Comments by Mrs Anne Lambourn on the

LATEST DRAFT PROPOSALS FOR EU DIRECTIVE 25 MARCH 2003

(Relevant quotations from EU Draft are in italics at the end. Any bold underlined text represents latest additions to Draft)

Confirmation of disease and killing of livestock.

  1. As I understand it, if there is a suspected new outbreak of FMD (i.e not linked to any previous outbreak) samples have to be taken to confirm the presence and strain of disease. They also must be taken for epidemiological purposes. (Article 4 Measures in case of suspicion of an outbreak of FMD).
  2. However, "the competent authority" may decide that samples do not have to be taken on premises which can be considered as secondary outbreaks. (Article 10 1b Measures in case of confirmation of an outbreak of FMD)
    The competent authority may decide that Article 4 (2) shall not apply in cases of appearance of a secondary source which is epidemiologically linked with a primary source for which samples have already been taken in accordance (with) that Article, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in Article 13 have been taken.
    In these cases, clinical diagnosis to confirm presence of disease would be acceptable. (Annex I.5d).
    (d) clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species.
    Note that these signs have to be observed, so this should means that if vets are not going to test to confirm the presence of FMD in these secondary outbreaks, the only way they can declare that the premises is an IP is by clinical diagnosis, where they have actually seen the symptoms in the animals.
  3. . For premises suspected of being infected or of being contaminated, the competent authority must have the necessary samples taken for confirmation of disease and for epidemiological purposes. (Article 4 and Annex III 2.2)
      Article 4.2. The competent authority shall immediately activate official investigation arrangements under its supervision to confirm or rule out the presence of the foot-and-mouth disease and, in particular, have the necessary samples taken for the laboratory examinations required to confirm an outbreak in accordance with the definition in Annex I and for the epidemiological inquiry referred to in paragraph 3 (f) in accordance with Annex III.
        Annex III 2.2. Sampling on holdings
        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 at least 5% prevalence with at least 95% level of confidence.
  4. Furthermore, the clinical examination of these animals must also take into account the transmission of FMD, the incubation period of the disease, and the way in which animals are kept. (see Annex III 1.3 Survey). This stipulation on its own could help to prevent a repeat of the mass killing of healthy animals long after the incubation period is over.
  5. Regarding Article 8 (Preventive Eradication Programme):

    This does not equate with Defra's pre-emptive firebreak culling of healthy animals around areas of infection. Article 8 is not an authorisation for mass culling of healthy animals over vast swathes of countryside, such as happened in Cumbria and Dumfries and Galloway. Article 8 states that killing may be allowed of susceptible species likely to be contaminated , and, if considered necessary, of "epidemiologically linked production units or adjoining holdings" provided taking of samples and clinical examinations are carried out "at least in accordance with Annex III.

    As the whole point of Annex III is to outline procedures for surveillance of live animals, and one is being asked to act in accordance with Annex III, presumably the sampling and diagnoses are meant to be carried out on live animals. (This approach would be consistent with the rest of the Directive, where the emphasis is very much on killing restricted to confirmed outbreaks, with testing/sampling and inspection elsewhere.

    (N.B. With holdings made up of different epidemiological production units, exemption from killing is possible using risk based assessment. See Article 18).

    Obviously, the soundness of the decision on whether animals are likely to be contaminated or epidemiologically linked depends on the calibre of the specifically trained veterinarians referred to in the DD, and the individuals in the Expert Group. Hopefully, with the extra guidelines in the DD concerning expertise involved, we will not have a repeat of 2001.

    The Commission has to be notified prior to carrying out this Eradication Programme.

  6. Article 14 links in to Point No. 5 above, in that it refers to the possibility of killing on epidemiologically linked production units and (epidemiologically linked) adjacent holdings. However, it again refers to the procedures of clinical inspection and sampling in Annex III (as a minimum requirement) which have to be carried out
  7. Article 19 states that Contact holdings should be placed under surveillance as per Annex III, until the suspicion of FMD has been ruled out i.e they are not automatically killed.
  8. Article 16.4 refers to contamination of premises next to infected slaughterhouses.
  9. Article 88 refers to the possibility of ad hoc epidemiological measures which can be taken if disease spread occurs despite following measures stated in the Directive,

    Article 2

    Definitions

    For the purposes of this Directive the following definitions shall apply:

    (i) "animal suspected of being infected" means any animal of a susceptible species exhibiting clinical symptoms or showing post-mortem lesions or reactions to laboratory tests which are such that the presence of foot-and-mouth disease may reasonably be suspected;

    (j) "animal suspected of being contaminated" means any animal of a susceptible species which, according to the epidemiological information collected, may have been directly or indirectly exposed to the foot-and-mouth disease virus;

    k) "case of foot-and-mouth disease" or "animal infected with foot-and-mouth disease" means any animal of a susceptible species or carcass of such animal in which

     clinical symptoms or post-mortem lesions consistent with foot-and-mouth disease have been officially confirmed, taking into account the definitions in Annex I, or

     the presence of the foot-and- mouth disease has been officially confirmed as the result of a laboratory examination carried out in accordance with Annexes XIII and XIV.

    Article 4

    Measures in case of suspicion of an outbreak of foot-and-mouth disease

    1. Member States shall ensure that the measures provided for in paragraphs 2 and 3 are carried out where a holding contains one or more animals suspected of being infected or of being contaminated.

    2. The competent authority shall immediately activate official investigation arrangements under its supervision to confirm or rule out the presence of the foot-and-mouth disease and, in particular, have the necessary samples taken for the laboratory examinations required to confirm an outbreak in accordance with the definition in Annex I and for the epidemiological inquiry referred to in paragraph 3 (f) in accordance with Annex III.

    3. The competent authority shall place the holding referred to in paragraph 1 under official surveillance as soon as the suspected infection is notified and shall in particular ensure that:

    . (f) an epidemiological inquiry is carried out in accordance with Article 13.

    ANNEX I

    Definition of outbreak

    An outbreak shall be declared where a holding meets one or more of the following criteria:

    1. foot-and-mouth disease virus has been isolated from an animal, any product derived from that animal, or its environment;

    2. 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;

    3. 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;

    4. 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;

    5. an epidemiological link has been established to a confirmed foot-and-mouth disease outbreak and at least one of the following conditions applies:

    (a) 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;

    (b) 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;

    (c) 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.

    (d) clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species.

    ANNEX III

    Survey

    1. Clinical examination

    1.1. Holdings must undergo clinical examinations of all animals of susceptible species for signs or symptoms of foot-and-mouth disease.

    1.2. Special emphasis must be laid on animals which may have been exposed to foot-and-mouth disease virus with a high probability, notably transport from holdings at risk or close contact to persons or equipment that had close contact to holdings at risk.

    1.3. The clinical examination must take into account the transmission of foot-and-mouth disease, including the incubation period referred to in Article 2 (h) and the way in which animals of susceptible species are kept.

    1.4. Relevant records kept on the holding must be examined in detail with particular regard to data required for animal health purposes by Community legislation and, where available, on morbidity, mortality and abortion, clinical observations, changes in productivity and feed intake, purchase or sale of animals, visits of persons likely to be contaminated and other anamnestically important information.

    2. Procedures for sampling

    2.1. General provisions

    2.1.1. Serological sampling shall be carried out:

    2.1.1.1. according to the recommendations of the epidemiological team established within the expert group referred to in Annex XVII (7), and

    2.1.1.2. in support of tracing and the provision of evidence for the absence of previous infection.

    2.1.2. Where sampling is carried out in the framework of disease surveillance after an outbreak, actions shall not commence before at least 21 days have elapsed since the elimination of susceptible animals on the infected holding(s) and the carrying out of preliminary cleansing and disinfection, unless otherwise provided for in this Annex.

    2.1.3. Sampling of animals of susceptible species shall be carried out in accordance with the provisions of this Annex in each case where sheep and goats or other susceptible animals not displaying clear clinical signs are involved in the outbreak, and in particular where such animals have been isolated from bovine and porcine animals.

    2.2. Sampling on holdings

    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 at least 5% prevalence with at least 95% level of confidence.

    2.3. Sampling in protection zones

    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 at least 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 to detect at least 2% prevalence of disease within the herd with at least 95% level of confidence.

    2.4. Sampling in surveillance zones

    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 that samples are taken:

    2.4.1. from holdings in all administrative units within the perimeter of the zone where sheep and goats have not been in direct and close contact with bovine animals during a period of at least 30 days prior to taking the samples, and

    2.4.2. from as many holdings referred to above as necessary to detect with 95% level of confidence at least 1 infected holding if the estimated prevalence of the disease was 2% equally distributed throughout the zone, and

    2.4.3. from as many sheep and goats per holding as necessary to detect at least 5% prevalence of disease within the herd with at least 95% level of confidence, but not more than 60 samples per holding and from all sheep and goats if there are less than 15 sheep and goats on the holding.

    2.5. Sampling for monitoring

    2.5.1. For monitoring the areas outside the zones established in accordance with the provisions of Article 21, and in particular to substantiate the absence of infection in the sheep and goat population which is not in close and direct contact with non-vaccinated bovine or porcine animals, a sampling protocol recommended for monitoring purposes by the OIE or a sampling protocol as provided for in paragraph 2.4. shall be applied with the difference compared to paragraph 2.4.2. that the estimated herd prevalence shall be set at 1 %.

    3. In the case the diagnostic sensitivity of the test employed to carry out the survey is lower than 100 %, the number of samples calculated in accordance with requirements in paragraphs 2.2, 2.3 and 2.4.3 shall be increased in order to take into account the established diagnostic sensitivity of the test employed.

    Article 8

    Preventive eradication programme

    The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive killing of animals of susceptible species likely to be contaminated and, if considered necessary, of epidemiologically linked production units or adjoining holdings.

    In that event, the taking of samples and clinical examinations of animals of susceptible species shall be carried out at least in accordance with Annex III.

    The Competent Authority shall notify the Commission prior to the implementation of the measures provided for in this Article.

    Article 10

    Measures in case of confirmation of an outbreak of foot-and-mouth disease

    1. As soon as an outbreak of foot-and-mouth disease is confirmed, Member States shall ensure that, in addition to the measures provided for in Articles 4 to 6 the following measures are also applied without delay on the holding:

    (a) All animals of susceptible species on the holding shall be killed on-the-spot.

    In exceptional circumstances the animals of susceptible species may be killed at the nearest suitable place for that purpose under official supervision and in such a way as to avoid the risk of spreading foot-and-mouth disease virus during transport and killing. The Member State concerned shall notify the Commission about the existence of such exceptional circumstances, and the action taken.

    (b) The official veterinarian shall ensure that before or during the killing of the animals of susceptible species all appropriate samples needed for the epidemiological inquiry referred to in Article 13 have been taken in accordance with Annex III, and in sufficient numbers.

    The competent authority may decide that Article 4 (2) shall not apply in cases of appearance of a secondary source which is epidemiologically linked with a primary source for which samples have already been taken in accordance that Article, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in Article 13 have been taken.

    Article 13

    Epidemiological inquiry

    1. Member States shall ensure that epidemiological inquiries in relation to outbreaks of foot-and-mouth disease are carried out by specifically trained veterinarians on the basis of questionnaires, prepared within the framework of the contingency plans provided for in Article 72, to ensure standardised, speedy and targeted inquiries. Such inquiries shall deal at least with:

    (a) the length of time during which the foot-and-mouth disease may have been present on a holding before being suspected or notified;

    (b) the possible origin of the foot-and-mouth disease virus on a holding and the identification of other holdings where there are animals suspected of being infected or animals suspected of being contaminated from the same source;

    (c) the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated;

    (d) the movement of animals, persons, vehicles and the substances referred to in Article 4 (3) (c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question.

    2. Member States shall inform and regularly update the Commission and the other Member States about the epidemiology and spread of the foot-and-mouth disease virus.

    Article 14

    Additional measures in case of confirmation of outbreaks of foot-and-mouth disease

    2. The competent authority may apply the measures provided for in Article 10 (1) (a) on epidemiologically linked production units or adjoining holdings, where epidemiological information or other evidence give reason to suspect a possible contamination of those holdings. The intention to make use of those provisions shall be notified to the Commission, where possible, prior to implementation. In this event, the measures regarding taking of samples and clinical examinations of animals shall be carried out at least as set out in Annex III.

    4. The competent authorities may apply the measures provided for in Articles 7 and 8.

    Article 16

    Measures to be applied in slaughterhouses, border inspection posts and means of transportation

    1. Where a case of foot-and-mouth disease is confirmed in a slaughterhouse, a border inspection post established in accordance with Directive 91/496/EEC or in a means of transport, the competent authority shall ensure that the following measures are carried out in relation to the affected premises or means of transport:

    (a) all animals of susceptible species in such premises or means of transport are killed without delay;

    (b) the carcasses of possibly infected and contaminated animals are disposed of under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading and any risk to the environment;

    (c) other animal waste, including offal, of possibly infected and contaminated animals are disposed of under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading and in accordance with Community legislation on waste;

    (d) cleansing and disinfection of buildings and equipment, including vehicles or means of transport, takes place under the supervision of the official veterinarian in accordance with Article 11 and with the instructions laid down by the competent authority;

    (e) an epidemiological inquiry is carried out in accordance with Article 13.

    2. Member States shall ensure that the measures provided for in Article 19 are applied in contact holdings.

    3. Member States shall ensure that no animals are reintroduced for slaughter, inspection or transport in the premises or means of transport referred to in paragraph 1 until at least 24 hours after completion of the cleansing and disinfection operations referred to in paragraph 1 (d).

    4. Where required by the epidemiological situation, in particular where contamination of animals of susceptible species in holdings adjacent to the premises ore means of transport referred to in paragraph 1 must be suspected, Member States shall ensure that by way of derogation from Article 2 (b) second sentence, the premises or means of transport referred to in paragraph 1 are declared an outbreak, and the measures provided for in Articles 10 and 21 are applied.

    Article 18

    Holdings consisting of different epidemiological production units

    1. In the case of holdings which consist of two or more separate production units, the competent authority may in exceptional cases, and after considering the risks, derogate from Article 10 (1) (a) as regards non-affected production units of such holdings.

    Article 19

    Contact holdings

    1. Holdings shall be recognised as contact holdings where the official veterinarian finds, or considers on the basis of confirmed data, that the foot-and-mouth disease virus may have been introduced as a result of the movement of persons, animals, products of animal origin, vehicles or in any other way either from other holdings onto a holding referred to in Articles 4 (1) or 10 (1) or from a holding referred to in Articles 4(1) or 10 (1) to other holdings.

    2. Contact holdings shall be subject to the measures provided for in Articles 4 (3) and 5 and these measures shall be maintained until the suspected presence of foot-and-mouth disease virus on these contact holdings has been officially ruled out in accordance with the survey requirements provided for in Annex III.