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Scope
Definitions
Notification
Actions on Suspicion
Actions on Confirmation
Holding on Multiple Sites
Epidemiological Investigation
Contact Premises
Movement Controls
Disinfectants
Laboratory Diagnosis
Movement of animals
Cessation of vaccination
Emergency vaccines
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The following text comprises the main Articles from Council Directive
85/511/EEC of 18 November 1985 as amended by Directive 90/423/EEC. This
is not intended as the definitive text of the directives. The articles
of the two directives have been merged, annotated and abbreviated for
clarity. Readers are urged to consult the original texts for legal purposes.
Article 1 - Scope
This Directive defines the minimum Community control measures to be applied
in the event of outbreaks of foot-and-mouth disease, whatever the type
of virus concerned .
Article 2 - Definitions
For the purposes of this Directive, the definitions given in Article 2
of Directive 64/432/EEC (1) shall apply as appropriate.
The following definitions shall also apply:
(a) 'animal of a susceptible species' means any domestic or wild ruminant
or swine present on a holding;
(b) 'receptive animal' means any animal of a susceptible species which
is not vaccinated, or which is vaccinated but whose immunization cover
is considered to be inadequate by the competent authority;
(c) 'infected animal' means any animal of a susceptible species:
in which clinical symptoms or post-mortem lesions which may arise
from foot-and-mouth disease have been ascertained, or
in which the presence of foot-and-mouth disease has been officially
ascertained following a laboratory examination;
(d) 'animal suspected of being infected' means any animal of a susceptible
species showing clinical symptoms or post-mortem lesions which are such
that the presence of foot-and-mouth disease may reasonably be suspected;
(e) 'animal suspected of being contaminated' means any animal of a
suspectible species which may - according to the epizoological information
collected - have been directly or indirectly exposed to the foot-and-mouth
virus.
Article 3 - Notification
Member States shall ensure that the presence, or suspected presence, of
foot-and-mouth disease is compulsorily and immediately notifiable to the
competent authority, in accordance with Directive 82/894/EEC (2).
Article 4 - Actions on Suspicion
Member States shall ensure that, where a holding contains one or more
animals suspected of being infected or of being contaminated with foot-and-mouth
disease, official means of investigation to confirm or rule out the
presence of the disease are set in motion immediately and, in particular,
that the official veterinarian takes the necessary samples, or has them
taken, for laboratory examination.
As soon as the suspected infection is notified, the competent authority
shall have the holding placed under official surveillance and shall
in particular order that:
a census be made of all categories of animals of susceptible species
and that, in respect of each of these categories, the number of
animals already dead, infected or liable to be infected or contaminated
be recorded; the census must be kept up to date to take account
of animals born or dying during the period of suspicion; the information
in the census must be produced on request and may be checked at
each visit;
all animals of susceptible species on the holding be kept in their
living quarters or some other place where they can be isolated;
no animals of susceptible species enter or leave the holding;
no animals of other species enter or leave the holding without
the authorization of the competent authority;
all movement from the holding of meat or carcases of animals of
susceptible species or of animal feed, utensils, objects or other
substance, such as wool or waste or rejected matter, liable to transmit
foot-and-mouth disease be prohibited, unless authorized by the competent
authority; - the movement of milk from the holding be prohibited;
in the event of difficulties in storing the milk on the holding,
the competent authority may authorize the milk to be moved from
the holding under veterinary supervision to a treatment establishment
in order that it may be given heat treatment ensuring the destruction
of the foot-and-mouth virus;
the movement of persons to or from the holding be made subject
to authorization by the competent authority;
the entry or exit of vehicles to or from the holding be made subject
to authorization by the competent authority which shall lay down
the conditions necessary in order to avoid propagation of the foot-and-mouth
virus;
appropriate means of disinfection be used at the entrances and
exits of buildings housing animals of susceptible species and of
the holding itself;
an epizoological inquiry be carried out in accordance with Articles
7 and 8.
The competent authority may extend the measures provided for in paragraph
1 to adjoining holdings should their location, their configuration,
or contacts with animals from the holding where the disease is suspected
give reason to suspect possible contamination.
The measures referred to in paragraphs 1 and 2 shall not be withdrawn
until the suspicion of foot-and-mouth disease has been officially ruled
out.
Member States which practise prophylactic vaccination in
the whole or part of their territory shall forego vaccination by 1 January
1992 at the latest and shall prohibit, from the date on which they stop
vaccination, vaccinated animals from being introduced into their territory.
However, paragraph 1 shall take effect on the date of the application of
the decisions referred to in Article 14 (3) of Directive 85/511/EEC and
Article 23 (1) of Directive 90/425/EEC in respect of live animals and animal
products which are susceptible to foot-and-mouth disease.
If the decisions referred to in paragraph 2 have not been adopted by 30
June 1991, the Commission will make the necessary proposals.
Article 5 - Actions on Confirmation
As soon as it has been confirmed that one or more of the animals defined
in Article 2 (c) are on a holding, the competent authority shall introduce
the following measures:
the official veterinarian takes adequate samples or has them taken
for examination by the laboratory referred to in Annex I, where these
samples and examinations have not been taken or carried out during the
period of suspicion in accordance with the first subparagraph of Article
4 (1);
in addition to the measures listed in Article 4 (1), the following
measures are taken without delay: (a) in Member States or regions where
vaccination is prohibited:
all animals of susceptible species on the holding shall be slaughtered
on the spot under official supervision in such a way as to avoid
all risk of spreading the foot-and-mouth virus;
after being slaughtered, the aforementioned animals shall be destroyed
under official supervision in such a way that there is no risk of
spreading the foot-and-mouth virus;
meat of animals of susceptible species coming from the holding
and slaughtered during the period between the probable introduction
of the disease to the holding and the implementation of official
measures shall, wherever possible, be traced and destroyed under
official supervision in such a way as to avoid any risk of spreading
the foot-and-mouth virus;
the carcases of animals of susceptible species which have died
on the holding shall be destroyed under official supervision in
such a way as to avoid any risk of spreading the foot-and-mouth
virus;
any substance referred to in Article 4 (1), second subparagraph,
fifth indent shall be destroyed or treated in such a way as to ensure
the destruction of any foot-and-mouth virus present; all treatment
must be carried out in accordance with the instructions of the official
veterinarian;
milk and milk products shall be destroyed in such a way as to
avoid any risk of spreading the foot-and-mouth virus;
after elimination of the animals of susceptible species and of
the substances referred to in Article 4 (1), second subparagraph,
fifth indent, the buildings used for housing, their surroundings
and the vehicles used for their transport and all equipment likely
to be contaminated shall be cleaned and disinfected in accordance
with Article 10;
no animals of susceptible species shall be reintroduced to the
holding until at least 21 days after completion of the cleaning
and disinfection operations carried out in accordance with Article
10; - an epizoological inquiry shall be carried out in accordance
with Articles 7 and 8;
(b) in the Member States or regions where a vaccination policy is organized
in compliance with the provisions of Article 14:
(i)
all animals of susceptible species on the holding shall be slaughtered
and destroyed under official supervision. When the animals are slaughtered
and destroyed, Member States shall take the measures necessary to
avoid any risk of the foot-and-mouth virus persisting and being
spread and any harmful consequence for the environment; in particular
when slaughtering is not carried out on the spot, the animals shall
be transported in specially equipped vehicles to avoid any risk
of spreading the foot-and-mouth virus;
when the type, sub-type or variant of the foot-and-mouth virus
has been identified or when the epidemiological information and
data make it possible to ascertain that the vaccines used provide
immunization cover valid for the type of virus in question, Member
States may:
restrict the slaughtering and destruction to receptive animals;
authorize meat and milk from animals not infected or not suspected
of being infected to be given appropriate heat treatment under veterinary
supervision;
(ii) the measures provided for in (i) shall be accompanied by vaccination
or re-vaccination of the remaining animals in accordance with Article
13 (1);
(iii) the measures provided for under the third, fourth and fifth indents
of (a) shall apply by analogy as well as, except in the case of the
heat treatment referred to in (i), the measures provided for in the
sixth indent of (a).
the provisions of paragraph 1 shall not apply in the case of appearance
of a secondary source which is linked epidemiologically with a primary
source for which samples have already been taken;
the competent authority may extend the measures provided for in paragraph
1 to adjoining holdings should their location, their configuration,
or contacts with animals from the holding where the disease has been
recorded give reason to suspect possible contamination.
Each Member state shall draw up a plan of warning, specifying the
national measures to be implemented in the event of an outbreak of foot-and-mouth
disease.
This plan should allow access to the plant, equipment, personnel and
all other appropriate materials necessary for the rapid and efficient
eradication of the outbreak. It must give a precise indication of the
vaccine requirements which each Member State concerned considers it
needs in the event of the reinstatement of emergency vaccination.
The Commission shall, in accordance with the procedure in Article
16 of Directive 85/511/EEC, lay down by 31 December 1990 the criteria
to be applied for drawing up plans.
Plans drawn up in accordance with the criteria provided for in paragraph
2 shall be submitted to the Commission by 31 December 1991.
The Commission shall examine the plans in order to determine whether
they permit the desired objective to be attained and shall suggest to
the Member State concerned any amendments required in particular to
ensure that they are compatible with those of the other Member States.
The Commission shall approve the plans, if necessary amended, in accordance
with the procedure laid down in Article 16 of Directive 85/511/EEC.
The plans may subsequently be amended or supplemented, in accordance
with the same procedure, to take into account developments in the situation.
The Commission may, in accordance with the procedure laid down in
Article 6 of Directive 82/894/EEC, establish, by way of derogation from
Article 3 (1) thereof, an early warning system for informing the Commission
and the other Member States of outbreaks of foot-and-mouth-disease.
Article 6 - Holdings on Multiple
Sites
In the case of holdings which consist of two or more separate production
units, the competent authority may derogate from the requirements of
Article 5 (2) (a), first and second indents and (2) (b) (i) as regards
healthy production units of a holding which is infected, provided that
the official veterinarian has confirmed that the structure and size
of these units and the operations carried out there are such that they
are completely separate as regards housing, keeping and feeding, so
that the virus cannot spread from one to another.
The same measures and the possibility of derogating from the requirements
of the sixth indent of Article 5 (2) (a) may be extended to holdings
producing milk, provided that, in addition, milking in each unit is
carried out quite separately.
Where recourse is made to paragraph 1, the Member States shall lay
down detailed rules for applying it in the light of the health guarantees
offered. They shall notify the Commission thereof.
It may be decided, in accordance with the procedure laid down in Article
16, that the measures laid down in paragraph 2 shall be amended in order
to ensure the coordination thereof with those adopted by the Member
States.
In order to take account of possible difficulties, in particular when
recourse is had to Article 13 (3) of Directive 85/511/EEC, which might
result from the transition from the arrangements which existed before
the application of this Directive in one or more Member States to the
arrangements established by this Directive, or where implementation
of the plans provided for in Article 5 makes it necessary, the Commission
may, in accordance with the procedure provided for in Article 16 of
Directive 85/511/EEC, adopt appropriate measures for a maximum period
of two years. In particular, without prejudice to Article 4 (a) of Directive
64/432/EEC, measures shall be adopted before 1 January 1991 in respect
of the movement of animals not vaccinated during the course of the last
12 months.
It may be decided, in accordance with the procedure laid down in Article
16, that the measures laid down in paragraph 2 shall be amended in order
to ensure the coordination thereof with those adopted by the Member
States.
Article 7 - Epidemiological Investigation
Before 1 January 1992, the Commission shall submit a report on the structure
of the veterinary services in the Community
The epizoological inquiry shall deal with.
the length of time during which the foot-and-mouth disease may have
existed on the holding before being notified or suspected;
the possible origin of the foot-and-mouth disease on the holding and
the identification of other holdings on which there are animals of susceptible
species which may have become infected or contaminated from the same
source;
the movement of persons, vehicles and substances referred to in Article
4 (1), second subparagraph, fifth indent, likely to have carried the
foot-and-mouth virus to or from the holdings in question.
Article 8 - Contact Premises
(a) Where the official veterinarian finds, or considers on the basis
of confirmed data, that foot-and-mouth disease could have been introduced
from other holdings on to the holding referred to in Article 4, or from
the latter holding on to other holdings as a result of the movement
of persons, animals or vehicles or in any other way, those other holdings
shall be placed under official surveillance in accordance with Article
4 and this surveillance shall not be lifted until the suspected presence
of foot-and-mouth disease on the holding referred to in Article 4 has
been officially ruled out;
(b) where the official veterinarian finds, or considers on the basis
of confirmed data, that foot-and-mouth disease could have been introduced
on to the holding referred to in Article 5 from other holdings as a
result of the movement of persons, animals or vehicles or in any other
way, those other holdings shall be placed under official surveillance
in accordance with Article 4;
(c) where the official veterinarian finds, or considers on the basis
of confirmed data, that foot-and-mouth disease could have been introduced
from the holding referred to in Article 5 on to other holdings as a
result of the movement of persons, animals or vehicles or in any other
way, those other holdings shall become subject to the provisions of
Article 4.
When a holding has been subject to the provisions of paragraph 1,
the competent authority shall prohibit removal of animals from the holding
other than for transport directly to a slaughterhouse under official
supervision for the purpose of emergency slaughter during a 15-day period
in the case of holdings referred to in 1 (a) and (b) and a 21-day period
in the case of holdings referred to in 1 (c), respectively. Prior to
granting such authorization, the official veterinarian must have carried
out an examination of the herd and confirmed that none of the animals
is suspected of being infected.
Where it considers that conditions permit, the competent authority
may limit the measures provided for in paragraph 1 (a) and (b) to a
part of the holding and the animals contained therein, provided that
the animals there have been housed, kept and fed completely separately.
The Member States shall bring into force the laws, regulations and administrative
provisions necessary to comply with this Directive before 1 January 1992.
They shall forthwith inform the Commission thereof.
Article 9 - Movement Controls
Member States shall ensure that, once the diagnosis of foot-and-mouth
disease has been officially confirmed, the competent authority establishes,
around the infected holding, a protection zone based on a minimum radius
of 3 km and a surveillance zone based on a minimum radius of 10 km.
The definition of zones shall take account of natural boundaries, supervision
facilities and technological progress which make it possible to foresee
the possible dispersion of the virus by air or any other means and will
have to be reviewed, if necessary, in the light of such elements.
(a) The following measures shall be applied in the protection zones:
a census of all the holdings with animals of susceptible species
must be carried out;
holdings which are the subject of such a census must periodically
undergo a veterinary inspection.
the movement of animals of susceptible species on public or private
roads, excluding the service roads of holdings, shall be prohibited;
animals of susceptible species may not be removed during the first
15 days from the holding on which they are kept except to be transported
directly under official supervision for the purpose of emergency
slaughter to a slaughterhouse located in that zone or, if that zone
has no slaughterhouse under veterinary supervision, to a slaughterhouse
designated by the competent authority. Such movement may be authorized
by the competent authority only after examination by the official
veterinarian of all the animals of susceptible species on the holding
has ruled out the presence of suspected animals;
itinerant service for breeding shall be prohibited;
artificial insemination shall be prohibited during the first 15
days except where it is carried out by the farmer with sperm that
is on the farm or with sperm delivered directly by an insemination
centre;
fairs, markets, shows or other gatherings of susceptible animals,
including collection and distribution, shall be prohibited;
without prejudice to the case provided for in the second sentence
of the third indent, the transport of animals of susceptible species
shall be prohibited, except for transit by major highways or mainline
railways.
(b) the measures applied in the protection zone shall be maintained
for at least 15 days after elimination of all the animals referred to
in Article 5 from the holding and the carrying out on that holding of
preliminary cleaning and disinfection operations in accordance with
Article 10. However, the measures described in paragraph 3 for the surveillance
zone shall remain in force in the protection zone for the period provided
for in paragraph 3 (b).
(a) The following measures shall be applied in the surveillance zone:
a census shall be taken of all holdings having animals of susceptible
species;
the movement of animals of susceptible species on public roads
shall be prohibited except for the purpose of leading them to pasture;
the transport of animals of susceptible species within the surveillance
zone shall be subject to the authorization of the competent authority;
the animals may not be removed from the surveillance zone during
the first 15 days. Between the 15th day and the 30th day the animals
may not be removed from the said zone except to be transported under
official supervision directly to a slaughterhouse for the purpose
of emergency slaughter. Such transport may be authorized by the
competent authority only after the official veterinarian has carried
out an examination of all the animals concerned and confirmed that
none of the animals is suspected of being infected;
itinerant service for breeding shall be prohibited;
fairs, markets, shows and other gatherings of susceptible animals
shall be prohibited.
(b) The measures in the surveillance zone shall be kept in force for
at least 30 days after the elimination of all the animals referred to
in Article 5 from the holding and the carrying out on that holding of
preliminary cleaning and disinfection operations in accordance with
Article 10.
Article 10 - Disinfectants
Member States shall ensure that:
the disinfectants to be used and their concentrations are officially approved
by the competent authority; - the cleaning and disinfection operations
are carried out under official supervision, in accordance with the instructions
given by the official veterinarian.
Article 11 - Laboratory Diagnosis
Member States shall ensure that:
laboratory testing to detect the presence of foot-and-mouth diesease
are carried out by a national laboratory indicated in Annex B which
may be amended or supplemented in accordance with the procedure
laid down in Article 17. This laboratory testing should, if necessary
and especially on the first appearance of the disease, show the
type, sub-type or, where appropriate, the variant of the relevant
virus which may be confirmed, if necessary, by a reference laboratory
designated by the Community;
one of the national laboratories indicated in Annex B is responsible
for coordinating standards and methods of diagnosis in each Member
State;
the national laboratories referred to in the first indent liaise
with a reference laboratory designated by the Community.
The Council, acting by a qualified majority on a proposal from the
Commission, shall designate, before 1 January 1987, the reference laboratory
referred to in paragraph 1 and shall determine its powers and the detailed
rules for applying the second indent of paragraph 1.
Article 12 - Movement of animals
Member States shall ensure that:
when animals of susceptible species are moved out of the holding on
which they are kept, they are identified in such a way as to enable
their holding of origin, or the holding from which they have come, and
their movements to be traced rapidly. However, for certain categories
of animals and without prejudice to Article 13 of Council Directive
80/217/EEC of 22 January 1980 introducing Community measures for the
control of classical swine fever (1), as last amended by Directive 84/645/EEC
(2), the competent authority may, in certain circumstances and having
regard to the health situation, authorize other ways of rapidly tracing
their holding of origin, or the holding from which they have come, and
their movements. The arrangements for identifying the animals or for
tracing the holding of origin shall be determined by the competent authority;
- the owner or keeper of the animals is required to supply the competent
authority, on request by that authority, with information concerning
animals entering or leaving his holding;
all persons engaged in the transport or marketing of animals of susceptible
species are able to supply the competent authority with information
concerning the movements of animals which they have transported or marketed
and to furnish all the details concerning such information.
Article 13 - Cessation of vaccination
Member States shall ensure that:
the use of foot-and-mouth vaccines is prohibited,
the manipulation of foot-and-mouth virus for research, diagnosis
and/or manufacture of vaccines shall be carried out only in approved
establishments and laboratories listed in Annex A and B,
the storage, supply, distribution and sale of foot-and-mouth vaccines
on the territory of the Community are carried out under official
control,
the establishments and laboratories referred to in the second
indent shall be approved only if they fulfil the minimum standards
recommended by the FAO for laboratories working on foot-and-mouth
viruses in vitro and in vivo.
Veterinary experts from the Commission, in collaboration with the
competent authorities of the Member States, shall carry out spot-checks
to ascertain whether the security systems applied in the establishments
and laboratories referred to in Annexes A and B comply with the FAO's
minimum standards. The Commission shall carry out these checks at least
once a year, the first of these checks being due before 1 January 1992,
and shall submit, also before that date, an initial report to the Standing
Veterinary Committee. The list of establishments and laboratories in
Annexes A and B may be reviewed in the light of these checks by the
Commission, in accordance with the procedure referred to in Article
17, by 31 December 1991. The list will be regularly updated in accordance
with the same procedure. In accordance with the same procedure, a decision
may be taken to adopt a uniform code of good conduct for the security
systems applied in the establishments and laboratories listed in Annexes
A and B.
Notwithstanding the provisions of paragraph 1 concerning the use of
foot-and-mouth disease vaccine, it may be decided, when foot-and-mouth
disease has been confirmed and threatens to become extensive, that emergency
vaccination using technical procedures guaranteeing the animals' total
immunity may be introduced. In this case, the measures to be taken shall
include: - the extent of the geographical area in which emergency vaccination
is to be carried out,
the species and the age of the animals to be vaccinated,
the duration of the vaccination campaign,
a specific standstill of vaccinated animals and their products,
the special identification and special registration of the vaccinated
animals,
other matters appropriate to the emergency situation.
The decision to introduce emergency vaccination shall be taken by the Commission
in collaboration with the Member State concerned, acting in accordance with
the procedure laid down in Article 16. This decision shall have particular
regard to the degree of concentration of animals in certain regions and
the need to protect special breeds. However, by way of derogation from the
first subparagraph, the decision to introduce emergency vaccination around
the outbreak may be taken by the Member State concerned following notification
to the Commission, provided that basic Community interests are not endangered.
This decision shall be immediately reviewed in the Standing Veterinary Committee
in accordance with the procedure laid down in Article 16.'.
Article 14 - Emergency vaccines
and strategic antigen reserves (90/423)
Pending the setting up of Community reserves of foot-and-mouth disease
vaccine, Member States shall be authorized to retain reserves of antigens
in one of the establishments referred to in the Annexes. For the purposes
of the first subparagraph, contracts between the Commission and those
responsible in the establishments designated by the Member States shall
be concluded; the contracts will in particular specify the quantities
of antigen doses necessary, taking account of the requirements estimated
in the context of the plans referred to in Article 5 (1) of Directive
90/423/EEC (*), for a maximum of 10 serotypes. After this transitional
period, Member States shall be authorized under Community supervision
to retain establishments for the packaging and storage of ready-to-use
vaccines for emergency vaccination.
Before 1 April 1991, the Council, acting by a qualfied majority on
a proposal from the Commission, shall designate a specialized institute
for vaccine and cross-immunity checks and shall determine its powers.
Before 1 April 1991, the Commission shall submit to the Council a
report accompanied, where appropriate, by proposals on the rules relating
to the packaging, production, distribution and state of the stocks of
anti-foot-and-mouth disease vaccines in the Community, together with
proposals on the setting up of at least two Community reserves of anti-foot-and-mouth
disease vaccines.'(*) OJ No L 224, 18. 8. 1990, p. 13.
Article 5 of 90/423 - Contingency Plans
Each Member State shall draw up a plan of warning, specifying the
national measures to be implemented in the event of an outbreak of foot-and-mouth
disease. This plan should allow access to the plant, equipment, personnel
and all other appropriate materials necessary for the rapid and efficient
eradication of the outbreak. It must give a precise indication of the
vaccine requirements which each Member State concerned considers it
needs in the event of the reinstatement of emergency vaccination.
The Commission shall, in accordance with the procedure in Article
16 of Directive 85/511/EEC, lay down by 31 December 1990 the criteria
to be applied for drawing up plans.
Plans drawn up in accordance with the criteria provided for in paragraph
2 shall be submitted to the Commission by 31 December 1991.
The Commission shall examine the plans in order to determine whether
they permit the desired objective to be attained and shall suggest to
the Member State concerned any amendments required in particular to
ensure that they are compatible with those of the other Member States.
The Commission shall approve the plans, if necessary amended, in accordance
with the procedure laid down in Article 16 of Directive 85/511/EEC.
The plans may subsequently be amended or supplemented, in accordance
with the same procedure, to take into account developments in the situation.
The Commission may, in accordance with the procedure laid down in
Article 6 of Directive 82/894/EEC, establish, by way of derogation from
Article 3 (1) thereof, an early warning system for informing the Commission
and the other Member States of outbreaks of foot-and-mouth-disease.
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