MEASURES FOR THE CONTROL OF NEWCASTLE DISEASE RULES *

NEWCASTLE DISEASE

SUBSIDIARY LEGISLATION 437.109

MEASURES FOR THE CONTROL OF

NEWCASTLE DISEASE RULES *

18th April 2019

LEGAL NOTICE 80 of 2019.

(1)

The title of these rules is Measures for the Control

of Newcastle Disease Rules.

(2)

The scope of these rules is to transpose Council Directive

92/66/EEC introducing Community measures for the control of

Newcastle disease as amended by Directive (EU) 2018/597 of the

European Parliament and of the Council of 18th April 2018.

(3)

These rules establish control measures to be taken in the

event of an outbreak of Newcastle disease in poultry, racing pigeons

and other birds kept in captivity.

(Rule 4)

AUTHORIZATION TO REMOVE EGGS FROM A HOLDING

SUBJECT TO THE CONDITIONS OF RULE 4(2)(e)

The authorization issued by the competent authority to transport

eggs from a suspect holding subject to the provisions of rule

4(2) (e) to an establishment approved for the manufacture and

processing of egg products in accordance with the provisions of

Article 6(1) of Directive 89/437/EEC, hereinafter called the

designated establishment, must meet the following conditions

1. in order to be allowed to be removed from a suspect

undertaking, eggs must

(a)

comply with the requirements laid down in Chapter

IV of the Annex to Directive 89/437 /EEC;

(b)

be sent directly from the suspect undertaking to the

designated establishment; each consignment must be

sealed before dispatch by the official veterinarian of

the suspect holding and must remain sealed

throughout transport to the designated establishment;

2. the official veterinarian of the suspect undertaking shall

inform the competent authority of the designated

establishment of his intention of sending eggs to it;

3. the competent authority responsible for the designated

establishment shall ensure that

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(a)

eggs referred to in item 1(b) will be kept isolated from

other eggs from the time they arrive until they are

processed;

(b)

the shells of such eggs shall be regarded as Category

3 Material in accordance with Article 3 Regulation

(EC) No 1069/2009 and shall be disposed of in

accordance with the requirements Article 13 of that

Regulation;

(c)

the packaging material, the vehicles used to transport

eggs referred to in item 1(b) and all premises with

which the eggs come into contact are cleaned and

disinfected in such a way as to destroy all Newcastle

disease virus;

(d)

the official veterinarian of the suspect holding shall

be informed of all consignments of processed eggs.

(1)

In these rules unless the context otherwise

requires, the definitions found in Article 2 of Council Directive 2009/

158/EC of 30th November 2009 on animal health conditions

governing intra-Community trade in, and imports from third countries

of, poultry and hatching eggs shall apply as appropriate.

(2)

The following definitions shall also apply

"the Act" means the Veterinary Services Act;

"The Commission" means the European Commission;

"competent authority" means the Department

of

Veterinary Services as established by article 2 of the Act;

"crisis unit" means the Animal Health Unit within the

competent authority;

"the Directive" means Council Directive 92/66/EEC as

amended by Directive (EU) 2018/597;

"European Union reference laboratory" means the

laboratory referred to in rule 15;

"infected poultry" means any poultry in which the

presence of Newcastle disease has been officially confirmed

following an examination by an approved laboratory or in the

case of second and subsequent outbreaks in which clinical

symptoms or post-mortem lesions consistent with Newcastle

disease are present;

*These rules have been repealed by Legal Notice 77 of 2025.

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"official veterinarian" means a warranted veterinarian

working for the competent authority;

"pigeon house" means any installation used for keeping or

breeding racing pigeons;

"poultry suspected of being contaminated" means any

poultry which may have been directly or indirectly exposed to

the Newcastle disease virus;

"poultry suspected of being infected" means any poultry

showing clinical signs or post-mortem lesions which are such

that the presence of Newcastle disease may reasonably be

suspected;

"racing pigeon" means any pigeon transported or intended

for transport from its pigeon house to any other destination;

"Standing Committee on the Food Chain and Animal

Health" means the committee referred to in Article 25 of the

Directive;

"swill" means waste from kitchens, restaurants or, where

appropriate, from industries using meat.

(Rule 5)

PROCEDURE FOR CLEANING AND DISINFECTING

AN INFECTED HOLDING

I.

Preliminary cleaning and disinfecting

(a)

as soon as the carcases of the poultry have been

removed for disposal, those parts of the premises in

which the poultry was housed and any parts of other

buildings, yards etc. contaminated during slaughter or

post-mortem examination should be sprayed with

disinfectants approved for use in accordance with rule

11;

(b)

any tissue of poultry or eggs which could have

contaminated buildings, yards, utensils etc. should be

carefully collected and disposed of with the carcases;

(c)

the used disinfectant must remain on the surface for at

least twenty-four (24) hours.

II.

Final cleaning and disinfection

(a)

grease and dirt should be removed from all surfaces

by the application of a degreasing agent and washed

with water;

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(b)

after washing with water as described in paragraph

(a), further spraying with disinfectant should be

applied;

(c)

after seven (7) days the premises should be treated

with a degreasing agent, rinsed with cold water,

sprayed with disinfectant and rinsed again with

water;

(d)

used litter and manure must be treated by a method

capable of killing the virus. This method must

comprise at least one (1) of the following practices

(i) incineration or steam treatment at a temperature of

70°C;

(ii) burying deep enough to prevent access by vermin

and wild birds;

(iii) stacking and dampening (if necessary to facilitate

fermentation), covering to keep in the heat so

that a temperature of 20°C is attained and

leaving covered for forty-two (42) days so as to

prevent access by vermin and wild birds.

These rules do not apply where Newcastle disease is

detected in wild birds living freely. In such cases the competent

authority shall inform the Commission of any measure it takes.

(Rule 12)

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 one (1) day-old

chicks greater than 0,7.

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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 in paragraph (1) 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

10-20% w/v suspensions in the medium. The suspensions

should be left for about two (2) hours at ambient temperature

(or longer periods at 4°C) and then clarified by

centrifugation (e.g. 800 to 1,000g for 10 minutes).

3. Antibiotic medium

Different laboratories have used various formulations of

antibiotic medium with success and laboratories referred to

in the Fourth Schedule 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, 10mg/ml streptomycin, 0,25mg/ml

gentamycin and 5 000 units/ml mycostatin in phosphate

buffered saline (PBS). These levels can be reduced up to

five-fold for tissues and tracheal swabs. For control of

Chlamydia organisms, 50mg/ml oxytetracycline may be

added. It is imperative when making the medium that the pH

is checked after the addition of the antibiotics and readjusted

to pH 7,0-7,4.

NEWCASTLE DISEASE

CHAPTER 2

Virus isolation

Virus isolation in embryonated fowls' eggs

The clarified supernatent fluid should be inoculated in 0,1-

0,2ml amounts into the allantoic cavity of each of a

minimum of four (4) embryonated, fowls' eggs which have

been incubated for eight (8) to ten (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 (6) 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 hemagglutination is detected the presence of bacteria

should be excluded by culture. If bacteria are present the

fluids may be passed through a 450nm membrane filter,

further antibiotics added and inoculated into embryonated

eggs as above.

CHAPTER 3

Differential diagnosis

1. Preliminary differentiation

It is intended that all hemagglutinating viruses should be

submitted to the national laboratory referred to in the Fourth

Schedule 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

hemagglutinating fluids should, therefore, be used in an

hemagglutination inhibition test as described in Chapters 5

and 6. Positive inhibition i.e. 24, or more, with the

Newcastle disease virus specific polyclonal antiserum of

titre known to be at least 29 would serve as preliminary

identification enabling the imposition of interim control

measures.

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2. Confirmatory identification

The national laboratory should undertake full differential

diagnosis of any hemagglutinating agent. Confirmation of

Newcastle disease virus would again be by inhibition in

hemagglutination 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 monoclonal antibody techniques, has enabled

grouping of the strains and isolates. In particular, some

monoclonal antibodies are available which are specific for

the vaccinal strains used on the territory of the Union and can

be employed in simple hemagglutination 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 the Fourth Schedule is

obvious. Such monoclonal antibodies should be obtained by

the Union reference laboratory as referred to in rule 14 and

supplied to the national laboratories to enable confirmation

of the isolation of vaccinal viruses.

The national laboratories should submit all hemagglutinating

agents to the Union reference laboratory.

3. Further typing and characterization of isolates

The Union reference laboratory should receive all

hemagglutinating 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 Union 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

NEWCASTLE DISEASE

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. No 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 hemagglutination inhibition

test and the recommendation described below relates 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 Fourth Schedule.

(a) Samples

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) Examination for antibodies

Individual serum samples should be tested for their ability

to inhibit Newcastle disease virus hemagglutinating antigen

in standard hemagglutination inhibition tests as defined in

Chapter 6.

There is some debate as to whether 4 or 8 haemagglutinin

units should be used for the HI 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 24 or

greater and for 8 HAU, a positive serum is any showing a

titre of 23 or greater.

NEWCASTLE DISEASE

CHAPTER 5

Hemagglutination (HA) test

Reagents

1. Isotonic saline buffered with phosphate (PBS) (0,05 M) to

pH 7,0-7,4.

2. Red blood cells (RBC) taken and pooled from a minimum of

three (3) 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 (3) times in

PBS before use. For the test a 1% suspension (packed cell v/

v) in PBS is recommended.

3. NDV strain Ulster 2C is recommended for use as standard

antigen.

Procedure

(a)

Dispense 0,025 ml PBS into each well of a plastic

microtitre plate (V-bottomed wells should be used).

(b)

Place 0,025ml 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 0,025ml of 1% red blood cells to each well.

(f)

Mix by tapping gently and place at 4°C.

(g)

Plates are read 30 - 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 hemagglutination inhibition tests (see Chapter 6).

NEWCASTLE DISEASE

CHAPTER 6

Hemagglutination inhibition (HI) test

Reagents (see Chapter 5)

(a)

Phosphate buffered saline (PBS)

(b)

Virus-containing allantoic fluid diluted with PBS

to contain 4 or 8 HAU per 0,025ml.

(c)

1% chicken RBCs.

(d)

Negative control chicken serum.

(e)

Positive control serum.

Procedure

(a)

Dispense 0,025ml PBS into all wells of a plastic

microtitre plate (with V-bottomed wells).

(b)

Place 0,025ml of serum into first well of plate.

(c)

Use microtitration diluter to make two-fold dilutions

of serum across plate.

(d)

Add 0,025ml 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.

(f)

Add 0,025ml 1% RBCs to all wells.

(g)

Mix by gentle tapping and place at 4°C.

(h)

Plates are read after 30-40 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 PBCs (0,05 ml)

only.

(i)

The HI titre is the highest dilution of antiserum

causing complete inhibition of 4 or 8 units of virus

(an 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 23 for 4 HAU or 22 for 8 HAU

with the negative control serum and a titre of within

NEWCASTLE DISEASE

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-

bodies must not be used).

2. 0,05 ml of the diluted virus is injected intracerebrally into

each of ten (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 (number of birds)

Clinical

signs

Total

Score



14 X 0

=

Normal

Sick

20 X 1

=

Dead

46 X 2

=

Total

=

Index is a mean score per bird per observation = 112/80 = 1,4

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 10ꞏ7 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 5cm diameter Petri dishes.

3. 0,2 ml of each virus dilution is added to each of two Petri

NEWCASTLE DISEASE

dishes and the virus allowed to absorb 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 0,01mg/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.

(1)

When poultry in a holding are suspected of being

infected or contaminated with Newcastle disease, the official

veterinarian shall immediately activate official investigation

arrangements to confirm or rule out the presence of the disease and

shall, in particular, take necessary samples for laboratory examination.

(2)

As soon as the suspected infection is notified, the

competent authority shall place the holding under official surveillance

and shall, in particular, have the power to order that

(a)

a record be made of all categories of poultry on the

holding showing in respect of each of the categories the numbers

of poultry which have died, which show clinical signs, and

which show no signs. The record shall be kept up-to-date to

include birds born or dying during the period in which there is a

suspicion. The data in the record shall be kept up-to-date and be

produced on request, and may be checked at each visit;

(b)

all poultry on the holding are kept in their living

quarters or confined in some other place where they can be

isolated and without contact with other poultry;

NEWCASTLE DISEASE

(c)

no poultry enter or leave the holding;

(d)

all movement

(i)

of persons, other animals and vehicles to or

from the holding,

(ii)

of poultry meat or carcasses, or of animal

feed, implements, waste, droppings, manure litter or

anything liable to transmit Newcastle disease, be subject

to authorisation by the competent authority;

(e)

no eggs shall leave the holding with the exception

of eggs sent directly to an establishment approved for the

manufacture and/or processing of egg products (according to

lists drawn up by the competent authority) and transported

under an authorisation which has been granted by the

competent authority. Such authorisation must meet the

requirements laid down in the First Schedule;

(f)

appropriate means of disinfection be installed at

the entrances and exits of buildings housing poultry and of the

holding itself;

(g)

an epizootiological inquiry be carried out in

accordance with rule 7.

(3)

Until such time as the official measures laid down in sub-

rule (2) are enforced, the owner or keeper of any poultry in which

disease is suspected shall take all reasonable action to ensure

compliance with sub-rule (2) except for the epizootiological inquiry.

(4)

The competent authority may apply any of the measures

provided for in sub-rule (2) to other holdings should their location,

their configuration or contacts with the holding where the disease is

suspected give reason to suspect possible contamination.

(5)

The measures referred to in sub-rules (1) and (2) shall

not be withdrawn until the suspicion of Newcastle disease has been

ruled out by the official veterinarian.

(Rule 14)

LIST OF NATIONAL NEWCASTLE DISEASE

LABORATORIES

National Veterinary Laboratory

Abattoir Square

Malta

Albertown, Marsa

Malta MRS 1123

(1)

Once the presence of Newcastle disease in poultry

has been officially confirmed on a holding, the competent authority

shall have the power to order that the following measures be

undertaken

(a)

all poultry on the holding shall without delay be

killed on the spot and the poultry which have died or been

killed and all eggs shall be destroyed. These operations shall be

carried out in a way which minimises the risk of spreading

disease;

NEWCASTLE DISEASE

(b)

any substance or waste, such as animal feed, litter

or manures liable to be contaminated, shall be destroyed or

treated appropriately in accordance with instructions given by

the official veterinarian in order to ensure the destruction of any

Newcastle disease virus present;

(c)

where poultry from the holding have been

slaughtered during the presumed incubation period of disease

the meat from those poultry shall wherever possible be traced

and destroyed;

(d)

hatching eggs laid during the presumed incubation

period which have been moved from the holding shall be traced

and destroyed; but poultry which have already hatched from the

eggs shall be placed under official surveillance; table eggs laid

during the presumed incubation period which have been moved

from the holding shall wherever possible be traced and

destroyed, unless they have previously been properly

disinfected;

(e)

after carrying out operations listed under

paragraphs (a) and (b), the buildings used for housing poultry,

their surroundings, the vehicles used for transport and all

equipment likely to be contaminated shall be cleaned and

disinfected in accordance with the provisions of rule 11;

(f)

no poultry shall be introduced to the holding until

at least twenty-one (21) days after completion of operations

provided for under paragraph (e);

(g)

an epizootiological inquiry shall be carried out in

accordance with rule 7.

(2)

The competent authority may extend the measures

provided for in sub-rule (1) to other neighbouring holdings should their

location, their configuration, or contact with the holding where the

disease has been confirmed give reason to suspect possible

contamination.

(3)

Where a strain of Newcastle disease virus with an ICPI

(intracerebral pathogenicity index) greater than 0,7 and lower than 1,2

is isolated in a flock of poultry that presents no clinical signs of

Newcastle disease and it has been demonstrated by the European Union

reference laboratory referred to in rule 15 that the virus isolate in

question derives from an attenuated live Newcastle disease vaccine, the

competent authority may grant a derogation from the requirements

under paragraphs (a) to (f) of sub-rule (1), provided that the holding

concerned is placed under official surveillance for thirty (30) days and

must require in particular that

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(a)

the provisions of rule 4(2) (a), (b), (d), (e), and (f)

are applied;

(b)

no poultry may leave the holding except to be

taken directly to a slaughterhouse designated by the competent

authority.

(4)

The competent authority responsible for this

slaughterhouse must be informed of the intention to send poultry there

for slaughter and as soon as the poultry arrive at the slaughterhouse

they shall be kept and slaughtered separately from other poultry.

(5)

Fresh meat from the poultry referred to in sub-rule (3)

must carry the identification mark applied in accordance with Annex

II, Section I of Regulation (EC) 853/2004.

(6)

The provisions laid down in sub-rule (3) shall be subject

to a review taking into account developments in scientific research

with a view to adopting harmonised rules for the use of Newcastle

disease vaccines in the Member States.

In the case of holdings which consist of two (2) or more

separate flocks, the competent authority may, in accordance with

criteria set by the Commission under the procedure laid down in

Article 5 of Regulation (EU) No 182/2011, grant a derogation from the

requirements of rule 5 for healthy flocks of a holding which is

infected, provided that the official veterinarian has confirmed that the

operations carried out there are such that the flocks are completely

separate as regards housing, keeping and feeding, so that the virus

cannot spread from one flock to another.

The epizootiological inquiry shall deal with

(a)

the length of time during which Newcastle disease

may have existed on the holding or in the pigeon house;

(b)

the possible origin of the Newcastle disease on the

holding or in the pigeon house and the identification of other

holdings or pigeon houses in which there are poultry, pigeons or

other birds kept in captivity which may have become infected

or contaminated from the same source;

(c)

the movement of persons, poultry, pigeons or

other birds kept in captivity or other animals, vehicles, eggs,

meat and carcases and any implement or substance likely to

have carried Newcastle disease virus to or from the holding or

pigeon house in question.

The crisis unit shall provide full coordination of all

measures necessary to ensure the eradication of Newcastle disease as

quickly as possible and to carry out the epizootiological inquiry.

NEWCASTLE DISEASE

(1)

Where the official veterinarian has reason to

suspect that poultry on any holding may have been contaminated as a

result of the movement of persons, animals or vehicles or in any other

way, that holding shall be placed under official control in accordance

with sub-rule (2).

(2)

The purpose of the official control shall be to detect

immediately any suspicion of Newcastle disease, count the poultry and

monitor their movements and, where appropriate, to take the action

provided for in sub-rule (3).

(3)

When a holding is subject to official control under sub-

rules (1) and (2), the competent authority shall prohibit removal of

poultry from the holding other than for transport directly to a

slaughterhouse under official supervision for the purpose of immediate

slaughter. Before granting such authorisation, the official veterinarian

must have carried out a clinical examination of all the poultry to

exclude presence of Newcastle disease on the holding. The movement

restrictions referred to in this rule shall be imposed for a period of

twenty-one (21) days from the latest date of potential contamination;

however, such restrictions must apply for a period of at least seven (7)

days.

(4)

Where it considers that conditions permit, the competent

authority may limit the measures provided for in this rule to a part of

the holding and to the poultry contained therein, provided that the

poultry there have been housed, kept and fed completely separately by

separate staff.

(5)

Where the official veterinarian has reason to suspect

racing pigeons or any pigeon house of being contaminated by the

Newcastle disease virus, he shall take all appropriate steps to ensure

that the pigeon house is subject to restrictions, including a ban on all

movement of racing pigeons outside the pigeon house for twenty-one

(21) days.

(1)

Once the diagnosis of Newcastle disease has been

officially confirmed in poultry, the competent authority shall establish

around the infected holding a protection zone based on a minimum

radius of three (3) kilometres, itself contained in a surveillance zone

based on a minimum radius of ten (10) kilometres. The establishment

of zones must take account of geographical, administrative, ecological

and epizootiological factors relating to Newcastle disease, and of

monitoring facilities.

(2)

The measures applied in the protection zone shall include

(a)

the identification of all holdings having poultry

within the zone;

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(b)

periodic visits to all the holdings having poultry, a

clinical examination of those poultry including, if necessary,

the collection of samples for laboratory examination; a record

of visits and findings must be kept;

(c)

the keeping of all poultry in their living quarters

or some other place where they can be isolated;

(d)

the use of appropriate means of disinfection at the

entrances and exits of the holding;

(e)

the control of movements or persons handling

poultry, poultry carcasses and eggs and vehicles carrying

poultry, carcasses and eggs within the zone; in general,

transport of poultry shall be prohibited;

(f)

a prohibition on removing poultry and hatching

eggs from the holding on which they are kept unless the

competent authority has authorised the transport

(i)

of poultry for immediate slaughter to a

slaughterhouse preferably located in the infected area or,

if that is not possible, to a slaughterhouse designated by

the competent authority outside the infected area;

(ii)

of one (1) day-old chicks or ready-to-lay

pullets to a holding within the surveillance zone at which

there are no other poultry. However, the competent

authority, may give authorisation for the said one (1)

day-old chicks and pullets to be transported to a holding

outside the surveillance zone. The holdings referred to

above shall be placed under official control in

accordance with rule 9(2);

(iii) of hatching eggs to a hatchery designated

by the competent authority; before dispatch, eggs and

their packing must be disinfected

Provided that movements allowed under

sub-paragraphs (i), (ii) and (iii) shall be directly

executed, under official control. They shall be authorised

only after the official veterinarian has carried out a health

inspection of the holding. The means of transport used

must be cleaned and disinfected before and after use;

(g)

a prohibition on removing or spreading used litter

or poultry manure without authorisation;

(h)

the prohibition of fairs, markets, shows or other

gatherings of poultry or other birds.

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(3)

The measures applied in the protection zone shall be

maintained for at least twenty-one (21) days after the carrying out of

preliminary cleaning and disinfection operations on the infected

holding in accordance with rule 11. The protection zone shall thereafter

be part of the surveillance zone.

(4)

The measures applied in the surveillance zone shall

include

(a)

the identification of all holdings having poultry

within the zone;

(b)

the control of poultry and hatching egg movement

within the zone;

(c)

a prohibition on the movement of poultry out of

the zone during the first fifteen (15) days, except for movement

directly to a slaughterhouse outside the surveillance zone

designated by the competent authority;

(d)

a prohibition on the movement of hatching eggs

out of the surveillance zone unless to a hatchery designated by

the competent authority. Before dispatch the eggs and their

packing must be disinfected;

(e)

a prohibition on the movement of used litter or

poultry manure out of the zone;

(f)

a prohibition of fairs, markets, shows or other

gatherings of poultry and other birds;

(g)

without prejudice to the provisions of paragraphs

(a) and (b), the prohibition of transport of poultry.

(5)

The measures applied in the surveillance zone shall be

maintained for at least thirty (30) days after the carrying out of

preliminary cleaning and disinfection operations on the infected

holding in accordance with rule 11.

(6)

Where the epizootiological enquiry referred to in rule 7

confirms that the outbreak is due to an infection where there is no

evidence of lateral spread, the size and duration of the protection and

surveillance zones may be reduced under the procedure laid down in

Article 5 of Regulation (EU) No 182/2011.

The competent authority has the power to;

(a)

determine the arrangements allowing it to trace the

movement of eggs, poultry and birds kept in captivity;

(b)

request the owner or keeper of poultry and/or

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racing pigeons and/or birds kept in captivity to supply

information concerning poultry and eggs entering or leaving his

holding, as well as information on the races or shows in which

the racing pigeons have taken part;

(c)

request all persons engaged in the transport or

marketing of poultry, eggs, racing pigeons and birds kept in

captivity to supply information concerning the movements of

poultry, eggs, racing pigeons and birds kept in captivity which

they have transported or marketed and to furnish all the details

concerning such information;

(d)

approve the disinfectants to be used and their

concentrations;

(e)

ensure that the cleaning and disinfection

operations are carried out under official supervision in

accordance with instructions given by the official veterinarian

and the procedure for cleaning and disinfecting an infected

holding, as laid down in the Second Schedule.

The collection of samples and laboratory testing to detect

the presence of Newcastle disease virus shall be carried out in

accordance with the Third Schedule.

The competent authority shall take all the necessary

measures for persons established in the protection and surveillance

zones to be informed of the restrictions in force and shall make all

necessary arrangements for the adequate implementation of the

measures in question.

(1)

The National Veterinary Laboratory shall

maintain facilities and expert personnel to permit full antigenic and

biological typing of Newcastle disease virus at all times.

(2)

Vaccines allowed for prophylactic use or stock-piled for

emergency use may be tested for efficacy, potency and purity at the

National Veterinary Laboratory.

(3)

The national laboratories listed in the Fourth Schedule

shall be responsible for coordinating standards and methods of

diagnosis, use of reagents and testing of vaccines.

(4)

The national laboratories listed in the Fourth Schedule

shall be responsible for co-ordinating the standards and diagnostic

methods laid down in each Newcastle disease diagnostic laboratory

within Malta and Gozo. To this end

(a)

they may provide diagnostic reagents to national

laboratories;

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(b)

they shall control the quality of all diagnostic

reagents used;

(c)

they shall arrange comparative tests periodically;

(d)

they shall hold isolates of Newcastle disease virus

from cases confirmed;

(e)

they shall ensure the confirmation of positive

results obtained in regional diagnostic laboratories.

(5)

The national laboratories listed in the Fourth Schedule

shall liaise with the European Union reference laboratory referred to in

rule 15.

(1)

The European Union reference laboratory referred

to in sub-rule (5) of rule 14 shall have the following functions and

duties

(a)

to coordinate, in consultation with the

Commission, the methods employed in the Member States for

diagnosing Newcastle disease, specifically by

(i)

typing, storing and supplying strains of

Newcastle disease virus for serological tests and the

preparation of antisera;

(ii)

supplying standard sera and other reference

reagents to the national reference laboratories in order to

standardise the tests and reagents used in the Member

States;

(iii) building up and retaining a collection of

Newcastle disease virus strains and isolates;

(iv) organising periodical comparative tests of

diagnostic procedures at Union level;

(v)

collecting and collating data and

information on the methods of diagnosis used and the

results of tests carried out in the Union;

(vi) characterising isolates of Newcastle disease

viruses by the most up-to-date methods available to

promote a greater understanding of the epidemiology of

Newcastle disease;

(vii) keeping abreast of developments in

Newcastle disease surveillance, epidemiology and

prevention throughout the world;

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(viii) retaining expertise on Newcastle disease

virus and other pertinent viruses to enable a rapid

differential diagnosis;

(ix) acquiring a thorough knowledge of the

preparation and use of the products of veterinary

immunology used to eradicate and control Newcastle

disease;

(b)

to actively assist in the diagnosis of outbreaks of

Newcastle disease in Member States by receiving virus isolates

for confirmatory diagnosis, characterisation and epidemiology

studies;

(c)

to facilitate the training or retraining of experts in

laboratory diagnosis with a view to the harmonisation of

techniques throughout the Union.

(2)

The designation of the European Union reference

laboratory for Newcastle disease referred to in Annex V to Directive

92/66/EEC, shall remain effective until a European Union reference

laboratory for Newcastle disease has been duly designated in

accordance with Article 15 of Directive 92/66/EEC, as substituted by

Directive (EU) 2018/597 of the European Parliament and of the

Council of 18 April 2018.

(1)

Vaccination against Newcastle disease authorised

by the competent authority may be used for a prophylactic purpose or

to supplement the control measures carried out when the disease

appears.

(2)

The only vaccines allowed are those which have received

a marketing authorisation from the competent authority.

(3)

Further criteria for using vaccines against Newcastle

disease may be established in accordance with the procedure laid down

in Article 5 of Regulation (EU) No 182/2011.

(4)

The competent authority shall inform the Commission

when voluntary or compulsory prophylactic vaccination against

Newcastle disease is carried out.

(5)

The information given in accordance with sub-rule (4)

must specify

(a)

the characteristics and composition of the vaccine

to be used;

(b)

the procedures for supervision of the distribution,

storage and use of vaccines;

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(c)

the species and categories of poultry which may or

shall be subject to vaccination;

(d)

the areas in which vaccination may or shall be

carried out;

(e)

the reasons for which vaccination is carried out.

(6)

The competent authority may provide for the

establishment of a vaccination programme for racing pigeons. Where

this is the case, the competent authority shall inform the Commission.

Without prejudice to such a programme, the competent authority shall

ensure that the organisers of races and shows take the necessary steps

so that only racing pigeons which have been vaccinated against

Newcastle disease may be entered in races and shows.

(1)

When Newcastle disease has been confirmed, the

competent authority, in order to supplement the other control measures

provided for in these rules, has the power to specify a territorial area

and period in which the prompt and systematic vaccination (emergency

vaccination) of designated species of poultry shall be carried out under

official control. The competent authority shall inform the Commission

and other Member States within the framework of the Standing

Committee on Plants, Animals, Food and Feed (PAFF Committee),

established by Article 58(1) of Regulation (EC) No 178/2002, about the

Newcastle disease situation and emergency vaccination programme.

(2)

In the case referred to in sub-rule (1), the vaccination or

re-vaccination of poultry on the holding subject to the restrictions

referred to in rule 4 is prohibited.

(3)

In the case referred to in sub-rule (1)

(a)

the designated species of poultry shall be

vaccinated as soon as possible;

(b)

all poultry of designated species born on or

transferred to a holding inside the vaccination area must be or

have been vaccinated;

(c)

throughout the vaccination operation provided for

in sub-rule (1) all poultry of designated species kept on holdings

inside the vaccination area must remain there except

(i)

one (1) day-old chicks moved to a holding

inside the vaccination area where they shall be

vaccinated;

(ii)

poultry moved directly to a slaughterhouse

for immediate slaughter. If the slaughterhouse is located

outside the vaccination area the movement of poultry

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shall be permitted only after the official veterinarian has

carried out a health inspection of the holding;

(d)

when the vaccination operations provided for in

paragraph (a) have been completed, movements out of the

vaccination area may be authorised for

(i)

one (1) day-old chicks intended for meat

production may be moved to a holding where they shall

be vaccinated; the holding in question must be kept under

surveillance until the poultry which have been moved

have been slaughtered;

(ii)

poultry vaccinated more than twenty-one

(21) days previously and intended for immediate

slaughter;

(iii) hatching eggs which originate from

breeding poultry vaccinated at least twenty-one (21) days

previously; the eggs and their packing must be

disinfected before movement.

(4)

The measures provided for in paragraphs (b) and (d) of

sub-rule (3) shall be applied for a period of three (3) months following

completion of vaccination operations provided for in sub-rule (1); they

may be extended for one or more additional periods of three (3)

months.

(5)

By way of derogation from paragraphs (a) and (b) of sub-

rule (3), the competent authorities may exempt certain flocks of

particular scientific value from systematic vaccination, provided that

all necessary steps are taken by the competent authority to ensure

protection of their health and to subject them to periodic serological

checks.

(1)

Where carrier pigeons or birds kept in captivity

are suspected of being infected with Newcastle disease, the official

veterinarian will immediately start the official investigation

procedures for confirming or notifying the presence of the disease; in

particular he shall take adequate samples for laboratory examination or

see that they are taken.

(2)

As soon as it has been notified of the suspicion, the

competent authority shall place the holding or pigeon house under

official surveillance and order that no pigeon or bird kept in captivity,

and nothing likely to transmit Newcastle disease, may leave the pigeon

house or holding.

(3)

The measures provided for in sub-rules (1) and (2) shall

not be withdrawn until the suspicion of Newcastle disease has been

ruled out by the official veterinarian.

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(4)

As soon as the presence of Newcastle disease has been

officially confirmed, the competent authority shall, inter alia, order

(a)

application of the control and eradication measures

provided for in rule 5(1)(a), (b), (e) and (f) to the carrier pigeons

or birds kept in captivity and pigeon houses infected with

Newcastle disease; or

(b)

at least

(i)

a ban on movement of the pigeons or birds

kept in captivity outside the pigeon house or holding for

at least sixty (60) days after the clinical signs of

Newcastle disease have disappeared;

(ii)

destruction or treatment of any matter or

waste likely to be contaminated. Treatment must

guarantee the destruction of any Newcastle disease virus

present and all waste that has accumulated during the

sixty-day (60) period referred to in sub-paragraph (i);

(c)

an epizootiological inquiry in accordance with rule

7. (5)

To the extent that it is required for the proper application

of the measures laid down in this rule, the competent authority shall

submit to the Commission, within the Standing Committee on Plants,

Animals, Food and Feed, information on the disease situation and the

control measures applied.

(1)

The use of swill originating from means of

international transport, such as ships, land vehicles or aircraft, shall be

prohibited for the feeding of poultry; such swill shall be collected and

destroyed under official supervision.

(2)

The use of swill other than as defined in sub-rule (1), or

poultry scraps, may be authorised for the feeding of poultry only after a

heat-treatment in appropriate facilities ensuring that the disease is not

transmitted and the Newcastle disease virus is destroyed.

(1)

The competent authority shall draw up a

contingency plan, specifying the national measures to be implemented

in the event of an outbreak of Newcastle disease. The contingency plan

shall be updated, as appropriate, to take account of developments in the

situation.

(2)

The contingency plan shall allow access to facilities,

equipment, personnel and all other appropriate materials necessary for

the rapid and efficient eradication of the outbreak of Newcastle disease.

It shall give a precise indication of the vaccine requirements which the

competent authority deems necessary for emergency vaccination.

NEWCASTLE DISEASE

(3)

The contingency plans and any updates thereto shall be

submitted to the Commission, which shall approve or if necessary

amend them in accordance with the examination procedure referred to

in Article 5 of Regulation (EU) No 182/2011.

Commission experts may, in collaboration with the

competent authority, make on-the-spot checks. In order to do this, they

may check a representative percentage of establishments to see

whether the competent authority is checking that these establishments

are fulfilling the requirements of the Directive. The Commission shall

inform the competent authority of the result of the checks carried out.

The competent authority shall give all the necessary assistance to the

experts in carrying out their duties.

The general provisions for implementing these rules shall be

determined in accordance with the procedure laid down in Article 5 of

Regulation (EU) No 182/2011.