Diseases in Aquatic Animals (Amendment No. 2) Rules, 2013

L.N. 129 of 2013

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 (Amendment No. 2) Rules, 2013

IN exercise of the powers conferred by article 5 of the

Veterinary Services Act, the Minister for Sustainable Development,

the Environment and Climate Change has made the following rules:-

The title of these rules is the Animal Health Requirements

for Aquaculture Animals and Products thereof, and on the Prevention

and Control of Certain Diseases in Aquatic Animals (Amendment No.

2) Rules, 2013 and these rules shall be read and construed as one with

the Animal Health Requirements for Aquaculture Animals and

Products thereof, and on the Prevention and Control of Certain

Diseases in Aquatic Animals Rules, hereinafter referred to as "the

principal rules".

Sub-rule (2) of rule 1 of the principal rules shall be

substituted by the following

"(2)

The scope of these rules is to transpose Council

Directive 2006/88/EC on animal health requirements for

aquaculture, animals and products thereof, and on the

prevention and control of certain diseases in aquatic animals,

repealing and replacing Council Directive 93/53/EEC

introducing minimum Community measures for the control of

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

introduction of minimum European Community measures for

the control of certain disease affecting bivalve molluscs.".

Sub-rule (1) of rule 3 of the principal rules shall be

amended as follows

(a)

immediately before the definition "aquaculture"

there shall be added the following new definition

" Cap. 437.

"the Act" means the Veterinary Services

Act";

(b)

immediately after the definition "authorised

processing establishment operator", there shall be added the

following new definitions

" "the Commission" means the European

Commission established by the Treaty on the European

Union as amended by the Lisbon Treaty of 2009, subject to

subsequent amendments;

"the department" means the department of

veterinary services in Malta as established by article 2 of

the Act;"; and

for the words "the competent authority", wherever they

occur in the principal rules, there shall be substituted the words

"the department";

(c)

immediately after the new definition "the

department" there shall be added the following new definition

" "EFTA Member States" means states which are

members of the European Free Trade Association;";

(d)

immediately after the definition "farming" there

shall be added the following new definition

" "Member State" means a state which is a member

of the European Union;";

(e)

immediately after the definition "relaying area"

there shall be added the following new definition

" "Standing Committee on the Food Chain and

Animal Health" or "the Committee" means a Committee

made up of the representatives of Member States named

committee members, who assist and consult the

Commission by delivering an Opinion regarding safety

measures with respect to animal health issues to be then

formally adopted by the Commission in accordance with

the appropriate procedure. Such committee procedure

covers the entire food supply chain, ranging from animal

health issues on the farm to the product which arrives to

the final consumer, therefore significantly enhancing its

ability to target risks to health wherever they arise in the

production of food;".

In sub-rule (2) of rule 7 of the principal rules, for the words Amends rule 7

"that are laid down in Part B of Schedule III" there shall be of

rules.

substituted the words "set out in Schedule III".

Rule 10 of the principal rules shall be amended as follows

(a)

in sub-rule (3) thereof, for the words "listed in Part

B of Schedule III" there shall be substituted the words "set out

in Schedule III"; and

(b)

in sub-rule (4) thereof, for the words "to be drawn

up by the Commission" there shall be substituted the words "set

out by the Commission".

In sub-rule (2) of rule 12 of the principal rules the words

"as referred to in Part A of Schedule III" shall be deleted.

In sub-rule (4)(b) of rule 15 of the principal rules, for the

words "as referred to in Part A of Schedule III" there shall be

substituted the words "as referred to in Schedule III".

Sub-rule (3) of rule 17 of the principal rules shall be

deleted.

Rule 23 of the principal rules shall be amended as follows

(a)

sub-rules (2) and (4) thereof shall be deleted;

(b)

sub-rule (3) thereof shall be renumbered as sub-

rule (2);

(c)

sub-rule (5) thereof shall be renumbered as sub-

rule (3); and

(d)

in sub-rule (3) thereof, as renumbered, immediately

after the words "public health purposes", there shall be added

the words "and shall be made available to the public".

In rule 28 of the principal rules for the words "with a

health status of either category I or III as referred to in Part A of

Schedule III" there shall be substituted the words "with a health status

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

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

disease-free status)".

In sub-rule (1)(b) of rule 29 of the principal rules for the

words "with a health status of either category I or III as referred to in

Part A of Schedule III" there shall be substituted the words "with a

health status categorised as being either "disease-free" or

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

programme for achieving disease-free status)".

Rule 34 of the principal rules shall be amended as follows: Amends rule 34

of the principal

rules.

(a)

in sub-rule (1) thereof, for the words "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", there shall be substituted

the words "in accordance with Regulation (EC) No 1069/2009

of the European Parliament and of the Council laying down

health rules as regards animal by-products and derived products

not intended for human consumption and repealing Regulation

(EC) No 1774/2002 (Animal by-products Regulation)"; and

(b)

in sub-rule (2) thereof, for the words "in

accordance with Regulation (EC) No. 1774/2002" there shall be

substituted the words "in accordance with Regulation (EC) No

1069/2009".

In rule 39(d) of the principal rules, for the words "in Amends rule 39

accordance with Regulation (EC) No. 1774/2002" there shall be of

rules.

substituted the words "in accordance with Regulation (EC) No 1069/

2009".

Rule 44 of the principal rules shall be amended as follows: Amends rule 44

of the principal

rules.

(a)

in sub-rule (1) thereof, the words "(category III as

referred to in Part A of Schedule III)" shall be deleted; and

(b)

in sub-rule (2) the words "(category V as referred

to in Part A of Schedule III)" shall be deleted.

Sub-rule (2) of rule 50 of the principal rules shall be Amends rule 50

of the principal

substituted by the following

rules.

"(2)

The department shall submit the declaration

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

Chain and Animal Health. Such declaration shall be supported

by evidence in a form determined in accordance with the

procedure referred to in rule 62(2) and shall be accessible by

electronic means to the Commission and to other Member

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

Sub-rule (2) of rule 51 of the principal rules shall be Amends rule 51

of the principal

deleted, and the whole rule shall be renumbered as rule 51.

rules.

In sub-rule (1) of rule 53 of the principal rules, the words Amends rule 53

of the principal

"as laid down in Part A of Schedule III" shall be deleted.

rules.

Rule 54 of the principal rules shall be substituted by the

following new rule

" General

54. (1)

Effective and continuous

obligations.

cooperation based on the free exchange of

information relevant to the implementation of

these rules shall be established between the

department and any of its other bodies or

entities involved in regulating aquaculture,

aquatic animals, and food and feed of

aquaculture origin. Such information shall

also, to the extent necessary, be exchanged

with the competent authorities of the other

Member States.

(2)

The department shall have access

to adequate laboratory services and state-of-

the-art know-how in risk analysis and

epidemiology, having a free exchange of any

information relevant to the implementation of

these rules between the competent authorities

of other Member States and their respective

designated laboratories.".

Rule 55 of the principal rules shall be substituted by the

following new rule

" Community

55. (1)

The Community Reference

Reference

Laboratory designated for the aquatic animal

Laboratory.

diseases relevant to these rules in accordance

with the procedure referred to in rule 62(2)

shall act and remain the single point of

contact for all designated national reference

laboratories in Member States and for the

Commission.

(2)

The

Community

Reference

Laboratory for aquatic animal diseases shall

comply with the functions and duties laid

down in Part I of Schedule VI.".

Rule 56 of the principal rules shall be substituted by the

following new rule

" National

56. (1)

The National Reference

Veterinary

Laboratory designated by the department in

Laboratory.

Malta is the National Veterinary Laboratory

referred to in Part II A of Schedule VI and

shall comply with the functions and duties

laid down in Part II B of Schedule VI.

(2)

The

National

Veterinary

Laboratory shall liaise with the relevant

Community Reference Laboratory referred to

in rule 55.

(3)

The

National

Veterinary

Laboratory shall collaborate with any

laboratory designated in other Member States

in order to ensure an efficient diagnostic

service and methods in accordance with the

requirements of rule 57.

(4)

The

National

Veterinary

Laboratory shall be adequately equipped and

staffed with the appropriate numbers of

trained personnel to carry out the laboratory

investigations required in accordance with

these rules.".

Rule 57 of the principal rules shall be substituted by the Substitutes rule

57 of the

following new rule

principal rules.

" Diagnostic

57. The department shall ensure that

services and

(a)

laboratory examinations for

methods.

the purposes of these rules are carried

out in the National Veterinary

Laboratory designated for such purpose

by the department;

(b)

laboratory examinations in

the case of suspicion and to confirm the

presence of the diseases listed in Part II

of Schedule IV are carried out by

diagnostic methods established in

accordance with the procedure referred

to in rule 62(2); and

(c)

the National Veterinary

Laboratory designated for diagnostic

services in accordance with this rule

shall comply with the functions and

duties laid down in Part II B of Schedule

VI.".

Rule 58 of the principal rules shall be amended as follows

(a)

in sub-rule (1) thereof, for the words "carrying out

their duties, and the Commission shall inform the competent

authority of the results of any such inspections and audits."

there shall be substituted the words "carrying out their duties.";

and

(b)

in the proviso to sub-rule (3) thereof, for the words

"in accordance with the procedure referred to in rule 62(3)"

there shall be substituted the words "in accordance with the

procedure referred to in rule 62(2)".

Sub-rule (2) of rule 59 of the principal rules shall be

deleted, and the whole rule shall be renumbered as rule 59.

Rule 60 of the principal rules shall be substituted by the

following new rule

" Offences and

60. The department shall take all

penalties.

necessary administrative measures to ensure

conformity with these rules, and shall where

applicable apply such penalties prescribed in

terms of the Act if any person fails to abide by

these rules. Such penalties shall apply without

prejudice to any criminal penalties which may

be applied in this regard and in pursuance of

any infringements committed against the

provisions contained in these rules.".

Rule 62 of the principal rules shall be amended as follows

(a)

sub-rule (2) thereof shall be substituted by the

following

"(2) Where reference is made to this sub-rule, the

procedure set out in the definition "Standing Committee on

the Food Chain and Animal Health" in rule 3(1) shall

apply."; and

(b)

sub-rules (3) and (4) thereof shall be deleted.

Schedule VI to the principal rules shall be substituted with Substitutes

Schedule VI to

the following new Schedule

the principal

rules.

"Schedule VI

Functions and duties of Laboratories

PART I

Community Reference Laboratory - Functions and Duties

1. The Community Reference Laboratory shall in accordance

with rule 55 fulfil the following requirements. It shall

(a)

have suitably qualified staff with adequate training

in diagnostic and analytical techniques applied in its area of

competence, including trained personnel available for

emergency situations occurring within the Community;

(b)

possess the equipment and products needed to

carry out the tasks assigned to it;

(c)

have an appropriate administrative infrastructure;

(d)

ensure that their staff respect the confidential

nature of certain subjects, results or communications;

(e)

have sufficient

knowledge

of

international

standards and practices;

(f)

have available, as appropriate, an updated list of

available reference substances and reagents and an updated list

of manufacturers and suppliers of such substances and reagents;

(g)

take account of research activities at national and

Community level.

The Community Reference Laboratory shall remain the contact

point for the national reference laboratories in the Member States, and

for the Commission.

2. Moreover, the Community Reference Laboratory shall

(a)

coordinate, in consultation with the Commission,

the methods employed in the Member States for diagnosing the

disease concerned, specifically by

(i) typing, storing and, where appropriate,

supplying strains of the pathogen of the relevant disease to

facilitate the diagnostic service in the Community;

(ii) supplying standard sera and other reference

reagents to the national reference laboratories in order to

standardise the tests and reagents used in each Member

State, where serological tests are required;

(iii) organising periodic comparative tests (ring

tests) of diagnostic procedures at Community level with

the national reference laboratories designated by the

Member States, in order to provide information on the

methods of diagnosis used and the results of tests carried

out in the Community;

(iv) retaining expertise on the relevant disease

pathogen and other pertinent pathogens to enable rapid

differential diagnosis;

(b)

assist actively in the diagnosis of outbreaks of the

relevant disease in Member States by receiving pathogen

isolates for confirmatory diagnosis, characterisation and

epizootic studies;

(c)

facilitate the training or retraining of experts in

laboratory diagnosis with a view to harmonising diagnostic

techniques throughout the Community;

(d)

collaborate, as regards methods of diagnosing

animal diseases falling within their areas of competence, with

the competent laboratories in third countries where those

diseases are prevalent;

(e)

collaborate with the relevant OIE reference

laboratories with regard to exotic diseases listed in Part II of

Schedule IV under their responsibility;

(f)

collate and forward information on exotic and

endemic diseases, that are potentially emerging in Community

aquaculture.

PART II

National Veterinary Laboratory

The National Reference Laboratory in Malta is the National

Veterinary Laboratory referred to in rule 56, situated at Civil Abattoir,

Albertown, Marsa.

B.

Functions and duties of the National Veterinary Laboratory

1. The National Veterinary Laboratory designated pursuant to

rule 56 shall be responsible for coordinating the diagnostic standards

and methods. Moreover, it shall

(a)

undertake to notify, without delay, the department

whenever the laboratory is aware of a suspicion of any of the

diseases referred to in Schedule IV;

(b)

coordinate, in consultation with the relevant

Community Reference Laboratory, the methods employed in

other Member States for diagnosing the diseases concerned

under their responsibility;

(c)

assist actively in the diagnosis of outbreaks of the

relevant disease by receiving pathogen isolates for confirmatory

diagnosis, characterisation and epizootic studies;

(d)

facilitate the training or retraining of experts in

laboratory diagnosis with a view to harmonising diagnostic

techniques in Malta;

(e)

ensure confirmation of positive results of all

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

of primary outbreaks of non-exotic diseases listed in that

Schedule;

(f)

organise periodic comparative tests (ring tests) of

diagnostic procedures at national level with the laboratories

designated by the Member States in order to provide

information on the methods of diagnosis used and the results of

tests carried out in the Malta;

(g)

cooperate with the Community Reference

Laboratory referred to in Article 55 and participate in the

comparative tests organised by national reference laboratories in

other Member States;

(h)

ensure a regular and open dialogue with the

department;

(i)

operate and be assessed and accredited in

accordance with the following European Standards account

being taken of the criteria for different testing methods laid

down in these rules

(i)

EN ISO/IEC 17025 on ‘General requirements

for the competence of testing and calibration laboratories’;

(ii) EN 45002 on ‘General criteria for the

assessment of testing laboratories’;

(iii) EN 45003 on ‘Calibration and testing

laboratory accreditation system - General requirements for

operation and recognition’.

2. The accreditation and assessment of testing laboratories

referred to in point 1(i) may relate to individual tests or groups of

tests.

3. The National Veterinary Laboratory may not comply with

the requirements referred to in point 1(i) (i), where operation under

EN ISO/IEC 17025 is practically difficult, provided the laboratory

operates under quality assurance in line with the guidelines in ISO

9001.

4. The National Veterinary Laboratory may take advantage of

the skills and capacity of other laboratories for one or more of the

diseases under their responsibility, provided that these laboratories

comply with the relevant requirements of this Part of the Schedule.

However, the National Veterinary Laboratory shall remain the contact

point for the department in Malta and for the Community reference

laboratory.".

€1.08