and Measures) Rules, 2012

L.N. 385 of 2012

VETERINARY SERVICES ACT

(CAP. 437)

African Horse Sickness (Control Rules

and Measures) Rules, 2012

IN EXERCISE of the powers conferred by article 5 of the

Veterinary Services Act, the Minister for Resources and Rural

Affairs, after consultation with the Minister for Health, the Elderly

and Community Care, has made the following rules:-

(1)

The title of these rules is the African Horse Title and scope.

Sickness (Control Rules and Measures) Rules, 2012.

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

92/35/EEC establishing control rules and measures to combat African

horse sickness. Furthermore, these rules are intended to harmonise

effective control measures to eradicate such disease for the purpose of

intra-Community trade and imports of equidae from third countries,

and should be read without prejudice to the Animal Health Conditions S.L. 437.60

governing the Movement and Import from Third Countries of

Equidae Rules, transposing European Union Council Directive 90/

426/EEC on animal health conditions governing the movement and

import from third countries of equidae.

A. NATIONAL REFERENCE LABORATORY FOR

AFRICAN HORSE SICKNESS

The National Reference Laboratory for African Horse Sickness in Malta is

the National Veterinary Laboratory situated in Abattoir Street, Albertown, Marsa.

B. FUNCTIONS AND DUTIES OF THE NATIONAL REFERENCE

LABORATORY FOR AFRICAN HORSE SICKNESS

The National Reference Laboratory for African Horse Sickness shall be

responsible for coordinating the standards and diagnostic methods prescribed by

the Community Reference Laboratory, for the use of reagents and for the testing of

vaccines. To this end, such National Reference Laboratory

(a)

may provide diagnostic reagents to the Community Reference

Laboratory, when the latter so requests;

(b)

shall control the quality of all diagnostic reagents used in Malta;

(c)

shall arrange comparative tests periodically;

(d)

shall hold isolates of African Horse Sickness virus from cases

confirmed in Malta;

(e)

shall ensure the confirmation of positive results obtained.

(1)

Unless otherwise provided in these rules, the Interpretation.

definitions prescribed in the Act and those contained in the Animal S.L. 437.60

Health Conditions governing the Movement and Import from Third

Countries of Equidae Rules shall mutatis mutandis apply, unless they

are inconsistent with these rules.

(2) For the purpose of these rules and unless the context

otherwise requires

"the Act" means the Veterinary Services Act;

"African horse sickness (AHS)" means a highly infectious and

deadly disease, which commonly affects horses, mules, donkeys and

zebras, and which is not directly contagious, but is known to be

spread by insect species;

"census" means an official count of animal population carried

out at set intervals commonly known as animal disease surveillance

prevention and control system in animal population carried out by

(a)

collecting complete information including updated

records of livestock production data, disease registries, specific

reports and disease notification systems;

(b)

obtaining a good knowledge of livestock

production data, including livestock population, which is

important for assessing the status of national, regional and

continental food security; and

(c)

providing guidelines on identification and

traceability of live animals for the direct or indirect benefit of

such data; such methodology facilitates the competent authority

to carry out its mandates and responsibilities with regard to

animal health.

The purpose of the census also aids the competent authority to

plan properly on how to combat animal diseases affecting equidae in

Malta in order to tackle the disease;

"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;

"the competent authority" means the Department of Veterinary

Services in Malta as established by article 2 of the Act;

"confirmation" means the declaration, by the competent

authority, of the presence of African horse sickness, based on

laboratory results, which disease however, in the event of an

epidemic, the competent authority may also confirm on the basis of

clinical and, or epidemiological results;

"crisis centre" means an animal disease crisis management

centre 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 centre 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;

"the Director" means the Director General responsible for

veterinary services or any veterinarian officer nominated by him;

"epidemic inquiry" means an inquiry carried out in relation to an

epidemic outbreak of disease in an animal population, often with the

implication that it may extend to humans, and which primarily affects

livestock and can cause disease in a large number of domestic animals

and among humans who are exposed to diseased animals;

"equidae" means wild or domesticated animals of the equine or

asinine species, (including zebras) or the offspring of crossings of

such species;

"holding" means an agricultural or training establishment, a

stable, or any premises or facilities in which equidae are habitually

kept or bred, for whatever use, and natural reserves in which equidae

live in freedom;

"importation" means the transfer of animals and their products

from a third country to a Member State;

"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;

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

European Union;

"Member State of destination" means such Member State to

which

(a)

for the purpose of intra-Community trade, equidae

are transported either directly from another Member State, or

from another Member State after being imported from a third

country;

(b)

for the purpose of importation, equidae are

transported directly from a third country;

"official veterinarian" means the veterinarian designated by the

competent authority of Malta or any person summoned to act on his

behalf, or the veterinarian nominated by the competent authority of

another Member State or of a third country;

"owner or keeper" means any natural or legal person having

ownership of the equidae or charged with their keep, whether for

financial remuneration or not;

"person" means any natural or legal person;

"Scientific Veterinary Committee" means a committee within

the Commission which monitors matters of a scientific nature and

whose 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;

"third country" means a state which is not a member of the

European Union;

"the Treaty" means the Treaty on the European Union

establishing the European Community as amended by the Lisbon

Treaty of 2007, and as may be subsequently amended;

"vector" means a disease-transmitting organism which for the

purpose of African horse sickness is known to be an insect of the

Culicoides imicola species or any other Culicoides insect liable to

transmit African horse sickness, identifiable under the procedure

provided in the definition "Standing Committee on the Food Chain

and Animal Health" in rule 2(2), following the opinion of the

Scientific Veterinary Committee.

A. COMMUNITY REFERENCE LABORATORY

The Community Reference Laboratory for African Horse Sickness is

Laboratorio de sanidad y producción animal,

Ministerio de Agricultura, Pesca y Alimentación,

28110 Algete,

Madrid - España.

B. THE FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE

LABORATORY FOR AFRICAN HORSE SICKNESS

The Community reference laboratory has the following functions and duties

1. to coordinate, in consultation with the Commission, the methods

employed in the Member States for diagnosing African Horse Sickness,

specifically by

(a)

typing, storing and supplying strains of African Horse Sickness

virus for serological tests and the preparation of antiserum;

(b)

supplying standard sera and other reference reagents to the

national reference laboratories in order to standardize the tests and reagents

used in each Member State;

(c)

building up and maintaining a collection of African Horse

Sickness virus strains and isolates;

(d)

organizing periodical comparative tests of diagnostic procedures

at Community level;

(e)

collecting and collating data and information on the methods of

diagnosis used and the results of tests carried out in the Community;

(f)

characterizing isolates of African Horse Sickness by the most

up-to-date methods available to allow greater understanding of the

epizootiology of African Horse Sickness;

(g)

monitoring developments in African Horse

Sickness

surveillance, epizootiology and prevention throughout the world.

2. To assist actively in the diagnosis of African Horse Sickness outbreaks

in Member States by receiving virus isolates for confirmatory diagnosis,

characterization and epizootiological studies.

3. To facilitate the training or retraining of experts in laboratory diagnosis

with a view to the harmonization of techniques throughout the Community.

4. To carry out a mutual and reciprocal exchange of information with the

world laboratory for African Horse Sickness designated by the International Office

of Epizootics (IOE), in particular with regard to developments in the world

situation concerning African Horse Sickness.

(1)

The provisions of these rules apply in particular to Applicability.

the following criteria

(a)

to liberalize the movement of equidae in the

Community both for the purpose of intra-Community trade

between Member States and imports from third countries while

introducing Community measures to harmonize rules for

controlling the disease and create measures, including the

carrying out of a detailed epizootiological enquiry, to combat

African horse sickness;

(b)

to make it possible to ensure rational development

of the farming sector and contribute to the protection of animal

health in Malta when it is the Member State of destination;

(c)

to eliminate as far as possible an outbreak of such

disease which may quickly assume epizootic proportions,

causing mortality and disturbance which may severely reduce

the profitability of livestock production;

(d)

to prevent the spread of African horse sickness

where the movement of animals is liable to transmit the

infection and which shall be strictly controlled, and insects shall

be eradicated from infected holdings;

(e)

to specify rules governing conditions under which

vaccination against African horse sickness may be carried out

and to ensure that such conditions are being complied with;

(f)

to ensure more effective control of the disease by

taking all necessary actions in order to establish protection and

surveillance zones.

(2) The competent authority shall apply all such necessary

administrative measures conforming to the requirements of the

Standing Committee of the Food Chain and Animal Health according

to the requirements of these rules, to ensure that there is no breach

thereof, and also to reduce the risk for final consumers and any

additional risk to animals and to the environment.

(3) These measures shall include the direct confiscation of the

product, the suspension of the activities carried out by the authorised

provider when these are creating a risk to final consumers and to the

environment, and the forfeiture of any authorisation, licence or permit

in terms of article 60 of the Act in addition to the application of any

other administrative penalty in terms of article 61 of the Act.

CRITERIA FOR CONTINGENCY PLANS

Contingency plans shall meet at least the following criteria

1. the establishment of a crisis centre on a national level, which shall

coordinate all control measures in Malta;

2. a list shall be provided of local disease control centres with adequate

facilities to coordinate the disease control measures at a local level;

3. detailed information shall be given about the staff involved in control

measures, their skills and their responsibilities;

4. each local disease control centre must be able to contact rapidly persons

or organizations which are directly or indirectly involved in an outbreak;

5. equipment and materials shall be available to carry out the disease

control measures properly;

6. detailed instructions shall be provided on action to be taken, including

means of disposal of carcases, on suspicion and confirmation of infection or

contamination;

7. training programmes shall be established to maintain and develop skills

in the field and to develop administrative procedures;

8. diagnostic laboratories shall have facilities for post-mortem

examination, the necessary capacity for serology, histology, etc., and shall

maintain the skills for rapid diagnosis (to that end arrangements should be made

for rapid transportation of samples);

9. details on the quantity of African Horse Sickness vaccine estimated to

be required in the event of a reinstatement of emergency vaccination, shall be

provided;

10. provisions shall be made, to ensure the legal powers necessary for the

implementation of the contingency plans.

€1.44

(1)

Where a holding contains one or more equidae

suspected of being infected with African horse sickness, the

competent authority shall ensure that the official veterinarian sets out

immediately official means of investigation to confirm or rule out the

presence of the said sickness.

(2) From the moment when the suspected infection is notified,

the official veterinarian shall

(a)

have the suspect holding(s) placed under official

surveillance;

(b)

initiate

(i) an official census of the species of equidae,

stating in the case of each species the number of equidae

already dead, infected or liable to be infected, and the

updating of that census to take account of equidae born or

dying during the period of suspicion; the information in the

census shall be produced on request and may be checked at

each inspection;

(ii) a census of places likely to facilitate the

survival of the vector or its accommodation and the use of

appropriate means of eradicating insects in such places;

(iii) an epizootiological inquiry in accordance

with rule 6;

(c)

regularly visit the holding(s), whereby he shall

(i)

examine each equidae kept there;

(ii) carry out a detailed clinical examination or an

autopsy on the suspect or dead animals and take the

samples necessary for laboratory examinations;

(d)

ensure that

(i) all equidae on the holding(s) are kept in their

living quarters or in other places protected against the

vector;

(ii) all movement of equidae to or from the

holding(s) is prohibited;

(iii) appropriate means of eradicating insects are

employed around and in the buildings housing the equidae;

(iv) the carcasses of equidae which have died on

the holding are destroyed, disposed of, or burnt in

accordance with the provisions of Council Regulation EC

1069/2009 laying down Health Rules as regards Animal

Byproducts 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.

(3) Pending the introduction of the official measures referred

to in sub-rule (2), the owner or keeper of any animals suspected of

having the disease shall take all the necessary precautionary actions

to ensure compliance with sub-rule (2)(d).

(4) The competent authority may apply any of the measures

provided for in sub-rule (2) to other holdings should their location,

their geographical situation or contacts with the holding where the

disease is suspected give reason to suspect possible contamination.

(5) Without prejudice to the provisions set out in sub-rule (2),

specific provisions for nature reserves in which equidae live in

freedom may be prescribed in accordance with the procedure

provided in the definition "Standing Committee on the Food Chain

and Animal Health" in rule 2(2).

(6) The measures covered by this rule shall be officially

discontinued only when the competent authority no longer suspects

the presence of African horse sickness.

(1)

Vaccination against African horse sickness may be Vaccination

practiced solely in accordance with the provisions provided in these against

confirmation of

rules.

African horse

sickness.

(2) Where the presence of African horse sickness is officially

confirmed, the official veterinarian shall

(a)

proceed immediately with the killing under official

control of any equidae on the infected holding, which are

infected or present clinical symptoms of African horse sickness;

(b)

coordinate and monitor the destruction, disposal,

burning or burial of the carcases of the aforesaid equidae in

accordance with Directive 90/667/EEC; and, or

(c)

extend the measures prescribed in rule 4 to

holdings situated within a 20 km radius (included in the

protection zone) around the infected holding(s);

(d)

proceed, in the protected zone mentioned in

paragraph (c), with the systematic vaccination of all equidae

using a vaccine authorized by the competent authority, and shall

identify them by a clear, indelible mark applied by an approved

method in accordance with the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" in rule 2(2). However, on the basis of the

epizootiological, meteorological, geographical or climatological

circumstances, the vaccination requirements may be waived by

the competent authority. The competent authority shall inform

the Commission thereof;

(e)

carry out an epizootiological enquiry in accordance

with rule 6.

(3) The competent authority may extend the measures

provided for in sub-rule (2), beyond the protected zone referred to in

paragraph (c) thereof if, on account of the geographical, ecological or

meteorological situation or of movements to or from the holding

where the disease has been confirmed, there are grounds for

suspecting an extension of African horse sickness, and shall inform

the Commission accordingly.

(4) Where the zone referred to in sub-rule (2) is situated in

other Member States the competent authority shall collaborate with

other Member States in defining such zone. If necessary, the zone

shall be defined in accordance with the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" in rule 2(2).

(1)

The epizootiological inquiry shall cover

(a)

the length of time during which African horse

sickness may have existed on the holding;

(b)

the possible origin of the African horse sickness on

the holding and the identification of other holdings on which

there are equidae which may have become infected or

contaminated from the same source;

(c)

the presence and distribution of disease vectors;

(d)

the movement of equidae to or from the holdings

concerned or any carcases of equidae removed from them.

(2) In order to provide full coordination of all measures

necessary to ensure eradication of African horse sickness as quickly

as possible and for the purpose of carrying out the epizootiological

inquiry, a crisis centre shall be established.

(1)

The competent authority shall ensure that, in Additional

addition to the measures referred to in rule 5, it establishes a measures

control

protection zone and a surveillance zone. The establishment of the structures

by the

zones shall take account of the geographical, administrative, competent

ecological and epizootiological factors in relation to African horse authority.

sickness and of the control structures.

(2) The protection zone shall consist of a part of the territory

of Malta with a radius of at least 100 km around the entire infected

holding and the surveillance zone shall consist of a part of the

territory of Malta extending at least 50 km beyond the protection

zone, in which no systematic vaccination has been carried out in the

last twelve months.

(3) Where such zones are situated in other Member States, the

competent authority shall collaborate with such other Member States

in order to define the zones referred to in sub-rule (2). However, if

necessary, the protection zone and the surveillance zone shall be

defined in accordance with the procedure provided in the definition

"Standing Committee on the Food Chain and Animal Health" in rule

2(2). At the request of the competent authority, which request shall be

duly substantiated, a decision may be taken in accordance with the

procedure provided in the definition "Standing Committee on the

Food Chain and Animal Health" in rule 2(2), with a view to amend

the demarcation of the zones defined in sub-rule (2), taking into

account

(a)

their geographical situation and ecological factors;

(b)

the meteorological conditions;

(c)

the presence and distribution of the vector;

(d)

the results of the epizootiological studies carried

out in accordance with rule 6;

(e)

the results of the laboratory examinations;

(f)

the application of the control measures, in

particular the insect eradication measures.

(1)

The competent authority shall ensure that the

following measures are applied in the protection zone

(a)

all holdings containing equidae within the zone are

identified;

(b)

the official veterinarian conducts

(i)

periodic visits to all holdings containing

equidae,

(ii) a clinical examination of the said equidae

including, if necessary, the collection of samples for

laboratory examination; a record of visits and findings

shall be kept;

(c)

equidae leave the holding on which they are kept

only for transport directly under official supervision for

immediate slaughter to a slaughterhouse located in that zone or,

if that zone has no slaughterhouse, to a slaughterhouse in the

surveillance zone designated by the competent authority.

(2) In addition to the measures provided for in sub-rule (1), a

decision to carry out systematic vaccination of equidae against

African horse sickness and to identify them in the protection zone,

may be taken under the procedure provided in the definition

"Standing Committee on the Food Chain and Animal Health" in rule

2(2).

The competent authority shall ensure that

(a)

the measures provided for in rule 8(1) apply in the

surveillance zone. However, if the surveillance zone has no

slaughterhouse, the equidae may be slaughtered in the

protection zone in a slaughterhouse designated by the competent

authority;

(b)

all vaccination against African horse sickness shall

be prohibited in the surveillance zone.

(1)

The period of application and maintenance of the

measures provided for in rules 5, 7, 8 and 9 shall be determined

according to the procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" in rule 2(2). The

period may in no case be less than twelve months where vaccination

has been carried out in accordance with rules 5(2) and 8(2).

(2) However, notwithstanding rules 8(1)(c) and 9(a), equidae

from the protection zone and from the surveillance zone may be

transported under official supervision and under the conditions

prescribed in regulation 5(3) of the Animal Health Conditions S.L. 437.60

governing the Movement and Import from Third Countries of

Equidae Rules, to the quarantine station referred to in regulation

5(3)(iv) of those regulations and movements of equidae within zones

of the same status shall be subject to authorization from the

competent authority on the basis of the following rules

(a)

equidae shall

(i)

undergo a prior official check;

(ii) require identification in accordance with

Commission Regulation EC504/2008 implementing

Council Directives 90/426/EEC and 90/427/EEC as

regards methods for the identification of equidae and

which finds its legal basis in the Trade with Member States S.L. 437.11

in Equidae (Zootechnical and Genealogical Conditions)

Regulations and the Animal Health Conditions governing S.L. 437.60

the Movement and Import from Third Countries of

Equidae Rules; and

(iii) be accompanied by an official document;

(b)

the competent authority shall ensure, in all events,

that equidae vaccinated less than sixty days previously cannot

leave the holding on which they were at the time the vaccination

was carried out;

(c)

the competent authority shall

inform

the

Commission on measures taken in this field.

Where the African horse sickness epizootic is Additional

exceptionally serious in a particular region, any additional measures measures

relation to

to be taken by the competent authority shall be adopted in accordance serious

horse sickness

with the procedure provided in the definition "Standing Committee on to be taken by

the competent

the Food Chain and Animal Health" in rule 2(2).

authority.

The competent authority shall take all necessary and Public

appropriate measures for all persons established in the protection and information

regarding

surveillance zones to be fully informed of the restrictions in force and restrictive

measures.

to take the steps necessary for the appropriate implementation of the

measures in question.

(1)

The competent authority shall designate a National Designation of a

Reference Laboratory as specified in Schedule I(A) to carry out the national

reference

laboratory examinations provided for in these rules, and shall make laboratory.

the details of that laboratory, and any subsequent changes thereto,

available to the 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" in rule 2(2).

(2) The functions and duties of the National Reference

Laboratory designated in accordance with sub-rule (1) are set out in

Schedule I(B).

(3) The National Reference Laboratory designated in

accordance with sub-rule (1) shall liaise with the Community

Reference Laboratory specified in Schedule II(A).

(1)

Experts from the Commission may, in so far as is

necessary for the uniform application of these rules and in

cooperation with the competent authority, make on-site checks. To

this end they may, by inspecting a representative percentage of

holdings, verify whether the competent authority is monitoring

compliance with the provisions of these rules.

(2) When an inspection referred to in sub-rule (1) is being

carried out, the competent authority shall give all necessary assistance

to the experts in carrying out their duties. The general rules for

implementing this rule shall be adopted in accordance with the

procedure provided in the definition "Standing Committee on the

Food Chain and Animal Health" in rule 2(2).

(1)

The competent authority shall draw up a

contingency plan, specifying how it shall implement the measures

prescribed in these rules. This plan shall allow access to facilities,

equipment, personnel and all other appropriate materials necessary

for the rapid and efficient eradication of the disease.

(2) The criteria to be applied for drawing up the plans referred

to in sub-rule (1) are established in Schedule III. The plans may

subsequently be amended or supplemented in accordance with the

same procedure to take account of developments in the situation.

(1)

Any person who fails to abide by these rules shall

be guilty of an offence in terms of the Act and the provisions and

measures of rule 3(2) and (3) shall apply to it.

(2) Any right given to the competent authority under these

rules to apply all such necessary measures prescribed in rule 3(2) and

(3) shall be given to the competent authority without prejudice to

other criminal procedures which may be taken under the Act or any

other law when a person commits an offence by failing to abide by

these rules.