CELEX: 51991PC0137
Language: en
Date: 1991-04-26
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) INTRODUCING COMMUNITY MEASURES FOR THE CONTROL OF NEWCASTLE DISEASE

No C 146/12                           Official Journal of the European Communities                                 5. 6. 91
                                                              II
                                                      (Preparatory Acts)
                                                 COMMISSION
               Proposal for a Council Regulation (EEC) introducing Community measures for the control of
                                                      Newcastle disease
                                                       (91/C 146/14)
                                                     COM(91) 137 final
                                      (Submitted by the Commission on 16 May 1991)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                         by the competent authorities to take account of whether
                                                                 or not a country carries out a prophylactic vaccination
                                                                 programme in all or part of its territory;
 Having regard to the Treaty establishing the European
Economic Community, and in particular Article 43
thereof,                                                         Whereas it is necessary to prevent any spread of the
                                                                 disease as soon as an outbreak occurs, by carefully moni-
                                                                 toring movements of animals and the use of products
                                                                 liable to be contaminated, and, where appropriate, by
Having regard to the proposal from the Commission,
                                                                 vaccination;
Having regard       to the opinion of the European               Whereas diagnosis of the disease must be carried out
Parliament,                                                      under the auspices of the responsible laboratory, the
                                                                 coordination of which must be ensured by a Community
                                                                 reference laboratory;
Having regard to the opinion of the Economic and
Social Committee,
                                                                 Whereas it is necessary to make provision for the
                                                                 Member States which vaccinate to draw up vaccination
                                                                 plans and to inform the Commission and other Member
Whereas poultry is listed in Annex II of the Treaty;             States about those plans;
whereas the marketing of poultry constitutes an
important source of revenue for the agricultural popu-
lation;                                                          Whereas it is appropriate to confer upon the
                                                                 Commission the task of taking the necessary applicatory
                                                                 measures,
"Whereas, it is necessary to establish at Community level
the control measures to be taken in the event of outbreak
of Newcastle disease in order to ensure development of           HAS ADOPTED THIS REGULATION:
the poultry sector and contribute to the protection of
animal health in the Community;
                                                                                         Article 1
                                                                 1. This Regulation defines the Community control
Whereas an outbreak of Newcastle disease can quickly             measures to be applied in the event of an outbreak of
take on epizootic proportions, causing mortality and             Newcastle disease in poultry other than racing pigeons,
disturbances on a scale liable to reduce sharply the prof-       without prejudice to the Community provisions
itability of farming or poultry as a whole;                      governing intra-Community trade.
Whereas action must be taken as soon as the presence of          2. This Regulation shall not apply in the event of
the disease is suspected so that immediate and effective         detection of Newcastle disease in other birds. However,
control measures can be implemented when its presence            in this case, Member States shall inform the Commission
is confirmed; whereas such measures must be modulated            of any measure they take.
 ---pagebreak--- 5.6.91                                 Official Journal of the European Communities                           No C 146/13
                           Article 2                             2.     As soon as the suspected infection is notified, the
                                                                 competent authority shall have the holding placed under
1.    For the purposes of this Regulation, the definitions       official surveillance and shall in particular require that:
given in Article 2 of Council Directive 90/539/EEC (')
shall apply as appropriate.
                                                                 (a) a record be made of all categories of poultry on the
                                                                      holding showing in respect of each of the categories
The following definitions shall also apply:                           the number of poultry which have died, which show
                                                                      clinical signs, and which show no signs. The record
(a) infected poultry means any poultry:                               shall be kept up-to-date and be produced on request;
                                                                      it may be checked at each visit;
    — in which the presence of Newcastle disease has
         been officially confirmed following an exam-
         ination by an approved laboratory, or                   (b) all poultry on the holding be kept in their living
                                                                      quarters or some other place where they can be
    — in the case of second and subsequent outbreaks                  isolated and without contact with other birds;
         in which clinical symptoms or post-mortem
         lesions consistent with Newcastle disease are
         present;                                                (c) no poultry enter or leave the holding;
(b) poultry suspected of being infected means any poultry        (d) all movement:
    showing clinical symptoms or post-mortem lesions
    which are such that the presence of Newcastle                     — of persons, other animals and vehicles to or from
     disease may reasonably be suspected;                                 the holding,
                                                                      — of poultry meat or carcases, or of animal feed,
(c) poultry suspected of being contaminated means any                     implements, waste and litter or any other thing
    poultry which may have been directly or indirectly                    liable to transmit Newcastle disease from the
     exposed to the Newcastle disease virus;                              holding,
(d) swill means waste from kitchens, restaurants or, as               be prohibited unles authorized by the official veter-
    the case may be, from industries using meat;                      inarian;
(e) competent authority means the veterinary authority           (e) no eggs leave the holding with the exception of table
     appointed for the purpose by the national adminis-               eggs which have been disinfected to the satisfaction
    tration of the country concerned, being directly                  of the official veterinarian;
    responsible to the national administration within the
    scope of this Regulation, and reporting through the
     national administration;                                    (f) appropriate means of disinfection be used at the
                                                                      entrances and exits of buildings housing poultry and
                                                                      of the holding itself;
(f) official    veterinarian     means   the     veterinarian
    designated by the competent          authority of the
     Member State.                                               (g) an epizootiological inquiry       be  carried   out in
                                                                      accordance with Article 7.
                           Article 3
                                                                 3.     Until such time as the official measures laid down
Any suspected case of Newcastle disease shall be                 in paragraph 2 are enforced, the owner or keeper of any
immediately notified to the competent authority.                 poultry in which disease is suspected shall take all
                                                                 reasonable action to ensure compliance with paragraph
                                                                 2, particularly points (b) to (e).
                           Article 4
1.    When poultry are suspected of being infected or            4.     The competent authority may extend any of the
contaminated with Newcastle disease, the official veter-         measures provided for in paragraph 2 to other holdings
inarian shall immediately arrange an investigation to            should their location, their configuration, or contacts
confirm or rule out the presence of the disease and, in          with the holding where the disease is suspected give
particular, must take or have taken the samples necessary        reason to suspect possible contamination.
for laboratory examination.
                                                                  5.    The measures referred to in paragraphs 2, 3 and 4
                                                                 shall not be withdrawn until the suspicion of Newcastle
O OJ No L 303, 31. 10. 1990, p. 6.                               disease has been ruled out by the official veterinarian.
 ---pagebreak---   N o C 146/14                           Official Journal of the European Communities                                       5.6.91
                             Article 5                              2.         The Commission shall, in accordance with the
                                                                    procedure laid down in Article 24, lay down the criteria
  1.     As soon as the presence of Newcastle disease has           to be applied for granting a derogation as referred to in
  been officially confirmed on a holding, the competent             paragraph 1.
  authority, in addition to the measures listed in Article 4
  (2), shall require the following measures to be taken:
                                                                                                 Article 7
  (a) all poultry on the holding shall be killed on the spot.
      The poultry which have died or have been killed and           1.        The epizootiological inquiry shall deal with:
       all eggs shall be destroyed. These operations shall be
       carried out in a manner which minimizes the risk of          — the length of time during which Newcastle disease
       spreading disease;                                                  may have existed on the holding,
  (b) any substance or waste, such as animal feed, litter or        — the possible origin of the Newcastle disease on the
      manures liable to be contaminated, shall be                          holding and the identification of other holdings on
      destroyed or treated; this treatment, carried out in                 which there are poultry which may have become
      accordance with the instructions of the official                     infected or contaminated from the same source,
      veterinarian, shall ensure the destruction of any
      Newcastle disease virus present;                             — the movement of persons, poultry or other animals,
                                                                           vehicles, eggs, meat and carcases and any implement
 (c) where poultry have been slaughtered during the                        or substance likely to have carried Newcastle disease
      presumed incubation period of disease the meat from                  virus to or from the holding in question.
      those poultry shall, wherever possible, be traced and
      destroyed;
                                                                   2.         In order to provide full coordination of all
                                                                   measures necessary to ensure eradication of Newcastle
 (d) eggs laid during the presumed incubation period
                                                                   disease as quickly as possible and for the purpose of
      which have been moved from the holding shall,
                                                                   carrying out the epidemiological enquiry, a crisis unit
      wherever possible, be traced and destroyed, but
                                                                   shall be established.
      poultry which have already hatched from these eggs
      shall be placed under official surveillance;
                                                                   The general rules concerning national crisis units and the
                                                                   Community crisis unit fixed by Council Regulation
 (e) after carrying out operations listed in (a) the
                                                                   . . . / . . ./EEC shall apply.
      buildings     used    for    housing    poultry,   their
      surroundings, the vehicles used for transport and all
      equipment likely to be contaminated shall be cleaned                                      Article 8
      and disinfected in accordance with the provisions of
      Article 11;                                                  1.         Where the official veterinarian has reason to
                                                                   suspect that poultry on any holding may have been
 (f) no poultry shall be reintroduced to the holding until         contaminated as a result of the movement of persons,
      at least 21 days after completion of operations              animals or vehicles or in any other way, that holding
      provided for in (e);                                         shall be placed under official control in accordance with
                                                                  paragraph 2.
 (g) an epizootiological inquiry shall be carried out in
      accordance with Article 7.                                  2.         The purpose of official control shall be to    detect
                                                                  immediately any suspicion of Newcastle disease,            count
 2.     The competent authority may extend the measures           the poultry and monitor their movements and,              where
provided for in paragraph 1 to other holdings should               appropriate, to take the action provided for in           para-
their location, their configuration, or contact with the          graph 3.
holding where the disease has been confirmed give
reason to suspect possible contamination.                         3.         "When a holding is subject to official control under
                                                                  the provisions of paragraph 2, the competent authority
                                                                  shall prohibit removal of poultry from the holding other
                           Article 6
                                                                  than for transport directly to a slaughterhouse under
 1.     In the case of holdings which consist of two or           official supervision for the purpose of immediate
more separate flocks the competent authority may grant          _ slaughter. Prior to granting such authorization, the
a derogation from the requirements of Article 5 (1) (a)           official veterinarian must have carried out a clinical
for healthy flocks of a holding which is infected,                examination of all the poultry to exclude the presence of
provided that the official veterinarian has confirmed that        Newcastle disease on the holding. The above movement
the structure and size of these units and the operations          restrictions shall cover a period of a least 21 days starting
carried out there are such that they are completely               from the latest date of potential contamination; if during
separate as regards housing, keeping and feeding, and             the 21-day period it is discovered that potential contami-
taking into account their possible vaccinal immunity, so          nation has taken place, then the minimum period of
that the virus cannot spread from one to another.                 restrictions shall be at least seven days.
 ---pagebreak---  5. 6.91                                 Official Journal of the European Communities                             No C 146/15
 4.     Where it considers that conditions permit, the                   (ii) of day-old chicks or ready-to-lay pullets to a
 competent authority may limit the measures provided for                      holding within the infected area at which there
 in this Article to a part of the holding and to the poultry                  are no other poultry. This holding must be
 contained therein, provided that the poultry there have                      placed under the official control provided for in
 been housed, kept and fed completely separately by                           Article 8 (2);
 separate staff.
                                                                        (iii) of hatching eggs to a hatchery situated inside
                                                                              the infected area or one outside the area
                                                                              designated by the competent authority; before
                            Article 9                                         dispatch eggs and their packing must be disin-
 1.     Once the diagnosis of Newcastle disease has been                      fected.
officially confirmed, the competent authority shall                     Movements allowed in (i), (ii) and (iii) shall be
establish around the infected holding an infected area                  directly executed, under official control. They shall
involving a protection zone based on a minimum radius                   be authorized only after the official veterinarian has
of 3 kilometres and a surveillance zone based on a                      carried out a health inspection of the holding. The
minimum radius of 10 kilometres. The establishment of                   means of transport used must be cleaned and disin-
these zones must take account of natural boundaries and                 fected before and after use;
the epidemiology of the outbreak.
                                                                   (g) a prohibition in removing or spreading poultry
2.      The measures applied in the protection zone shall               manure or litter without authorization;
include:
                                                                   (h) the prohibition of fairs, markets, shows or other
(a) the identification     of all holdings having poultry              gatherings of poultry or other birds.
     within the zone;
                                                                   3.    The measures applied in the protection zone shall
(b) periodic visits to all the holdings having poultry, a          be maintained for at least 21 days after the carrying out
     clinical examination of those poultry including, if           of preliminary cleaning and disinfection operations on
     necessary, the collection of samples for laboratory           the infected holding in accordance with Article 11. The
     examination; a record of visits and findings must be          protection zone shall thereafter be part of the
     kept;                                                         surveillance zone.
(c) the keeping of all poultry in their living quarters or         4.    The measures applied in the surveillance zone shall
     some other place where they can be isolated;                  include:
(d) the use of appropriate means of disinfection at the            (a) the identification    of all holdings having poultry
     entrances and exits of the holdings;                              within the zone;
                                                                   (b) the control of poultry and hatching egg movements
(e) the control of movements of persons handling
                                                                       within the zone;
     poultry, poultry carcases and eggs and vehicles
     carrying poultry, carcases and eggs to and from the
     holdings; in general transport of poultry is                  (c) a prohibition on the movement of poultry out of the
     prohibited, except for transit by major highways or               zone during the first 15 days, except for movement
     railways;                                                         directly to a slaughterhouse outside the infected area
                                                                       designated by the competent authority. The special
                                                                       health mark provided for in Article 6 of Regulation
(f) a prohibition on removing poultry and hatching eggs                (EEC) No . . . / . . . (on animal health conditions
     from the holding on which they are kept unless the                governing intra-Community trade and imports from
     competent authority has authorized the transport:                 third countries of fresh poultry meat and fresh meat
       (i) of poultry for immediate slaughter to a slaugh-             of reared game birds) must be applied to this poultry
           terhouse preferably located in the infected area            meat;
           or, if that is not possible, to a slaughterhouse
           designated by the competent authority outside           (d) a prohibition on the movement of hatching eggs out
           the infected area. The special health mark                  of the infected area, unless to premises designated by
           provided for in Article 6 (1) of Council Regu-              the competent authority. Before dispatch the eggs
           lation (EEC) No . . . / . . . (on animal health             and their packing must be disinfected;
           conditions governing intra-Community trade in
           and imports from third country of fresh poul-
           trymeat and fresh meat of reared game birds)            (e) a prohibition on the movement of poultry manure
           must be applied to this poultry meat;                       and litter out of the zone;
 ---pagebreak---  No C 146/16                            Official Journal of the European Communities                                  5.6.91
 (f) a prohibition of fairs, markets, shows or other               2.    The national laboratories listed in Annex II are
      gatherings of poultry and other birds;                      responsible for coordinating standards and methods of
                                                                  diagnosis, use of reagents and testing of vaccines.
 (g) without prejudice to the provisions of (b) and (c) the
      prohibition of transport of poultry, except for transit
      by major highways or railways.                               3.    The national Newcastle disease laboratories
                                                                  referred to in paragraph 2 shall be responsible for coor-
 5.    The measures applied in the surveillance zone shall        dinating the standards and diagnostic methods laid down
be maintained for at least 30 days after the carrying out         in each Newcastle disease diagnostic laboratory within
of preliminary cleaning and disinfection operations on            the Member State. To this end:
the infected holding in accordance with Article 11.
                                                                  (a) they may provide diagnostic reagents to regional
                           Article 10                                  laboratories;
 1.    The competent authority shall determine the
arrangements allowing them to trace the movement of               (b) they shall control the quality of all diagnostic
eggs and poultry.                                                      reagents used in that Member State;
2.     The owner or keeper of poultry shall be required to
supply the competent authority, on request by that                (c) they shall arrange comparative tests periodically;
authority, with information concerning poultry and eggs
entering or leaving his holding.                                  (d) they shall hold isolates of Newcastle disease virus
                                                                       from cases confirmed in that Member State;
3.     All persons engaged in the transport or marketing
of poultry and eggs shall be in a position to supply the
competent authority with information concerning the               (e) they shall ensure the confirmation of positive results
movements of poultry and eggs which they have trans-                   obtained in regional diagnostic laboratories.
ported or marketed and to furnish all the details
concerning such information.
                                                                  4.     The national laboratories listed in Annex II shall
                                                                  liaise with the Community reference laboratory referred
                           Article 11                             to in Article 14.
 1.    The disinfectants to be used and their concen-
trations shall be approved by the competent authority.
                                                                                            Article 14
2.     The cleaning and disinfection operations shall be          The Community reference laboratory of Newcastle
carried out under official supervision, in accordance with        disease is named in Annex III. The powers and duties of
instructions given by the official veterinarian.                  the laboratory shall be laid down, in so far they are not
                                                                  already covered by Article 28 of Council Decision
                           Article 12                             90/424/EEC ('), in accordance with the procedure laid
                                                                  down in Article 24.
Collection of samples and laboratory testing to detect the
presence of Newcastle disease virus shall be carried out
in accordance with Annex I.
                                                                                            Article 15
                                                                  1.     Vaccination against Newcastle disease with
                           Article 13
                                                                  vaccines authorized by the competent authority may be
1.     Each Member State shall designate:                         used for a prophylactic purpose or to supplement the
                                                                  control measures carried out when the disease appears.
(a) one or more national laboratories at which facilities
     and expert personnel shall be maintained to permit
     full antigenic and biological typing of Newcastle            2.     Only vaccines which meet the following conditions
     disease virus at all times and to confirm results            shall be authorized:
     obtained in regional diagnostic laboratories;
(b) one or more national laboratories at which reagents           (a) the vaccine must conform with the provisions of the
     for use in regional laboratories are tested;                      European Pharmacopeia and have been produced,
                                                                       tested and distributed under official control;
(c) one or more national institutes or laboratories at
     which vaccines allowed for prophylactic use in the
     country or stock-piled for emergency use may be
     tested for efficacy, potency and purity.                     (') OJ No L 224, 18. 8. 1990, p. 19.
 ---pagebreak---  5. 6. 91                                Official Journal of the European Communities                            N o C 146/17
 (b) any vaccine imported from a third country shall                (c) throughout the vaccination operation provided for in
      satisfy the requirements laid down in (a).                        paragraph 1 all poultry of designated species kept on
                                                                        holdings inside the vaccination area must remain
                                                                        there except:
 3.     Further criteria for using vaccines against
 Newcastle disease may be established in accordance with
the procedure laid down in Article 24.                                  — day-old chicks moved to a holding inside the
                                                                            vaccination area where they shall be vaccinated,
                           Article 16
                                                                        — poultry moved direct to a slaughterhouse for
 1.    A Member State in which voluntary or compulsory                      immediate slaughter. If the slaughterhouse is
prophylactic vaccination against Newcastle disease is                       located outside the vaccination area the
carried out shall inform the Commission and the other                       movement of poultry shall be permitted only after
Member States.                                                              the official veterinarian has carried out a health
                                                                            inspection of the holding;
2.     The information given          in   accordance    with
paragraph 1 must specify:
                                                                    (d) when the vaccination operations provided for in (a)
                                                                        have been completed movements out of the vacci-
— the characteristics and composition of each vaccine
                                                                        nation area may be authorized for:
     used,
— the procedures for supervision of the distribution,                   — day-old chicks intended for meat production may
     storage and use of vaccines,                                           be moved to a holding where they shall be
                                                                            vaccinated; the holding must be kept under
— the species and categories of poultry which may or                        surveillance until the poultry which have been
     shall be subject to vaccination,                                       moved have been slaughtered,
— the areas in which vaccination may or shall be carried                — poultry vaccinated more than 21 days previously
     out.                                                                   and intended for immediate slaughter,
                          Article 17                                    — hatching eggs which originate from breeding
                                                                            poultry vaccinated at least 21 days previously; the
1.     When Newcastle disease has been confirmed, the                       eggs and their packing must be disinfected before
competent authority, in order to supplement the other                       movement.
control measures provided for in this Regulation, may
specify a territorial area and period in which the prompt
and systematic vaccination (emergency vaccination) of              4.    The measures provided for in (b) and (d) of
designated species of poultry shall be carried out under           paragraph 3 shall be applied for a period of 3 months
official control. A Member State applying emergency                following completion of vaccination operations provided
vaccination shall inform the Commission and other                  for in paragraph 1; they may be extended for one or
Member States within the framework of the Standing                 more additional periods of three months.
Veterinary Committee, set up by Council Decision
68/361/EEC O , about the Newcastle disease situation
and emergency vaccination programme.                               5.    By way of derogation from (a) and (b) of
                                                                   paragraph 3, the competent authorities may exempt
                                                                   certain flocks of particular scientific value from
2.     In the case referred to in paragraph 1, the vacci-          systematic vaccination, provided that all necessary steps
nation or re-vaccination of poultry on the holding                 are taken by the competent authority to ensure
subject to the restrictions referred to in Article 4 is            protection of their health and to subject them to periodic
prohibited.                                                        serological checks.
3.     In the case referred to in paragraph 1:
                                                                   6.    The Commission shall follow the development of
                                                                   the disease situation and if necessary it may, in
(a) the designated species of poultry shall be vaccinated          accordance with the procedure laid down in Article 24,
     as soon as possible;                                          take a decision in particular in relation to control of
                                                                   movements and vaccination.
(b) all poultry of designated species born on or trans-
     ferred to a holding inside the vaccination area must
     be or have been vaccinated;                                                             Article 18
                                                                   1.    When, in a given region, an epizootic of Newcastle
                                                                   disease is exceptionally serious and is tending to spread,
0) OJ No L 255, 18. 10. 1968, p. 23.                               the Member State concerned:
 ---pagebreak---  No C 146/18                            Official Journal of the European Communities                                 5. 6. 91
 — shall declare a demarcated territorial area including           2. The criteria to be applied for drawing up the
     at least all the protection and surveillance zones in         contingency plan shall be those laid down in Commission
     that area to be a 'high health risk' area,                    Decision 91/42/EEC (*), which apply mutatis mutandis.
                                                                  The Commission may, in accordance with the procedure
 — shall apply the measures provided for in Article 9 (3)
                                                                   laid down in Article 24, amend or supplement those
     in the high health risk area,
                                                                  criteria taking into account the specific nature of
                                                                   Newcastle disease.
 — shall prohibit all live poultry and hatching eggs from
     leaving the high health risk area,                           3. Plans drawn up in accordance with the criteria
                                                                  provided for in paragraph 2 shall be submitted to the
— shall inform the Commission and other Member                    Commission not later than 12 months after this Regu-
     States within the framework of the Standing                  lation enters into force.
     Veterinary Committee about the disease situation and
     applied control measures.                                    4. The Commission shall examine the plans in order
                                                                  to determine whether they permit the desired objective to
                                                                  be attained and shall suggest to the Member State
 2. The boundaries of the high health risk area may be            concerned any amendments required, in particular to
 revised with a progessive elimination of surveillance            ensure that they are compatible with those of the other
 zones. The measures laid down in paragraph 1 shall be            Member States.
 discontinued after the elimination of the last surveillance
 zone.                                                            The Commission shall approve the plans, if necessary
                                                                  amended, in accordance with the procedure laid down in
                                                                  Article 24.
 3. If an exceptionally serious situation continues, the
measures to be taken by the Member State concerned, in
particular determination of the high health risk area and         The plans may subsequently be amended or
recourse to the provisions of Article 17, must be decided         supplemented, in accordance with the same procedure,
in accordance with the procedure laid down in Article             to take into account developments in the situation.
24.
                                                                                           Article 21
                          Article 19                              Veterinary experts from the Commission may, in colla-
                                                                  boration with the authorities of the Member State
 1. The use of swill originating from means of interna-           concerned, in so far as is necessary to ensure uniform
tional transport, such as ships, land vehicles, or aircraft,      application of this Regulation, make on-the-spot checks;
is prohibited for the feeding of poultry; such swill shall        the Commission shall inform the Member States of the
be collected and destroyed under official supervision.            results of the investigation.
                                                                  A Member State in whose territory a check is being
2. The use of swill other than as defined in paragraph            carried out shall give all the necessary assistance to the
 1, or poultry scraps may be authorized for the feeding of        experts in carrying out their duties.
poultry only after a heat-treatment ensuring the
destruction of Newcastle disease virus.                           The general provisions for implementing this Article shall
                                                                  be determined in accordance with the procedure laid
                                                                  down in Article 24.
3. If necessary, the Commission shall, in accordance
with the procedure laid down in Article 24, lay down the
criteria for the implementation of paragraph 2.                                            Article 22
                                                                  Detailed rules for financial participation by the
                          Article 20                              Community in steps taken pursuant to this Regulation
                                                                  are laid down in Decision 90/424/EEC.
1. Each Member State shall draw up a contingency
plan, specifying the national measures to be implemented
in the event of an outbreak of Newcastle disease.                                          Article 23
                                                                  The Annexes to this Regulation may be amended by the
                                                                  Commission, in accordance with the procedure laid
This plan should allow access to facilities, equipment,           down in Article 24, in particular in order to take into
personnel and all other appropriate materials necessary           account the development in diagnostic procedures.
for the rapid and efficient eradication of the outbreak. It
must give a precise indication of the vaccine
requirements which each Member State concerned
considers it needs in the event of emergency vaccination.         O OJ No L 33, 29. 1. 1991, p. 29.
 ---pagebreak--- 5. 6. 91                                   Official Journal of the European Communities                                   No C 146/19
                           Article 24                                     The opinion shall be recorded in the minutes; in
                                                                          addition, each Member State shall have the right to ask
1.    The Commission shall be assisted by the Standing                    to have its position recorded in the minutes.
Veterinary Committee, hereinafter referred to as 'the
Committee'.                                                               The Commission shall take the utmost account of the
                                                                          opinion delivered by the Committee. It shall inform the
2.    Where the procedure laid down in this Article is to                 Committee of the manner in which its opinion has been
be followed, the following provisions shall apply.                        taken into account.
The representative of the Commission shall submit to the                                           Article 25
Committee a draft of the measures to be taken. The
Committee shall deliver its opinion on the draft within a                 This Regulation shall enter into force on 1 July 1991.
time limit which the chairman may lay down according
to the urgency of the matter, if necessary by taking a                    This Regulation shall be binding in its entirety and
vote.                                                                     directly applicable in all Member States.
                                                                ANNEX I
            DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION AND DIFFERENTIAL DIAGNOSIS
                                                      OF NEWCASTLE DISEASE
            The following procedures for the isolation and characterization of Newcastle disease viruses should be
            regarded as guidelines and the minima to be applied in the diagnosis of the disease.
            The virus responsible for Newcastle disease is the prototype virus of the paramyxoviridae. At present, there
             are nine serologically distinguishable groups of avian paramyxoviruses, which have been designated PMV-1
            to PMV-9. All Newcastle disease viruses are placed in the PMV-1 group. For the purpose of the diagnostic
            procedures for the confirmation and differential diagnosis of Newcastle disease the following definition
             shall apply:
             Newcastle disease means an infection of poultry caused by any avian strain of the paramyxovirus 1 with an
             intracerebral pathogenicity index (ICPI) in day-old chicks greater than 0,7.
                                                              CHAPTER 1
                                                    Sampling and treatment of samples
             1. Samples
                 Cloacal swabs (or faeces) and tracheal swabs from sick birds; faeces or intestinal contents, brain tissue,
                 trachea, lungs, liver, spleen and other obviously affected organs from recently dead birds.
             2. Treatment of samples
                The organs and tissues listed above may be pooled, but separate treatment of faecal material is essential.
                 Swabs should be placed in sufficient antibiotic medium to ensure full immersion. Faeces samples and
                 organs should be homogenized (in an enclosed blender or using a pestle and mortar and sterile sand) in
                 antibiotic medium and made to 10 to 20 °/o w/v suspensions in the medium. The suspensions should be
                 left for about two hours at ambient temperature (or longer periods at 4 ° C) and then clarified by
                 centrifugation (e.g. 800 to 1 000 x g for 10 minutes).
 ---pagebreak--- No C 146/20                               Official Journal of the European Communities                                     5. 6. 91
          3. Antibiotic   medium
              Different laboratories have used various formulations of antibiotic medium with success and laboratories
              referred to in Annex II will be able to offer advice for a particular country. High concentrations of
              antibiotics are required for faeces samples and a typical mixture is: 10 000 units/ml penicillin, 10 mg/ml
              streptomycin, 0,25 mg/ml gentamycin and 5 000 units/ml mycostatin in phosphate buffered saline.
              These levels can be reduced up to five-fold for tissues and tracheal swabs. For control of Chlamydia
              organisms 50 mg/ml oxytetracycline may be added. It is imperative when making the medium that the
              p H is checked after the addition of the antibiotics and readjusted to p H 7,0 to 7,4.
                                                            CHAPTER 2
                                                           Virus isolation
           Virus isolation in embryonated fowls' eggs
          The clarified supernatent fluid should be inoculated in 0,1 to 0,2 ml amounts into the allantoic cavity of
          each of a minimum of four embryonated, fowls' eggs which have been incubated for 8 to 10 days. Ideally,
          these eggs should be obtained from a specific pathogen free flock, but when this is impracticable it is
          acceptable to use eggs obtained from a flock shown to be free of antibodies to Newcastle disease virus. The
          inoculated eggs are held at 37 °C and candled daily. Eggs with dead or dying embryos as they arise, and
          all remaining eggs six days after inoculation should be chilled to 4 °C and the allantoic-amniotic fluids
          tested for haemagglutination activity. If no haemagglutination is detected the above procedure is repeated
          using undiluted allantoic/amniotic fluid as inoculum.
          When haemagglutination is detected the presence of bacteria should be excluded by culture. If bacteria are
          present the fluids may be passed through a 450 nm membrane filter, further antibiotics added and
          inoculated into embryonated eggs as above.
                                                            CHAPTER 3
                                                        Differential diagnosis
          1. Preliminary differentiation
              It is intended that all haemagglutinating viruses should be submitted to the national laboratory referred
              to in Annex II for full identification, characterization and pathogenicity tests. However, it is important
              that interim control measures for Newcastle disease aimed at limiting the spread of the virus should be
              implemented as soon as possible and regional laboratories should be able to identify the presence of
              Newcastle disease virus. The haemagglutinating fluids should, therefore, be used in a haemagglutination
             inhibition test as described in Chapters 5 and 6. Positive inhibition, i.e. 2 4 , or more, with the Newcastle
             disease virus specific polyclonal antiserum of titre known to be at least 2 9 would serve as preliminary
             identification enabling the imposition of interim control measures.
          2. Confirmatory     identification
             The national laboratory should undertake full differential diagnosis of any haemagglutinating agent.
              Confirmation of Newcastle disease virus would again be by inhibition in haemagglutination inhibition
              tests with monospecific chicken antisera. Intracerebral pathogenicity index tests as described in Chapter
              7 should be carried out on all positive isolates. Pathogenicity indices of greater than 0,7 indicate the
             presence of virus requiring the full implementation of control measures.
              Recent developments in typing Newcastle disease viruses, particularly monocional antibody techniques,
             has enabled grouping of the strains and isolates. In particular, some monocional antibodies are available
             which are specific for the vaccinal strains used on the territory of the European Community and can be
             employed in simple haemagglutination inhibition tests. Since live vaccine strains may often be isolated
             from sampled poultry the advantage of their rapid identification at the national laboratory referred to in
             Annex II is obvious. Such monoclonal antibodies should be obtained by the Community reference
             laboratory as referred to in Article 14 and supplied to the national laboratories to enable confirmation
             of the isolation of vaccinal viruses.
             The national laboratories should submit all haemagglutinating agents to the Community reference
             laboratory.
 ---pagebreak--- 5. 6. 91                                 Official Journal of the European Communities                                    N o C 146/21
         3. Further typing and characterization of isolates
            The Community reference laboratory should receive all haemagglutinating viruses from the national
            laboratories for further antigenic and genetic studies to enable a greater understanding of the
            epizootiology of the disease(s) within the European Community in keeping with the functions and
            duties of the reference laboratory.
                                                                 CHAPTER 4
                                   Rapid tests for detection of Newcastle disease virus and antibodies
         Rapid tests for the detection of Newcastle disease virus in vaccinated birds and the detection of antibodies in
                                                     unvaccinated birds are outlined below
         1. Detection of Newcastle disease virus
            Several rapid tests that directly detect Newcastle disease antigens have been employed in the diagnosis
            of infections in vaccinated birds. Those most commonly used to date are fluorescent antibody tests on
            longitudinal sections of the trachea and peroxidase antibody tests on the brain. There seems no reason
            to doubt that other direct antigen detection tests could be applied to Newcastle disease virus infections.
            The drawback to such tests is that it is impracticable to examine all the potential sites of replication of
            Newcastle disease virus in the vaccinated birds. So that, for example, absence of evidence of virus in the
            trachea does not preclude virus replication in the gut. N o direct detection method is recommended for
            routine use in the diagnosis of Newcastle disease, although in specific circumstances such tests may have
            a useful role.
         2. Detection of antibodies in unvaccinated birds
            The majority of laboratories involved in Newcastle disease diagnosis are familiar with the haemaggluti-
            nation inhibition test and the recommendation described below relate to this test for the measurement of
            antibodies to the virus. However, enzyme-linked immunosorbent assays (Elisa) may be successfully used
            to detect antibodies to the virus. It is suggested that if there is a wish to employ an Elisa test at regional
            laboratory level the test should be monitored by the national laboratory referred to in Annex II.
            (a) S a m p l e s
                 Blood samples should be taken from all birds if the flock size is less than 20 and from 20 birds from
                 larger flocks. (This will give a > 99 % probability of detecting at least one positive serum if 25 %
                 or more of the flock is positive, regardless of flock size.) The blood should be allowed to clot and
                 serum removed for testing.
            (b) E x a m i n a t i o n for a n t i b o d i e s
                 Individual serum samples should be tested for their ability to inhibit Newcastle disease virus
                 haemagglutinating antigen in standard haemagglutination inhibition tests as defined in Chapter 6.
                 There is some debate as to whether four or eight haemagglutinin units should be used for the H I
                 test. It would appear that either is valid and the choice should be left to the discretion of the
                 national laboratories.
                 However, the antigen used will affect the level at which a serum is considered positive: for 4 HAU
                 a positive serum is any showing a titre of 2* or greater, for 8 HAU a positive serum is any showing
                 a titre of 23 or greater.
 ---pagebreak--- N o C 146/22                           Official Journal of the European Communities                                        5. 6. 91
                                                            CHAPTER 5
                                                   Haemagglutination (HA) Test
           1. Reagents
              (a) Isotonic saline buffered with phosphate (0,05 M) to pH 7,0 to 7,4.
              (b) Red blood cells (RBC) taken and pooled from a minimum of three specific pathogen free chickens
                  (if not available blood may be taken from birds regularly monitored and shown to be free of NDV
                  antibodies) into an equal volume of Alsever's solution. Cells should be washed three times in PBS
                  before use. For the test a 1 % suspension (packed cell v/v) in PBS is recommended.
              (c) NDV strain Ulster 2C is recommended for use as standard antigen.
           2. Procedure
              (a) Dispense 0,025 ml PBS into each well of a plastic microtitre plate (V-bottomed wells should be
                  used).
              (b) Place 0,025 ml of virus suspension (i.e. allantoic fluid) in the first well.
              (c) Use a microtitration diluter to make two-fold dilutions (1:2 to 1:4096) of virus across the plate.
              (d) Dispense a further 0,025 ml of PBS to each well.
              (e) Add 0,25 ml of 1 % red blood cells to each well.
              (f) Mix by tapping gently and place at 4 ° C.
              (g) Plates are read 30 to 40 minutes later when controls are settled. Reading is done by tilting the plate
                  and observing the presence or absence of tear-shaped streaming of the RBCs. Wells with no HA
                  should flow at the same rate as the control cells with no virus.
              (h) The HA titre is the highest dilution that causes agglutination of the RBCs. That dilution may be
                  regarded as containing one HA unit (HAU). A more accurate method for determining the HA titre
                  is to do HA tests on virus from a close range of initial dilutions, i.e. 1:3, 1:4, 1:5, 1:6 etc. This is
                  recommended for the accurate preparation of antigen for haemagglutination inhibition tests
                  (Chapter 6).
                                                            CHAPTER 6
                                              Haemagglutination inhibition (HI) test
           1. Reagents (see Chapter 5)
              (a) PBS.
              (b) Virus-containing allantoic fluid diluted with PBS to contain 4 or 8 HAU per 0,025 ml.
              (c) 1 % chicken RBCs.
              (d) Negative control chicken serum.
              (e) Positive control serum.
 ---pagebreak--- 5.6.91                             Official Journal of the European Communities                                      No C 146/23
       2. Procedure
          (a) Dispense 0,025 ml PBS into all wells of a plastic microtitre plate (with V-bottomed wells).
          (b) Place 0,025 ml of serum into first well of plate.
          (c) Use microtitration diluter to make two-fold dilutions of serum accross plate.
          (d) Add 0,025 ml of diluted allantoic fluid containing 4 or 8 HAU.
          (e) Mix by tapping and place plate at 4 °C for a minimum of 60 minutes or room temperature for a
              minimum of 30 minutes.
          (0 Add 0,025 ml 1 % RBCs to all wells.
          (g) Mix by gentle tapping and place at 4 °C.
          (h) Plates are read after 30 to 40 minutes when control RBCs are settled. This is done by tilting and
              observing the presence or absence of tear-shaped streaming at the same rate as control wells
              containing RBCs (0,025 ml) and PBS (0,05 ml) only.
          (i) The HI titre is the highest dilution of antiserum causing complete inhibition of four or eight units of
              virus (a HA titration to confirm the presence of the required HAU should be included in each test).
          (j) The validity of the results is dependent on obtaining a titre of less than 25 for 4 HAU or 22 for 8
              HAU with the negative control serum and a titre of within one dilution of the known titre of the
              positive control serum.
                                                       CHAPTER 7
                                           Intracerebral pathogenicity index test
       1. Infective freshly harvested allantoic fluid (HA titre must be greater than 24) is diluted 1:10 in sterile
          isotonic saline (anti-biotics must not be used).
       2. 0,05 ml of the diluted virus is injected intracerebrally into each of 10 one-day-old chicks (i.e. > 24
          hours < 40 hours after hatching). The chicks should be hatched from eggs obtained from a specific
          pathogen free flock.
       3. The birds are examined at intervals of 24 hours for eight days.
       4. At each observation each bird is scored: 0 = normal; 1 = sick; 2 = dead.
       5. The index is calculated as shown in the following example:
                                                                   Day after inoculation
                  Clinical signs
                                                                     number of birds
                                        1    2     3    4     5    6    7      8         Total           Score
          Normal                       10    4     0    0     0    0    0     0        14 @ 0           -     0
          Sick                          0    6    10    4     0    0    0     0        20 @ 1           -    20
          Dead                          0    0     0    6    10   10   10    10        46 @ 2           -    92
                                                                                         TOTAL          = 112
          Index is mean score per bird per observation = 112/80 = 1,4.
 ---pagebreak--- N o C 146/24                            Official Journal of the European Communities                                        5. 6. 91
                                                             CHAPTER 8
                                                Assessment of plaque-forming ability
            1. It is usually best to use a dilution range of virus to ensure that an optimum number of plaques are
               present on the plate. Ten-fold dilutions up to 10"7 in PBS should be sufficient.
           2. Confluent monolayers of chick embryo cells or a suitable cell line (Madin-Darby bovine kidney for
               example) are prepared in 5 cm diameter Petri dishes.
           3. 0,2 ml of each virus dilution is added to each of two Petri dishes and the virus allowed to adsorb for 30
               minutes.
           4. After washing three times with PBS the infected cells are overlaid with the relevant medium containing
               1 % w/v agar and either 0,01 mg/ml trypsin or no trypsin, it is important that no serum is added to the
               overlay medium.
           5. After 72 hours incubation at 37 °C the plaques should be of sufficient size. They are best seen by
               removing the agar overlay and staining the cell monolayer with crystal violet (0,5 % w/v) in 25 % v/v
               ethanol.
           6. All viruses should give clear plaques when incubated in the presence of trypsin in the overlay. When
               trypsin is absent from the overlay only viruses virulent for chickens will produce plaques.
                                                              ANNEX II
                               LIST OF NATIONAL NEWCASTLE DISEASE LABORATORIES
           BELGIUM                                      Institut national de recherches veterinaires, Groeselenberg 99,
                                                        B-1180 Bruxelles
           DENMARK                                      National Veterinary Laboratory, Poultry Disease Division,
                                                        Hangavej 2, DK-8200 Arhus N
           FEDERAL REPUBLIC OF GERMANY Institut fur Kleintierzucht der Bundesforschungsanstalt fiir
                                                        Landwirtschaft, Braunschweig-Vdlkenrode, Postfach 2 80,
                                                        D-W-3100 Celle
           FRANCE                                       Centre national d'etudes veterinaires et alimentation —
                                                        Laboratoire central de recherches agricoles et porcine, boite
                                                        postale 53, F-22440 Ploufragan
           GREECE                                       Institut de maladies infectieuses et parasitaires d'Athenes, 25 rue
                                                        Neapoleos, 153 10, Agia Paraskevi, Attiki
           IRELAND                                      Veterinary Research Laboratory, Abbotstown, Castleknock,
                                                        IRL-Dublin 15
           ITALY                                        Istituto zooprofilattico sperimentale di Padova, via G. Orus
                                                        n. 2, 1-35100 Padova
           LUXEMBOURG                                   Institut national de recherches veterinaires, Groeselenberg 99,
                                                        B-1180 Bruxelles
           NETHERLANDS                                  Centraal Diergeneeskundig Instituut, Vestiging Virologie,
                                                        Hourtibweg 39, NL-8221 RA Lelystad
 ---pagebreak--- 5. 6. 91                  Official Journal of the European Communities                           No C 146/25
         PORTUGAL                        Laborat6rio Nacional de Investigate) Veterinaria (LNIV),
                                         Estrada de Benfica, 701, P-1500 Lisboa
         SPAIN                           Laboratorio de Sanidad y Producci6n Animal, Zona Franca,
                                         Circcunvalaci6n — Tramo 6, Esquina Calle 3, E-08004
                                         Barcelona
         UNITED KINGDOM                  Central Veterinary Laboratory,     New Haw,    Weybridge,
                                         UK-Surrey KT15 3NB
                                             ANNEX III
           NAME OF THE COMMUNITY REFERENCE LABORATORY FOR NEWCASTLE DISEASE
                                    Central Veterinary Laboratory
                                    New Haw
                                    Weybridge
                                    UK-Surrey KT15 3NB