Newcastle Disease Rules, 2019

L.N. 80 of 2019

VETERINARY SERVICES ACT

(CAP. 437)

Measures for the Control of

Newcastle Disease Rules, 2019

IN EXERCISE of the powers conferred by article 5(1) and (2) of

the Veterinary Services Act, the Minister for the Environment,

Sustainable Development and Climate Change, in conjunction with the

Parliamentary Secretary for Agriculture, Fisheries and Animal Rights

has made the following rules

(1) The title of these rules is Measures for the Control of

Newcastle Disease Rules, 2019.

(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 5)

PROCEDURE FOR CLEANING AND DISINFECTING

AN INFECTED HOLDING

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.

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;

(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.

(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;

"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 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.

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.

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.

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 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.

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).

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 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)

Total

Score

14 X 0

=

20 X 1

=

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 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 5cm diameter Petri dishes.

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

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.

These rules do not apply where Newcastle disease is Non-

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

authority shall inform the Commission of any measure it takes.

(Rule 14)

LIST OF NATIONAL NEWCASTLE DISEASE

LABORATORIES

National Veterinary Laboratory

Abattoir Square

Malta

Albertown, Marsa

Malta MRS 1123

B

€2.43

(1) When poultry in a holding are suspected of being Notification

infected or contaminated with Newcastle disease, the official requirements.

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;

(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.

(Regola 14)

LISTA TA’ LABORATORJI NAZZJONALI GĦALL-MARDA

NEWCASTLE

Laboratorju Veterinarju Nazzjonali

Abattoir Square

Malta

Albertown, Marsa

Malta MRS 1123

(1) Once the presence of Newcastle disease in poultry Procedures.

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;

(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

(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

Procedure for

the

epizootiological

(a) the length of time during which Newcastle disease

inquiry.

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 The crisis unit.

measures necessary to ensure the eradication of Newcastle disease as

quickly as possible and to carry out the epizootiological inquiry.

(1) Where the official veterinarian has reason to suspect Holdings placed

that poultry on any holding may have been contaminated as a result of under

control.

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;

(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.

(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

(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 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 Samples and

the presence of Newcastle disease virus shall be carried out in laboratory

testing.

accordance with the Third Schedule.

The competent authority shall take all the necessary Information

measures for persons established in the protection and surveillance requirements.

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 National

facilities and expert personnel to permit full antigenic and biological Laboratory.

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;

(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 The European

in sub-rule (5) of rule 14 shall have the following functions and duties: Union

laboratory.

(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;

(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 Vaccination

the competent authority may be used for a prophylactic purpose or to requirements.

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;

(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 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 Investigation

suspected of being infected with Newcastle disease, the official Procedures.

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.

(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

The use of swill.

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.

(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 On-the-spot

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

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.

Legal Notice 367 of 2018 is hereby repealed.

Repeal of Legal

Notice 367 of

2018. FIRST SCHEDULE

(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

(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.