Measures for the Control of Avian Influenza Rules , 2008

L.N. 88 of 2008

VETERINARY SERVICES ACT

(CAP. 437)

Measures for the Control of Avian Influenza Rules , 2008

IN exercise of the powers conferred by article 5 of the Veterinary

Services Act, 2001, the Minister for Rural Affairs and the Environment

has made the following rules>-

(1) The title of these rules is Measures for the Control of Title and Scope.

Avian Influenza Rules, 2008.

(2) The scope of the rules is to transpose Council Directive

2005#94#EC of 20 th December ,2005 on Community measures for the

control of avian influenza and repealing Directive 92#40#EEC.

Subject matter and

(1) These Rules set out>

(referred to in Rule 3)

Definition of avian influenza

1. ‘avian influenza’ means an infection of poultry or other captive birds caused by any

influenza A virus

(a) of the subtypes H5 or H7; or

(b) with an intravenous pathogenicity index (IVPI) in six-week old chickens greater than

1.2;

2. ‘highly pathogenic avian influenza (HPAI)’ means an infection of poultry or other

captive birds caused by

(a) avian influenza viruses of the subtypes H5 or H7 with genome sequences codifying

for multiple basic amino acids at the cleavage site of the haemagglutinin molecule similar

to that observed for other HPAI viruses, indicating that the haemagglutinin molecule can

be cleaved by a host ubiquitous protease; or

(b) avian influenza viruses with an intravenous pathogenicity index in six-week old

chickens greater than 1.2;2;

3. ‘low pathogenic avian influenza (LPAI)’ means an infection of poultry or other captive

birds caused by avian influenza viruses of subtypes H5 or H7 that do not come within the

definition in sub-Rule 2.

B

scope.

(a) certain preventive measures relating to the surveillance

and the early detection of avian influenza and increasing the level

of the competent authorities’ and the farming community’s

awareness of, and preparation for, the risks of that disease<

(b) the minimum control measures to be applied in the event

of an outbreak of avian influenza in poultry or other captive birds

and the early detection of possible spread of avian influenza viruses

to mammals<

(c) other subsidiary measures to avoid the spread of

influenza viruses of avian origin to other species.

(2) Malta shall remain free to take more stringent measures

in the field covered by these Rules.

CHAPTER I

DEFINITIONS

(referred to in Rule 6(2)

Notification of disease and further epidemiological information to be provided by

Member States

1. Within 24 hours of the confirmation of any primary outbreak or detection of avian

influenza in a slaughterhouse or means of transport, the Malta shall notify in accordance

with the procedure referred to in Rule 5 of Directive 82/894/EEC

(a) the date of notification;

(b) the time of notification;

(c) the name of the country;

(d) the name of the disease;

(e) the number of the outbreak or positive finding of avian influenza in a slaughterhouse

or means of transport;

(f) the date on which the disease was first suspected;

(g) the date of confirmation;

(h) the methods used for confirmation;

(i) whether the disease has been confirmed in a holding, slaughterhouse or means of

transport;

(j) the geographical location of the outbreak or positive finding of avian influenza in a

slaughterhouse or means of transport;

(k) the disease control measures applied.

2. In the case of positive findings for avian influenza in slaughterhouses or means of

transport, Malta must forward the following information in addition to the data referred to

in sub-Rule 1

(a) the estimated number, by category, of susceptible poultry or other captive birds in the

slaughterhouse or means of transport;

(b) the estimated number, by category, of dead poultry or other captive birds in the

slaughterhouse or means of transport;

(c) for each of the categories of poultry or other captive birds, the identified morbidity

and the estimated number of poultry or other captive birds in which avian influenza has

been confirmed;

(d) the estimated number of poultry or other captive birds killed or slaughtered in the

slaughterhouse or means of transport;

(e) the estimated number of poultry or other captive birds disposed of;

(f) in the case of a slaughterhouse, the distance from the nearest commercial holding

containing poultry or other captive birds;

(g) the location of the holding or holdings of origin of the infected poultry or carcases.

3. In the case of secondary outbreaks, the information referred to in sub-rules 1 and 2

must be forwarded within the time-limits laid down in Rule 4(1) of Directive

82/894/EEC.

B

4. Malta shall ensure that the information to be provided in accordance with sub-rules 1,

2 and 3, in relation to any outbreak or positive finding of avian influenza in a

slaughterhouse or means of transport is followed as soon as possible by a written report

to the Commission and the other Malta including at least

(a) the date on which the poultry or other captive birds on the holding, slaughterhouse or

means of transport were killed or slaughtered and their carcases disposed of;

(b) any information relating to the possible origin of avian influenza or, if ascertained, its

actual origin;

(c) information on the control system established to ensure that the measures in place for

the control of animal movements are effectively implemented;

(d) in the case of detection of avian influenza in a slaughterhouse or means of transport,

the genetic type of virus responsible;

(e) where poultry or other captive birds have been killed or slaughtered in contact

holdings or in holdings containing poultry or other captive birds suspected of being

infected with avian influenza virus, information on

(i) the date of killing or slaughtering and the estimated number of poultry or other captive

birds of each category killed or slaughtered in each holding;

(ii) the epidemiological link between the source of infection and each contact holding or

the other reasons that have given rise to the suspicion that avian influenza is present;

(iii) where poultry or other captive birds in contact holdings have not been killed or

slaughtered, information must be provided concerning the reasons for the decision not to

kill or slaughter them.

(5) In the case of confirmation of avian influenza in live poultry, other captive birds or

poultry products being imported or introduced at Community borders, in border

inspection posts or in quarantine facilities or centres operating in accordance with

Community legislation on imports, the competent authority must notify this confirmation

to the Commission without delay and report on the measures taken.

(6) The Commission and the other Member State must be notified within 24 hours where

a serious threat to health is identified as a result of any surveillance.

B

For the purposes of these Rules , the following definitions Definitions.

shall apply>

“avian influenza” means any of the influenza infections so

described in Schedule I(1)<

“carcase” means poultry or other captive birds which have

died or have been killed and are unfit for human consumption, or

parts thereof.

“commercial poultry holding” means a holding where poultry

are kept for commercial purposes<

“competent authority” means the Veterinary Services<

“Community vaccine bank” means appropriate premises

designated in accordance with Rule 59(1) for the storage of

Community reserves of avian influenza vaccines<

“contact holding” means a holding where avian influenza

could have come from or have been introduced to as a result of its

location, the movement of persons, poultry or other captive birds,

vehicles or in any other way<

“day-old chicks means all poultry less than 72 hours old, not

yet fed, and muscovy ducks (Cairina moschata) or their crosses,

less than 72 hours old, whether or not fed<

“diagnostic manual” means the diagnostic manual provided

for in Rule 51(1)<

“highly pathogenic avian influenza (HPAI)” means any of

the avian influenza infections so described in Schedule I<

“Differentiating Infected from Vaccinated Animal (DIVA)

strategy” means a vaccination strategy which enables a

differentiation to be made between vaccinated#infected and

vaccinated#non-infected animals through the application of a

diagnostic test designed to detect antibodies against the field virus

and the use of non-vaccinated sentinel birds<

“disposing of” means the act of collecting, transporting,

storing, handling, processing and using or disposing of animal by-

products in accordance with>

(a)

Rule (EC) No 1774#2002< or

(b) rules to be adopted under the procedure referred to

in Rule 64(2)<

“flock” means all poultry or other captive birds within a single

production unit<

“holding” means any agricultural or other premises, including

hatcheries, circuses, zoos, pet bird shops, bird markets, and aviaries,

where poultry or other captive birds are being bred or kept>

Provided that this definition does not include slaughterhouses,

means of transport, quarantine facilities and centres, border

inspection posts and laboratories authorised by the competent

authority to hold avian influenza virus<

“killing” means any process other than slaughter causing the

death of a mammal, poultry or other captive birds<

“low pathogenic avian influenza (LPAI)” means any of the

avian influenza infections so described in Schedule I(3)<

“mammal” means an animal of the class Mammalia, except

humans<

“non-commercial holding” means a holding where poultry

or other captive birds are kept by their owners>

(a)

for their own consumption or use< or

(b) as pets<

“official veterinarian” means the veterinarian designated by

the competent authority<

“official supervision” means the actions taken by the

competent authority to verify that the requirements of these Rules

and of any instructions from that authority as to how those

requirements should be met are being, or have been, complied with<

“official surveillance” means the action of careful monitoring

by the competent authority of the health status of poultry or other

captive birds or mammals on a holding in relation to avian

influenza<

“officially registered rare breeds of poultry or other captive

birds” means any poultry or other captive birds that the competent

authority has officially recognised as a rare breed within their

contingency plan provided for in Rule 63<

“other captive bird” means any bird other than poultry that is

kept in captivity for any reason other than those referred to in

paragraph 4 including those that are kept for shows, races,

exhibitions, competitions, breeding or selling<

“outbreak” means a holding where avian influenza has been

confirmed by the competent authority<

“owner” means any person or persons, either natural or legal

having ownership of poultry or other captive birds, or charged

with keeping such, whether or not for commercial purposes<

“poultry” means all birds that are reared or kept in captivity

for the production of meat or eggs for consumption, the production

of other products, for restocking supplies of game birds or for the

purposes of any breeding programme for the production of these

categories of birds<

“poultry compartment” or “other captive birds compartment”

means a holding or holdings under a common biosecurity

management system containing a poultry or other captive birds

sub-population with a distinct health status with respect to avian

influenza subjected to appropriate surveillance, control and

biosecurity measures<

“poultry or other captive birds suspected of being infected”

means any poultry or other captive birds exhibiting clinical signs

or showing post-mortem lesions or reactions to laboratory tests

which are such that the presence of avian influenza cannot be

excluded<

“primary outbreak” means an outbreak not epidemiologically

linked with a previous outbreak in the same region of a Member

State or the first outbreak in a different region of the same Member

State<

“production unit” means a unit on a holding which the official

veterinarian is satisfied is completely independent of any other

unit in the same holding in terms of its location and day-to-day

management of the poultry or other captive birds kept there<

“slaughter” means any process causing the death of a mammal

or poultry by bleeding, for the purpose of human consumption<

“suspected outbreak” means a holding where the competent

authority suspects the presence of avian influenza<

“wild bird” means a free-living bird which is not kept on any

holding

CHAPTER II

PREVENTIVE BIOSECURITY, SURVEILLANCE,

NOTIFICATIONS AND EPIDEMIOLOGICAL INQUIRIES

(referred to in Rules 9(3) and 14(3)

Authorisation to remove eggs from a holding in accordance with Rule 9(3) and

Rule 14(3)

The competent authority may authorise the transport of eggs from a holding subject to the

provisions of Rule 9(3) and Rule 14(3) of these Rules to an establishment approved for

the manufacture of egg products in accordance with Rule (EC) No 853/2004 (‘the

designated establishment’), subject to the following conditions

1. in order to be allowed to be removed from the holding of origin, the eggs must be sent

directly from the suspected holding to the designated establishment; each consignment

must be sealed before dispatch by the official veterinarian responsible for the suspected

holding or under his supervision and must remain sealed throughout transport to the

designated establishment;

2. the official veterinarian responsible for the holding of origin of the eggs shall inform

the competent authority of the designated establishment of the intention to send the eggs

to it;

3. the competent authority responsible for the designated establishment shall ensure that

(a) the eggs referred to in sub-Rule 1 are kept isolated from other eggs from the time

they arrive until they are processed;

(b) the shells of such eggs are disposed of;

(c) the packaging used for the eggs is either destroyed or cleansed and disinfected in such

a way as to destroy all avian influenza viruses;

(d) the eggs referred to in sub-Rule 1 are transported in cleansed and disinfected

vehicles. Biosecurity measures are applied to staff and equipment and vehicles involved

in the transport of the eggs.

B

Specific provisions concerning preventive biosecurity Preventive

biosecurity

measures may be established in accordance with the procedure referred measures.

to in Rule 65(2).

(1) Malta shall carry out surveillance programmes in order Surveillance

(referred to in Rule 16(2), Rule 33(2) and Rule 43(2)

Main criteria and risk factors to be considered for the Decision to apply measures in

contact holdings or holdings and areas at risk in the further restricted zones

Indicative criteria

For depopulation

Against depopulation

Clinical signs suggesting avian influenza in No clinical signs suggesting avian

contact holdings

influenza on the contact

holdings and no epidemiological link

High susceptibility of predominant poultry

Low susceptibility of predominant poultry

species

species

Movement of poultry or other captive birds

No known movement of poultry or other

from holdings where avian influenza has

captive birds from the holdings where

been confirmed to contact holdings after

avian influenza has been confirmed to

the likely time of introduction of virus on

contact holdings after the likely time of

to those infected holdings

introduction of virus on to those infected

holdings

Location of contact holdings in an area

Location of contact holdings in an area

with a high density of poultry

with a low density of poultry

Disease has been present for some time

Disease present but with limited spreading

with likely spreading of virus from the

of virus from the holdings where avian

holdings where avian influenza has been

influenza has been confirmed before

confirmed before application of eradication

application of eradication measures

measures

Location of contact holdings within 500 Location of contact holdings more than 500

metres (1) of the holdings where avian metres (1) from the holdings where avian

influenza has been confirmed

influenza has been confirmed

The contact holdings are linked to more

The contact holdings are not linked to

than one holding where avian influenza has

holdings where avian influenza has been

been confirmed

confirmed

The epidemic is not under control and the

The epidemic is under control

number of holdings where avian influenza

has been confirmed is rising

(1) In cases where poultry density is very high, a greater distance must be considered

B

programmes.

to>

(a) detect the prevalence of infections with avian influenza

virus subtypes H5 and H7 in different species of poultry<

(b) contribute, on the basis of a regularly updated risk

assessment, to the knowledge on the threats posed by wild birds in

relation to any influenza virus of avian origin in birds.

(2) The surveillance programmes referred to in sub-Rule

1(a) shall comply with guidelines to be drawn up by the Commission in

accordance with the procedure referred to in Rule 64(2).

(referred to in Rule 40(1)

Criteria for the Decision to apply measures to holdings in relation to LPAI

When deciding on the movement of poultry or eggs and on depopulation of holdings in

accordance with Rule 40(1) the competent authority shall consider the following criteria

at least

(a) species in question;

(b) number of holdings in the area around the holding of dispatch;

(c) location of designated slaughterhouses, hatcheries and packing centres;

(d) biosecurity measures applied in holdings, poultry or other captive bird compartments,

during transport and during slaughter;

(e) transport route;

(f) evidence of spread;

(g) public health risk, if any;

(h) further treatments of the products in question;

(i) socio-economic and other impacts.

B

(1) Malta shall ensure that the suspected presence and Notification.

presence of avian influenza are compulsorily and immediately notified

to the competent authority.

(2) In addition to the requirements provided for in

Community legislation on notification of outbreaks of animal diseases,

Malta shall notify the Commission in accordance with Schedule II of

any avian influenza confirmed by the competent authority in

slaughterhouses, means of transport, border inspection posts and other

places at Community borders and quarantine facilities or centres

operating in accordance with Community legislation on imports of

poultry or other captive birds.

(3) Malta shall notify the results of any surveillance for avian

influenza virus carried out in mammals.

(referred to in Rule 49)

Principles and procedures for cleansing, disinfection and treatment of holdings

1. The following general principles and procedures shall be applied for the cleansing,

disinfection and treatment provided for in Rule 49

(a) the cleansing and disinfection and, where necessary, the measures to destroy rodents

and insects must be carried out under official supervision and in accordance with the

instructions given by the official veterinarian;

(b) the disinfectants to be used and their concentrations must be authorised by the

competent authority to ensure the destruction of avian influenza virus;

(c) disinfectants should either be used in accordance with the recommendations of the

manufacturer where provided or in accordance with the instructions of the official

veterinarian and/or the instructions of the competent authority, if any;

(d) the choice of disinfectants and of procedures for disinfection must be made taking

into account the nature of the holdings, vehicles and objects which are to be treated;

(e) the conditions under which degreasing agents and disinfectants are used must ensure

that their efficacy is not impaired; in particular, technical parameters indicated by the

manufacturer, such as pressure, minimum temperature and required contact time must be

observed;

(f) irrespective of the disinfectant used, the following general rules shall be applied

(i) a thorough soaking of bedding and litter, as well as faecal matter, with the

disinfectant;

(ii) washing and cleansing by careful brushing and scrubbing of the ground, floors, ramps

and walls following the removal or dismantling, where possible, of equipment or

installations otherwise impairing the effective cleansing and disinfection procedures;

(iii) then, further application of disinfectant for a minimum contact time as stipulated in

the manufacturer’s recommendations;

(g) where washing is carried out with liquids applied under pressure, re-contamination of

the previously cleansed parts must be avoided;

(h) washing, disinfecting or destroying of equipment, installations, Rule s or anything

likely to be contaminated must be envisaged;

(i) following disinfection procedures, re-contamination must be avoided;

(j) cleansing and disinfection as required in the framework of this Directive must be

documented in the holding or vehicle register and, where official approval is required, be

certified by the supervising official veterinarian or person under his supervision;

(k) cleansing and disinfection of vehicles used for transport and by staff.

2. Cleansing and disinfection of infected holdings shall be carried out in accordance with

the following principles and procedures

(a) preliminary cleansing and disinfection

(i) during the killing of the poultry or other captive birds all necessary measures must be

taken to avoid or minimise the dispersion of avian influenza virus; those measures must

B

include the installation of temporary disinfection equipment, supply of protective

clothing, showers, decontamination of used equipment, instruments and facilities and the

interruption of power supply to the ventilation;

(ii) carcases of killed poultry or other captive birds must be sprayed with disinfectant;

(iii) any transport of carcases of poultry or other captive birds which have to be removed

from the holding for disposal shall be carried out in closed, leak proof vehicles or

containers under official supervision in such a way as to prevent the spread of avian

influenza virus;

(iv) as soon as the killed poultry or other captive birds have been removed to be disposed

of, those parts of the holding in which they were housed and any parts of other buildings,

yards etc. contaminated during the killing, or the post-mortem examination must be

sprayed with disinfectants authorised in accordance with Rule 49;

(v) any tissue or blood spilled during the killing or from the post-mortem examinations

must be carefully collected and disposed of with the killed poultry or other captive birds;

(vi) the disinfectant must remain on the surface for at least 24 hours;

(b) final cleansing and disinfection

(i) manure and used bedding must be removed and treated as provided in sub-Rule 3(a);

(ii) grease and dirt must be removed from all surfaces by the application of a degreasing

agent, and the surfaces

cleansed with water;

(iii) after washing with cold water, further spraying with disinfectant must be applied;

(iv) after seven days the holding must be treated with a degreasing agent, rinsed with

water, sprayed with disinfectant and rinsed again with water.

3. Disinfection of contaminated bedding, manure and slurry shall be carried out in

accordance with the following principles and procedures

(a) manure and used bedding shall either

(i) undergo a steam treatment at a temperature of at least 70 °C;

(ii) be destroyed by burning;

(iii) be buried deep enough to prevent access by wild birds and other animals; or

(iv) be stacked to heat, sprayed with disinfectant and left for at least 42 days;

(b) slurry must be stored for at least 60 days after the last addition of infectious material,

unless the competent authorities authorises a reduced storage period for slurry which has

been effectively treated in accordance with the instructions of the official veterinarian so

as to ensure the destruction of the virus.

The competent authority may authorise the transportation of manure, litter and bedding

likely to be contaminated to either an approved treatment plant where a treatment

ensuring the destruction of any influenza virus is carried out, or for intermediate storage

before destruction or treatment, in accordance with Regulation (EC) No 1774/2002 or

with the specific rules referred to in Rule 64(1) of these Rules . Such transport shall be

carried out in closed, leak proof vehicles or containers under official supervision in such

a way as to prevent the spread of avian influenza virus.

4. However, by way of derogation from sub-rules 1 and 2, the competent authority may

establish specific procedures for cleansing and disinfection, taking into account the type

B

of holding and the climatic conditions. The competent authority shall notify the

Commission when this derogation is applied and provide them with details of the specific

procedures.

5. Without prejudice to Rule 49(b), if the competent authority is satisfied that any

holding or part of any holding cannot, for any reason, be cleansed and disinfected, it may

prohibit the entry of any person, vehicle, poultry, other captive bird or mammal of

domestic species or any thing on to those holdings, or part of those holdings, and such

prohibition shall remain in force for a minimum of 12 months.

B

(1) Malta shall ensure that epidemiological inquiries are Epidemiological

inquiry.

started on the basis of questionnaires, established within the framework

of the contingency plans provided for in Rule 63.

(2) The epidemiological inquiry shall include the following

(a) the length of time during which avian influenza may have

been present on the holding or other premises or means of transport<

(b) the possible origin of avian influenza<

(c) the identification of any contact holding<

(d) the movements of poultry, other captive birds, persons,

mammals, vehicles or any material or other means by which the

avian influenza virus could have spread.

(3) The competent authority shall take account of the

epidemiological inquiry when>

(a) deciding whether additional disease control measures,

as provided for in these rules need to be applied< and

(b) granting derogations as provided for in these rules

(4) If the epidemiological inquiry suggests that avian

influenza may have spread from or to other Member States, the

Commission and the other Member State concerned shall be immediately

informed of the results of all findings of the inquiry.

CHAPTER III

SUSPECTED OUTBREAKS

(referred to in Rule 52(1))

Community reference laboratory for avian influenza

1. The Community reference laboratory for avian influenza is: Veterinary Laboratories

Agency (VLA), New Haw, Weybridge, Surrey KT 15 3NB, United Kingdom.

2. The functions and duties of the Community reference laboratory shall be

(a) to coordinate, in consultation with the Commission, the methods employed in Malta

for diagnosing avian influenza, specifically by;

(i) typing, storing and supplying strains of avian influenza 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 avian influenza virus strains and isolates;

(iv) organising periodical comparative tests of diagnostic procedures at Community level;

(v) collecting and collating data and information on the methods of diagnosis used and

the results of tests carried out in the Community;

(vi) characterising isolates of avian influenza viruses by the most up-to-date methods

available to allow greater understanding of the epidemiology of avian influenza and to

gain an insight into the epidemiology of the virus and the emergence of highly pathogenic

and potentially pathogenic strains;

(vii) keeping abreast of developments in avian influenza surveillance, epidemiology and

prevention worldwide;

(viii) retaining expertise on avian influenza virus and other pertinent viruses to enable

rapid differential diagnosis;

(ix) acquiring a knowledge of the preparation and use of the products of veterinary

immunology used to control avian influenza;

(b) to assist actively in the diagnosis of outbreaks in the Community by receiving isolates

of influenza viruses of avian origin for confirmatory diagnosis, characterisation and

epidemiological studies and to obtain virus isolates from primary outbreaks to be

submitted from third countries authorised for the importation of live poultry and meat

into the Community pursuant to the relevant Community legislation; on the virus isolates

received, the Community reference laboratory shall in particular carry out the following

(i) nucleotide sequencing analysis to allow determination of the deduced amino acid

sequence at the cleavage site of the haemagglutinin molecule;

(ii) determination of the intravenous pathogenicity index (IVPI);

(iii) antigenic typing;

(iv) phylogenetic analysis to assist in epidemiological investigations;

(c) to facilitate the training or retraining of experts in laboratory diagnosis with a view to

the harmonisation of techniques throughout the Community;

B

(d) to prepare the programme and working documents for the Annual Meeting of

National Reference Laboratories;

(e) to assist in the conduct of avian influenza surveys in poultry and wild birds to be

carried out in the Member States by supplying antigens in the framework of the

programme and the approved testing procedures and prepare a summary report on the

results of the surveys;

(f) to keep under review the possible zoonotic impact arising from avian influenza viruses

and collaborate with internationally recognised human influenza laboratories;

(g) to develop, in consultation with the Commission, a crisis and contingency plan which

shall include provision for the cooperation with the OIE and FAO reference laboratory

for avian influenza and, as appropriate, with other internationally recognised laboratories

within the Community.

B

(1) In the case of a suspected outbreak, the competent

authority shall immediately set in motion an investigation to confirm or

exclude the presence of avian influenza in accordance with the diagnostic

manual and place the holding under official surveillance. The competent

authority shall also ensure that the measures provided for in sub-rules

(2)and (3) are complied with.

(2) The competent authority shall ensure that the following

measures are applied on the holding>

(a) poultry, other captive birds and all mammals of domestic

species are counted or, if appropriate, their numbers estimated by

the type of poultry or species of other captive bird<

(b) a list is compiled of the approximate number of poultry,

other captive birds and all mammals of domestic species already

sick, dead or likely to be infected in each category on the holding<

that list shall be updated daily to take account of hatchings, births

and deaths throughout the period of the suspected outbreak and

shall be produced on request to the competent authority<

(c) all poultry and other captive birds are brought inside a

building on their holding and kept there. Where this is impractical

or if their welfare is compromised they are confined in some other

place on the same holding such that they do not have contact with

other poultry or other captive birds on other holdings. All

reasonable steps are taken to minimise their contact with wild birds<

(d) no poultry or other captive birds may enter or leave the

holding<

(e) no carcases of poultry or other captive birds, meat of

poultry including offal (‘poultry meat’), poultry feed (‘feed’),

utensils, materials, waste, droppings, poultry or other captive birds

manure (‘manure’), slurry, used litter or anything likely to transmit

avian influenza may leave the holding without an authorisation

from the competent authority, observing appropriate biosecurity

measures such as to minimise any risk of the spread of avian

influenza<

(f)

no eggs may leave the holding<

(g) the movement of persons, mammals of domestic species,

vehicles and equipment to or from the holding is subject to the

conditions and authorisation of the competent authority<

(h) appropriate means of disinfection are used at the

entrances and exits of buildings housing poultry or other captive

birds and of the holding itself in accordance with the instructions

of the competent authority.

(3) The competent authority shall ensure that an

epidemiological inquiry is carried out in accordance with Rule 7 (‘the

epidemiological inquiry’).

(4) Notwithstanding sub-Rule 1, the competent authority

may provide for the submission of samples in other cases. In such

circumstances the competent authority may proceed without adopting

some or all of the measures referred in sub-Rule (2).

(referred to in Rule 52(3))

Function and duties of the national reference laboratories

1. The national reference laboratories shall be responsible for ensuring that in each

Member State the laboratory testing to detect the presence of avian influenza and the

identification of the genetic type of virus isolates are carried out in accordance with the

diagnostic manual. For that purpose, they may make special agreements with the

Community reference laboratory or with other national laboratories.

2. The national reference laboratories shall submit isolates of influenza virus of avian

origin to the Community reference laboratory without delay for full characterisation

(a) from all primary outbreaks of avian influenza;

(b) in case of secondary outbreaks, from representative number of outbreaks;

(c) in case of detection of influenza viruses other than those referred to in Schedule I in

poultry, other captive birds or mammals posing a serious threat to health.

3. The national reference laboratory in each Member State shall be responsible for

coordinating the standards and diagnostic methods in each avian influenza diagnostic

laboratory within that Member State. For that purpose

(a) it may provide individual laboratories with diagnostic reagents;

(b) it shall control the quality of all diagnostic reagents used in that Member State;

(c) it shall arrange comparative tests periodically;

(d) it shall hold isolates of avian influenza virus from outbreaks and of any other

influenza viruses of avian origin detected in that Member State;

(e) it shall collaborate with the national human influenza laboratories.

B

(1) The competent authority may grant derogations from the

measures provided for in Rule 8(2) paragraphs (c) to (e) on the basis of

a risk assessment and taking into account the precautions taken and the

destination of the birds and products to be moved.

(2) The competent authority may also grant derogations

from the measures provided for in Rule 8(2), paragraph(h) in the case

of other captive birds kept on non-commercial holdings.

(3) With reference to Rule 8(2) paragraph(f), the competent

authority may authorise the sending of eggs>

(a) directly to an establishment for the manufacture of egg

products, as set out in Chapter II of Section X of Annex III to

Regulations (EC) No 853#2004, to be handled and treated in

accordance with Chapter XI of Annex II to Rule (EC) No 852#2004<

where the competent authority issues such an authorisation, the

latter shall be subject to the conditions set out in Schedule III to

these rules < or

(b) for disposal.

(referred to in Rule 56(1)(b)

Requirements for movements of poultry or other captive birds and poultry products

applicable in relation to emergency vaccination

1. Malta shall ensure that movement controls on poultry or other captive birds vaccinated

in accordance with Rule 56 and on their products are applied as set out in sub-rules (3)

to (8) in accordance with the diagnostic manual.

2. Any vehicles or means of transport and equipment used for transporting live poultry or

other captive birds, eggs or poultry meat within the context of this Schedule shall

undergo one or more of the cleansing, disinfection or treatment procedures provided for

in Rule 49 without delay after it has been used.

3. The following provisions shall apply to the movements of live poultry or other captive

birds and eggs within the vaccination area

(a) hatching eggs shall

(i) originate from a vaccinated or unvaccinated breeding flock which has been examined,

with favourable results, in accordance with the diagnostic manual;

(ii) have been disinfected before dispatch in accordance with a method approved by the

competent authority;

(iii) be transported directly to the hatchery of destination;

(iv) be traceable within the hatchery;

(b) eggs shall originate from a vaccinated or non-vaccinated layer flock which has been

examined, with favourable results, in accordance with the diagnostic manual and shall be

transported to

(i) a packing centre designated by the competent authority (‘the designated packing

centre’), provided that they are packed in disposable packaging and that all biosecurity

measures required by the competent authority are applied, or

(ii) an establishment for the manufacture of egg products as set out in Chapter II of

Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in

accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004;

(c) day-old chicks shall

(i) originate from hatching eggs satisfying the conditions set out in (a);

(ii) be placed in a poultry house or shed where there is no resident poultry;

(d) live poultry or other captive birds shall

(i) have been vaccinated against avian influenza, if provided for in the vaccination

programme;

(ii) have been examined, with favourable results, in accordance with the diagnostic

manual;

(iii) be placed in a poultry house or shed where there is no resident poultry;

(e) poultry for slaughter shall

B

(i) be examined with favourable results before loading in accordance with the diagnostic

manual;

(ii) be sent directly to a designated slaughterhouse for immediate slaughter.

4. The following provisions shall apply to the movements of live poultry or other captive

birds and eggs from holdings outside the vaccination area to holdings within the

vaccination area

(a) hatching eggs shall

(i) be transported directly to the hatchery of destination;

(ii) be traceable within the hatchery;

(b) eggs shall be transported to

(i) a packing centre designated by the competent authority (‘the designated packing

centre’), provided that they are packed in disposable packaging and that all biosecurity

measures required by the competent authority are applied, or

(ii) an establishment for the manufacture of egg products as set out in Chapter II of

Section X of Annex III to Rule (EC) No 853/2004 to be handled and treated in

accordance with Chapter XI of Schedule II to Rule (EC) No 852/2004;

(c) day-old chicks shall be placed in a poultry house or shed where there is no resident

poultry;

(d) live poultry or other captive birds shall

(i) be placed in a poultry house or shed where there is no resident poultry;

(ii) be vaccinated at the farm of destination, if provided for in the vaccination

programme;

(e) poultry for slaughter shall be sent directly to a designated slaughterhouse for

immediate slaughter.

5. The following provisions shall apply to movements of live poultry or other captive

birds, and eggs from holdings within the vaccination area to a holding outside the

vaccination area

(a) hatching eggs shall

(i) originate from a vaccinated or unvaccinated breeding flock which has been examined,

with favourable results, in accordance with the diagnostic manual;

(ii) have been disinfected before dispatch in accordance with a method approved by the

competent authority;

(iii) be transported directly to the hatchery of destination;

(iv) be traceable within the hatchery;

(b) eggs shall originate from a vaccinated or non-vaccinated layer flock which has been

examined, with favourable results, in accordance with the monitoring diagnostic manual

and shall be transported to

(i) a packing centre designated by the competent authority (‘the designated packing

centre’), provided that they are packed in disposable packaging and that all biosecurity

measures required by the competent authority are applied, or

(ii) an establishment for the manufacture of egg products as set out in Chapter II of

Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in

accordance with Chapter XI of Schedule II to Rule (EC) No 852/2004;

B

(c) day-old chicks shall

(i) not have been vaccinated;

(ii) originate from hatching eggs satisfying the conditions set out in paragraph(a) of sub-

Rule 2, paragraph(a) of sub-Rule 3 or paragraph(a) of sub-Rule 4;

(iii) be placed in a poultry house or shed where there is no resident poultry;

(d) live poultry or other captive birds shall

(i) not have been vaccinated;

(ii) have been examined with favourable results, in accordance with the diagnostic

manual;

(iii) be placed in a poultry-house or shed where there is no resident poultry;

(e) poultry for slaughter shall

(i) be examined before loading with favourable results, in accordance with the diagnostic

manual;

(ii) be sent directly to a designated slaughterhouse for immediate slaughter.

6. For meat obtained from poultry kept within the vaccination area the following

provisions shall apply

(a) for meat obtained from vaccinated poultry, the poultry shall

(i) have been vaccinated with a vaccine that complies with a DIVA strategy;

(ii) have been inspected and tested with negative results in accordance with the diagnostic

manual;

(iii) have been clinically inspected by an official veterinarian within 48 hours before

loading and if appropriate any

sentinel birds on the holding shall have been examined by the official veterinarian;

(iv) have been sent directly to a designated slaughterhouse for immediate slaughter;

(b) for any meat obtained from non-vaccinated poultry being sent for slaughter, the

poultry shall undergo monitoring in accordance with the diagnostic manual.

7. The competent authority may authorise the movement of carcases or eggs for disposal

from holdings.

8. No further restrictions shall apply to movements of eggs packed and meat from poultry

slaughtered in accordance with this Schedule.

9. The movement of poultry (including day-old chicks) or other captive birds from the

territory of Malta is prohibited from the start of the emergency vaccination campaign

until the emergency plan is approved under Rule 55 and without prejudice to any further

Community measures, unless it is authorised by the competent authority of the receiving

Member State.

B

The measures to be applied on holdings in cases of suspected

outbreaks, as provided for in Rule 8, shall continue to be applied until

the competent authority is satisfied that the suspicion of avian influenza

where outbreaks are

on the holding has been ruled out.

(referred to in Rule 63(1))

Criteria for contingency plans

Contingency plans shall meet the following criteria at least

1. The establishment of a crisis centre on a national level, which shall coordinate all

control measures in the Member State.

2. A list shall be provided of local disease control centres with adequate facilities to

coordinate disease control measures at local level.

3. Detailed information shall be given about the staff involved in control measures, their

skills, their responsibilities and the instructions for staff, taking account of the need for

personal protection and the potential risk to human health posed by avian influenza.

4. Each local disease control centre must be able to contact rapidly persons and

organisations directly or indirectly involved in an outbreak.

5. Equipment and materials shall be available to carry out effectively the disease control

measures.

6. Detailed instructions shall be provided on action to be taken on suspicion and

confirmation of infection or contamination, including proposed means of disposal of

carcases.

7. Training programmes shall be established to maintain and develop skills in field and

administrative procedures.

8. Diagnostic laboratories must have facilities for post-mortem examination, the

necessary capacity for serology, histology etc. and must maintain the skills for rapid

diagnosis. Arrangements must be made for rapid transportation of samples. The

contingency plan shall also outline the testing capacity for the laboratory and the

resources available to deal with an outbreak of disease.

9. A vaccination plan dealing with a number of scenarios shall be produced which shall

give an indication of which populations of poultry or other captive birds may be

vaccinated, an estimate of the amount of vaccine required and its availability.

10. Provision shall be made for the availability of data on registration of commercial

poultry holdings on their territory, without prejudice to other relevant provisions

established by Community legislation in this field.

11. Provision shall be made for the recognition of officially registered rare breeds of

poultry or other captive birds.

12. Provision shall be made for the identification of areas with a high density of poultry.

B

13. Provision shall be made to ensure the legal powers necessary for the implementation

of the contingency plans.

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€6.34 (Lm2.72)

(1) Based on the preliminary results of an epidemiological

Additional measures

inquiry, the competent authority may apply the measures provided for

in sub-rules (2), (3) and (4) in particular if the holding is located in an

area with a high density of poultry.

(2) Temporary restrictions may be introduced on the

movements of poultry, other captive birds and eggs and the movement

of vehicles used by the poultry sector in a defined area or in the whole

of the territory of Malta. Such restrictions may be extended to movements

of mammals of domestic species, but in that case shall not exceed 72

hours, unless justified.

(3) The measures provided for in Rule 13 may be applied

to the holding. However, if conditions permit, application of those

measures may be limited to the poultry or other captive birds suspected

of being infected and their production units. Samples shall be taken

from the poultry or other captive birds if they are killed in order for the

risk of a suspected outbreak to be confirmed or excluded, in accordance

with the diagnostic manual.

(4) A temporary control zone around the holding may be

established and some or all of the measures provided for in Rule 8(2)

shall be applied as necessary to the holdings within that zone.

CHAPTER IV

HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI)

SECTION 1

Holdings, separate production units and contact holdings

(1) In case of an outbreak of HPAI, the competent authority Measures to be

applied on holdings

shall ensure that the measures provided for in Rule 8(2) and (3) and where outbreaks are

sub-rules (2) to (10) of this Rule are applied.

confirmed.

(2) All poultry and other captive birds on the holding shall

be killed without delay under official supervision. The killing shall be

carried out in such a way as to avoid the risk of spread of avian influenza,

in particular during transport>

Provided that Malta may grant derogations for certain species

of poultry or other captive birds not to be killed, on the basis of an

assessment of the risk of further spread of avian influenza. The competent

authority may take appropriate measures to limit any possible spread of

avian influenza to any wild birds on the holding.

(3) All carcases and eggs on the holding shall be disposed

of under official supervision.

(4) Poultry already hatched from eggs collected from the

holding during the period between the probable date of introduction of

HPAI on the holding and the application of the measures provided for

in Rule 8(2), shall be placed under official supervision and investigations

shall be carried out in accordance with the diagnostic manual.

(5) Meat of poultry slaughtered and eggs collected from

the holding during the period between the probable date of introduction

of HPAI on the holding and the application of the measures provided

for in Rule 8(2) shall, wherever possible, be traced and disposed of

under official supervision.

(6) All substances and waste likely to be contaminated, such

as feed, shall be destroyed or undergo a treatment ensuring the

destruction of the avian influenza virus, in accordance with the

instructions of the official veterinarian.

(7) However, manure, slurry and bedding likely to be

contaminated shall undergo one or more of the procedures provided for

in Rule 49.

(8) Following the disposal of carcases, the buildings used

for housing them, pastures or land, the equipment likely to be

contaminated and the vehicles used for transporting the poultry or other

captive birds, carcases, meat, feed, manure, slurry, bedding and any

other material or substance likely to be contaminated shall undergo one

or more of the procedures provided for in Rule 49.

(9) Other captive birds or mammals of domestic species

shall not enter or leave the holding without the authorisation of the

competent authority. That restriction shall not apply to mammals of

domestic species which have access only to the living areas for humans.

(10) In the case of a primary outbreak, the virus isolate shall

be subjected to the laboratory procedure in accordance with the

diagnostic manual to identify the genetic subtype. That virus isolate

shall be submitted to the Community reference laboratory, as provided

for in Rule 52(1) as soon as possible.

(1) Malta shall draw up detailed rules for granting

derogations, as provided for in Rules 12(2), 14 and 15, including

alternative appropriate measures and conditions. Such derogations shall

be based on a risk assessment carried out by the competent authority.

(2) Malta shall immediately notify the Commission of any

derogation granted in accordance with Rule 14(1) and Rule 15.

(3) Where a derogation has been granted, as provided for

in Rule 14(1) and Rule 15, the Commission shall immediately review

the situation with the Member State concerned and in the Standing

Committee on the Food Chain and Animal Health (‘the Committee’) as

soon as possible.

(4) Taking account of any derogation granted, as provided

for in Rule 14 (1) and Rule 15, measures to prevent the spread of avian

influenza may be adopted in accordance with the procedure referred to

in Rule 65(3).

(1) The competent authority may grant derogations from

the measures provided for in the first sub-Rule of Rule 12(2) in cases of

an outbreak of HPAI in a non-commercial holding, a circus, a zoo, a

pet bird shop, a wild life park, a fenced area where poultry or other

captive birds are kept for scientific purposes or purposes related to the

conservation of endangered species or officially registered rare breeds

of poultry or other captive birds, provided that such derogations do not

endanger disease control.

(2) The competent authority shall ensure that where a

derogation is granted, as provided for in sub-Rule 1, the poultry and

other captive birds concerned by the derogation>

(a) are brought inside a building on their holding and kept

there. Where this is impractical or if their welfare is compromised

they are confined in some other place on the same holding such

that they do not have contact with other poultry or other captive

birds on other holdings. All reasonable steps are taken to minimise

their contact with wild birds<

(b) are subjected to further surveillance and testing in

accordance with the diagnostic manual and are not moved until

the laboratory tests have indicated that they no longer pose a

significant risk of further spread of HPAI< and

(c) are not moved from their holding of origin, except for

slaughter or to another holding>

(i) located in the same Member State, in accordance

with the instructions of the competent authority< or

(ii) in another Member State, subject to the agreement

of the Member State of destination.

(3) The competent authority may grant derogations from

the measures provided for in Rule 12(5), for eggs to be sent directly to

an establishment for the manufacture of egg products as set out in

Chapter II of Section X of Annex III to Rule (EC) No 853#2004 to be

handled and treated in accordance with Chapter XI of Schedule II to

Regulation (EC) No 852#2004. Any such authorisations shall be subject

to the conditions set out in Schedule III of these rules.

In cases of an outbreak of HPAI in a holding which consists Measures to be

applied in cases of

of two or more separate production units, the competent authority may outbreaks of HPAI

grant derogations from the measures provided for in the Rule 12(2) for in

production units.

production units containing poultry or other captive birds where no HPAI

is suspected, provided that such derogations do not endanger disease

control.

Such derogations shall only be granted in respect of two or more

separate production units where the official veterinarian, taking account

of the structure, size, operation, type of housing, feeding, water source,

equipment, staff and visitors to the holding, is satisfied that they are

completely independent of other production units in terms of location

and day-to-day management of the poultry or other captive birds kept

there.

(1) Based on the epidemiological inquiry, the competent

authority shall decide if a holding is to be considered as a contact holding.

The competent authority shall ensure that the measures

provided for in Rule 8(2) are applied to contact holdings until the

presence of HPAI has been excluded in accordance with the diagnostic

manual.

(2) Based on the epidemiological inquiry, the competent

authority may apply the measures provided for in Rule 12 to contact

holdings and in particular if the contact holding is located in an area

with a high density of poultry. The main criteria to be considered for

the application of the measures provided for in Rule 12 in contact

holdings are set out in Schedule IV.

(3) The competent authority shall ensure that samples are

taken from poultry and other captive birds when they are killed in order

to confirm or exclude the presence of HPAI virus in those contact

holdings in accordance with the diagnostic manual.

(4) The competent authority shall ensure that, on any holding

where poultry or other captive birds are killed and disposed of and avian

influenza is subsequently confirmed, the buildings and any equipment

likely to be contaminated and the vehicles used for transporting the

poultry, other captive birds, carcases, meat, feed, manure, slurry, bedding

and any other material or substance likely to be contaminated undergo

one or more of the procedures provided for in Rule 49.

SECTION 2

Protection, surveillance and further restricted zones

(1) Immediately following an outbreak of HPAI, the

competent authority shall establish>

(a) a protection zone with a radius of at least three kilometers

around the holding<

(b) a surveillance zone with a radius of at least 10 kilometres

around the holding, including the protection zone.

(2) If the outbreak of HPAI is confirmed in other captive

birds in a non-commercial holding, circus, zoo, pet bird shop, wildlife

park, a fenced area where other captive birds are kept for scientific

purposes or purposes related to the conservation of endangered species

or officially registered rare breeds of other captive birds that do not

contain poultry, the competent authority may, following a risk

assessment, derogate to the extent necessary from the provisions of

Sections 2 to 4 concerning the establishment of the protection and

surveillance zones and the measures to be applied therein, provided

that such derogations do not endanger disease control.

(3) When establishing protection and surveillance zones,

as provided for in sub-Rule (1), the competent authority shall take

account of the following criteria at least>

(a)

the epidemiological inquiry<

(b) the geographical situation, particularly natural

boundaries<

(c) the location and proximity of holdings and the estimated

number of poultry<

(d) patterns of movements and trade in poultry, other captive

birds<

(e) the facilities and personnel available to control any

movement within the protection and surveillance zones of poultry

or other captive birds, their carcases, manure, bedding or used litter,

in particular if the poultry or other captive birds to be killed and

disposed of have to be moved from their holding of origin.

(4) The competent authority may establish further restricted

zones around or adjacent to the protection and surveillance zones, taking

account of the criteria provided for in sub-Rule (3).

(5) If a protection, surveillance or further restricted zone

covers the territories of different Member States, the competent

authorities of the Member States concerned shall collaborate to establish

the zone.

(1) The competent authority shall ensure that the following Measures to be

applied both in the

measures are applied within the protection and surveillance zones>

protection and in the

surveillance zones.

(a) arrangements are put in place which permit the tracing

of anything likely to spread the avian influenza virus including

poultry, other captive birds, meat, eggs, carcases, feed, litter, people

who have been in contact with the infected poultry or other captive

birds or vehicles with a link to the poultry industry<

(b) owners are to provide the competent authority, on

request, with any relevant information concerning the poultry or

other captive birds and eggs entering or leaving the holding.

(2) The competent authority shall take all reasonable steps

to ensure that all persons in the protection and surveillance zones affected

by the restrictions concerned are fully aware of the restrictions in place.

That information may be conveyed through warning notices, media

resources such as the press and television or any other appropriate means.

(3) The competent authority may, where epidemiological

information or other evidence indicates, implement a preventive

eradication programme, including preventive slaughtering or killing of

poultry or other captive birds, in holdings and areas at risk.

(4) In the event that Malta applies the measures provided

for in sub-Rule 3 shall immediately inform the Commission thereof,

and the Commission shall review the situation with Malta and in the

Committee as soon as possible.

SECTION 3

Measures to be applied in protection zones

The competent authority shall ensure that the following

measures are applied in protection zones>

(a)

a census of all the holdings is made as soon as possible<

(b) all commercial holdings are visited by an official

veterinarian as soon as possible for a clinical examination of the

poultry and other captive birds and, if necessary, the collection of

samples for laboratory tests in accordance with the diagnostic

manual< a record of such visits and the findings thereof shall be

kept< non-commercial holdings are visited by an official

veterinarian before the lifting of the protection zone<

(c) additional surveillance is immediately implemented in

accordance with the diagnostic manual in order to identify any

further spread of avian influenza in the holdings located in the

protection zone.

The competent authority shall ensure that the following Measures

applied on holdings

measures are applied on holdings in protection zones>

in protection zones.

(a) all poultry and other captive birds are brought inside a

building on their holding and kept there. Where this is impractical

or if their welfare is compromised, they are confined in some other

place on the same holding such that they do not have contact with

other poultry or other captive birds on other holdings. All

reasonable steps are taken to minimise their contact with wild birds<

(b) carcases are disposed of as soon as possible<

(c) vehicles and equipment used for transporting live poultry

or other captive birds, meat, feed, manure, slurry and bedding and

any other material or substances likely to be contaminated, undergo

without delay one or more of the procedures provided for in Rule

49<

(d) all parts of vehicles used by staff or other persons which

enter or leave holdings and are likely to have become contaminated

undergo without delay one or more of the procedures provided for

in Rule 49<

(e) no poultry, other captive birds or domestic mammals

may enter or leave a holding without authorisation of the competent

authority. This restriction shall not apply to mammals which have

access only to the living areas for humans in which they>

(i) have no contact with resident poultry or other

captive birds, and

(ii) have no access to any cages or areas where such

resident poultry or other captive birds are kept.

(f) any increased morbidity or mortality or significant drop

in production data in holdings is immediately reported to the

competent authority, which shall carry out appropriate

investigations in accordance with the diagnostic manual<

(g) any person entering or leaving holdings observes

appropriate biosecurity measures aimed at preventing the spread

of avian influenza<

(h) records of all persons visiting holdings, except dwellings,

are kept by the owner in order to facilitate disease surveillance

and control and must be made available upon request by the

competent authority. Such records do not have to be kept where

the visitors are to holdings such as zoos and wildlife parks where

they have no access to the areas where the birds are kept.

The competent authority shall ensure that the removal or

spreading of used litter, manure or slurry from holdings in protection

zones are prohibited, unless authorised by it.

However, the movement of manure or slurry may be authorized

from holdings under biosecurity measures to a designated plant for

treatment or for intermediate storage for subsequent treatment to destroy

the possible presence of avian influenza viruses in accordance with

Regulation (EC) No 1774#2002 or with specific rules which may be

adopted in accordance with the procedure referred to in Rule 65(2).

The competent authority shall ensure that fairs, markets,

other gatherings and

shows or other gatherings of poultry or other captive birds are prohibited

in protection zones. The competent authority shall ensure that poultry

or other captive birds for restocking of game are not released in

protection zones.

(1) The competent authority shall ensure that within

protection zones, the movement and transport from holdings on to roads,

excluding private service roads of holdings, or by rail, of poultry, other

captive birds, ready-to-lay poultry, day-old chicks, eggs and carcases

are prohibited.

(2) The competent authority shall ensure that the transport

of poultry meat from slaughterhouses, cutting plants and cold stores is

prohibited unless it has been produced>

(a) from poultry which has originated from outside the

protection zones and has been stored and transported separately

from the meat of poultry from within the protection zones< or

(b) on a date at least 21 days before the estimated date of

earliest infection on a holding in the protection zone and which

since production has been stored and transported separately from

such meat produced after that date.

(3) However, the prohibitions in sub-Rules (1) and (2) shall

not apply to transit through the protection zone on roads or rail without

unloading or stopping.

(1) By way of derogation from Rule 23, the competent Derogations for the

direct transport of

authority may authorise the direct transport of poultry originating from poultry for

a holding in the protection zone for immediate slaughter to a designated immediate

and the movement

slaughterhouse subject to the following conditions>

or treatment of

poultry meat.

(a) a clinical examination of the poultry on the holding of

origin is carried out by the official veterinarian within 24 hours of

being sent for slaughter<

(b) where appropriate, laboratory tests have been carried

out on poultry on the holding of origin in accordance with the

diagnostic manual, with favourable results<

(c) the poultry are transported in vehicles sealed by the

competent authority or under its supervision<

(d) the competent authority responsible for the designated

slaughterhouse is informed and agrees to receive the poultry and

then confirms the slaughter to the competent authority of dispatch<

(e) the poultry from the protection zone are kept separately

from other poultry and are slaughtered separately or at different

times from other poultry, preferably at the end of a working day<

subsequent cleansing and disinfection shall be completed before

other poultry are slaughtered<

(f) the official veterinarian shall ensure that a detailed

examination of the poultry is carried out at the designated

slaughterhouse when the poultry arrive and after they are

slaughtered<

(g) the meat does not enter into intra-Community or

international trade and bears the health mark for fresh meat provided

for in Schedule II to the Animal Health (Production, Processing,

Distribution and Introduction of Products for Human

Consumption), Rules, 2005 , unless otherwise decided in

accordance with the procedure referred to in Rule 65(3) of these

rules<

(h) the meat is obtained, cut, transported and stored

separately from meat intended for intra-Community and

international trade and is used in such a way as to avoid it being

introduced into meat products intended for intra- Community or

international trade, unless>

(i) it has undergone a treatment set out in Schedule III

to the Animal Health (Production, Processing, Distribution

and Introduction of Products for Human Consumption), Rules,

2005<

or

(ii) it is otherwise decided in accordance with the

procedure referred to in Rule 65(3).

(2) By way of derogation from Rule 23, the competent

authority may authorise the direct transport of poultry from outside the

protection zone for immediate slaughter to a designated slaughterhouse

within the protection zone and subsequent movement of the meat derived

from such poultry providing that>

(a) the competent authority responsible for the designated

slaughterhouse is informed and agrees to receive the poultry and

then confirms the slaughter to the competent authority of dispatch<

(b) the poultry are kept separate from other poultry

originating within the protection zone and are slaughtered

separately or at different times from other poultry<

(c) the poultry meat produced is cut, transported and stored

separately from poultry meat obtained from other poultry

originating in the protection zone<

(d) the by-products are disposed of.

(1) By way of derogation from Rule 23, the competent

authority may authorise the direct transport of day-old chicks, originating

from holdings within the protection zone to a holding or shed of that

holding in the same Member State, preferably located outside the

protection and the surveillance zones, subject to the following conditions>

(a) they are transported in vehicles sealed by the competent

authority or under its supervision<

(b) appropriate biosecurity measures are applied during

transport and at the holding of destination<

(c) the holding of destination is placed under official

surveillance following the arrival of the day-old-chicks<

(d) if moved outside the protection or surveillance zone,

the poultry shall remain on the holding of destination for at least

21 days.

(2) By way of derogation from Rule 23, the competent

authority may authorise the direct transport of day-old chicks, hatched

from eggs originating from holdings located outside the protection and

surveillance zones, to any other holding in the same Member State,

preferably located outside the protection and the surveillance zones,

provided that the hatchery of dispatch can ensure by its logistics and by

its hygienic working conditions that no contact has occurred between

those eggs and any other hatching eggs or day-old chicks originating

from poultry flocks within such zones and which are therefore of a

different health status.

By way of derogation from Rule 23, the competent authority Derogations for the

direct transport of

may authorise the direct transport of ready-to-lay poultry to a holding ready to lay poultry.

or shed of that holding preferably within the protection or the surveillance

zone in which there is no other poultry, subject to the following

conditions>

(a) a clinical examination of the poultry and other captive

birds in the holding of origin and in particular of those to be moved

is carried out by the official veterinarian<

(b) where appropriate, laboratory tests have been carried

out on poultry in the holding of origin in accordance with the

diagnostic manual with favourable results<

(c) the ready-to-lay poultry is transported in vehicles sealed

by the competent authority or under its supervision<

(d) the holding or shed of destination is placed under official

surveillance following the arrival of the ready-to-lay poultry<

(e) if moved outside the protection or surveillance zone,

the poultry shall remain on the holding of destination for at least

21 days.

(1) By way of derogation from Rule 23, the competent Derogation for the

direct transport of

authority may authorise the direct transport of hatching eggs either from hatching and table

any holding to a hatchery located, in the protection zone and designated eggs.

by the competent authority (‘the designated hatchery’) or, subject to

the following conditions, from a holding located in the protection zone

to any designated hatchery>

(a) the parent flocks from which the hatching eggs are

derived have been examined in accordance with the diagnostic

manual and avian influenza is not suspected on these holdings<

(b) the hatching eggs and their packaging are disinfected

before dispatch and the tracing back of these eggs can be ensured<

(c) the hatching eggs are transported in vehicles sealed by

the competent authority or under its supervision<

(d) biosecurity measures are applied in the designated

hatchery in accordance with the instructions of the competent

authority.

(2) By way of derogation from Rule 23, the competent

authority may authorise the direct transport of eggs>

(a) to a packing centre designated by the competent authority

(“the designated packing centre”), provided that they are packed

in disposable packaging and that all biosecurity measures required

by the competent authority are applied<

(b) to an establishment for the manufacture of egg products

as set out in Chapter II of Section X of Schedule III to Rule (EC)

No 853#2004 to be handled and treated in accordance with Chapter

XI of Schedule II to Rule (EC) No 852#2004< or

(c)

for disposal.

By way of derogation from Rule 23, the competent authority

may authorise the direct transport of carcasses provided that they are

transported to be disposed of.

The competent authority shall ensure that the vehicles and

equipment used for the transport as provided for in rules 24 to 28 are

cleansed and disinfected without delay by one or more of the procedures

set down in Rule 49 following the transport.

(1) The measures provided for in this Section shall be

maintained for at least 21 days following the date of completion of

preliminary cleansing and disinfection on the infected holding by one

or more of the procedures set down in Rule 49 and until holdings located

in the protection zone have been tested in accordance with the diagnostic

manual.

(2) When the measures referred to in this Section are no

longer to be maintained, as provided for in sub-Rule (1) of this Rule ,

the measures laid down in Rule 31 shall apply in the former protection

zone, until they are no longer to be applied as provided for in Rule 32.

SECTION 4

Measures to be applied in the surveillance zones

The competent authority shall ensure that the following Measures to be

applied in the

measures are applied in surveillance zones>

surveillance zones.

(a) a census of all commercial poultry holdings is made as

soon as possible<

(b) the movement of poultry, ready-to-lay poultry, day-old

chicks, eggs within the surveillance zone is prohibited unless

authorisation is granted by the competent authority, which ensures

that appropriate biosecurity measures are applied to prevent the

spread of avian influenza< this prohibition shall not apply to transit

thorough the surveillance zone on road or rail without unloading

or stopping<

(c) the movement of poultry, ready-to-lay poultry, day-old

chicks and eggs to holdings, slaughterhouses, packing centres or

an establishment for the manufacture of egg products located

outside the surveillance zone is prohibited<

However, the competent authority may authorise the direct

transport of>

(i) poultry for slaughter to a designated slaughterhouse,

for the purpose of immediate slaughter subject to Rule 24(1),

paragraphs (a), (b) and (d)<

The competent authority may authorise the direct

transport of poultry from outside the protection and

surveillance zones for immediate slaughter to a designated

slaughterhouse within the surveillance zone and the

subsequent movement of the meat derived from such poultry<

(ii) ready-to-lay poultry to a holding in which there is

no other poultry in the same Member State< that holding shall

be placed under official surveillance following the arrival of

the ready-to-lay poultry and the ready-to-lay poultry shall

remain on the holding of destination for at least 21 days<

(iii) day-old chicks>

to a holding or shed of such holding in the same Member

State provided that appropriate biosecurity measures are

applied and the holding is placed under official surveillance

following the transport and day-old chicks shall remain on

the holding of destination for at least 21 days, or if hatched

from hatching eggs originating from poultry holdings located

outside the protection and surveillance zones, to any other

holding, provided that the hatchery of dispatch can ensure by

its logistics and biosecurity working conditions that no contact

has occurred between these eggs and any other hatching eggs

or day-old-chicks originating from poultry flocks within those

zones and which are therefore of a different health status<

(iv) hatching eggs to a designated hatchery located

inside or outside the surveillance zone< the eggs and their

packaging shall be disinfected before dispatch and the tracing

back of these eggs must be ensured<

(v) table eggs to a designated packing centre, provided

that they are packed in disposable packaging and that all

biosecurity measures required by the competent authority are

applied<

(vi) eggs to an establishment for the manufacture of

egg products as set out in Chapter II of Section X of Schedule

III to Regulation (EC) No 853#2004 to be handled and treated

in accordance with Chapter XI of Annex II to Regulation (EC)

No 852#2004 located inside or outside the surveillance zone<

(vii) eggs for disposal<

(d) any person entering or leaving holdings in the

surveillance zone observes appropriate biosecurity measures aimed

at preventing the spread of avian influenza<

(e) vehicles and equipment used for transporting live poultry

or other captive birds, carcases, feed, manure, slurry and bedding

and any other material or substances likely to be contaminated,

are cleansed and disinfected without delay after contamination by

one or more of the procedures provided for in Rule 49<

(f) no poultry, other captive birds or mammals of domestic

species may enter or leave a holding where poultry is kept without

authorisation of the competent authority.

This restriction shall not apply to mammals which have access

only to the living areas for humans in which they>

(i) have no contact with resident poultry or other

captive birds, and

(ii) have no access to any cages or areas where such

resident poultry or other captive birds are kept<

(g) any increased morbidity or mortality or significant drop

in production data in holdings is immediately reported to the

competent authority, which shall carry out appropriate

investigations in accordance with the diagnostic manual<

(h) the removal or spreading of used litter, manure or slurry

is prohibited unless authorised by the competent authority< the

movement of manure may be authorised from a holding situated

in the surveillance zone under biosecurity measures to a designated

plant for treatment or for intermediate storage for subsequent

treatment to destroy the possible presence of avian influenza

viruses, in accordance with Rule (EC) No 1774#2002 or with

specific rules which may be adopted in accordance with the

procedure referred to in Rule 65(2)<

(i) fairs, markets, shows or other gatherings of poultry or

other captive birds are prohibited<

(j) poultry for restocking of game are not released.

The measures provided for in this Section shall be maintained Duration of

measures.

for at least 30 days following the date of completion of preliminary

cleansing and disinfection on the infected holding in accordance with

Rule 49.

SECTION 5

Measures to be applied in further restricted zones

(1) The competent authority may provide that some or all Measures to be

applied in further

the measures provided for in Sections 3 and 4 shall apply inside the restricted zones.

further restricted zones provided for in Rule 17(4) (‘the further restricted

zones’).

(2) The competent authority may, where epidemiological

information or other evidence indicates, implement a preventive

eradication programme, including preventive slaughtering or killing of

poultry or other captive birds, in holdings and areas at risk, according

to the criteria of Schedule IV, located in further restricted zones. The

restocking of those holdings shall take place in accordance with the

instructions of the competent authority.

(3) In the event that Malta applies the measures provided

for in sub-rules (1) and (2) it shall immediately inform the Commission

thereof.

(4) The Commission shall review the situation with Malta

and in the Committee as soon as possible.

(5) Without prejudice to decisions to be adopted pursuant

to Council Decision 90#424#EEC of 26th June,1990 on expenditure in

the veterinary field, further surveillance, biosecurity and control

measures to prevent the spreading of avian influenza may be adopted in

accordance with the procedure referred to in Rule 65(3).

SECTION 6

Derogations and additional biosecurity measures

(1) Malta shall define the detailed arrangements under

which they may grant derogations provided for in Rules 17 and 24 to

28, including alternative appropriate measures and conditions. Such

derogations shall be based on a risk assessment carried out by the

competent authority.

(2) The competent authority may, based on a risk

assessment, grant derogations from the measures provided in Sections

3 and 4 in cases of confirmation of HPAI in a hatchery.

(3) The competent authority may grant derogations from

the measures provided for in Rule 19, paragraphs (b) and (c), Rule 23,

and in Rule 31, paragraphs (b), (c) and (f), in cases of an outbreak of

HPAI in a non-commercial holding, a circus, a zoo, a wild life park, a

fenced area where poultry or other captive birds are kept for scientific

purposes or purposes related to the conservation of endangered species

or officially registered rare breeds of poultry or other captive birds.

(4) By way of derogation from Sections 3 and 4, in cases of

outbreaks of HPAI Malta may, based on a risk assessment, introduce

specific measures on movements of racing pigeons into, from and within

the protection and surveillance zones.

(5) The derogations provided for in sub-rules (1) to (4) shall

only be granted provided that such derogations do not endanger disease

control.

(6) Malta granting derogations provided for in sub-rules

(1)to (4) shall immediately inform the Commission thereof.

(7) The Commission shall in all cases review the situation

with the Member State concerned and in the Committee as soon as

possible. Taking account of any derogation granted, as provided for in

sub-rules (1) to (4), measures to prevent the spread of avian influenza

may be adopted in accordance with the procedure referred to in Rule

65(3).

(8) Any poultry (including day-old-chicks), other captive

birds, hatching eggs, used litter, manure or slurry which come from a

holding that has been granted a derogation under this Rule, cannot be

marketed outside the Member State concerned unless otherwise decided

in accordance with the procedure referred in Rule 65(3).

(1) In order to prevent the spread of avian influenza, the Additional

biosecurity

competent authority may, in addition to the measures provided for in measures.

Sections 3, 4 and 5, order the implementation of additional biosecurity

measures in holdings in the protection and surveillance zones and in

the further restricted zones, as well as in poultry compartments and

other captive birds compartments in the Member State concerned.Those

measures may include restrictions on movements of vehicles or persons

for feed supply, egg collection, the transport to slaughterhouses of

poultry, the collection for disposal of carcases and other movements of

personnel, veterinarians or persons supplying farm equipment.

(2) When Malta adopts the measures, as provided for in

sub-Rule 1, it shall immediately inform the Commission thereof.

(3) The Commission shall review the situation with the

Member State concerned and in the Committee as soon as possible.

(4) Without prejudice to decisions to be adopted pursuant

to Decision 90#424#EEC, further surveillance, biosecurity and control

measures to prevent the spread of avian influenza maybe adopted in

accordance with the procedure referred to in Rule 65(3).

SECTION 7

Measures to be applied in cases of suspicion and confirmation of

highly pathogenic Avian Influenza (HPAI) in certain premises

other than holdings and in means of transport

Where there is suspicion or confirmation of the presence of

HPAI in slaughterhouses or means of transport, the competent authority

shall immediately set in motion an investigation in the holding of origin

slaughterhouses and

of the poultry or other captive birds to confirm or exclude its presence

in accordance with the diagnostic manual.

(1) Where HPAI is suspected or confirmed in a

slaughterhouse, the competent authority shall ensure that, on the basis

of a risk assessment, all poultry present in the slaughterhouse is either

killed or slaughtered as soon as possible under official supervision.

Where such poultry is slaughtered, the poultry meat and any

by-products derived from the poultry and poultry meat and byproducts

of any other poultry which may have been contaminated during the

slaughter and production process, shall be kept separate and under

official supervision until investigations in accordance with the diagnostic

manual have been completed.

(2) If HPAI is confirmed, the poultry meat and any

byproducts derived from the poultry and poultry meat and byproducts

of any other poultry which may have been contaminated during the

slaughter and production process shall be disposed of as soon as possible

under official supervision.

(1) Where HPAI is suspected or confirmed in border

inspection posts or means of transport, the competent authority shall

ensure that, on the basis of a risk assessment, all poultry and other captive

birds present in the border inspection post or in the means of transport

are killed, slaughtered or placed in isolation away from poultry or other

captive birds and kept under official supervision until the investigation

is completed in accordance with the diagnostic manual. The competent

authority shall apply the measures provided for in Rule 8 as appropriate.

The competent authority may authorise the movement of the poultry or

other captive birds to another place where they are killed, slaughtered

or placed into isolation. The competent authority may decide not to kill

or slaughter those poultry or other captive birds present in the border

inspection post that have not been in contact with the poultry or other

captive birds suspected of being infected.

(2) Where poultry referred to in sub-Rule (1) is slaughtered,

the poultry meat and any by products derived from those poultry and

poultry meat and by-products of any other poultry which may have

been contaminated during the slaughter and production process, shall

be kept separate and under official supervision until investigations in

accordance with the diagnostic manual have been completed.

(3) If HPAI is confirmed, the poultry meat and any

byproducts derived from those poultry and poultry meat and by-products

of any other poultry which may have been contaminated during the

slaughter and production process shall be disposed of as soon as possible

under official supervision.

The competent authority shall ensure that the following Additional measures

additional measures are applied where HPAI is suspected or confirmed to

slaughterhouses,

in a slaughterhouse, border inspection post or means of transport>

border inspection

posts or means of

transport.

(a) no poultry or other captive birds are introduced into the

slaughterhouse, the border inspection post or the means of transport

until at least 24 hours after the cleansing and disinfection as

provided for in paragraph(b) are completed by one or more of the

procedures set down in Rule 49< in the case of border inspection

posts, the prohibition on introduction may be extended to other

animals<

(b) the cleansing and disinfection of contaminated buildings,

equipment and vehicles takes place in accordance with one or more

of the procedures set down in Rule 49 and under the official

supervision of the official veterinarian<

(c)

an epidemiological inquiry is carried out<

(d) the measures provided for in Rule 8(2) are applied in

the holding of origin of the infected poultry or carcases and in

contact holdings<

(e) unless otherwise indicated by the epidemiological

inquiry and the further investigations, as provided for in Rule 36,

the measures provided for in Rule 12 are applied in the holding of

origin<

(f) the avian influenza virus isolate is subjected to the

laboratory procedure in order to identify the subtype of the virus,

in accordance with the diagnostic manual.

CHAPTER V

LOW PATHOGENIC AVIAN INFLUENZA (LPAI)

SECTION 1

Measures to be applied on holdings where outbreaks are

confirmed

(1) In case of an outbreak of LPAI, the competent authority

shall ensure that the measures provided for in paragraphs (a), (b), (c),

(e), (g) and (h) of Rule 8(2), Rule 8(3) and sub-rules 2 to 5 of this Rule

are applied on the basis of a risk assessment and taking account of at

least the criteria set out in Schedule V.

(2) The competent authority shall ensure that all poultry on

the holding and all other captive birds of the species in which LPAI has

been confirmed are depopulated under official supervision in such a

way as to prevent the spread of avian influenza. The depopulation may

be extended to other captive birds on the holding based on the assessment

of the risk that they pose as regards further spread of avian influenza

and to other holdings that may be considered as contact holdings, based

on the epidemiological inquiry. Before depopulation, no poultry or other

captive birds shall enter or leave the holding, unless authorised by the

competent authority.

(3) For the purpose of sub-Rule (2), the depopulation shall

be carried out in accordance with Animal Slaughter or Killing

(Protection) Rules, 2003 and the competent authority shall decide that

the poultry or other captive birds are>

(a)

killed as soon as possible, or

(b) slaughtered in a designated slaughterhouse in accordance

with sub-Rule 4.

When depopulation is by slaughter in a designated

slaughterhouse, the poultry shall be subjected to further surveillance

and testing. The poultry shall not be moved from the holding to the

designated slaughterhouse until the competent authority, taking account,

in particular, of the investigations and the laboratory tests directed at

determining the extent of any excretion of the virus by the poultry carried

out in accordance with the diagnostic manual and a risk assessment, is

satisfied that the risk of further spread of LPAI is minimal.

(4) Slaughter in a designated slaughterhouse in accordance

with sub-Rule (3) may take place only provided that>

(a) the poultry is sent directly from the holding to the

designated slaughterhouse<

(b) each consignment is sealed before dispatch by the official

veterinarian responsible for the holding or under his supervision<

(c) each consignment remains sealed throughout transport

to the designated slaughterhouse<

(d) further biosecurity measures prescribed by the competent

authority are complied with<

(e) the competent authority responsible for the designated

slaughterhouse is informed and agrees to receive the poultry<

(f) vehicles and equipment used for transporting live poultry

and any other material or substances likely to be contaminated are

cleansed and disinfected without delay after contamination, by one

or more of the procedures set down in Rule 48, and

(g) the by-products of such poultry at the slaughterhouse

are disposed of.

(5) The competent authority shall ensure that the following

are disposed of under official supervision>

(a)

carcases, and

(b) hatching eggs on the holding.

(6) The competent authority shall ensure that the following

measures are taken>

(a) hatching eggs collected from the holding during the

period between the probable introduction of LPAI into the holding

and the taking of the measures provided for in this Directive, are

whenever possible traced and hatched under official surveillance<

(b) poultry already hatched from eggs collected from the

holding during the period between the probable introduction of

LPAI into the holding and the taking of the measures provided for

in this Directive, are whenever possible placed under official

surveillance and investigations are carried out in accordance with

the diagnostic manual<

(c) eggs present on the holding and further produced on the

holding before depopulation as provided for in sub-Rule (2), are

transported provided that the risk of spread of LPAI is minimised>

(i) to a packing centre designated by the competent

authority (‘the designated packing centre’), provided that they

are packed in disposable packaging and that all biosecurity

measures required by the competent authority are applied<

(ii) to an establishment for the manufacture of egg

products as set out in Chapter II of Section X of Schedule III

to Rule (EC) No 853#2004 to be handled and treated in

accordance with Chapter XI of Schedule II to Rule (EC) No

852#2004< or

(iii) for disposal.

(d) any material or substance likely to be contaminated are

either treated in accordance with the instructions of the official

veterinarian or disposed of<

(e) manure, slurry and bedding likely to be contaminated

undergo one or more of the procedures provided for in Rule 49<

(f) after depopulation, the buildings used for housing the

poultry or other captive birds, the equipment likely to be

contaminated and the vehicles used for transporting carcasses, feed,

manure, slurry, and bedding or any other material or substance

likely to be contaminated undergoes without delay one or more of

the procedures provided for in Rule 49<

(g) mammals of domestic species do not enter or leave the

holding without the authorisation of the competent authority. This

restriction shall not apply to mammals which have access only to

the living areas for humans in which they>

(i) have no contact with resident poultry or other

captive birds, and

(ii) have no access to any cages or areas where such

resident poultry or other captive birds are kept.

(h) in the case of a primary outbreak of LPAI, the virus

isolate is subjected to the laboratory tests to identify the subtype

of virus in accordance with the diagnostic manual< the virus isolate

shall be submitted to the Community reference laboratory, as

provided for in Rule 52(1), as soon as possible.

(7) Malta applying the measures provided for in sub-rules

(2), (4) and (5) shall inform the Commission thereof.

(1) The competent authority may grant derogations from Derogations for

certain holdings.

the measures provided for in Rule 40(2) and paragraph(b) of Rule 40(5)

in cases of an outbreak of LPAI in a non commercial holding, a circus,

a zoo, a pet bird shop, a wild life park, a fenced area where poultry or

other captive birds are kept for scientific purposes or purposes related

to the conservation of endangered species or officially registered rare

breeds of poultry or other captive birds, provided that such derogations

do not endanger disease control.

(2) The competent authority shall ensure that where a

derogation is granted, as provided for in sub-Rule (1), the poultry or

other captive birds concerned by the derogation>

(a) are brought inside a building on their holding and kept

there. Where this is impractical or if their welfare is compromised

they are confined in some other place on the same holding such

that they do not have contact with other poultry or other captive

birds on other holdings. All reasonable steps are taken to minimise

their contact with wild birds<

(b) are subjected to further surveillance and testing in

accordance with the diagnostic manual and are not moved until

the laboratory tests have indicated that they no longer pose a

significant risk of further spread of LPAI< and

(c) are not moved from their holding of origin, except for

slaughter or to another holding>

(i) located in the same Member State, in accordance

with the instructions of the competent authority< or

(ii) in another Member State, subject to the agreement

of the Member State of destination.

(3) The competent authority may in cases of outbreaks of

LPAI in hatcheries, based on a risk assessment, grant derogations from

some or all of the measures provided for in Rule 40.

(4) Malta shall draw up detailed rules for applying the

derogations provided for in sub-rules (1) and (3).

(5) Malta shall immediately inform the Commission of any

derogation granted in accordance with sub-rules (1) and (3).

(6) The Commission shall review the situation with Malta

and in the Committee as soon as possible.

(7) Taking account of any derogation granted, as provided

for in sub-Rule 1, measures to prevent the spread of avian influenza

may be adopted in accordance with the procedure referred to in Rule

65(3).

SECTION 2

Separate production units and contact holdings

(1) In cases of an outbreak of LPAI in a holding which

consists of two or more separate production units, the competent

authority may grant derogations from the measures provided for in Rule

40(2), for production units containing healthy poultry provided that such

derogations do not endanger disease control.

(2) Malta shall draw up detailed rules for applying the

derogations provided for in sub-Rule (1), taking account of the animal

health guarantees which may be obtained and shall provide for

alternative appropriate measures.

(3) Malta shall immediately inform the Commission of any

derogations granted in accordance with sub-Rule (1).

(4) The Commission shall review the situation with Malta

and in the Committee as soon as possible.

(5) Taking account of any derogation granted, as provided

for in sub-Rule 1, measures to prevent the spread of avian influenza

may be adopted in accordance with the procedure referred to in Rule

65(3).

(1) Based on the epidemiological inquiry, the competent

authority shall decide if a holding is to be considered as a contact holding.

The competent authority shall ensure that the measures provided for in

Rule 8(2) are applied to contact holdings until the presence of LPAI

has been excluded in accordance with the diagnostic manual.

(2) Based on the epidemiological inquiry, the competent

authority may apply the measures provided for in Rule 40 to contact

holdings and in particular if the contact holding is located in an area

with a high density of poultry. The main criteria to be considered for

the application of the measures provided for in Rule 40 in contact

holdings are set out in Schedule IV.

(3) The competent authority shall ensure that samples are

taken from the poultry when they are killed in order to confirm or exclude

the presence of the LPAI virus in those contact holdings in accordance

with the diagnostic manual.

(4) The competent authority shall ensure that, on any holding

where poultry or other captive birds are slaughtered or killed and

disposed of, and LPAI is subsequently confirmed, the buildings and

any pastures used for housing them, farm yards and any equipment

likely to be contaminated and the vehicles used for transporting the

poultry, other captive birds, carcases, meat, feed, manure, slurry, bedding

and any other material or substance likely to be contaminated undergo

one or more of the procedures provided for in Rule 49.

SECTION 3

Establishment of restricted zones

Immediately following an outbreak of LPAI, the competent Establishment of

restricted zones in

authority shall establish a restricted zone with a radius of at least one cases of outbreaks

kilometre around the holding.

of LPAI.

(1) The competent authority shall ensure that the following Measures

applied in the

measures are applied in the restricted zone>

restricted zone.

(a) a census of all commercial holdings is made as soon as

possible<

(b) laboratory tests are carried out on commercial poultry

holdings within a radius of at least one kilometre around the holding

in accordance with the diagnostic manual<

(c) all movements of poultry, other captive birds, ready-to-

lay poultry, day old chicks and eggs within or into the restricted

zone are subject to authorisation and to other control measures

deemed appropriate by the competent authority< this restriction

shall not apply to the transit through the restricted zone on road or

rail without unloading or stopping<

(d) the movement of poultry, other captive birds, ready-to-

lay poultry, day-old chicks and eggs from the restricted zone are

prohibited unless the competent authority authorises the direct

transport of>

(i) poultry for slaughter to a slaughterhouse in the same

Member State<

(ii) live poultry to a holding or shed in the same

Member State in which there is no other poultry. The live

poultry shall remain there for 21 days and the holding shall

be placed under official surveillance following their arrival<

(iii) day-old chicks>to a holding or shed of such holding

in the same Member State< the day old chicks shall remain

there for 21 days and the holding shall be placed under official

surveillance following their arrival< or if hatched from eggs

originating from poultry holdings located outside of the

restricted zone to any other holding provided that the hatchery

can ensure by its logistics and biosecurity working conditions

that any contact is excluded with hatching eggs or day-old

chicks originating from poultry flocks within the restricted

zone and which are therefore of a different health status<

(iv) hatching eggs to a designated hatchery< the eggs

and their packaging shall be disinfected before dispatch and

the tracing back of these eggs must be ensured<

(v) table eggs to a packing centre provided that they

are packed in disposable packaging and that all biosecurity

measures required by the competent authority are applied<

(vi) eggs to an establishment for the manufacture of

egg products as set out in Chapter II of Section X of Annex

III to Regulation (EC) No 853#2004 to be handled and treated

in accordance with Chapter XI of Schedule II to Regulation

(EC) No 852#2004 located inside or outside the restricted zone<

(vii) eggs for disposal<

(e)

carcases shall be disposed of<

(f) any person entering or leaving holdings in the restricted

zone observes appropriate biosecurity measures aimed at

preventing the spread of avian influenza<

(g) vehicles and equipment used for transporting live poultry

or other captive birds, feed, manure, slurry and bedding and any

other material or substances likely to be contaminated are cleansed

and disinfected without delay after contamination, by one or more

of the procedures set down in Rule 49<

(h) no poultry, other captive birds or mammals of domestic

species may enter or leave a holding without authorization of the

competent authority. This restriction shall not apply to mammals

which have access only to the living areas for humans in which

they>

(i) have no contact with resident poultry or other

captive birds, and

(ii) have no access to any cages or areas where such

resident poultry or other captive birds are kept.

(i) the removal or spreading of used litter, manure or slurry

is prohibited, unless authorised by the competent authority< the

movement of manure or slurry may be authorized from a holding

situated in the restricted zone under biosecurity measures to a

designated plant for treatment or for intermediate storage for

subsequent treatment to destroy the possible presence of avian

influenza viruses in accordance with Rule (EC) No 1774#2002 or

with specific rules which may be adopted in accordance with the

procedure referred to in Rule 65(2)<

(j) fairs, markets, shows or other gatherings of poultry or

other captive birds are prohibited, unless authorised by the

competent authority<

(k) poultry or other captive birds for restocking of game

are not released.

(2) The competent authority may, based on a risk

assessment, introduce further measures in addition to the measures

provided for in this Section and shall inform the Commission thereof.

(3) Further measures may be adopted to prevent the spread

of avian influenza in accordance with the procedure referred to in Rule

65(3).

The measures provided for in this Section shall be maintained> Duration of

measures.

(a) at least 21 days following the date of completion of

preliminary cleansing and disinfection of the infected holding by

one or more of the procedures set down in Rule 49, and until the

competent authorities, based on the investigations and laboratory

tests carried out in the restricted zone in accordance with the

diagnostic manual and a risk assessment, consider that the risk of

spread of LPAI is negligible<

(b) at least 42 days following the date of confirmation of

the outbreak and until the competent authorities, based on the

investigations and laboratory tests carried out in the restricted zone

in accordance with the diagnostic manual and a risk assessment,

consider that the risk of spread of LPAI is negligible< or

(c) for any other duration and under conditions to be

established in accordance with the procedure referred to in Rule

65(3).

(1) Where LPAI is confirmed in a hatchery, the competent

authority may, based on a risk assessment, derogate from some or all of

the measures provided for in Rules 44 and 45.

(2) The competent authority may grant derogations from

the measures provided for in this Section in cases of an outbreak of

LPAI in a non-commercial holding, a circus, a zoo, a pet bird shop, a

wild life park, a fenced area where poultry or other captive birds are

kept for scientific purposes or purposes related to the conservation of

endangered species or officially registered rare breeds of poultry or

other captive birds, provided that such derogations do not endanger

disease control.

(3) In granting the derogation provided for in sub-rules (1)

and (2) Malta shall immediately inform the Commission thereof.

(4) The Commission shall review the situation with Malta

and in the Committee as soon as possible.

(5) Taking account of any derogation granted, as provided

for in sub-rules 1 and 2, measures to prevent the spread of avian influenza

may be adopted in accordance with the procedure referred to in Rule 65

(3).

CHAPTER VI

MEASURES AIMED AT AVOIDING THE SPREAD OF

INFLUENZA VIRUSES OF AVIAN ORIGIN TO OTHER

SPECIES

(1) The competent authority shall ensure that following Laboratory tests and

other measures

confirmation of avian influenza on any holding, appropriate laboratory concerning pigs and

tests, in accordance with the diagnostic manual, are carried out on any other species.

pigs present on the holding to confirm or exclude that those pigs are, or

have been, infected with the avian influenza virus. No pigs shall be

moved from the holding pending the results of those tests.

(2) Where laboratory tests provided for in sub-Rule (1)

confirm positive findings for avian influenza viruses in pigs, the

competent authority may authorise the movement of those pigs to other

pig holdings or to designated slaughterhouses, provided that subsequent

appropriate tests have shown that the risk of spread of avian influenza

is negligible.

(3) The competent authority shall ensure that where

laboratory tests provided for in sub-Rule 1 confirm a serious health

threat, the pigs are killed as soon as possible under official supervision

and in such a way as to prevent the spread of avian influenza virus, in

particular during transport, and in accordance with the Animal Slaughter

or Killing (Protection) Rules, 2003.

(4) The competent authority may, following confirmation

of avian influenza on any holding, and based on a risk assessment, apply

the measures provided for in sub-rules (1), (2) and (3) to any other

mammals present on the holding and may extend those measures to

contact holdings.

(5) Malta shall inform the Commission within the

framework of the Committee of the results of the tests and measures

applied pursuant to sub-rules (1)to (4).

(6) The competent authority may, following confirmation

of avian influenza virus in pigs or any other mammals on any holding,

undertake surveillance in accordance with the diagnostic manual to

identify any further spread of avian influenza virus.

(7) Additional measures to prevent the spread of influenza

viruses of avian origin to other species, may be adopted in accordance

with the procedure referred to in Rule 65(3).

CHAPTER VII

CLEANSING, DISINFECTION AND RE-POPULATION

Malta shall ensure that>

(a) the cleansing, disinfection and treatment of holdings and

any materials or substances therein which are contaminated or likely

to be contaminated with avian influenza viruses are carried out

under official supervision in accordance with>

(i) the instructions of the official veterinarian< and

(ii) the principles and procedures for cleansing,

disinfecting and treatment set out in Schedule VI<

(b) any land or pastures used by poultry or other captive

birds on a holding where avian influenza has been confirmed are

not used by poultry or other captive birds until the competent

authority is satisfied that any avian influenza virus present has

been eliminated or inactivated<

(c) the cleansing, disinfection and treatment of

slaughterhouses, vehicles, trailers or any other means of transport,

border inspection posts and any materials or substances therein

which are contaminated or likely to be contaminated with avian

influenza viruses are carried out under official supervision in

accordance with the instructions of the official veterinarian<

(d) any equipment, materials or substances therein which

are contaminated or likely to be contaminated with avian influenza

viruses and which cannot be effectively cleansed and disinfected

or treated are destroyed<

(e) the disinfectants to be used and their concentrations are

authorised by the competent authority.

(1) Malta shall ensure that sub-rules 2 to 6 of this Rule are

complied with, following the application of the measures provided for

in Rules 12 and 40.

(2) The re-population of commercial poultry holdings shall

not take place for a period of 21 days following the date of completion

of the final cleansing and disinfection as provided for in Rule 49.

(3) The following measures shall be performed during a

period of 21 days following the date of the re-population of the

commercial poultry holdings>

(a) the poultry undergo at least one clinical examination

carried out by the official veterinarian. That clinical examination,

or if more than one is carried out, the final clinical examination, is

undertaken as near as possible to the end of the 21 day period

referred to above<

(b) laboratory tests are carried out in accordance with the

diagnostic manual<

(c) poultry that die during the re-population phase are tested

in accordance with the diagnostic manual<

(d) any person entering or leaving the commercial poultry

holding complies with appropriate biosecurity measures aimed at

preventing the spread of avian influenza<

(e) during the re-population phase no poultry leaves the

commercial poultry holding without the authorisation of the

competent authority<

(f) the owner keeps a record on the production data,

including morbidity and mortality data, which must be updated

regularly<

(g) any significant change in production data, as referred to

in paragraph(f), and other abnormalities are immediately reported

to the competent authority.

(4) Based on a risk assessment, the competent authority may

order that the procedures provided for in sub-Rule 3 be applied to

holdings other than commercial poultry holdings or other species on a

commercial poultry holding.

(5) The re-repopulation of poultry in contact holdings shall

take place in accordance with the instructions of the competent authority

based on a risk assessment.

CHAPTER VIII

DIAGNOSTIC PROCEDURES, DIAGNOSTIC MANUAL AND

REFERENCE LABORATORIES

(1) Malta shall ensure that diagnostic procedures, sampling

and laboratory testing to detect the presence of avian influenza in poultry

or other captive birds or avian influenza virus in mammals are carried

out in accordance with the diagnostic manual in order to ensure uniform

procedures for its diagnosis. That manual shall be adopted in accordance

with the procedure referred to in Rule 65(2). Any subsequent amendment

to the manual shall be adopted in accordance with the same procedure.

(2) The diagnostic manual provided for in sub-Rule 1 shall

establish at least the following>

(a) minimum biosecurity requirements and quality standards

to be observed by approved laboratories carrying out tests for the

diagnosis of avian influenza<

(b) criteria and procedures to be followed when clinical or

postmortem examinations are carried out to confirm or exclude

the presence of avian influenza<

(c) criteria and procedures to be followed for the collection

of samples from poultry or other captive birds for laboratory tests

to confirm or exclude the presence of avian influenza< including

sampling methods for serological or virological screenings carried

out in accordance with these rules <

(d) laboratory tests to be used for the diagnosis of avian

influenza, including>

(i) tests for the differential diagnosis<

(ii) tests to distinguish HPAI and LPAI viruses<

(iii) suitable tests to distinguish between birds

vaccinated and those infected with the field strain of avian

influenza<

(iv) criteria for the evaluation of the results of the

laboratory tests<

(e) laboratory techniques for the typing of avian influenza

virus isolates.

(3) Malta shall ensure that avian influenza viruses, their

genome and antigens, and vaccines for research, diagnosis or

manufacture of vaccine shall be manipulated or used only in places,

establishments or laboratories approved by the competent authority

where the appropriate biosecurity requirements are guaranteed. The list

of approved places, establishments or laboratories shall be transmitted

to the Commission and kept up-to-date.

(1) The laboratory named in Schedule VII shall be the Reference

laboratories.

Community reference laboratory for avian influenza (hereinafter referred

to as ‘the Community reference laboratory’).

Without prejudice to Decision 90#424#EEC, the Community

reference laboratory shall carry out the functions and duties listed in

Schedule VII.

(2) Malta shall designate national reference laboratories and

communicate to the Commission and other Member States the details

thereof and any subsequent changes. The Commission shall publish

and update the list of such national reference laboratories.

(3)

Malta shall ensure that the national reference

laboratories>

(a)

carry out the functions and duties set out in Schedule

VIII<

(b) are responsible for co-ordinating standards and methods

of diagnosis in each Member State in accordance with Schedule

VIII and liasing with the Community reference laboratory.

(4) The Community reference laboratory shall maintain

close cooperation and contact with the OIE and FAO reference

laboratory for avian influenza and, as appropriate, with other

internationally recognised laboratories within the Community in order

to ensure training, excellence and support to national reference

laboratories in Malta and Third Countries.

CHAPTER IX

VACCINATION

SECTION 1

General prohibition of vaccination

(1) Malta shall ensure that>

(a) vaccination against avian influenza is prohibited on their

territory, except as provided for in Sections 2 and 3<

(b) the handling, manufacture, storage, supply, distribution

and sale of avian influenza vaccines on their territory are carried

out under official supervision<

(c) only vaccines authorised in accordance with the

Veterinary Medical Products Rules, 2004 or Regulation No

726#2004 of the European Parliament and of the Council of the 31

March 2004 laying down Community procedures for the

authorisation and supervision of medicinal products for human

and veterinary use and establishing a European Medicines Agency

are used.

(2) Rules relating to the conditions of supply and storage

of stocks of avian influenza vaccines in the Community may be adopted

in accordance with the procedure referred to in Rule 65(2).

SECTION 2

Emergency vaccination

(1) Malta may introduce emergency vaccination in poultry

or other captive birds as a short term measure to contain an outbreak

when a risk assessment indicates there is a significant and immediate

threat of avian influenza spreading within or into the Member State

concerned in accordance with this Section where there is one or more

of the following>

(a)

an outbreak within that Member State<

(b) an outbreak in a nearby Member State< or

(c) where avian influenza has been confirmed in poultry or

other captive birds in a nearby third country.

(2) Where a Member State intends to introduce emergency

vaccination, as provided for in sub-Rule 1, it shall submit an emergency

vaccination plan to the Commission for its approval. That plan shall be

in accordance with a DIVA strategy and contain at least the following

information>

(a) the disease situation which has led to the application for

emergency vaccination<

(b) the geographical area in which emergency vaccination

is to be carried out and the number of holdings in that area and the

number of holdings to be vaccinated if different<

(c) the species and categories of poultry or other captive

birds or, if appropriate, the poultry or other captive birds

compartment to be vaccinated<

(d) the approximate number of poultry or other captive birds

to be vaccinated<

(e)

the summary of the vaccine characteristics<

(f) the envisaged duration of the emergency vaccination

campaign<

(g) the specific provisions on the movements of vaccinated

poultry or other captive birds which shall be without prejudice to

the measures provided for in Sections 3, 4 and 5 of Chapter IV and

Section 3 of Chapter V<

(h) the criteria for deciding if emergency vaccination is to

be applied in contact holdings<

(i) the record keeping and registration of the vaccinated

poultry or other captive birds<

(j) clinical and laboratory tests to be carried out in the

holdings where emergency vaccination is to be carried out and in

other holdings located in the emergency vaccination area in order

to monitor the epidemiological situation, the effectiveness of the

emergency vaccination campaign and the control of movements

of vaccinated poultry or other captive birds.

(3) Detailed rules for emergency vaccination may be

established in accordance with the procedure referred to in Rule 65(2).

(1) The Commission shall immediately examine the

emergency vaccination plan, as provided for in Rule 54(2), together

with the Member State concerned and shall review the situation in the

Committee as soon as possible.

(2) The emergency vaccination plan shall be approved in

accordance with the procedure referred to in Rule 65(3).

The approval of the emergency vaccination plan may include

measures restricting the movements of poultry or other captive birds

and their products. Those measures may include restrictions concerning

specific poultry compartments and other captive birds compartments

and the establishment of restricted zones.

(1) By way of derogation from Rule 55, Malta may apply

emergency vaccination before approval of the emergency vaccination

plan, subject to the following conditions>

(a) the Commission is notified of the emergency vaccination

plan and the decision to apply emergency vaccination before the

commencement of the emergency vaccination<

(b) Malta prohibits the movement of poultry or other captive

birds and their products except under the conditions provided for

in Schedule IX<

(c) the decision to apply emergency vaccination does not

endanger disease control.

(2) When a Member State applies the derogation provided

for in sub-Rule 1, the disease situation and the emergency vaccination

plan shall be reviewed in the Committee as soon as possible.

(3) The measures applied may be approved or changed in

accordance with the procedure referred to in Rule 65(3).

SECTION 3

Preventive vaccination

(1) Malta may introduce preventive vaccination in poultry

or other captive birds as a long term measure in accordance with this

Section where they deem that on the basis of a risk assessment certain

areas of their territory, type of poultry husbandry or certain categories

of poultry or other captive birds or the poultry or other captive birds

compartments are exposed to the risk of avian influenza.

(2) Where a Member State intends to introduce preventive

vaccination, as provided for in sub-Rule 1, it shall submit a preventive

vaccination plan to the Commission for its approval. That plan shall be

in accordance with a DIVA strategy and contain at least the following

information>

(a) a clear description of the reasons for the preventive

vaccination, including the disease history<

(b) the area, type of poultry husbandry or certain categories

of poultry or other captive birds or the poultry or other captive

birds compartments in which the preventive vaccination is to be

carried out and the number of holdings in that area and the number

and type of holdings to be vaccinated if different<

(c) the species and categories of poultry or other captive

birds or, if appropriate, the poultry or other captive birds

compartment to be vaccinated<

(d) the approximate number of poultry or other captive birds

to be vaccinated<

(e)

a summary of the vaccine characteristics<

(f) the envisaged duration of the preventive vaccination

campaign<

(g) the specific provisions on the movements of vaccinated

poultry or other captive birds which shall be without prejudice to

the measures provided for in Sections 3, 4 and 5 of Chapter IV and

Section 3 of Chapter V<

(h) the record keeping and registration of the vaccinated

poultry or other captive birds<

(i) the laboratory tests to be carried out in accordance with

the Diagnostic Manual in the holdings where preventive vaccination

is to be carried out at the same time as surveillance and testing in

an appropriate number of other holdings located in the vaccination

area or the poultry or other captive birds compartments in order to

monitor the epidemiological situation, the effectiveness of the

preventive vaccination campaign and the control of movements of

vaccinated poultry or other captive birds.

(3) Detailed rules for preventive vaccination may be

established in accordance with the procedure referred to in Rule 65(2).

(1) The Commission shall immediately examine the

preventive vaccination plan provided for in Rule 57(2), together with

the Member State concerned and shall review the situation in the

Committee as soon as possible.

(2) The preventive vaccination plan shall be approved in

accordance with the procedure referred to in Rule 65(3).

The approval of the preventive vaccination plan may include

measures restricting the movements of poultry or other captive birds

and their products. Those measures may include restrictions concerning

specific poultry compartments and other captive birds compartments

and the establishment of restricted zones.

SECTION 4

Vaccine banks

Community vaccine

(1) A Community vaccine bank for the storage of

Community reserves of avian influenza vaccines authorised in

accordance with the Veterinary Medical Products Rules, 2004, or Rule

(EC) No 726#2004 may be established in accordance with the procedure

referred to in Rule 65(2).

(2) Malta shall have access to the Community vaccine bank

on request to the Commission.

(3) Where it is in the interest of the Community, the

Commission may supply vaccines to third countries. Without prejudice

to agreements concluded between the Community and third countries,

the access of third countries to the Community vaccine bank shall be

authorised in accordance with the procedure referred to in Rule 65(3),

subject to detailed arrangements between the Commission and the third

country concerned on the financial and technical cooperation to be

adopted in accordance with that procedure.

(1) Malta may, within the framework of the contingency

plan provided for in Rule 63, establish or maintain a national vaccine

bank for storage of reserves of avian influenza vaccines authorised in

accordance with Regulation 5 to Regulation 15 of Veterinary Medicinal

Products Regulations, 2004, to be used for emergency or preventive

vaccination.

(2) Malta maintaining a national vaccine bank shall inform

the Commission of the quantities and types of the stored vaccines.

CHAPTER X

COMMUNITY CONTROLS, PENALTIES AND

CONTINGENCY PLANS

Commission experts may make on-the-spot checks in Community

controls.

cooperation with the competent authority, in so far as it is necessary to

ensure uniform application of this Directive in accordance with

Commission Decision 98#139#EC of 4th February,1998, laying down

certain detailed rules concerning on-the-spot checks carried out in the

veterinary field by Commission experts in the Member State and Article

45 of Regulation (EC) No 882#2004 of the European Parliament and of

the Council of 29 th April, 2004 on official controls performed to ensure

the verification of compliance with feed and food law, animal health

and animal welfare rules.

Malta shall lay down the rules on penalties applicable to Penalties.

infringements of national provisions adopted pursuant to these rules

and shall take all measures necessary to ensure that they are

implemented. The penalties provided for shall be effective, proportionate

and dissuasive. Malta shall notify the Commission and shall notify it

without delay of any subsequent amendment affecting them.

(1) Malta shall draw up a contingency plan in accordance Contingency plan.

with Schedule X specifying the national measures to be implemented

in the event of an outbreak and submit that plan to the Commission for

approval.

(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. It shall give an

indication of the number and location of all commercial poultry holdings.

The contingency plan should give an indication of the maximum number

of poultry, by species, that could be present on these commercial

holdings. Malta should also estimate the amount of vaccine that would

be needed in the event of emergency vaccination.

(3) Provisions shall be in place for close cooperation

between the competent authorities responsible for the different sectors,

particularly those in charge of animal health, public health,

environmental matters and health and safety of workers, in particular to

ensure proper risk communication to farmers, workers in the poultry

sector and the public.

(4) The Commission shall examine the contingency plans

in order to determine whether they permit the desired objective to be

attained and shall suggest to the Member State concerned any

amendments required, in particular to ensure that they are compatible

with those of the other Member States. The contingency plans shall be

approved in accordance with the procedure referred to in Rule 65(2).

Any subsequent amendments to that plan shall be adopted in accordance

with the same procedure.

(5) Malta shall update the contingency plan at least every

five years and submit it to the Commission for approval in accordance

with the procedure referred to in Rule 65(2).

(6) In addition to the measures provided for sub-rules (1)

to 4, further rules to ensure a rapid and efficient eradication of avian

influenza, including provisions on disease control centres, expert groups

and real-time alert exercises, may be adopted in accordance with the

procedure referred to in Rule 65(2).

CHAPTER XI

IMPLEMENTING POWERS AND COMMITTEE

PROCEDURE

(1) Detailed rules necessary for the implementation of these

rules shall be adopted in accordance with the procedure referred to in

Rule 65(2) and may include in particular specific rules concerning>

(a)

the disposal of carcases, and

(b) the movement and treatment of feed, bedding, used litter,

manure and slurry contaminated or suspected to be contaminated.

(2) Any amendments to the Schedules to take account of

scientific and technical progress shall be decided in accordance with

the procedure referred to in Rule 65(2).

(3) Detailed rules required by the epidemiological situation

to supplement the minimum control measures provided for in this

Directive shall be adopted in accordance with the procedure referred to

in Rule 65(3).

(4) Without prejudice to the safeguard measures provided

for in Regulation 10 of the Veterinary Checks applicable in Intra-

Community Trade with Member States in Animal Products Regulations,

2003, or Regulation 11 of the Veterinary and Zootechnical Checks

applicable in Trade with Member States in certain Live Animals and

Products Regulations, 2003, temporary emergency measures required

due to a serious health threat caused by influenza viruses of avian origin

other than those referred to in paragraph1 of Rule 2, shall be adopted in

accordance with the procedure referred to in Rule 65(3).

(1) The Commission shall be assisted by the Standing Committee

procedure.

Committee on the Food Chain and Animal Health established by

Regulation (EC) No 178#2002 of the European Parliament and of the

Council of 28 January 2002 laying down the general principles and

requirements of food law, establishing the European Food Safety

Authority and laying down procedures in matters of food safety.

(2) Where reference is made to this sub-Rule, Articles 5

and 7 of Decision 1999#468#EC shall apply. The period laid down in

Rule 5(6) of Decision 1999#468#EC shall be set at three months.

(3) Where reference is made to this sub-rule , Rules 5 and

7 of Decision 1999#468#EC shall apply. The period laid down in Rule

5(6) of that Decision shall be set at 15 days.

(4) The Committee shall adopt its Rules of Procedure.

B