Control of Diseases) Rules, 2005

L.N. 316 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Bivalve Molluscs (Minimum Measures for the

Control of Diseases) Rules, 2005

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

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

with the concurrence of the Prime Minister and Minister of Finance,

made the following rules>-

(1) The title of these rules is Bivalve Molluscs (Minimum Title, scope and

definitions.

Measures for the Control of Diseases) Rules, 2005.

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

under European Union Council Directive 95#70#EEC on the Introduction

of Minimum European Community Measures for the Control of certain

Diseases affecting Bivalve Molluscs, and in accordance with article 5

(1) of the Veterinary Services Act.

(3) These rules establish minimum measures for the control

of the diseases affecting bivalve molluscs referred to in these rules.

(4) For the purposes of these rules, the definitions laid down

in Article 2 of European Union Council Directive 91#67#EEC and Article

2 of European Union Council Directive 91#492#EEC shall apply as

necessary.

(5) In addition, ‘observed abnormal mortality’ shall mean

sudden mortality affecting approximately 15 % of stocks and occurring

over a short period between two inspections (confirmed within 15 days).

In hatchery a mortality shall be considered abnormal when the farmer

cannot obtain larvae during a period which included successive spawns

from different brood-stocks. In nursery a mortality shall be considered

abnormal when a sudden sizeable mortality occurs in a short time on a

number of tubes.

MALTA NATIONAL REFERENCE LABORATORY

FOR DISEASES OF BIVALVE MOLLUSCS

ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE,

Area Ittiopatologia Laboratorio Patologia Molluschi,

Via della Roggia, 94

I-33030 Basaldella di Campoformido (UD)

Italy.

B

(1) All farms rearing bivalve molluscs in Malta shall be Registration and

records to be kept

registered by the official service. Such registration must be kept by bivalve molluscs

constantly up to date.

farms.

(2) All farms rearing bivalve molluscs in Malta shall keep

a record of>

(a) live bivalve molluscs entering the farm, containing all

information relating to their delivery, their number or weight, their

size and their origin<

(b) bivalve molluscs leaving the farm for re-immersion,

containing all information relating to their dispatch, their number

or weight, their size and destination<

(c) observed abnormal mortality. This record, which shall

be open to scrutiny by the official service at all times, on demand,

shall be updated regularly and kept for four years.

DISEASES OF BIVALVE MOLLUSCS AND THE SUSCEPTIBLE HOST SPECIES

Disease

Pathogen

Susceptible Host Species

Bonamiosis

Bonamia exitiosus

Tiostrea chilensis and Ostrea angasi

Mikrocytos roughleyi

Saccostrea (Crassotrea)

Commercialis

Marteiliosis

Marteilia sydneyi

Marteiliosis Saccostrea (Crassotrea)

commercialis

Microcytosis

Mikrocytos mackini

Crassotrea gigas; C. virginica;

Ostrea edulis; O. conchaphila

Perkinsosis

Perkinsus marinus

Crassotrea virginica and C. gigas

Perkinsus olseni/ atlanticus

Haliotis ruber; H. cyclobates; H.

scalaris; H. laevigata; Ruditapes

philippinarum and R. decussates

MSX disease

Haplosporidium nelsoni

Crassotrea virginica and C. gigas

SSO disease

Haplosporidium costale

Crassotrea virginica

Withering syndrome of abalones

Candidatus Xenohaliotis

Members of the genus Haliotis

californiensis

including black abalone (H.

cracherodii), red abalone (H.

rufescens), pink abalone (H.

corruguta), green abalone (H.

fulgens) and white abalone (H.

sorenseni)

Note: Susceptible host species also includes any other species specified, for the pathogen in question, in the

International Office of Epizooties' (OIE) most recent edition of the International Aquatic Animal Health Code.

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

(1) A monitoring and sampling programme shall be applied

in bivalve mollusc farms, farming areas and harvested natural beds in

order to observe whether there is an abnormal mortality and keep track

of the health situation of stocks. In addition, the official service may

apply the above programme to purification centres and storage tanks

which discharge water into the sea. If, during application of this

programme, any abnormal mortality is observed, or if the official service

has information giving it reason to suspect the presence of diseases, the

following measures shall be taken>

(a) a list shall be drawn up of the sites where the diseases

referred to in Schedule A, list II to European Union Council

Directive 91#67#EEC are present, provided that such diseases are

not the subject of a programme approved pursuant to the said

European Union Council Directive,

(b) a list shall be drawn up of the sites at which abnormal

mortality has been observed as a result of the presence of the

diseases referred to in Schedule B, or on which the official service

has information giving it reason to suspect the presence of diseases,

(c) monitoring of the evolution and geographical spread of

the diseases referred to in sub-rule (1) (a) and (b) hereof.

(2) The detailed rules for implementing this rule, and inter

alia the rules to be applied for establishing the programme referred to

in sub-rule 1 of this rule, particularly as regards the frequency and

timetable of monitoring, procedures for taking samples (statistically

representative volume) and methods of diagnosis, shall be adopted, if

necessary, in accordance with the requirements of the European

Community and under the procedure provided for in article 5(1) of the

Veterinary Services Act.

(1) The suspected presence of any diseases referred to in Measures

taken in the event of

rule 3 and any abnormal mortality rate observed in bivalve molluscs in suspicion of

farms, in farming areas or in harvested natural beds or in purification diseases.

centres or storage tanks which discharge water into the sea shall be

notified as soon as possible to the official service by the shellfish-farmers

or any other person who has made such observations.

(2) In the case referred to in sub-rule 5 (1), the official

service shall ensure that>

(a) samples are taken for examination in an approved

laboratory<

(b) pending the result of the examination referred to in

paragraph (a), no molluscs leave the affected farm, farming area

or harvested natural beds or purification centres or storage tanks

which discharge water into the sea for relaying or re-immersion in

another farm or in the aquatic environment, unless authorized by

the official service.

(3) If the examination referred to in sub-rule 5(2)(a) fails to

demonstrate the presence of a pathogen, the restrictions referred to in

sub-rule 5(2)(b) shall be lifted.

(4) (a) If the examination referred to in sub-rule 5(2)

shows the presence of a pathogen causing the observed abnormal

mortality capable of being the cause of that mortality, or of a pathogen

of one of the diseases referred to in rule 4, an epizootic investigation

must be carried out by the official service in order to determine the

possible means of contamination and to investigate whether molluscs

have left the farm, the farming area or the harvested natural beds for

relaying or re-immersion elsewhere during the period preceding

observation of the abnormal mortality.

(b) If the epizootic investigation shows that the disease

has been introduced into one or more farms, farming areas or harvested

natural beds as a result inter alia of molluscs being moved, the provisions

of sub-rule 5(2) shall apply. However, by way of derogation from article

3 (1) (c) of European Union Council Directive 91#67#EEC, the official

service may, within its territory, authorize the movement of live bivalve

molluscs to other farms, farming areas or harvested natural beds which

are infected with the same disease.

(c) If necessary, further appropriate measures may be

decided by the official service in accordance with the requirements of

the European Community and under the procedure laid down in article

5(1) of the Veterinary Services Act.

(5) The official service shall ensure that the European

Commission and the other European Union Member States are

immediately informed, in accordance with the current European

Community procedures, of any cases of abnormal mortality rates

observed involving a pathogen, of any measures taken to analyse and

control the situation and of the cause of the mortality.

(1) Sampling and laboratory testing for the determination

of the cause of abnormal mortality of bivalve molluscs shall be carried

out using the methods established by the European Community.

(2) A national reference laboratory for Malta is designated

in Schedule A of these rules, with facilities and expert personnel enabling

it to carry out the testing referred to in sub-rule 6(1).

(3) National reference laboratories shall cooperate with the

European Community reference laboratory for molluscs diseases.

(1) European Commission experts may, to the extent

necessary to ensure uniform application of European Union Council

Directive 95#70#EEC, carry out on-the-spot checks. In so doing, they

may carry out random, non-discriminatory checks to ensure that the

official service in charge of molluscs diseases is monitoring compliance

with the said Directive.

(2) The checks referred to in sub-rule (1) shall be carried

out in collaboration with the official service in charge of molluscs

diseases in Malta.

(3) The official service in charge of molluscs diseases in

Malta shall provide the experts with any assistance they require to

accomplish their task.