Control and Eradication of the Bluetongue Disease

L.N. 381 of 2012

VETERINARY SERVICES ACT

(CAP. 437)

Control and Eradication of the Bluetongue Disease

(Amendment) Rules, 2012

IN EXERCISE of the powers conferred by article 5 of the

Veterinary Services Act, the Minister for Resources and Rural Affairs

has made the following rules:-

The title of these rules is the Control and Eradication of the

Bluetongue Disease (Amendment) Rules, 2012 and these regulations

shall be read and construed as one with the Control and Eradication of

the Bluetongue Disease Rules, hereinafter referred to as "the principal

Rule 2 of the principal rules shall be amended as follows

(a)

immediately before the definition "animal", there

shall be added the following new definition

" "the Act" means the Veterinary Services

Act;";

(b)

in the definition "animal" for the words "in

accordance with the procedure laid down in rule 20(2)" there

shall be substituted the words "in accordance with the procedure

provided in the definition "Standing Committee on the Food

Chain and Animal Health" under this rule";

(c)

immediately after the definition "animal" there

shall be added the following new definitions

" "bluetongue disease" means a non-contagious

insect-borne viral disease of ruminants, mainly sheep and

less frequently cattle, such as goats, buffalos, and antelope,

caused by the bluetongue virus which is transmitted by an

insect of the species Culicoides imicola and any other

Culicoides insects, hereinafter referred to as "vectors";

"the

Commission"

means

the

European

Commission;

"the Community" means the European Community

as established by the Treaty on the European Union as

amended by subsequent treaties;";

(d)

the definition "the competent authority" shall be

substituted by the following new definition

" "the competent authority" means the Department

of Veterinary Services in Malta as established by article 2

of the Act;";

(e)

immediately after the definition "holding" there

shall be added the following new definitions

" "intra-Community trade" means trade between

Member States in animals and their products, a business or

occupation to make profit or gain, particularly in retail or

wholesale sales and includes dealings in a particular

business activity;

"live attenuated vaccines" means vaccines which

are produced by adapting bluetongue virus field isolate

through serial passages in tissue culture or in embryonated

hens’ eggs;

"Member State" means a state which is a member

of the European Union;

"national crisis unit" means an animal disease

crises management unit or a facility which provides animal

disease analysis and information, and which deploys or

sets up international resources to prevent and contain

dangerous animal diseases. Such unit aims at

(a) strengthening of disease intelligence

and emergency preparedness;

(b) supporting broad awareness creation

and risk communication;

(c) analyzing the social and economic

consequences of both the disease and its control;

(d) strengthening

field

surveillance,

laboratory capabilities, global surveillance and early

warning capabilities;

(e) advising the government and building

capacities on disease surveillance prevention and

control programmes;";

(f)

immediately after the definition " "owner" or

"holder" " there shall be added the following new definitions

" "person" means any natural or legal person;

"Scientific Veterinary Committee" means a

committee within the Commission which monitors matters

of a scientific nature and which aim and scope is inter alia

to

(a) protect and raise the health status and

condition of animals in the Community, in

particular food-producing animals, while promoting

intra-Community trade and imports of animals and

animal products in accordance with the appropriate

health and zootechnical standards’ improvement

and technology of animal husbandry and

international obligations;

(b) analyse scientific and technical

questions concerning all aspects of animal health,

hygiene, and animal diseases;

"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;"; and

(g)

in the definition "vector" for the words "according

to the procedure laid down in rule 20(2)" there shall be

substituted the words "in accordance with the procedure

provided in the definition "Standing Committee on the Food

Chain and Animal Health" under rule 2".

Rule 4 of the principal rules shall be amended as follows

Amends rule 4

of the principal

rules.

(a)

in paragraph (d)(iv) of sub-rule (2)

thereof, for the words "in accordance with

Council Directive 90/667/EEC of the 27th

November, 1990 laying down the veterinary

rules for the disposal and processing of

animal waste, for its placing on the market

and for the prevention of pathogens in feeding

stuffs of animal or fish origin, and amending

Directive 90/425/EEC" there shall be

substituted the words "in accordance with

Regulation EC 1069/2009 laying down Health

Rules as regards Animal By-products and

Derived Products not Intended for Human

Consumption and repealing Regulation EC

1774/2002 (Animal by-products Regulation),

which provisions shall be read without

prejudice to the Waste Regulations"; and

(b)

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

the procedure laid down in rule 20(2)" there shall be substituted

the words "in accordance with the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" under rule 2".

Rule 5 of the principal rules shall be substituted by the Substitutes rule

5 of the

following

principal rules.

"5. (1) The competent authority may decide to allow

the use of vaccines against bluetongue provided that

(a) such decision is based on the result of a

specific risk assessment carried out by the competent

authority;

(b) the Commission is informed before such

vaccination is carried out.

(2)

Whenever live attenuated vaccines are used, the

competent authority shall demarcate

(a) a protection zone, consisting of at least the

vaccination area;

(b) a surveillance zone, consisting of a part of the

Maltese territory with a depth of at least 50 kilometres

extending beyond the limits of the protection zone.".

Sub-rule (1) of rule 6 of the principal rules shall be

amended as follows

(a)

in paragraph (b) thereof, for the

words "in accordance with Directive 90/667/

EEC" there shall be substituted the words "in

accordance with Regulation EC 1069/2009,

which provisions shall be read without

prejudice to the Waste Regulations";

(b)

paragraph (d) thereof shall be substituted by the

following

"(d) implement the measures adopted in

accordance with the procedure provided in the definition

"Standing Committee on the Food Chain and Animal

Health" under rule 2, in particular with regard to the

introduction of any vaccination programme or other

alternative measures;"; and

(c)

in paragraph (e) thereof, for the words "in

accordance with the procedure laid down in rule 20(2)" there

shall be substituted the words "in accordance with the procedure

provided in the definition "Standing Committee on the Food

Chain and Animal Health" under rule 2".

The proviso to sub-rule (2) of rule 7 of the principal rules

shall be substituted by the following

"Provided that general rules concerning the national crisis

unit shall be laid down according to the procedure provided in

the definition "Standing Committee on the Food Chain and

Animal Health" under rule 2.".

Rule 8 of the principal rules shall be amended as follows

(a)

in paragraph (a) of sub-rule (2) thereof, for the

words "part of the Community territory" there shall be

substituted the words "part of the Maltese territory";

(b)

paragraph (b) of sub-rule (2) thereof shall be

substituted by the following

"(b) The surveillance zone shall consist of a part

of the Maltese territory with a depth of at least 50

kilometres extending beyond the limits of the protection

zone and in which no vaccination against bluetongue with

live attenuated vaccines has been carried out during the

previous twelve months.";

(c)

in paragraph (d) of sub-rule (2) thereof, for the

words "according to the procedure laid down in rule 20(2)"

there shall be substituted the words "in accordance with the

procedure provided in the definition "Standing Committee on

the Food Chain and Animal Health" under rule 2"; and

(d)

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

accordance with the procedure laid down in rule 20(2)" there

shall be substituted the words "in accordance with the procedure

provided in the definition "Standing Committee on the Food

Chain and Animal Health" under rule 2".

Sub-rule (2) of rule 10 of the principal rules shall be Amends rule 10

of the principal

substituted by the following

rules.

"(2)

The competent authority shall prohibit any

vaccination against bluetongue using live attenuated vaccines in

the surveillance zone.".

Rule 15 of the principal rules shall be substituted by the Substitutes rule

15 of the

following

principal rules.

" National

(1)

The competent authority

Reference

shall designate a National Reference

Laboratory.

Laboratory responsible for carrying out the

laboratory tests provided for by these rules,

and shall make the details of such laboratory,

and any subsequent changes thereto, available

to other Member States and to the public.

Detailed rules for the uniform application of

this sub-rule shall be adopted in accordance

with the procedure provided in the definition

"Standing Committee on the Food Chain and

Animal Health" under rule 2.

(2)

The tasks of the national reference

laboratory indicated in Annex I(A), as

designated by the competent authority in

accordance with sub-rule (1) are listed in

Annex I(B). Such laboratory shall liaise with

the Community Reference Laboratory

referred to in rule 16.".

10. Rule 16 of the principal rules shall be substituted by the Substitutes rule

16 of the

principal rules.

following

" Community

The

Community

Reference

Reference

Laboratory for bluetongue is indicated in

Laboratory.

Annex II(A) and the tasks of such laboratory

are set out in Annex II(B).".

11. Rule 17 of the principal rules shall be amended as follows

(a)

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

Directive 2000/75/EC transposed by these rules" there shall be

substituted the words "of these rules"; and

(b)

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

following

"(2) If the Commission carries out a check in

accordance with sub-rule (1), the competent authority shall

provide the experts with all the necessary assistance in the

performance of their task. The general implementing

provisions for this rule shall be laid down in accordance

with the procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" under

rule 2.".

12. Rule 18 shall be amended as follows

(a)

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

Directive" there shall be substituted the words "these rules"; and

(b)

sub-rule (3) thereof shall be deleted.

13. In rules 9, 11, 12, 13, and 19 of the principal rules, for the

words "the procedure laid down in rule 20(2)" wherever they occur,

there shall be substituted the words "the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" under rule 2".

14. Rule 20 of the principal rules shall be deleted.

15. Annex I to the principal rules shall be substituted by the

following

"Annex I

A. NATIONAL REFERENCE LABORATORY FOR

BLUETONGUE DISEASE

The National Reference Laboratory for Bluetongue disease in

Malta is the National Veterinary Laboratory situated in Abattoir

Street, Albertown, Marsa.

B. TASKS OF THE NATIONAL REFERENCE LABORATORY

FOR BLUETONGUE

The National Reference Laboratory for bluetongue shall be

responsible for the co-ordination of the standards and diagnostic

methods prescribed by the Community Reference Laboratory, the use

of reagents and the testing of vaccines. To this end such National

Reference Laboratory

(a)

may supply diagnostic reagents to the Community

Reference Laboratory when the latter so requests;

(b)

shall check the quality of all the diagnostic

reagents used in Malta;

(c)

shall

organise

comparative

tests

at

regular

intervals;

(d)

shall preserve isolates of the bluetongue virus

taken from confirmed cases in Malta;

(e)

shall ensure the confirmation of positive results

obtained.".

€0.81