ANIMAL HEALTH REQUIREMENTS FOR AQUACULTURE ANIMALS AND PRODUCTS THEREOF, AND ON THE PREVENTION AND

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

SUBSIDIARY LEGISLATION 437.95

ANIMAL HEALTH REQUIREMENTS FOR

AQUACULTURE ANIMALS AND PRODUCTS

THEREOF, AND ON THE PREVENTION AND

CONTROL OF CERTAIN DISEASES IN AQUATIC

ANIMALS RULES *

20th Janury, 2009

LEGAL NOTICE 24 of 2009, as amended by Legal Notices 125 and 129

of 2013, and 24 of 2015.

CHAPTER I

Title, Scope and Definitions

(1) The title of these rules is the Animal Health

Requirements for Aquaculture Animals and Products thereof, and

on the Prevention and Control of Certain Diseases in Aquatic

Animals Rules.

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

2006/88/EC on animal health requirements for aquaculture, animals

and products thereof, and on the prevention and control of certain

diseases in aquatic animals, repealing and replacing Council Directive

93/53/EEC introducing minimum Community measures for the control

of certain fish diseases and Council Directive 95/70/EEC on the

introduction of minimum European Community measures for the

control of certain disease affecting bivalve molluscs.

(3)

These rules shall define

(a) the animal health requirements to be applied for the

placing on the market, the importation and the transit

of aquaculture animals and the products thereof;

(b) the minimum preventive measures aimed at increasing

the awareness and preparedness of the competent

authorities, aquaculture production business operators

and others related to this industry, for diseases in

aquaculture animals;

(c) the minimum control measures to be applied in the

event of a suspicion of, or an outbreak of certain

diseases in aquatic animals.

Amended by

L.N. 129 of 2013.

Definitions

In addition to the definitions in rule 3, the following technical definitions shall

apply

"common biosecurity system" means that the same aquatic animal health

surveillance, disease prevention, and disease control measures are applied;

"compartment" means one or more farms under a common biosecurity system

containing an aquatic animal population with a distinct health status with respect to a

specific disease;

"containment area" means an area around an infected farm or mollusc farming

area where disease control measures are applied with the purpose of preventing the

spread of the disease;

"disease" means a clinical or non-clinical infection with one or more aetiological

agents in aquatic animals;

"disease-free zones or compartments" means zones or compartments declared

disease-free in accordance with rules 49 or 50;

"emerging disease" means a newly identified serious disease, the cause of which

may or may not yet be established, that has the potential to be spread within and

between populations, such as by way of trade in aquatic animals and, or aquatic

animal products. It also means a listed disease identified in a new host species not

yet included in Part II of Schedule IV as a susceptible species;

"epidemiological unit" means a group of aquatic animals that share approximately

the same risk of exposure to a disease agent within a defined location. This risk may

be because they share a common aquatic environment, or because management

practices make it likely that a disease agent in one group of animals would quickly

spread to another group of animals;

"fallowing" means, for disease management purposes, an operation where a farm

is emptied of aquaculture animals susceptible to the disease of concern or known to

be capable of transferring the disease agent, and, where feasible, of the carrying

water;

"further processing" means processing of aquaculture animals before human

consumption by any type of measures and techniques affecting anatomical

wholeness, such as bleeding, gutting/evisceration, heading, slicing and filleting,

which produces waste or by-products and could cause a risk of spreading diseases;

"increased mortality" means unexplained mortalities significantly above the level

of what is considered to be normal for the farm or mollusc farming area in question

under the prevailing conditions. What is considered to be increased mortality shall

be decided in cooperation between the farmer and the department;

"infected zone or compartment" means zones or compartments where the infection

is known to occur;

"infection" means the presence of a multiplying, or otherwise developing, or latent

disease agent in, or on, a host;

"quarantine" means maintaining a group of aquatic animals in isolation with no

direct or indirect contact with other aquatic animals, in order to undergo observation

for a specified length of time and, where appropriate, testing and treatment,

including proper treatment of the effluent waters;

"susceptible species" means any species in which infection by a disease agent has

been demonstrated by natural cases or by experimental infection that mimics the

natural pathways;

"vector" means a species that is not susceptible to a disease but which is capable

of spreading infection by conveying pathogens from one host to another;

"zone" means a precise geographical area with a homogeneous hydrological

system comprising part of a water catchment area from the source or sources to a

natural or artificial barrier that prevents the upward migration of aquatic animals

from lower stretches of the water catchment area, an entire water catchment area

from its source or sources to its estuary, or more than one water catchment area,

including their estuaries, due to the epidemiological link between the catchment

areas through the estuary.

(1)

These rules shall not apply to

(a) ornamental aquatic animals reared in non-commercial

aquaria;

(b) wild aquatic animals harvested or caught for direct

entry into the food chain;

(c) aquatic animals caught for the purpose of production

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

of fish-meal, fish feed, fish oil and similar products.

(2) Chapter II, Sections 1 to 4 of Chapter III, and Chapter VII

shall not apply where ornamental aquatic animals are kept in pet

shops, garden centers, garden ponds, commercial aquaria, or with

wholesalers

(a) without any direct contact with natural waters in the

Community; or

(b) which are equipped with an effluent treatment system

reducing the risk of transmitting diseases to the natural

waters to an acceptable level.

(3) These rules shall apply without prejudice to provisions on

the conservation of species or the introduction of non-native

species.

L.N. 129 of 2013.

Information Required in the Official Register of

Aquaculture Production Businesses and Authorised

Processing Establishments

PART I

Authorised Aquaculture Production Business

1. The following minimum information on each aquaculture production

business shall be kept by the department in a register, as provided for in rule 6

(a) the name and addresses of the aquaculture production business, and

contact details (telephone, facsimile, e-mail);

(b) the registration number and particulars of the authorisation delivered

(that is, dates for specific authorisations, identification codes or

numbers, specified conditions for production, any other matter relevant

to the authorisations);

(c) the geographical position of the farm defined by a suitable system of

coordinates of all farm-sites (if possible, GIS coordinates);

(d) the purpose, type (that is, type of culture system, or facilities such as

land-based facilities, sea cages, earth ponds) and maximum volume of

production where this is regulated;

(e) for continental farms, dispatch centres and purification centres, details

on the farm’s water supply and discharges;

(f)

the species of aquaculture animals reared at the farm (for multi-species

farms or ornamental farms, it shall as a minimum be registered whether

any of the species are known to be susceptible to diseases listed in Part

II of Schedule IV, or known vectors of such diseases);

(g) updated information on the health status (that is, if the farm is disease-

free (located in a Member State, zone or compartment), where the farm

is under a programme with a view of achieving such status, or where the

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

farm is declared infected by a disease referred to in Schedule IV).

2. Where an authorisation is granted to a mollusc farming area in accordance

with the second proviso to rule 4(1), the data required pursuant to point 1 (a) of this

Part shall be recorded for all aquaculture production businesses which operate within

the mollusc farming area. The data required pursuant to points 1 (b) to 1 (g) of this

Part shall be recorded at mollusc farming area level.

PART II

Authorised Processing Establishments

The following minimum information on each authorised processing establishment

shall be kept by the department in a register, as provided for in rule 6

(a) the name and addresses of the authorised processing establishment, and

contact details (telephone, facsimile, e-mail);

(b) the registration number and particulars of the authorisation delivered

(that is, dates for specific authorisations, identification codes or

numbers, specified conditions for production, any other matter relevant

to the authorisations);

(c) the geographical position of the processing establishment defined by a

suitable system of coordinates (if possible GIS coordinates);

(d) details on the authorised processing establishment’s water effluent

treatment systems;

(e) the species of aquaculture animals handled in the authorised processing

establishment.

(1) For the purposes of these rules, the following

definitions shall apply

"the Act" means the Veterinary Services Act;

"aquaculture" means the rearing or cultivation of aquatic

organisms including fish, molluscs, crustaceans, other invertebrates

and aquatic plants, using techniques designed to increase the

production of those organisms beyond the natural capacity of the

environment and where the organisms remain the property of one or

more natural or legal persons throughout the rearing or culture

stages, up to and including harvesting;

"aquaculture anim al" means any aquatic animal at all its

lifestages, including eggs and sperm or gametes, reared in a farm or

mollusc farming area, including any aquatic animal from the wild

intended for a farm or mollusc farming area;

"aquaculture production business" means any undertaking,

whether for profit or not and whether public or private, carrying out

any of the activities related to the rearing, keeping or cultivation of

aquaculture animals;

"aquaculture production business operator" means any natural or

legal person responsible for ensuring that the requirements of these

rules are met within the aquaculture production business under

their control;

"aquatic animal" means

(a) fish belonging to the superclass Agnatha and to the

classes Chondrichthyes and Osteichthyes;

(b) mollusc belonging to the Phylum Mollusca;

(c) crustacean belonging to the Subphylum Crustacea;

"authorised processing establishment" means any food business

approved in accordance with Article 4 of Regulation (EC) No. 853/

2004 of the European Parliament and of the Council of 29 April

2004 laying down specific hygiene rules for food of animal origin,

f or pr o c e s s in g a q u a c u lt u re a ni m a l s f o r f o od pu r po s e s , a n d

authorised in accordance with rules 4 and 5 hereof;

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

"authorised processing establishment operator" means any

natural or legal person responsible for ensuring that the

requirements of these rules are met within the authorized

processing establishment under their control;

"the Commission" means the European Commission established

by the Treaty on the European Union as amended by the Lisbon

Treaty of 2009, subject to subsequent amendments;

"the department" means the department of veterinary services in

Malta as established by article 2 of the Act;

"EFTA Member States" means states which are members of the

European Free Trade Association;

"farm" means any premises, enclosed area, or installation

operated by an aquaculture production business in which

aquaculture animals are reared with a view to their being placed on

the market, with the exception of those where wild aquatic animals

harvested or caught for the purpose of human consumption are

temporarily kept awaiting slaughter without being fed;

"farming" means the rearing of aquaculture animals in a farm or

in a mollusc farming area;

"M e m b e r St a t e" m e an s a s t a t e w h i c h i s a m e m b e r o f t h e

European Union;

"mollusc farming area" means a production area or relaying area

in which all aquaculture production businesses operate under a

common biosecurity system;

"ornamental aquatic animal" means an aquatic animal which is

kept, reared, or placed on the market for ornamental purposes only;

"placing on the market" means the sale, including offering for

sale or any other form of transfer, whether free of charge or not,

and any form of movement of aquaculture animals;

" p r o d u c t i o n a r e a " m e a n s a n y f r e s h w a t e r, s e a , e s t u a r i n e ,

continental or lagoon area containing natural beds of molluscs or

sites used for the cultivation of molluscs, and from which molluscs

are taken;

"put and take fisheries" means ponds or other installations where

the population is maintained only for recreational fishing by

restocking with aquaculture animals;

"relaying area" means any freshwater, sea, estuarine or lagoon

area with boundaries clearly marked and indicated by buoys, posts

or any other fixed means, and used exclusively for the natural

purification of live molluscs;

"Standing Committee on the Food Chain and Animal Health" or

"the Committee" means a Committee made up of the

representatives of Member States named committee members, who

assist and consult the Commission by delivering an Opinion

regarding safety measures with respect to animal health issues to be

then formally adopted by the Commission in accordance with the

appropriate procedure. Such committee procedure covers the entire

food supply chain, ranging from animal health issues on the farm to

t h e p r o d u c t w h i c h a r r i v e s t o t he f i n a l c o n s u m e r, t h e r e f o r e

significantly enhancing its ability to target risks to health wherever

they arise in the production of food;

"wild aquatic animal" means an aquatic animal which is not an

aquaculture animal.

(2) For the purposes of these rules, the following definitions

shall also apply

(a) the technical definitions laid down in Schedule I;

(b) as appropriate, the definitions laid down respectively

in

(i)

Articles 2 and 3 of 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;

(ii) Article 2 of Regulation (EC) No. 852/2004;

(iii) Article 2 of Regulation (EC) No. 853/2004;

(iv) Article 2 of Regulation (EC) No. 882/2004.

CHAPTER II

Aquaculture Production Businesses

and Authorised Processing Establishments

Amended by

L.N. 129 of 2013.

Risk levels

A high-risk farm or mollusc farming area is a farm or mollusc farming area which

(a) has a high risk of spreading diseases to or contracting diseases from

other farms or wild stocks;

(b) operates under farming conditions which could increase the risk of

disease outbreaks (high biomass, low water quality), taking into account

the species present;

(c) sells live aquatic animals for further farming or restocking.

A medium-risk farm or mollusc farming area is a farm or mollusc farming area

which

(a) has medium risk of spreading diseases to or contracting diseases from

other farms or wild stocks;

(b) operates under farming conditions which would not necessarily increase

the risk of disease outbreaks (medium biomass and water quality),

ANIMAL HEALTH REQUIREMENTS FOR AQUACULTURE ANI-

MALS AND PRODUCTS THEREOF, AND ON THE PREVENTION

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

taking into account the species present;

(c) sells live aquatic animals mainly for human consumption.

A low-risk farm of mollusc farming area is a farm or mollusc farming area which

(a) has a low risk of spreading diseases to or contracting diseases from

other farms or wild stocks;

(b) operates under farming conditions which would not increase the risk of

disease outbreaks (low biomass, good water quality), taking into

account the species present;

(c) sells live aquatic animals for human consumption only.

Types of health surveillance

Passive surveillance shall include mandatory immediate notification of the

occurrence or suspicion of specified diseases or of any increased mortalities. In such

cases investigation in accordance with Section 2 of Chapter V shall be required.

Active surveillance shall include

(a) routine inspection by the department or by other qualified health

services on behalf of the competent authorities;

(b) examination of the aquaculture animal population on the farm or in the

mollusc farming area for clinical disease;

(c) diagnostic samples to be collected on suspicion of a listed disease or

observed increased mortality during inspection;

(d) mandatory immediate notification of occurrence or suspicion of

specified diseases or of any increased mortalities.

Targeted surveillance shall include

(a) routine inspection by the department or by other qualified health

services on behalf of the competent authorities;

(b) prescribed samples of aquaculture animals to be taken and tested for

specific pathogen(s) by specified methods;

(c) mandatory immediate notification of occurrence or suspicion of

specified diseases or of any increased mortalities.

(1) Each aquaculture production business in the territory of

Malta shall ensure that it is duly authorised by the department in

accordance with rule 5

Provided that such authorisation may cover several

aquaculture production businesses for molluscs in a mollusc

farming area

Provided also that dispatch centres, purification centres or

similar businesses located inside a mollusc farming area shall have

an individual authorisation.

(2) Each processing establishment slaughtering aquaculture

animals for disease control purposes in accordance with rule 33 of

Chapter V in the territory of Malta shall ensure that it is duly

authorised by the department in accordance with rule 5.

(3) Each aquaculture production business and authorised

processing establishment in the territory of Malta shall have a

unique authorisation number.

(4) By way of derogation from the authorisation requirement in

sub-rule (1), the territory of Malta may require only the registration

by the department of the following

(a) installations other than aquaculture production

businesses, where aquatic animals are kept without the

intention of being placed on the market;

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

(b) put and take fisheries; and

(c) aquaculture production businesses which place

aquaculture animals on the market solely for human

consumption in accordance with Article 1(3)(c) of

Regulation (EC) No. 853/2004

Provided that, the provisions of these rules shall apply

mutatis mutandis, taking into account the nature, characteristics

and situations of the installation, put and take fishery or business

concerned and the risk of spreading aquatic animal diseases to

other populations of aquatic animals as a result of their operation.

(5) In the case of non-compliance with the provisions of these

rules, the department shall act in accordance with Article 54 of

Regulation (EC) No. 882/2004.

Amended by

L.N. 125 of 2013;

Disease Listing

L.N. 24 of 2015.

PART I

Criteria for Listing Diseases

Exotic diseases shall meet the following criteria laid down in point 1 and

either point 2 or 3.

1. The disease is exotic to the Community, that is, the disease is not established

in Community aquaculture, and the pathogen is not known to be present in

Community waters.

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

2. It has potential for significant economic impact if introduced into the

Community, either by production losses in Community aquaculture or by restricting

the potential for trade in aquaculture animals and products thereof.

3. It has potential for detrimental environmental impact if introduced into the

Community, to wild aquatic animal populations of species, which are an asset worth

protecting by Community law or international provisions.

B.

Non-exotic diseases shall meet the following criteria laid down in points 1,

4, 5, 6, 7, and 2 or 3.

1. Several Member States, or regions in several Member States, are free of the

specific disease.

2. It has potential for significant economic impact if introduced into a Member

State free of the disease, either by production losses, and annual costs associated

with the disease and its control exceeding 5% of the value of the production of the

susceptible aquaculture animal species production in the region, or by restricting the

possibilities for international trade in aquaculture animals and products thereof.

3. The disease has shown, where it occurs, to have a detrimental environmental

impact if introduced into a Member State free of the disease, to wild aquatic animal

populations of species that is an asset worth protecting under Community law or

international provisions.

4. The disease is difficult to control and contain at farm or mollusc farming

area level without stringent control measures and trade restrictions.

5. The disease may be controlled at Member State level, experience having

shown that zones or compartments free of the disease may be established and

maintained, and that this maintenance is cost-beneficial.

6. During placing on the market of aquaculture animals, there is a risk that the

disease will establish itself in a previously uninfected area.

7. Reliable and simple tests for infected aquatic animals are available. The

tests must be specific and sens itive and the testing m ethod harmonised at

Community level.

Part II

Listed Diseases

Exotic diseases

Disease

Susceptible species

Fish

Epizootic

Rainbow trout (Oncorhynchus mykiss)

haematopoietic necrosis and redfin perch (Perca fluviatilis)

Molluscs

Infection with Bonamia Australian mud oyster (Ostrea angasi)

and Chilean flat oyster (O. chilensis)

exitiosa

Infection with Perkinsus Pacific oyster (Crassostrea gigas) and

Eastern oyster (C. virginica)

marinus

Infection

w i t h Pacific oyster (Crassostrea gigas),

Eastern oyster (C. virginica), Olympia

Microcytos mackini

flat oyster (Ostrea conchaphila) and

European flat oyster (O. edulis)

Taura syndrome

Gulf white shrimp (Penaeus setiferus),

Pacific blue shrimp (P. stylirostris),

and Pacific white shrimp (P. vannamei)

Yellowhead disease

Gulf brown shrimp (Penaeus aztecus),

G u l f p i n k s h r i m p ( P. d u o r a r u m ) ,

Kuruma prawn (P. japonicus), black

tiger shrimp (P. monodon), Gulf white

s h ri m p (P. se ti feru s), P acific blue

shrimp (P. stylirostris), and Pacific

white shrimp (P. vannamei)

Non-exotic diseases

Diseases

Susceptible species

Vi r a l h a e m o r r h a g i c H e r r i n g ( C l u p e a s p p . ) , w h i t e f i s h

septicaemia (VHS)

(Coregonus sp.), pike (Esox lucius),

haddock (Gadus aeglefinus), Pacific

cod (G. macrocephalus), Atlantic cod

( G. m o r h u a ) , P a c i f i c s a l m o n

(Oncorhynchus spp.) rainbow trout (O.

mykiss), rockling (Onos mustelus),

brown trou t (S almo t ru tta), t urbot

( Scophthalmus maximus ), sprat

( Sprattus sprattus ), grayling

( Thymallus thymallus ) and olive

flounder (Paralichthys olivaceus)

Infectious

Chum salmon (Oncorhynchus keta),

haematopoietic necrosis c o h o s a l m o n ( O . k i s u t c h ) , M a s o u

(IHN)

salmon ( O. masou ), rainbow or

steelhead trout (O. mykiss), sockeye

salmon (O. nerka), pink salmon (O.

rhodurus ) chinook salmon ( O.

tshawytscha), and Atlantic salmon

(Salmo salar)

Koi herpes virus (KHV) Common carp and koi carp (Cyprinus

disease

carpio)

Infectious

s a l m o n Rainbow trout (Oncorhynchus mykiss),

anaemia (ISA): infection Atlantic salmon (Salmo salar), and

w i t h g e n o t y p e H P R - brown and sea trout (S. trutta)

deleted of the genus

Isavirus (ISAV)

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

Molluscs

Infection with Marteilia Australian mud oyster (Ostrea angasi),

C hi l e a n f la t o y s t e r (O . c h i l e n s i s) ,

refringens

European flat oyster ( O. edulis ),

Argentinian oyster (O. puelchana),

blue mussel ( Mytilus edulis ) and

Mediterranean

mussel

( M.

galloprovincialis)

Infection with Bonamia Australian mud oyster (Ostrea angasi),

C hi l e a n f la t o y s t e r (O . c h i l e n s i s) ,

ostreae

Olympia flat oyster (O. conchaphila),

Asiatic oyster (O. denselammellosa),

European flat oyster (O. edulis), and

Argentinian oyster (O. puelchana)

Crustaceans

White spot disease

All decapod crustaceans (order

Decapoda)".

(1) The department in the territory of Malta shall ensure

that authorisations, as provided for in rule 4(1) and (2), are only

gran te d if th e aqu acu l tu re p r od uc ti on b u sin ess op erat or or

authorised processing establishment operator

(a) fulfils the relevant requirements of rules 8, 9 and 10;

(b) has a system in place which enables the operator to

demonstrate to the department that those relevant

requirements are being fulfilled; and

(c) remains under the supervision of the department,

which shall perform the duties laid down in rule 54(1).

(2) Authorisation shall not be granted if the activity in question

were to lead to an unacceptable risk of spreading diseases to farms,

mollusc farming areas or to wild stocks of aquatic animals in the

vicinity of the farm or mollusc farming area

Provided that, before a decision to refuse authorisation is

taken, consideration shall be given to risk-mitigation measures,

including possible alternative siting of the activity in question.

(3) The aquaculture production business operator or authorised

processing establishment operator shall submit all relevant

information to the department in order to allow the department to

assess that the conditions for authorisation are fulfilled, including

the information required in accordance with Schedule II.

Amended by

L.N. 129 of 2013.

Requirements for Declaring a Member State, Zone

or Compartment Disease-Free

PART I

Disease-Free Member State

1. On historical grounds

1.1. A Member State where susceptible species are present, but where there has

not been any observed occurrence of the disease for at least for a period of ten years

before the date of application for the disease-free status despite conditions that are

conducive to its clinical expression may be considered disease-free where

(a) basic biosecurity measure conditions have been in place continuously

for at least a period of ten years before the date of application for the

disease-free status;

(b) infection is not known to be established in wild populations;

(c) the implementation of trade and imports conditions to prevent the

introduction of the disease into the Member State is effective.

A Member State wishing to benefit from a disease-free status, shall submit an

application in accordance with rule 49 before 1 November 2008. After this date,

disease-free status may only be granted in accordance with Part I.2.

1.2. The basic biosecurity measures referred to in point 1.1 (a) shall consist, as a

minimum, of the following

(a) the disease is compulsorily notifiable to the department, including

notification of suspicion;

(b) an early detection system is in place throughout the Member State,

enabling the department to undertake effective disease investigation and

reporting, and ensuring in particular

(i)

the rapid recognition of any clinical signs consistent with the

ANIMAL HEALTH REQUIREMENTS FOR AQUACULTURE ANI-

MALS AND PRODUCTS THEREOF, AND ON THE PREVENTION

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

suspicion of a disease, emerging disease, or unexplained mortality

in farms or molluscs farming areas, and in the wild;

(ii) the rapid communication of the event to the department with the

aim to activating diagnostic investigation with minimum delay.

1.3. The early detection system referred to in point 1.2 (b) shall include at least

the following

(a) broad awareness, among the personnel employed in aquaculture

businesses or involved in the processing of aquaculture animals, of any

signs consistent with the presence of a disease, and training of

veterinarians or aquatic animal health specialists in detecting and

reporting unusual disease occurrence;

(b) veterinarians or aquatic animal health specialists trained in recognising

and reporting suspicious disease occurrence;

(c) access by the department to laboratories with the facilities for

diagnosing and differentiating listed and emerging diseases.

2. Based on targeted surveillance

A Member State where the last known clinical occurrence was within ten years

before the date of application for the disease-free status or where the infection status

prior to targeted surveillance was unknown, for example because of the absence of

conditions conducive to clinical expression, may be considered free of the specific

disease where

(a) the Member State meets the basic disease control conditions laid down

in point 1.2; and

(b) targeted surveillance in accordance with methods adopted pursuant to

rule 49(3), has been in place for at least a period of two years without

detection of the disease agent on farm, or in mollusc farming areas that

rears any of the susceptible species.

Where there are parts of the Member State in which the number of farms, or

molluscs farming areas is limited, and consequently targeted surveillance in these

parts do not provide sufficient epidemiological data, but in which there are wild

populations of any of the susceptible species, those wild populations shall be

included in the targeted surveillance.

PART II

Disease-Free Zone or Compartment

1. Zones

1.1. A zone may comprise

(a) an entire water catchment area from its source to its estuary; or

(b) part of a water catchment area from the sources to a natural or artificial

barrier that prevents the upward migration of aquatic animals from

lower stretches of the water catchment area; or

(c) more than one water catchment area, including their estuaries, due to

the epidemiological link between the catchment areas through the

estuary.

The geographical demarcation of the zone shall be clearly identified on a map.

1.2. Where a zone extends over more than one Member State, it may not be

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

declared a disease-free zone unless the conditions outlined in points 1.3, 1.4 and 1.5

apply to all areas of that zone. In that case both Member States concerned shall apply

for approval for the part of the zone situated in their territory.

1.3. A zone where susceptible species are present, but where there has not been

any observed occurrence of the disease for at least a period of ten years before the

date of application for the disease-free status, despite conditions that are conducive

to its clinical expression, may be considered disease-free if it complies mutatis

mutandis with the requirements laid down in Part I.1.

A Member State wishing to benefit from a disease-free status shall notify its

intention in accordance with rule 50(2) before 1 November 2008. After this date,

disease-free status may only be granted in accordance with Part I.2.

1.4. A zone where the last known clinical occurrence was within a period of 10

years before the date of application for the disease-free status or where the infection

status prior to targeted surveillance was unknown, for example because of the

absence of conditions conducive to clinical expression, may be considered disease-

free where it complies mutatis mutandis with the requirements laid down in Part I.2.

1.5. A buffer zone in which a monitoring programme is carried out shall be

established, as appropriate. The demarcation of the buffer zones shall be such that it

protects the disease-free zone from passive introduction of the disease.

2. Compartments comprising one or more farms or mollusc farming areas

where the health status regarding a specific disease is dependent on the health status

regarding that disease of surrounding natural waters

2.1. A compartment may comprise one or more farms, a group or cluster of farms

or a mollusc farming area that may be considered as one epidemiological unit due to

its geographical localisation and distance from other groups or clusters of farms or

mollusc farming areas, provided that all farms comprising the compartment fall

w i t h i n a c o m m o n b i o s e c u r i t y s y s t e m . T h e g e o g r a p h i c a l d e m ar c a t i on o f a

compartment shall be clearly identified on a map.

2.2. A compartment where susceptible species are present, but where there has

not been any observed occurrence of the disease for at least a period of ten years

before the date of application for the disease-free status despite conditions that are

conducive to its clinical expression, may be considered disease-free if it complies

mutatis mutandis with the requirements in Part I.1 of this Schedule.

Member States wishing to benefit from this provision shall notify their intention in

accordance with rule 50(2) before 1 November 2008. After this date, disease-free

status may only be granted in accordance with Part I.2.

2.3. A compartment where the last known clinical occurrence was within 10

years before the date of application for the disease-free status, or where the infection

status in the compartment or in the waters surrounding the compartment prior to

targeted surveillance was unknown, for example because of the absence of

conditions conducive to clinical expression, may be considered disease-free if it

complies mutatis mutandis with the requirements laid down in Part I.2.

2.4. Each farm or mollusc farming area in a compartment shall be subject to

additional measures imposed by the department, when considered necessary to

prevent the introduction of diseases. Such measures may include the establishment

of a buffer zone around the compartment in which a monitoring programme is

carried out, and the establishment of additional protection against the intrusion of

possible pathogen carriers or vectors.

ANIMAL HEALTH REQUIREMENTS FOR AQUACULTURE ANI-

MALS AND PRODUCTS THEREOF, AND ON THE PREVENTION

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

3. Compartments comprising one or more individual farms where the health

status regarding a specific disease is independent of the health status regarding that

disease of the surrounding natural waters.

3.1. A compartment may comprise

(a) an individual farm which may be considered a single epidemiological

unit, as it is not influenced by the animal health status in the

surrounding waters; or

(b) more than one farm where each farm in the compartment complies with

the criteria laid down in point 3.1 (a) and points 3.2 to 3.6, but, due to

extensive movement of animals between farms, shall be considered as a

single epidemiological unit, provided that all farms are under a common

biosecurity system.

3.2. A compartment shall be supplied with water

(a) through a water treatment plant inactivating the relevant pathogen in

order to reduce the risk of the introduction of the disease to an

acceptable level; or

(b) directly from a well, a borehole or a spring. Where such water supply is

situated outside the premises of the farm, the water shall be supplied

directly to the farm, and be channelled through a pipe.

3.3. There shall be natural or artificial barriers that prevent aquatic animals from

entering each farm in a compartment from the surrounding watercourses.

3.4. The compartment shall, where appropriate, be protected against flooding

and infiltration of water from the surrounding watercourses.

3.5. The compartment shall comply, mutatis mutandis, with the requirements laid

down in Part I.2.

3.6. A compartment shall be subject to additional measures imposed by the

department, when considered necessary to prevent the introduction of diseases. Such

measures may include the establishment of additional protection against the

intrusion of possible pathogen carriers or vectors.

3.7. Implementing measures concerning point 3.2 (a) shall be laid down in

accordance with the procedure referred to in rule 62(2).

4. Special provisions for individual farms which commence or recommence

their activities

4.1. A new farm, which meets the requirements referred to in points 3.1 (a) and

3.2 to 3.6, but which commences its activities with aquaculture animals from a

compartment declared disease-free may be considered disease-free without

undergoing the sampling required for approval.

4.2. A farm which recommences its activities after a break with aquaculture

animals from a compartment declared disease-free, and meets the requirements

referred to in points 3.1 (a) and 3.2 to 3.6, may be considered disease-free without

undergoing the sampling required for approval, provided that

(a) the health history of the farm over the last four years of its operation is

known to the department; however, if the farm concerned has been in

operation for less than four years, the actual period in which it has been

in operation will be taken into account;

(b) the farm has not been subject to animal-health measures in respect of

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

the diseases listed in Part II of Schedule IV and there have been no

antecedents of those diseases on the farm;

(c) prior to the introduction of the aquaculture animals, eggs or gametes,

the farm is cleaned and disinfected, followed, as necessary, by a period

of fallowing.

The department shall establish, maintain and make publicly

available a register of aquaculture production businesses and

authorised processing establishments containing the information

set out in Schedule II.

Substituted by

L.N. 129 of 2013.

Functions and Duties of Laboratories

PART I

Community Reference Laboratory - Functions and Duties

1. The Community Reference Laboratory shall in accordance with rule 55 fulfil

the following requirements. It shall

(a) have suitably qualified staff with adequate training in diagnostic and

analytical techniques applied in its area of competence, including

trained personnel available for emergency situations occurring within

the Community;

(b) possess the equipment and products needed to carry out the tasks

assigned to it;

(c) have an appropriate administrative infrastructure;

(d) ensure that their staff respect the confidential nature of certain subjects,

results or communications;

(e) have sufficient knowledge of international standards and practices;

(f)

have available, as appropriate, an updated list of available reference

substances and reagents and an updated list of manufacturers and

suppliers of such substances and reagents;

(g) take account of research activities at national and Community level.

The Community Reference Laboratory shall remain the contact point for the

national reference laboratories in the Member States, and for the Commission.

2. Moreover, the Community Reference Laboratory shall

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

in the Member States for diagnosing the disease concerned, specifically

by

(i) typing, storing and, where appropriate, supplying strains of the

pathogen of the relevant disease to facilitate the diagnostic

service in the Community;

(ii) supplying standard sera and other reference reagents to the

national reference laboratories in order to standardise the tests

and reagents used in each Member State, where serological tests

are required;

(iii) organising periodic comparative tests (ring tests) of diagnostic

procedures at Community level with the national reference

laboratories designated by the Member States, in order to provide

information on the methods of diagnosis used and the results of

tests carried out in the Community;

(iv)

retaining expertise on the relevant disease pathogen and other

pertinent pathogens to enable rapid differential diagnosis;

(b) assist actively in the diagnosis of outbreaks of the relevant disease in

Member States by receiving pathogen isolates for confirmatory

diagnosis, characterisation and epizootic studies;

(c) facilitate the training or retraining of experts in laboratory diagnosis

with a view to harmonising diagnostic techniques throughout the

Community;

(d) collaborate, as regards methods of diagnosing animal diseases falling

within their areas of competence, with the competent laboratories in

third countries where those diseases are prevalent;

(e) collaborate with the relevant OIE reference laboratories with regard to

exotic diseases listed in Part II of Schedule IV under their

responsibility;

(f)

collate and forward information on exotic and endemic diseases, that

are potentially emerging in Community aquaculture.

PART II

National Veterinary Laboratory

The National Reference Laboratory in Malta is the National Veterinary Laboratory

referred to in rule 56, situated at Civil Abattoir, Albertown, Marsa.

Functions and duties of the National Veterinary Laboratory

1. The National Veterinary Laboratory designated pursuant to rule 56 shall be

responsible for coordinating the diagnostic standards and methods. Moreover, it

(a) undertake to notify, without delay, the department whenever the

laboratory is aware of a suspicion of any of the diseases referred to in

Schedule IV;

(b) coordinate, in consultation with the relevant Community Reference

Laboratory, the methods employed in other Member States for

diagnosing the diseases concerned under their responsibility;

(c) assist actively in the diagnosis of outbreaks of the relevant disease by

receiving pathogen isolates for confirmatory diagnosis, characterisation

and epizootic studies;

(d) facilitate the training or retraining of experts in laboratory diagnosis

with a view to harmonising diagnostic techniques in Malta;

(e) ensure confirmation of positive results of all outbreaks of exotic

diseases listed in Part II of Schedule IV, and of primary outbreaks of

non-exotic diseases listed in that Schedule;

(f)

organise periodic comparative tests (ring tests) of diagnostic procedures

at national level with the laboratories designated by the Member States

in order to provide information on the methods of diagnosis used and

the results of tests carried out in the Malta;

(g) cooperate with the Community Reference Laboratory referred to in

Article 55 and participate in the comparative tests organised by national

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

reference laboratories in other Member States;

(h) ensure a regular and open dialogue with the department;

(i)

operate and be assessed and accredited in accordance with the following

European Standards account being taken of the criteria for different

testing methods laid down in these rules

(i) EN ISO/IEC 17025 on ‘General requirements for the competence

of testing and calibration laboratories’;

(ii) EN 45002 on ‘General criteria for the assessment of testing

laboratories’;

(iii) EN 45003 on ‘Calibration and testing laboratory accreditation

system - General requirements for operation and recognition’.

2. The accreditation and assessment of testing laboratories referred to in point

1(i) may relate to individual tests or groups of tests.

3. The National Veterinary Laboratory may not comply with the requirements

referred to in point 1(i) (i), where operation under EN ISO/IEC 17025 is practically

difficult, provided the laboratory operates under quality assurance in line with the

guidelines in ISO 9001.

4. The National Veterinary Laboratory may take advantage of the skills and

capacity of othe r laboratories for one or more o f the diseases un der t hei r

r e s p o n s i b i l i t y, p r o v i d e d t h a t t h e s e l a b o r a t o r i e s c o m p l y w i t h t h e r e l e v a n t

requirements of this Part of the Schedule. However, the National Veterinary

Laboratory shall remain the contact point for the department in Malta and for the

Community reference laboratory.

(1) Official controls shall be carried out by the department

in accordance with Article 3 of Regulation (EC) No 882/2004 on

aquaculture production businesses and authorised processing

establishments.

(2) The official controls provided for in sub-rule (1) shall

consist of regular inspections, visits, audits, and where appropriate,

sampling, for each aquaculture production business, taking account

of the risk the aquaculture production business and authorised

processing establishment poses in relation to the contracting and

spreading of diseases. The frequencies of such controls depend on

the health status of the concerned zone or compartment and should

be fixed in accordance with the recommendations set out in

Schedule III.

(3) Detailed rules for the implementation of this rule may be

adopted in accordance with the procedure referred to in rule 62(2).

Criteria and Requirements for Contingency Plans

Member States shall ensure that contingency plans meet at least the following

requirements

1. Provision must be made to ensure the legal powers needed to implement

contingency plans and put into effect a rapid and successful eradication

campaign;

2. Provision must be made to ensure access to emergency funds, budgetary

means and financial resources in order to cover all aspects of the fight

against exotic diseases listed in Part II of Schedule IV;

3. A chain of command must be established to guarantee a rapid and

effective decision-making process for dealing with exotic diseases listed

in Schedule IV or emerging diseases. A central decision-making unit

must be in charge of the overall direction of control strategies;

4. Detailed plans must be available for Member States to be prepared for

the immediate establishment of local disease control centres in the event

of an outbreak of exotic diseases listed in Part II of Schedule IV or

emerging diseases and to implement disease control and environment

protection measures at a local level;

5. Member States must ensure cooperation between the competent

authorities and competent environmental authorities and bodies in order

to ensure that actions on veterinary and environmental safety issues are

properly coordinated;

6. Provision must be made for adequate resources to ensure a rapid and

effective campaign, including personnel, equipment and laboratory

capacity;

7. An up-to-date operations manual must be available, with a detailed,

comprehensive and practical description of all the actions, procedures,

instructions and control measures to be employed in handling exotic

diseases listed in Part II of Schedule IV or emerging diseases;

8. Detailed plans must be available for emergency vaccination, where

appropriate;

9. Staff must be regularly involved in training in clinical signs,

epidemiological enquiry and control of epizootic diseases, in real-time

alert exercises, and in training in communication skills to provide

ongoing disease awareness campaigns for authorities, farmers and

veterinarians;

10. Contingency plans must be prepared that take into account the resources

needed to control a large number of outbreaks occurring within a short

period of time;

11. Without prejudice to the veterinary requirements laid down in

Regulation (EC) No 1774/2002, contingency plans must be prepared to

ensure that, in the event of an outbreak of diseases, any mass disposal of

aquatic animal carcases and aquatic animal waste is done without

endangering animal and human health, using processes or methods

which prevent damage to the environment and in particular

(i)

with minimum risk to soil, air, surface and groundwater, and to

plants and animals;

(ii) with minimum nuisance caused by noise or odours;

(iii) with minimum adverse effects on the nature or places of special

interest;

12. Such plans must include the identification of appropriate sites and

undertakings for the treatment or disposal of animal carcasses and

animal waste in the event of an outbreak in accordance with Regulation

(EC) No 1774/2002.

(1)

Aquaculture production businesses shall keep a record

of

(a) all movements of aquaculture animals and products

thereof into and out of the farm or mollusc farming

area;

(b) the mortality in each epidemiological unit as relevant

for the type of production; and

(c) the results of the risk-based animal health surveillance

scheme provided for in rule 10.

(2) Authorised processing establishments shall keep a record of

all movement of aquaculture animals and products thereof into and

out of such establishments.

(3)

The transporters of aquaculture animals shall keep a record

of

(a) the mortality during transport, as practicable for the

type of transport and the species transported;

(b) the farms, mollusc farming areas and processing

establishments visited by the means of transport; and

(c) any water exchange during transport, in particular the

sources of new water and site of release of water.

(4) Without prejudice to specific provisions on traceability, the

aquaculture production business operators as provided for in sub-

rule (1)(a) shall ensure that all movements of animals are recorded

and registered in such a way that the tracing of the place of origin

and destination can be guaranteed. Such movements have to be

submitted to the department and shall be recorded on a national

register and kept in a computerised form.

The aquaculture production businesses and authorised

processing establishments have to implement good hygiene

practice, as relevant for the activity concerned, to prevent the

introduction and spreading of diseases, which practice must be

approved by the department.

(1) The department shall ensure that a risk-based animal

health surveillance scheme shall be applied in all farms and

mollusc farming areas, as appropriate for the type of production.

(2) The risk-based animal health surveillance scheme referred

to in sub-rule (1) shall aim at the detection of

(a) any increased mortality in all farms and mollusc

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

farming areas as

appropriate

for

the

type

of

production; and

(b) the diseases listed in Part II of Schedule IV, in farms

and mollusc farming areas were species susceptible to

those diseases are present.

(3) Such animal health surveillance schemes, depending on the

health status of the concerned zone or compartment are laid down

in accordance with the recommendations set out in Schedule III.

This surveillance shall apply without prejudice to the sampling and

surveillance carried out in accordance with Chapter V or rules

49(3), 50(4) and 52.

(4) The risk-based animal health surveillance scheme referred

to in sub-rule (1) shall take account of guidelines to be drawn up by

the Commission in accordance with the procedure referred to in

rule 62(2).

(5) A report shall be submitted by the department on the overall

operation of risk-based animal health surveillance, in the light of

the outcome of official controls carried out in accordance with rule

7 and of the outcome of Community controls carried out in

accordance with rule 58, and of any other relevant information.

This report may be accompanied by an appropriate proposal, in

accordance with the procedure referred to in rule 62(2).

CHAPTER III

Animal Health Requirements for Placing on the Market

of Aquaculture Animals and Products thereof

SECTION 1

General Provisions

(1) Unless otherwise provided, this Chapter shall apply

only to the diseases and the species susceptible thereto listed in

Part II of Schedule IV.

(2) The department may, under strict supervision, allow the

placing on the market for scientific purposes of aquaculture

animals and products thereof, which do not comply with this

Chapter. The department shall ensure that such placing on the

market does not jeopardise the health status with regard to the

diseases listed in Part II of Schedule IV of aquatic animals at the

place of destination or at places of transit.

Any such movements between Member States shall not take

place without prior notification of the competent authorities of the

Member States concerned.

(1) Producers shall ensure that the placing on the market

of aquaculture animals and products thereof shall not jeopardize the

health status of aquatic animals at the place of destination with

regard to the diseases listed in Part II of Schedule IV.

(2) Producers shall ensure that they will follow the detailed

rules on the movement of aquaculture animals as laid down in this

Chapter, in particular relating to movements between Member

States, zones and compartments with different health statuses.

(1) The department shall ensure that

(a) the necessary disease prevention measures are applied

during the transport of aquaculture animals in order

not to alter the health status of those animals during

transport, and to reduce the risk of spreading diseases;

and

(b) aquaculture animals are transported under conditions

which neither alter their health status nor jeopardise

the health status of the place of destination, and where

appropriate, of places of transit.

This sub-rule shall also apply to diseases and the species

susceptible thereto not listed in Part II of Schedule IV.

(2) The transporters must make sure that any water exchanges

during transport shall be carried out at places and under conditions

that do not jeopardise the health status of

(a) the aquaculture animals being transported;

(b) any aquatic animals at the place of water exchange;

and

(c) aquatic animals at the place of destination.

(1) The placing on the market of aquaculture animals is

subject to animal health certification by the department of the area

of origin when the animals are introduced into a zone or

compartment within the territory of Malta declared disease-free in

accordance with rules 49 and 50 or subject to surveillance, or to the

eradication programme in accordance with rule 44(1) or (2) for

(a) farming and restocking purposes; or

(b) further processing before human consumption, unless

(i)

as regards fish, they are slaughtered and

eviscerated before dispatch;

(ii) as regards molluscs and crustaceans, they are

dispatched as unprocessed or processed

products.

(2) The placing on the market of aquaculture animals is subject

to animal health certification by the department when the animals

are allowed to leave an area subject to the control provisions

provided for in Sections 3, 4, 5 and 6 of Chapter V.

This sub-rule shall also apply to diseases and the species

susceptible thereto not listed in Part II of Schedule IV.

(3) The following movements shall be subject to notification

under the computerised system provided for in Article 20 (1) of

Directive 90/425/EEC

(a) movements of aquaculture animals between Member

States where animal health certification is required in

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

accordance with sub-rules (1) or (2); and

(b) all other movements of live aquaculture animals for

farming or restocking purposes between Member

States where no animal health certification is required

under these rules.

(4) The computerised system provided for in sub-rule (3) may

be used by the department to trace movements taking place entirely

within its territory.

SECTION 2

Aquaculture Animals intended for Farming and Restocking

(1) Without prejudice to the provisions laid down in

Chapter V, the department shall ensure that aquaculture animals

placed on the market for farming are

(a) clinically healthy; and

(b) do not come from a farm or mollusc farming area

where there is any unresolved increased mortality.

This sub-rule shall also apply in relation to diseases and the

species susceptible thereto not listed in Part II of Schedule IV.

(2) By way of derogation from sub-rule (1)(b), such placing on

the market may be permitted by the department based on an

assessment of risk, provided that the animals originate from a part

of the farm or mollusc farming area independent of the

epidemiological unit where the increased mortality has occurred.

(3) Aquaculture animals intended for destruction or slaughter

in accordance with the disease control measures provided for in

Chapter V shall not be placed on the market for farming and

restocking purposes.

(4) Aquaculture animals may only be released into the wild for

restocking purposes or into put and take fisheries if they

(a) comply with the requirements in sub-rule (1); and

(b) come from a farm or mollusc farming area with a

health status as referred to in Schedule III, at least

equivalent to the health status of the waters in which

they are to be released

Provided that, aquaculture animals must originate from a

zone or compartment declared disease-free in accordance with rules

49 or 50. The department may also decide to apply this sub-rule to

programmes drawn up and applied in accordance with rule 43.

(1) Aquaculture animals of species susceptible to a

specific disease originating from a zone or compartment within the

territory of Malta declared free of that disease may be introduced

for farming or restocking into another Member State, zone or

compartment declared free of a specific disease in accordance with

rules 49 or 50.

(2)

Where it can be scientifically justified that species

susceptible to the specific disease at certain life stages do not

transmit that disease, sub-rule (1) shall not apply to those life

stages

Provided that a list of species and life stages to which sub-

rule (1) may apply shall be adopted and when necessary amended

to take account of scientific and technological developments in

accordance with the procedure referred to in rule 62(2).

(1) Any species other than those referred to in Part II of

Schedule IV which may be responsible for the transmission of a

specific disease by acting as vector species as sustained by

scientific data or practical experience, such species introduced for

farming or restocking purposes into a zone or compartment within

the territory of Malta declared free of that specific disease in

accordance with rules 49 or 50, shall

(a) originate from another Member State, zone or

compartment declared free of that specific disease; or

(b) be held in quarantine facilities in water free of the

pathogen in question, for an appropriate period of

time, where, in the light of the scientific data or

practical experience provided, proves to be sufficient

to reduce the risk of transmission of the specific

disease to a level acceptable for preventing the

transmission of the disease concerned.

(2) A list of vector species and life stages of such species to

which this rule applies and, where appropriate, the conditions under

which these species can transmit a disease shall be adopted and

when necessary amended, taking into account scientific and

technological developments in accordance with the procedure

referred to in rule 62(2).

SECTION 3

Aquaculture Animals and Products thereof intended

for Human Consumption

(1) Aquaculture animals of species susceptible to one or

more of the non-exotic diseases listed in Part II of Schedule IV, and

products thereof, may only be placed on the market for further

processing in a zone or compartment within the territory of Malta

declared free of those diseases in accordance with rules 49 or 50, if

they comply with one of the following conditions

(a) they originate from another Member State, zone or

compartment declared free of the disease in question;

(b) they are processed in an authorised processing

establishment under conditions which prevent the

spreading of diseases;

(c) as regards fish, they are slaughtered and eviscerated

before dispatch; or

(d) as regards molluscs and crustaceans, they

are

dispatched as unprocessed or processed products.

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

(2) Live aquaculture animals of species susceptible to one or

more of the non-exotic diseases listed in Part II of Schedule IV

which are placed on the market for further processing in a zone or

compartment within the territory of Malta declared free of those

diseases in accordance with rules 49 or 50, may only be temporarily

stored at the place of processing if

(a) they originate from another Member State, zone, or

compartment declared free of the disease in question;

or

(b) they are temporarily kept in dispatch centres,

purification centres or similar businesses which are

equipped with an effluent treatment system

inactivating the pathogens in question, or where the

effluent is subject to other types of treatment reducing

the risk of transmitting diseases to the natural waters

to an acceptable level.

(1) Where aquaculture animals of species susceptible to

one or more of the diseases listed in Part II of Schedule IV, or

products thereof, are placed on the market for human consumption

without further processing, this section shall not apply, provided

that they are packed in retail-sale packages which comply with the

provisions for packaging and labelling provided for in Regulation

(EC) No. 853/2004.

(2) Where live molluscs and crustaceans of species susceptible

to one or more of the diseases listed in Part II of Schedule IV are

temporarily relayed in Community waters, or introduced into

dispatch centres, purification centres or similar businesses, they

shall comply with rule 18(2).

SECTION 4

Wild Aquatic Animals

(1) Wild aquatic animals of species susceptible to one or

more of the diseases listed in Part II of Schedule IV which are

caught in a zone or compartment within the territory of Malta not

declared disease-free in accordance with rules 49 or 50 shall be

placed in quarantine under the supervision of the department in

suitable facilities for a period of time sufficient to reduce to an

acceptable level the risk of transmission of the disease, before they

may be released into a farm or mollusc farming area situated in a

Member State, zone, or compartment declared free from that

disease in accordance with rules 49 or 50.

(2) Traditional extensive lagoon aquaculture practice without

the quarantine provided for in sub-rule (1) may be permitted by the

department, provided a risk assessment is undertaken and that the

risk is considered not higher than what is expected from the

application of sub-rule (1).

SECTION 5

Ornamental Aquatic Animals

(1) Traders and retailers shall ensure that the placing on

the market of ornamental aquatic animals shall not jeopardise the

health status of aquatic animals with regard to the diseases listed in

Part II of Schedule IV.

(2) This rule shall apply also in relation to diseases not listed in

Part II of Schedule IV.

CHAPTER IV

Introduction of Aquaculture Animals and Products thereof

into the Community from Third Countries

Aquaculture animals and products thereof shall be

introduced into the Community only from third countries or parts

of third countries that appear on a list drawn up and updated in

accordance with the procedure referred to in rule 62(2).

(1) A third country, or a part of a third country, shall

appear on the list provided for in rule 22 only if a Community

assessment of that country, or that part of a third country, has

demonstrated that the department provides appropriate guarantees

as regards compliance with the relevant animal health requirements

of Community legislation.

(2) When drawing up or updating the lists provided for in rule

22, particular account shall be taken of

(a) the legislation of the third country;

(b) the organisation of the department and its inspection

services in the third country, the powers of these

services, the supervision to which they are subject, and

the means at their disposal, including staff capacity, to

apply their legislation effectively;

(c) the aquatic animal health requirements in force that

apply to the production, manufacture, handling,

storage and dispatch of live aquaculture animals

intended for the Community;

(d) the assurances which the department of the third

country may give regarding compliance or equivalence

with the relevant aquatic animal health conditions;

(e) any experience of marketing live aquaculture animals

from the third country and the results of any import

controls carried out;

(f)

the results of the Community assessment, in particular

the results of the assessment carried out by the

competent authorities of the third country concerned

or, where the Commission so requests, the report

submitted by the competent authorities of the third

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

country on any inspections carried out;

(g) the health status of farmed and wild aquatic animals in

the third country, with particular regard to exotic

animal diseases and any aspects of the general aquatic

animal health situation in the country which might

pose a risk to aquatic animal health in the Community;

(h) the regularity, speed and accuracy with which the third

country supplies information on the existence of

infectious or contagious aquatic animal diseases in its

territory, particularly the notifiable diseases, listed by

the World Organisation for Animal Health (OIE); and

(i)

the rules on the prevention and control of aquatic

animal diseases in force in the third country and their

implementation, including rules on imports from other

countries.

(3) Lists drawn up in accordance with rule 22 may be combined

with other lists drawn up for animal and public health purposes and

shall be made available to the public.

(1) All consignments of aquaculture animals and products

thereof shall be accompanied by a document containing an animal

health certificate upon their entry into the Community.

(2) The animal health certificate shall certify that the

consignment satisfies

(a) the requirements laid down for such commodities

under these rules; and

(b) any special import conditions

established

in

accordance with rule 25(a).

(3) The document may also include details required under other

provisions of Community public and animal health legislation.

Where necessary, detailed rules for the application of this

Chapter may be established in accordance with the procedure

referred to in rule 62(2). These rules may concern in particular

(a) special import conditions for each third country, parts

thereof or group of third countries;

(b) the criteria for classifying third countries and parts

thereof with regard to aquatic animal diseases;

(c) the use of electronic documents;

(d) model animal health certificates and other documents;

and

(e) procedures and certification for transit.

CHAPTER V

Notification and Minimum Measures for Control of Diseases

of Aquatic Animals

SECTION 1

Disease Notification

(1) Any person within the territory of Malta shall ensure

(a) when there are any reasons to suspect the presence of a

disease listed in Part II of Schedule IV, or the presence

of such disease is confirmed in aquatic animals, the

suspicion and, or the confirmation is immediately

notified to the department; and

(b) when increased mortality occurs in aquaculture

animals, the mortality is immediately notified to the

department or a private veterinarian for further

investigations.

(2) The obligation to notify the matters referred to in sub-rule

(1) are imposed on

(a) the owner and any person attending aquatic animals;

(b) any person accompanying aquaculture animals during

transport;

(c) veterinary practitioners and other professionals

involved in aquatic animal health services;

(d) official veterinarians, senior staff of veterinary or

other official or private laboratories; and

(e) any other person with an occupational relationship to

aquatic animals of susceptible species or to products of

such animals.

Other Member States, the Commission and EFTA Member

States shall be notified within twenty-four hours in case of

confirmation of

(a) an exotic disease listed in Part II of Schedule IV; and

(b) a non-exotic disease listed in Part II of Schedule IV

where the Member State concerned, zone, or

compartment has been declared free of that disease.

SECTION 2

Suspicion of a Listed Disease - Epizootic Investigation

In the case of a suspicion of an exotic disease listed in Part

II of Schedule IV or, in the case of suspicion of a non-exotic

disease listed in Part II of Schedule IV in the territory of Malta,

co mp ri sing an y zone s or co mp artm ent s with a health status

categorised as being either "disease-free" or "undetermined" (not

known to be infected but not subject to a programme for achieving

disease-free status), the department shall ensure that for such

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

disease

(a) appropriate samples are taken and examined in a

laboratory designated in accordance with rule 57; and

(b) pending the result of the examination provided for in

paragraph (a)

(i)

the farm, or mollusc farming area, in which the

disease is suspected, is placed under official

surveillance and relevant control measures are

implemented to prevent the spreading of the

disease to other aquatic animals;

(ii) no aquaculture animals are allowed to leave or

enter the affected farm or mollusc farming area

in which the disease is suspected, unless duly

authorised;

(iii) the epizootic investigation provided for in rule

29 is initiated.

(1) The epizootic investigation initiated in accordance

with rule 28(b)(iii) shall be carried out where the examination

provided for in rule 28(a) shows the presence of

(a) an exotic disease listed in Part II of Schedule IV in any

Member State; or

(b) a non-exotic disease listed in Part II of Schedule IV in

Member States, zones or compartments with a health

status categorised as being either "disease-free" or

"undetermined" (not known to be infected but not subject

to a programme for achieving disease-free status), for the

disease in question.

(2) The epizootic investigation provided for in sub-rule (1)

shall be aimed at

(a) determining the

possible

origin

and

means

of

contamination;

(b) investigating whether aquaculture animals have left

the farm or mollusc farming area during the relevant

period preceding the notification of the suspicion

provided for in rule 26(1);

(c) investigating whether other farms have been infected.

(3) Where the epizootic investigation provided for in sub-rule

(1) shows that the disease may have been introduced into one or

more farms, mollusc farming areas or unenclosed waters, the

Member State concerned shall ensure that the measures provided

for in rule 28 are applied in such farms, mollusc farming areas or

unenclosed waters

Provided that in the case of extensive water catchment areas

or coastal areas, the department may decide to limit the application

of rule 28 to a less extensive area in the vicinity of the farm or the

mollus c f arming area s uspec t ed o f be ing infecte d w he re it

considers that such less extensive area is sufficiently large to

guarantee that the disease does not spread.

(4) Where necessary, the department of neighbouring Member

States or third countries shall be informed of the suspected case of

disease. In that event, the competent authorities of the Member

States involved shall take appropriate action to apply the measures

provided for in this rule within their territory.

The department shall lift the restrictions provided for in

rule 28(b) where the examination provided for in rule 28(a) fails to

demonstrate the presence of the disease.

SECTION 3

Minimum Control Measures in the case of Confirmation

of Exotic Diseases in Aquaculture Animals

This Section shall apply in the case of confirmation of an

exotic disease listed in Part II of Schedule IV in aquaculture

animals.

The department shall ensure that

(a) the farm or mollusc farming area is officially declared

infected;

(b) a containment area appropriate to the disease in

question is established, including a protection zone

and surveillance zone, around the farm or mollusc

farming area declared infected;

(c) no restocking takes place and no aquaculture animals

are moved into, within, and out of the containment

area unless authorised by the department; and

(d) any additional measures necessary to prevent the

further spread of the disease are implemented.

(1) Aquaculture animals which have reached commercial

size and show no clinical sign of disease may be harvested under

the supervision of the department for human consumption, or for

further processing.

(2) Any operations involved in the preparation of the

aquaculture animals for entry into the food chain, including

harvesting, the introduction into dispatch centres or purification

centres, and any further processing, shall be carried out under the

conditions which prevent the spread of the pathogen responsible for

causing the disease.

(3) Dispatch centres, purification centres or similar businesses

shall be equipped with an effluent treatment system inactivating the

pathogen responsible for causing the disease. In the absence of

such system, the effluent shall be subject to other types of

treatment reducing the risk of transmitting diseases to the natural

waters to an acceptable level.

(4) Further processing shall be performed in authorised

processing establishments.

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

(1) Dead fish and crustaceans, as well as live fish and

crustaceans showing clinical signs of disease, shall be removed and

disposed of as soon as possible under the supervision of the

department in accordance with Regulation (EC) No 1069/2009 of the

European Parliament and of the Council laying down health rules as

regards animal by-products and derived products not intended for

human consumption and repealing Regulation (EC) No 1774/2002

(Animal by-products Regulation), and the contingency plan provided

for in rule 47.

(2) Aquaculture animals which have not reached commercial

si z e a n d d o n o t sh o w c l i n i c a l s i g n s o f d i s e a se s h a l l , i n an

appropriate timeframe taking into account the type of production

and the risk such animals pose for further spread of the disease, be

removed and disposed of under the supervision of the department in

accordance with Regulation (EC) No 1069/2009, and the contingency

plan provided for in rule 47.

Infected farms or mollusc farming areas shall undergo an

appropriate period of fallowing after being emptied and, where

appropriate, cleansed and disinfected

Provided that with regards to farms or mollusc farming

areas rearing aquaculture animals not susceptible to the disease in

question, decisions on fallowing shall be based on a risk

assessment.

Necessary measures shall be adopted by the department

within the territory of Malta to prevent the spreading of diseases to

other aquatic animals.

The measures provided for in this Section shall be

maintained until

(a) the eradication measures provided for in this Section

have been carried out; and

(b) the sampling and surveillance as appropriate for the

disease in question and the types of aquaculture

production businesses affected has been carried out in

the containment area with negative results.

SECTION 4

Minimum Control Measures in the Case of Confirmation

of Non-Exotic Diseases in Aquaculture Animals

(1) In the case of confirmation of a non-exotic disease

listed in Part II of Schedule IV in any zone or compartment within

the territory of Malta declared free of that disease, the department

may

(a) apply the measures provided for in Section 3 in order

to regain such disease-free status, or

(b) draw up an eradication programme in accordance with

rule 44(2).

(2)

By way of derogation from rule 34(2), where the

department decides to apply the measures provided for in Section 3,

it may allow clinically healthy animals to be raised to market size

before slaughter for human consumption or to be moved to another

infected zone or compartment. In such cases, measures shall be

taken to reduce and as far as possible, prevent the further spreading

of the disease.

(3) Where the department does not wish to regain disease-free

status, rule 39 shall apply.

In the case of confirmation of a non-exotic disease listed in

Part II of Schedule IV in a zone or compartment within the territory

of Malta not declared free of that disease, the department shall take

measures to contain the disease.

Those measures shall at least consist of

(a) declaring the farm or mollusc farming area to be

infected;

(b) establishing a containment area appropriate to the

disease in question, including a protection zone and

surveillance zone around the farm or mollusc farming

area declared infected;

(c) restricting the movement of aquaculture animals from

the containment area to the effect that such animals

may only be

(i)

introduced into farms or mollusc farming areas

in accordance with rule 12(2); or

(ii) harvested

and

slaughtered

for

human

consumption in accordance with rule 33(1); and

(d) the removal and disposal of dead fish and crustaceans,

under the supervision of the department in accordance

with Regulation (EC) No 1069/2009, in an appropriate

time-frame taking into account the type of production

and the risk such dead animals pose for further spread

of the disease.

SECTION 5

Minimum Control Measures in the Case of Confirmation of

Diseases Listed in Part II of Schedule IV in Wild Aquatic Animals

(1) Where wild aquatic animals are infected or suspected

of being infected with exotic diseases listed in Part II of Schedule

IV, the department shall monitor the situation, and take measures to

reduce and, as far as possible, to prevent the further spreading of

the disease.

(2) Where wild aquatic animals are infected or suspected of

being infected with non-exotic diseases listed in Part II of Schedule

IV in a zone or compartment within the territory of Malta declared

free of that disease, the department shall also monitor the situation

and take measures to reduce, and as far as possible, to prevent the

further spreading of the disease.

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

(3) The department shall inform the Commission and the other

Member States within the Committee referred to in rule 62(1) of

the measures they have taken in accordance with sub-rules (1) and

(2) hereof.

SECTION 6

Control Measures in case of Emerging Diseases

(1) Appropriate measures shall be taken by the department

to control an emerging disease situation and prevent that disease

from spreading, where the emerging disease in question has the

potential to jeopardise the health situation of aquatic animals.

(2) In the case of an emerging disease situation, the department

shall inform the other Member States, the Commission and EFTA

Member States without delay thereof, where the findings are of

epidemiological significance to another Member State.

(3) Within four weeks of informing the other Member States,

the Commission and EFTA Member States as required in sub-rule

(2), the matter shall be brought to the attention of the Committee

referred to in rule 62(1). The measures taken by the department

pursuant to sub-rule (1) may be extended, amended or repealed in

accordance with the procedure referred to in rule 62(2).

(4) Where appropriate, the list set out in Part II of Schedule IV

shall be amended in accordance with the procedure referred to in

rule 62(2) to include the emerging disease in question or a new

susceptible host species to a disease already listed in that Schedule.

SECTION 7

Alternative Measures and National Provisions

A decision may be adopted in accordance with the

procedure referred to in rule 62(2) to authorise the implementation

of ad hoc measures for a limited period of time, under conditions

appropriate to the epidemiological situation where

(a) the measures provided for in this Chapter are found

not to be suited to the epidemiological situation; or

(b) the disease appears to be spreading despite the

measures taken in accordance with this Chapter.

(1) Where a disease not listed in Part II of Schedule IV

constitutes a significant risk for the animal health situation of

aquaculture or wild aquatic animals in the territory of Malta, the

department may take measures to prevent the introduction of or to

control that disease

Provided that these measures shall not exceed the limits of

what is appropriate and necessary to prevent the introduction of or

to control the disease.

(2) The Commission shall be notified with any measures

referred to in sub-rule (1) by the department, which may affect

trade between Member States. Those measures shall be subject to

approval in accordance with the procedure referred to in rule 62(2).

(3) The approval referred to in sub-rule (2) shall only be

granted where the establishmen t o f i ntra-C omm un ity trade

restrictions is necessary to prevent the introduction of or to control

the disease, and shall take into account the provisions laid down in

Chapters II, III, IV and V.

CHAPTER VI

Control Programmes and Vaccination

SECTION 1

Surveillance and Eradication Programmes

(1) Where the territory of Malta is not known to be

infected but not declared free of one or more of the non-exotic

diseases listed in Part II of Schedule IV, the department shall draw

up a surveillance programme for achieving a disease-free status for

one or more of those diseases. The department shall submit that

programme for approval in accordance with the procedure referred

to in rule 62(2), and these programmes may also be amended or

terminated in accordance with that procedure and the specific

requirements for surveillance, sampling and diagnostic shall be

those provided for in rule 49(3)

Provided that, where a programme provided for in this sub-

regulation is to cover individual compartments or zones, which

comprise less than 75% of the territory of Malta, and the zone or

compartment consists of a water catchment area not shared with

another Member State or third country, the procedure referred to in

rule 50(2) shall apply for any approval, or amendment or

termination of such programme.

(2) If the territory of Malta is known to be infected by one or

more of the non-exotic diseases listed in Part II of Schedule IV, the

department shall draw up an eradication programme for one or

more of those diseases and shall submit that programme for

approval in accordance with the procedure referred to in rule 62(2),

and such programmes may also be amended or terminated in

accordance with that procedure.

(3) An overview of the programmes approved in accordance

with sub-rules (1) and (2) shall be made available at Community

level in accordance with the procedures provided for in rule 51.

(4) From the date of approval of the programmes referred to in

this rule, the requirements and measures provided for in rule 14,

Sections 2, 3, 4 and 5 of Chapter III, Section 2 of Chapter V, and

rule 38(1) in relation to areas declared disease-free shall apply to

the areas which are covered by the programmes.

Programmes shall not be approved unless they contain at

least the following

(a) a description of the epidemiological situation of the

disease before the date of commencement of the

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

programme;

(b) an analysis of the estimated costs and the anticipated

benefits of the programme;

(c) the likely duration of the programme and the objective

to be attained by the completion date of the

programme; and

(d) a description and demarcation of the geographical and

administrative area in which the programme is to be

applied.

(1) Programmes shall continue to be applied until

(a) the requirements laid down in Schedule V have been

fulfilled, and the zone or compartment within the

territory of Malta is declared free of the disease; or

(b) the programme is withdrawn, namely if it no longer

fulfils its purpose, by the department, or by the

Commission.

(2) If the programme is withdrawn as provided for in sub-rule

(1)(b), the department shall apply the containment measures in rule

39 from the date of withdrawal of the programme.

SECTION 2

Contingency Plan for Emerging and Exotic Diseases

(1) A contingency plan shall be drawn up by the

department and it shall specify the national measures required to

maintain a high level of disease awareness and preparedness and to

ensure environmental protection.

(2)

The contingency plan shall

(a) provide the authority and means to access all facilities,

equipment, personnel and other appropriate materials

necessary for the rapid and efficient eradication of an

outbreak;

(b) ensure

coordination

and

compatibility

with

neighbouring Member States and encourage

cooperation with neighbouring third countries; and

(c) where relevant, it shall give a precise indication of the

vaccine requirements and vaccination conditions

considered necessary in the event of emergency

vaccination.

(3) The department shall comply with the criteria and

requirements laid down in Schedule VII when drawing up

contingency plans.

(4) The department shall submit the contingency plans for

approval in accordance with the procedure referred to in rule 62(2),

and every five years, the department shall update its contingency

plan and it shall submit the updated plan for approval in accordance

with that procedure.

(5) The contingency plan shall be implemented in the event of

an outbreak of emerging diseases and of exotic diseases listed in

Part II of Schedule IV.

SECTION 3

Vaccination

(1) Vaccination against the exotic diseases listed in Part II

of Schedule IV shall be prohibited unless such vaccination is

approved in accordance with rules 41, 42, 44 or 47.

(2) Vaccination against the non-exotic diseases listed in Part II

of Schedule IV shall be prohibited in any part of the territory of

Malta declared free of the diseases in question in accordance with

rules 49 or 50, or covered by a surveillance programme, approved

in accordance with rule 44(1)

Provided that vaccination in parts of the territory of Malta

which have not declared free from the diseases in question may be

permitted or where vaccination is a part of an eradication

programme approved in accordance with rule 44(2).

(3) The vaccines must be authorised in accordance with

Directive 2001/82/EC and Regulation (EC) No. 726/2004.

(4) Sub-rules (1) and (2) shall not apply to scientific studies for

the purpose of developing and testing vaccines under controlled

conditions and during such studies, the appropriate measures shall

be taken to protect other aquatic animals from any adverse effect of

the vaccination carried out within the frame-work of the studies.

CHAPTER VII

Disease-Free Status

(1) The territory of Malta shall be declared free of one or

more of the non-exotic diseases listed in Part II of Schedule IV in

accordance with the procedure referred to in rule 62(2), if sub-rule

(2) hereof is complied with, and

(a) none of the species susceptible to the diseases in

question is present within its territory; or

(b) the pathogen is known not to be able to survive in its

territory, and in its water source; or

(c) the territory of Malta meets the conditions laid down

in Part I of Schedule V.

(2) The department shall establish appropriate buffer zones

within the territory of Malta where its neighbouring Member

States, or water catchment areas shared with its neighbouring

Member States are not declared disease-free. The demarcation of

buffer zones shall be such that they protect the territory of Malta

declared disease-free from any passive introduction of the disease.

(3) The specific requirements for surveillance, buffer zones,

sam pli ng and di agno st ic met hod s th at sh all be u sed b y t he

department to grant disease-free status in accordance with this rule

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

shall be adopted in accordance with the procedure referred to in

rule 62(2).

(1) A zone or a compartment within the territory of Malta

may be declared free of one or more of the non-exotic diseases

listed in Part II of Schedule IV, where

(a) none of the species susceptible to the diseases in

question is present in the zone or compartment, and

where relevant in its water source; or

(b) the pathogen is known not to be able to survive in the

zone or compartment, and where relevant in its water

source; or

(c) the zone or compartment complies with the conditions

laid down in Part II of Schedule V.

(2) The department shall submit the declaration referred to in sub-

rule (1) to the Standing Committee on Food Chain and Animal Health.

Such declaration shall be supported by evidence in a form determined

in accordance with the procedure referred to in rule 62(2) and shall be

accessible by electronic means to the Commission and to other

Member States, in accordance with the requirements of rule 59.

(3) Where the zones or compartments referred to in sub-rule (1)

comprise more than 75% of the territory of Malta, or if the zone or

compartment consists of a water catchment area shared by another

Member State or third country, the procedure referred to in sub-rule

(2) shall be replaced by the procedure referred to in rule 62(2).

(4) The specific requirements of the surveillance, sampling and

diagnostic methods used by the department to obtain disease-free

status in accordance with this Article shall be laid down in

accordance with the procedure referred to in sub-rule 62 (2).

The department shall establish and maintain an updated list

of zones and compartments declared disease-free in accordance

with rule 50(2). Such lists shall be made publicly available.

When declared free from one or more non-exotic diseases

listed in Part II of Schedule IV in accordance with rule 49, the

department may discontinue targeted surveillance and maintain its

disease-free status provided that the conditions conducive to

clinical expression of the disease in question exist, and the relevant

provisions of these rules are implemented

Provided that, for disease-free zones or compartments

within the territory of Malta not declared disease-free, and in all

cases where conditions are not conducive to clinical expression of

the disease in question, targeted surveillance shall be continued in

accordance with the methods provided for in rules 49(3) or 50(4) as

appropriate, but at a level commensurate with the degree of risk.

(1) Where the territory of Malta has reason to believe that

any of the conditions for maintaining its status as a disease-free

zone or compartment have been breached, it shall immediately

suspend trade in susceptible species and vector species to other

Member States, zones or compartments with a higher health status

for the disease in question and it shall apply the provisions of

Sections 2 and 4 of Chapter V.

(2) Where the epizootic investigation provided for in rule 29(1)

confirms that the suspected breach has not taken place, the disease-

free status of the zone or compartment within the territory of Malta

shall be restored.

(3) Where the epizootic investigation confirms a significant

likelihood that infection has occurred, the disease-free status of the

zone or com partment within the territory of Malta shall be

withdrawn, in accordance with the procedure under which that

status was declared. The requirements laid down in Schedule V

shall be complied with before the disease-free status is restored.

CHAPTER VIII

Competent Authorities and Laboratories

(1) Effective and continuous cooperation based on the free

exchange of information relevant to the implementation of these rules

shall be established between the department and any of its other bodies

or entities involved in regulating aquaculture, aquatic animals, and

food and feed of aquaculture origin. Such information shall also, to the

extent necessary, be exchanged with the competent authorities of the

other Member States.

(2) The department shall have access to adequate laboratory

services and state-of-the-art know-how in risk analysis and

epidemiology, having a free exchange of any information relevant to

the implementation of these rules between the competent authorities of

other Member States and their respective designated laboratories.

(1) The Community Reference Laboratory designated for the

aquatic animal diseases relevant to these rules in accordance with the

procedure referred to in rule 62(2) shall act and remain the single point

of contact for all designated national reference laboratories in Member

States and for the Commission.

(2) The Community Reference Laboratory for aquatic animal

diseases shall comply with the functions and duties laid down in Part I

of Schedule VI.

(1) The National Reference Laboratory designated by the

department in Malta is the National Veterinary Laboratory referred to

in Part II A of Schedule VI and shall comply with the functions and

duties laid down in Part II B of Schedule VI.

(2) The National Veterinary Laboratory shall liaise with the

relevant Community Reference Laboratory referred to in rule 55.

(3)

The National Veterinary Laboratory shall collaborate with any

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS

laboratory designated in other Member States in order to ensure an

efficient diagnostic service and methods in accordance with the

requirements of rule 57.

(4) The National Veterinary Laboratory shall be adequately

equipped and staffed with the appropriate numbers of trained

personnel to carry out the laboratory investigations required in

accordance with these rules.

The department shall ensure that

(a) laboratory examinations for the purposes of these rules

are carried out in the National Veterinary Laboratory

designated for such purpose by the department;

(b) laboratory examinations in the case of suspicion and to

confirm the presence of the diseases listed in Part II of

Schedule IV are carried out by diagnostic methods

established in accordance with the procedure referred to

in rule 62(2); and

(c) the National Veterinary Laboratory designated for

diagnostic services in accordance with this rule shall

comply with the functions and duties laid down in Part II

B of Schedule VI.

CHAPTER IX

Inspections, Electronic Management and Penalties

(1) On-the-spot inspections including audits, may be

carried out by experts from the Commission in cooperation with the

department, insofar as they are necessary for the uniform

application of these rules and the department shall provide the

experts carrying out such inspections and audits with all the

assistance necessary for carrying out their duties.

(2) Experts from the Commission may also carry out on-the-

spot inspections, including audits, in third countries, in cooperation

with the competent authorities of the third country concerned, in

order to verify conformity with or equivalence to Community

aquatic animal health rules.

(3) Where a serious animal health risk is identified during a

Commission inspection, the department shall immediately take all

measures necessary to safeguard animal health

Provided that, where such measures are not taken, or where

they are considered to be insufficient, the measures necessary to

safeguard animal health shall be adopted in accordance with the

procedure referred to in rule 62(2) and the department shall be

informed thereof.

All procedures and formalities relating to making the

information provided for in rules 6, 50(2), 51(1) and 56(2)

available by electronic means shall be in place.

The department shall take all necessary administrative

measures to ensure conformity with these rules, and shall where

applicable apply such penalties prescribed in terms of the Act if any

person fails to abide by these rules. Such penalties shall apply without

prejudice to any criminal penalties which may be applied in this regard

and in pursuance of any infringements committed against the

provisions contained in these rules.

CHAPTER X

Amendments, Detailed Rules and Committee Procedure

(1) Rule 50(2) may be amended in accordance with the

procedure referred to in rule 62(2).

(2) The Schedules to these rules may be amended in

accordance with the procedure referred to in rule 62(2).

(3) The measures necessary for the implementation of these

rules shall be adopted in accordance with the procedure referred to

in rule 62(2).

(1) The Commission shall be assisted by the Standing

Committee on the Food Chain and Animal Health (hereinafter

referred to as "the Committee").

(2) Where reference is made to this sub-rule, the procedure set out

in the definition "Standing Committee on the Food Chain and Animal

Health" in rule 3(1) shall apply.

AND CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS