MT
Swine Rules, 2004
Table of Provisions (26)
Statutory Text (26 Articles)
B
L.N. 505 of 2004
VETERINARY SERVICES ACT
(CAP. 437)
Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and
Swine Rules, 2004
IN exercise of the powers conferred by article 8 of the Veterinary Services Act,
2001, the Minister for Rural Affairs and the Environment has made the following rules:-
Title, scope and applicability
(1) The title of these regulations is Animal Health Problems Affecting Intra-
Community Trade in Bovine Animals and Swine rules, 2004.
(2) The scope of these rules is to implement the rules laid down under European
Union Council Directive 64/432/EEC on animal health problems affecting intra-
Community trade in bovine animals and swine
Provided that for the purposes of these regulations any reference made under
European Union Council Directive 64/432/EEC to Annex F has now been harmonised
under Commission Regulation (EC) No 599/2004 of the 30 th March 2004 concerning the
adoption of a harmonised model certificate and inspection report linked to intra-
Community trade in animals and products of animal origin
Provided further the certificate found under commission decision 599/2004 shall
apply to these rules.
(3) These rules shall shall apply to intra-Community trade in bovine animals and
swine with the exception of feral pigs as defined in Article 2 (e) of the European Union
Council Directive 80/217/EEC without prejudice to the provisions laid down in the
European Union Council Directives 80/215/EEC, 85/511/EEC, 88/407/EEC, 89/608/
EEC, 90/425/EEC, 90/429/EEC, 90/667/EEC, 91/496/EEC, 91/628/EEC, 92/102/EEC,
92/119/EEC and Decision 90/424/EEC.
Definitions
I. Officially tuberculosis-free bovine herd
For the purposes of this section “bovine animals” means all bovine animals with the exception of animals
taking part in cultural or sporting events.
1. A bovine herd is officially tuberculosis-free if -
(a) all the animals are free from clinical signs of tuberculosis;
(b) all the bovine animals over six weeks old have reacted negatively to at least two official intra-
dermal tuberculin tests carried out in accordance with Schedule B, the first six months after the
elimination of any infection from the herd and the second six months later or, where the herd has
been assembled solely from animals that originate in officially tuberculosis-free herds, the first
test shall be carried out at least 60 days after assembly and the second shall not be required;
(c) following the completion of the first test referred to in (b), no bovine animal over six weeks old
has been introduced into the herd unless it has reacted negatively to an intra-dermal tuberculin test
performed and assessed according to Schedule B and carried out either in the 30 days prior to, or
the 30 days after the date of its introduction into the herd; in the latter case the animal(s) must be
isolated physically from the other animals of the herd in a way to avoid any direct or indirect
contact with the other animals until proven negative.
However, the competent authority may not require this test to be carried out for movements of
animals on its own territory if the animal is from an officially tuberculosis-free herd, except in a
Member State where, on 1 January 1998 and until the status of officially tuberculosis-free region is
obtained, the competent authority required such tests to be carried out for animals moving between
herds participating in a network system as referred to in regulation 14.
2. A bovine herd will retain officially tuberculosis-free status if -
(a) the conditions detailed in 1(a) and (c) continue to apply;
(b) all animals entering the holding come from herds of officially tuberculosis-free status;
(c) all animals on the holding, with the exception of calves under six weeks old which were born in
the holding, are subjected to routine tuberculin testing in accordance with Schedule B at yearly
intervals.
However, the competent authority of a Member State may, for the Member State or part of the Member
State where all the bovine herds are subject to an official programme to combat tuberculosis,
alter the frequency of the routine tests as follows -
if the average — determined at 31 December of each year — of the annual percentages of bovine
herds confirmed as infected with tuberculosis is not more than 1 % of all herds within the defined
area during the two most recent annual supervisory periods, the interval between routine herd tests
may be increased to two years and male animals for fattening within an isolated epidemiological
unit may be exempted from tuberculin testing provided that they come from officially
tuberculosis-free herds and that the competent authority guarantees that the males for fattening
will not be used for breeding and will go direct for slaughter,
if the average — determined at 31 December of each year — of the annual percentages of bovine
herds confirmed as infected with tuberculosis is not more than 0,2 % of all herds within the defined
area during the two most recent biennial supervisory periods, the interval between routine tests may
be increased to three years and/or the age at which animals have to undergo these tests may be
increased to 24 months,
if the average — determined at 31 December of each year — of the annual percentages of bovine
herds confirmed as infected with tuberculosis is not more than 0,1 % of all herds within the defined
area during the two most recent supervisory triennial periods, the interval between routine tests
may be increased to four years, or, providing the following conditions are met, the competent
authority may dispense with tuberculin testing of the herds -
(1) before the introduction into the herd all the bovine animals are subjected to an intra-dermal
tuberculin test with negative results;
or
(2) all bovine animals slaughtered are examined for lesions of tuberculosis and any such
lesions are submitted to a histopathological and bacteriological examination for evidence
of tuberculosis.
The competent authority may also, in respect of the Member State or a part thereof, increase the
frequency of tuberculin testing if the level of the disease has increased.
3A. The officially tuberculosis-free status of a herd is to be suspended if -
(a) the conditions detailed in paragraph 2 are no longer fulfilled; or
(b) one or more animals are deemed to have given a positive reaction to a tuberculin test, or a case
of tuberculosis is suspected at post-mortem examination.
When an animal is considered to be a positive reactor it will be removed from the herd and
slaughtered. Appropriate post-mortem, laboratory and epidemiological examinations shall be
carried out on the positive reactor or the carcase of the suspect animal. The status of the
herd will remain suspended until such time as all laboratory examinations have been completed. If
the presence of tuberculosis is not confirmed, the suspension of the officially tuberculosis-free status
may be lifted following a test of all animals over six weeks of age with negative results at least 42
days after the removal of the reactor animal(s);
or
(c) the herd contains animals of unresolved status as described in Schedule B. In this case, the
status of the herd is to remain suspended until the animals’ status has been clarified. Such
animals must be isolated from the other animals of the herd until their status has been clarified,
either by a further test after 42 days or by post-mortem and laboratory examination;
(d) however, by way of derogation from the requirements of paragraph (c), in a Member State
where the competent authority carries out routine herd testing using the comparative tuberculin test
described in Schedule B, and in the case of a herd where no confirmed reactor animals have been
disclosed for at least three years, the competent authority may decide not to restrict the movement
of other animals in the herd, provided that the status of any inconclusive reactors is resolved
by a further test after 42 days and that no animals from the holding are allowed to enter into intra-
Community trade until the status of any inconclusive reactors has been resolved. If at this further test
any animal either gives a positive reaction or continues to give an inconclusive reaction, then the
conditions of paragraph (b) apply. If the presence of disease is subsequently confirmed, all animals
leaving the holding since the time of the last clear herd test must be traced and tested.
3B. The officially tuberculosis-free status of the herd is to be withdrawn if the presence of tuberculosis is
confirmed by the isolation of M. bovis on laboratory examination.
The competent authority may withdraw status if -
(a) the conditions detailed in point 2 are no longer fulfilled, or
(b) classical lesions of tuberculosis are seen at post-mortem examination, or
(c) an epidemiological enquiry establishes the likelihood of infection,
(d) or for any other reasons considered necessary for the purpose of controlling bovine
tuberculosis.
Tracing and checking is to be undertaken by the competent authority of any herd considered to be
epidemiologically related. The officially tuberculosis-free status of a herd is to remain
withdrawn until cleansing and disinfection of the premises and utensils has been completed and
all animals over six weeks of age have reacted negatively to at least two consecutive tuberculin
tests, the first no less than 60 days and the second no less than four months and no more than 12
months after the removal of the last positive reactor.
4. On the basis of information supplied in accordance with regulation 8, a Member State or part of a Member
State may be declared officially tuberculosis-free according to the procedure laid down in Article 17 of the
European Union Council Directive 64/432/EEC if it meets the following conditions -
(a) the percentage of bovine herds confirmed as infected with tuberculosis has not exceeded 0,1 % per
year of all herds for six consecutive years and at least 99,9 % of herds have achieved officially
tuberculosis-free status each year for six consecutive years, the calculation of this latter
percentage to take place on 31 December each calendar year;
(b) an identification system making it possible to identify the herds of origin and transit for each
bovine animal is in existence in accordance with European Union Regulation (EC) No. 1760/2000;
(c) all bovine animals slaughtered are subjected to an official post-mortem examination;
(d) the procedures for suspension and withdrawal of officially tuberculosis-free status are complied
with.
5. The Member State or part of a Member State will retain officially tuberculosis-free status if the
conditions 4(a) to (d) continue to be met. However, if there is evidence of a significant change in the
situation as regards tuberculosis in a Member State or part of a Member State which has been recognised as
officially tuberculosis-free, the European Commission may, in accordance with the procedure laid down in
Article 17 of the European Union Council Directive 64/432/EEC, take a Decision suspending or revoking
the status until the requirements of the Decision have been fulfilled.
II. Officially brucellosis-free and brucellosis-free bovine herds
For the purposes of this section “bovine animals” means all bovine animals with the exception of
males for fattening provided that they come from officially brucellosis-free herds and that the
competent authority guarantees that the males for fattening will not be used for breeding and
will go direct for slaughter.
1. A bovine herd is officially brucellosis-free if -
(a) it contains no bovine animals which have been vaccinated against brucellosis, except
females which have been vaccinated at least three years previously;
(b) all the bovine animals have been free from clinical signs of brucellosis for at least six months;
(c) all the bovine animals over 12 months old have been subjected to one of the following test
regimes with negative results in accordance with Schedule C -
(i) two serological tests specified in paragraph 10 at an interval of more than three
months and less than 12 months;
(ii) three tests on milk samples at three-monthly intervals followed at least six weeks
later by a serological test specified in paragraph 10;
(d) any bovine animal entering the herd comes from a herd of officially brucellosis-free status and,
in the case of bovine animals over 12 months old, has shown a brucella titre of less than 30 IU
of agglutination per ml when given a serum agglutination test in accordance with Schedule C or
has reacted negatively to any other test approved in accordance with the procedure at Article 17
during the 30 days prior to or the 30 days after the date of its introduction into the herd: in the
latter case, the animal(s) must be isolated physically from the other animals of the herd in such a
way as to avoid direct or indirect contact with the other animals until proven negative.
2. A bovine herd will retain officially brucellosis-free status if -
(a) one of the following test regimes is carried out annually with negative results in accordance with
Schedule C -
(i) three milk ring tests carried out at intervals of at least three months;
(ii) three milk ELISAs carried out at intervals of at least three months;
(iii) two milk ring tests carried out at an interval of at least three months followed at least
six weeks later by a serological test referred to in paragraph 10;
(iv) two milk ELISAs carried out at an interval of at least three months followed at least
six weeks later by a serological test referred to in paragraph 10;
(v) two serological tests carried out at an interval of at least three months and not more
than 12 months.
However, the competent authority of a Member State may, for the Member State or part of the
Member State which is not officially brucellosis-free but where all the bovine herds are subject to
an official programme to combat brucellosis, alter the frequency of the routine tests as
follows -
— where not more than 1 % of bovine herds are infected, it may be sufficient to carry out
each year two milk ring tests or two milk ELISAs at an interval of at least three months, or
one serological test,
— where at least 99,8 % of bovine herds have been recognised as officially brucellosis-
free for at least four years, the interval between checks may be extended to two years if all
animals over 12 months of age are tested, or testing may be restricted to animals over
24 months of age if herds continue to be tested each year. The checks must be carried out
using one of the serological tests referred to in paragraph 10;
(b) all bovine animals entering the herd come from herds of officially brucellosis-free status and,
in the case of bovine animals over 12 months old, have shown a brucella titre of less than
30 IU of agglutination per ml when given a serum agglutination test in accordance with Schedule
C or have reacted negatively to any other test approved in accordance with the procedure at Article
17 during the 30 days prior to or the 30 days after the date of their introduction into the herd;
in the latter case, the animal(s) must be isolated physically from the other animals of the herd in
such a way as to avoid direct or indirect contact with the other animals until proven negative.
However, the test described in point (b) need not be required in Member States, or regions of
Member States, where the percentage of bovine herds infected with brucellosis has not
exceeded 0,2 % for at least two years and where the animal comes from an officially
brucellosis-free bovine herd within that Member State or region and has not during transportation
come into contact with bovine animals of lesser status;
(c) notwithstanding point (b), bovine animals from a brucellosis-free bovine herd may be intro-
duced into an officially brucellosis-free herd if they are at least 18 months old and, if vaccinated
against brucellosis, the vaccination was carried out more than a year previously.
Such animals must have shown, in the 30 days prior to introduction, a brucella titre lower than
30 IU of agglutination per ml and a negative result when given a complement fixation test, or other
test approved under the procedure set out in Article 17 of the European Union Council Directive
64/432/EEC.
If, however, a female bovine animal from a brucellosis-free herd is introduced into an officially
brucellosis-free herd, under the provisions of the above paragraph, that herd shall be considered to
be brucellosis-free for two years from the date on which the last vaccinated animal was intro-
duced.
3A. The officially brucellosis-free status of a herd is to be suspended if -
(a) the conditions detailed in paragraphs 1 and 2 are no longer fulfilled; or
(b) as a result of laboratory tests or on clinical grounds one or more bovine animals is suspected of
having brucellosis and the suspect animals have been slaughtered or isolated in a way to avoid
any direct or indirect contact with the other animals.
Where the animal has been slaughtered and is no longer available for testing, the suspension
may be lifted if two serum agglutination tests, carried out in accordance with Schedule C on all
bovine animals in the herd over 12 months old, show a titre lower than 30 IU of agglutination per
ml. The first test shall be carried out at least 30 days after the removal of the animal and the
second at least 60 days later.
Where the animal has been isolated from the animals in the herd, it may be reintroduced into
the herd and the status of the herd may be restored following -
(a) a serum agglutination test which has shown a titre lower than 30 IU of agglutination
per ml and has given a negative result to a complement fixation test, or
(b) a negative result to any other combination of tests approved for that purpose under the
procedure set out in Article 17 of the European Union Council Directive 64/432/EEC.
3B. The officially brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests
or epidemiological investigations, brucella infection has been confirmed in the herd.
The status of the herd is not to be restored until either all bovine animals present in the herd at the time
of the outbreak have been slaughtered, or the herd has been subject to check testing and all animals
over 12 months of age have given negative results to two consecutive tests at 60-day intervals, the
first being carried out not less than 30 days after removal of the positive animal(s).
In the case of bovine animals which were pregnant at the time of the outbreak, the final check must be
carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.
4. A bovine herd is brucellosis-free if it complies with the conditions in 1(b) and (c) and when
vaccination has been carried out as follows -
(i) female bovine animals have been vaccinated -
— before the age of six months old with live strain 19 vaccine, or
— before the age of 15 months old with killed 45/20 adjuvant vaccine which has been officially
inspected and approved, or
— with other vaccines approved under the procedure laid down in Article 17 of the European
Union Council Directive 64/432/EEC;
(ii) bovine animals under 30 months old which have been vaccinated with live strain 19 vaccine
may give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutina-
tion per millilitre provided that, on the complement fixation test, they give a result less than 30
EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC
units in all other cases.
5. A bovine herd will retain brucellosis-free status if -
(i) it is subject to one of the testing regimes listed in 2(a);
(ii) bovine animals entering the herd comply with the requirements of 2(b); or
— come from herds of brucellosis-free status, and in the case of bovine animals over 12
months old, have shown, in the 30 days prior to or in isolation after introduction into the
herd, less than 30 IU of agglutination per ml when given a serum agglutination test and a
negative result to a complement fixation test in accordance with Schedule C, or
— come from herds of brucellosis-free status, are under 30 months old and have been vac-
cinated with live strain 19 vaccine if they give a serum agglutination test result greater
than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the
complement fixation test, they give a result less than 30 EEC units in the case of
females vaccinated less than 12 months previously or less than 20 EEC units in all other
cases.
6A. The brucellosis-free status of a herd is to be suspended if -
(a) the conditions detailed in paragraphs 4 and 5 have not been complied with; or
(b) as a result of laboratory tests or on clinical grounds one or more bovine animals over 30
months old is suspected of having brucellosis and the animal(s) under suspicion have been
slaughtered, or isolated in a way to avoid any direct or indirect contact with other animals.
Where the animal has been isolated, it may be reintroduced into the herd and the status of the
herd may be restored, if it subsequently shows a serum agglutination titre lower than 30 IU of
agglutination per ml and has given a negative result to a complement fixation test, or other test
approved under the procedure set out in Article 17 of the European Union Council Directive
64/432/EEC.
Where the animals have been slaughtered and are no longer available for testing, the
suspension may be lifted if two serum agglutination tests, carried out in accordance with
Schedule C on all bovine animals in the holding over 12 months old, show a titre lower than
30 IU of agglutination per ml. The first test is to be carried out at least 30 days after the removal
of the animal and the second at least 60 days later.
If the animals to be tested in the previous two subparagraphs are under 30 months old and have
been vaccinated with live strain 19 vaccine they may be considered to be negative if they give a
serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per
millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units
in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all
other cases.
6B. The brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests of epid-
emiological investigations, brucella infection has been confirmed in a herd. The status of the
herd is not to be restored until either all the bovine animals present in the herd at the time of the
outbreak have been slaughtered or the herd has been subject to check testing and all
unvaccinated animals over 12 months of age have given negative results to two consecutive
tests at 60 day intervals, the first being carried out not less than 30 days after removal of
the positive animal(s).
If all the animals to be tested referred to in the preceding paragraph are less than 30 months old
and have been vaccinated with live strain 19 vaccine, they may be considered negative if they
show a brucella titre of more than 30 IU but less than 80 IU of agglutination per ml, provided that
in the complement fixation test they show a titre of less than 30 EEC units in the case of females
vaccinated less than 12 months previously or a titre of less than 20 EEC units in all other cases.
In the case of bovine animals which were pregnant at the time of the outbreak, the final check
must have been carried out at least 21 days after the last animal pregnant at the time of
the outbreak has calved.
7. A Member State or a region of a Member State may be declared officially brucellosis-free
according to the procedure laid down in Article 17 of the European Union Council Directive
64/432/EEC if it meets the following conditions -
(a) no case of abortion due to brucella infection and no isolation of B. abortus has been recorded for
at least three years and at least 99,8 % of herds have achieved officially brucellosis-free status each
year for five consecutive years, the calculation of this percentage to take place on 31 December
each calendar year. However, where the competent authority adopts a policy of whole herd
slaughter, isolated incidents shown by epidemiological enquiry to be due to the introduction of
animals from outside the Member State or part of the Member State and herds whose officially
brucellosis-free status has been suspended or withdrawn for reasons other than suspicion of
disease, is to be disregarded for the purpose of the above calculation provided that the central
competent authority of the Member State concerned by these incidents makes an annual record
and forwards them to the European Commission in accordance with regulation 8(2), and
(b) an identification system making it possible to identify the herds of origin and transit for each
bovine animal is in existence in accordance with European Union Regulation (EC) No.
820/97, and
(c) notification of cases of abortion is mandatory and they are investigated by the competent
authority.
8. Subject to paragraph 9, a Member State or a region of a Member State declared officially brucellosis
free is to retain this status if -
(a) the conditions imposed by paragraph 7(a) and (b) are still fulfilled and notification of cases of
abortion suspected of being due to brucellosis is mandatory and are investigated by the competent
authority;
(b) every year for the first five years after attaining status, all bovine animals over 24 months of
age in not less than 20 % of herds have been tested and have reacted negatively to a serological
test carried out in accordance with Schedule C or, in the case of dairy herds, by examination of milk
samples in accordance with Schedule C;
(c) every bovine animal suspected of being infected with brucellosis is notified to the
competent authority and undergoes official epidemiological investigation for brucellosis
comprising at least two serological blood tests, including the complement fixation test, and a
microbiological examination of appropriate samples;
(d) during the period of suspicion, which is to continue until negative results have been obtained
from the tests provided for in (c), the officially brucellosis-free status of the herd of origin or transit
of the suspected bovine animal and of the herds linked epidemiologically to it is to be suspended;
(e) in the event of an outbreak of brucellosis that has spread, all bovine animals have been
slaughtered. Animals of the remaining susceptible species will undergo appropriate tests and
premises and equipment will be cleaned and disinfected.
9. A Member State or a region of a Member State declared officially brucellosis-free is to report the
occurrence of all cases of brucellosis to the European Commission. If there is evidence of a
significant change in the situation as regards brucellosis in a Member State or part of a Member State
which has been recognised as officially brucellosis-free, the European Commission may according
to the procedure laid down in Article 17 of the European Union Council Directive 64/432/EEC
propose that the status be suspended or revoked until the requirements of the Decision have been
fulfilled.
10. For the purposes of section II, a serological test means either a serum agglutination test, buffered
brucella antigen test, complement fixation test, plasma agglutination test, plasma ring test, micro-
agglutination test or individual blood ELISA, as described in Schedule C. Any other diagnostic test
approved under the procedure laid down in in Article 17 of the European Union Council Directive
64/432/EEC and described in Schedule C will also be accepted for the purposes of section II. A
milk test means a milk ring test or a milk ELISA in accordance with Schedule C.
(1) (a) The definitions given in article 2 of European Union Council Directive
90/425/EEC relating to veterinary checks applicable in trade in bovine and porcine
animals and in article 2 of European Union Council Directive 91/628/EEC relating to
animal welfare during transport shall apply to these regulations.
(b) “Member States” means Member States of the European Union;
“Third Countries” means countries which are not Member States
within the European Union;
(2) In addition, the following definitions apply for the purposes of these
regulations -
“animals for breeding or production” means bovine animals (including the species
Bison bison and Bubalus bubalus) and swine other than those referred to as
animals for slaughter, including those intended for breeding, milk or meat
production, or draft purposes, shows or exhibition with the exception of animals
taking part in cultural and sporting events;
“animal for slaughter” means a bovine animal (including the species Bison bison
and Bubalus bubalus) or swine intended to be taken to a slaughterhouse or
assembly centre from which it may only move to slaughter;
“approved veterinarian” means any veterinarian approved by the Veterinary
Services, in accordance with the provisions of rule 14 (3) (B) ;
“assembly centre” means holdings, collection centres and markets, at which
bovine animals or swine originating from different holdings are grouped together
to form consignments of animals intended for trade. These assembly centres must
be approved for trading purposes and meet the requirements laid down in rule 11;
“brucellosis-free bovine herd” means a bovine herd which satisfies the conditions
laid down in Annex A. II, paragraphs 4, 5 and 6 to European Union Council
Directive 64/432/EEC;
“competent authority” means –
(i) for Malta: the Veterinary Services as established under article 2 of the
Veterinary Services Act;
(ii) for a Member State: the central authority competent to carry out
veterinary checks in animal health or any authority to which it has
delegated that competence;
“compulsorily notifiable diseases” means the diseases listed in Annex E (I) to
European Union Council Directive 64/432/EEC;
“dealer” means any natural or legal person who buys and sells animals
commercially either directly or indirectly, who has a regular turnover of these
animals and who within a maximum of 30 days of purchasing animals resells
them or relocates them from the first premises to other premises not within his
ownership and meets the conditions laid down in rule 13;
“herd” means an animal or group of animals kept on a holding (within the
meaning of Article 2 (b) of Directive 92/102/EEC) 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;
“officially brucellosis free bovine herd” means a bovine herd which satisfies the
conditions laid down in Annex A. II, paragraphs 1, 2 and 3 to European Union
Council Directive 64/432/EEC;
“officially brucellosis free Member State” means a Member State which satisfies
the conditions laid down in Annex A. II, paragraphs 10, 11 and 12 to European
Union Council Directive 64/432/EEC;
“officially brucellosis free region” means a region of a Member State which
satisfies the conditions laid down in Annex A. II, paragraphs 7, 8 and 9 to
European Union Council Directive 64/432/EEC;
“officially enzootic-bovine-leukosis-free herd” means a herd which satisfies the
conditions laid down in Annex D, Chapter I, Sections A and B, C and D to
European Union Council Directive 64/432/EEC;
“officially enzootic-bovine-leukosis-free Member State or region” means a region
or Member State which meets the requirements laid down in Annex D, Chapter I,
Sections E and F, and G to European Union Council Directive 64/432/EEC;
“officially tuberculosis free bovine herd” means a bovine herd which satisfies the
conditions laid down in Annex A. I, paragraphs 1, 2 and 3 to European Union
Council Directive 64/432/EEC;
“officially tuberculosis free Member State or region of a Member State” means a
Member State or part of a Member State which satisfies the conditions laid down
in Annex A. I, paragraphs 4, 5 and 6 to European Union Council Directive
64/432/EEC;
“official veterinarian” means the veterinarian appointed by the competent
authority of a Member State;
“region” means that part of a Member State's territory which is subject to
inspection by the competent authorities.
(i) Belgium: province/provincie;
(ii) Germany: Regierungsbezirk;
(iii) Denmark: amt or island;
(iv) France: department;
(v) Italy: provincial;
(vi) Luxemburg Netherlands: rrv-kring;
(vii) United Kingdom - England, Wales and Northern Ireland: county;
(viii) Scotland: district or island area;
(ix) Ireland: county;
(x) Greece: Nomos;
(xi) Spain: provincial;
(xii) Portugal: continente: distrito, and other parts of Portugal's territory
região autónoma;
(xiii) Austria: Bezirk;
(xiv) Sweden: län;
(xv) Finland: lääni/län.
Conditions to be fulfilled by animals for export
TUBERCULOSIS
1. IDENTIFICATION OF THE AGENT
The presence of Mycobacterium bovis (M. bovis), agent of bovine tuberculosis, in clinical and
post-mortem specimens may be demonstrated by examination of stained smears or
immunoperoxidase techniques and confirmed by cultivation of the organism on primary isolation
medium.
Pathological material for the confirmation of M. bovis should be taken from abnormal lymph
nodes and parenchymatous organs such as lungs, liver, spleen, etc. In the cases where the animal
does not present pathological lesions, samples from the retropharyngeal, bronchial, mediastinal,
supramammary, mandibular and some mesenteric lymph nodes and liver should be collected for
examination and culture.
Identification of isolates may be usually carried out by determining cultural and biochemical
properties. The polymerase chain reaction (PCR) may also be employed for the detection of the
M. tuberculosis complex. DNA analysis techniques may prove to be faster and more reliable than
biochemical methods for the differentiation of M. bovis from other members of the M.
tuberculosis complex. Genetic fingerprinting allows distinguishing between different strains of
M. bovis and will enable patterns of origin, transmission and spread of M. bovis to be described.
The techniques and media used, their standardisation and the interpretation of results must
conform to that specified in the OIE Manual of Standards for Diagnostic Tests and Vaccines,
Fourth Edition, 2000, Chapter 2.3.3 (bovine tuberculosis).
2. THE TUBERCULIN SKIN TEST
Tuberculin PPD (Purified Protein Derivatives) that fulfil the standards laid down in paragraph 2.1
shall be used for carrying out official tuberculin skin test following the procedures referred to in
paragraph 2.2.
Standards for tuberculin (bovine and avian)
2.1.1. Definition
Tuberculin purified protein derivative (tuberculin PPD, bovine or avian) is a preparation obtained
from the heat-treated products of growth and lysis of Mycobacterium bovis or Mycobacterium
avium (as appropiate) capable of revealing a delayed hypersensitivity in an animal sensitised to
microorganisms of the same species.
Production
It is obtained from the water-soluble fractions prepared by heating in free-flowing steam and
subsequently filtering cultures of M. bovis or M. avium (as appropiate) grown in a liquid synthetic
medium. The active fraction of the filtrate, consisting mainly of protein, is isolated by
precipitation, washed and re-dissolved. An antimicrobial preservative that does not give rise to
false positive reactions, such as phenol, may be added. The final sterile preparation, free from
mycobacteria, is distributed aseptically into sterile tamper-proof glass containers which are then
closed so as to prevent contamination. The preparation may be freeze-dried.
Identification of the product
Inject a range of graded doses intradermally at different sites into suitably sensitised albino guinea-
pigs, each weighing not less than 250 g. After 24 h to 28 h, reactions appear in the form of
oedematous swellings with erythema with or without necrosis at the points of injection. The size
and severity of the reactions vary according to the dose. Unsensitised guinea-pigs show no
reactions to similar injections.
Tests
2.1.4.1. pH: The pH is 6.5 to 7.5.
2.1.4.2. Phenol: If the preparation to be examined contains phenol, its concentration is not more
than 5 g/l.
2.1.4.3. Sensitising effect: Use a group of three guinea-pigs that have not been treated with any
material which will interfere with the test. On 3 occasions at intervals of five days inject
intradermally into each guinea-pig a dose of the preparation to be examined equivalent to 500 IU
in 0,1 ml. 15 to 21 days after the third injection inject the same dose (500 IU) intradermally into
these animals and into a control group of three guinea-pigs of the same mass and which have not
previously received injections of tuberculin. 24 to 28 hours after the last injections, the reactions
of the two groups are not significantly different.
2.1.4.4. Toxicity: Use two guinea-pigs, each weighing not less than 250 g and which have not
previously been treated with any material which will interfere with the test. Inject subcutaneously
into each guinea-pig 0,5 ml of the preparation to be examined. Observe the animals for seven
days. No abnormal effects occur during the observation period.
2.1.4.5. Sterility: It complies with the test for sterility prescribed in the monograph on Vaccines
for veterinary use 4th Edition 2002 of the European Pharmacopoeia.
Potency
The potency of tuberculin purified protein derivative (bovine and avian) is determined by
comparing the reactions produced in sensitised guinea-pigs by the intradermal injection of a series
of dilutions of the preparation to be examined with those produced by known concentrations of a
reference preparation of tuberculin (bovine or avian, as appropiate) purified protein derivative
calibrated in international Units.
To test the potency, sensitise not fewer than nine albino guinea-pigs, each weighing 400 g to 600
g, by the deep intramuscular injection of 0,0001 mg of wet mass of living M. bovis of strain AN5
suspended in 0.5 ml of a 9 g/l solution of sodium chloride R for bovine tuberculin, or a suitable
dose of inactivated or live M. avium for avian tuberculin. Not less than four weeks after the
sensitisation of the guinea-pigs, shave their flanks to provide space for not more than four
injection sites on each side. Prepare dilutions of the preparation to be examined and of the
reference preparation using isotonic phosphate-buffered saline (pH 6,5-7,5) containing 0,005 g/l of
polysorbate 80 R. Use not fewer than three doses of the reference preparation and not fewer than
three doses of the preparation to be examined. Choose the doses such that the lesions produced
have a diameter of not less than 8 mm and not more than 25 mm. Allocate the dilutions randomly
to the sites using a Latin square design. Inject each dose intradermally in a constant volume of 0,1
ml or 0,2 ml. Measure the diameters of the lesions after 24 to 28 hours and calculate the result of
the test using the usual statistical methods and assuming that the diameters of the lesions are
directly proportional to the logarithm of the concentration of the tuberculins.
The test is not valid unless the fiducial limits of error (P = 0,95) are not less than 50 % and not
more then 200 % of the estimated potency. The estimated potency is not less than 66 % and not
more than 150 % of the stated potency for bovine tuberculin. The estimated potency is not less
than 75 % and not more than 133 % of the stated potency for avian tuberculin. The stated potency
is not less than 20 000 IU/ml for both tuberculins (bovine and avian).
Storage
Store protected from light, at a temperature of 5 ± 3 °C.
Labelling
The label states -
- the potency in International Units per millilitre,
- the name and quantity of any added substance,
- for freeze-dried preparations
(a) the name and volume of the reconstituting liquid to be added,
(b) that the product should be used immediately after reconstitution.
Test procedures
The following shall be recognised as official intra- dermal tuberculin tests -
- the single intradermal test: this test requires a single injection of bovine tuberculin,
- the intradermal comparative test: this test requires one injection of bovine tuberculin and one
injection of avian tuberculin given simultaneously.
The dose of tuberculin injected shall be -
- not less than 2 000 IU of bovine tuberculin,
- not less than 2 000 IU of avian tuberculin.
The volume of each injection dose shall not exceed 0,2 ml.
Tuberculin tests shall be carried out by injecting tuberculin(s) into the skin of the neck. The
injection sites shall be situated at the back of the anterior and middle thirds of the neck. When both
avian and bovine tuberculins are injected in the same animal, the site for injection of avian
tuberculins shall be about 10 cm from the crest of the neck and the site for the injection of bovine
tuberculin about 12,5 cm lower on a line roughly parallel with the line of the shoulder or on
different sides of the neck; in young animals in which there is not room to separate the sites
sufficiently on one side of the neck, one injection shall be made on each side of the neck at
identical sites in the centre of the middle third of the neck.
The technique of tuberculin testing and interpretation of reactions shall be as follows -
2.2.5.1.
Technique -
Injection sites shall be clipped and cleansed. A fold of skin within each clipped area shall be taken
between the forefinger and thumb and measured with callipers and recorded. The dose of
tuberculin shall then be injected by a method that ensures that the tuberculin is delivered
intradermically. A short sterile needle, bevel edge outwards, with graduated syringe charged with
tuberculin, inserted obliquely into the deeper layers of the skin may be used. A correct injection
shall be confirmed by palpating a small pea-like swelling at each site of injection. The skin-fold
thickness of each injection site shall be remeasured 72 hours (± 4 hours) after injection and
recorded.
2.2.5.2.
Interpretation of reactions
The interpretation of reactions shall be based on clinical observations and the recorded
increase(s) in skin-fold thickness at the sites of injection 72 hours after injection of
tuberculin(s).
(a) Negative reaction: if only limited swelling is observed, with an increase of not more
than 2 mm in the thickness of the fold of skin without clinical signs such as diffuse or
extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in
that region or of the lymph nodes.
(b) Inconclusive reaction: if no clinical signs such as mentioned in (a) are observed and
if the increase in skin-fold thickness is more than 2 mm and less than 4 mm.
(c) Positive reaction: if clinical signs such as mentioned in (a) are observed or there is
an increase of 4 mm or more in the thickness of the fold of skin at the injection site.
2.2.5.3. The interpretation of official intradermal tuberculin tests shall be as follows -
2.2.5.3.1. Single intradermal test-
(a) positive: a positive bovine reaction as defined in
paragraph 2.2.5.2(c);
(b) inconclusive: an inconclusive reaction as defined in
paragraph 2.2.5.2(b);
(c) negative: a negative bovine reaction as defined in
paragraph 2.2.5.2(a).
Animals inconclusive to the single intradermal test shall be subjected to another test
after a minimum of 42 days.
Animals which are not negative to this second test shall be deemed to be positive to
the test.
Animals positive to the single intradermal test may be subjected to an intradermal
comparative test if false positive reaction or interference reaction is suspected.
2.2.5.3.2. Intradermal comparative test for the establishment and maintenance of officially
tuberculosis-free herd status -
(a) positive: a positive bovine reaction which is more than 4 mm greater than the avian
reaction, or the presence of clinical signs;
(b) inconclusive: a positive or inconclusive bovine reaction which is from 1 to 4 mm greater
than the avian reaction, and the absence of clinical signs;
(c) negative: a negative bovine reaction, or a positive or inconclusive bovine reaction but
which is equal to or less than a positive or inconclusive avian reaction and the absence of
clinical signs in both cases.
Animals inconclusive to the intradermal comparative test shall be subjected to another test
after a minimum of 42 days. Animals, which are not negative to this second test, shall be
deemed to be positive to the test.
2.2.5.3.3. Officially tuberculosis-free herd status may be suspended and animals from the herd shall
not be allowed to enter intra-Community trade until such time as the status of the following animals
is resolved -
(a) animals which have been deemed to be inconclusive to the single intradermal tuberculin
test;
(b) animals which have been deemed to be positive to the single intradermal tuberculin test
but are awaiting retest with an intradermal comparative test;
(c) animals which have been deemed to be inconclusive to the intradermal comparative test.
2.2.5.3.4. Where animals are required by European Community legislation to be subjected to an
intradermal test prior to movement, the test shall be interpreted so that no animal which
shows an increase in skin-fold thickness greater than 2 mm or the presence of clinical
signs is entered into Intra-Community trade.
2.2.5.3.5. To enable detection of the maximum number of infected and diseased animals in a herd
or in a region, Member States may modify the criteria for the interpretation of the test in
to achieve improved test sensitivity considering all inconclusive reactions referred in
2.2.5.3.1(b) and 2.2.5.3.2(b) as positive reactions.
3. SUPPLEMENTARY TESTING
To enable detection of the maximum number of infected and diseased animals in a herd or in a
region, Member States may authorise the employ of the gamma-interferon assay referred in the OIE
Manual of Standards for Diagnostic Tests and Vaccines, 4th Edition, 2000, Chapter 2.3.3. (bovine
tuberculosis), in addition to the tuberculin test.
4. STATE INSTITUTES AND NATIONAL REFERENCE LABORATORIES
Tasks and responsibilities
The State Institutes and Reference Laboratories included in paragraph 3.2 shall be responsible for
the official testing of tuberculins or reagents included in paragraph 2 and 3 in their respective States
to ensure each of these tuberculins or reagents are adequate in relation to the standards above
referred.
List of State institutes and national reference laboratories
1. Germany
Paul-Ehrlich Institut (PEI), Bundesamt fur Sera and Impstoffe, D-23207 Langen; Bundesinstitut
fur gesundheitlichen Verbraucherschutz and Veterinarmedizin - Bereich Jena - D-07743 Jena;
2. Belgium
Institut Scientifique de la Sante Publique - Louis Pasteur, 14 Rue Juliette Wytsman - B 1050
Bruxelles - Belgique;
3. France
Laboratoire national des medicaments veterinaires, Fougeres;
4. Grand Duchy of Luxembourg
Institute of the supplying country; 5.
5. Italy
Istituto superiore di sanita, Rome;
6. Netherlands
Centraal Instituut voor Dierziekte Controle Lelystad (CIDC-Lelystad), Lelystad;
7. Denmark
Danmarks Veterinacrinstitut, Bulowsvej 27, DK-1790 Kobenhavn;
8. Ireland
Institute of the supplying country;
9. United Kingdom
Veterinary Laboratory Agency, Addlestone, Weybridge;
10. Greece
Kєvrpo KTgviarptia v I8puµfTmv, NeanoAeuc 25, 153 10 ABnva;
11. Spain
Laboratorio de Sanidad y produccion animal de Granada;
12. Portugal
Laboratorio Nacional de Investigacao Veterinaria, Lisbon;
13. Austria
Bundesanstalt fiir veterinarmedizinische Untersuchungen, Modling;
14. Finland
Elainlaakinta - ja elintarviketutkimus - laitos - Forskningsanstalten for veterinarmedicin och
livsmedel, Helsinki;
15. Sweden
Statens veterinarmedicinska anstalt, Uppsala.'
(1) Only animals that fulfil the relevant conditions laid down in these rule are
sent from the Maltese territory to that of another Member State.
(2) Bovine animals and swine covered by these rule must -
(a) be subjected -
(i) to an identity check, and
(ii) to a clinical inspection within 24 hours of departure by an
official veterinarian and show no clinical sign of disease;
(b) not have been obtained from a holding or an area which for health
reasons is subject to prohibition or restriction affecting the species
involved in accordance with Community and or national legislation;
(c) be identified as provided for in European Union Council Directive
92/102/EEC
(d) not be animals which are to be slaughtered and not be restricted under
a contagious or infectious disease eradication programme in Malta;
(e) comply with the provisions of rules 4 and 5.
Contact between animals
BRUCELLOSIS
1. IDENTIFICATION OF THE AGENT
The demonstration by modified acid-fast or immunospecific staining of
organisms of Brucella morphology in abortion material, vaginal discharges or
milk provides presumptive evidence of brucellosis, especially if supported by
serological tests.
After isolation, the species and biovar should be identified by phage lysis and,
or oxidative metabolism tests, cultural, biochemical and serological criteria.
The techniques and media used, their standardisation and the interpretation of
results must conform to that specified in the CIE Manual of Standards for
Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1 (bovine
brucellosis), Chapter 2.4.2 (caprine and ovine brucellosis) and Chapter 2.6.2
(porcine brucellosis).
2. IMMUNOLOGICAL TESTS
Standards
2.1.1. The Brucella abortus biovar I Weybridge strain No 99 or USDA strain 1119-3
must be used for the preparation of all antigens used in the rose bengal test
(RBT), serum agglutination test (SAT), complement fixation test (CFT) and
the milk ring test (MRT).
2.1.2. The standard reference serum for the RBT, SAT, CFT and MRT is the OIE
international reference standard serum (OIEISS) formerly named WHO
second international anti-Brucella abortus Serum (ISAbS).
2.1.3. The standard reference sera for ELISAs are -
- the OIEISS,
- the weak positive
OIE
ELISA
standard
serum
(OIEELISA WP SS),
- the strong positive
OIE
ELISA
standard
serum
(OIEELISA SP SS),
- The negative OIE ELISA standard serum (OIEELISA N SS).
2.1.4. The above listed standard sera are available from the Veterinary Laboratories
Agency (VLA), Weybridge, United Kingdom.
2.1.5. The OIEISS, the OIEELISA H , P SS, the OIEELISA,,SS and the OIEELISA N SS
are international primary standards from which secondary reference national
standards ("working standards') must be established for each test in each
Member State.
Enzyme-linked immunosorbent assays (ELISAs) or other binding assays
for the detection of bovine brucellosis in serum or milk
2.2.1. Material and reagents
The technique used and the interpretation of results must have been validated
in accordance with the principles laid down in Chapter 1.1.3 of the CIE
Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition,
2000, and should at least include laboratory and diagnostic studies.
2.2.2. Standardisation of the test
2.2.2.1. Standardisation of the test procedure for individual serum samples -
(a) a 1/150 pre-dilution ( 1 ) of the OIEISS or a 1/2 pre-dilution of the
OIEELISA, SS or a 1/16 pre-dilution of the OIEELISA,,SS made up in a
negative serum (or in a negative pool of sera) should give a positive
reaction;
(b) a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the
OIEELISA,,SS or a 1/64 pre-dilution of the OIEELISA,,SS made up in a
negative serum (or in a negative pool of sera) should give a negative
reaction;
(c) the OIEELISA N SS should always give a negative reaction.
2.2.2.2. Standardisation of the test procedure for pooled serum samples -
(a) a 1/150 pre-dilution of the MISS or a 1/2 pre-dilution of the
OIEELISA Wp SS or a 1/16 pre-dilution of the OIEELISA sr SS made up in a
negative serum (or in a negative pool of sera) and again diluted in
negative sera by the number of samples making up the pool should give a
positive reaction;
(b) the OIEELISA N SS should always give a negative reaction;
(c) the test must be adequate to detect evidence of infection in a single
animal of the group of animals, of which samples of serum have been
pooled.
2.2.2.3. Standardisation of the test procedure for pooled milk or whey samples -
For the purpose of this Schedule, dilutions given for making up liquid reagents are expressed as, for example, 1 150 shall mean a I in
(a) a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the
OIEELISA. SS or a 1/125 pre-dilution of the OIEELISA 5 SS made up in a
negative serum (or in a negative pool of sera) and again diluted 1/10 in
negative milk should give a positive reaction;
(b) the OIEELISA N SS diluted 1/10 in negative milk should always give a
negative reaction;
(c) the test must be adequate to detect evidence of infection in a single
animal of the group of animals, of which samples of milk or whey have
been pooled.
2.2.3. Conditions for use of the ELISAs for diagnosis of bovine brucellosis -
2.2.3.1. Using the abovementioned calibrating conditions for ELISAs on serum
samples, the diagnostic sensitivity of ELISA shall be equal or greater than the
RBT or CFT taking into account the epidemiological situation under which it
is employed.
2.2.3.2. Using the abovementioned calibrating conditions for ELISA on pooled milk
samples, the diagnostic sensitivity of ELISA shall be equal or greater than the
MRT taking into account not only the epidemiological situation but also the
average and expected extreme husbandry systems.
2.2.3.3. Where ELISAs are used for certification purposes in accordance with
regulation 6(1) or for the establishment and maintenance of a herd status in
accordance with Schedule A(Il)(10), pooling of samples of serum must be
carried out in such a way that the test results can be undoubtedly related to
the individual animal included in the pool. Any confirmatory test must be
carried out on samples of serum taken from individual animals.
2.2.3.4. The ELISAs may be used on a sample of milk taken from the milk collected
from a farm with at least 30 % of dairy cows in milk. If this method is used,
measures must be taken to ensure that the samples taken for examination can
be undoubtedly related to the individual animals from which the milk
derived. Any confirmatory test must be carried out on samples of serum
taken from individual animals.
Complement fixation test (CFT)
2.3.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85 %
(m/v) and phenol at 0,5 % (v/v)) or in a veronal buffer. Antigens may be
delivered in the concentrated state provided the dilution factor to be used is
indicated on the bottle label. The antigen must be stored at 4 °C and not
frozen.
2.3.2. Serums must be inactivated as follows -
- bovine serum: 56 to 60 °C for
30 to 50 minutes,
- porcine serum: 60 °C for 30 to
50 minutes.
2.3.3. In to carry out the genuine reaction within the test procedure, a complement
dose higher than the minimum necessary for total haemolysis should be used.
2.3.4. In carrying out the complement fixation test, the following controls must be
made each time -
(a) control of the anti-complementary effect of the serum;
(b) control of the antigen;
(c) control of sensitised red blood cells;
(d) control of the complement;
(e) control using a positive serum of sensitivity at
the start of the reaction; (I) control of the
specificity of the reaction using a negative
serum.
2.3.5. Calculation of results
The OIEISS contains 1 000 international CFT units (ICFTU) per ml. If the OIEISS~ is tested in
a given method the result is given as a titre (TOIEISS). The test result for the test serum given as titre
(TTESTSERUM) must be expressed in ICFTU per ml. In to convert the expression of a titre into
ICFTU, the factor (F) necessary to convert a titre of an unknown test serum (TTESTSERUM) tested by
that method into the ICFTU expression can be found from the Formula -
F = 1 000 x 1 /T OIEISS
and the content of international CFT units per ml of test serum (ICFTU,.ESTSERUM) from the formula -
ICFFU TESTSERU = F x T TESTSERUM
2.3.6. Interpretation of results
A serum containing 20 or more ICFTU per ml is considered to be positive.
2.4.
Milk ring test (MRT)
2.4.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85 % (m/v) and
phenol at 0,5 % (v/v)) stained with haematoxylin. The antigen must be stored at 4'C and not
frozen.
2.4.2. The antigen sensitivity must be standardised in relation to the OIEISS in such a way that
the antigen produces a positive reaction with a 1/500 dilution of the OIEISS in negative milk,
while a 1/1 000 dilution should be negative.
2.4.3. The ring test must be made on samples representing the contents of each milk chum or
the content of each bulk tank from the farm.
2.4.4. The milk samples must not have been frozen, heated or subjected to
violent shaking.
2.4.5. The reaction must be carried out using one of the following methods -
- on a column of milk of at least 25 mm height and on a volume of milk of 1 ml to which
either 0,03 ml or 0,05 ml of one of the standardised stained antigens has been added,
- on a column of milk of at least 25 mm height and on a volume of milk of 2 ml to which
0,05 ml of one of the standardised stained antigens has been added,
- on a volume of milk of 8 ml to which 0,08 ml of one of the standardised stained
antigens has been added.
2.4.6. The mixture of milk and antigens must be incubated at 37 °C for 60 minutes, together
with positive and negative working standards. A subsequent 16 to 24 hour incubation at 4 °C
increases the sensitivity of the test.
2.4.7. Interpretation of results -
(a) negative reaction: coloured milk,
colourless cream;
(b) positive reaction -
-
identically coloured milk
and cream, or
-
colourless milk and
coloured cream.
2.5.
Rose bengal plate Test (RBT)
2.5.1. The antigen represents a bacterial suspension in buffered Brucella antigen diluent at a pH
of 3,65 i 0,05, stained by the use of rose bengal dye. The antigen shall be delivered ready for use
and must be stored at 4 °C and not frozen.
2.5.2. The antigen shall be prepared without reference to the cell concentration, but its sensitivity
must be standardised in relation to the OIEISS in such a way that the antigen produces a positive
reaction with a serum dilution of 1/45 and a negative reaction with a dilution of 1/55.
2.5.3. The RBT shall be carried out in the following manner -
(a) serum (20-30 pd) is mixed with an equal volume of antigen on a white tile or enamel plate to
produce a zone approximately 2 cm in diameter. The mixture is rocked gently for 4 minutes at
ambient temperature, and then observed in a good light for agglutination;
(b) an automated method may be used but must be at least as sensitive and accurate as the
manual method.
2.5.4. Interpretation of results
Any visible reaction is considered to be positive, unless there has been excessive drying round
the edges. Positive and negative working standards should be included in each series of tests.
2.6.
Serum agglutination test (SAT)
2.6.1. The antigen represents a bacterial suspension in phenol-saline (NaCI 0,85 % (m/v) and
phenol at 0,5 % (v/v)). Formaldehyde must not be used.
Antigens may be delivered in the concentrated state provided the dilution factor to be used is
indicated on the bottle label.
EDTA may be added to the antigen suspension to 5 mM final test dilution to reduce the level of
false positives to the serum agglutination test. Subsequently the pH of 7,2 must be readjusted in
the antigen suspension.
2.6.2. The OIEISS contains 1 000 international units of agglutination.
2.6.3. The antigen shall be prepared without reference to the cell concentration, but its sensitivity
must be standardised in relation to the OIEISS in such a way that the antigen produces either a
50 % agglutination with a final serum dilution of 1/600 to 1/1 000 or a 75 % agglutination with a
final serum dilution of 1/500 to 1/750.
It may also be advisable to compare the reactivity of new and previously standardised batches of
antigen using a panel of defined sera.
2.6.4. The test is performed either in tubes or in microplates. The mixture of antigen and serum
dilutions should be incubated for 16 to 24 hours at 37'C.
At least three dilutions must be prepared for each serum. Dilutions of suspect serum must be
made in such a way that the reading of the reaction at the positivity limit is made in the median
tube (or well for the microplate method).
2.6.5. Interpretation of results
The degree of Brucella agglutination in a serum must be expressed in IU per ml.
A serum containing 30 or more IU per ml is considered to be positive.
3. COMPLEMENTARY TESTS
3.1.
Brucellosis skin test (BST)
3.1.1. Conditions for the use of BST
(a) The brucellosis skin test shall not be used for the purpose of certification for Intra-
Community trade.
(b) The brucellosis skin test is one of the most specific tests for the detection of
brucellosis in unvaccinated animals, however diagnosis should not be made on the basis
of positive intradermal reactions alone.
(c) Bovine animals, tested with negative result in one of the serological tests defined in
this Annex and reacting positively to the BST shall be regarded as infected.
(d) Bovine animals, tested with positive result in one of the serological tests defined in
this Annex may be subject to a BST in to support the interpretation of the serological test
results, in particular where in brucellosis free or officially free herds a cross-reaction with
antibodies against other bacteria cannot be excluded.
3.1.2. The test must be carried out by use of a standardised and defined brucellosis allergen
preparation that does not contain smooth lipopolysaccharide (LPS) antigen, as this may provoke
non-specific inflammatory reactions or interfere with subsequent serological tests.
One of such preparation is Brucellin INRA prepared from a non smooth strain of B. melitensis.
The requirements for its production are detailed in Section B2 of Chapter 2.4.2. of the OIE
Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000.
3.1.3. Test procedure
3.1.3.1. A volume of 0,1 ml of brucellosis allergen is injected intradermally into the caudal fold,
the skin of the flank, or the side of the neck.
3.1.3.2. The test is read after 48-72 hours.
3.1.3.3. The skin thickness at the injection site is measured with vernier callipers before injection
and at re-examination.
3.1.3.4. Interpretation of results -
Strong reactions are easily recognised by local swelling and induration.
Skin thickening of 1,5 to 2 mm shall be considered as positive reaction to the BST.
3.2. Competitive enzyme-linked immunosorbent assay (cELISA)
3.2.1. Conditions for the use of cELISA
(a) The cELISA shall not be used for the purpose of certification for intra-Community
trade.
(b) The cELISA has shown to have a higher specificity than for example the indirect
ELISA and may therefore be used in to support the interpretation of the serological test
results.
3.2.2. Test procedure
The test shall be carried out in accordance with the prescription in the CIE Manual of Standards for
Diagnostic Tests and Vaccines, Fourth Edition, 2000, Chapter 2.3.1(2)(a).
4. NATIONAL REFERENCE LABORATORIES
4.1. Tasks and responsibilities
National reference laboratories shall be responsible for -
(a) the approval of the results of the validation studies demonstrating the reliability of the
test method used in the Member State;
(b) determination of the maximum number of samples to be pooled in ELISA kits used;
(c) calibration of the standard secondary reference national standard sera ('working
standards) against the primary international standard serum referred to in paragraph
2.1;
(d) quality checks of all antigens and ELISA kits batches used in the Member State;
(e) cooperation within the European Union Network of National Reference
Laboratories for Brucellosis.
4.2. List of national reference laboratories
Centre d'etudes et de recherches veterinaires et agrochimiques (CERVA/CODA) Groeselenberg 99
B-1180 Bruxelles/Brussel
DENMARK
Danish Veterinary Institute Bulowsvej 27 DK-1790 Copenhagen
GERMANY
Bundesinstitut fur Gesundheitlichen Verbraucherschutz and Veterinarmedizin (BGVV) Nationales
Veterindrmedizinisches Referenzlabor fiir Brucellose Postfach 33 00 13 D-14191 Berlin
GREECE
Veterinary Laboratory of Larissa Department of Microbiology
6th km of National Road Larissa-Trikala GR-4111 10 Larissa
SPAIN
Laboratorio Central de Veterinaria de Santa Fe Camino del Jau S/N
E-18320 Santa Fe (Granada)
FRANCE
Laboratoire national et OIE/FAO de reference pour la brucellose Agence frangaise de securite sanitaire
des aliments (AFSSA) BP 67
F-94703 Maisons-Alfort Cedex
IRELAND
Brucellosis Laboratory Model Farm Road Cork
Ireland
ITALY
Istituto Zooprofilattico Sperimentale dell'Abruzzo e del Molise Via Campo Boario
1-64100 Teramo
LUXEMBOURG
State Laboratory for Veterinarian Medicine 54, avenue Gaston Diderich B.P. 2081
L-1020 Luxembourg
NETHERLANDS
Centraal Instituut voor DierziekteControle CIDC-Lelystad
Houtribweg 39 P.O. Box 2004 8203 AA Lelystad Nederland
AUSTRIA
Bundesanstalt fur veterinarmedizinische Untersuchungen Robert-Koch-Gasse 17
A-2340 Modling
PORTUGAL
Laboratorio Nacional de Investigacao Veterinaria (LNIV) Estrada de Benfica, n. , 701 P-1549-011 Lisboa
FINLAND
National Veterinary and Food Research Institute Hameentie 57
PO Box 45
FIN-00581 Helsinki
SWEDEN
National Veterinary Institute S-751 89 Uppsala
UNITED KINGDOM
1. FAO/WHO Collaborating Centre for Reference and Research on Brucellosis Veterinary
Laboratories Agency
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
2. Immunodiagnostics Department Veterinary Sciences Division Stoney Road Stormont Belfast BT4 3SD
United Kingdom'
(1) Bovine animals and swine covered by these regulations must at no time
between leaving the holding of origin and arriving at destination come into contact with
cloven-hoofed animals other than animals that have the same health status.
(2) Bovine animals and swine covered by these regulations must be transported by
means of transport meeting the requirements of European Union Council Directive
91/628/EEC and in addition the requirements of rule 12.
(3) Rules for the approval of sites where cleansing and disinfection may be
carried out shall be determined in accordance with the procedure set out in Article 17 of
the European Union Council Directive 64/432/EEC .
Health certificate to accompany animals during transportation
CHAPTER I
OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND
REGIONS
A. Officially enzootic-bovine-leukosis-free herd means a herd in which -
(i) there is no evidence, either clinical or as a result of a laboratory test, of any case of
enzootic bovine leukosis in the herd and no such case has been confirmed in the
previous two years; and
(ii) all animals over 24 months of age have reacted negatively during the preceding 12
months to two tests carried out in accordance with this Annex, at an interval of at
least four months; or
(iii) it meets the requirements of (i) above and is situated in an officially enzootic-bovine-
leukosis-free Member State or region.
B. A herd shall retain officially enzootic-bovine-leukosis-free status provided -
(i) the condition in A(i) continues to be fulfilled;
(ii) any animals introduced into the herd come from an officially enzootic-bovine-
leukosis-free herd;
(iii) all animals over 24 months of age continue to react negatively to a test carried out in
accordance with Chapter II at intervals of three years;
(iv) breeding animals introduced into a herd and originating from a third country have
been imported in accordance with European Union Council Directive 72/462/EEC.
C. The officially leukosis-free status of a herd is to be suspended if the conditions detailed in B are not
fulfilled, or where as a result of laboratory tests or on clinical grounds one or more bovine animals are
suspected of having enzootic bovine leukosis and the suspect animal(s) are immediately slaughtered.
D. The status is to remain suspended until the following requirements are complied with -
1. If a single animal in an officially enzootic-bovine-leukosis-free herd has reacted positively to one
of the tests referred to in Chapter II, or where infection is otherwise suspected in one animal in a
(i) the animal which has reacted positively, and, in the case of a cow, any calf it may have
produced, must have left the herd for slaughter under the supervision of the veterinary
authorities;
(ii) all animals in the herd more than 12 months old have reacted negatively to two
serological tests (at least 4 months and less than 12 months apart) carried out in
accordance with Chapter II three months at least after removal of the positive animal
and any possible progeny thereof;
(iii) an epidemiological inquiry has been conducted with negative results and the herds
linked epidemiologically to the infected herd have been subjected to the measures laid
down in (ii). However, the competent authority may grant a derogation from the
obligation to slaughter the calf of an infected cow where it was separated from its mother
immediately after calving. In this case, the calf must be made subject to the requirements
provided for in 2(iii).
2. Where more than one animal from an officially enzootic-bovine-leukosis-free herd has reacted
positively to one of the tests referred to in Chapter II, or where infection has otherwise been
suspected in more than one animal in a herd -
(i) any animals which have reacted positively and, in the case of cows, their calves,
must be removed for slaughter under the supervision of the veterinary authorities;
(ii) all animals in the herd aged over 12 months must react negatively to two tests carried
out in accordance with Chapter II at an interval of at least four months and no more than
12 months;
(iii) all other animals in the herd must, after identification, remain on the holding until
they are aged over 24 months and have been tested in accordance with Chapter II after
reaching that age, except that the competent authority may permit such animals to go
directly for slaughter under official supervision;
(iv) an epidemiological inquiry has been conducted with negative results and any herd
linked epidemiologically to the infected herd has been subjected to the measures
laid down in (ii). However, the competent authority may grant a derogation from the
obligation to slaughter the calf of an infected cow where it was separated from its mother
immediately after calving. In this case, the calf must be made subject to the requirements
provided for in 2(iii).
E. In accordance with the procedure in Article 17 of the European Union Council Directive 64/432/EEC and
on the basis of information supplied in accordance with regulation 8, a Member State or part of a Member
State may be considered officially enzootic-bovine leukosis-free if -
(a) all the conditions of paragraph A are fulfilled and at least 99,8 % of the bovine herds are
officially enzootic-bovine-leukosis-free;
(b) no case of enzootic bovine leukosis has been confirmed in the Member State or the part
of the Member State for the past three years, and the presence of tumours suspected of being due to
EBL is compulsorily notifiable, with investigations of cause being carried out, and in the case of a
Member State, all animals aged over 24 months in at least 10 % of the herds, selected randomly,
have been tested with negative results in accordance with Chapter II in the previous 24 months, or
in the case of a part of a Member State, all animals aged over 24 months have undergone a test
provided for in Chapter II with negative results in accordance with Chapter II in the previous 24
months;
(c) any other method which demonstrates to a confidence rating of 99 % that less than 0,2 % of
herds were infected.
F. A Member State or a region of a Member State is to retain officially enzootic-bovine-leukosis-free status if
(a) all animals slaughtered within the territory of that Member State or region are submitted to
official post-mortem examinations at which all tumours which could be due to the EBL virus are
sent for laboratory examination,
(b) the Member State reports to the European Commission all cases of enzootic bovine leukosis that
occur in the region,
(c) all animals which react positively to any of the tests provided for in Chapter II are slaughtered
and their herds remain subject to restrictions until re-establishment of their status in accordance
with Section D, and
(d) all animals more than two years old have been tested, either once in the first five years after
the status is granted under Chapter II or during the first five years after the grant of the status
under any other procedure demonstrating with a certainty level of 99 % that less than 0,2 %
of herds have been infected.
However, where no case of enzootic bovine leukosis has been recorded in a Member
State or in a region of a Member State in a proportion of one herd out of 10 000 for at least three
years, a decision may be taken in accordance with the procedure laid down in Article 17 of the
European Union Council Directive 64/432/EEC that routine serological tests may be reduced
provided that all bovine animals more than 12 months old in at least 1 % of herds, selected at
random each year, have been subjected to a test carried out in accordance with Chapter II.
G. The officially enzootic-bovine-leukosis-free status of a Member State or part of a Member State is to be
suspended, in accordance with the procedure in Article 17 of the European Union Council Directive
64/432/EEC if, as a result of investigations carried out in accordance with paragraph F above, there is
evidence of a significant change in the situation as regards enzootic bovine leukosis in a Member State or
part of a Member State which has been recognised as officially enzootic-bovine-leukosis-free.
The officially enzootic-bovine-leukosis-free status may be restored in accordance with the procedure in
regulation 17 when the criteria laid down by the same procedure are fulfilled.
CHAPTER II
TESTS FOR ENZOOTIC BOVINE LEUKOSIS
Tests for enzootic bovine leukosis shall be carried out by the immunediffusion test under the conditions
described in A and B or by the enzymelinked immunosorbent assay (ELISA) under the conditions
described in C. The immune diffusion method may only be used for individual tests. If test results are.the
subject of a dulysubstantiated challenge, an additional check shall be carried out by means of the
immunediffusion test.
A. Agar gel immunediffusion test for enzootic bovine leukosis
1. The antigen to be used in the test must contain bovine leukosis virus glycoproteins. The antigen
must be standardized against a standard serum (EI serum) supplied by the State Veterinary Serum
Laboratory, Copenhagen.
2. The official institutes indicated below must be made responsible for calibrating the standard
working antigen of the laboratory against the official EEC standard serum (EI serum) provided by
the State Veterinary Serum Laboratory, Copenhagen.
(a) Germany
Bundesforschungsanstalt für Viruskrankheiten der Tiere, Tubingen;
(b) Belgium
Institut national de recherches vétérinaires, Brussels;
(c) France
Laboratoire national de pathologie bovine, Lyon;
(d) Grand Duchy of Luxembourg
(e) Italy
Istituto zooprofilattico spenmentale, Perugia;
(f) Netherlands
Instituut voor Dierhouderij en Diergezondheid (IDDLO), Lelystad;
(g) Denmark
Statens Veterinaere Serum Laboratorium, Copenhagen;
(h) Ireland
Veterinary Research Laboratory, Abbotstown, Dublin;
(i) United Kingdom
(1) Great Britain
Veterinary Laboratory Agency, Addlestone, Weybridge, England;
(2) Northern Ireland
Veterinary Research Laboratory, Stormont, Belfast;
(j) Spain
Subdirección general de sanidad animal. Laboratorio de sanidad y producción anima
ALGETE, Madrid;
(k) Portugal
Laboraório Nacional de Investigação Veterinária, Lissabon;.
(l) Greece: Κέντρο Κτηνιατρικών Ιδρυµάτων Νεαπόλεως 25, 15310 Αθήνα;;
(m) Austria
Bundesanstalt für Tierseuchenbekämpfung, Mödling;
(n) Finland
eläinlääkintä ja elintarvikelaitos, Helsinki/anstalten för veterinärmedicin och livsmedel,
Helsingfors;
(o) Sweden
Statens veterinärmedicinska anstalt, Uppsala.
3. The standard antigens used in the laboratory must be submitted at least once a year to the EEC
reference laboratories listed in 2 for testing against the official EEC standard serum. Apart from
this standardization, the antigen in use can be calibrated in accordance with B.
4. The reagents for the test shall consist of -
(a) antigen: the antigen must contain specific glycoproteins of enzootic bovine leukosis
virus which has been standardized against the official EEC serum;
(b) the test serum;
(c) known positive control serum;
(d) agar gel
0, 8% agar, 8, 5 % NaCl, 0, 05 M Trisbuffer pH 7, 2; 15 ml of this agar must be
introduced into a petri dish of 85 mm diameter, resulting in a depth of 2, 6 mm of agar.
5. A test pattern of seven moisture free wells must be cut in the agar to the bottom of the plate; the
pattern must consist of one central well and six wells in a circle around it.
Diameter of central well: 4 mm
Diameter of peripheral wells: 6 mm
Distance between central and peripheral wells: 3 mm
6. The central well must be filled with the standard antigen. Peripheral wells 1 and 4 (see diagram
below) are filled with the known positive serum, wells 2, 3, 5 and 6 with the test sera. The wells
must be filled until the meniscus disappears.
7. This results in the following quantities being obtained -
antigen: 32 µl
control serum: 73 µl
test serum: 73 µl.
8. Incubation must be for 72 hours at room temperature (20 to 27°C) in a closed humid chamber.
9. The test may be read at 24 and 48 hours but a final result may not be obtained before 72 hours
(a) a test serum is positive if it forms a specific precipitin line with the BLV antigen and
forms a complete line of identity with the control serum;
(b) a test serum is negative if it does not form a specific precipitin line with the BLV
antigen and if it does not bend the line of the control serum;
(c) the reaction cannot be considered conclusive if it -
(i) bends the line of the control serum towards the BLV antigen well without
forming a visible precipitin line with the antigen;
or
(ii) if it cannot be read either as negative or as positive. In inconclusive reactions
the test may be repeated and concentrated serum utilized.
10. Any other well configuration or pattern may be utilized provided that the E4 serum diluted
1:10 in negative serum can be detected as positive.
B. Method for antigen standardization
Solutions and materials required
1. 40 ml of 1, 6 % agarose in 0, 05 M Tris/HCl buffer, pH 7, 2 with 8, 5 % NaCl;.
2. 15 ml of a bovine leukosis serum, having antibody only to bovine leukosis virus glycoproteins,
diluted 1:10 in 0, 05 M Tris/HCl buffer, pH 7, 2 with 8, 5 % NaCl;
3. 15 ml of a bovine leukosis serum, having antibody only to bovine leukosis virus glycoproteins,
diluted 1:5 in 0, 05 M Tris/HCl buffer, pH 7, 2 with 8, 5 % NaCl;
4. four plastic petri dishes with a diameter of 85 mm;
5. a punch with a diameter of 4 to 6 mm;
6. a reference antigen;
7. the antigen which is to be standardized;
8. a water bath (56°C).
Procedure
Dissolve the agarose (1, 6 %) in the Tris/HCl buffer by carefully heating to 100°C. Place in WC water bath
for approximately one hour. Also, place the bovine leukosis serum dilutions in a WC water bath.
Now mix 15 ml of the 56°C agarose solution with the 15 ml bovine leukosis serum (1:10), quickly shake
and pour 15 ml into each of two petri dishes. Repeat this procedure with the bovine leukosis serum diluted
When the agarose has hardened, holes are made in it as follows -
Addition of antigen
(i) Petri dishes 1 and 3
well A undiluted reference antigen;
well B 1:2 diluted reference antigen;
wells C and E reference antigen;
well D undiluted test antigen.
(ii) Petri dishes 2 and 4
well A undiluted test antigen;
well B 1:2 diluted test antigen;
well C 1:4 diluted test antigen;
well D 1:8 diluted test antigen.
Additional instructions
1. The experiment shall be carried out with two serum dilutions (1:5 and 1:10) in to achieve
optimal precipitation
2. If the precipitation diameter is too small with both dilutions, then the serum must be further
diluted.
3. If the precipitation diameter in both dilutions is too large and faint, then a lower serum must be
chosen.
4. The final concentration of the agarose must be 0, 8%; that of the sera 5 and 10% respectively.
5. Plot the measured diameters in the following co-ordinate system. The dilution of the antigen to
be tested with the same diameter as the reference antigen is the working dilution.
C. Enzymelinked immunosorbent assay (ELISA) for detecting enzootic bovine leukosis
1. The material and reagents to be used are as follows -
(a) solidphase microplates, cuvettes or any other solid phase;
(b) the antigen is fixed to the solid phase with or without the aid of polyclonal or
monoclonal catching antibodies. If antigen is coated directly to the solid phase, all test
samples giving positive reactions have to be retested against control antigen in the case of
EBL. The control antigen should be identical to the antigen except for the BLV antigens.
If catching antibodies are coated to the solid phase, the antibodies must not react to
antigens other than BLV antigens;
(c) the biological fluid to be tested;
(d) a corresponding positive and negative control;
(e) conjugate;
(f) a substrate adapted to the enzyme used;
(g) a stopping solution, if necessary;
(h) solutions for the dilution of the test samples for preparations of the reagents and for
washing;
(i) a reading system appropriate to the substrate used..
2. Standardization and sensitivity of test The sensitivity of the ELISA assay must be of such a
level that E4 serum is scored positive when diluted 10 times (serum samples) or 250 times (milk
samples) more than the dilution obtained of individual samples when these are included in pools.
In assays where samples (serum and milk) are tested individually E4 serum diluted 1 to 10 (in
negative serum) or 1 to 250 (in negative milk) must be scored positive when tested in the same
assay dilution as used for the individual test samples. The official institutes listed in A.2 will be
responsible for checking the quality of the ELISA method, and in particular for determining, for
each production batch, the number of samples to be pooled on the basis the count obtained for the
E4 serum.
The E4 serum will be supplied by the National Veterinary Laboratory, Copenhagen.
3. Conditions for use of the ELISA test for EBL The Elisa method may be used on a sample of milk or
whey taken from the milk collected from a farm with at least 30 % of dairy cows in milk.
If this method is used, measures must be taken to ensure that the samples taken can be identified with the
animals from which the milk or sera examined were taken.
(1) Bovine animals and swine covered by these rule smust be accompanied
during transportation to destination by a health certificate conforming to the model 1 or 2
set out in Annex F as appropriate. The certificate shall consist of a single sheet or, where
more than one page is required, shall be in such a form that any two or more pages are
part of an integrated whole and indivisible and shall contain a serial number. It shall be
drawn up on the day of the health inspection, in one of the official language, of the
country of destination at least. The certificate shall be valid for 10 days from the date of
the health examination.
(2) The health inspection for the issuing of the health certificate (including
additional guarantees) for a consignment of animals may be carried out in the holding of
origin or of an assembly centre. For this purpose the Veterinary Services shall ensure that
any certificate is drawn up by the official veterinarian after inspections, visits and
controls as provided by these rules. However as regards -
(a) animals coming from approved assembly centres such certification
shall be -
(i) on the basis of an official document containing the necessary
information completed by the official veterinarian for the holding
of origin, or
(ii) in the form of the certificate according to either model 1 or 2 in
Annex F as appropriate with Sections A and B duly completed and
certified by the official veterinarian for the holding of origin;
(b) animals coming from an approved holding which is participating in the
surveillance network provided for in regulation 14, such certification shall
be
(i) on the basis of an official document containing the necessary
information completed by the approved veterinarian for the
holding of origin, or
(ii) in the form of the certificate according to either model 1 or 2 in
Annex F as appropriate with Sections A and B duly completed and
certified by the approved veterinarian for the holding of origin. For
this purpose, the official veterinarian will ensure where appropriate
that the additional guarantees provided for in Community
legislation are fulfilled.
(3) The official veterinarian for the assembly centre shall carry out all necessary
checks on animals arriving there.
(4) The official veterinarian completing Section C of the certificate according to
either model 1 or 2 in Annex F as appropriate, shall ensure that the movement is
registered on the Animo system on the day the certificate is issued .
(5) The animals covered by these regulations may transit through an assembly
centre which is located in one other Member State before being consigned to the Member
State of destination. In this case, the certificate according to either model 1 or 2 in Annex
F as appropriate (including Section C) must be completed by the official veterinarian
responsible in the Member states where the animals originate. The official veterinary
responsible for the assembly centre of transit shall provide certification to the member
state of destination by completing a second certificate according to either model 1 or 2 in
Annex F as appropriate, endorsing it with the serial number of the original attaching it to
the original certificate or to an officially endorsed copy thereof. In this case the
combined validity of the certificates shall not exceed that provided for in sub- rule (1).
Further requirements for animals for breeding or production
(I)
(a) Bovine diseases
- Foot-and-mouth disease
- Rabies
- Tuberculosis
- Brucellosis
- Contagious bovine pleuropneumonia
- Enzootic bovine leukosis
- Anthrax
(b) Swine diseases
- Rabies
- Brucellosis
- Classical swine fever African swine fever
- Foot-and-mouth disease
- Swine vesicular disease
- Anthrax
(1) Animals for breeding or production must, in addition to the requirements of
rules 3, 4 and 5 -
(a) have remained in a single holding of origin for a period of 30 days
prior to loading, or since birth in the holding of origin where the animals
are less than 30 days old. The official veterinarian must, on the basis of the
official identification provided for in regulation 3 (2) (c) and official
records, be satisfied that the animals have complied with this condition
and furthermore that the animals have originated in Malta or in the
European Community or have been imported from a third country in
compliance with European Community animal health legislation
Provided that in the case of animals transiting through an approved
assembly centre in Malta or in the Member State of origin, the period
during which the assembly of these animals takes place outside the
holding of origin shall not exceed six days;
(b) with regard to animals imported from a third country into the territory
of Malta which is not the ultimate destination, be transported to the
Member State of destination as quickly as practicable under cover of a
certificate issued under Article 7 of European Union Council Directive
91/496/EEC;
(c) with regard to animals imported from a third country upon arrival In
the territory of Malta and before any further movements, satisfy the
requirements of these regulations, and in particular the residency
requirement in sub- rule (1)(a), and may not be brought into the herd until
the veterinarian responsible for that holding has ascertained that the
animals in question are not likely to jeopardise the health status of the
holding
Provided that if an animal from a third country is introduced into a holding
no animal from the holding may be traded for 30 days following
introduction unless the imported animal is isolated from all other animals
on the holding.
(2) Bovine animals for breeding and production must, in addition to the
requirements in rule 3, 4 and 5 -
(a) come from an officially tuberculosis-free bovine herd, and in the case
of animals more than six weeks old, have reacted negatively to an
intradermal tuberculin test carried out during the 30 days prior to leaving
the herd of origin, in accordance with the provisions of Schedule B point
32 (d)
Provided that this intradermal tuberculin test is not required if the animals
originate in a Member State or part of a Member State recognised as
officially tuberculosis free or in a Member State or part of a Member State
with an approved surveillance network;
(b) in the case of uncastrated animals which come from an officially
brucellosis free bovine herd and more than 12 months old, have shown a
brucella count lower that 30 international units (IU) of agglutination per
millilitre when given a serum agglutination test (or any test approved by
Standing Veterinary Committee (SVC) procedure following the adoption
of the relevant protocols) carried out during the 30 days prior the leaving
the herd of origin and complying with the provisions of Annex C Section
2.2.2.1. (a)
Provided that this serum agglutination test (or any test approved by SVC
procedure following the adoption of the relevant protocols) is not required
if the animals originate in a Member State or part of a Member State
recognized as officially brucellosis free or in a Member State or part of a
Member State with an approved surveillance network;
(c) come from an officially enzootic-bovine-leukosis-free herd and, if
more than 12 months old, have reacted negatively to an individual test
carried out during the 30 days prior to leaving the herd of origin and
complying with the provisions of Schedule D
Provided that the test is not required if the animals originate in a Member
State or part of a Member State recognised as officially enzootic-bovine-
leukosis free or in a Member State or part of a Member State with an
approved surveillance network;
(d) at no time between leaving the holding of origin and arriving at
destination come into contact with bovine animals which meet only the
requirements in sub- rule (3);
(e) until 31 December 2000, not be subject to the test requirements laid
down in paragraph (a) or (b) in the case of bovine animals aged less than
30 months intended for meat production which-
(i) come from a beef holding officially tuberculosis-free and
officially brucellosis-free;
(ii) are accompanied by an animal health certificate with paragraph
7 in Section A of Annex F Model 1 duly completed;
(iii) remain under supervision until their slaughter;
(iv) have not come into contact during transport with bovine
animals not coming from herds officially free from those diseases.
and provided that-
(i) these arrangements are restricted to trade between Member
States or regions of Member States with the same health status
with regard to tuberculosis or brucellosis;
(ii) the Member State of destination takes all necessary measures to
avoid any contamination of indigenous herds;
(iii) the Member States put in place a proper system of random
sampling, inspections and controls designed to ensure the efficient
implementation of these rules;
(iv) the Commission monitors the proper operation of this
Directive so as to ensure that Member States comply fully with the
rules.
(3) Bovine animals for slaughter must, in addition to the requirements in rules 3, 4
and 5, come from herds that are officially tuberculosis free, officially enzootic-bovine-
leukosis free and in the case of uncastrated bovines, from herds that are officially
brucellosis free.
Animals for slaughter
(II)
- Aujeszky's disease
- Infectious bovine rhinotracheitis
- Brucella suis infection
- Transmissible gastroenteritis.
Animals for slaughter which have been taken on arrival in the territory of Malta
(a) to a slaughterhouse, must be slaughtered there as soon as possible but at least
within 72 hours of arrival, in accordance with animal health requirements, or
(b) to an approved assembly centre, must be removed directly to a slaughterhouse
to be slaughtered as soon as possible but at the latest within three working days of
arrival at the assembly centre, in accordance with animal health requirements. At
no time, between their arrival at the assembly centre and their arrival at the
slaughterhouse, may they come into contact with cloven-hoofed animals other
than animals that fulfil the conditions laid down in these rules.
Immediate notification of suspected disease
Where in these regulations reference is made to Schedule F of these regulations or Annex F of the
European Union Council Directive 64/432/EEC reference should be made to the European Union
Commission Regulation (EC) No 599/2004 concerning the adoption of a harmonised model certificate and
inspection report linked to intra-Community trade in animals and products of animal origin
The suspected presence of any of the diseases referred to in Schedule E (I) of
these regulations is compulsorily and immediately notifiable to the competent authority.
The competent authority shall forward to the European Commission by 31 May
each year, and for the first time in 2004, details of the occurrence of diseases listed in
Schedule E (1) of these rules and of any other diseases covered by the additional
guarantees provided for by European Community legislation in the territory of Malta in
the previous calendar year including details of the monitoring and eradication
programmes in operation. This information shall be based on uniform criteria established
by European Commission. The Commission shall present this information to the Member
States in the framework of the SVC and in particular may utilize it in relation to the
decisions referred to in Schedules A and D.
Compulsory national control programme for contagious diseases
(1) On the basis of a Veterinary services proposal, the Minister in charge of
Agriculture may define, by virtue of implementary regulation a compulsory national
control programme for one of the contagious diseases listed in Annex E (II) to Directive
64/432/EEC for all of the territory of Malta. The said programme shall be submitted to
the European Commission and outlined in particular
(a) the distribution of the disease in the Member State,
(b) the reasons for the programme, taking into consideration the
importance of the disease and the programme's likely benefit in relation to
its cost,
(c) the geographical area in which the programme will be implemented,
(d) the status categories to be applied to the animal establishments, the
standards which must be attained in each category, and the test procedures
to be used,
(e) the programme monitoring procedures, the results of which must be
supplied at least annually to the Commission,
(f) the action to be taken if, for any reason, an establishment loses its
status,
(g) the measures to be taken if the results of the tests carried out in
accordance with the provisions of the programme are positive.
(2) The Commission shall examine the programmes presented by the Member
States. Programmes as referred to in sub-rule (1) may be approved in compliance with the
criteria laid down in paragraph 1 in accordance with the procedure provided for in Article
17 of the European Union Council Directive 64/432/EEC. According to the same
procedure, the additional guarantees, general or limited, which may be required in intra-
Community trade, shall be defined at the same time or at the latest three months after
approval of the programmes. Such guarantees must not exceed those which the Member
State implements nationally.
(3) Programmes submitted by Member States may be amended or supplemented
in accordance with the procedure laid down in Article 17 of the European Union Council
Directive 64/432/EEC. Amendments or additions to programmes which have already
been approved or to guarantees which have been defined in accordance with sub-rule (2)
may be approved under the same procedure.
(4 )The dispatching of pigs intended for breeding or production destined for the
Member States or regions free of Aujeszky's disease listed in Annex I of Commission
Decision 2001/618/EC and coming from the territory of Malta or region not listed in that
Annex is authorised subject to the following conditions
(a) Aujeszky's disease must be compulsorily notifiable in Malta or region
of origin;
(b) a plan for the control and eradication of Aujeszky's disease, fulfilling
the criteria laid down in the first paragraph of this Article, must be in place
in Malta or regions of origin under the supervision of the Veterinary
Services. Appropriate measures on pig transport and movements must be
in place according to this plan for preventing a spread of disease between
holdings of a different status;
(c) with regard to the holding of origin of the pigs
(i) no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in the holding
in question;
(ii) no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in the
holdings located in an area of 5 km surrounding the holding of
origin of the pigs; however, this provision shall not apply if, in
these latter holdings, disease monitoring and eradication measures
have been regularly applied under the supervision of the
Veterinary Services and in accordance with the eradication plan
referred to in point (b), and these measures have effectively
prevented any spread of disease to the holding in question;
(iii) vaccination against Aujeszky's disease has not been carried out
for at least 12 months;
(iv) the pigs have been subjected on at least two occasions at a
distance of at least four months to a serological survey for the
presence of ADV-gE or ADV-gB or ADV-gD antibody or to the
whole Aujeszky's disease virus. This survey must have shown the
absence of Aujeszky's disease and that vaccinated pigs have been
free from gE antibodies;
(v) no pigs have been introduced from holdings of a lower animal
health status as regards Aujeszky's disease in the previous 12
months, unless they have been tested for Aujeszky's disease with
negative results;
(d) the pigs to be moved
(i) have not been vaccinated;
(ii)have been kept isolated in accommodation approved by the
Veterinary Services, during the 30 days prior to movement, and in
such a way that any risk of spreading Aujeszky's disease to these
pigs is prevented;
(iii) must have lived in the holding of origin or in a holding of an
equivalent status since birth, and have remained in the holding of
origin for at least
- 30 days, in the case of pigs intended for production;
- 90 days, in the case of pigs intended for breeding, have
been subjected with negative results to at least two
serological tests for ADV-gB or ADV-gD or the whole
Aujeszky's disease virus, at a distance of at least 30 days
between each test. However, in case of pigs less than four
months old, the serological test for ADV-gE may also be
used. Sampling for the last test must be performed within
15 days prior to shipment. The number of pigs tested in the
isolation unit must be sufficient to detect
(i) 2 % seroprevalence with 95 %
confidence in the isolation unit in case of
pigs intended for production;
(ii) 0,1 % seroprevalence with 95 %
confidence in the isolation unit in c ase of
pigs intended for breeding.
However, the first of the two tests shall not be necessary if
(i) in the framework of the plan referred to in point (b), a serological survey has
been carried out in the holding of origin between 45 and 17 days prior to
shipment, demonstrating the absence of Aujeszky's disease antibodies and that
vaccinated pigs have been free from gE antibodies;
(ii) the pigs to be moved have lived in the holding of origin since birth;
(iii) no pigs have moved on to the holding of origin while the pigs to be moved
have been kept in isolation.
(5) The dispatching of pigs intended for slaughter destined for the Member States
or regions free of Aujeszky's disease listed in Annex I of Commission Decision
2001/618/EC and coming from Malta or region not listed in that Annex, is authorised
subject to the following conditions
(a) Aujeszky's disease must be compulsorily notifiable in Malta or region
(b) a plan for the control and eradication of Aujeszky's disease is in place
in Malta or regions of origin of the pigs, fulfilling the criteria laid
downunder European Union Law;
(c) all the pigs in question must be transported directly to the
slaughterhouse of destination and either
(i) they come from a holding which fulfils the conditions required
by European Union Law, or
(ii) they have been vaccinated against Aujeszky's disease at least
15 days prior to their shipment and come from a holding of origin
where
-in the framework of the plan referred to in point (b),
Aujeszky's disease monitoring and eradication measures
have been regularly applied under the supervision of the
Veterinary Services for the previous 12 months;
- they had remained for at least 30 days before dispatch and
where no clinical or pathological evidence of this disease
has been detected at the moment of completion of the
health certificate referred to in rule 5, or
- they have not been vaccinated and they proceed from a
holding where
(i) in the framework of the plan referred to in point
(b), Aujeszky's disease monitoring and eradication
measures have been regularly applied under the
supervision of the Veterinary Services in the
previous 12 months and no clinical, pathological or
serological evidence of Aujeszky's disease has been
recorded in the previous six months;
(ii) vaccination against Aujeszky's disease and
introduction of vaccinated pigs have been forbidden
by the Veterinary Services, since the holding is in
the process of reaching the highest status as regards
Aujeszky's disease in accordance to the plan
referred to in point (b);
(iii) they have lived for at least 90 days before
dispatch.
(6) Pigs intended for breeding destined for the Member States or regions listed in
Annex II of Commission Decision 2001/618/EC, where approved Aujeszky's disease
eradication programmes are in place, must either
(a) come from Member States or regions listed in Annex I of Commission
Decision 2001/618/EC, or
(b) come from
(i) Member States or regions listed in Annex II, and
(ii) a holding which fulfils the requirements of paragraph 3 (c); or
(c) fulfil the following conditions
(i) Aujeszky's disease must be compulsorily notifiable in Malta or
region where pigs are originating,
(ii) a plan for the control and eradication of Aujeszky's disease is
in place in Malta or region of origin, which fulfils the criteria laid
down in paragraph 3 (b),
(iii) no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in the holding
of origin of the pigs in question,
(iv) the pigs must have been isolated in accommodation approved
by the Veterinary Services for the 30 days immediately prior to
movement and kept isolated in such a way that any risk of
spreading of Aujeszky's disease is prevented,
(v) the pigs must have been subjected, with negative results, to a
serological test for the presence of gE antibodies. Sampling for the
last test must be performed within 15 days prior to shipment. The
number of pigs tested must be sufficient to detect 2 %
seroprevalence with 95 % confidence in these pigs,
(vi) the pigs must lave lived in the bolding of origin or in a holding
of an equivalent status since birth, and have remained in the
holding of origin for at least 90 days.
(7) Pigs intended for production destined for the Member States or regions listed
in Annex II Commission Decision 2001/618/EC, where approved Aujeszky's disease
eradication programmes are in place, must either
(a) come from Member States or regions listed in Annex I Commission
Decision 2001/618/EC, or
(b) come from
(i) Member States or regions listed in Annex II Commission
Decision 2001/618/EC, and
(ii) a holding which fulfils the requirements of sub regulation (3)
(c) of this regulation; or
(c) fulfil the following conditions-
(i)Aujeszky's disease must be compulsorily notifiable in Malta or
region of origin,
(ii) a plan for the control and eradication of Aujeszky's disease is
in place in Malta or region of origin, which fulfils the criteria laid
down in sub regulation (3) (b) of this regulation;
(iii) no clinical, pathological or serological evidence of Aujeszky's
disease has been recorded in the previous 12 months in the holding
of origin of the pigs in question;
(iv) a serological survey for Aujeszky's disease, demonstrating its
absence and that vaccinated pigs have been free from gE
antibodies, has been carried out in the holding of origin and
between 45 and 170 days prior to shipment;
(v) the pigs must either have lived in the holding of origin since
birth or have remained in such holdings for at least 30 days after
introduction from a holding of an equivalent status, where a
serological survey equivalent to the one referred to in the fourth
indent above has been carried out;
(8) The serological tests carried out to monitor or detect Aujeszky's disease in
pigs in accordance with these regulations must meet the standards laid down in Annex III
to the European Union Commission Decision 2001/618/EC.
(9) Without prejudice to Article 10(3) of Directive 64/432/EEC, information of
the occurrence of Aujeszky's disease, including details of the monitoring and eradication
programmes in operation in Malta where monitoring and eradication programmes will be
in place, must be provided at least annually by the Veterinary Services in accordance
with the uniform criteria laid down in Annex IV to Commission Decision 2001/618/EC.
(10) Without prejudice to the provisions laid down in Community legislation
concerning health certificates, before the completion, for animals of the porcine species
destined for Member States or regions listed in Annex I or II to Commission Decision
2001/618/EC, of section C of the health certificate required by Directive 64/432/EC, the
official veterinarian shall ascertain
(a) the status of the holding and of the Member State or region of origin of
the pigs in question as regards Aujeszky's disease;
(b) in case the pigs are not originating from a Member State or a region
free of the disease, the status of the holding and of the Member State or
regions of destination for the pigs in question as regards Aujeszky's
disease;
(c) the compliance of the pigs in question with the conditions laid down in
Commission Decision 2001/618/EC.
(11) For animals of the porcine species destined for Member States or regions
listed in Annex I or II, European Union Commission Decision 2001/618/EC, the
certification under sub regulation 10 shall be completed and supplemented as follows
(a) in the first indent, after the word "disease:" the word "Aujeszky" must
be added;
(b) in the second indent, reference shall be made to Commission Decision
2001/618/EC. In the same line, the number of the Article of Commission
Decision 2001/618/EC, which is relevant for the pigs in question, shall be
quoted between brackets.
(12) The Veterinary Services must ensure that when pigs destined for Member
States or regions listed in Annex I or II to Commission Decision 2001/618/EC, are
transported, they shall not come in contact with pigs of different or unknown status, as
regards Aujeszky's disease, during transport or transit.
Territory free from the diseases listed in Annex E to EU Council Directive
(1) Where the competent authority considers that the Maltese territory is free
from one of the diseases listed in Annex E (II) of these rules, they shall present to the
European Commission appropriate supporting documentation, setting out in particular-
(a) the nature of the disease and the history of its occurrence in its
territory;
(b) the results of surveillance testing based on serological,
microbiological, pathological or epidemiological investigation and on the
fact that the disease must by law be notified to the competent authorities;
(c) the period over which the surveillance was carried out;
(d) where applicable, the period during which vaccination against the
disease has been prohibited and the geographical area concerned by the
prohibition;
(e) the arrangements for verifying the absence of the disease.
(2) The documentation submitted by the competent authority shall be examined
by the European Commission. The additional guarantees, general or specific, which may
be required in Intra-Community trade may be defined in accordance with Article 17 of
the European Union Council Directive 64/432/EEC. Such guarantees must not exceed
those which are implemented nationally.
(3) The competent authority shall notify the European Commission of any change
in the details specified in sub-regulation (1) which relate to the disease, in particular
regarding any new outbreaks of the disease. The guarantees defined in accordance with
sub-regulation (2) may, in the light of such notification, be amended or withdrawn in
accordance with the procedure laid down in Article 17 of the European Union Council
Directive 64/432/EEC.
Minimum conditions for assembly centres
(1) To be approved by the competent authority, assembly centres meet the
following conditions at least. They must -
(a) be under the control of an official veterinarian who shall ensure that, in
particular, the provisions of rule 4 (1) and (2) are complied with;
(b) be located in an area which is not subject to prohibition or restrictions
in accordance with relevant European Community legislation and, or
Maltese rules on animal diseases;
(c) be cleaned and disinfected before use, as required by the official
veterinarian;
(d) they must have, taking into account the animal capacity of the
assembly centre -
(i) a facility dedicated exclusively for this purpose when used as an
assembly centre;
(ii) appropriate facilities for loading, unloading and adequate
housing of a suitable standard for the animals, for watering and
feeding them, and for giving them any necessary treatment; these
facilities must be easy to clean and disinfect;
(iii) appropriate inspection facilities;
(iv) appropriate isolation facilities;
(v) appropriate equipment for cleaning and disinfecting rooms and
trucks;
(vi) an appropriate storage area for fodder, litter and manure;
(vii) an appropriate system for collecting waste water;
(viii) the use of an office for the official veterinarian;
(e) admit only animals that are identified and come from herds that are
officially free of tuberculosis, brucellosis and leukosis or slaughter
animals meeting the conditions set out in the present regulations and in
particular rule 6 (3). To this end, when animals are admitted the owner or
person in charge of the centre shall ensure they are properly identified and
accompanied by health documents or appropriate certificates for the
species and categories involved;
(f) be regularly inspected to ascertain that the requirements for approval
continue to be fulfilled.
(2) The owner or person in charge of the assembly centre shall be required, on the
basis either of the accompanying documents for the animals or of the identification
numbers or marks of the animals, to record on a register or a data base and retain for a
minimum period of three years the following information -
(a) the name of the owner, the origin, date of entry and exit, number and
identification of the bovine animals or the registration number of the
holding of origin or of the herd of origin of the pigs entering the centre
and their proposed destination,
(b) the registration number of the transporter and the licence number of the
lorry delivering or collecting animals from the centre.
(3) The competent authority shall issue an approval number to each approved
assembly centre. Such approval may be limited to a particular species or to animals for
breeding and production or to animals for slaughter. The competent authority shall notify
the European Commission of the list of approved assembly centres and of any updates.
(4) The competent authority may suspend or withdraw approval in the event of
failure to comply with this regulation or other appropriate provisions of these regulations
or other regulations in respect of health restrictions. Approval may be restored when the
competent authority is satisfied that that assembly centre is in full compliance with all the
appropriate provisions of these regulations.
(5) The competent authority shall ensure that when operating assembly centres
have sufficient approved veterinarians to carry out all duties.
(6) Any detailed rules shall be adopted in accordance with this regulation shall be
adopted requirements of the European Community and under the procedure provided for
in Article 17 of the European Union Council Directive 64/432/EEC.
Additional conditions for transporters
(1) The transporters referred to in Article 5 of European Union Council
Directive 91/628/EEC meet the following additional conditions -
(a) for the carriage of animals they must use means of transport that are -
(i) constructed in such a way that the animal faeces, litter or feed
cannot leak or fall out of the vehicle;
(ii) cleaned and disinfected immediately after every animal
transport operation or that of any product which could affect
animal health and if necessary before any new loading of animals,
using disinfectants officially authorised by competent authority;
(b) they must either have appropriate cleaning and disinfection facilities
approved by the competent authority, including facilities for storing litter
and dung, or they must provide documentary evidence that these
operations are performed by a third party approved by the competent
authority.
(2) The transporter must ensure that for each vehicle used for the transport of
animals a register is kept containing the following information at least which shall be
retained for a minimum period of three years -
(i) places and dates of pickup, and the name or business name and
address of the holding of assembly centre where the animals are
picked up;
(ii) places and dates of delivery, and the name or business name
and address of the consignee(s);
(iii) species and number of animals carried;
(iv) date and place of disinfection;
(v) details of accompanying documentation, number, (serial
number etc).
(3) Transporters shall ensure that the consignment or animals do not at any time,
between leaving the holdings or the assembly centre of origin and arriving at their
destination, come into contact with animals of a lower health status.
(4) Transporters shall give a written undertaking stating in particular that -
(i) all the measures necessary to comply with these regulations shall be
taken and in particular the provisions laid down in this regulation and
relating to the appropriate documentation that must accompany the
animals,
(ii) the transport of animals is entrusted to staff who possess the necessary
ability, professional competence and knowledge.
(5) In the event of failure to comply with the provisions of this regulation the
requirements of Article 18 of European Union Council Directive 91/628/EEC shall apply
mutatis mutandis relating to animal health.
Approval number for dealers
(1) In the territory of Malta all dealers are registered, approved and issued
with an approval number by the competent authority and that they comply with the
following conditions at least -
(a) they must deal only in animals that are identified and come from herds
that are officially free of tuberculosis, brucellosis and leukosis or slaughter
animals meeting the conditions set out in these regulations and in
particular rule 6 (3). To this end, the dealer shall ensure that the animals
are properly identified and are accompanied by health documents as
appropriate for the species involved.
However, the competent authority may authorise the marketing of
identified animals originating from the territory of Malta which do not
fulfil the conditions laid down in this paragraph, in so far as they are
brought direct to a slaughterhouse in the territory of Malta without passing
through their facilities, for slaughter as soon as possible in order to prevent
the spreading of diseases. The necessary provisions should be taken to
ensure that such animals, when they reach the abattoir, cannot come into
contact with other animals and that they are slaughtered apart from other
animals;
(b) the dealer shall be required, either on the basis of the document
accompanying the animals, or on the basis of identification numbers or
marks on the animals, to keep a record or data base and to store the
following data for at least three years -
(i) the name of the owner, origin, date of purchase, categories,
number and identification of bovine animals or registration number
of the holding of origin or of the herd of origin of pigs purchased,
(ii) the registration number of the transporter and, or the licence
number of the lorry delivering and collecting animals,
(iii) the name and address of the purchaser and the destination of
the animal,
(iv) copies of route plans and, or serial number of health
certificates as applicable;
(c) when the dealer keeps animals on his premises he shall ensure that -
(i) specific training is given to the staff in charge of the animals in
applying the requirements of these rules and in the care and
welfare of the animals,
(ii) controls and tests if necessary on the animals are carried out
regularly by the official veterinarian and that all necessary steps
are taken to prevent the spread of disease.
(2) In the territory of Malta all premises used a by dealer in connection with his
business shall be registered and issued with an approval number by the competent
authority and that they comply with the following conditions at least -
(a) they must be under the control of an official veterinarian;
(b) they must be located in an area which is not subject to prohibition or
restrictions in accordance with relevant European Community legislation
or Maltese legislation;
(c) they must have -
(i) appropriate facilities of sufficient capacity and in particular
inspection facilities and isolation facilities so that all animals can
be isolated in the event of an outbreak of a contagious disease,
(ii) appropriate facilities for unloading and where necessary
adequate housing of a suitable standard for the animals, for
watering and feeding them, and for giving them any necessary
treatment; these facilities must be easy to clean and disinfect,
(iii) an appropriate reception area for litter and manure,
(iv) an appropriate system for collecting waste water;
(d) be cleaned and disinfected before use, as required by the official
veterinarian.
(3) The competent authority may suspend or withdraw approval in the event of
failure to comply with this rule or other appropriate provisions of these regulations or
other regulations in respect of health restrictions. Approval may be restored when the
Veterinary Services is satisfied that the dealer is in full compliance with all the
appropriate provisions of these rules.
(4) The competent authority must carry out regular inspections in to ascertain that
the requirements of this rule are fulfilled.
Surveillance network system
(1) The competent authority may carry out a system of surveillance network.
(a)The surveillance network system must comprise at least the following
elements -
(i) the herds;
(ii) the owner or any other natural or legal person responsible for
the holding;
(iii) the approved veterinarian or the official veterinarian
responsible for the holding;
(iv) the competent authority of Malta;
(v) the official veterinary diagnostic or any other laboratory
approved by the competent authority;
(vi) a computer database
Provided that official veterinarians for the slaughtering establishments and
approved assembly centres will be associated with the network system.
(2) The main objectives of the surveillance network system are to make the
official classification of holdings, to maintain such classification by regular inspection, to
collect epidemiological data and to carry out disease monitoring so as to ensure
compliance with all the provisions of these regulations and other regulations in respect of
Provided that this surveillance network system shall be mandatory on all holdings
operating such a system in the territory of Malta. However, the competent authority may
authorize the establishment of such a network on part of the territory made up of one or
several adjacent regions. Where this derogation is accorded, animal movements to that
part of the territory from other regions which are not part of the network system shall be
subject to the provisions of these rules
Further provided the competent authority shall lay down the obligations and rights
incumbent upon the approved veterinarians, the persons responsible for the holdings or
their owners and any other participants in the system including the persons responsible
for issuing health certificates.
(3) The competent authority shall ensure that the obligations referred to in sub-
rule at least include the following-
(a) Every owner of or person responsible for a holding must-
(i) secure, by contract or legal instrument, the services of a
veterinarian approved by the competent authority;
(ii) immediately call in the approved veterinarian for the holding
when he suspects the occurrence of an infectious disease or of any
notifiable disease;
(iii) notify the approved veterinarian of all arrivals of animals on
his holding;
(iv) isolate the animals before introducing them into his holding to
enable the approved veterinarian to check, where appropriate by
means of the required tests, whether the holding's status may be
maintained.
(b) The approved veterinarians shall be under the control of the competent
authority and must comply with the following requirements-
(i) meet the conditions for pursuing the veterinary profession;
(ii) have no financial interest or family links with the owner of or
person responsible for the holding;
(iii) possess particular knowledge in the field of animal health as it
applies to animals of the species concerned. This means that they
must-
— regularly update their knowledge, especially as regards
the relevant health regulations;
— meet the requirements laid down by the competent
authority to ensure the proper functioning of the network;
— provide the owner of or person responsible for the
holding with information and assistance in order that all
steps are taken to ensure that the holding's status is
maintained, particularly on the basis of programmes
agreed with the competent authority,
— ensure compliance with the requirements concerning-
(i) the identification and health certification of the
animals of the herd, the animals introduced and
those traded;
(ii) compulsory reporting of infectious animal
diseases and any other risk factor for animal health
or welfare, and for human health;
(iii) establishing as far as possible the cause of
death of animals and where they are to be
consigned;
(iv) the hygiene conditions of the herd and of the
livestock production units
Provided that if the proper functioning of the system so requires, each Member State may
limit the veterinarians' responsibility to a specific number of holdings or to a specific
geographical area
Provided further that the competent authority shall draw up lists of approved
Veterinarians and of the approved holdings participating in the network. If the competent
authority finds that a participant in the network no longer fulfils the conditions set out
above, it shall suspend or withdraw approval, without prejudice to any penalties that may
be applied.
(c) The computer database must contain at least the following information-
(i) For each animal-
— identification code;
— date of birth;
— sex;
— breed or colour of coat;
— identification code of the mother or, in the case of an
animal imported from a third country, the identification
number given following inspection under European
Union Council Directive 92/102/EEC and
corresponding to the identification number of origin;
— identification number of the holding where born;
— identification numbers of all holdings where the animal
has been kept and the dates of each change of holding;
— date of death or slaughter.
(ii) For each holding-
— an identification number consisting of not more than 12
figures(apart from the country code);
— name and address of the holder.
(iii) The database must be able to supply the following particulars
at any time-
— the identification number of all animals of the bovine
species present on a holding, or in the case of groups of
animals of the porcine species, the registration number of
the holding of origin or herd of origin and the number of
the health certificate where applicable,
— a list of all changes of holding for each animal of the
bovine species starting from the holding of birth, or the
holding of importation in the case of animals imported
from third countries; and for groups of pigs the registration
number of the last holding or last herd and for imported
animals from third countries the holding of importation
Provided that these particulars will be held on the database
until three consecutive years have elapsed since the death
of the bovine animal or until three consecutive years have
elapsed since the record was made in the case of records for
pigs. However, only points2, 3 and 4 shall be applicable to
porcine animals.
(iv) In order to ensure the operation of the national computer
databases concerning porcine animals, appropriate rules of
application, including the information that the national databases
must contain, shall be adopted in accordance with the procedure
laid down in Article 17 of the European Union Council Directive
64/432/EEC.
(4) All participants in the surveillance network other than those provided for in
3A and B shall be accountable to the competent authority. The competent authority in
each Member State shall be responsible for setting up the network and shall carry out
regular checksto ensure that it operates properly.
(5) Member States which introduce a system of surveillance networks as outlined
in regulation 14 (3) (c), operational for a period of at least 12 months, shall apply to the
Commission to have it approved under the procedure provided for in regulation 17
Provided that for this purpose the European Commission shall examine documentation
submitted by Member States.
(6) When the competent authority has implemented a through out its jurisdiction a
recognized surveillance network system as laid down in this regulation shall be
authorized not to apply the provision referred to in Article 3 (2) (a), second indent to
animal movements referred to by this regulation within their own territory .
(7) The financing of the surveillance network system will be covered within the
framework of the revision of Annex B to European Union Council Directive 85/73/EEC
in accordance with the provisions laid down in Article 8 of European Union Council
Directive 96/43/EC.
Penalties
(1) Any infringement of these regulations whether by a natural or a legal
person shall be penalised by the appropriate specific measures laid down in the Maltese
legislation.
(2) If it is confirmed that at the arrival in Malta the provisions of these regulations
are not or have not been complied with, the competent authority shall take all appropriate
measures to safeguard animal health and to prevent the spread of disease. Depending on
the circumstances, such action by the competent authority may consist of taking the
measures required to -
(a) arrange for the journey to be completed or the animals returned to their
place of departure by the most direct route, providing this course of action
would not further jeopardise the health or welfare of the animals;
(b) arrange for the animals to be held in suitable accommodation with
appropriate care in the event of interruption of the journey;
(c) arrange for the slaughter of the animals. The destination and use of
such animals after slaughter shall be regulated -
(i) in accordance with the provisions of European Union Council
Directive 64/433/EEC on fresh meat; or
(ii) in accordance with the provisions of the European Union
Council Directive 90/667/EEC where the health status of the
animals cannot be established or where they are liable to be a risk
to animal health or public health. However, where the provisions
of European Union Council Directive 90/667/EEC should apply, a
regularization period may be accorded to the owner or his agent
before that final possibility is invoked. In that case, the provisions
of sub-rule (3) shall apply;
(3) The Competent Authority shall immediately notify the competent authority of
the Member State of origin on the establishment of any infringement of these regulations.
In accordance with the provisions established by European Union Council Directive
89/608/EEC, the competent authority shall provide mutual assistance to one another
Member State in the application of these regulations in order to ensure, in particular,
compliance with the provisions laid down in this regulation.
(4) This regulation shall not affect other national rules applicable to penal
sanctions.
Interim period between computer database and network system
(1) Pending the introduction in Malta of an approved surveillance network
system a computer database complying with the provisions laid down in regulation 14
shall be fully operational for bovine animals on the 31 December 2002 at the latest
Provided that with regards to porcine animals, there shall be an entry in the database for
each separate movement of porcine animals. The entry shall comprise at least the
following -
(i) the number of porcine animals being moved,
(ii) the identification number of the holding or herd of departure,
(iii) the identification number of the holding or herd of arrival, and
(iv) the departure and arrivals dates.
The recording of all movements of porcine animals shall be fully operational on the 31
December 2003 at the latest.
Contract to be established between the Maltese competent authority and listed
laboratories or Institutes
A contract may be established between the competent authority of Malta and
the laboratories or Institutes listed in the Annex B, Annex C, Annex D, chapter II of
European Union Council Directive 64/432/EEC and Annex III of European Union
Commission Decision 2001/618/EC, for the purpose of the tasks indicated in the relevant
Annexes.
Checks at origin and at destination
The competent authority shall ensure that the rules laid down in the European Union
Council Directive 90/425/EEC shall apply in particular to checks at origin, to the
organization of, and follow-up to, the checks to be carried out by the country of
destination, and to the safeguard measures to be implemented.
SCHEDULE A, B, C, D, E and F to the European council Directive 64/432/EEC