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sl_437.93 MT

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

76 Articles / Provisions · Malta
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Table of Provisions (76)

Preamble Reg. 1 Title and scope. Schedule I Reg. 2 Subject matter. Schedule Ii Reg. 3 Definitions. Schedule Iii Reg. 4 Preventive biosecurity measures. Schedule Iv Reg. 5 Surveillance programmes. Schedule V Reg. 6 Notification. Schedule Vi Reg. 7 Epidemiological inquiry. Schedule Vii Reg. 8 Measures to be applied on holdings where outbreaks are suspected. Schedule Viii Reg. 9 Derogations from certain measures to be applied on holdings where outbreaks are suspected. Schedule Ix Reg. 10 Duration of the measures to be applied on holdings where outbreaks are suspected. Schedule X Reg. 11 Additional measures based on an epidemiological inquiry. Reg. 12 Measures to be applied on holdings where outbreaks are confirmed. Reg. 13 Derogations. Reg. 14 Derogations concerning certain holdings. Reg. 15 Measures to be applied in cases of outbreaks of HPAI in separate production units. Reg. 16 Measures to be applied in contact holdings. Reg. 17 Establishment of protection, surveillance and further restricted zones in cases of outbreaks of HPAI. Reg. 18 Measures to be applied both in the protection and in the surveillance zones. Reg. 19 Census and visits by the official veterinarian and surveillance. Reg. 20 Measures to be applied on holdings in protection zones. Reg. 21 Prohibition on the removal or spreading of used litter, manure or slurry from holdings. Reg. 22 Fairs, markets or other gatherings and re-stocking of game. Reg. 23 Prohibition on the movement and transport of birds, eggs, poultry meat and carcases. Reg. 24 Reg. 25 Derogations for the direct transport of day-old chicks. Reg. 26 Derogations for the direct transport of ready to lay poultry. Reg. 27 Derogation for the direct transport of hatching and table eggs. Reg. 28 Derogation for the direct transport of carcases. Reg. 29 Cleansing and disinfecting of means of transport. Reg. 30 Duration of measures. Reg. 31 Measures to be applied in the surveillance zones. Reg. 32 Duration of measures. Reg. 33 Measures to be applied in further restricted zones. Reg. 34 Derogations. Reg. 35 Additional biosecurity measures. Reg. 36 Investigation of suspected presence of HPAI in slaughterhouses and in means of transport. Reg. 37 Measures to be applied in slaughterhouses. Reg. 38 Measures to be applied in border inspection posts or means of transport. Reg. 39 Additional measures to be applied to slaughterhouses, border inspection posts or means of transport. Reg. 40 Measures to be applied. Reg. 41 Derogations for certain holdings. Reg. 42 Measures to be applied in cases of outbreaks of LPAI in separate production units. Reg. 43 Measures to be applied in contact holdings. Reg. 44 Establishment of restricted zones in cases of outbreaks of LPAI. Reg. 45 Measures to be applied in the restricted zone. Reg. 46 Duration of measures. Reg. 47 Derogations. Reg. 48 Laboratory tests and other measures concerning pigs and other species. Reg. 49 Cleansing, disinfection and procedures for eliminating avian influenza virus. Reg. 50 Re-population of holdings. Reg. 51 Diagnostic procedures and diagnostic manual. Reg. 52 Reference laboratories. Reg. 53 Manufacture, sale and use of avian influenza vaccines. Reg. 54 Emergency vaccination in poultry or other captive birds. Reg. 55 Approval of emergency vaccination plans. Reg. 56 Derogations. Reg. 57 Preventive vaccination in poultry or other captive birds. Reg. 58 Approval of preventive vaccination plan. Reg. 59 Community vaccine bank. Reg. 60 National vaccine banks. Reg. 61 Community controls. Reg. 62 Penalties. Reg. 63 Contingency plan. Reg. 64 Implementing powers. Reg. 65 Committee procedure.

Statutory Text (76 Articles)

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

SUBSIDIARY LEGISLATION 437.93

MEASURES FOR THE CONTROL OF AVIAN

INFLUENZA RULES *

29th February, 2008

LEGAL NOTICE 88 of 2008, as amended by Legal Notice 256 of 2010.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

of Avian Influenza Rules.

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

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

the control of avian influenza and repealing Directive 92/40/EEC.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 paragraph 2.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1)

These rules set out

(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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[Rule 6(2)]

Notification of disease and further epidemiological information

to be provided by Member States

1. Within twenty-four hours of the confirmation of any primary outbreak or

detection of avian influenza in a slaughterhouse or means of transport, Malta shall

notify in accordance with the procedure referred to in Article 5 of Directive 82/894/

(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;

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

(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 paragraph 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 paragraphs

1 and 2 must be forwarded within the time-limits laid down in Article 4(1) of

Directive 82/894/EEC.

4. Malta shall ensure that the information to be provided in accordance with

paragraphs 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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

twenty-four hours where a serious threat to health is identified as a result of any

surveillance.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

For the purposes of these rules, the following 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

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

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

vehicles or in any other way;

"day-old chicks" means all poultry less than seventy-two hours

old, not yet fed, and muscovy ducks (Cairina moschata) or their

crosses, less than seventy-two 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) Regulation (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 the

definition of "poultry" 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 re-stocking 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[Rules 9(3) and 14(3)]

Authorisation to remove eggs from a holding in accordance

with rules 9(3) and 14(3)

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

subject to the provisions of rules 9(3) and 14(3) to an establishment approved for the

manufacture of egg products in accordance with Regulation (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 paragraph 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 paragraph 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.

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

Specific provisions concerning preventive biosecurity

measures may be established in accordance with the procedure

referred to in rule 65(2).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[Rules 16(2), 33(2) and 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 N o c l i n i c a l s i g n s s u g g e s t i n g a v i a n

in contact holdings

influenza on the contact holdings and

no epidemiological link

High susceptibility of predominant poultry L o w s u s c e p t i b i l i t y o f p r e d o m i n a n t

species

poultry species

Movement of poultry or other captive N o k n o w n m o v e m e n t o f p o u l t r y o r

birds from holdings where avian influenza other captive birds from the holdings

has been confirmed to contact holdings w h e r e a v i a n i n f l u e n z a h a s b e e n

after the likely time of introduction of confirmed to contact holdings after the

virus on to those infected holdings

likely time of 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 D i s e a s e p r e s e n t b u t w i t h l i m i t e d

with likely spreading of virus from the spreading of virus from the holdings

holdings where avian influenza has been w h e r e a v i a n i n f l u e n z a h a s b e e n

confirmed before application of confirmed before application of

eradication measures

eradication measures

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

metres (1) of the holdings where avian 500 metres (1) from the holdings where

influenza has been confirmed

avian influenza has been confirmed

The contact holdings are linked to more The contact holdings are not linked to

than one holding where avian influenza holdings where avian influenza has

has been confirmed

been 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1)

Malta shall carry out surveillance programmes in order

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 rule 2(1)(a)

shall comply with guidelines to be drawn up by the Commission in

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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) Malta shall ensure that the suspected presence and

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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-

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

contamination of the previously cleansed parts must be avoided;

(h) washing, disinfecting or destroying of equipment, installations, articles

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 these rules

rules 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 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 twenty-

four hours;

(b) final cleansing and disinfection

(i)

manure and used bedding must be removed and treated as

provided in paragraph 3(a) of this Schedule;

(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.

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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

forty-two days;

(b) slurry must be stored for at least sixty 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). 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 paragraphs 1 and 2, the competent

authority may establish specific procedures for cleansing and disinfection, taking

into account the type 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 twelve

months.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) Malta shall ensure that epidemiological inquiries are

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 at

least

(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

shall be immediately informed of the results of all findings of the

inquiry.

CHAPTER III

SUSPECTED OUTBREAKS

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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;

(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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

appropriate, with other internationally recognised laboratories within

the Community.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority may grant derogations from

the measures provided for in rule 8(2)(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)(h) in the case of other

captive birds kept on non-commercial holdings.

(3) With reference to rule 8(2)(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 Regulation (EC) No 853/2004, to be

handled and treated in accordance with Chapter XI of

Annex II to Regulation (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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[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

paragraphs 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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

sub-paragraph (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

(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 Regulation (EC) No 853/

2004 to be handled and treated in accordance with Chapter XI of

Schedule II to Regulation (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 Regulation (EC) No 852/2004;

(c) day-old chicks shall

(i) not have been vaccinated;

(ii) originate from hatching eggs satisfying the conditions set out in

paragraph 2(a), paragraph 3(a) or paragraph 4(a) of this Schedule;

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

poultry;

(d) live poultry or other captive birds shall

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

(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

forty-eight 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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 on the holding has been ruled out.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

[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.

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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 estimat e of the amount of vaccine r equired and it s

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.

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

implementation of the contingency plans.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) Based on the preliminary results of an epidemiological

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 seventy-two 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) In case of an outbreak of HPAI, the competent

authority shall ensure that the measures provided for in rule 8(2)

and (3) and sub-rules (2) to (10) of this rule are applied.

(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

ho usi ng them , pastures or land, the equipm ent lik ely 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 Malta 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 rules 14(1) and 15, measures to prevent the spread of avian

influenza may be adopted in accordance with the procedure

referred to in rule 65(3).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority may grant derogations from

the measures provided for in the first paragraph 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 Regulation (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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

In cases of an outbreak of HPAI in a holding which

consists of two or more separate production units, the competent

authority may grant derogations from the measures provided for in

the rule 12(2) for 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 ten

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority shall ensure that the

following measures are applied within the protection and

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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

accordance with the diagnostic manual in order to

identify any further spread of avian influenza in the

holdings located in the protection zone.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The competent authority shall ensure that the following

measures are applied on holdings 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The competent authority shall ensure that the removal or

spreading of used litter, m anure 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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The competent authority shall ensure that fairs, markets,

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 twenty-one 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

authority may authorise the direct transport of poultry originating

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

designated slaughterhouse subject to the following conditions

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

origin is carried out by the official veterinarian within

twenty-four 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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, 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; 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 another

holding or shed of that holding, 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 twenty-one 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, 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

By way of derogation from rule 23, the competent

authority may authorise the direct transport of ready-to-lay poultry

to a holding 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 twenty-one days.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

authority may authorise the direct transport of hatching eggs either

from any holding to a hatchery located, in the protection zone and

designated 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 Regulation (EC) No 853/2004 to be

handled and treated in accordance with Chapter XI of

Schedule II to Regulation (EC) No 852/2004; or

(c) for disposal.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

maintained for at least twenty-one 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), 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The competent authority shall ensure that the following

measures are applied in 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)(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; 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 twenty-one days;

(iii) day-old chicks;

to another holding or shed of such holding 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

twenty-one 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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 Regulation (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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The measures provided for in this Section shall be

maintained for at least thirty 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

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

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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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(b) and (c), rule 23, and in rule

31(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 H PAI Malta may, based on a r isk 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

Malta 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 Malta unless otherwise decided in accordance

with the procedure referred in rule 65(3).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

competent authority may, in addition to the measures provided for

in 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. Those

measures may include restrictions on movements of vehicles or

p e r s o n s f o r f e e d s u p p l y, e g g c o l l e c t i o n , t h e t r a n s p o r t t o

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 Malta

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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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 of the poultry or other captive birds to confirm or

exclude its presence in accordance with the diagnostic manual.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 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.

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

derived from the 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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,

s h a l l b e ke p t s e pa r a t e a nd u n d e r o ff i c i a l s u pe r v i s i o n u n ti l

investigations in accordance with the diagnostic manual have been

completed.

(3) If HPAI is confirmed, 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 disposed of as soon as

possible under official supervision.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The competent authority shall ensure that the following

additional measures are applied where HPAI is suspected or

confirmed in a slaughterhouse, border inspection post 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 twenty-four 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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

authority shall ensure that the measures provided for in rule

8(2)(a), (b), (c), (e), (g) and (h) and (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, 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

for in these rules 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 these rules 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 Regulation (EC) No 853/2004 to

be handled and treated in accordance with

Chapter XI of Schedule II to Regulation (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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority may grant derogations from the

measures provided for in rule 40(2) and (5) (b) 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 Malta, 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

Immediately following an outbreak of LPAI, the competent

authority shall establish a restricted zone with a radius of at least

one kilometre around the holding.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority shall ensure that the

following measures are applied in the 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

Malta;

(ii) live poultry to a holding or shed in Malta, where

there is no other poultry. The live poultry shall

remain there for twenty-one 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 Malta, where there is no other

poultry; the day old chicks shall remain there for

twenty-one 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

MEASURES FOR THE CONTROL OF AVIAN INFLUENZA

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 Regulation (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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

The measures provided for in this Section shall be

maintained

(a) at least twenty-one 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 forty-two 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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The competent authority shall ensure that following

confirmation of avian influenza on any holding, appropriate

laboratory tests, in accordance with the diagnostic manual, are

carried out on any 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.

(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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) Malta shall ensure that sub-rules (2) to (6) 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 twenty-one 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 twenty-one 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 twenty-one 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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

post mortem 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The laboratory named in Schedule VII shall be the

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) The competent authority shall designate a national

reference laboratory and shall make the details thereof, and any

subsequent changes thereto, available to the other Member States

and to the public in a manner that may be specified in accordance

with the procedure referred to in rule 65(2).

(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 Malta 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 Medicinal Products Regulations, 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 Malta

in accordance with this Section where there is one or more of the

following

(a) an outbreak within Malta;

(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 Malta 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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The Commission shall immediately examine the

emergency vaccination plan, as provided for in rule 54(2), together

with Malta 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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) By way of derogation from rule 55, Malta may apply

e m e rg e n c y v a c c i n a t i o n b e f o r e a p p r o v a l o f t h e e m e rg e n c y

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 Malta 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 Malta 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).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The Commission shall immediately examine the

preventive vaccination plan provided for in rule 57(2), together

with Malta 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) A Community vaccine bank for the storage of

Community reserves of avian influenza vaccines authorised in

accordance with the Veterinary Medicinal Products Regulations, or

Regulation (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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 regulations 5 to 15 of the Veterinary

Medicinal Products Regulations, to be used for emergency or

preventive vaccination.

(2) Where Malta maintains a national vaccine bank, it shall

inform the Commission of the quantities and types of the stored

vaccines.

CHAPTER X

COMMUNITY CONTROLS, PENALTIES AND

CONTINGENCY PLANS

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

Commission experts may make on-the-spot checks in

coo peration wit h the competent auth ority, in so far as it is

necessary to ensure uniform application of these rules 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 29th April, 2004

on official controls performed to ensure the verification of

compliance with feed and food law, animal health and animal

welfare rules.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

Malta shall lay down the rules on penalties applicable to

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.

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) Malta shall draw up a contingency plan in accordance

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 Malta 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

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(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 these

rules 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-

C om m un ity Tr a de wi th M e m be r St a tes in An im a l P ro duct s

Regulations, or regulation 11 of the Veterinary and Zootechnical

Checks applicable in Trade with Member States in certain Live

Animals and Products Regulations, temporary emergency measures

required due to a serious health threat caused by influenza viruses

of avian origin other than those referred to in paragraph 1 of

Schedule I, shall be adopted in accordance with the procedure

referred to in rule 65(3).

Laws of Malta — Subsidiary Legislation 437.93 — MEASURES FOR THE CONTROL OF AVIAN INFLUENZA RULES *

(1) The Commission shall be assisted by the Standing

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

Article 5(6) of Decision 1999/468/EC shall be set at three months.

(3) Where reference is made to this sub-rule, Articles 5 and 7

of Decision 1999/468/EC shall apply. The period laid down in

Article 5(6) of that Decision shall be set at fifteen days.

(4)

The Committee shall adopt its Rules of Procedure.

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