease was confirmed in a slaughterhouse or means of transport, the location of the holding or holdings of origin of the infected animals or carcasses.
the date on which the animals of susceptible species on the holding, slaughterhouse or means of transport were killed and their carcasses processed;
the results of the tests carried out on samples taken when animals of susceptible species were killed;
where the derogation provided for in Article 18 has been applied, the number of animals of susceptible animals killed and processed and where applicable the number of animals of susceptible species which are to be slaughtered at a later date and the time limit laid down for their slaughter;
any information relating to the possible origin of the disease or the origin of the disease if this has been ascertained;
in the case of a primary outbreak or a case of foot-and-mouth disease in a slaughterhouse or means of transport, the genetic type of virus responsible for the outbreak or the case;
in cases where animals of susceptible species have been killed in contact holdings or in holdings containing animals of susceptible species suspected of being infected with foot-and-mouth disease virus, information on:
the date of killing and the number of animals of susceptible species of each category killed in each holding and in cases where animals of susceptible species in contact holdings were not killed, information must be provided on the reasons for this decision,
the epidemiological link between the outbreak or case of foot-and-mouth disease and each contact holding or the reasons that have induced suspicion of foot-and-mouth disease in each suspected holding,
the results of the laboratory tests carried out on the samples taken from the animals of susceptible species in the holdings and when they were killed.
In holdings where the presence of foot-and-mouth disease is suspected but in the absence of clinical signs, sheep and goats, and on recommendation of the epidemiological team other susceptible species, should be examined pursuant to a sampling protocol suitable to detect 5 % prevalence with at least 95 % level of confidence.
In order to seek the repeal in accordance with Article 36 of the measures provided for in Articles 21 to 35, all holdings within the perimeters of the protection zone where sheep and goats have not been in direct and close contact with bovine animals during a period of at least 21 days prior to taking the samples shall be examined pursuant to a sampling protocol suitable to detect 5 % prevalence of disease with at least 95 % level of confidence.
However, the competent authorities may decide where epidemiological circumstances allow and in particular in application of the measures provided for in Article 36(1)(b), that samples are taken not earlier than 14 days after the elimination of susceptible animals on the infected holding(s) and the carrying out of preliminary cleansing and disinfection, under the condition that the sampling is carried out in accordance with point 2.3 using statistical parameters suitable to detect 2 % prevalence of disease within the herd with at least 95 % level of confidence.
In order to seek the repeal in accordance with Article 44 of the measures provided for in Articles 37 to 43, holdings within the perimeters of the surveillance zone where the presence of foot-and-mouth disease in the absence of clinical signs must be suspected, notably where sheep and goats are kept, shall be examined. For the purpose of this survey the model of a multistage sampling shall be sufficient, provided that samples are taken:
However no animals of species susceptible to foot-and-mouth disease may leave the holding until all the re-introduced animals in all units and buildings have fulfilled all restocking procedures.
Where at least one outbreak of foot-and-mouth disease has been confirmed in accordance with Article 10, Member States shall ensure that equidae are not dispatched to other Member States, unless accompanied in addition to the identification document provided for in Decisions 93/623/EEC or 2000/68/EC by an animal health certificate provided for in Annex C of Directive 90/426/EEC.
In the case where the competent authorities apply a complete stand-still as provided for in Article 7(3), transport of equidae from holdings under restrictions laid down in Articles 4 and 10 may be authorised for equidae which need special veterinary treatment in premises without animals of susceptible species, if the following conditions are met:
either a heat treatment in a hermetically sealed container with an Fo value of 3,00 or more; or
a heat treatment in which the centre temperature is raised to at least 70 °C for at least 60 minutes.
either has undergone the action of
steam in a closed chamber for at least 10 minutes and at a minimum temperature of 80 °C, or
formalin fumes (formaldehyde gas) produced in a chamber kept closed for at least 8 hours and at a minimum temperature of 19 °C, using commercial-type solutions at 35-40 % concentration, or
has been stored in package or bales under shelter at premises situated not closer than 2 km to the nearest outbreak of foot-and-mouth disease and is not released from the premises before at least three months have elapsed following the completion of cleansing and disinfection measures provided for in Article 11 and in any case not before the end of the restrictions in the protection zone.
Meat as described in Article 2(a) of Directive 64/433/EEC together with diaphragms but excluding offal, from which the bone and the main accessible lymphatic glands have been removed.
heart from which lymphatic glands, connective tissue and adhering fat have been completely removed;
liver from which lymphatic glands, adhering connective tissue and fat have been completely removed;
whole masseter muscles, incised in accordance with paragraph 41(a) of Chapter VIII of Annex I to Directive 64/433/EEC, from which lymphatic glands, connective tissue and adhering fat have been completely removed;
tongues with epithelium and without bone, cartilage and tonsils;
lungs from which the trachea and main bronchi and the mediastinal and bronchial lymphatic glands have been removed;
other offal without bone or cartilage from which lymphatic glands, connective tissue, adhering fat and mucous membrane have been completely removed.
maturation of carcasses at a temperature of more than + 2 °C for at least 24 hours;
pH value in the middle of Longissimus dorsi muscle recorded as less than 6,0.
in the case of ruminants:
the animals have been subjected to the controls provided for in Article 24(2), and
the meat is subject to the treatment provided for in points 1, 3 and 4 of Part A;
in the case of all animals of susceptible species:
the animals have been resident on the holding for at least 21 days and are identified so as to allow the tracing of the holding of origin, and
the animals have been subjected to the controls provided for in Article 24(2), and
the meat is clearly identified and detained under official supervision for at least 7 days and is not released until any suspicion of infection with the foot-and-mouth disease virus on the holding of origin has been officially ruled out at the end of the detention period;
in the case of all animals of susceptible species:
the animals have completed a 21-day standstill on the holding of origin during which no animal of a species susceptible to foot-and-mouth disease has been introduced onto the holding, and
the animals have been subjected to the controls provided for in Article 24(2) within 24 hours of loading, and
samples taken in accordance with the statistical requirements provided for in point 2.2 of Annex III within 48 hours of loading have been tested with negative result in an assay for the detection of antibodies against the foot-and-mouth disease virus, and
the meat is detained under official control for 24 hours and not released before a repeat inspection of the animals in the holding of origin has ruled out on clinical inspection the presence of infected or suspected of being infected animals.
The following treatments are recognised to provide sufficient guaranties with regard to the destruction of the foot-and-mouth disease virus in milk and milk products for human consumption. Necessary precautions must be taken to avoid contact of the milk or milk products with any potential source of foot-and-mouth virus after processing.
The following treatments are recognised to provide sufficient guaranties with regard to the destruction of the foot-and-mouth disease virus in milk and milk products not intended for human consumption or intended for animal consumption. Necessary precautions must be taken to avoid contact of the milk or milk products with any potential source of foot-and-mouth virus after processing.
Criteria | Decision | |
---|---|---|
For vaccination | Against vaccination | |
Population density of susceptible animals | High | Low |
Predominant species clinically affected | pigs | ruminants |
Movement of potentially infected animals or products out of the protection zone | Evidence | No evidence |
Predicted airborne spread of virus from infected holdings | High | Low or absent |
Suitable vaccine | Available | Not available |
Origin of outbreaks (traceability) | Unknown | Known |
Incidence slope of outbreaks | Rising rapidly | Shallow or slow rise |
Distribution of outbreaks | Widespread | Restricted |
Public reaction to total stamping out policy | Strong | Weak |
Acceptance of regionalisation after vaccination | Yes | No |
a 24/48 hours rule means: (a) infected herds on holdings referred to in Article 10 cannot be stamped out within 24 hours after the confirmation of the disease, and (b) the pre-emptive killing of animals likely to be infected or contaminated cannot be safely carried out within less than 48 hours. | ||
Criteria | Decision | |
---|---|---|
For vaccination | Against vaccination | |
Acceptance of regionalisation by third countries | known | unknown |
Economic assessment of competing control strategies | If it is foreseeable that a control strategy without emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors | If it is foreseeable that a control strategy with emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors |
It is foreseeable that the 24/48 hours rule cannot be implemented effectively for two consecutive daysa | Yes | No |
Significant social and psychological impact of total stamping out policy | Yes | No |
Existence of large holdings of intensive livestock production in a non-densely populated livestock area | Yes | No |
The definition may be modified in the light of new scientific evidence in accordance with the procedure referred to in Article 89(2).
In the case of animals of susceptible species a DPLA shall be a geographical area, with a radius of 10 km around a holding containing animals of susceptible species suspected of or infected with foot-and-mouth disease, where there is a density of animals of susceptible species higher than 1 000 head per km2. The holding in question must be situated either in a sub-region as defined in Article 2(s) where there is a density of animals of susceptible species higher than 450 head per km2 or at a distance of less than 20 km from such a sub-region.
Member State where laboratory is situated | Laboratory | Member States using the services of laboratory | |
---|---|---|---|
ISO-code | Name | ||
AT | Austria | Österreichische Agentur für Gesundheit und Ernährungssicherheit Veterinärmedizinische Untersuchungen Mödling | Austria |
BE | Belgium | Veterinary and Agrochemical Research Centre CODA-CERVA-VAR Uccle | Belgium Luxembourg |
CZ | Czech Republic | Statní veterinární ústav Praha, Praha | Czech Republic |
DE | Germany | Friedrich-Loeffler-Institut Bundesforschungsinstitut für Tiergesundheit, Greifswald — Insel Riems | Germany Slovakia |
DK | Denmark | Danmarks Fødevareforskning, Afdeling for Virologi, Lindholm | Denmark Finland Sweden |
ES | Spain | Laboratorio Central de Sanidad Animal, Madrid | Spain |
FR | France | Agence française de sécurité sanitaire des aliments (AFSSA)
| France |
GB | United Kingdom | Institute for Animal Health, Pirbright | United Kingdom Estonia Finland Ireland Malta Sweden |
GR | Greece | Ινστιτούτο αφθώδους πυρετού, Αγία Παρασκευή Αττικής | Greece |
HU | Hungary | Országos Állategészségügyi Intézet (OÁI), Budapest | Hungary |
IT | Italy | Istituto zooprofilattico sperimentale della Lombardia e dell'Emilia Romagna, Brescia | Italy Cyprus |
LT | Lithuania | Nacionalinė veterinarijos laboratorija, Vilnius | Lithuania |
LV | Latvia | Valsts veterinārmedicīnas diagnostikas centrs, Rīga | Latvia |
NL | Netherlands | CIDC-Lelystad Central Institute for Animal Disease Control Lelystad | Netherlands |
PL | Poland | Zakład Pryszczycy Państwowego Instytutu Weterynaryjnego – Państwowego Instytutu Badawczego, Zduńska Wola | Poland |
SI | Slovenia | Nacionalni veterinarski inštitut, Lubljana | Slovenia] |
Textual Amendments
Member State where laboratory is situated | Laboratory | |
---|---|---|
ISO-code | Name | |
DE | Germany | Intervet International GmbH, Köln |
FR | France | Merial, S.A.S., Laboratoire IFFA, Lyon |
GB | United Kingdom | Merial, S.A.S., Pirbright Laboratory, Pirbright |
NL | Netherlands | CIDC-Lelystad, Central Institute for Animal Disease Control, Lelystad] |
Textual Amendments
F2 Substituted by Commission Decision of 3 August 2006 amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production (notified under document number C(2006) 3447) (Text with EEA relevance) (2006/552/EC).
one expert from the Commission,
one expert in foot-and-mouth disease,
one independent expert for questions of bio-security in laboratories working with microbiological hazards.
In the context of this Annex, a ‘test’ refers to a laboratory diagnostic procedure and a ‘standard’ to a reference reagent that has become an internationally accepted standard following a procedure of comparative testing carried out in several different laboratories.
Diagnostic tests described in the OIE Manual, hereinafter the ‘OIE Manual’, as the ‘Prescribed Tests’ for international trade, constitute the reference tests for vesicular disease diagnosis within the Community. National Laboratories must adopt standards and tests at least as stringent as those defined in the OIE Manual.
The Commission may, in accordance with the procedure referred to in Article 89(2) decide to adopt more stringent testing procedures than those defined in the OIE Manual.
The use of tests defined in the OIE Manual as ‘Alternative Tests’, or other tests not included in the OIE Manual, is permitted provided that the performance of the test has been shown to match or exceed the sensitivity and specificity parameters laid down in the OIE Manual or in the annexes to Community legislation, whichever is the more stringent.
National Laboratories generating results for the purposes of national, intra-Community or international trade must generate and store the necessary records demonstrating compliance of their testing procedures with the relevant OIE or Community requirements.
National Laboratories shall participate in periodic standardisation and external quality assurance exercises organised by the Community Reference Laboratory.
In the framework of such exercises, the Community Reference Laboratory may take account of the results achieved by a National Laboratory which has within a reasonable timespan participated in a quality assurance exercise organised by one of the international organisations responsible for external quality assurance of vesicular virus disease diagnosis, such as OIE, the Food and Agriculture Organisation (FAO) of the United Nations or the International Atomic Energy Agency.
National Laboratories shall operate internal quality assurance programmes. The specification of such programmes may be laid down in accordance with the procedure referred to in Article 89(2). Pending the adoption of detailed provisions, the specifications in the OIE Guidelines for Laboratory Quality Evaluation shall apply (OIE Standards Commission, September 1995).
As part of quality assurance, National Laboratories shall demonstrate compliance of the tests in routine use with the requirements for sensitivity and specificity defined in the OIE Manual, or in Annexe XIV of this Directive, whichever is more stringent.
Tests and standards for vesicular virus disease diagnosis shall be adopted in accordance with the procedure referred to in Article 89(2).
The Commission may consider the scientific advice produced by the meetings of the National Laboratories to be organised by the Community Reference Laboratory.
Data from standardisation and external quality assurance exercises organised by the Community Reference Laboratory shall be assessed at the annual meetings of the National Laboratories and communicated to the Commission for review of the list of National Laboratories as laid down in Part A of Annex XI.
Those laboratories whose tests do not meet the prescribed requirements for sensitivity and specificity shall be required by the Commission to adapt their procedures within an appropriate period of time to ensure that these requirements are met. Failure to demonstrate the required level of proficiency within the time limit required shall result in loss of recognition within the Community of all testing performed after that deadline.
An aliquot of field material should be sent to one of the laboratories listed in Part A of Annex XI. However, where such samples are not available or not suitable for transport, animal passage material, obtained from the same host species, or low passage cell culture material is acceptable.
The history of animal or cell passage material should be provided.
Samples for vesicular virus diagnosis can be transported at 4 °C if the anticipated transport time to the recipient laboratory is less than 24 hours.
For oesophageal-pharyngeal (probang) samples, transportation above solid carbon dioxide or liquid nitrogen is recommended, especially if delays at airports cannot be excluded.
Special precautions are required for the safe packaging of material from suspect cases of foot-and-mouth disease both within and between countries. These regulations are mainly designed to prevent breakage or leakage of containers and the risk of contamination, but are also important to ensure that specimens arrive in a satisfactory state. Ice-packs are preferred to wet ice to prevent the possibility of escape of water from the package.
Prior notice of arrival, and agreement for receipt, must be arranged with the receiving laboratory before despatch of samples.
Compliance with the import and export regulations of the Member States involved must be ensured.
The protocols specified in the OIE Manual provide reference procedures for virus isolation, antigen detection and antibody detection for vesicular diseases.
The standards for detecting foot-and-mouth disease virus antigen shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Standardised, inactivated antigens of all seven serotypes are available from the OIE/FAO World Reference Laboratory for foot-and-mouth disease (WRL).
National Laboratories should ensure that their antigen detection system complies with these minimum standards. They shall where necessary receive advice from the Community Reference Laboratory on the dilutions of these antigens to be used as strong and weak positive controls.
The standards for foot-and-mouth disease virus detection shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Isolates of foot-and-mouth disease virus are available from the WRL.
National Laboratories shall ensure that the tissue culture systems in use for foot-and-mouth virus isolation are sensitive to the full range of serotypes and strains for which the laboratory maintains a diagnostic capacity.
The standards for the detection of foot-and-mouth disease viral RNA shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
The Commission may arrange that for future standardisation, comparative testing of the sensitivity of RNA detection methods is carried out between National Laboratories.
The Commission may arrange that, taking into account the practical difficulties of storing nucleic acids for prolonged periods of time, standardised quality assurance reagents for the detection of foot-and-mouth viral RNA will become available from the Community Reference Laboratory.
The standards for the detection of antibody to foot-and-mouth disease virus shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Standardised antisera for foot-and-mouth disease virus types O1-Manisa, A22-Iraq and C-Noville have been defined by the ‘FAO Phase XV Standardisation Exercise in foot-and-mouth disease antibody detection’ in 1998.
The Commission may arrange that standardised reference sera for all the main antigenic variants of foot-and-mouth disease virus are adopted as a result of standardisation exercises between the Community Reference Laboratory and the National Laboratories. These reference sera will be adopted as the standards for use by National Laboratories within the Community.
The standards for the detection of antibody to foot-and-mouth disease virus shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
The Commission may arrange that standardised reference sera are adopted as a result of standardisation exercises between the Community Reference Laboratory and the National Laboratories. These reference sera will be adopted as the standards for use by National Laboratories within the Community.
Diagnosis of SVD must be carried out in accordance with Decision 2000/428/EC.
Where necessary, the Commission may arrange that standards for the laboratory diagnosis of vesicular stomatitis or vesicular exanthema of swine are established in accordance with the procedure referred to in Article 89(2).
Member States may maintain the laboratory capacity to diagnose the vesicular virus diseases other than foot-and-mouth disease and SVD, i.e. vesicular stomatitis and vesicular exanthema of swine.
National Laboratories wishing to maintain a diagnostic capacity for these viruses can obtain reference reagents from the WRL, Pirbright or from the relevant OIE Reference Laboratory.
each antigen consists of a single homogeneous batch;
each batch is split in order to permit it to be stored at two separate geographical sites under the responsibility of the designated premises of the Community antigen and vaccine bank;
the antigen meets at least the requirements of the European Pharmacopoeia and the relevant provisions of the OIE Manual;
the principles of Good Manufacturing Practise are maintained throughout the production process and this shall include the storage and finishing of the vaccine reconstituted from the antigens in store;
if not otherwise specified in the texts referred to in point (c), the antigen is purified to remove non-structural proteins of the foot-and-mouth disease virus. The purification shall at least ensure that the residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce detectable levels of antibody against non-structural proteins in animals which had received one initial and one subsequent booster vaccination.
rapid formulation into vaccine of the antigen referred to in Article 81;
production of a safe, sterile and efficient vaccine with a potency of at least 6 PD50 in accordance with the tests prescribed by the European Pharmacopoeia, and suitable for use in case of emergency vaccination of ruminants and pigs;
a capacity to formulate from concentrated inactivated antigen in stock:
up to one million doses of vaccine within four days of instruction from the Commission;
additionally, up to four million doses of vaccine within 10 days of instruction from the Commission;
rapid bottling, labelling and distribution of the vaccine according to the specific needs of the area where vaccination is to be carried out.
The functions and duties of National Laboratories referred to in Article 68 for foot-and-mouth and other vesicular diseases shall be as follows:
All National Laboratories handling live foot-and-mouth disease virus must operate under high security conditions laid down in ‘Minimum Standards for Laboratories working with foot-and-mouth disease virus in vitro and in vivo’, European Commission for the Control of Foot-and-Mouth Disease — 26th Session, Rome, 1985, as amended by Appendix 6 (ii) of the Report of the 30th Session, Rome, 1993.
National Laboratories must provide an uninterrupted service for diagnosing vesicular viral diseases and must be equipped and skilled for providing a rapid initial diagnosis.
National Laboratories must keep inactivated reference strains of all serotypes of foot-and-mouth disease virus, and immune sera against the viruses, as well as all other reagents necessary for a rapid diagnosis. Appropriate cell cultures should be in constant readiness for confirming a negative diagnosis.
National Laboratories must be equipped and skilled for large-scale serological surveillance.
In all suspected primary outbreaks appropriate samples must be collected and quickly transported, according to a set protocol, to a National Laboratory. In anticipation of a suspicion of foot-and-mouth disease, the National Authority shall ensure that the necessary equipment and materials for sample collection and transportation to a National Laboratory are stored in readiness at local sites.
Antigenic typing and genomic characterisation must be carried out on all viruses responsible for new incursions into the Community. This can be performed by the National Laboratory, if facilities exist. Otherwise, at the earliest possible occasion, the National Laboratory must send a sample of virus from the primary case to the Community Reference Laboratory for confirmation and further characterisation, including advice on the antigenic relationship of the field strain to vaccine strains in the Community antigen and vaccine banks. The same procedure should be followed for viruses received by National Laboratories from third countries in situations where characterisation of the virus is likely to be of benefit to the Community.
National Laboratories should provide disease data to their State Veterinary Service, which shall provide these data to the Community Reference Laboratory.
National Laboratories should collaborate with the Community Reference Laboratory in ensuring that members of the field section of State Veterinary Services have the opportunity of seeing clinical cases of foot-and-mouth disease in National Laboratories as part of their training.
National Laboratories shall collaborate with the Community Reference Laboratory and other National Laboratories to develop improved diagnostic methods and exchange relevant materials and information.
National Laboratories shall participate in external quality assurance and standardisation exercises organised by the Community Reference Laboratory.
National Laboratories shall use tests and standards that meet or exceed the criteria laid down in Annex XIII. National Laboratories shall provide the Commission on request with data proving that the tests in use meet or exceed the requirements.
National Laboratories should have the competence to identify all vesicular disease viruses and encephalomyocarditis virus in order to avoid delays in diagnosis and consequently in implementing control measures by the competent authorities.
National Laboratories shall cooperate with other laboratories designated by the competent authorities for performing tests, for example serological tests, that do not involve handling of live foot-and-mouth disease virus. These laboratories shall not carry out virus detection in samples taken from suspect cases of vesicular diseases. Such laboratories need not comply with the bio-security standards referred to in Annex XII, point 1, but must have established procedures which ensure that the possible spread of foot-and-mouth disease virus is effectively prevented.
Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.
The functions and duties of the Community Reference Laboratory referred to in Article 69 for foot-and-mouth disease shall be as follows:
Member States shall ensure that contingency plans meet at least the following requirements:
with a minimum risk to soil, air, surface and groundwater, to plants and animals,
with a minimum nuisance through noise or odours,
with a minimum adverse effect to the countryside or places of special interest.
notify the primary case in accordance with Annex II;
epidemiologists. The expert group shall assist the competent authority in:
studying the epidemiological situation and defining an infected area, in accordance with the provisions laid down in point 4(b) of Part B,
establishing appropriate measures to be applied in the infected area in addition to the ones referred to in points (c) and (d); these measures may include suspension of hunting and a ban in feeding wild animals,
drawing up the eradication plan to be submitted to the Commission in accordance with Part B,
carrying out audits to verify the effectiveness of the measures adopted to eradicate foot-and-mouth disease from the infected area;
immediately place under official surveillance holdings keeping animals of susceptible species in the defined infected area and shall in particular order that:
an official census be carried out of all species and categories of animals of susceptible species on all holdings; the census shall be kept up to date by the owner. The information in the census shall be produced on request and may be checked at each inspection. However, as regards open-air holdings, the first census carried out may be done on the basis of an estimate,
all animals of susceptible species on the holdings situated in the infected area be kept in their living quarters or some other place where they can be isolated from wild animals. Wild animals must not have access to any material which may subsequently come in contact with animals of susceptible species on the holdings,
no animal of a susceptible species enter or leave the holding save where authorised by the competent authority having regard to the epidemiological situation,
appropriate means of disinfection be used at the entrance and exits of buildings housing animals of susceptible species and of the holding itself,
appropriate hygiene measures be applied by all persons coming in contact with wild animals, to reduce the risk of spread of foot-and-mouth disease virus, which may include a temporary ban on persons having been in contact with wild animals from entering a holding keeping animals of susceptible species,
all dead or diseased animals of susceptible species with foot-and-mouth disease symptoms on a holding be tested for the presence of foot-and-mouth disease,
no part of any wild animals, whether shot or found dead, as well as any material or equipment which could be contaminated with foot-and-mouth disease virus shall be brought into a holding keeping animals of susceptible species,
animals of susceptible species, their semen, embryos or ova shall not be moved from the infected area for the purpose of intra-Community trade;
arrange that all wild animals shot or found dead in the defined infected area are inspected by an official veterinarian and examined for foot-and-mouth disease to officially rule out or confirm foot-and-mouth disease in accordance with the definition for an outbreak in Annex I. Carcasses of all wild animals found positive as regards foot-and-mouth disease shall be processed under official supervision. Where such testing proves negative as regards foot-and-mouth disease, Member States shall apply the measures laid down in Article 11(2) of Directive 92/45/EEC. Parts not intended for human consumption shall be processed under official supervision;
ensure that the foot-and-mouth disease virus isolate is subject to the laboratory procedure required to identify the genetic type of virus and its antigenic characteristic in relation to existing vaccines strains.
If these amendments concern the redefinition of the infected area, Member States shall ensure that the Commission and the other Member States are informed of these amendments without delay.
If the amendments concern other provisions of the plan, Member States shall submit the amended plan to the Commission for examination and possible approval in accordance with the procedure referred to in Article 89(3).
the results of the epidemiological investigations and controls carried out in accordance with Part A and the geographical distribution of the disease;
a defined infected area within the territory of the Member State concerned.
When defining the infected area, the competent authority shall take into account:
the results of the epidemiological investigations carried out and the geographical distribution of the disease,
the wild animal population in the area,
the existence of major natural or artificial obstacles to movements of wild animals;
the organisation of close cooperation between wildlife biologists, hunters, hunting organisations, the wildlife protection services and veterinary services (animal health and public health);
the information campaign to be enforced to increase hunters' awareness of the measures they have to adopt in the framework of the eradication plan;
specific efforts made to determine the number and location of groups of wild animals with limited contacts to other groups of wild animals in and around the infected area;
the approximate number of groups of wild animals referred to in paragraph (e) and their size in and around the infected area;
specific efforts made to determine the extent of the infection in wild animals, by investigation of wild animals shot by hunters or found dead, and by laboratory testing, including age-stratified epidemiological investigations;
the measures adopted to reduce spread of disease due to movements of wild animals and/or contact between groups of wild animals; these measures may include a prohibition of hunting;
the measures adopted to reduce the population of wild animals and in particular young animals of susceptible species in the wild animal population;
the requirements to be complied with by hunters in order to avoid any spread of the disease;
the method of removal of wild animals found dead or shot, which shall be based on:
processing under official supervision, or
inspection by an official veterinarian and laboratory tests as provided for in Annex XIII. Carcasses of all wild animals found positive as regards foot-and-mouth disease shall be processed under official supervision. Where such testing proves negative as regards foot-and-mouth disease, Member States shall apply the measures laid down in Article 11(2) of Directive 92/45/EEC. Parts not intended for human consumption shall be processed under official supervision;
the epidemiological enquiry which is carried out on each wild animal of a susceptible species, whether shot or found dead. This enquiry must include the completion of a questionnaire which supplies information about:
the geographical area where the animal was found dead or shot,
the date on which the animal was found dead or shot,
the person who found or shot the animal,
the age and sex of the animal,
if shot: symptoms before shooting,
if found dead: the state of the carcass,
laboratory findings;
surveillance programmes and prevention measures applicable to the holdings keeping animals of susceptible species situated in the defined infected area, and if necessary, in its surroundings, including the transport and movement of animals of susceptible species within, from and to the area; these measures shall at least include the ban of moving animals of susceptible species, their semen, embryos or ova from the infected area for the purposes of intra-Community trade;
other criteria to be applied for lifting the measures taken to eradicate the disease in the defined area and the measures applied to holdings in the area;
the authority charged with supervising and coordinating the departments responsible for implementing the plan;
the system established in order that the expert group appointed in accordance with point 1(b) in Part A can review on a regular basis the results of the eradication plan;
the disease monitoring measures that shall be enforced after a period of at least 12 months has elapsed from the last confirmed case of foot-and-mouth disease in wild animals in the defined infected area; these monitoring measures shall stay in place for at least 12 months and shall at least include the measures already enforced in accordance with points (g), (k) and (l).
Directive | Deadline for transposition |
---|---|
85/511/EEC | 1 January 1987 |
90/423/EEC | 1 January 1992 |
This Directive | Directive 85/511/EEC |
---|---|
Article 1, paragraph 1 (a) | Article 1 |
Article 1, paragraph 1 (b) | — |
Article 1, paragraph 2 | — |
Article 2 (a) | Article 2 (a) |
Article 2 (b) to (h) and (l) to (y) | — |
Article 2 (i) | Article 2 (d) |
Article 2 (j) | Article 2 (e) |
Article 2 (k) | Article 2 (c) |
Article 3 (1) (a) | Article 3 |
Article 3 (1) (b) and (c) | — |
Article 3 (2) | — |
Article 4 (1) | — |
Article 4 (2) | Article 4 (1), first subparagraph |
Article 4 (3) first sentence | Article 4 (1) second subparagraph |
Article 4 (3) (a) | Article 4 (1) second subparagraph first indent, first part of sentence |
Article 4 (3) (b) | Article 4 (1) second subparagraph first indent, second part of sentence |
Article 4 (3) (c) | — |
Article 4 (3) (d) | Article 4 (1) second subparagraph second and third indent |
Article 4 (3) (e) | Article 4 (1) second subparagraph ninth indent |
Article 4 (3) (f) | Article 4 (1) second subparagraph tenth indent |
Article 4 (3) (g) | — |
Article 5 (1) (a) | Article 4 (1) second subparagraph fifth indent |
Article 5 (1) (b) | Article 4 (1) second subparagraph fourth indent |
Article 5 (1) (c) | Article 4 (1) second subparagraph seventh indent |
Article 5 (1) (d) | Article 4 (1) second subparagraph eighth indent |
Article 5 (2) | Article 4 (1) second subparagraph sixth indent |
Article 5 (3) | — |
Article 6 (1) | Article 4 (2) |
Article 6 (2) | — |
Article 7 | — |
Article 8 | — |
Article 9 | Article 4 (3) |
Article 10 (1) (a) first sentence | Article 5 (2) first indent |
Article 10 (1) (a) second sentence | — |
Article 10 (1) (b) first subparagraph | Article 5 (1) |
Article 10 (1) (b) second subparagraph | Article 5 (3) |
Article 10 (1) (c) first sentence | Article 5 (2) second and fourth indent |
Article 10 (1) (c) second and third sentences | — |
Article 10 (1) (d) | Article 5 (2) fifth and sixth indent |
Article 10 (2) (a) | Article 5 (2) seventh indent |
Article 10 (2) (b) | — |
Article 10 (2) (c) | Article 5 (2) eighth indent |
Article 11 (1) | Article 10 |
Article 11 (2) | — |
Article 11 (3) | — |
Article 11 (4) | — |
Article 12 (relating to meat) | Article 5 (2) third indent |
Article 12 (relating to other substances) | — |
Article 13 (1) | Article 5 (2) ninth indent and Article 7 |
Article 13 (2) | — |
Article 14 | — |
Article 15 | — |
Article 16 | — |
Article 17 | — |
Article 18 (1) | Article 6 |
Article 18 (2) | Decision 88/397/EEC |
Article 18 (3) | Article 6 (1) second subparagraph |
Article 18 (4) | — |
Article 19 (1) to (4) | Article 8 |
Article 19 (5) | — |
Article 20 | Article 6 (3) |
Article 21 (1) | — |
Article 21 (2) | Article 9 (1) |
Article 21 (3) | — |
Article 21 (4) to (6) | — |
Article 22 (1) (a) | Article 9 (2) (a) first indent |
Article 22 (1) (b) | Article 9 (2) (a) second indent |
Article 22 (1) (c) | Article 9 (2) (a) third indent first part of sentence |
Article 22 (2) | Article 9 (2) (a) third indent second part of sentence |
Article 23 (a) | Article 9 (2) (a) fifth to sixth indent |
Article 23 (b) | — |
Article 23 (c) | — |
Article 23 (d) | — |
Article 24 (1) (a) | — |
Article 24 (1) (b) to (f) | — |
Article 24 (2) (a) | Article 9 (2) (a) seventh indent last part of sentence |
Article 24 (2) (b) | — |
Article 24 (2) (c) | Article 9 (2) (a) fourth indent |
Article 24 (2) (d) | — |
Article 25 | — |
Article 26 | — |
Article 27 | — |
Article 28 | — |
Article 29 | — |
Article 30 | — |
Article 31 | — |
Article 32 | — |
Article 33 | — |
Article 34 | — |
Article 35 | — |
Article 36 (1) (a) | Article 9 (2) (b) first sentence |
Article 36 (1) (b) | — |
Article 36 (2) | Article 9 (2) (b) second sentence |
Article 36 (3) | — |
Article 37 (1) | — |
Article 37 (2) | Article 9 (3) (a) |
Article 38 (1) | Article 9 (3) (a) second indent first part |
Article 38 (2) (a) | Article 9 (3) (a) second indent last part |
Article 38 (2) (b) to (d) | — |
Article 38 (3) | — |
Article 38 (4) | — |
Article 38 (5) | — |
Article 39 | — |
Article 40 | — |
Article 41 | — |
Article 42 | — |
Article 43 | — |
Article 44 (1) (a) | Article 9 (3) (b) |
Article 44 (1) (b) and (c) | — |
Article 44 (2) | — |
Article 45 | — |
Article 46 | — |
Article 47 (1) | Article 12, first indent |
Article 47 (2) | — |
Article 48 | Article 12, second and third indent |
Article 49 (a) | Article 13 (1) first indent |
Article 49 (b) | Article 13 (1) third indent |
Article 49 (c) and (d) | — |
Article 50 (1) (a) | Article 13 (3) first subparagraph first sentence |
Article 50 (1) (b), (c) and (d) | — |
Article 50 (2) | — |
Article 50 (3) | Article 13 (3) second subparagraph |
Article 50 (4) and (5) | Article 13 (3) third subparagraph |
Article 50 (6) | — |
Article 51 (1) | Article 13 (3) first subparagraph first to sixth indent |
Article 51 (2) | — |
Article 52 | — |
Article 53 | — |
Article 54 | — |
Article 55 | — |
Article 56 | — |
Article 57 | — |
Article 58 | — |
Article 59 | — |
Article 60 | — |
Article 61 | — |
Article 62 | — |
Article 63 | — |
Article 64 | — |
Article 65 (a), (b) and (c) | Article 13 (1) second indent |
Article 65 (d) | Article 13 (1) fourth indent |
Article 66 | Article 13 (2) first and second subparagraph |
Article 67 | Article 13 (2) second subparagraph |
Article 68(1) (a) and (b) | Article 11 (1) first indent |
Article 68 (1) (c) and (e) | Article 11 (1) second and third indent |
Article 68 (1) (d) | — |
Article 68 (2), (3) and (4) | — |
Article 69 | Council Decision 89/531/EEC |
Article 70 (1) | — |
Article 70 (2) | Article 13 (2) third subparagraph |
Article 71 | — |
Article 72 | Article 5 of Directive 90/423/EEC |
Article 73 | — |
Article 74 | — |
Article 75 | — |
Article 76 | — |
Article 77 | — |
Article 78 | — |
Article 79 (1) | Article 14 (1) first subparagraph second half sentence |
Article 79 (2) | Article 14 (1) third subparagraph second half sentence |
Article 79 (3) | — |
Article 79 (4) | — |
Article 80 | Decision 91/666/EEC |
Article 81 | — |
Article 82 | — |
Article 83 | — |
Article 84 | Decision 91/665/EEC |
Article 85 | — |
Article 86 | — |
Article 87 | — |
Article 88 | — |
Article 89 | Articles 16 and 17 |
Article 90 | — |
Article 91 | — |
Article 92 (1) | Article 6 of Directive 90/423/EEC |
Article 92 (2) first subparagraph | — |
Article 92 (2) second and third subparagraphs | Article 5(4) of Directive 90/423/EEC |
Article 93 | Article 19 |
Article 94 | — |
Article 95 | Article 20 |
Annex I | — |
Annex II | — |
Annex III | — |
Annex IV | — |
Annex V | — |
Annex VI | — |
Annex VII | — |
Annex VIII | — |
Annex IX Part A | — |
Annex IX Part B | — |
Annex X | — |
Annex XI Part A | Annex B |
Annex XI Part B | Annex A |
Annex XII | — |
Annex XIII | — |
Annex XIV | Decision 91/666/EEC |
Annex XV | — |
Annex XVI | Decision 89/531/EEC |
Annex XVII | Decision 91/42/EEC |
Annex XVIII | — |
Annex XIX | — |
Annex XX | — |
Financial Statement | — |
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Ultra-High Temperature treatment at 132 °C for at least one second.
=
High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test.
=
Ultra High Temperature treatment at 132 °C for at least one second.
=
High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test.
in accordance with the report of the Scientific Committee on Animal Health 1999