MT
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) RULES *
Table of Provisions (96)
Statutory Text (96 Articles)
SUBSIDIARY LEGISLATION 437.50
FOOT-AND-MOUTH DISEASE
(CONTROL MEASURES) RULES *
16th December, 2004
LEGAL NOTICE 510 of 2004.
CHAPTER I
General Provisions
(1) The title of these rules is the Foot-and-Mouth Disease
(Control Measures) Rules.
(2) The scope of these rules is to implement the rules found
under European Union Council Directive 2003/85/EC regarding
measures for the control of foot-and-mouth disease to be taken in
the territory of Malta.
(3)
These rules set out
(a) the minimum control measures to be applied in the
event of an outbreak of foot-and-mouth disease, of
whatever type of virus;
(b) certain preventative measures aimed at increasing
awareness and preparedness of the competent
authorities and the farming community for foot-and-
mouth disease.
(4) The competent authority shall remain free to take more
stringent action in the field covered by these rules.
DEFINITION OF OUTBREAK
An outbreak shall be declared where a holding meets one or more of the following
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 five
days apart, in the case of structural proteins, and at least twenty-one
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.
For the purposes of these rules -
"animal of a susceptible species" means any domestic or wild
animal of the suborders Ruminantia, Suina, and Tylopoda of the
order Artiodactyla. For specific measures, notably in application of
rule 16(4), rule 15 and rule 75(2), other animals, such as for
example of the order Rodentia or Proboscidae, may be considered
susceptible to foot-and-mouth disease in accordance with scientific
evidence;
"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;
"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 f oot-and -mo uth di sease may reasonably be
suspected;
"authorisation" means a written authorisation given by the
competent authorities, of which the necessary copies must be
available for subsequent inspections in accordance with the
*These rules have been repealed by Legal Notice 77 of 2025.
appropriate legislation in Malta;
"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 foot-andmouth disease has been
officially confirmed, taking into account the definitions in
Schedule I, either on clinical symptoms or post-mortem lesions
consistent with foot-and-mouth disease have been officially
confirmed, or as the result of a laboratory examination carried out
in accordance with Schedule XIII;
"Community antigen and vaccine bank" means appropriate
premises designated in accordance with these rules for the storage
of Community reserves of both concentrated inactivated antigen of
the foot-and-mouth disease virus for the production of foot-and-
mouth disease vaccines and veterinary immunological products
(vaccines) reconstituted from such antigens and authorised in
accordance with European Council Directive 2001/82/EC relating
to veterinary medicinal products;
"the competent authority" means the Veterinary Services within
Malta as provided under article 2 of the Veterinary Services Act, or
any other authority to which such responsibility has been delegated
by the Veterinary Services;
"emergency slaughter" means the slaughter in emergency cases
within the meaning of Article 2(7) of European Council Directive
93/119/EEC of animals which on the basis of epidemiological data
or clinical diagnosis or results of laboratory testing are not
considered infected or contaminated with the foot-and-mouth
disease virus, including slaughter for reasons of animal welfare;
"emergency vaccination" means vaccination in accordance with
rule 48(1);
"herd" means an animal or group of animals kept on a holding as
an epidemiological unit; if more than one herd is kept on a holding,
each of these herds shall form a distinct unit and shall have the
same health status;
"holding" means any agricultural or other premises, including
circuses, located in Malta where animals of susceptible species are
being bred or kept on a permanent or temporary basis. However, for
the purpose of rule 10(1), this definition does not include living
areas for humans on such premises, unless animals of susceptible
species, including those referred to in rule 75(2), are kept on a
permanent or temporary basis therein, slaughterhouses, means of
transport, border inspection posts or fenced areas where animals of
susceptible species are kept and may be hunted, if such fenced
areas are of a size which makes the measures provided for in rule
10 inapplicable;
"incubation period" means the length of the time between
infection and the occurrence of clinical signs of foot-and mouth
disease. Namely, for the purposes of these rules, fourteen days for
bovine and porcine animals, and twenty-one days for ovine and
caprine animals and any other animal of susceptible species;
"killing" means any process which causes the death of an animal;
"Member State" means a State which is a Member within the
European Community;
"official veterinarian" means the veterinarian designated by the
competent authority of Malta;
"outbreak of foot-and-mouth disease" means a holding where
animals of susceptible species are kept, which meets one or more of
the criteria set out in Schedule I;
"owner" means any person or persons, either natural or legal,
having ownership of an animal of a susceptible species, or charged
with keeping such animals, whether or not for financial reward;
"primary case of foot-and-mouth disease in wild animals" means
any case of foot-and-mouth disease which is detected in a wild
animal in an area in which no measures are in place in accordance
with rule 75(3) or (4);
"primary outbreak" means an outbreak not epizootiologically
linked with a previous outbreak in the same region of Malta as
defined in Article 2 of European Council Directive 64/432/EEC or
the first outbreak in a different region of Malta;
"processing" means one of the treatments for high risk material
laid down in European Council Regulation (EC) No 1774/2002, and
any implementing legislation thereof, applied in such a way as to
avoid the risk of spread of foot-and-mouth disease virus;
"protective vaccination" means emergency vaccination carried
out on holdings in a designated area in order to protect animals of
susceptible species within this area against airborne spread or
spread through fomites of foot-and-mouth disease virus and where
the animals are intended to be kept alive following vaccination;
"region" means that part of the territory of Malta which is at least
2,000 square kilometres in area and which is subject to inspection
by the competent authority;
"regionalisation" means the delimitation of a restricted zone in
which restrictions are applied on the movements of or trade in
certain animals or animal products as provided for in rule 43 in
order to prevent the spread of foot-and-mouth disease into the free
zone where no restrictions are applied in accordance with these
rules;
"sub-region" means an area specified in the Annex to European
Council Decision 2000/807/EC;
"suppressive vaccination" means emergency vaccination which
is carried out exclusively in conjunction with a stamping-out policy
in a holding or area where there is an urgent need to reduce the
amount of foot-and-mouth disease virus circulating and to reduce
the risk of it spreading beyond the perimeters of the holding or the
area and where the animals are intended to be destroyed following
vaccination;
"wild animal" means an animal of a susceptible species living
outside any holding or premises referred to in rules 15 and 16.
CHAPTER II
Control of outbreaks of foot-and-mouth disease
NOTIFICATION OF DISEASE AND FURTHER EPIDEMIOLOGICAL
INFORMATION TO BE PROVIDED BY THE COMPETENT AUTHORITY
WHERE FOOT-AND-MOUTH DISEASE HAS BEEN CONFIRMED
1. Within twenty-four hours from the confirmation of each primary outbreak or
case in premises or means of transport referred to in rule 16, the competent authority
must notify by means of the Animal Disease Notification System established in
accordance with Article 5 of European Council Directive 82/894/EEC
(a) date of dispatch;
(b) time of dispatch;
(c) country of origin;
(d) name of disease and type of virus, where appropriate;
(e) serial number of outbreak;
(f)
type of outbreak;
(g) reference number of outbreak linked to this outbreak;
(h) region and geographical location of the holding;
(i)
other region affected by restrictions;
(j)
date of confirmation and method used for confirmation;
(k) date of suspicion;
(l)
date of estimation of first infection;
(m) origin of disease, as far as can be indicated;
(n) disease control measures taken.
2. In case of primary outbreaks or cases in premises or means of transport
referred to in rule 16, in addition to the data referred to in point 1, the competent
authority must also forward the following information
(a) the number of animals of each susceptible species in the outbreak, or
premises and means of transport referred to in rule 16;
(b) 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;
(c) 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;
(d) the number of animals of susceptible species killed in the outbreak,
slaughterhouse or means of transport;
(e) the number of carcasses processed and disposed of;
(f)
the distance of the outbreak from the nearest holding on which animals
of susceptible species are kept;
(g) 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.
3. In case of secondary outbreaks, the information referred to in points 1 and 2
must be forwarded within the time limit laid down in Article 4 of European Union
Council Directive 82/894/EEC.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
4. The competent authority shall ensure that the information to be provided in
relation to any outbreak or case of foot-and-mouth disease in a holding,
slaughterhouse or means of transport in accordance with points 1, 2 and 3 is
followed as soon as possible by a written report to the Commission and the other
Member States including at least
(a) the date on which the animals of susceptible species on the holding,
slaughterhouse or means of transport were killed and their carcasses
processed;
(b) the results of the tests carried out on samples taken when animals of
susceptible species were killed;
(c) where the derogation provided for in rule 17 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;
(d) any information relating to the possible origin of the disease or the
origin of the disease if this has been ascertained;
(e) 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;
(f)
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
(i)
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,
(ii) 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,
(iii) 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.
5. Where the Animal Disease Notification System is for whatever reason
temporarily not operational, other means of communication shall be employed.
(1)
In Malta
(a) foot-and-mouth disease is listed by the competent
authority as a compulsorily notifiable disease;
(b) the owner and any person attending animals,
accompanying animals during transport or looking
after animals shall be obliged to notify without delay
to the competent authority or the official veterinarian
the presence or suspected presence of foot-and-mouth
disease and keep animals infected with foot-and-
mouth disease or animals suspected of being infected,
away from places where other animals of susceptible
species are at risk of being infected or contaminated
with the foot-and-mouth disease virus;
(c) veterinary practitioners, official veterinarians, senior
staff of veterinary or other official or private
laboratories and any person with a occupational
relation to animals of susceptible species or products
derived from such animals shall be obliged to notify
without delay to the competent authority any
knowledge of the presence or suspected presence of
foot-and-mouth disease they have obtained prior to
official intervention within the framework of these
rules.
(2) Without prejudice to existing European Community
legislation on notification of outbreaks of animal disease, in case of
an outbreak of foot-and-mouth disease or a primary case of foot-
and-mouth disease in wild animals is confirmed, the competent
authority shall give notification of the disease and provide
information and written reports to the European Commission and
the other Member States in accordance with Schedule II.
SURVEY
1. Clinical examination
Holdings must undergo clinical examinations of all animals of
susceptible species for signs or symptoms of foot-and-mouth disease.
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
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
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 the definition
"incubation period” in rule 2, 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 European
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 rule 73, and
2.1.1.2. in support of tracing and the provision of evidence, taking also into
account the definition in Schedule I, 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 twenty-one 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 Schedule.
2.1.3.
Sampling of animals of susceptible species shall be carried out in
accordance with the provisions of this Schedule 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 recom mendation of the
epidemiological team other susceptible species, should be examined pursuant to a
samp ling protocol suitable to detect 5% prevalence with at least 95% level of
confidence.
2.3.
Sampling in protection zones
In order to seek the repeal in accordance with rule 34 of the measures provided for
in rules 19 to 33, 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 twenty-one 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.
H o w e v e r, t h e co m p e t e n t a u t h or i t i es m a y d e c i d e w h e r e e p i d e m i o l o gi c a l
circumstances allow and in particular in application of the measures provided for in
rule 34(1)(b), that samples are taken not earlier than fourteen 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
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
confidence.
2.4.
Sampling in surveillance zones
In order to seek the repeal in accordance with rule 42 of the measures provided for
in rules 35 to 41, 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
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 thirty days prior to taking the samples, and
2.4.2.
from as many holdings referred to above as necessary to detect with at
least 95% level of confidence at least one 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 5%
prevalence of disease within the herd with at least 95% level of confidence, and from
all sheep and goats if there are less than fifteen 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 rule 19, 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. 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.
(1) The competent authority shall ensure that the measures
provided for in sub-rules (2) and (3) are carried out where a holding
contains one or more animals suspected of being infected or
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
of outbreak in Schedule I.
(3) The competent authority shall place the holding referred to
in sub-rule (1) under official surveillance as soon as the suspected
infection is notified and shall in particular ensure that
(a) a census is made of all categories of animals on the
holding and that, in respect of each category of
animals of susceptible species, the number of animals
that are already dead and the animals suspected of
being infected or of being contaminated, is recorded;
(b) the census as referred to in paragraph (a) is kept up to
date to take account of those animals of susceptible
species born or dying during the period of suspicion.
Such information is produced by the owner on request
of the competent authority and is checked by that
authority at each visit;
(c) all stocks of milk, milk products, meat, meat products,
carcasses, hides and skins, wool, semen, embryos, ova,
slurry, manure as well as animal feed and litter on the
holding are recorded and those records are maintained;
(d) no animals of susceptible species enter or leave the
holding, except in cases of holdings consisting of
different epidemiological production units referred to
in rule 17, and that all animals of susceptible species
on the holding are kept in their living quarters or
another place where they can be isolated;
(e) appropriate means of disinfection are used at the
entrances and exits of buildings or places housing
animals of susceptible species and of the holding
itself;
(f)
an epidemiological inquiry is carried out in accordance
with rule 13;
(g) to facilitate the epidemiological inquiry, the necessary
samples shall be taken for laboratory testing in
accordance with point 2.1.1.1 of Schedule III.
PRINCIPLES AND PROCEDURES FOR CLEANSING AND DISINFECTION
1. General principles and procedures
1.1.
Cleansing and disinfection operations as provided for in rule 11 shall be
carried out under official supervision and in accordance with the instructions given
by the official veterinarian.
1.2.
The disinfectants to be used and their concentrations shall be officially
recognised by the competent authority to ensure destruction of foot-and-mouth virus.
1.3.
The activity of disinfectants must not be impaired by prolonged storage.
1.4.
The choice of disinfectants and of procedures for disinfection should be
made taking into account the nature of the premises, vehicles and objects which are
to be treated.
1.5.
The conditions under which degreasing agents and disinfectants are used
must ensure that their efficacy is not impaired. In particular technical parameters
provided by the manufacturer, such as pressure, minimum temperature and required
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
contact time must be observed. The activity of the disinfectant must not be
compromised by interaction with other substances, such as degreasing agents.
1.6.
Independently of the disinfectant used, the following general rules shall
apply
1.6.1. thorough soaking of bedding and litter as well as faecal matter with the
disinfectant,
1.6.2. washing and cleaning by careful brushing and scrubbing of all surfaces
possibly contaminated and in particular of the ground, floors, ramps and walls after
the removal or dismantling, where possible, of equipment or installations otherwise
impairing the effective cleansing and disinfection procedures,
1.6.3. then further application of disinfectant for a minimum contact time as
stipulated in the manufacturers recommendations;
1.6.4. the water used for cleaning operations is to be disposed of in such a way as
to avoid any risk of spreading the foot-and-mouth disease virus and in accordance
with the instructions of the official veterinarian.
1.7.
Where washing is carried out with liquids applied under pressure and
following the disinfection, recontamination of the previously cleansed or disinfected
parts must be avoided.
1.8.
Washing, disinfecting or destroying of equipment, installations, articles or
compartments likely to be contaminated should be included.
1.9.
Cleansing and disinfection operations required in the framework of these
rules must be documented in the holding register or, in the case of vehicles, in the
log-book and where official approval is required be certified by the supervising
official veterinarian.
2. Special provisions on cleansing and disinfection of infected holdings
2.1.
Preliminary cleansing and disinfection
2.1.1. During the killing of the animals all necessary measures shall be taken to
avoid or minimise the dispersion of foot-and-mouth virus. This shall include among
other things the installation of temporary disinfection equipment, supply of
protective clothing, showers, decontamination of used equipment, instruments and
facilities and the interruption of power supply to the ventilation.
2.1.2. Carcasses of killed animals must be sprayed with disinfectant and removed
from the holding in covered and leak-proof containers for processing and disposal.
2.1.3. As soon as the carcasses of the animals of susceptible species have been
removed for processing and disposal, those parts of the holding in which these
animals were housed and any parts of other buildings, yards, etc. contaminated
during killing, slaughter or post-mortem examination should be sprayed with
disinfectants approved for this purpose.
2.1.4. Any tissue or blood which may have been spilled during slaughter or post-
mortem examination and any gross contamination of buildings, yards, utensils, etc.
should be carefully collected and disposed of with the carcasses.
2.1.5. The used disinfectant shall remain on the surface for at least twenty-four
hours.
2.2.
Final cleansing and disinfection
2.2.1. Grease and dirt should be removed from all surfaces by the application of a
degreasing agent and washed with cold water.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
2.2.2. After washing with cold water further spraying with disinfectant should be
applied.
2.2.3. After seven days the premises should be treated again with a degreasing
agent, rinsed with cold water, sprayed with dis infectant and rinsed again with cold
water.
3. Disinfection of contaminated bedding, manure and slurry
3.1.
The solid phase of manure and used bedding should be stacked to heat,
preferably by adding 100 kg granulated quick lime on 1m 3 manure, ensuring a
temperature of at least 70°C throughout the stack, sprayed with disinfectant and left
for at least forty-two days, during which the stack should be either covered or rule
stacked to ensure thermic treatment of all layers.
3.2.
The liquid phase of manure and slurry should be stored for at least forty-
two days after the last addition of infective material. This period may be extended if
the slurry has been heavily contaminated or during adverse weather conditions. This
period may be shortened if disinfectant has been added so as to alter the pH
sufficiently throughout the substance to destroy the foot-and-mouth disease virus.
4. Special cases
4.1.
Where for technical or security reasons the cleansing and disinfection
procedures cannot be completed in accordance with these rules, the buildings or
premises must be cleansed and disinfected as much as possible to avoid spread of the
foot-and-mouth disease virus and must remain unoccupied by animals of susceptible
species for at least one year.
4.2.
By way of derogation from points 2.1 and 2.2, in case of open-air holdings,
the competent authority may establish specific procedures for cleaning and
disinfection, taking into account the type of holding and the climatic conditions.
4.3.
By way of derogation from point 3, the competent authority may establish
specific procedures for the disinfection of dung and manure in accordance with
scientific evidence that the procedure ensure effective destruction of the foot-and-
mouth disease virus.
(1) The competent authority shall ensure that in addition to
the measures provided for in rule 4, all movement onto and off a
holding where there is a suspicion of an outbreak of foot-and-
mouth disease is prohibited. That prohibition shall apply in
particular to
(a) movement from the holding of meat or carcasses, meat
products, milk or milk products, semen, ova or
embryos of animals of susceptible species or of animal
feed, utensils, objects or other substance, such as
wool, hides and skins, bristles or animal waste, slurry,
manure or anything liable to transmit foot-and-mouth
disease virus;
(b) movement of animals of species not susceptible to
foot-and-mouth disease;
(c) movement of persons onto or out of the holding;
(d) movement of vehicles onto or out of the holding.
(2) By way of derogation from the prohibition in sub-rule
(1)(a), the competent authority may in the event of difficulties in
storing the milk on the holding either order that the milk shall be
destroyed on the holding, or authorise the milk to be transported
under veterinary supervision and only by means of transport
suitably equipped to ensure no risk of spreading foot-and-mouth
disease virus from the holding to the nearest possible place for
disposal or treatment ensuring destruction of the foot-and-mouth
disease virus.
(3) By way of derogation from the prohibitions provided for in
sub-rule (1)(b), (c) and (d), the competent authority may authorise
such movements onto and off the holding subject to all conditions
necessary in order to avoid the spread of foot-and-mouth disease
virus.
RESTOCKING OF HOLDINGS
1. General principles
1.1.
Restocking should not commence until twenty-one days after
completion of the final disinfection of the holding.
1.2.
Animals for restocking can only be introduced under the following
conditions
1.2.1.
the animals shall not come from areas subject to animal health
restrictions in relation to foot-and-mouth disease;
1.2.2.
the competent authority must be satisfied that any possible residual foot-
and-mouth disease virus can be detected in the animals intended for restocking either
on the base of clinical signs, in the case of bovine or porcine animals, or though
laboratory investigations in the case of other species susceptible to foot-and-mouth
disease, carried out at the end of the observation period specified in paragraph 1.3;
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
1.2.3.
in order to ensure an adequate immune response referred to in paragraph
1.2.2 in the animals intend for restocking, the animals must
1.2.3.1. either originate in and come from a holding situated in an area of at least
10 km radius centred on that holding where there was no outbreak of foot-and-mouth
disease for at least thirty days, or
1.2.3.2. the animals have been tested with negative results in an assay as
described in Schedule XIII for the detection of antibodies against the foot-and-
mouth disease virus carried out on samples taken prior to introduction onto the
holding.
1.3.
Irrespective of the type of farming practised on the holding, re-
introduction must conform with the following procedures
1.3.1.
animals must be introduced in all units and buildings of the holding
involved;
1.3.2.
in the case of a holding consisting of more than one unit or building, re-
introduction is not necessary for every unit or building at the same time;
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 re-stocking procedures.
1.3.3.
animals must be subjected to clinical inspection every three days for the
first fourteen days following the introduction;
1.3.4.
during the period from fifteen to twenty-eight days after re-introduction,
animals are to be subjected to clinical inspection once every week;
1.3.5.
not earlier than twenty-eight days after the last re-introduction, all
animals must be clinically examined and samples for testing for the presence of
antibody against foot-and-mouth disease virus shall be taken in accordance with the
requirements of point 2.2 of Schedule III;
1.4.
The restocking procedure shall be considered completed when the
measures provided for in point 1.3.5 have been completed with negative results.
2. Extension of measures and derogations
2.1.
The competent authority may impose
2.1.1.
the use of sentinel animals, in particular in holdings difficult to clean
and disinfect and notably openair holdings. Detailed provision on the use of
sentinels may be laid down in accordance with the procedure referred to in rule
78(1).
2.1.2.
additional safeguard and control measures within the framework of
restocking.
2.2.
The competent authorities may derogate from the measures provided for
in points 1.3.2 to 1.3.4 of this Schedule where restocking is carried out after three
months have elapsed following the last outbreak in an area of 10km radius centred
on the holding subject to the restocking operation.
3. Restocking in connection with emergency vaccination
3.1.
Restocking in a vaccination zone established in accordance with rule 50
shall be carried out either in accordance with paragraphs 1 and 2 of this Schedule or
in accordance with rules 56(2) or (4)(a), (c) and (d).
3.2.
The competent authority may authorise the restocking of holdings
situated outside the vaccination zone with vaccinated animals after the completion of
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
the measures provided for in rule 59 and under the following conditions
3.2.1.
the proportion of vaccinated animals used for restocking exceeds 75% in
which case, not earlier than twenty-eight days after the last re-introduction of
animals of susceptible species, the vaccinated animals are tested for the detection of
antibodies against non-structural proteins, randomly, the sampling using the
statistical parameters provided for in point 2.2 of Schedule III and for the non-
vaccinated animals the provisions of paragraph 1 shall apply, or
3.2.2.
the proportion of vaccinated animals does not exceed 75% in which case
the non-vaccinated animals shall be considered sentinels and provisions of paragraph
1 shall apply.
(1) The competent authority shall extend the measures
provided for in rules 4 and 5 to other holdings where their location,
their construction and layout, or contacts with animals from the
holding referred to in rule 4, give reason to suspect contamination.
(2) The competent authority shall apply at least the measures
provided for in rules 4 and 5(1) to premises or means of transport
referred to in rule 16 should the presence of animals of susceptible
species give reason to suspect infection or contamination with the
foot-and-mouth disease virus.
RESTRICTIONS ON THE MOVEMENT OF EQUIDAE
1. Minimum measures
Where at least one outbreak of foot-and-mouth disease has been confirmed in
accordance with rule 10, the competent authority 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 European Council Directive 90/
426/EEC.
2. Recommended additional measures
2.1.
Measures during the stand-still
In the case where the competent authorities apply a complete stand-still as
provided for in rule 7(3), transport of equidae from holdings under restrictions laid
down in rules 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
2.1.1.
the emergency must be documented by the veterinary surgeon on call
twenty-four hours per day, seven days per week;
2.1.2.
the agreement of the clinic of destination must be producible;
2.1.3.
the transport operation must be authorised by the competent authorities
who must be reachable twenty-four hours per day, seven days per week;
2.1.4.
equidae must be accompanied during the transport by an identification
document in accordance with Decisions 93/623/EEC or 2000/68/EC;
2.1.5.
the on-call official veterinarian must be informed about the route prior
to departure;
2.1.6.
equidae must be groomed and treated with an effective disinfectant;
2.1.7.
equidae must travel in dedicated equine transport which is recognisable
as such and cleansed and disinfected prior to and after use.
2.2.
Controls on equidae in relation to protection and surveillance zones
2.2.1.
Movement of equidae outside the protection and surveillance zones is
not subject to conditions in excess of those resulting from European Council
Directive 90/426/EEC.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
2.2.2.
Movement of equidae within the protection and surveillance zones
established in accordance with rule 19 is subject to the following conditions
2.2.2.1. the use of equidae kept on holdings in the protection and surveillance
zone not keeping animals of susceptible animals may be authorised in the protection
zone, subject to appropriate cleansing and disinfection measures, and may not be
restricted on premises situated in the surveillance zone;
2.2.2.2. equidae may be transported without restrictions in dedicated equine
transport to a holding not keeping animals of susceptible species;
2.2.2.3. the competent authorities may in exceptional cases authorise the
transport of equidae in dedicated or registered equine transport from a holding not
keeping animals of susceptible species to another holding keeping animals of
susceptible species situated in the protection zone, subject to cleansing and
disinfection of the transport prior to loading of the animals and before leaving the
holding of destination;
2.2.2.4. movement of equidae may be allowed on public roads, on pastures
belonging to holdings not keeping animals of susceptible species and exercise
premises.
2.2.3.
The collection of equine semen, ova and embryos from donor animals
on holdings not keeping animals of susceptible species in the protection and
surveillance zone and the transport of equine semen, ova and embryos to recipient
equine animals on holdings not keeping animals of susceptible species shall not be
restricted.
2.2.4.
Visits from owners of equidae, the veterinary surgeon, the inseminator
and the farrier on holdings keeping animals of susceptible species in the surveillance
zones but not subject to the restrictions provided for in rules 4 and 10 shall be
subject to the following conditions
2.2.4.1. equidae are kept separated from animals of susceptible species and
access of the persons referred to above to animals of susceptible species is
effectively prevented;
2.2.4.2.
all visitors must be registered;
2.2.4.3.
cleansing and disinfecting of means of transportation and of the boots of
visitors.
(1) The competent authority may establish a temporary
control zone, where required by the epidemiological-situation, and
in particular when that situation involves a high density of animals
of susceptible species, intensive movement of animals or persons in
contact with animals of susceptible species, delays in suspect status
notifications, or insufficient information on the possible origin and
ways of introduction of the foot-and-mouth disease virus.
(2) At least the measures provided for in rule 4(2) and (3)(a),
(b) and (d) and in rule 5(1) shall be applied to holdings in the
temporary control zone where animals of susceptible species are
kept.
(3) The measures applied in the temporary control zone may be
supplemented by a temporary ban on movements of all animals in a
larger area or on the whole of the territory of Malta. However, the
ban on movement of animals of species not susceptible to foot-and-
mouth disease shall not exceed seventy-two hours, unless justified
by exceptional circumstances.
TREATMENT OF PRODUCTS TO ENSURE THE DESTRUCTION
OF FOOT-AND-MOUTH DISEASE VIRUS
PART A
Products of animal origin
1. Meat products that have undergone at least one of the treatments provided
for in the first column in Table 1 of Annex III of European Council Directive 2002/
99/EC.
2. Hides and skins complying with the requirements in Article 20 of European
Council Directive 2003/85/EC and points A(2)(c) or (d) of Chapter VI of Annex VIII
to European Council Regulation (EC) No 1774/2002.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
3. Sheep wool, ruminant hair and pig bristles complying with the requirements
in Article 20 of European Council Directive 2003/85/EC and point A(1) of Chapter
VI of Annex VIII to Regulation (EC) No 1774/2002.
4. Products derived from animals of susceptible species which have undergone
(a) either a heat treatment in a hermetically sealed container with an Fo
value of 3,00 or more; or
(b) a heat treatment in which the centre temperature is raised to at least
70°C for at least sixty minutes.
5. Blood and blood products of animals of susceptible species used for
technical purposes, including pharmaceuticals, in vitro diagnostics and laboratory
reagents which have undergone at least one of the treatments referred to in point
B(3)(e)(ii) of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002.
6. Lard and rendered fats which have undergone the heat treatment referred to
in point B(2)(d)(iv) of Chapter IV of Annex VII to Regulation (EC) No 1774/2002.
7. Petfood and dogchews which comply with the requirements of points B(2),
(3) or (4) of Chapter II of Annex VIII to Regulation (EC) No 1774/2002.
8. Game trophies of ungulates which comply with the requirements of points
A(1), (3) or (4) of Chapter VII of Annex VIII to Regulation (EC) No 1774/2002.
9. Animal casings which in accordance with Chapter 2 of Annex I to Directive
92/118/EEC have been cleaned, scraped and either salted with sodium-chloride for
thirty days or bleached or dried after scraping and were protected from re-
contamination after treatment.
PART B
Products not of animal origin
1. Straw and forage which -
(a) either has undergone the action of -
(i)
steam in a closed chamber for at least ten minutes and at a
minimum temperature of 80°C, or
(ii) formalin fumes (formaldehyde gas) produced in a chamber kept
closed for at least eight hours and at a minimum temperature of
19°C, using commercial-type solutions at 35 - 40% concentration,
or
(b) 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 rule 11 and in any case not before the end of
the restrictions in the protection zone.
(1) 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 necessary, of
animals from epidemiologically-linked production units or
adjoining holdings.
(2) In that event, the taking of samples and clinical
examinations of animals of susceptible species shall be carried out
at least in accordance with point 2.1.1.1 of Schedule III.
(3) The competent authority shall notify the European
Commission prior to the implementation of the measures provided
for in this rule.
PART A
Treatment of fresh meat
1. De-boned fresh meat
Meat as described in Article 2(a) of European Union Council Directive 64/433/
EEC together with diaphragms but excluding offal, from which the bone and the
main accessible lymphatic glands have been removed.
2. Trimmed offal
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 European Union Council 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.
3. Maturation
maturation of carcasses at a temperature of more than + 2°C for at least
twenty-four hours;
pH value in the middle of Longissimus dorsi muscle recorded as less
than 6,0.
4. Effective measures must be applied to avoid cross-contamination.
PART B
Additional measures applicable to the production of fresh meat from animals
of susceptible species originating in the surveillance zone
1. Fresh meat, excluding heads, viscera and offals, intended for placing on the
market outside the protection and surveillance zone shall be produced according to
at least one of the following additional conditions
(a) in the case of ruminants
(i)
the animals have been subjected to the controls provided for in
Article 24(2), and
(ii) the meat is subject to the treatment provided for in points 1, 3 and
4 of Part A;
(b) in the case of all animals of susceptible species
(i)
the animals have been resident on the holding for at least twenty-
one days and are identified so as to allow the tracing of the
holding of origin, and
(ii) the animals have been subjected to the controls provided for in
rule 22(2), and
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
(iii) the meat is clearly identified and detained under official
supervision for at least seven 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;
(c) in the case of all animals of susceptible species
(i)
the animals have completed a twenty-one-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
(ii) the animals have been subjected to the controls provided for in
rule 22(2) within twenty-four hours of loading, and
(iii) samples taken in accordance with the statistical requirements
provided for in point 2.2 of Schedule III within forty-eight 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
(iv) the meat is detained under official control for twenty-four 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.
2. Trimmed offal shall be marked with the health mark provided for in
European Union Council Directive 2002/99/EC and shall be subject to one of the
treatments provided for in point 1 in Part A of Schedule VII.
3. Other products shall be subjected to the treatment provided for in rule 30.
The competent authority shall not withdraw the measures
provided for in rules 4 to 7 until the suspicion of foot-and-mouth
disease has been officially ruled out.
TREATMENT OF MILK TO ENSURE DESTRUCTION
OF FOOT-AND-MOUTH VIRUS
PART A
Milk and milk products intended for human consumption
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.
1. Milk intended for human consumption must be subject to at least one of
the following treatments
sterilisation at a level of at least F 0 3;
UHT * treatment;
HTST † treatment applied twice to milk with a pH equal to or above 7,0;
*UHT = Ultra High Temperature treatment at 132°C for at least one second.
†HTST = 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.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
1.4.
HTST treatment of milk with a pH below 7,0;
1.5.
HTST combined with another physical treatment by
1.5.1.
either lowering the pH below 6 for at least one hour, or
1.5.2.
additional heating to 72°C or more, combined with desiccation.
2. Milk products must either undergo one of the above treatments or be
produced from milk treated in accordance with paragraph 1.
3. Any other treatment shall be decided in accordance with the procedure
referred to in rule 78(1), in particular in relation to raw milk products undergoing an
extended period of ripening including a lowering of the pH below 6.
PART B
Milk and milk products not intended for human consumption and milk
and milk products for animal consumption
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.
1. Milk not intended for human consumption and milk intended for animal
consumption must be subject to at least one of the following treatments
1.1.
sterilisation at a level of at least F 0 3;
UHT * combined with another physical treatment referred to in either
1.2.
paragraph 1.4.1 or 1.4.2;
HTST † applied twice;
1.3.
1.4.
HTST combined with another physical treatment by
1.4.1.
either lowering the pH below 6 for at least one hour, or
1.4.2.
additional heating to 72°C or more, combined with desiccation.
2. Milk products must either undergo one of the above treatments or be
produced from milk treated in accordance with paragraph 1.
3. Whey to be fed to animals of susceptible species and produced from
milk treated as described in paragraph 1 must be collected at least sixteen hours after
milk clotting and its pH must be recorded as <6.0 before transport to pig holdings.
*UHT = Ultra High Temperature treatment at 132°C for at least one second.
†HTST = 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.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
(1) As soon as an outbreak of foot-and-mouth disease is
confirmed, the competent authority shall ensure that, in addition to
the measures provided for in rules 4 to 6 the following measures are
also applied without delay on the holding
(a) all animals of susceptible species 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 competent authority shall
notify the European 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 rule 13 have been taken in
accordance with point 2.1.1.1 of Schedule III, and in
sufficient numbers. The competent authority may
decide that rule 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
to that rule, provided that appropriate and sufficient
numbers of samples needed for the epidemiological
inquiry referred to in rule 13 have been taken;
(c) the carcasses of animals of susceptible species which
have died on the holding and the carcasses of animals
which have been killed in accordance with paragraph
(a) shall be processed without undue delay under
official supervision in such a way that there is no risk
of spreading foot-and-mouth disease virus. Where
particular circumstances require the carcasses to be
buried or burned, on site or off site, such operations
shall be carried out in conformity with the instructions
prepared in advance in the framework of the
contingency plans referred to in rule 67;
(d) all products and substances referred to in rule 4(3)(c)
shall be isolated until contamination can be ruled out,
or treated in accordance with the instructions of the
official veterinarian in such a way as to ensure the
destruction of any foot-and-mouth disease virus, or
processed.
(2) After the killing and processing of the animals of
susceptible species and the completion of the measures provided
for in sub-rule (1)(d), the competent authority shall ensure that
(a) the buildings used for housing animals of susceptible
species, their surroundings and the vehicles used for
their transportation, as well as all other buildings and
equipment likely to be contaminated shall be cleaned
and disinfected in accordance with rule 11;
(b) in addition, where there is a reasonable suspicion that
the living area for humans or the office area of the
holding are contaminated with the foot-and-mouth
disease virus, these areas shall also be disinfected by
appropriate means;
(c) restocking of animals is carried out in accordance with
Schedule V.
CRITERIA FOR THE DECISION TO APPLY PROTECTIVE VACCINATION AND
GUIDELINES FOR THE EMERGENCY VACCINATION PROGRAMMES
1. Criteria for the decision to apply protective vaccination
Criteria
Decision
For vaccination Against vaccination
Population density of susceptible animals
High
Low
Predominant species clinically affected
Pigs
Ruminants
M o v e m e n t o f p o t e n t i a l l y i n f e c t e d a n i m a l s or Evidence
No evidence
products out of the protection zone
Predicted airborne spread of virus from infected High
Low or absent
holdings
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 regionalization after vaccination
Yes
No
2. Additional citeria for the decision to introduce emergency vaccination
Criteria
Decision
For vaccination Against vaccination
Acceptance of regionalization by third countries
known
unknown
Economic assessment of competing control If
it
i s If it is foreseeable
strategies
foreseeable that a t h a t a c o n t r o l
control strategy s t r a t e g y
with
without
emergency
emergency
vaccination would
vaccination
lead to significantly
would lead to higher economic
significantly losses
in
the
higher economic a g r i c u l t u r a l a n d
losses in the non-agricultural
agricultural and sectors
non-agricultural
sectors
It is foreseeable that the 24/48 hours rule cannot be Yes
No
implemented effectively for two consecutive days
1 )
(
Significant social and psychological impact of total Yes
No
stamping out policy
Existence of large holdings of intensive livestock Yes
No
production in a non-densely populated livestock
area
( 1 ) 24/48 hours rule means
(a) infected herds on holdings referred to in rule 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 carried out with
less than 48 hours.
3. Definition of Densely Populated Livestock Areas (DPLAs)
3.1. When deciding about the measures to be taken in application of these rules,
and in particular the measures provided for in rule 50(2), the competent authority
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
shall in addition to a thorough epidemiological assessment consider the definitions
of DPLAs as provided for in point 3.2. or where applicable as provided for in Article
2(u) of European Council Directive 2001/89/EC and use the definition which is the
more stringent.
The definition may be modified in the light of new scientific evidence in
accordance with the procedure referred to in rule 78(1).
3.2. Animals of susceptible species
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 km 2 . The holding in
question must be situated either in a sub-region where there is a density of animals
of susceptible species higher than 450 head per km 2 or at a distance of less than 20
km from such a subregion.
(1) The competent authority shall ensure that cleansing
and disinfection operations, as integral parts of the measures
provided for in these rules, are adequately documented and are
carried out under official supervision and in accordance with the
instructions given by the official veterinarian, using disinfectants
and working concentrations of such disinfectants officially
au th orised and r egi stered for p laci ng o n t he marke t b y the
competent authority as veterinary hygiene biocidal products in
accordance with European Union Directive 98/8/EC, in order to
ensure destruction of the foot-and-mouth disease virus.
(2) The competent authority shall ensure that cleansing and
disinfection operations, which shall include appropriate pest
control, are carried out in a way to reduce as much as possible any
adverse environmental impact that may arise from such operations.
(3) The competent authority shall endeavour to ensure that any
disinfectants used, in addition to being able to disinfect effectively,
also have the lowest possible adverse impacts on the environment
and public health in accordance with best available technology.
(4) The competent authority shall ensure that cleansing and
disinfection operations are carried out in accordance with Schedule
IV.
PART A
National laboratories authorised to handle live foot-and-mouth disease virus
Member State
Laboratory
Member States using
where Laboratory
the services of
is situated
laboratory
Belgium
Veterinary and Agrochemical Research Centre Belgium
CODA-CERVA-VAR, Uccle
Luxembourg
Denmark
D a n i s h Ve t e r i n a r y I n s t i t u t e , D e p a r t m e n t o f Denmark
Virology, Lindholm
Finland
Sweden
Germany
B u n d e s f o r s c h u n g s a n s t a l t d e r T i e r e f ü r Germany
Viruskrankheiten,
- Anstalsteil Tübingen
- Anstaltsteil Friedrich-Loeffler-Institut, Insel
Riems
Greece
Ivoτιτovτo αφξωδovς πvρετov, Αγια Παρασκεvη Greece
Αττικης
Spain
Laboratorio Central de Veterinaria Algete, Madrid Spain
France
Agence francaise de sécurité sanitaire des aliments France
(AFSSA)
- Laboratoire d’études et de recherches en
pathologie bovine et hygiène des viandes, Lyon
- Laboratoire d’études et de recherches en
pathologie animale et zoonoses, Maison-Alfort
Italy
I s t i t u t o z o o p r o f i l a t t i c o s p e r i m e n t a l e d e l l a Italy
Lombardia e dell’Emilia Romagna, Brescia
Netherland
CIDC-Lelystad, Central Institute for Animal Netherlands
Disease Control, Lelystad
Austria
Austria Österreichische Agentur für Gesundheit Austria
und Ernährungssicherheit
Veterinärmedizinische Untersuchungen Mödling
United Kingdom Institute for Animal Health, Pirbright
United Kingdom
Ireland
Sweden
Finland
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
PART B
Laboratories authorised to andel live foot-and-mouth virus for vaccine production
Member State
Manufacturer
Germany
Bayer AG, Köln
France
Merial, S.A.S., Laboratoire IFFA, Lyon
Netherlands
CIDC-Lelystad, Central Institute for Animal Disease Control, Lelys tad
United Kingdom
Merial, S.A.S., Pirbright Laboratory, Pirbright
The competent authority shall ensure that the products and
substances referred to in rule 4(3)(c) of animals of susceptible
species collected from a holding where an outbreak of foot-and-
mouth disease has been confirmed and semen, ova and embryos
collected from animals of susceptible species present on that
holding, during the period between the probable introduction of the
disease to the holding and the implementation of official measures,
shall be traced and processed or, in the case of substances other
than semen, ova and embryos, be treated under official supervision
and in such a way as to ensure destruction of foot-and-mouth
disease virus and to avoid any risk of it spreading further.
BIOSECURITY STANDARDS FOR LABORATORIES AND ESTABLISHMENTS
HANDLING LIVE FOOT-AND-MOUTH DISEASE VIRUS
1. The laboratories and establishments handling live foot-and-mouth disease
virus must meet or exceed the minimum requirements laid down in the ‘Minimum
standards for Laboratories working with foot-and-mouth virus in vitro and in vivo’
established by the European Commission for the control of foot-and-mouth disease,
26th session, Rome, April 1985, as modified in 1993.
2. The laboratories and establishments handling live foot-and-mouth disease
virus must be subject to at least two inspections within five years, with one of the
inspections being carried out unannounced.
3. The inspection team shall comprise at least of
-
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.
4. The inspection team shall submit a report to the Commission and the
Member States in accordance with European Union Council Decision 98/139/EC.
(1) The competent authority 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 rule 67, 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 rule 4(3)(c) likely to have
carried the foot-and-mouth disease virus to or from the
holdings in question.
(2) The competent authority shall inform and regularly update
the European Commission and the other Member States about the
epidemiology and spread of the foot-and-mouth disease virus.
DIAGNOSTIC TESTS AND STANDARDS FOR FOOT-AND-MOUTH DISEASE
AND FOR THE DIFFERENTIAL DIAGNOSIS OF OTHER VESICULAR
VIRUS DISEASES
In the context of this Schedule, 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.
PART A
Diagnostic tests
1. Recommended procedures
Diagnostic tests described in the OIE Manual, hereinafter the ‘OIE Manual’, as the
‘Prescribed Tests’ for international trade, constitute the reference tests for vesicular
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
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 rule 78(1)
decide to adopt more stringent testing procedures than those defined in the OIE
Manual.
2. Alternative procedures
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.
3. Standards and quality control
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 rule 78(1). 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 Schedule XIV, whichever is more stringent.
4. Procedures for adoption and review of tests and standards for vesicular virus
disease diagnosis.
Tests and standards for vesicular virus disease diagnosis shall be adopted in
accordance with the procedure referred to in rule 78(1).
The Commission may consider the scientific advice produced by the meetings of
the National Laboratories to be organised by the Community Reference Laboratory.
5. Compliance procedure
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 Schedule 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
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
required shall result in loss of recognition within the Community of all testing
performed after that deadline.
6. Selection and transportation of samples
An aliquot of field material should be sent to one of the laboratories listed in Part
A of Schedule 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 twenty-four 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 rules 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 rules of the Member States involved must
be ensured.
PART B
Standards
The protocols specified in the OIE Manual provide reference procedures for virus
isolation, antigen detection and antibody detection for vesicular diseases.
1. Foot-and-mouth disease
1.1. Antigen detection
The standards for detecting foot-and-mouth disease virus antigen shall be
established in accordance with the procedure referred to in rule 78(1) 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.
1.2. Virus isolation
The standards for foot-and-mouth disease virus detection shall be established in
accordance with the procedure referred to in rule 78(1) 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
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
which the laboratory maintains a diagnostic capacity.
1.3. Nucleic acid detection methods
The standards for the detection of foot-and-mouth disease viral RNA shall be
established in accordance with the procedure referred to in rule 78(1) 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.
1.4. Antibody detection (structural proteins)
The standards for the detection of antibody to foot-and-mouth disease virus shall
be established in accordance with the procedure referred to in rule 78(1) 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.
1.5. Antibody detection (non-structural proteins )
The standards for the detection of antibody to foot-and-mouth disease virus shall
be established in accordance with the procedure referred to in rule 78(1) after
consultation of the Community Reference Laboratory.
The Commission may arrange that standardised reference sera are adopted as a
result of standardization 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.
2. Swine vesicular disease (SVD)
Diagnosis of SVD must be carried out in accordance with Decision 2000/428/EC.
3. Other vesicular diseases
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 rule 78(1).
The competent authority 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.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
(1) The competent authority may order that, besides the
animals of susceptible species, animals of species not susceptible to
foot-and-mouth disease on the holding where an outbreak of foot-
and-mouth disease has been confirmed shall also be killed and
processed of in such a way as to avoid any risk of spreading the
foot-and-mouth disease virus
Provided that the provisions of this sub-rule do not apply to
animals of species not susceptible to foot-and-mouth disease which
may be isolated, effectively cleansed and disinfected, and provided
that they are individually identified, in the case of equidae in
accordance with European Community legislation, so as to allow
the control of their movement.
(2) The competent authority may apply the measures provided
for in rule 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 European 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 point 2.1.1.1 of Schedule III.
(3) The competent authority shall, immediately upon
confirmation of the first outbreak of foot-and-mouth disease,
prepare all arrangements necessary for emergency vaccination in an
area of at least the size of the surveillance zone established in
accordance with rule 19.
(4) The competent authority may apply the measures provided
for in rules 7 and 8.
COMMUNITY ANTIGEN AND VACCINE BANK
1. Conditions for the supply and storage of the concentrated inactivated
antigen supplied to the Community antigen and vaccine bank
(a) each antigen consists of a single homogeneous batch;
(b) 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;
(c) the antigen meets at least the requirements of the European
Pharmacopoeia and the relevant provisions of the OIE Manual;
(d) 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;
(e) if not otherwise specified in the texts referred to in point (c), the antigen
is purified to remove nonstructural 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.
2. Conditions for the formulation, finishing, bottling, labelling and delivery of
vaccines reconstituted from concentrated inactivated antigen supplied to the
Community antigen and vaccine bank
(a) rapid formulation into vaccine of the antigen;
(b) 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;
(c) a capacity to formulate from concentrated inactivated antigen in stock
(i)
up to one million doses of vaccine within four days of instruction
from the Commission;
(ii) additionally, up to four million doses of vaccine within 10 days of
instruction from the Commission;
(d) rapid bottling, labelling and distribution of the vaccine according to the
specific needs of the area where vaccination is to be carried out.
(1) Where an outbreak of foot-and-mouth disease
threatens to infect animals of susceptible species in a laboratory,
zoo, wildlife park, and fenced area or in bodies, institutes or centres
approved in accordance with Article 13(2) of European Directive
92/65/EEC and where animals are kept for scientific purposes or
purposes related to conservation of species or farm animal genetic
resources, the competent authority shall ensure that all appropriate
bio-security measures are taken to protect such animals from
infection. Those measures may include restricting access to public
institutions or making such access subject to special conditions.
(2) Where an outbreak of foot-and-mouth disease is confirmed
in one of the premises referred to in sub-rule (1), the competent
authority may decide to derogate from rule 10(1)(a), provided that
basic European Community interests, and in particular the animal
health status of other Member States, are not endangered and that
all necessary measures are in place to prevent any risk of spreading
foot-and-mouth disease virus.
(3) The decision referred to in sub-rule (2) shall immediately
be notified to the European Commission. In the case of farm animal
genetic resources, this notification shall include a reference to the
list of premises established in accordance with rule 72(2)(f), by
which the competent authority has identified these premises in
advance as breeding nucleus of animals of susceptible species
indispensable for the survival of a breed.
FUNCTIONS AND DUTIES OF NATIONAL LABORATORIES
The functions and duties of National Laboratories referred to in Article 68 for
foot-and-mouth and other vesicular diseases shall be as follows
1. 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,
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
1993.
2. National Laboratories must provide an uninterrupted service for diagnosing
vesicular viral diseases and must be equipped and skilled for providing a rapid initial
diagnosis.
3. 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.
4. National Laboratories must be equipped and skilled for large-scale
serological surveillance.
5. 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 competent 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.
6. 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.
7. National Laboratories should provide disease data to the competent
authority, which shall provide these data to the Community Reference Laboratory.
8. 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.
9. National Laboratories shall collaborate with the Community Reference
Laboratory and other National Laboratories to develop improved diagnostic methods
and exchange relevant materials and information.
10. National Laboratories shall participate in external quality assurance and
standardisation exercises organised by the Community Reference Laboratory.
11. National Laboratories shall use tests and standards that meet or exceed the
criteria laid down in Schedule XIII. National Laboratories shall provide the
Commission on request with data proving that the tests in use meet or exceed the
requirements.
12. 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.
13. 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 Schedule XII, point 1, but must have established procedures which ensure that
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
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.
(1) Where a case of foot-and-mouth disease is confirmed
in a slaughterhouse, a border inspection post established in
accordance with European Union Council 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 shall be killed without delay;
(b) the carcasses of the animals referred to in paragraph
(a) shall be processed under official supervision in
such a way as to avoid the risk of foot-and-mouth
disease virus spreading;
(c) other animal waste, including offal, of infected or
suspected of being infected and contaminated animals
shall be processed under official supervision in such a
way as to avoid the risk of foot-and-mouth disease
virus spreading;
(d) dung, manure and slurry shall be subject to
disinfection and shall only be removed for treatment in
accordance with point 5 of Section II in Part A of
Chapter III of Annex VIII to European Regulation No
1774/2002;
(e) cleansing and disinfection of buildings and equipment,
including vehicles or means of transport, shall take
place under the supervision of the official veterinarian
in accordance with rule 11 and with the instructions
laid down by the competent authority;
(f)
an epidemiological inquiry shall be carried out in
accordance with rule 13.
(2)
The competent authority shall ensure that the measures
provided for in rule 18 are applied in contact holdings.
(3) The competent authority shall ensure that no animals are
reintroduced for slaughter, inspection or transport in the premises
or means of transport referred to in sub-rule (1) until at least
twenty-four hours after completion of the cleansing and
disinfection operations referred to in sub-rule (1)(e).
(4) Where required by the epidemiological situation, in
particular where contamination of animals of susceptible species in
holdings adjacent to the premises or means of transport referred to
in sub-rule (1) must be suspected, the competent authority shall
ensure that by way of derogation from the definition of a ‘holding’
in rule 2, second sentence, an outbreak is declared on the premises
or means of transport referred to in sub-rule (1), and the measures
provided for in rules 10 and 19 are applied.
CRITERIA AND REQUIREMENTS FOR CONTINGENCY PLANS
The competent authority shall ensure that contingency plans meet at least the
following requirements
1. Provision shall be made to ensure the legal powers necessary for the
implementation of contingency plans and allow for a rapid and successful
eradication campaign.
2. Provision must be made to ensure access to emergency funds, budgetary
means and financial resources in order to cover all aspects of the fight against a foot-
and-mouth disease epizootic.
3. A chain of command shall be established guaranteeing a rapid and effective
decision-making process for dealing with foot-and-mouth disease epizootics. A
central decision-making unit shall be in charge of the overall direction of control
strategies and the chief veterinary officer shall be a member of this unit.
4. The competent authority must be prepared to immediately establish a
functional national disease control centre in the event of an outbreak, which shall
coordinate the implementation of all decisions taken in the central decision-making
unit. A permanently operational coordinator shall be appointed to guarantee the
prompt establishment of the centre.
5. Detailed plans shall be available to enable the competent authority to be
prepared for the immediate establishment of local disease control centres in the
event of foot-and-mouth disease outbreaks in order to implement disease control and
environment protection measures at a local level.
6. The competent authority shall ensure the cooperation between the national
disease control centre, the local disease control centres and environmental competent
authorities and bodies in order to ensure that actions on veterinary and
environmental safety issues are appropriately coordinated.
7. A permanently operational expert group shall be created, where necessary in
collaboration with other Member States, to maintain expertise and assist the relevant
authority in qualitative disease preparedness.
8. Provision must be made for adequate resources to ensure a rapid and
effective campaign, including personnel, equipment and laboratory capacity.
9. An up-to-date operations manual shall be available. It shall describe in
detail and in a comprehensive and practical way all the actions procedures,
instructions and control measures to be employed in handling an outbreak of foot-
and-mouth disease.
10. Detailed plans shall be available for emergency vaccination.
11. Staff shall be regularly involved in
11.1. training in clinical signs, epidemiological enquiry and control of epizootic
diseases;
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
11.2. real-time alert exercises, conducted as follows
11.2.1. two times within a five years period, the first of which should not have
started later than three years after the approval of the plan, or
11.2.2. during the five years period after an outbreak of a major epizootic disease
has been effectively controlled and eradicated, or
11.2.3. one of the two exercises referred to in paragraph 11.2.1 is replaced by a
real-time exercise required within the framework of contingency plans for other
major epidemic diseases affecting terrestrial animals, or
11.2.4. by way of derogation from paragraph 11.2.1 and subject to appropriate
provisions in the contingency plan, Malta may arrange for the participation in and
contribution to real-time exercises carried out in a neighbouring Member States and
alarm-drills are carried out as provided for in paragraph (g)(ii) of Annex VII of
European Union Council Directive 2001/89/EC in relation to all animals of species
susceptible to foot-and-mouth disease.
11.3. Training in communication skills to provide ongoing disease awareness
campaigns for authorities, farmers and veterinarians.
12. Contingency Plans shall be prepared taking into account the resources
needed to control a large number of outbreaks occurring within a short time and
caused by several antigenically distinct serotypes or strains as it may be necessary
amongst others in the case of deliberate release of foot-and-mouth disease virus.
13. Without prejudice to veterinary requirements, contingency plans shall be
prepared with a view to ensuring that in the event of an outbreak of foot-and-mouth
disease, any mass disposal of animal carcasses and animal waste is done without
endangering human health and without using processes or methods which prevent
any avoidable damage to the environment and in particular
(i)
with a minimum risk to soil, air, surface and groundwater, to plants and
animals,
(ii) with a minimum nuisance through noise or odours,
(iii) with a minimum adverse effect to the countryside or places of special
interest.
14. Such plans shall include the identification of appropriate sites and
undertakings for the treatment or disposal of animal carcasses and animal waste in
the event of an outbreak.
15. The competent authority shall ensure that farmers, the rural populace and
the population in general are kept informed. Direct and accessible contact shall be
provided for the inhabitants of affected areas (inter alia via helplines), as well as
information through the national and regional media.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
(1) In the case of holdings which consist of two or more
sep arate p rod uctio n un its, the comp etent autho rit y m ay, in
exceptional cases and after considering the risks, derogate from
rule 10(1)(a) as regards production units of such holdings not
affected by foot-and-mouth disease.
(2) The derogation provided for in sub-rule (1) shall only be
granted after the official veterinarian has confirmed at the time of
the official investigation referred to in rule 4(2), that the following
conditions to prevent the spread of foot-and-mouth disease virus
between the production units referred to in sub-rule (1), have been
in place for at least two incubation periods prior to the date the
outbreak of foot-and-mouth disease was identified on the holding
(a) the structure, including the administration, and size of
the premises allow a complete separation of housing
and keeping for the distinct herds of animals of
susceptible species, including separate air space;
(b) the operations on the different production units, and in
particular stable and pasture management, feeding,
removal of dung or manure are completely separated
and carried out by different personnel;
(c) the machinery, working animals of species not
susceptible to foot-and-mouth disease, equipment,
installations, instruments and disinfection facilities
used in the production units are completely separate.
(3) In relation to milk, a derogation from rule 10(1)(d) may be
granted to a holding producing milk provided that
(a) such holding complies with the conditions set out in
sub-rule (2), and
(b) milking in each unit is carried out separately, and
(c) depending on the intended use, the milk is subject to at
least one of the treatments described in Part A or Part
B of Schedule IX.
(4) Where a derogation is granted in accordance with sub-rule
(1), the competent authority shall lay down in advance detailed
rules for applying such derogation. The competent authority shall
notify the European Commission of the derogation and provide
details of the measures taken.
PART A
Measures in case of confirmation of the presence of foot-and-mouth disease
in wild animals
1. As soon as confirmation of a primary case of foot-and-mouth disease in wild
animals of susceptible species has taken place, in order to reduce the spread of
disease, the competent authority shall immediately
(a) notify the primary case in accordance with Schedule II;
(b) epidemiologists. The expert group shall assist the competent authority
(i)
studying the epidemiological situation and defining an infected
area, in accordance with the provisions laid down in point 4(b) of
Part B,
(ii) 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,
(iii) drawing up the eradication plan to be submitted to the
Commission in accordance with Part B,
(iv) carrying out audits to verify the effectiveness of the measures
adopted to eradicate foot-and-mouth disease from the infected
area;
(c) place under official surveillance holdings keeping animals of
susceptible species in the defined infected area and shall in particular
order that
(i)
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,
(ii) 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,
(iii) no animal of a susceptible species enter or leave the holding save
where authorised by the competent authority having regard to the
epidemiological situation,
(iv) appropriatemeans of disinfection be used at the entrance and exits
of buildings housing animals of susceptible species and of the
holding itself,
(v) 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,
(vi) all dead or diseased animals of susceptible species with foot-and-
mouth disease symptoms on a holding be tested for the presence
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
of foot-and-mouth disease,
(vii)
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,
(viii) animals of susceptible species, their semen, embryos or ova shall
not be moved from the infected area for the purpose of intra-
Community trade;
(d) 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 Schedule 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, the
competent authority shall apply the measures laid down in Article 11(2)
of European Union Council Directive 92/45/EEC. Parts not intended for
human consumption shall be processed under official supervision;
(e) 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.
2. By way of derogation to the provisions in point 1 specific measures may be
adopted in accordance with the procedure referred to in rule 78(2), if a case of foot-
and-mouth disease has occurred in wild animals in an area of Malta where extensive
keeping of domestic animals of susceptible species makes certain provisions in
paragraph 1 inapplicable.
PART B
Plans for the eradication of foot-and-mouth disease in wild animals
1. Without prejudice to the measures laid down in Part A, the competent
authority shall submit to the European Commission within ninety days from the
confirmation of the primary case of foot-and-mouth disease in wild animals a written
plan of the measures taken to eradicate the disease in the area defined as infected and
of the measures applied on the holdings in that area.
2. The European Commission shall examine the plan in order to determine
whether it permits the desired objective to be attained. The plan, if necessary with
amendments, shall be approved in accordance with the procedure referred to in rule
78(2). The plan may subsequently be amended or supplemented to take account of
developments in the situation.
If these amendments concern the re-definition of the infected area, the competent
authority 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, the competent authority
shall submit the amended plan to the European Commission for examination and
possible approval in accordance with the procedure referred to in rule 78(2).
3. After the measures provided for in the plan mentioned in paragraph 1 have
been approved, they shall replace the initial measures laid down in Part A, on a date
which shall be decided upon when approval is given.
4. The plan mentioned in paragraph 1 shall contain information on
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
(a) the results of the epidemiological investigations and controls carried out
in accordance with Part A and the geographical distribution of the
disease;
(b) a defined infected area within Malta.
When defining the infected area, the competent authority shall take into
account
(i)
the results of the epidemiological investigations carried out and
the geographical distribution of the disease,
(ii) the wild animal population in the area,
(iii) the existence of major natural or artificial obstacles to movements
of wild animals;
(c) the organisation of close cooperation between wildlife biologists,
hunters, hunting organisations, the wildlife protection services and
veterinary services (animal health and public health);
(d) the information campaign to be enforced to increase hunters’ awareness
of the measures they have to adopt in the framework of the eradication
plan;
(e) 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;
(f)
the approximate number of groups of wild animals referred to in
paragraph (e) and their size in and around the infected area;
(g) 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;
(h) 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;
(i)
the measures adopted to reduce the population of wild animals and in
particular young animals of susceptible species in the wild animal
population;
(j)
the requirements to be complied with by hunters in order to avoid any
spread of the disease;
(k) the method of removal of wild animals found dead or shot, which shall
be based on
(i) processing under official supervision, or
(ii) inspection by an official veterinarian and laboratory tests as
provided for in Schedule 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, the competent
authority shall apply the measures laid down in Article 11(2) of
European Council Directive 92/45/EEC. Parts not intended for
human consumption shall be processed under official supervision;
(l)
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
(i)
the geographical area where the animal was found dead or shot,
(ii)
the date on which the animal was found dead or shot,
(iii)
the person who found or shot the animal,
(iv)
the age and sex of the animal,
(v)
if shot: symptoms before shooting,
(vi)
if found dead: the state of the carcass,
(vii)
laboratory findings;
(m) 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;
(n) 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;
(o) the authority charged with supervising and coordinating the departments
responsible for implementing the plan;
(p) 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;
(q) the disease monitoring measures that shall be enforced after a period of
at least twelve 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 twelve months and
shall at least include the measures already enforced in accordance with
points (g), (k) and (l).
5. A report concerning the epidemiological situation in the defined area and the
results of the eradication plan shall be transmitted to the European Commission and
to the other Member States every six months.
6. More detailed rules relating to the establishment of plans for the eradication
of foot-and-mouth disease in wild animals may be adopted in accordance with the
procedure referred to in rule 78(2).
(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 rules 4(1) or 10(1) or
from a holding referred to in rules 4(1) or 10(1) to other holdings.
(2) Contact holdings shall be subject to the measures provided
for in rules 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 definition in Schedule I and the survey requirements provided
for in point 2.1.1.1 of Schedule III.
(3) The competent authority shall prohibit the removal of all
animals from contact holdings during a period corresponding to the
incubation period specified for the species which has to undergo an
‘emergency slaughter’ in terms of the definition in rule 2. However,
the competent authority may, by way of derogation from rule
4(3)(d), authorise the transport of animals of susceptible species
u n d e r o ff i c i a l s u p e r v i s i o n d i r e c t l y t o t h e c l o s e s t p o s s i b l e
designated slaughterhouse for emergency slaughter. Prior to
granting such derogation, the official veterinarian shall at least
carry out the clinical examinations provided for in point 1 of
Schedule III.
(4) Where the competent authority considers that the
epidemiological situation permits, it may limit the recognition as a
contact holding provided for in sub-rule (1), to one identified
epidemiological production unit of the holding and to the animals
contained therein, provided that the epidemiological production
unit complies with rule 17.
(5) Where an epidemiological link between an outbreak of
foot-and-mouth disease and premises or means of transportation
referred to in rules 15 and 16 respectively cannot be excluded, the
competent authority shall ensure that the measures provided for in
rule 4(2) and (3) and in rule 5 shall apply to such premises or
means of transportation. The competent authority may decide to
apply the measures provided for in rule 8.
(1) The competent authority shall ensure that, without
prejudice to measures provided for in rule 7, at least the measures
laid down in sub-rules (2), (3) and (4) are taken immediately after
an outbreak of foot-and-mouth disease is confirmed.
(2) The competent authority shall establish a protection zone
based on a minimum radius of three kilometres and a surveillance
zone based on a minimum radius of ten kilometres centred on the
outbreak of foot-and-mouth disease referred to in sub-rule (1). The
geographical delimitation of those zones shall take account of
administrative boundaries, natural barriers, supervision facilities
and technological progress which makes it possible to predict the
probable dispersion of the foot-and-mouth disease virus by air or
any other means. That delimitation shall be reviewed, if necessary,
in the light of such elements.
(3) The competent authority shall ensure that the protection and
surveillance zones are marked by posting signs of sufficient size on
roads entering the zones.
(4) In order to ensure full coordination of all measures
necessary to eradicate foot-and-mouth disease as quickly as
possible, national and local disease control centres as referred to in
rules 69 and 71 shall be established. For the purpose of carrying out
the epidemiological inquiry as provided for in rule 13, those centres
shall be assisted by an expert group as provided for in rule 73.
(5) The competent authority shall without delay trace animals
dispatched from the zones during the period of at least twenty-one
days before the estimated date of earliest infection on a holding in
the protection zone and they shall inform the competent authorities
in other Member States and the European Commission about their
results from tracing of animals.
(6) The competent authority shall collaborate in tracing fresh
meat, meat products, raw milk and raw milk products derived from
animals of susceptible species originating in the protection zone
and produced between the date of estimated introduction of the
foot-and-mouth disease virus until the date the measures provided
for in sub-rule (2) come into force. Such fresh meat, meat products,
raw milk and raw milk products shall be treated in accordance with
ru les 2 3, 24 and 2 5 respecti vel y o r detai ned un til p ossibl e
contamination with the foot-and-mouth disease virus is officially
ruled out.
(1) The competent authority shall ensure that at least the
following measures are applied in the protection zone without
delay
(a) the registration of all holdings with animals of
susceptible species and the establishment of a census
of all animals present on these holdings shall be
carried out as soon as possible and kept up to date;
(b) all holdings with animals of susceptible species shall
periodically undergo a veterinary inspection, carried
out in such a way as to avoid the spread of foot-and-
mouth disease virus possibly present on the holdings,
which shall include in particular the relevant
documentation, notably the records referred to in
paragraph (a) and the measures applied to prevent the
introduction or escape of foot-and-mouth disease virus
and which may include clinical inspection as described
in point 1 of Schedule III or taking of samples from
animals of susceptible species in accordance with
point 2.1.1.1 of Schedule III;
(c) animals of susceptible species shall not be removed
from the holding on which they are kept.
(2)
By way of derogation from sub-rule (1)(c), animals of
susceptible species may be transported, under official supervision
f o r t h e p u r p o s e o f e m e rg e n c y s l a u g h t e r, d i r e c t l y t o a
slaughterhouse situated inside the same protection zone or, if that
zone has no slaughterhouse to a slaughterhouse outside the zone
designated by the competent authority in means of transport
cleansed and disinfected under official control after each transport
operation.
(3) The movement referred to in the sub-rule (1) shall only be
authorised if the competent authority is satisfied, on the basis of a
clinical examination in accordance with point 1 of Schedule III by
the official veterinarian of all the animals of susceptible species
present on the holding and after evaluation of epidemiological
circumstances, that there is no reason to suspect the presence of
infected or contaminated animals on the holding. The meat of such
animals shall be subject to the measures provided for in rule 23.
The competent authority shall ensure that the following
activities are prohibited within the protection zone
(a) movement between holdings and transport of animals
of susceptible species;
(b) fairs, markets, shows and other gatherings of animals,
including collection and dispersion of susceptible
species;
(c) itinerant service for breeding of animals of susceptible
species;
(d) artificial insemination of and collection of ova and
embryos from animals of susceptible species.
(1) The competent authority may extend the prohibitions
in rule 21 to
(a) movement or transport of animals of non-susceptible
species between holdings situated within the zone or
out of or into the protection zone;
(b) transit of animals of all species through the protection
zone;
(c) events with gatherings of people with possible contact
with animals of susceptible species, where there is a
risk of spreading the foot-and-mouth disease virus;
(d) artificial insemination of, or collection of ova and
embryos from, animals of species not susceptible to
foot-and-mouth disease;
(e) movement of means of transport designed for the
transportation of animals;
(f)
the slaughter on the holding of animals of susceptible
species for private consumption;
(g) transport of goods referred to in rule 31 to holdings
keeping animals of susceptible species.
(2)
The competent authority may authorise
(a) the transit of animals of all species through the
protection zone undertaken exclusively via major
highways;
(b) the transport of animals of susceptible species which
have been certified by the official veterinarian as
coming from holdings outside the protection zone and
transported on designated routes directly to designated
slaughterhouses for immediate slaughter, provided that
the means of transport are cleansed and disinfected
after delivery under official supervision at the
slaughterhouse and such decontamination of transport
is recorded in the logbook of the means of transport;
(c) the artificial insemination of animals on a holding
carried out by the personnel of that holding by use of
semen collected from animals on that holding or
semen stored on that holding or semen delivered from
a semen collection centre to the outside perimeter of
that holding;
(d) the movement and transport of equidae taking into
account the conditions set out in Schedule VI;
(e) the transport, under certain conditions, of goods
referred to in rule 31 to holdings keeping animals of
susceptible species.
(1) The competent authority shall ensure that the placing
on the market of fresh meat, minced meat and meat preparations,
derived from animals of susceptible species originating in the
protection zone, shall be prohibited.
(2) The competent authority shall ensure that the placing on the
market of fresh meat, minced meat and meat preparations from
animals of susceptible species produced in establishments situated
in the protection zone, shall be prohibited.
(3) The competent authority shall ensure that fresh meat,
minced meat and meat preparations as referred to in sub-rule (1),
shall be marked in accordance with European Union Council
Directive 2002/99/EC and subsequently transported in sealed
containers to an establishment designated by the competent
authorities for transformation into meat products treated in
accordance with point 1 in Part A of Schedule VII of these rules.
(4) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to fresh meat, minced meat and meat
preparations which were produced on a date at least twenty-one
days before the estimated date of earliest infection on a holding in
the protection zone and which since production have been stored
and transported separately from such meats produced after that
date. Such meats must be readily distinguished from meats not
eligible for dispatch outside the protection zone by means of a clear
mark estab lish ed i n con form it y w it h Eu ro pean Com m un ity
legislation.
(5) By way of derogation, the prohibition provided for in sub-
rule (2), shall not apply to fresh meat, minced meat or meat
preparations obtained from establishments situated in the
protection zone under the following conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) only fresh meat, minced meat or meat preparations as
described in sub-rule (4), or fresh meat, minced meat
or meat preparations obtained from animals reared and
slaughtered outside the protection zone or from
animals transported to the establishment and
slaughtered therein in accordance with the provisions
in rule 22(2)(b) shall be processed in the
establishment;
(c) all such fresh meat, minced meat or meat preparations,
must bear the health mark in accordance with Chapter
XI of Annex I to European Union Council Directive
64/433/EEC or in the case of meat from other
biungulates the health mark provided for in Chapter III
of Annex I to European Union Council Directive 91/
495/EEC, or in the case of minced meat and meat
preparations the health mark as provided for in
Chapter VI of Annex I to European Union Council
Directive 94/65/EC;
(d) during the whole production process all such fresh
meat, minced meat or meat preparations must be
clearly identified, and transported and stored
separately from fresh meat, minced meat or meat
preparations which are not eligible for dispatch outside
the protection zone in accordance with these rules.
(6) Compliance with the conditions in sub-rule (5) shall be
certified by the competent authority for fresh meat, minced meat
and meat preparations intended for intra-European Community
trade. The competent authority shall supervise the control of
compliance undertaken by the local veterinary authority and, in the
case of intra-European Community trade, communicate to other
Member States and the European Commission a list of those
establishments which it has approved for the purpose of such
certification.
(7) Derogation from the prohibition provided for in sub-rule (1)
may be granted subject to specific conditions adopted in
accordance with European Union legislation, in particular with
regard to the health marking of meat produced from animals of
susceptible species originating in protection zones maintained for
more than thirty days.
(1) The competent authority shall ensure that the placing
on the market of meat products produced from meat derived from
animals of susceptible species originating in the protection zone
shall be prohibited.
(2) By way of derogation, the prohibition in sub-rule (1) shall
not apply to meat products which have either undergone one of the
treatments as set out in point 1 in Part A of Schedule VII or which
have been produced from meats referred to in rule 23(4).
(1) The competent authority shall ensure that the placing
on the market of milk derived from animals of susceptible species
originating in the protection zone and of milk products produced
from such milk shall be prohibited.
(2) The competent authority shall ensure that the placing on the
market of milk and milk products from animals of susceptible
species produced in an establishment situated in the protection zone
shall be prohibited.
(3) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to milk and milk products derived from
animals of susceptible species originating in the protection zone
which were produced on a date at least twenty-one days before the
estimated date of earliest infection on a holding in the protection
zone and which since production have been stored and transported
separately from milk and milk products produced after that date.
(4) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to milk derived from animals of susceptible
species originating in the protection zone and milk products
produced from such m ilk which have undergone one of the
treatments as set out in Parts A or B of Schedule IX, depending on
the use of the milk or milk products. The treatment shall be carried
out under the conditions set out in sub-rule (6) in establishments
referred to in sub-rule 5 or, if there is no establishment situated in
th e p r ot ect io n zon e, i n est abl i shm en ts sit ua ted o ut sid e th e
protection zone under the conditions set down in sub-rule 8.
(5) By way of derogation, the prohibition provided for in sub-
rule (2) shall not apply to milk and milk products which have been
prepared in establishments situated in the protection zone under the
conditions set out in sub-rule (6).
(6) Establishments referred to in sub-rules (4) and (5) shall
comply with the following conditions
(a) the establishment shall be operated under permanent
and strict official control;
(b) all milk used in the establishment shall either comply
with sub-rules (3) and (4) or the raw milk shall be
obtained from animals outside the protection zone;
(c) during the whole production process the milk shall be
clearly identified and transported and stored separately
from raw milk and raw milk products which are not
destined for dispatch outside the protection zone;
(d) transport of raw milk from holdings situated outside
the protection zone to the establishments shall be
carried out in vehicles which were cleaned and
disinfected prior to the transport operation, and which
have had no subsequent contact with holdings in the
protection zone keeping animals of susceptible
species.
(7) Compliance with the conditions in sub-rule 6 shall be
certified by the competent authority for milk intended for intra-
European Com mu nity trade. Th e co mpetent authority shall
supervise the control of compliance undertaken by the local
veterinary authority and, in the case of intra-European Community
trade, communicate to other Member States and the European
Commission a list of those establishments which it has approved
for the purpose of such certification.
(8) Transport of raw milk from holdings situated within the
protection zone to establishments situated outside the protection
zone and the processing of that milk shall be subject to the
following conditions
(a) processing in establishments situated outside the
protection zone of raw milk produced from animals of
susceptible species kept within the protection zone
shall be authorised by the competent authorities;
(b) the authorisation shall include instructions on and
designation of the transport route to the designated
establishment;
(c) transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport
operation, which are constructed and maintained in
such a way that there is no leakage of milk during
transport and which are equipped to avoid aerosol
dispersion during the loading and unloading of the
milk;
(d) before leaving the holding from where milk of animals
of susceptible species was collected the connection
pipes, tyres, wheel cases, the lower parts of the vehicle
and any spillage of milk are cleansed and disinfected
and after the last disinfection and before leaving the
protection zone the vehicle had no subsequent contact
with holdings in the protection zone keeping animals
of susceptible species;
(e) the means of transport are strictly assigned to a
defined geographical or administrative area, they are
marked accordingly and may only be moved to another
area after cleansing and disinfection under official
supervision.
(9) The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
protection zone to a laboratory other than a veterinary diagnostic
laboratory approved for diagnosis of foot-and-mouth disease and
the processing of the milk in such laboratories shall be forbidden.
(1) The competent authority shall ensure that the placing
on the market of semen, ova and embryos derived from animals of
susceptible species originating in the protection zone shall be
prohibited.
(2) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to frozen semen, ova and embryos collected
and stored at least twenty-one days before the estimated date of
earliest infection with the foot-and-mouth disease virus on a
holding in the zone.
(3) Frozen semen collected in accordance with European
Community legislation after the date of infection referred to in sub-
rule (2), shall be stored separately and shall only be released after
(a) all the measures relating to the outbreak of foot-and-
mouth disease have been removed in accordance with
rule 36, and
(b) all animals accommodated in the semen collection
centre have undergone a clinical examination, and
samples taken in accordance with point 2.2 of
Schedule III have been subjected to a serological test
to substantiate the absence of infection in the semen
collection centre concerned, and
(c) the donor animal has been subjected with negative
result to a serological test for the detection of
antibodies against the foot-and-mouth disease virus on
a sample taken not earlier than 28 days after the
collection of the semen.
(1) The competent authority shall ensure that the transport
and distribution of dung or manure from holdings and premises or
means of transport referred to in rule 16 situated in the protection
zone where animals of susceptible species are kept, shall be
prohibited within the protection zone.
(2) By way of derogation from the prohibition in sub-rule (1)
the competent authority may authorise the removal of manure of
animals of susceptible species from a holding situated in the
protection zone to a designated plant for treatment in accordance
with point 5 of Section II in Part A of Chapter III of Annex VIII to
European Regulation 1774/2002 or for intermediate storage.
(3) By way of derogation from the prohibition in sub-rule (1)
the competent authority may authorise the removal of manure of
animals of susceptible species from holdings situated in the
protection zone which are not subject to the measures provided for
in rules 4 or 10 for distribution on designated fields under the
following conditions
(a) the entire volume of manure has been produced at least
twenty-one days before the estimated date of earliest
infection on a holding in the protection zone and the
manure or dung is distributed close to the ground and
in sufficient distance from holdings keeping animals of
susceptible species and immediately incorporated into
the ground, or
(b) in the case of manure from bovine animals or pigs
(i)
an examination by an official veterinarian of all
the animals on the holding has ruled out the
presence of animals suspected of being infected
with the foot-and-mouth disease virus, and
(ii) the entire volume of manure has been produced
at least four days prior to the examination
referred to in sub-paragraph (i), and
(iii) the manure is incorporated into the ground on
designated fields close to the holding of origin
and in sufficient distance to other holdings
keeping animals of susceptible species in the
protection zone.
(4) The competent authority shall ensure that any authorisation
to remove dung or manure from a holding keeping animals of
susceptible species is subject to stringent measures to avoid spread
of the foot-and-mouth disease virus, in particular by ensuring
cleansing and disinfection of the leak-proof transport vehicles after
loading and before leaving the holding.
(1) The competent authority shall ensure that the placing
on the market of hides and skins of animals of susceptible species
originating in the protection zone, shall be prohibited.
(2) By way of derogation, the prohibition as provided for in
sub-rule (1) shall not apply to hides and skins which either
(a) were produced at least twenty-one days before the
estimated date of infection on the holding referred to
in rule 10(1), and that have been stored separately
from hides and skins produced after that date; or
(b) comply with the requirements laid down in point 2 in
Part A of Schedule VII.
(1) The competent authority shall ensure that the placing
on the market of sheep wool, ruminant hair and pig bristles
originating in the protection zone shall be prohibited.
(2) By way of derogation, the prohibition as provided for in
sub-rule (1) shall not apply to unprocessed wool, hair and bristles
which
(a) were produced at least twenty-one days before the
estimated date of infection on the holding referred to
in rule 10(1) and have been stored separately from
wool, hair and bristles produced after that date; or
(b) comply with the requirements laid down in point 3 in
Part A of Schedule VII.
(1) The competent authority shall ensure that the placing
o n t h e m a r k e t o f a ni m a l p r o d u c t s d e r i v e d f r o m a n i m a l s o f
susceptible species not referred to in rules 23 to 29 shall be
prohibited.
(2) By way of derogation, the prohibitions provided for in sub-
rule (1) shall not apply to products referred to in sub-rule (1)
which
(a) either have been produced at least twenty-one days
before the estimated date of infection on the holding
referred to in rule 10(1) and have been stored and
transported separately from products produced after
that date, or
(b) have undergone the treatment in accordance with point
4 in Part A of Schedule VII, or
(c) for specific products, comply with the appropriate
requirements in points 5 to 9 in Part A of Schedule
VII, or
(d) are composite products which are not subject to further
treatment containing products of animal origin which
either have undergone a treatment ensuring destruction
of possible foot-and-mouth disease virus or have been
obtained from animals not subject to restrictions under
the provisions of these rules, or
(e) are packed products intended for use as in-vitro
diagnostic or laboratory reagents.
(1) The competent authority shall ensure that the placing
on the market of feed, forage, hay and straw originating in the
protection zone shall be prohibited.
(2) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to feed, forage, hay and straw
(a) produced at least twenty-one days before the estimated
date of infection on holdings referred to in rule 10(1),
and stored and transported separately from feed,
forage, hay and straw produced after that date; or
(b) intended for use within the protection zone, subject to
authorisation by the competent authorities; or
(c) produced on premises not keeping animals of
susceptible species; or
(d) produced in establishments not keeping animals of
susceptible species and sourcing the raw material from
premises referred to in paragraph (c) or from premises
situated outside the protection zone.
(3) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to forage and straw produced on holdings
keeping animals of susceptible species which comply with the
requirements in point 1 in Part B of Schedule VII.
(1) Any derogation from the prohibitions provided for in
rules 22 to 31 shall be granted by a specific decision of the
competent authority only after it has satisfied itself that all relevant
requirements have been met for a sufficient period before the
products leave the protection zone, and that there is no risk of
spreading the foot-and-mouth disease virus.
(2) Any derogation from the prohibitions provided for in rules
23 to 31 requires, in the case of intra-European Community trade,
additional certification by the competent authority.
(3) Detailed rules for the implementation of the measures
provided for in sub-rule (2) may be adopted in accordance with the
European Community legislation.
In addition to the measures applicable in the protection
zone in accordance with these rules, the competent authority may
take additional national measures which are deemed necessary and
proportionate to contain the foot-and-mouth disease virus taking
into account the particular epidemiological, animal husbandry,
commercial and social conditions prevailing in the affected area.
The competent authority shall inform the European Commission
and the other Member States about such additional measures.
(1) The competent authority shall ensure that the measures
applied in the protection zone are maintained until the following
requirements have been met
(a) at least fifteen days have elapsed since the killing and
safe disposal of all the animals of susceptible species
from the holding referred to in rule 10(1) and the
completion of the preliminary cleansing and
disinfection on that holding, carried out in accordance
with rule 11;
(b) a survey has been concluded with negative results in
all holdings keeping animals of susceptible species
and situated within the protection zone.
(2) After the removal of the measures specific to the protection
zone, the measures applied in the surveillance zone as provided for
in rules 35 to 40, shall continue to apply for at least fifteen days
until those measures are removed in accordance with rule 42.
(3) The survey referred to in sub-rule (1)(b) shall be carried out
to substantiate the absence of infection and at least in compliance
with the criteria of point 1 of Schedule III and shall include the
measures provided for in point 2.3 of Schedule III based on the
criteria set out in points 2.1.1. and 2.1.3. of Schedule III.
(1) The competent authority shall ensure that the measures
provided for in rule 20(1) are applied in the surveillance zone.
(2) By way of derogation from the prohibition provided for in
rule 20(1)(c) and where there is no or insufficient slaughter
capacity available within the surveillance zone, the competent
authorities may authorise the removal from holdings situated in the
surveillance zone of animals of susceptible species for transporting
them directly and under official supervision for slaughter to a
slaughterhouse located outside the surveillance zone, subject to the
following conditions
(a) the records referred to in rule 20(1) have been
subjected to official control, and the epidemiological
situation of the holding does not indicate any suspicion
of infection or contamination with the foot-and-mouth
disease virus, and
(b) all the animals of susceptible species on the holding
have been subjected with negative result to an
inspection by the official veterinarian, and
(c) a representative number of animals, taking into
account the statistical parameters in point 2.2 of
Schedule III, has been subjected to thorough clinical
examination to rule out the presence or suspicion of
clinically infected animals, and
(d) the slaughterhouse is designated by the competent
authority and located as near to the surveillance zone
as possible, and
(e) the meat produced from such animals shall be subject
to the treatment specified in rule 37.
(1) The competent authority shall ensure that animals of
susceptible species shall not be removed from holdings within the
surveillance zone.
(2) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to movement of animals for one of the
following purposes
(a) for leading them without coming into contact with
animals of susceptible species of different holdings to
pasture situated within the surveillance zone not
earlier than fifteen days after the last outbreak of foot-
and-mouth disease has been recorded in the protection
zone;
(b) for transporting them directly, and under official
supervision, for the purpose of slaughter to a
slaughterhouse located inside the same zone;
(c) for transporting them in accordance with rule 35(2);
(d) for transporting them in accordance with rule 22(2)(a)
and (b).
(3) Movements of animals provided for in sub-rule (2)(a) shall
be authorised by the competent authority only after an examination
by an official veterinarian of all the animals of susceptible species
on the holding, including testing of samples taken in accordance
with point 2.2 of Schedule III, has ruled out the presence of animals
suspected of being infected or animals suspected of being
contaminated.
(4) Movements of animals provided for in sub-rule (2)(b) shall
be authorised by the competent authority only after the measures
provided for in rule 37(2)(a) and (b) have been completed with
satisfactory results.
(5) The competent authority shall without delay trace animals
of susceptible species dispatched from the surveillance zone during
a period of least twenty-one days before the estimated date of
earliest infection on a holding in the surveillance zone and they
shall inform the competent authorities in other Member States
about their results from tracing animals.
(1) The competent authority shall ensure that the placing
on the market of fresh meat, minced meat and meat preparations
derived from animals of susceptible species originating in the
surveillance zone and of meat products produced from such meats
shall be prohibited.
(2) The competent authority shall ensure that the placing on the
market of fresh meat, minced meat, meat preparations and meat
products from animals of susceptible species produced in
establishments situated in the surveillance zone shall be prohibited.
(3) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to fresh meat, minced meat and meat
preparations which were produced on a date at least twenty-one
days before the estimated date of earliest infection on a holding in
the corresponding protection zone and which since production have
been stored and transported separately from such meats produced
after that date. Such meats must be readily distinguished from
meats not eligible for dispatch outside the surveillance zone by
means of clear mark established in conformity with European
Community legislation.
(4) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to fresh meat, minced meat and meat
preparations which were produced from animals transported to the
slaughterhouse under conditions at least as strict as provided for in
rule 35(2)(a) to (e) under the condition that the meat is subject to
the measures provided for in sub-rule (5).
(5) By way of derogation, the prohibition provided for in sub-
rule (2), shall not apply to fresh meat, minced meat or meat
preparations obtained from establishments situated in the
surveillance zone under the following conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) only fresh meat, minced meat or meat preparations as
described in sub-rule (4) and subject to the additional
conditions provided for in Part B of Schedule VIII or
obtained from animals reared and slaughtered outside
the surveillance zone or obtained from animals
transported in accordance with the provisions in rule
22(2)(b) shall be processed in the establishment;
(c) all such fresh meat, minced meat or meat preparations
must bear the health mark in accordance with Chapter
XI of Annex I to European Union Council Directive
64/433/EEC or in the case of meat from other
biungulates the health mark provided for in Chapter III
of Annex I to European Union Council Directive 91/
495/EEC, or in the case of minced meat and meat
preparations the health mark as provided for in
Chapter VI of Annex I to European Union Council
Directive 95/65/EC;
(d) during the whole production process all such fresh
meat, minced meat or meat preparations must be
clearly identified, and transported and stored
separately from fresh meat, minced meat or meat
preparations which are not eligible for dispatch outside
the surveillance zone in accordance with these rules.
(6) By way of derogation, the prohibition provided for in sub-
rule (1), shall not apply to meat products produced from fresh meat
obtained from animals of susceptible species originating in the
surveillance zone which was marked with the health mark provided
for European Union Council Directive 2002/99/EC and transported
under official supervision to a designated establishment for
treatment in accordance with point 1 in Part A of Schedule VII.
(7) By way of derogation, the prohibition provided for in sub-
rule (2), shall not apply to meat products produced in
establishm ent s situated i n the surveillance zone and either
complying with the provisions in sub-rule (6), or produced from
meat complying with sub-rule (5).
(8) Compliance with the conditions in sub-rules (5) and (7)
shall be certified by the competent authority for fresh meat, minced
meat and meat preparations intended for intra-European
Community trade. The competent authority shall supervise the
control of compliance undertaken by the Veterinary Services and in
the case of intra-European Community trade communicate to other
Member States and the European Commission a list of those
establishments which it has approved for the purpose of such
certification.
(9) Derogation from the prohibition provided for in sub-rule (1)
may be granted subject to specific conditions adopted in
accordance with European Community legislation, in particular
with regard to the health marking of meat produced from animals of
susceptible species originating in surveillance zone maintained for
more than thirty days.
(1) The competent authority shall ensure that placing on
the market of milk derived from animals of susceptible species
originating in the surveillance zone and of milk products produced
from such milk shall be prohibited.
(2) The competent authority shall ensure that the placing on the
market of milk and milk products from animals of susceptible
species produced in the surveillance zone shall be prohibited.
(3) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to milk and milk products derived from
animals of susceptible species originating in the surveillance zone
which were produced on a date at least twenty-one days before the
estimated date of earliest infection on a holding in the
corresponding protection zone and which since production have
been stored and transported separately from milk and milk products
produced after that date.
(4) By way of derogation, the prohibition provided for in sub-
rule (1) shall not apply to milk derived from animals of susceptible
species originating in the surveillance zone and milk products
produced from such m ilk which have undergone one of the
treatments as set out in Parts A or B of Schedule IX depending on
the use of the milk or milk products. The treatment shall be carried
out under the condition set out in sub-rule (6) in establishments
referred to in sub-rule (5) or, if there is no establishment situated in
th e su r vei l la nc e zo ne , i n e sta bl i s hm e nt s de s i gn a t e d b y t h e
competent authorities and situated outside the protection and
surveillance zones.
(5) By way of derogation, the prohibition provided for in sub-
rule (2) shall not apply to milk and milk products which have been
prepared in establishments situated in the surveillance zone under
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
the conditions set out in sub-rule (6).
(6) Establishments referred to in sub-rules (4) and (5) shall
comply with the following conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) all milk used in the establishment shall either comply
with sub-rule (4) or be obtained from animals outside
the surveillance and protection zone;
(c) throughout the production process the milk shall be
clearly identified and transported and stored separately
from milk and milk products which are not destined
for dispatch outside the surveillance zone;
(d) transport of raw milk from holdings situated outside
the protection and surveillance zone to the
establishments shall be carried out in vehicles which
were cleaned and disinfected prior to the transport
operation, and which have had no subsequent contact
with holdings in the protection and surveillance zones
keeping animals of susceptible species.
(7) Compliance with the conditions in sub-rule (6) shall be
certified by the competent authority for milk intended for intra-
Euro pean Com muni ty trade. The competent authority shall
supervise the control of compliance undertaken by the Veterinary
Services and, in the case of intra-European Community trade,
communicate to other Member States and the European
Commission a list of those establishments which it has approved
for the purpose of such certification.
(8) Transport of raw milk from holdings situated within the
surveillance zone to establishments situated outside the protection
and surveillance zones and the processing of that milk shall be
subject to the following conditions
(a) processing in establishments situated outside the
protection and surveillance zones of raw milk
produced from animals of susceptible species kept
within the surveillance zone shall be authorised by the
competent authorities;
(b) the authorisation shall include instructions on and
designation of the transport route to the designated
establishment;
(c) transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport
operation, which are constructed and maintained in
such a way that there is no leakage of milk during
transport and which are equipped to avoid aerosol
dispersion during the loading and unloading of the
milk;
(d) before leaving the holding from where milk of animals
of susceptible species was collected, the connection
pipes, tires, wheel cases, the lower parts of the vehicle
and any spillage of milk are cleansed and disinfected
and after the last disinfection and before leaving the
surveillance zone the vehicle had no subsequent
contact with holdings in the protection and
surveillance zones keeping animals of susceptible
species;
(e) the means of transport are strictly assigned to a
defined geographical or administrative area, they are
marked accordingly and may only be moved to another
area after cleansing and disinfection under official
supervision.
(9) The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
surveillance zone to a laboratory other than a veterinary diagnostic
laboratory approved for diagnosis of foot-and-mouth disease and
the processing of the milk in such laboratories shall be subject to
official authorisation and measures to avoid any spread of possible
foot-and-mouth disease virus.
(1) The competent authority shall ensure that the transport
and distribution of dung or manure from holdings and other
premises such as those mentioned in rule 16 situated in the
surveillance zone where animals of susceptible species are kept
shall be prohibited within and outside that zone.
(2) By way of derogation from the prohibition provided for in
sub-rule (1) the competent authorities may in exceptional
circumstances authorise the transport of dung or manure in means
of transport thoroughly cleansed and disinfected prior to and after
use for distribution in designated areas within the surveillance zone
and at sufficient distance to holdings where animals of susceptible
species are kept under the following alternative conditions
(a) either an examination by an official veterinarian of all
the animals of susceptible species on the holding has
ruled out the presence of animals suspected of being
infected with the foot-and-mouth disease virus and the
manure or dung is distributed close to the ground to
avoid the generation of aerosols and immediately
ploughed into the ground, or
(b) a clinical inspection by an official veterinarian of all
the animals of susceptible species on the holding has
been carried out with negative result and the manure is
injected into ground, or;
(c) manure is subject to the provision of rule 27(2).
The competent authority shall ensure that the placing on
the market of products of animal origin other than those referred to
in rules 37 to 39 shall be subject to the conditions provided for in
rules 26 and 28 to 30.
In addition to the measures provided for in rules 35 to 40,
the competent authority may take additional national measures
which are deemed necessary and proportionate to contain foot-and-
mouth disease virus taking into account the particular
ep idemi ological, anim al husbandry, comm ercial and soci al
conditions prevailing in the affected area. Where specific measures
to restrict the movement of equidae are considered necessary, such
measures shall take into account those provided for in Schedule VI.
(1) The competent authority shall ensure that the measures
applied in the surveillance zone are maintained until the following
requirements have been met
(a) at least thirty days have elapsed since the killing and
safe disposal of all animals of susceptible species from
the holding referred to in rule 10(1) and the
completion of the preliminary cleansing and
disinfection on that holding, carried out in accordance
with rule11;
(b) the requirements provided for in rule 34 have been met
in the protection zone;
(c) a survey has been concluded with negative results.
(2) The survey referred to in sub-rule (1)(c) shall be carried out
to substantiate the absence of infection in the surveillance zone in
compliance with the criteria of point 1 of Schedule III and shall
include the measures provided for in point 2.4 of Schedule III
based on the criteria of point 2.1 of Schedule III.
(1) Without prejudice to European Union Council
Directive 90/425/EC, and in particular Article 10 thereof, where the
foot-and-mouth disease virus appears to be spreading despite the
measures taken in accordance with these rules and the epizootic
becomes extensive and in any case when emergency vaccination is
implemented, the competent authority shall ensure that Malta is
regionalised into one or more restricted and free zones.
(2) The competent authority shall notify to the European
Commission without delay the details of the measures implemented
in the restricted zone and the European Commission shall review,
where necessary amend, and endorse the measures in accordance
with European Community legislation.
(3) Without prejudice to the obligation of the competent
authority to regionalise referred to in sub-rule (1), regionalisation,
and the measures to be applied within the restricted zone, may be
decided in accordance with the procedure established in rule 78(2).
This decision may extent its effects to neighbouring Member States
not infected at the time the measures are taken.
(4) Prior to the delimitation of the restricted zone, a thorough
epidemiological assessment of the situation shall be carried out,
especially with respect to the possible time and probable location
of introduction, the possible spread and the probable period of time
necessary to eradicate the foot-and-mouth disease virus.
(5) The restricted zone shall as far as possible be delimited on
the basis of administrative boundaries or geographical barriers.
Regionalisation shall take as its starting point larger administrative
units rather than regions. The restricted zone may be reduced in the
light of the results of the epidemiological inquiry provided for in
rule 13, to an area of the size not less than a sub-region, and where
necessary the surrounding sub-regions. In the event of the foot-and-
mouth disease virus spreading, the restricted zone shall be enlarged
by including additional regions or sub-regions.
(1) Where regionalisation is applied, the competent
authority shall ensure that at least the following measures are
taken
(a) control within the restricted zone of transport and
movement of animals of susceptible species, animal
products and goods and of the movement of means of
transport as potential carriers of foot-and-mouth
disease virus;
(b) tracing and marking in accordance with European
Community legislation of fresh meat and raw milk and
as far as possible other products in stock not eligible
for dispatch outside the restricted zone;
(c) specific certification of animals of susceptible species
and products derived from such animals and health
marking, in accordance with European Community
legislation, of products for human consumption
intended and eligible for dispatch outside the restricted
zone.
(2) Where regionalisation is applied, the competent authority
shall ensure that at least the animals of susceptible species
dispatched from the restricted zone to other Member States during
the time between the date of estimated introduction of the foot-and-
mouth disease virus until the date regionalisation is implemented
shall be traced, and such animals shall be isolated under official
veterinary control until possible infection or contamination is
officially ruled out.
(3) The competent authority shall collaborate in tracing fresh
meat and raw milk and raw milk products derived from animals of
susceptible species produced in the restricted zone between the date
of estimated introduction of the foot-and-mouth disease virus until
the date regionalisation is implemented. Such fresh meat shall be
treated in accordance with point 1 in Part A of Annex VII, and raw
milk and milk products shall be treated in accordance with Part A
or B of Schedule IX depending on the use, or detained until
possible contamination with the foot-and-mouth disease virus is
officially ruled out.
(4) Specific measures, in particular in relation to health
marking of products derived from animals of susceptible species
originating in the restricted zone and not intended for placing on
the market outside the restricted zone may be adopted in
accordance with Article 4(3) of European Union Council Directive
2002/99/EC.
(1) Without prejudice to European Community legislation
on identification of domestic bovine, ovine and caprine animals and
swine, the competent authority shall ensure that in the event of an
outbreak of foot-and-mouth disease on their territory animals of
susceptible species shall only leave the holding on which they are
kept, if they are identified in such a way as to enable the competent
authorities to trace rapidly their movements and their holding of
origin, or any holding from which they have come. However, for
special cases referred to in rule 15(1) and rule 16(1), the competent
authority may, in certain circumstances and having regard to the
health situation, authorise other ways of rapidly tracing the
movement of those animals and of their holding of origin, or of any
holding from which they hav e come. The arrangements for
identifying such animals or for tracing their holdings of origin shall
be determined by the competent authority and notified to the
European Commission.
(2) The measures taken by the competent authority on
additional, permanent and indelible marking of animals for the
particular purpose of control of the foot-and-mouth disease, and in
particular in case of vaccination carried out in accordance with
rules 50 and 51, may be modified in accordance with rule 77(2).
(1) The competent authority shall ensure that, in the event
of an outbreak of foot-and-mouth disease in Malta the following
measures to control movement of animals of susceptible species are
applied in the restricted zone established in accordance with rule
43
(a) owners shall supply the competent authority, on
request of that authority, with appropriate information
concerning animals entering or leaving their holding.
That information shall, in relation to all animals of
susceptible species, include at least the details
required by Article 14 of European Union Council
Directive 64/432/EEC;
(b) persons engaged in the transport or marketing of
animals of susceptible species shall supply the
competent authority, on request of that authority, with
appropriate information concerning the movements of
such animals which they have transported or marketed.
That information shall include at least the details
required by Articles 12(2) and 13(1)(b) of European
Union Council Directive 64/432/EEC.
(2) The competent authority may extend some or all the
measures provided for in sub-rule (1) to a part or the entire free
zone.
The competent authority shall ensure that
(a) the use of foot-and-mouth disease vaccines and the
administration of hyperimmune sera against foot-and-
mouth disease are prohibited on their territory except
as provided for in these rules;
(b) the production, storage, supply, distribution and sale of
foot-and-mouth disease vaccines are carried out under
official control;
(c) the marketing of foot-and-mouth disease vaccines is
under the supervision of the competent authorities in
accordance with European Community legislation;
(d) the use of foot-and-mouth disease vaccines for
purposes other than to induce active immunity in
animals of susceptible species, notably laboratory
investigations, scientific research or testing of
vaccines, is authorised by the competent authorities
and carried out under appropriate bio-security
conditions.
(1) The competent authority may decide to introduce
em ergency vaccination w her e at l east one of t he f ollowing
conditions applies
(a) outbreaks of foot-and-mouth disease have been
confirmed and threaten to become widespread in Malta
where such outbreaks have been confirmed;
(b) other Member States are at risk due to the geographical
situation of or the prevailing meteorological
conditions in relation to reported outbreaks of foot-
and-mouth disease in Malta;
(c) other Member States are at risk due to
epidemiologically relevant contacts between holdings
on their territories and holdings keeping animals of
susceptible species in Malta where there are outbreaks
of foot-and-mouth disease;
(d) the territory of Malta is at risk due to the geographical
situation or the prevailing meteorological conditions in
a neighbouring third country where there are outbreaks
of foot-and-mouth disease.
(2) When deciding on the introduction of emergency
vaccination, consideration shall be given to the measures provided
for in rule 15 and to the criteria listed in Schedule X.
(3) The decision to introduce emergency vaccination shall be
adopted in accordance with European Community legislation.
(4) The decision referred to in sub-rule (3) to introduce
emergency vaccination on its own territory may be requested
(a) either by the competent authority referred to in sub-
rule (1)(a), or
(b) by a Member State referred to in sub-rule (1)(b), (c) or
(d).
(5) By way of derogation from sub-rule (3), the decision to
introduce emergency vaccination may be taken by the competent
authority and implemented in accordance with these rules, after a
written notification to the European Commission which shall
include the specifications provided for in rule 49.
(6) If the competent authority introduces emergency
vaccination in accordance with sub-rule (5), that decision shall be
immediately reviewed in the Standing Committee on the Food
Chain and Animal Health and European Community measures shall
be adopted in accordance with the procedure referred to in rule
78(2).
(7) By way of derogation from sub-rule (4), a decision to
introduce emergency vaccination in Malta referred to in sub-rule
(1)(a) may be adopted in concertation with the affected Member
State in accordance with European Community legislation on the
European Commission’s own initiative, if the condition in sub-rule
(1)(a) and sub-rule (1)(b) apply.
(1) The decision to introduce emergency vaccination in
accordance with rules 48(3) and (4) shall specify the conditions
under which such vaccination shall be carried out and these
conditions must specify at least
(a) the delimitation in accordance with rule 43 of the
geographical area in which emergency vaccination is
to be carried out;
(b) the species and the age of the animals to be vaccinated;
(c) the duration of the vaccination campaign;
(d) a specific prohibition on movements of vaccinated and
non-vaccinated animals of susceptible species and
their products;
(e) the special additional and permanent identification and
special registration of the vaccinated animals pursuant
to rule 45(2);
(f)
other matters appropriate to the emergency situation.
(2) The conditions for emergency vaccination as provided for
in sub-rule (1), shall ensure that such vaccination is carried out in
accordance with rule 50, irrespective of whether the vaccinated
animals are subsequently slaughtered or stay alive.
(3) The competent authority shall ensure that an information
programme shall be put in place to inform the public about the
safety of meat, milk and dairy products from vaccinated animals for
human consumption.
(1) Where the competent authority applies protective
vaccination it shall ensure that
(a) the vaccination zone shall be regionalised in
accordance with rule 43, where necessary in close
cooperation with neighbouring Member States;
(b) vaccination shall be carried out swiftly and in
conformity with the rules of hygiene and bio-security
so as to avoid the spread of foot-and-mouth disease
virus;
(c) all measures applied in the vaccination zone shall be
carried out without prejudice to the measures provided
for in these rules;
(d) where the vaccination zone includes parts of or the
entire protection or surveillance zone
(i)
the measures applicable for the protection zone
or surveillance zone in accordance with these
rules shall be maintained within that part of the
vaccination zone until such measures have been
removed in accordance with rule 34 or rule 42;
(ii) after the measures applied in the protection zone
and surveillance zone have been removed, the
measures applicable for the vaccination zone, as
provided for in rules 52 to 56, shall continue to
apply.
(2) The competent authority applying protective vaccination
shall ensure that the vaccination zone is surrounded by a
surveillance area (surveillance zone as defined by OIE) of at least
10 kilometres width from the perimeters of the vaccination zone
(a) in which vaccination is prohibited;
(b) in which intensified surveillance is carried out;
(c) in which the movement of animals of susceptible
species is subject to controls by the competent
authorities;
(d) which remains in place until the foot-and-mouth
disease and infection free status is recovered in
accordance with rule 59.
(1) The competent authority shall notify the European
Commission if it decides in accordance with rule 48 and taking into
account all relevant circumstances, to introduce suppressive
vaccination and shall provide details of the control measures to be
taken which shall include at least those provided for in rule 19.
(2) The competent authority shall ensure that suppressive
vaccination is carried out
(a) only within a protection zone;
(b) only on clearly identified holdings subject to the
measures provided for in rule 10(1) and in particular
paragraph (a) thereof
Provided that, for logistical reasons and by way of
derogation from rule 10(1)(a), the killing of all animals on such
holdings may be delayed as long as necessary to comply with
European Community legislation and the provisions of rule
10(1)(c).
(1) The competent authority shall ensure that the measures
provided for in sub-rules (2) to (6) are applied in the vaccination
zone during the period from the beginning of the emergency
vaccination until at least thirty days have elapsed following the
completion of such vaccination.
(2) Movement of live animals of susceptible species shall be
prohibited between holdings within and out of the vaccination
zone
Provided that by way of derogation from such prohibition
provided for herein, and after clinical inspection of such live
animals and the herds of origin or dispatch of those animals, the
competent authority may authorise their direct transport for
imm ediate slaugh ter in a slaughterhouse designated by t he
competent authority and situated within the vaccination zone or in
exceptional cases close to that zone.
(3) Fresh meat produced from vaccinated animals slaughtered
during the period referred to in sub-rule (1) shall
(a) bear the mark provided for in European Union Council
Directive 2002/99/EC and European Community
legislation;
(b) be stored and transported separately from meat not
bearing the mark referred to in paragraph (a), and shall
subsequently be transported in sealed containers to an
establishment designated by the competent authorities
for treatment in accordance with point 1 in Part A of
Schedule VII.
(4) Milk and milk products produced from vaccinated animals
may be placed on the market within or outside the vaccination
zone, provided that, depending on the final use for either human
consumption or non-human consumption, it has undergone at least
one of the treatments referred to in Parts A and B of Schedule IX.
The treatment shall be carried out under the conditions set out in
sub-rule (5) in establishments situated in the vaccination zone or, if
there is no establishment in that zone, in establishments situated
outside the vaccination zone to which the raw milk is transported
under the conditions set down in sub-rule (7).
(5) Establishments referred to in sub-rule (4) shall comply
with the following conditions
(a) the establishment shall be operated under permanent
and strict official control;
(b) all milk used in the establishment shall either comply
with sub-rule (4) or the raw milk shall be obtained
from animals outside the vaccination zone;
(c) during the whole production process the milk shall be
clearly identified and transported and stored separately
from raw milk and raw milk products which are not
destined for dispatch outside the vaccination zone;
(d) transport of raw milk from holdings situated outside
the vaccination zone to the establishments shall be
carried out in vehicles which were cleaned and
disinfected prior to the transport operation, and which
have had no subsequent contact with holdings in a
restricted zone keeping animals of susceptible species.
(6) Compliance with the conditions in sub-rule (5) shall be
certified by the competent authority for milk intended for intra-
Euro pean Com muni ty trade. The competent authority shall
supervise the control of compliance undertaken by the Veterinary
Services and in the case of intra-European Community trade
communicate to other Member States and the European
Commission, a list of those establishments which it has approved
for the purpose of such certification.
(7) Transport of raw milk from holdings situated within the
vaccination zone to establishments situated outside the vaccination
zone and the processing of that milk shall be subject to the
following conditions
(a) processing in establishments situated outside the
vaccination zone of raw milk produced from animals
of susceptible species kept within the vaccination zone
shall be authorised by the competent authorities;
(b) the authorisation shall include instructions on and
designation of the transport route to the designated
establishment;
(c) transport shall be carried out in vehicles which were
cleaned and disinfected prior to the transport
operation, which are constructed and maintained in
such a way that there is no leakage of milk during
transport and which are equipped to avoid aerosol
dispersion during the loading and unloading of the
milk;
(d) before leaving the holding from where milk of animals
of susceptible species was collected, the connection
pipes, tires, wheel cases, the lower parts of the vehicle
and any spillage of milk are cleansed and disinfected
and after the last disinfection and before leaving the
vaccination zone the vehicle had no subsequent
contact with holdings in the vaccination zone keeping
animals of susceptible species;
(e) the means of transport are strictly assigned to a
defined geographical or administrative area, they are
marked accordingly and may only be moved to another
area after cleansing and disinfection under official
supervision.
(8) The collection and transport of samples of raw milk of
animals of susceptible species from holdings situated in the
vaccination zone to a laboratory other than a veterinary diagnostic
laboratory approved for diagnosis of foot-and-mouth disease and
the processing of the milk in such laboratories shall be forbidden.
(9) The collection of semen for artificial insemination from
donor animals of susceptible species kept in semen collection
centres situated within the vaccination zone shall be suspended. By
way of derogation from the prohibition provided for herein, the
competent authorities may authorise the collection of semen at
semen collection centres within the vaccination zone for the
production of frozen semen, subject to the following conditions
(a) it is ensured that the semen collected during the period
referred to in sub-rule (1) is stored separately for at
least thirty days, and
(b) prior to dispatch of the semen
(1) either the donor animal has not been vaccinated
and the conditions of rule 26(3)(b) and (c) apply,
or
(2) the donor animal has been vaccinated following
a negative test for antibodies against foot-and-
mouth disease virus carried out prior to
vaccination; and
(i) a negative result has been achieved in a
test for the detection of either virus or
viral genome or an approved test for the
detection of antibody against non-
structural proteins, carried out at the end
of the quarantine period for the semen on
samples taken from all animals of
susceptible species present at that time on
the semen collection centre, and
(ii) the semen complies with the conditions of
Article 4(3) of Chapter II of European
Union Council Directive 88/407/EEC.
(10) Collection of ova and embryos from donor animals shall be
prohibited.
(11) The placing on the market of products of animal origin
other than those referred to in sub-rules (9) and (10) shall be
subject to the conditions provided for in rules 28, 29, 30 and 39.
(1) The competent authority shall ensure that the measures
provided for in sub-rules (2) to (5) are applied in the vaccination
zone during a period starting not earlier than thirty days from the
date of completion of emergency vaccination and terminating with
the completion of the measures provided for in rules 54 and 55.
(2) Movement of animals of susceptible species between
holdings within and out of the vaccination zone shall be prohibited.
(3) By way of derogation from the prohibition provided for in
sub-rule (2), the competent authorities may authorise direct
transport for immediate slaughter of animals of susceptible species
from holdings referred to in rule 55(5) to a slaughterhouse situated
within or out of the vaccination zone on the following conditions
(a) during transport and in the slaughterhouse those
animals shall not come into contact with other animals
of susceptible species;
(b) the animals shall be accompanied by an official
document certifying that all animals of susceptible
species on the holding of origin or dispatch have
undergone a survey provided for in rule 54(2);
(c) the transport vehicles shall be cleansed and disinfected
before loading and after the animals have been
delivered, with the date and time of the cleaning and
disinfection being recorded in the logbook of the
means of transport;
(d) the animals shall have passed the ante-mortem health
inspection at the slaughterhouse during the twenty-
four hours before slaughter and have in particular
undergone examination for mouth and feet disease and
not shown signs of that disease.
(4)
Fresh meat, excluding offal, produced from vaccinated
large and small ruminants during the period referred to in sub-rule
(1), may be placed on the market within and outside the vaccination
zone under the following conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) only fresh meat, excluding offal, which was subjected
to the treatment described in points 1, 3 and 4 in Part A
of Schedule VIII or fresh meat obtained from animals
reared and slaughtered outside the vaccination zone
shall be processed in the establishment;
(c) all such fresh meat shall bear the health mark in
accordance with Chapter XI of Annex I to European
Union Council Directive 64/433/EEC or, in the case of
meat from other biungulates, the health mark provided
for in Chapter III of Annex I of European Union
Council Directive 91/495/EEC, or, in the case of
minced meat and meat preparations, the health mark
provided for in Chapter VI of Annex I of European
Union Council Directive 94/65/EC;
(d) throughout the production process the fresh meat shall
be clearly identified, and transported and stored
separately from meat of different animal health status
in accordance with these rules.
(5) Compliance with the conditions in sub-rule (4) shall be
certified by the competent authority for fresh meat intended for
intra-European Community trade. The competent authority shall
supervise the control of compliance undertaken by the local
veterinary authorities and, in the case of intra-European
Community trade, communicate to other Member States and the
European Commission a list of those establishments which it has
approved for the purpose of such certification.
(6) Fresh meat produced from vaccinated porcine animals
slaughtered during the period referred to in sub-rule (1) shall bear
the health mark provided for in European Union Council Directive
2002/99/EC and shall be stored and transported separately from
meat not bearing that mark and subsequently be transported in
sealed containers to an establishment designated by the competent
authorities for treatment in accordance with point 1 in Part A of
Schedule VII.
(7) Milk and milk products produced from vaccinated animals
may be placed on the market within or outside the vaccination
zone, provided that depending on the final use for either human
consumption or non-human consumption it has undergone at least
one of the treatments referred to in Parts A and B of Schedule IX.
Such treatment shall have been undergone in an establishment
located within or outside the vaccination zone in accordance with
the provisions in rule 52(4) to (8).
(8) For the collection of semen, ova and embryos from animals
of susceptible species, the measures provided for in rule 52(9) and
(10) shall continue to apply.
(9) The placing on the market of products of animal origin
other than those referred to in sub-rules (4), (6), (7) and (8) shall be
subject to the conditions provided for in rules 28, 29, 30 and 39.
(1) The competent authority shall ensure that the measures
provided for in sub-rules (2) and (3) are applied in the vaccination
zone during a period starting not earlier than thirty days from the
date of completion of emergency vaccination and terminating with
the completion of a clinical and serological survey.
(2) A survey shall be carried out with the aim to identify herds
of animals of susceptible species that had contact with the foot-
and-mouth disease virus without showing overt clinical signs of the
foot-and-mouth disease. That survey shall include a clinical
inspection of all animals of susceptible species in all herds in the
vaccination zone, and laboratory testing in accordance with sub-
rule (3).
(3) Laboratory testing shall be carried out by use of tests
complying with the criteria for diagnostic tests as set out in
Schedule XIII and approved in accordance with the procedure
referred to in rule 77(1), and shall comply with one of the following
conditions
(a) testing for infection with the foot-and-mouth disease
virus, either by an assay for antibodies against
nonstructural proteins of the foot-and-mouth disease
virus, or by another approved method, shall meet
criteria for sampling on holdings set out in point 2.2 of
Schedule III. Where the competent authority use in
addition sentinel animals, the conditions for restocking
of infected holdings in Schedule V shall be taken into
account;
(b) testing for antibodies against non-structural proteins of
the foot-and-mouth disease virus shall be carried out
on samples taken from all vaccinated animals of
susceptible species and their non-vaccinated offspring
in all herds in the vaccination zone.
(1) The competent authority shall ensure that the holdings
containing animals of susceptible species -
(a) are classified according to the outcome of the survey
referred to in rule 54(2) and the criteria set out in
Schedule I;
(b) comply with the measures set out in sub-rules (2) to
(4).
(2) Holdings containing at least one animal suspected of being
infected and where the presence of foot-and-mouth disease virus is
confirmed in accordance with the criteria laid down in Schedule I
shall be subject to the measures provided for in rules 10 and 19.
(3) Holdings containing at least one animal of susceptible
species suspected of being infected through previous contact with
t he fo ot-an d-m out h di sease vi rus b ut wh ere furt her t est ing
including all animals of susceptible species present on the holding,
confirmed the absence of circulating foot-and-mouth disease virus,
shall be subject to at least the following measures
(a) animals of susceptible species on the holding shall
(1) either be killed and the carcasses processed, or
(2) the animals shall be classified and -
(i) the animals positive to at least one of the
approved tests referred to in rule 54(3) shall
be killed and their carcasses processed, and
(ii) the remaining animals of susceptible
species on the holding shall be slaughtered
under conditions authorised by the
competent authority;
(b) cleansing and disinfection
of
the
holdings
in
accordance with rule 11;
(c) restocking of animals in accordance with Schedule V.
(4) The competent authority shall ensure that the following
measures are applied to products derived from animals of
susceptible species and produced during the period referred to in
rule 54(1)
(a) fresh meat produced from the animals referred to in
sub-rule (3)(a)(2)(ii) shall be subject to rule 53(4), for
meat from ruminants, and in rule 53(6), for meat from
porcine animals, respectively;
(b) milk and milk products produced from the animals
referred to in sub-rule (3)(a)(2)(ii) shall undergo at
least one of the treatments specified in Parts A and B
of Schedule IX depending on the intended use and in
compliance with the provisions in rule 52(4) to (8).
(5) Animals of susceptible species on holdings where the
presence of previous or present infection with the foot-and-mouth
disease virus has been officially ruled out in accordance with rule
54(3) may be subject to the measures provided for in rule 56.
(1) The competent authority shall ensure that the measures
provided for in sub-rules (2) to (6) are applied in the vaccination
zone after the completion of the measures laid down in rule 55 and
until the foot-and-mouth disease and infection-free status has been
recovered in accordance with rule 57.
(2) The competent authority shall ensure that movement of
animals of susceptible species between holdings situated in the
vaccination zone is subject to authorisation.
(3) Movement of animals of susceptible species out of the
vaccination zone shall be prohibited. By way of derogation from
this prohibition, direct transport to a slaughterhouse for immediate
slaughter of animals of susceptible species may be authorised under
the conditions provided for in rule 53(3).
(4) By way of derogation from the prohibition in sub-rule (2),
the competent authorities may authorise the transport of
unvaccinated animals of susceptible species in accordance with the
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)
following provisions
(a) within twenty-four hours of loading, all animals of
susceptible species on the holding have been subjected
to clinical examination and have not shown clinical
signs of foot-and-mouth disease, and
(b) the animals have completed a standstill on the holding
of origin of at least thirty days during which no animal
of susceptible species has been introduced onto the
holding, and
(c) the holding of origin is not situated in a protection or
surveillance zone, and
(d) the animals intended for transport were either
individually subjected with negative results to tests for
the detection of antibodies against the foot-and-mouth
disease virus at the end of the isolation period, or a
serological survey was completed on that holding in
accordance with point 2.2 of Schedule III irrespective
of the species concerned;
(e) the animals were not exposed to any source of
infection during their transportation from the holding
of origin to the place of destination.
(5) Non-vaccinated offspring of vaccinated dams shall be
p rohi bited from leaving the h oldi ng o f origi n un less b eing
transported to
(a) a holding within the vaccination zone of the same
health status as the holding of origin;
(b) a slaughterhouse for immediate slaughter;
(c) a holding designated by the competent authority, from
which the offspring are to be sent directly to the
slaughterhouse;
(d) any holding, after having obtained a negative result in
a serological test for the detection of antibody against
the foot-and-mouth disease virus carried out on a
sample of blood taken prior to dispatch from the
holding of origin.
(6) Fresh meat produced from unvaccinated animals of
susceptible species may be placed on the market inside and outside
the vaccination zone under the following conditions
(a) either the measures provided for in rule 55(3) have
been completed in the entire vaccination zone or the
animals are transported to the slaughterhouse under
the conditions provided for in sub-rule (3) or (4)(d),
and;
(b) the establishment shall be operated under strict
veterinary control;
(c) only fresh meat produced from animals referred to in
paragraph (a) or from animals reared and or
slaughtered outside the vaccination zone or fresh meat
referred to in sub-rule (8) shall be processed in the
establishment;
(d) all such fresh meat shall bear the health mark in
accordance with Chapter XI of Annex I to European
Union Council Directive 64/433/EEC or in the case of
meat from other biungulates, the health mark provided
for in Chapter III of Annex I of European Union
Council Directive 91/495/EEC, or in the case of
minced meat and meat preparations the health mark
provided for in Chapter VI of Annex I of European
Union Council Directive 94/65/EC;
(e) throughout the production process the fresh meat shall
be clearly identified, and transported and stored
separately from meat of different animal health status
in accordance with these rules.
(7) Fresh meat produced from vaccinated animals of
susceptible species or from non-vaccinated seropositive offspring
of vaccinated dams slaughtered during the period referred to in sub-
rule (1) shall bear the health mark provided for in European
Council Directive 2002/99/EC and shall be stored and transported
separately from meat not bearing that stamp and subsequently be
transported in sealed containers to an establishment designated by
the competent authorities for treatment in accordance with point 1
in Part A of Schedule VII.
(8) By way of derogation from sub-rule (7), fresh meat and
trimmed offal produced from vaccinated large and small ruminants
or their non-vaccinated seropositive offspring may be placed on the
market within and outside the vaccination zone under the following
conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) only fresh meat excluding offal, which was subjected
to the treatment described in point 1, 3 and 4 in Part A
of Schedule VIII or fresh meat referred to in sub-rule
(6) or produced from animals reared and, or
slaughtered outside the vaccination zone, are
processed in the establishment;
(c) all such fresh meat shall bear the health mark in
accordance with Chapter XI of Annex I to European
Directive 64/433/EEC or in the case of meat from
other biungulates the health mark provided for in
Chapter III of Annex I to European Directive 91/495/
EEC, or in the case of minced meat and meat
preparations the health mark provided for in Chapter
VI of Annex I to European Directive 94/65/EC;
(d) throughout the production process the fresh meat shall
be clearly identified, and transported and stored
separately from meat which is of different animal
health status in accordance with these rules.
(9) By way of derogation from sub-rule (7), fresh meat from
vaccinated porcine animals and their non-vaccinated seropositive
offspring, produced during the period from the beginning of the
survey until the measures provided for in rule 55 have been
completed in the entire vaccination zone and until at least three
months have elapsed after the last outbreak recorded in that zone,
may only be placed on the national market of Malta within and
outside the vaccination zone under the following conditions
(a) the establishment shall be operated under strict
veterinary control;
(b) only fresh meat from animals originating in holdings
complying with the conditions in rule 55(5) or fresh
meat obtained from animals reared and slaughtered
outside the vaccination zone are processed in the
establishment;
(c) all such fresh meat shall bear a health mark to be
decided in accordance with Article 4(3) of European
Directive 2002/99/EC;
(d) throughout the production process the fresh meat shall
be clearly identified, and transported and stored
separately from meat of different animal health status
in accordance with these rules.
(10) A Member State other than the territory of Malta may
request a decision in accordance with European Community
legislation to extend the marketing of the meat referred to in sub-
rule (9) to its territory or part of its territory under conditions to be
laid down under the same procedure.
(11) The rules for dispatch from the vaccination zone of fresh
meat from vaccinated porcine animals produced after the period
referred to in sub-rule (9) until free status has been regained in
accordance with rule 59, shall be decided in accordance with the
procedure provided for in rule 78(2).
(12) Compliance with the conditions provided for in sub-rule
(6), sub-rule (8) and where applicable under the provisions of sub-
rule (10), shall be certified by the competent authority. The
competent authority shall supervise the control of compliance
undertaken by the Veterinary Services and shall in the case of intra-
European Community trade communicate to other Member States
and the European Commission a list of those establishments which
they have approved for such certification.
(13) By way of derogation from sub-rule (8) a special health
mark which cannot be confused with the health mark referred to in
sub-rules (8)(c) and (9)(c), may be decided in accordance with the
procedure referred to in rule 78(2) for fresh meat of ruminants not
subjected to the treatment in accordance with Part A of Schedule
VIII, and minced meat and meat preparations produced from such
meat, which are intended for placing on the market in a specific
region of Malta.
(14) Milk and milk products produced from vaccinated animals
may be placed on the market within and outside the vaccination
zone, provided that depending on the final use for either human
consumption or non-human consumption, it has undergone at least
one of the treatments referred to in Parts A and B of Schedule IX.
Such treatment shall have been undergone in an establishment
located in the vaccination zone or in accordance with the provisions
in rules 52(4) to (7).
(15) The collection and transport of samples of raw milk of
animals of susceptible species, from holdings situated in the
surveillance zone to a laboratory other than a veterinary diagnostic
laboratory approved for diagnosis of foot-and-mouth disease, and
the processing of the milk in such laboratories, shall be subject to
official authorisation and to appropriate measures to avoid any
possible spread of foot-and-mouth disease virus.
(16) The placing on the market of products of animal origin
other than those referred to in sub-rules (6) to (11) and (13) to (15)
shall be subject to the conditions provided for in rules 28, 29, 30
and 40.
The foot-and-mouth disease and infection free status of
Malta or a region thereof shall be recovered in accordance with the
procedure referred to in rule 78(2), taking into account the
conditions referred to in rules 58 and 59.
(1) When Malta has been regionalised in accordance with
rule 43, it shall recover its previous foot-and-mouth disease and
infection free status following the control and eradication of one or
more outbreaks of foot-and-mouth disease without vaccination
under the following conditions
(a) all the measures provided for in rules 34 and 42 have
been completed, and
(b) at least one of the following conditions applies
(i)
the relevant recommendations in the foot-and-
mouth disease Chapter, as last amended, of the
Animal Health Code of the OIE are met;
(ii) at least three months have elapsed after the last
recorded outbreak of foot-and-mouth disease
and clinical and laboratory surveillance carried
out in accordance with Schedule III has
confirmed the absence of infection with the foot-
and-mouth disease virus in Malta or region
concerned.
(2) Decisions on recovering a foot-and-mouth disease and
infection-free status shall be adopted in accordance with the
procedure referred to rule 78(2).
(1) Malta, or any region thereof regionalised in
accordance with rule 43, shall recover its previous foot-and-mouth
disease and infection free status f ollo win g th e cont ro l and
eradication of one or more outbreaks of foot-and-mouth disease
with vaccination under the following conditions
(a) all the measures provided for in rules 34, 42, 52, 53,
54 and 55 have been completed, and
(b) at least one of the following conditions applies
(i)
the relevant recommendations in the foot-and-
mouth disease Chapter, as last amended, of the
Animal Health Code of the OIE are met;
(ii) at least three months have elapsed since the
slaughter of the last vaccinated animal and
serological surveillance has been carried out in
accordance with the guidelines established in
accordance with rule 65(3);
(iii) at least six months have elapsed since the last
outbreak of foot-and-mouth disease or the
completion of emergency vaccination, what ever
event occurred later, and in accordance with the
guidelines established in accordance with rule
65(3), a serological survey based on the
detection of antibodies against non-structural
proteins of the foot-and-mouth disease virus has
demonstrated the absence of infection in
vaccinated animals.
(2) Decisions on recovering a foot-and-mouth and infection
free status shall be adopted in accordance with the procedure
referred to rule 78(2).
(1) By way of derogation from rule 58 it may be decided
in accordance with the procedure referred to in rule 78(2), to
withdraw the restrictions applied in accordance with these rules
after the requirements provided for in rules 34 and 42 have been
met and the clinical and serological survey has been completed and
confirmed the absence of foot-and-mouth disease virus infection.
(2) By way of derogation from rule 59 it may be decided in
accordance with the procedure referred to in rule 78(2), to
withdraw the restrictions applied in accordance with these rules
after the clinical and serological survey provided for in rule 54 and
the measures provided for in rule 55 have been completed and
confirmed the absence of foot-and-mouth disease virus infection.
(3) Without prejudice to sub-rules (1) and (2) it may be decided
in accordance with the procedure referred to in rule 78(2) that no
animals of a susceptible species shall be removed from the territory
or region of Malta where the outbreak of foot-and-mouth disease
has occurred to another Member State until the foot-and-mouth
disease and infection free status is recovered in accordance with the
conditions of the Animal Health Code of the OIE, unless such
animals
(a) have not been vaccinated and are consigned directly to
a slaughter house for immediate slaughter; or
(b) have been isolated for at least thirty days immediately
prior to loading and have undergone a serological test
for the detection of antibody against foot-and-mouth
disease virus structural proteins, carried out with
negative results on samples taken during the ten days
prior to loading.
(4) Without prejudice to sub-rule (2) it may be decided, in
accordance with the procedure referred to in rule 78(2), that until
the foot-and-mouth disease and infection free status is recovered in
accordance with the conditions of the Animal Health Code of the
OIE the radius of the surveillance area around the vaccination zone
referred to in rule 50(2) shall be reduced after the completion with
satisfactory results of the measures provided for in rule 55.
The competent authority shall ensure that additional
certification for intra-Community trade in animals of susceptible
s pe c i e s o r p r o du c t s d e r i ve d f r o m s uc h an i m a l s r e q ui r e d in
accordance with these rules shall be continued until the foot-and-
mouth disease and infection free status of Malta or part of the
territory, has been recovered in accordance with rules 58 and 59.
(1) The dispatch from Malta to another Member State of
animals of susceptible species vaccinated against foot-and-mouth
disease, shall be prohibited.
(2) By way of derogation from the prohibition in sub-rule (1),
the competent authority it may be decided in accordance with the
procedure referred to in rule 78(1) to adopt specific measures with
regard to vaccinated animals of susceptible species kept in zoos and
included in a programme for wildlife conservation or kept on
premises for farm animal resources, that have been listed by the
competent authority as breeding nucleus of animals indispensable
for the survival of the breed, subject to appropriate provisions in
the Animal Health Code of the OIE.
CHAPTER III
Preventive Measures
The competent authority shall ensure that
(a) laboratories and establishments in which live foot-and-
mouth disease virus, its genome, antigens or vaccines
produced from such antigens are handled for research,
diagnosis or manufacture are strictly controlled by the
competent authorities;
(b) the handling of live foot-and-mouth disease virus for
research and diagnosis is carried out only in approved
laboratories listed in Part A of Schedule XI;
(c) the handling of live foot-and-mouth disease virus for
the manufacturing of either inactivated antigens for the
production of vaccines or vaccines and related
research is carried out only in the approved
establishments and laboratories listed in Part B of
Schedule XI;
(d) the laboratories and establishments referred to in
paragraphs (b) and (c) are operated at least according
to the biosecurity standards set out in Schedule XII.
(1) Member States shall ensure that
(a) laboratory testing for foot-and-mouth disease is
carried out in laboratories authorised for such testing
by the competent authorities;
(b) laboratory testing to confirm the presence of foot-and-
mouth disease virus or other vesicular disease viruses
is carried out in accordance with rule 65 by one of the
laboratories listed in Part A of Schedule XI;
(c) one of the laboratories listed in Part A of Schedule XI
shall be designated as the national reference laboratory
for Malta;
(d) the national reference laboratory carries out at least the
functions and duties set out in Schedule XV;
(e) the national reference laboratory referred to in
paragraph (c) liases with the Community Reference
Laboratory according to European Community
legislation and in particular ensures the sending of
appropriate samples to the Community Reference
Laboratory.
(2) The national reference laboratory referred to in sub-rule
(1)(c) of one Member State may provide the services of a national
reference laboratory to Malta. In this case, the cooperation shall be
formalised in a mutual agreement between the competent
authorities of Malta and of the Member States concerned, which
shall be notified to the Commission. Such cooperation shall be
listed in the special column in the table in Part A of Schedule XI.
(3)
(a) The competent authority shall ensure that laboratory
investigations provided for in these rules are first of all
carried out to confirm or rule out foot-and-mouth
disease and to exclude other vesicular diseases.
(b) Where an outbreak of foot-and-mouth disease has been
confirmed and the serotype of the virus was identified,
that virus shall be antigenically characterised in
relation to the reference vaccine strains, where
necessary with the assistance of the Community
Reference Laboratory.
(c) Samples from domestic livestock showing signs of
vesicular disease which are negative for foot-and-
mouth disease virus and, where relevant, Swine
Vesicular Disease virus shall be sent to the Community
Reference Laboratory for further investigation.
(4) The competent authority shall ensure that the national
reference laboratory on their territory is adequately equipped and
staffed with the appropriate numbers of trained personnel to carry
out the laboratory investigations required in accordance with these
rules.
(1) An Operational Manual for Minimum Standards for
Laboratories working with the foot-and-mouth disease virus in
vitro and in vivo may be adopted in accordance with the procedure
referred to in rule 78(1).
(2) Guidelines for the surveillance required to recover the foot-
and-mouth disease and infection free status may be adopted in
accordance with the procedure referred to in rule 78(1).
(3) A uniform code of good conduct for the security systems
applied in the establishments and laboratories listed in Parts A and
B of Schedule XI may be adopted in accordance with the procedure
referred to in rule 78(1).
(1) The competent authority shall ensure that the national
laboratories use the tests and standards for diagnosis set out in
Schedule XIII.
(2) A decision regarding the suitable arrangements for the
purchase, storage and supply to national laboratories of sufficient
quantities of specific reagents or diagnostic tests in case of an
emergency, in particular with regard to the measures provided for
in rule 54(3) may be adopted in accordance with the procedure
referred to in rule 78(1).
(3) An Operational Manual for the diagnosis of foot-and-mouth
disease and the differential diagnosis of vesicular diseases other
than swine vesicular disease, may be adopted in accordance with
the procedure referred to in rule 78(1).
(1) The competent authority shall draw up a contingency
plan specifying the national measures required to maintain a high
level of foot-and-mouth disease awareness and preparedness, and
environmental protection and to be implemented in the event of an
outbreak of foot-and-mouth disease.
(2) The contingency plan shall provide for the access to all
facilities, equipment, personnel and other appropriate materials
necessary for the rapid and efficient eradication of an outbreak of
foot-and-mouth disease, it shall ensure coordination with
neighbouring Member States and encourage cooperation with
neighbouring third countries.
(3) The contingency plan shall provide for measures to be
implemented in the event of a worst case scenario as referred to in
point 12 of Schedule XVII and shall give indications of
(a) the vaccine requirements considered necessary in the
event of emergency vaccination, and
(b) the regions containing densely populated livestock
areas, taking into account the criteria set down in
Schedule X.
(4) The contingency plan shall ensure that all necessary
arrangements are made to prevent any avoidable damage to the
environment in the event of an outbreak, while ensuring at the same
time the highest disease control level, and minimise any damage
caused as a result of an outbreak, in particular if it is necessary to
bury or burn the carcasses of dead or killed animals on site.
(5) The criteria and requirements for drawing up the
contingency plan shall be those set out in Schedule XVI. Those
criteria and requirements may be amended taking into account the
specific nature of foot-and-mouth disease and progress made in the
development of disease control and environmental protection
measures in accordance with the procedure referred to in rule
78(1).
(6) The Commission shall examine the contingency plans in
order to determine whether they permit the objective provided for
in sub-rule (1) to be attained and shall suggest to the Member State
concerned any amendments required, in particular to ensure that
such plans are compatible with those of the other Member States.
(7) The contingency plans shall be approved in accordance
with the procedure referred to in rule 78(1).
(8) The competent authority shall ensure that significant
modifications in their approved contingency plans are notified to
the European Commission without delay.
(9) The revised contingency plans may subsequently be
approved in accordance with the procedure referred to in rule
78(1), to take into account developments in the situation.
(10) In any case, every five years the competent authority shall
update its contingency plan in particular in the light of realtime
alert exercises referred to in rule 68, and submit it to the
Commission for approval in accordance with the procedure referred
to in rule 78(1).
(1) The competent authority shall ensure that real-time
alert exercises are carried out in accordance with their approved
contingency plan and Schedule XVI.
(2) The competent authority shall ensure that, where possible
and practical, realtime alert exercises are carried out in close
collaboration with the competent authorities of neighbouring
Member States or third countries.
(3) The competent authority shall inform the European
Commission about the main results of real-time alert exercises.
That information shall be submitted to the Commission as part of
the information required in Article 8 of European Council Directive
64/432/EEC.
(1) The competent authority shall ensure that a fully
functional national/central disease control centre may be
immediately established in the event of foot-and-mouth disease
outbreaks.
(2) The national/central disease control centre shall first of all
direct and monitor the operations of local disease control centres as
provided for in rule 70. Certain functions originally attributed to
the national/central disease control centre may subsequently be
transferred to the local disease control centre operated at the
administrative level provided for in Article 2(2)(p) of European
Council Directive 64/432/EEC or higher provided that the tasks of
the national disease control centre are not compromised.
(3) The national/central disease control centre shall be at least
responsible for
(a) designing the necessary control measures;
(b) ensuring the prompt and efficient implementation of
those measures by the local disease control centres;
(c) deploying staff and other resources to local disease
control centres;
(d) providing information to the European Commission, to
the competent authorities of other Member States and
other national authorities including competent
environmental authorities and bodies, as well as
veterinary, agricultural and trading organisations and
bodies;
(e) organising an emergency vaccination campaign and
also the delimitation of vaccination zones;
(f)
liasing with diagnostic laboratories;
(g) liasing with competent environmental authorities to
coordinate the actions on veterinary and environmental
safety;
(h) liasing with the media;
(i)
liasing with the enforcement bodies to ensure adequate
implementation of specific legal measures.
(1) The competent authority shall ensure that the national/
central disease control centres have all the necessary means
including staff, facilities and equipment, to manage an efficient
eradication campaign.
(2) The means referred to in sub-rule (1) shall include at least
the following
(a) a herd identifier and
animal
location
system,
preferably computerised;
(b) all suitable means of communication including
telephones, fax and if possible facilities for
communication with the media;
(c) a communication system allowing exchange of
information with the local disease control centres, the
laboratories and other relevant organisations,
preferably computerised;
(d) maps and other sources of information that can be used
in directing control measures;
(e) a shared daily journal which shall be maintained to
record in chronological order all the events associated
with an outbreak of foot-and-mouth disease and
allowing different activities to be linked and
coordinated;
(f)
lists of national and international organisations and
laboratories that are interested in an outbreak of foot-
and-mouth and shall be contacted in such an event;
(g) lists of staff and other persons who may be called upon
immediately to serve at local disease control centres or
in expert groups provided for in rule 73 in the event of
an outbreak of foot-and-mouth disease;
(h) lists of competent environmental protection authorities
and bodies to contact in the event of an outbreak of
foot-and-mouth disease;
(i)
maps identifying appropriate processing site areas;
(j)
lists of treatment and processing undertakings
authorised to treat or process animal carcasses and
animal waste that could be commissioned in the event
of an outbreak of foot-and-mouth disease, in
particular, indicating their capacity, address and other
contact details;
(k) lists of measures to monitor and control disinfectant
runoff as well as body tissue and fluid displacement
into the surrounding environment as a result of carcass
decomposition, particularly into surface waters and
groundwaters.
(1) The competent authority shall ensure that fully
functional local disease control centres may be established
immediately in the event of outbreaks of foot-and-mouth disease.
(2) The competent authority shall ensure that within the
framework of their contingency plans, provisions are made for
likely locations of local disease control centres, their organisation,
staff, accommodation, facilities and equipment, management
systems, communication lines as well as information channels.
(3) The competent authority shall ensure the local disease
control centres act in close coordination and cooperation with the
national/central disease control centre, in particular in relation to
the measures provided for in rule 68(3)(b).
(4) The competent authority shall ensure that local disease
control centres have the necessary organisation to ensure the
prompt implementation of the measures provided for in these rules
to be applied in the event of an outbreak of foot-and-mouth disease.
(1) The competent authority shall ensure that the local
disease control centres have staff, facilities and equipment as
r e q u i r e d , a n d a c l e a r m a n a g e m e n t s t r u c t u r e a n d e ff e c t i v e
management to ensure the prompt implementation of the measures
relating to the epidemiological inquiry, environmental protection,
processing of carcasses from infected herds, official surveillance of
the zones, tracing, welfare and emergency slaughter, cleansing and
d i s i n f e c t i on a nd o t h e r s m e a s u r e s o f sa n i ta t i on , e m e rg e n c y
vaccination, and all other policy decisions.
(2)
The local disease control centres shall have at least
(a) one telephone line reserved for communication with
the national disease control centre accessible phone
lines where farmers and other rural residents can
obtain recent, accurate information about the measures
taken;
(b) field staff equipped with necessary tools for
communication and effective management of all
necessary data;
(c) a record system, preferably computer-based, connected
to the national disease control centre and to all
necessary
databases,
laboratories
and
other
organisations;
(d) a shared daily journal which shall be maintained to
record in chronological order all the events associated
with an outbreak of foot-and-mouth and allowing
different activities to be linked and coordinated;
(e) up-to-date lists of persons, including private
veterinarians, and local organisations in each region
who shall be contacted and may be involved in the
event of an outbreak of foot-and-mouth disease;
(f)
up-to-date lists of holdings to which the provisions of
rules 15 and 18 may be applied in the case of an
outbreak of foot-and-mouth disease;
(g) up-to-date inventories of possible burning or burial
places for animals killed in accordance with these
rules and to be processed in accordance with
Community and national legislation on the protection
of the environment;
(h) up-to-date list of competent environmental authorities
in each region, as well as other environmental bodies
who must be contacted and are to be involved in the
event of an outbreak of foot-and-mouth disease;
(i)
maps identifying suitable disposal sites for burial of
carcasses that will not present a risk of harm to the
environment, in particular to surface waters or
groundwaters;
(j)
list of treatment and disposal undertakings authorised
to treat or dispose of animal carcasses and animal
waste;
(k) list of measures to monitor and control disinfectant
runoff as well as body tissue and fluid displacement
into the surrounding environment as a result of carcass
decomposition, particularly into surface waters and
groundwaters.
(1) The competent authority shall create a permanently
operational expert group, which is composed of epidemiologists,
veterinary scientists and virologists in a balanced way, to maintain
expertise in order to assist the competent authority in ensuring
preparedness against an outbreak of foot-and-mouth disease
Provided that by way of derogation hereof, the competent
authority may arrange a formalised agreement with other Member
States on mutual assistance in regard of the expert group. These
arrangements shall be detailed in the contingency plans referred to
in rule 66.
(2) In case of a suspicion of an outbreak of foot-and-mouth
disease the expert group shall at least
(a) evaluate the clinical picture and the epidemiological
situation;
(b) give advice regarding the sampling and analyses
needed for diagnosing the foot-and-mouth disease
together with the additional actions and measures to be
taken.
(3) In case of an outbreak of foot-and-mouth the expert group
shall at least
(a) conduct at least in the index case and if necessary on
the spot, an evaluation of the clinical picture and an
analysis of the epidemiological inquiry in order to
collect the necessary data for determining
(i) the origin of the infection;
(ii) the date of introduction of the infectious agent;
(iii) the possible spread of the disease;
(b) report to the Chief Veterinary Officer and the national
disease control centre;
(c) give advice on screening, sampling, test procedures,
control and the other measures to be applied and on the
strategy to be implemented, including advice on
biosecurity measures on holdings or on premises
referred to in rule 16, and in relation to emergency
vaccination;
(d) follow up and guide the epidemiological inquiry;
(e) supplement
the
epidemiological
data
with
geographical, meteorological and other necessary
information;
(f)
analyse the epidemiological data and perform risk
assessments at regular intervals;
(g) assist in ensuring that the processing of animal
carcasses and animal waste is done with a minimum of
detrimental effect on the environment.
(1) Malta may within the framework of the contingency
plan establish or maintain national antigen and vaccine banks for
the storage of reserves for emergency vaccination of antigens or
vaccines authorised in accordance with European Council Directive
2001/82/EC.
(2) The competent authority may retain establishments for the
packaging and storage of vaccines in the case of emergency
vaccination.
(3) The competent authority shall ensure that the antigen and
formulated vaccine in the national antigen and vaccine banks
comply with the minimum standards laid down for the Community
antigen and vaccines bank with respect to safety, sterility and
content of non-structural proteins.
(4) In the event that Malta maintains a national antigen and
vaccine bank, the competent authority shall inform the European
Union Commission about the antigen and vaccine stocks kept. Such
information shall be submitted to the European Commission every
twelve months as part of the information required by Article 8 of
European Council Directive 64/432/EEC. The information on
quantities and sub-types of antigens or authorised vaccines stored
in the national antigen and vaccine bank shall be treated as
classified information and in particular shall not be published.
(1) Without prejudice to Regulation (EC) No 1774/2002,
and any European Comunity legislation, the competent authority
shall ensure that the prohibition on swill feeding in accordance
with Community and national legislation is applicable to all
animals irrespective of their use or the place inhabited by these
animals. Detailed rules for the control measures to be applied by
the competent authority may be adopted in accordance with the
procedure referred to in rule 78(1).
(2) Detailed rules for the control of foot-and-mouth disease in
animals referred to in the second sentence of the definition of
‘animal of a susceptible species’ in rule 2 may be adopted in
accordance with the procedure referred to in rule 78(1).
(3) Immediately after the competent authority has information
that wild animals are suspected of being infected with foot-and-
mouth disease, it shall take all appropriate measures to confirm or
rule out the presence of the disease by investigations of all wild
animals of susceptible species shot or found dead, including
laboratory testing. It shall inform owners of animals of susceptible
species and hunters on the suspicion.
(4) As soon as the competent authority has confirmation of a
primary case of foot-and-mouth disease in wild animals, it shall
immediately apply the measures provided for in Part A of Schedule
XVII in order to reduce the spread of disease, and shall draw up a
plan for the eradication of foot-and-mouth disease in accordance
with Part B of Schedule XVII. It shall inform owners of animals of
susceptible species and hunters of the confirmed case.
CHAPTER IV
Implementing Measures
The competent authority shall lay down the rules on
penalties applicable to infringements of these rules and shall take
all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and
dissuasive. The competent authority shall notify those provisions to
the Commission and shall notify it without delay of any subsequent
amendment affecting them.
(1) Detailed rules for the implementation of sub-rule (2)
and rule 69(2) may be adopted in accordance with the procedure
referred to in rule 78(1).
(2) Further detailed rules for the implementation of these rules
may be adopted in accordance with the procedure referred to in rule
78(1).
(3) The Schedules to these rules may be amended in
accordance with the procedure referred to in rule 78(1) or, in the
case of Schedule XI, in accordance with the procedure referred to
in rule 78(2).
(1) Where reference is made to this sub-rule, Articles 5
and 7 of European Council Decision 1999/468/EC shall apply. The
period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
(2) Where reference is made to this sub-rule, Articles 5 and 7
of Decision 1999/468/EC shall apply. The period laid down in
Article 5(6) of that Decision shall be set at fifteen days.
FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)