24 tal-2009 - Regoli tal-2009 Dwar il-Ħtiġiet tas-Saħħa ta’ l-Annimali għall-Annimali ta’ l-Akkwakultura u l-Prodotti tagħhom, u dwar il-Prevenzjoni u l-Kontroll ta’ Ċertu Mard f’Annimali Akkwatiċi

L.N. 24 of 2009

VETERINARY SERVICES ACT

(CAP. 437)

Animal Health Requirements for Aquaculture Animals and

Products thereof, and on the Prevention and Control of

Certain Diseases in Aquatic Animals Rules, 2009

IN the exercise of the powers conferred by article 5(1) of

the Veterinary Services Act, the Minister for Resources and Rural

Affairs has made the following rules:-

CHAPTER I

Title, Scope and Definitions

(1) These rules may be cited as the Animal Health

Requirements for Aquaculture Animals and Products thereof, and on

the Prevention and Control of certain Diseases in Aquatic Animals

Rules, 2009.

(2) The scope of these rules is to implement the rules

contained in the European Union Council Directive 2006/88/EC

of the 24th October 2006 and in the European Union Commission

Directive 2008/53/EC of the 30th April 2008, repealing and replacing

the Measures for the Control of Fish Diseases Rules, 2005 and the

Bivalve Molluscs (Minimum Measures for the Control of Diseases)

Rules, 2005 which implement the rules contained in European Union

Council Directive 93/53/EEC introducing minimum Community

measures for the control of certain fish diseases and the rules

contained in European Union Council Directive 95/70/EEC on the

introduction of minimum European Community measures for the

control of certain disease affecting bivalve molluscs, respectively.

(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.

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 competent

authority;

“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

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.

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 competent authority in a register, as provided for in rule

(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 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 sub-paragraph of sub-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 competent authority 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

“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 animal” 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, for processing aquaculture animals

for food purposes, and authorised in accordance with rules 4

and 5 hereof;

“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;

“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;

“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;

“production area” means any freshwater, sea, estuarine,

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;

“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

Risk levels

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

(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),

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 competent authority 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 competent authority 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 competent

authority in accordance with rule 5.

Provided that such authorisation may cover several

aquaculture production businesses for molluscs in a mollusc farming

area, also 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 competent authority in accordance with rule

Disease Listing

PART I

Criteria for Listing Diseases

A. 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.

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 sensitive and the testing method harmonised at

Community level.

PART II

Listed diseases

(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) hereof, the territory of Malta may require

only the registration by the competent authority of the following

(a)

installations other than aquaculture production

businesses, where aquatic animals are kept without the intention

of being placed on the market;

(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 competent authority shall act in accordance with

Article 54 of Regulation (EC) No. 882/2004.

5. (1) The competent authority in the territory of Malta

shall ensure that authorisations, as provided for in sub-rules 4 (1)

and (2), are only granted if the aquaculture production business

operator 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 competent authority that those relevant

requirements are being fulfilled; and

(c) remains under the supervision of the competent

authority, which shall perform the duties laid down in sub-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 competent authority in order to allow the

competent authority to assess that the conditions for authorisation

are fulfilled, including the information required in accordance with

Schedule II.

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

10 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 10 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 competent authority,

including notification of suspicion;

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

enabling the competent authority to undertake effective disease investigation

and reporting, and ensuring in particular

(i)

the rapid recognition of any clinical signs consistent with the

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 competent authority

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 competent authority 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 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 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 sub-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 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 10 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 sub-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 within a common biosecurity system. The geographical demarcation of 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 10

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 sub-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 competent authority, 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.

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 competent authority, 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 sub-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 competent authority; 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

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 competent authority 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.

Functions and Duties of Laboratories

PART I

Community Reference Laboratories

1. In order to be designated as a Community reference laboratory in accordance

with rule 55, laboratories shall fulfil the following requirements. They must

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

and analytical techniques applied in their 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 them;

(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.

2. However, the Commission may designate only laboratories that operate and

are 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

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

of testing and calibration laboratories’;

(b)

EN 45002 on ‘General criteria for the assessment of testing

laboratories’;

(c)

EN 45003 on ‘Calibration and testing laboratory accreditation

system - General requirements for operation and recognition’.

3. The accreditation and assessment of testing laboratories referred to in

paragraph 2 may relate to individual tests or groups of tests.

4. For one or more of the diseases under their responsibility, the Community

reference laboratories may take advantage of the skills and capacity of laboratories

in other Member States or EFTA Member States, provided that the laboratories

concerned comply with the requirements laid down in points 1, 2 and 3 of this

Schedule. Any intention to take advantage of such cooperation shall be part of the

information provided as a basis for the designation in accordance with sub-rule 55

(1). However, the Community reference laboratory shall remain the contact point for

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

5. The Community reference laboratories 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 Reference Laboratories

1. The national reference laboratories designated pursuant to rule 56 shall

be responsible for coordinating the diagnostic standards and methods within their

field of responsibility in the Member State concerned. These national reference

laboratories shall

(a) undertake to notify, without delay, the competent authority 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 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 throughout the Member

State;

(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 accordance with rule 57, in order to provide information on the

methods of diagnosis used and the results of tests carried out in the Member

State;

(g) cooperate with the Community reference laboratory referred to in

rule 55 and participate in the comparative tests organised by the Community

reference laboratories;

(h) ensure a regular and open dialogue with their national competent

authorities;

(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 Member States may designate national reference laboratories which

do not comply with the requirements referred to in point 1 (i)(i) of this Part, 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. Member States may authorise a national reference laboratory situated on their

territory to take advantage of the skills and capacity of other laboratories designated

pursuant to rule 57, for one or more of the diseases under their responsibility, provided

that these laboratories comply with the relevant requirements of this Part. However, the

national reference laboratory shall remain the contact point for the central competent

authority of the Member State, and for the Community reference laboratory.

PART III

Designated Laboratories in Member States

1. The competent authority of a Member State shall designate only laboratories

for diagnostic services pursuant to rule 57 that fulfil the following requirements. They

must

(a) undertake to notify, without delay, the competent authority whenever

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

IV;

(b) undertake to participate in comparative tests (ring-tests) of diagnostic

procedures arranged by the national reference laboratory;

(c) 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

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

3. The Member States may designate laboratories which do not comply with

the requirements referred to in point 1 (c)(i) of this Part, where operation under EN

ISO/IEC 17025 is practically difficult, provided that the laboratory operates under

quality assurance in line with the guidelines in ISO 9001.

4. The competent authority shall cancel the designation where the conditions

referred to in this Schedule are no longer fulfilled.

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

authority 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)

hereof 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 that

are laid down in Part B of Schedule III.

(3) Detailed rules for the implementation of this rule

may be adopted in accordance with the procedure referred to in sub-

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 competent authority 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

competent authority.

(1) The competent authority 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) hereof shall aim at the detection of

(a) any increased mortality in all farms and mollusc

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 listed in Part B of

Schedule III. This surveillance shall apply without prejudice to the

sampling and surveillance carried out in accordance with Chapter V

or sub-rules 49 (3) and 50 (4), and rule 52.

(4) The risk-based animal health surveillance scheme

referred to in sub-rule (1) hereof shall take account of guidelines to

be drawn up by the Commission in accordance with the procedure

referred to in sub-rule 62 (2).

(5) A report shall be submitted by the competent authority

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 sub-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 competent authority 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 competent authority 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

aquaculture animals on

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, as

referred to in Part A of Schedule III.

(1) The competent authority 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 competent authority

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 competent authority

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 paragraph 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

accordance with paragraphs (1) or (2) of this Article; 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 competent authority 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 competent authority 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 paragraph 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 competent authority

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 Part A of 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 competent authority may also decide to apply this

paragraph 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

the first sub-rule 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 sub-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 sub-rule 62 (2).

(3) In accordance with the procedure referred to in sub-

rule 62 (3) together with the possible inclusion of a species on the

list referred to in sub-rule (2), the Commission may decide to permit

the application of the provisions provided for in sub-rule (1).

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.

(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 sub-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 competent authority

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) hereof may be

permitted by the competent authority, 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) hereof.

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 sub-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 competent authority provides appropriate

guarantees as regards compliance with the relevant animal health

requirements of Community legislation.

(2) In the completion of the assessment of the third

country, or part of the third country, as provided for in sub-rule (1)

hereof, the Commission may also request an inspection as referred

to in sub-rule 58 (2).

(3) 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 competent authority 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 competent authority 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 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.

(4) All lists shall be drawn up or updated by the

Commission in accordance with rule 22 and shall be made available

to the public.

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

combined with other lists drawn up for animal and public health

purposes.

(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 sub-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 sub-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 competent

authority; and

(b) when increased mortality occurs in aquaculture

animals, the mortality is immediately notified to the competent

authority or a private veterinarian for further investigations.

(2) The obligation to notify the matters referred to in

sub-rule (1) hereof 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 24 hours in case of confirmation of

(a)

an exotic disease listed in Part II of Schedule IV;

(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, comprising

any zones or compartments with a health status of either category I

or III as referred to in Part A of Schedule III, the competent authority

shall ensure that for such 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 point (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 sub-rule 28 (b) (iii) shall be carried out where the examination

provided for in sub-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

of either category I or III, as referred to in Part A of Schedule

III, for the disease in question.

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

(1) hereof 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 sub-

rule 26 (1);

(c)

investigating whether other farms have been

infected.

(3) Where the epizootic investigation provided for in

sub-rule (1) hereof 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 competent authority may decide to limit

the application of rule 28 to a less extensive area in the vicinity of

the farm or the mollusc farming area suspected of being infected

where it considers that such less extensive area is sufficiently large

to guarantee that the disease does not spread.

(4) Where necessary, the competent authority 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 competent authority shall lift the restrictions provided

for in sub-rule 28 (b) where the examination provided for in sub-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 competent authority 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 competent authority; 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 competent authority 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.

(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 competent

authority in accordance with Regulation (EC) No. 1774/2002 of the

European Parliament and of the Council of 3 October 2002 which

lays down health rules concerning animal by-products not intended

for human consumption, and the contingency plan provided for in

rule 47 of these rules.

(2) Aquaculture animals which have not reached

commercial size and do not show clinical signs of disease shall, in

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 competent

authority in accordance with Regulation (EC) No. 1774/2002, and

the contingency plan provided for in rule 47 of these rules.

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 competent

authority 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 competent

authority 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 sub-rule 44 (2).

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

the competent authority 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 competent authority 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 competent

authority 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 sub-rule 12 (2); or

(ii) harvested and slaughtered for human

consumption in accordance with sub-rule 33 (1); and

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

under the supervision of the competent authority in accordance

with Regulation (EC) No. 1774/2002, 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 competent authority 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 competent authority shall

also monitor the situation and take measures to reduce, and as far as

possible, to prevent the further spreading of the disease.

(3) The competent authority shall inform the

Commission and the other Member States within the Committee

referred to in sub-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

competent authority 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

competent authority 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) hereof, the matter shall be brought to the attention of

the Committee referred to in sub-rule 62 (1). The measures taken

by the competent authority pursuant to sub-rule (1) hereof may be

extended, amended or repealed in accordance with the procedure

referred to in sub-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 sub-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 sub-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

competent authority 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) hereof by the competent authority, which

may affect trade between Member States. Those measures shall be

subject to approval in accordance with the procedure referred to in

sub-rule 62 (2).

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

only be granted where the establishment of intra-Community 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 (category III as referred to in Part

A of Schedule III) of one or more of the non-exotic diseases listed

in Part II of Schedule IV, the competent authority shall draw up a

surveillance programme for achieving a disease-free status for one

or more of those diseases. The competent authority shall submit that

programme for approval in accordance with the procedure referred

to in sub-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 sub-rule 49 (3)

Provided that, where a programme provided for in this

paragraph 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 sub-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

(category V as referred to in Part A of Schedule III) by one or

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

competent authority 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 sub-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) hereof 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 sub-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 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 competent authority, or by the

Commission.

(2) If the programme is withdrawn as provided for

in sub-rule 1 (b) hereof, the competent authority 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

competent authority 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 competent authority shall comply with the

criteria and requirements laid down in Schedule VII when drawing

up contingency plans.

(4) The competent authority shall submit the contingency

plans for approval in accordance with the procedure referred to in

sub-rule 62 (2), and every five years, the competent authority 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 sub-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 sub-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) hereof 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 sub-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 competent authority 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, sampling and diagnostic methods that shall be used by the

competent authority to grant disease-free status in accordance with

this rule shall be adopted in accordance with the procedure referred

to in sub-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 competent authority shall submit the declaration

referred to in sub-rule (1) hereof to the Standing Committee on

Food Chain and Animal Health in accordance with the following

procedure

(a)

the declaration shall be supported by evidence in

a form to be determined in accordance with the procedure

referred to in sub-rule 62 (2) and be accessible by electronic

means to the Commission and to other Member States, in

accordance with the requirements of rule 59;

(b) the Commission shall add the notification of the

declaration to the agenda of the next meeting of the Committee

referred to in sub-rule 62 (1) as an information point. The

declaration shall take effect 60 days after the date of the

meeting;

(c) within this period, the Commission or Member

States may seek clarification or additional information on the

supporting evidence from the competent authority making the

declaration;

(d) where written comments are made by at least one

Member State, or the Commission, within the period referred

to in paragraph (b) of sub-rule (2) hereof indicating significant

objective concerns related to the supporting evidence, the

Commission and the Member States concerned shall together

examine the submitted evidence in order to resolve the

concerns. In that case, the period referred to in paragraph (b)

of sub-rule (2) hereof may be prolonged for 30 days and such

comments shall be submitted to the declaring Member State

and to the Commission;

(e) if the arbitration referred to in paragraph (d) of sub-

rule (2) hereof fails, the Commission may decide to make an

on-the-spot inspection in accordance with rule 58 to verify the

compliance of the declaration submitted with the criteria set

out in sub-rule (1) hereof, unless the declaring Member State

withdraws its declaration;

(f) where necessary in the light of the results achieved,

a decision in accordance with the procedure referred to in sub-

rule 62 (2) shall be taken, to suspend the self-declaration of the

disease-free status of the zone or compartment concerned.

(3) Where the zones or compartments referred to in

sub-rule (1) hereof 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 sub-rule 62 (2).

(4) The specific requirements of the surveillance,

sampling and diagnostic methods used by the competent authority

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).

(1) The competent authority shall establish and maintain

an updated list of zones and compartments declared disease-free in

accordance with sub-rule 50 (2). Such lists shall be made publicly

available.

(2) The Commission shall draw up and update a list

of Member States, zones or compartments declared disease-free in

accordance with rules 49 or sub-rule 50 (3), and shall make the list

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 competent authority 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 sub-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 as laid down in Part A of Schedule III and

it shall apply the provisions of Sections 2 and 4 of Chapter V.

(2) Where the epizootic investigation provided for in

sub-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 compartment 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) The territory of Malta shall designate its competent

authorities for the purposes of these rules and shall notify the

Commission thereof and the competent authorities shall operate

and perform their duties in accordance with Regulation (EC) No.

882/2004.

(2) Effective and continuous cooperation based on the

free exchange of information relevant to the implementation of these

rules shall be established between the competent authority and any

of its other authorities involved in regulating aquaculture, aquatic

animals, and food and feed of aquaculture origin. Such information

shall also, to the extent necessary, be exchanged between the

competent authorities of the different Member States.

(3) The competent authorities 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 and laboratories.

(1) Community reference laboratories for the aquatic

animal diseases relevant to these rules shall be designated in

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

period to be defined in accordance with that procedure.

(2) Community reference laboratories for aquatic

animal diseases shall comply with the functions and duties laid

down in Part I of Schedule VI.

(3) The Commission shall review the designation of the

Community reference laboratories by the end of the period referred

to in sub-rule (1) hereof at the latest, in the light of their compliance

with the functions and duties referred to in sub-rule (2) hereof.

(1) A national reference laboratory shall be designated

by the competent authority for each of the Community reference

laboratories referred to in rule 55 and the competent authority may

designate a laboratory situated in another Member State or EFTA

Member State, and a single laboratory may be the national reference

laboratory for more than one Member State.

(2) The competent authority shall inform the

Commission with the name and address of each designated national

reference laboratory, the relevant Community reference laboratory

and other Member States, including any updates hereto.

(3) The national reference laboratory shall liaise with

the relevant Community reference laboratory provided for in rule

55. (4) The national reference laboratory shall collaborate

with any laboratory designated in accordance with rule 57 in order

to ensure an efficient diagnostic service in accordance with the

requirements of these rules.

(5) Any national reference laboratory within the

territory of Malta 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 and shall

comply with the functions and duties laid down in Part II of Schedule

VI.

The competent authority shall ensure that

(a) laboratory examinations for the purposes of these

rules are carried out in laboratories designated for such purpose

by the competent authority;

(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 to be

established in accordance with the procedure referred to in

sub-rule 62 (2); and

(c) laboratories designated for diagnostic services in

accordance with this rule shall comply with the functions and

duties laid down in Part III 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 competent authority, insofar as they are necessary for the

uniform application of these rules and the competent authority shall

provide the experts carrying out such inspections and audits with

all the assistance necessary for carrying out their duties, and the

Commission shall inform the competent authority of the results of

any such inspections and audits.

(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 competent authority 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 sub-rule 62 (3) and the competent authority

shall be informed thereof.

(1) All procedures and formalities relating to making

the information provided for in rule 6, sub-rules 50 (2), 51 (1) and

56 (2) available by electronic means shall be in place.

(2) The Commission shall, in accordance with the

procedure referred to in sub-rule 62 (2), adopt detailed rules for

the implementation of sub-rule (1) hereof in order to facilitate the

interoperability of information systems and use of procedures by

electronic means between Member States.

The competent authority shall lay down the rules on

penalties applicable to infringements pursuant to these rules and shall

take all measures necessary to ensure that they are implemented. The

competent authority shall notify those provisions to the Commission

and shall notify it without delay of any subsequent amendment

affecting them.

CHAPTER X

Amendments, Detailed Rules and Committee Procedure

(1) Sub-rule 50 (2) may be amended in accordance

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

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

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

(3) The measures necessary for the implementation

of these rules shall be adopted in accordance with the procedure

referred to in sub-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, articles

5 and 7 of Decision 1999/468/EC shall apply and the period laid

down in sub-article 5 (6) of Decision 1999/468/EC shall be set at

three months.

(3) Where reference is made to this sub-rule, articles

5 and 7 of Decision 1999/468/EC shall apply and the period laid

down in sub-article 5 (6) of Decision 1999/468/EC shall be set at

15 days.

(4) The Committee shall adopt its Rules of Procedure.