Newcastle Disease Regulations, 2018

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,083, 6 ta’ Novembru, 2018

L.N. 367 of 2018

VETERINARY SERVICES ACT

(CAP. 437)

Community Measures for the Control of

Newcastle Disease Regulations, 2018

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 regulations

(1) The title of these regulations is the Community Citation and

scope.

Measures for the Control of Newcastle Disease Regulations, 2018.

(2) These regulations shall come into force on such date as the

Minister responsible for the Environment, Sustainable Development and

Climate Change may by notice in the Gazette appoint, and different

dates may be so appointed for different provisions and different

purposes of these regulations.

(3) The scope of these regulations 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 18thApril 2018.

(4) These regulations 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.

AUTHORIZATION TO REMOVE EGGS FROM A HOLDING

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

The authorization issued by the competent authority to transport eggs

from a suspect holding subject to the provisions of regulation 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 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 that

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 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 regulations unless the context otherwise Interpretation.

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 regulation 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; and

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

appropriate, from industries using meat;

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 regulation

11 of these regulations.

(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 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 (a), further spraying

with disinfectant should be applied.

(c)

After seven 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 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 42

days so as to prevent access by vermin and wild birds.

These regulations 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.

DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION

AND DIFFERENTIAL DIAGNOSIS OF NEWCASTLE DISEASE

The following procedures for the isolation and characterization of

Newcastle-disease viruses should be regarded as guidelines and the

minima to be applied in the diagnosis of the disease.

The virus responsible for Newcastle disease is the prototype virus of the

Paramyxoviridae. At present, there are nine serologically distinguishable

groups of Avian Paramyxoviruses, which have been designated PMV-1

to PMV-9. All Newcastle disease viruses are placed in the PMV-1 group.

For the purpose of the diagnostic procedures for the confirmation and

differential diagnosis of Newcastle disease the following definition shall

apply

'Newcastle disease' means an infection of poultry caused by any avian

strain of the paramyxovirus 1 with an intracerebral pathogenicity index

(ICPI) in day-old chicks greater than 0,7.

CHAPTER 1

Sampling and treatment of samples

1. Samples

Cloacal swabs (or faeces) and tracheal swabs from sick birds; faeces or

intestinal contents, brain tissue, trachea, lungs, liver, spleen and other

obviously affected organs from recently dead birds.

2. Treatment of samples

The organs and tissues listed 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 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 Schedule II will be

able to offer advice for a particular country. High concentrations of

antibiotics are required for faeces samples and a typical mixture is: 10

000 units/ml penicillin, 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 embryonated, fowls'

eggs which have been incubated for 8 to 10 days. Ideally, these eggs should

be obtained from a specific pathogen-free flock, but when this is

impracticable it is acceptable to use eggs obtained from a flock shown to be

free of antibodies to Newcastle-disease virus. The inoculated eggs are held

at 37°C and candled daily. Eggs with dead or dying embryos as they arise,

and all remaining eggs six days after inoculation should be chilled to 4°C

and the allantoic-amniotic fluids tested for haemagglutination activity. If no

haemagglutination is detected the above procedure is repeated using

undiluted allantoic/ amniotic fluid as inoculum.

When hemagglutination is detected the presence of bacteria should be

excluded by culture. If bacteria are present the fluids may be passed through

a 450 nm membrane filter, further antibiotics added and inoculated into

embryonated eggs as above.

CHAPTER 3

Differential diagnosis

1. Preliminary differentiation

It is intended that all hemagglutinating viruses should be submitted to the

national laboratory referred to in Schedule II for full identification,

characterization and pathogenicity tests. However, it is important that

interim control measures for Newcastle disease aimed at limiting the spread

of the virus should be implemented as soon as possible and regional

laboratories should be able to identify the presence of Newcastle disease

virus. The hemagglutinating fluids should, therefore, be used in an

hemagglutination inhibition test as described in Chapters 5 and 6. Positive

inhibition 1. 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 Community 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 Schedule II is obvious. Such monoclonal antibodies should be obtained

by the Community reference laboratory as referred to in regulation 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

Community reference laboratory.

3. Further typing and characterization of isolates

The Community 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 Community in keeping with the functions and duties of

the reference laboratory.

CHAPTER 4

Rapid tests for detection of Newcastle-disease virus and antibodies

Rapid tests for the detection of Newcastle disease virus in vaccinated birds

and the detection of antibodies in unvaccinated birds are outlined below

1. Detection of Newcastle disease virus

Several rapid test 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 relate to this test for the measurement

of antibodies to the virus. However, enzyme-linked immunosorbent

assays (Elisa) may be successfully used to detect antibodies to the virus.

It is suggested that if there is a wish to employ an Elisa test at regional

laboratory level the test should be monitored by the national laboratory

referred to in Schedule II.

(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

specific pathogen free chickens (if not available blood may be taken

from birds regularly monitored and shown to be free of NDV antibodies)

into an equal volume of Alsever's solution. Cells should be washed three

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

in PBS is recommended.

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-bonomed 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 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.

(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

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

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

-

of persons, other animals and vehicles to or from

the holding,

-

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

Schedule I;

(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 regulation 7.

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

regulation (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-regulation (2) except for the epizootiological

inquiry;

(4) The competent authority may apply any of the measures

provided for in sub-regulation (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-regulation (1) and sub-

regulation (2) shall not be withdrawn until the suspicion of Newcastle

disease has been ruled out by the official veterinarian.

LIST OF NATIONAL NEWCASTLE DISEASE LABORATORIES

Malta

National Veterinary Laboratory

Abattoir Square

Albertown, Marsa

Malta MRS 1123

€1.08

(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;

(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 regulation 11;

(f) no poultry shall be introduced to the holding until at

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

for under (e);

(g) an epizootiological inquiry shall be carried out in

accordance with regulation 7.

(2) The competent authority may extend the measures provided

for in sub-regulation (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 regulation 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-regulation (1), provided that the

holding concerned is placed under official surveillance for thirty (30)

days and must require in particular that

-

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

(f) are applied;

-

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-regulation (3)

of this regulation must carry the identification mark applied in

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

(6) The provisions laid down in sub-regulation (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 or more separate Derogation.

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 regulation 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.

(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-

regulation (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-regulation (3).

(3) When a holding is subject to official control under sub-

regulations (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 regulation 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 regulation 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 Measures to be

officially confirmed in poultry, the competent authority shall establish taken.

around the infected holding a protection zone based on a minimum

radius of three kilometres, itself contained in a surveillance zone based

on a minimum radius of ten 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 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 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 regulation 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 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 regulation 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 regulation 11.

(6) Where the epizootiological enquiry referred to in regulation

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;

Powers of the

competent

authority.

(i) determine the arrangements allowing it to trace

the movement of eggs, poultry and birds kept in captivity;

(ii) 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;

(iii) 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.;

(iv) approve the disinfectants to be used and their

concentrations;

(v) 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 Schedule II.

The collection of samples and laboratory testing to detect the Samples and

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

testing.

with Schedule III.

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 implementation of the measures in

question.

(1) The National Veterinary Laboratory (NVL) in Malta

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 Schedule IV shall be

responsible for coordinating standards and methods of diagnosis, use of

reagents and testing of vaccines.

(4) The national laboratories listed in Schedule IV 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 Schedule IV shall liaise

with the European Union reference laboratory referred to in regulation

15. (1) The European Union reference laboratory referred to

in sub-regulation (5) of regulation 14 shall have the following functions

and duties

(i) to coordinate, in consultation with the Commission,

the methods employed in the Member States for diagnosing

Newcastle disease, specifically by

(a) typing, storing and supplying strains of

Newcastle disease virus for serological tests and the

preparation of antisera;

(b) 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;

(c) building up and retaining a collection of

Newcastle disease virus strains and isolates;

(d) organising periodical comparative tests of

diagnostic procedures at Union level;

(e) collecting and collating data and information on

the methods of diagnosis used and the results of tests carried

out in the Union;

(f) 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;

(g) keeping abreast of developments in Newcastle

disease surveillance, epidemiology and prevention

throughout the world;

(h) retaining expertise on Newcastle disease virus

and other pertinent viruses to enable a rapid differential

diagnosis;

(i) acquiring a thorough knowledge of the

preparation and use of the products of veterinary

immunology used to eradicate and control Newcastle

disease;

(ii) 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;

(iii) 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 Schedule 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.

(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-regulation (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 Regulations 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-regulation (1), the vaccination

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

referred to in Article 5 is prohibited.

(3)

In the case referred to in sub-regulation (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-regulation (1) all poultry of designated species kept on

holdings inside the vaccination area must remain there except

(i) day-old chicks moved to a holding inside the

vaccination area where they shall be vaccinated;

(ii) poultry moved direct 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) 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-

regulation (3) shall be applied for a period of three (3) months following

completion of vaccination operations provided for in sub-regulation (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-

regulation (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-regulations (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 regulation 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

regulation 7.

(5) To the extent that it is required for the proper application of

the measures laid down in this regulation, 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-regulation (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 Drawing up of a

plan, specifying the national measures to be implemented in the event of contingency

plan.

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 this regulation shall be

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

Regulation (EU) No 182/2011.