78 tal-2005 - Regoli tal-2005 dwar il-Ġbir ta’ Informazzjoni fuq Żoonosi u Aġenti Żoonotiċi

L.N. 78 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Collection of Information on Zoonoses and Zoonotic Agents

Rules, 2005

BY virtue of the powers conferred by article 5 of the Veterinary

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

consultation with the Veterinary Services, has made the following rules>-

(1) The title of these rules is the Collection of Information Title and scope.

on Zoonoses and Zoonotic Agents Rules, 2005.

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

under European Union Council Directive 92#117#EEC concerning

measures for protection against specified zoonoses and specified

zoonotic agents in animals and products of animal origin in order to

prevent outbreaks of foodborne infections and intoxications in Malta.

Definitions.

For the purposes of these rules -

LIST OF THE ZOONOSES COVERED BY RULE 4

I.

— Tuberculosis due to Mycobacterium bovis

— Brucellosis and the agents thereof

— Salmonellosis and the agents thereof

— Trichinosis.

II.

— Campylobacteriosis

— Echinococcosis

— Listeriosis

— Rabies

— Toxoplasmosis

— Yersiniosis

— Other zoonoses and the agents thereof.

III.

Any other zoonosis not found in the European Community and the agents of that

zoonosis.

“approved national laboratory” means a laboratory approved

or recognized by the competent authority of Malta to carry out

examinations of official samples in order to detect a zoonotic agent<

“the competent authority” means the Veterinary Services

within the territory of Malta as provided under article 2 of the

Veterinary Services Act, or any other authority to which such

responsibility has been delegated by the Veterinary Services<

“Member State” means a State which is a Member within the

European Community<

“official sample” means a sample taken by the competent

authority to test for a zoonotic agent. The official sample bears a

reference to the species, the type, the amount and the method of

collection, and the identification of the origin of the animal or the

product of animal origin. Such sample is to be taken without prior

warning<

“sample” means a sample taken by the owner of or person

responsible for the establishment or the animals, or taken on his

behalf, to be examined for a zoonotic agent<

“Third country” means a State which is not a Member within

the European Community<

“zoonosis” means any disease and, or infection which is likely

to be naturally transmitted from animals to man<

“zoonotic” agent means any bacterium, virus or parasite which

is likely to cause a zoonosis.

CRITERIA FOR DRAWING UP PLANS FOR MONITORING SALMONELLA

IN FOWL FLOCKS

The plans must indicate

— the number and type of samples to be taken,

— the number and type of official samples to be taken,

— the methods of sampling,

— the methods of examination of the samples and identification of the zoonotic agents.

The plans must take into account the following criteria for establishing the sampling

procedures

(a) factors likely to encourage the spread of one or more zoonoses;

(b) previous history of the zoonosis in question in a country or region, in domestic animals or

wildlife;

(c) the animal population concerned as regards

— total size of population,

— homogenity of the population group,

— age of animals,

— animal production;

(d) the environment of the farms as regards

— regional differences,

— density of flocks,

— relations with urban areas,

— relations with areas populated by wildlife;

(e) farm production systems including

— intensive farming units,

— extensive farming units,

— husbandry systems, in particular feeding regimes and animal health care measures;

(f) problems likely to arise in the light of known precedents and other information;

(g) the required degree of protection according to the nature and gravity of the zoonosis in

question.

(1) In Malta measures taken in accordance with these rules

by the competent authority are coordinated at national and local level,

in particular in relation to epidemiological surveys.

(2) The competent authority at local level shall be assisted

by approved national laboratories.

(3) The competent authority shall designate the approved

national reference laboratories for the zoonoses and zoonotic agents

listed in Schedule I, point I, at which the identification of a zoonotic

agent or final confirmation of its presence may be carried out.

(1) The following rules shall be ensured in Malta>

INSPECTION FOR SALMONELLA

Sect ion I

MONITORING AND CONTROL — PRESENCE OF SALMONELLA IN

BREEDING FLOCKS

Breeding flocks

A breeding flock comprises at least 250 birds (Gallus gallus), kept or reared on a single holding for

the production of hatching eggs.

Monitoring for salmonella in breeding flocks

The owner or the person responsible for hatcheries or for a breeding flock must, at his own expense,

have samples taken for analysis for the detection of salmonella either in an approved national

laboratory or in a laboratory recognized by the competent authority, with the minimum levels of

sampling indicated below being respected.

A. Rearing flocks

1. Samples must be taken from birds being reared for breeding purposes at least when the

chicks are one day old, when the birds are four weeks old and two weeks prior to pullets

entering the laying phase.

2. The samples to be taken must comprise

(a) in the case of day-old chicks, samples from the internal linings of the boxes in which

the chicks were delivered to a holding and from the carcases of chicks found to be dead

on arrival; and

(b) in the case of pullets at four weeks of age or two weeks prior to entering the laying

phase, pooled faeces samples made up of separate samples of fresh faeces each

weighing not less than 1 g taken at random from a number of sites in the building in

which the birds are kept, or, where the birds have free access to more than one building

on a particular holding, from each group of buildings on the holding in which the birds

are kept;

(c) the number of sites from which separate faeces samples are to be taken in order to

make a pooled sample shall be as follows

Number of birds kept in a

Number of faeces samples to be

building

taken in the building or group of

buildings on the holding

1 – 243

(number equal to the number

of birds up to a maximum of

20)

25 – 29

30 – 39

40 – 49

50 – 59

60 – 89

90 – 199

200 – 499

500 or more

B. Adult breeding flocks

1. All adult breeding flocks must be sampled at least every two weeks during the laying

period.

2. Breeding flocks whose eggs are hatched at a hatchery with a total incubator capacity of less

than 1000 eggs must be sampled on the holding and the samples to be taken shall consist of

a pooled faeces sample made up of separate faeces samples, each weighing not less than 1

g, collected in accordance with point A (2) (b).

3. Breeding flocks whose eggs are hatched at a hatchery with a total incubator capacity of 1

000 eggs or more must be sampled through the hatchery and the samples to be taken shall

consist of

(a) pooled samples of meconium taken from 250 chicks hatched from eggs supplied to the

hatchery from each breeding flock; or

(b) samples of carcases of 50 chicks which are dead in the shells of eggs or which have

been hatched from eggs supplied to the hatchery from each breeding flock.

4. Such samples must also be taken from breeding flocks comprising less than 250 birds

whose eggs are hatched in hatcheries with a total incubator capacity of 1 000 eggs or more.

5. Every eight weeks, the sampling provided for in point B must be replaced by official

sampling, which must be conducted in accordance with point 4.

C. Examination of samples for salmonella

The total number of samples taken in each building may be pooled for analysis. The analyses

and tests for salmonella shall be carried out by methods recognized in accordance with the

procedure laid down in article 5(3) of the Veterinary Services Act.

Notification of results

Where, as a result of monitoring carried out in accordance with point II, the presence of Salmonella

enteritidis or Salmonella typhimurium is detected in a breeding flock, the person responsible for the

laboratory carrying out the examination, the person carrying out the examination or the owner of the

flock shall notify the results to the competent authority.

Investigation of flocks declared positive after monitoring

Where the presence of Salmonella enteritidis or Salmonella typhimurium is notified in accordance

with point III, the flock shall be officially sampled in order to confirm the initial results. A sample of

birds must be taken at random from within each house of birds on the farm, the size of sample being

selected in accordance with the table at point II (A)(2)(c). For the purposes of examination, the birds

from each house must be grouped into batches of five and samples of liver, ovary and intestines

taken from each bird in the batch must be examined for salmonella using analyses and tests

recognized in accordance with the procedures laid down in article 5(3) of the Veterinary Services

Act or pending such recognition by tried and tested national methods.

Measures to be taken in respect of flocks where infection is confirmed

The measures must comply with the following minimum standards.

1. Where, as a result of an investigation carried out in accordance with point IV, the presence of

Salmonella enteritidis or Salmonella typhimurium is confirmed in the birds in a house, the

following measures must be taken

(a)

no bird may leave the house concerned unless the competent authority has authorized the

slaughter and destruction under supervision or slaughter in a slaughterhouse designated

by the competent authority in accordance with (c);

(b)

non-incubated eggs produced by the birds in the house in question must be destroyed on

the spot or after appropriate marking be taken under supervision to an approved egg-

processing establishment to be heat treated in accordance with the requirements of

European Union Council Directive 89/437/EEC;

(c)

all the birds in the house must be slaughtered in accordance with Annex I, Chapter VI,

point 31 (c) of European Union Council Directive 71/118/EEC, the official veterinarian

of the slaughterhouse being informed of the decision to slaughter, in accordance with

Annex I, Chapter VI, point 25 (a) of that Directive, or be slaughtered and destroyed so as

to reduce as much as possible the risk of spreading salmonella.

2. Once a house occupied by a flock infected with Salmonella enteritidis or Salmonella

typhimurium has been emptied of birds, effective cleansing and disinfection must be carried out,

including safe disposal of manure or litter, in accordance with procedures laid down by the local

B

veterinary authority. Restocking must be with chicks satisfying the requirements of point II (A)

(1).

3. Where eggs for hatching from flocks in which the presence of Salmonella enteriditis or

Salmonella typhimurium has been confirmed are still present in a hatchery, they must be

destroyed or treated as high risk material in accordance with European Union Council Directive

90/667/EEC (1).

Under the procedure provided for in article 5(3) of the Veterinary Services Act,

(a) surveillance systems based on a serological check at the holding may be recognized if they offer

guarantees equivalent to the system of inspection at the hatchery provided for in point II (A) (1),

(B) (3) and (4) and (C);

(b) alternative solutions to compulsory slaughter provided for in point V (c), such as antibiotic

treatment, may be approved for breeding flocks;

(c) specific rules may be established with a view to safeguarding valuable genetic material.

The checks provided for in this Chapter may, according to the procedure laid down in article 5(3) of

the Veterinary Services Act, be reviewed in the light of the development of scientific knowledge.

Section II

INSPECTION FOR SALMONELLA AT THE FINAL PRODUCTION STAGE

OF COMPOUND FEEDINGSTUFFS FOR POULTRY

When official samples are being taken on a holding or in cases of justified suspicion, sampling may be

carried out on the compound feedingstuffs used to feed poultry.

Where a sample is positive for salmonella, the competent authority shall carry out an investigation in order

(a) identify the source of contamination, in particular by means of official samples taken at different stages

of production;

(b) examine the application of rules and controls concerning the disposal and processing of animal waste

and in particular those laid down in European Union Council Directive 90/667/EEC;

(c) establish procedures for good manufacturing practices and ensure compliance with recognized

procedures.

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

(a) the operators or managers of establishments approved

in accordance with European Union Council Directives

64#433#EEC, 71#118#EEC and 77#99#EEC are obliged to keep for

a minimum period to be specified by the competent authority and

to communicate to the latter at its request, the results of

examinations for the presence of the zoonoses listed in Schedule

I, point I<

(b) the isolation and identification of zoonotic agents or the

establishment of any other evidence of their presence rests with

the person responsible for the laboratory or, where the identification

is carried out elsewhere than at a laboratory, with the person

responsible for the examination<

(c) the diagnosis and identification of a zoonotic agent are

reported to the competent authority<

(d) the competent authority collects information on any

zoonotic agents the presence of which has been confirmed in the

course of the tests or examinations carried out and on any clinical

cases in humans or animals of the zoonoses listed in Schedule I,

point I<

(e) the other Member States are regularly informed within

the Standing Veterinary Committee set up by European Decision

68#361#EEC of clinical cases recorded in accordance with

paragraph (d).

(2) In accordance with the procedure laid down in article

5(3) of the Veterinary Services Act, the provisions of this regulation

may be extended to cover the zoonoses and zoonotic agents listed in

Schedule I, points II and III.

(1) The competent authority shall evaluate the information Evaluation of

information

collected in accordance with rule 4 (1)(d). It shall report to the European collected.

Commission, by the 31st May of each year, the trends and sources of

the zoonotic infections recorded during the previous year.

(2) Sub-rule (1) hereof shall not rule out more frequent

reporting for additional information, where the circumstances warrant.

The systems for tracing the movement of farm animals laid Systems for tracing

the movement of

down in European Commission Decision 89#153#EEC shall be enforced farm animals.

in relation to the measures for zoonoses and zoonotic agents laid down

in these rules.

(1) (a) The competent authority shall submit to the National measures

to be submitted by

Government the national measures which are being taken to achieve the competent

the objectives of these rules in respect of the zoonoses listed in Schedule authority.

I, points I and II, with the exception of those already being taken for

brucellosis and tuberculosis under plans already approved within the

framework of veterinary legislation. These measures will be forwarded

to the relevant International organisation and the Member States.

(b) Such measures may include measures to detect the

zoonoses and zoonotic agents listed in Schedule I, point III.

(c) The competent authority shall forward to the

European Commission, every year, a report on the epidemiological

situation for trichinosis.

(2) In the case of salmonella in fowls, the competent

authority must forward to the European Commission, plans drawn up

in accordance with the criteria laid down in Schedules II and III. These

plans shall>

(a) specify as regards salmonella the measures taken to

comply with the minimum requirements laid down in Schedule

III<

(b) take into account the specific situation in Malta<

(c) indicate the number of approved national laboratories

at which examination and identification of salmonella will take

place and the approval procedures for those laboratories.

(3) In accordance with the procedure laid down in article

5(3) of the Veterinary Services Act -

(a) the plans referred to in sub-regulation (2) hereof, shall

be approved by the Minister responsible for Veterinary Services,

and

(b) amendments or additions may be made to a plan

previously approved in order to take account of developments in

the situation in Malta.

(1) (a) Detailed rules governing the financial contribution

towards the measures for slaughter and destruction and official sampling

imposed pursuant to Schedule III, Section I, point V may be laid down

in accordance with any European Community law and articles 18 and

19 of the Veterinary Services Act.

(b) As regards the measures provided for in Schedule

III, the financial contribution provided for in articles 18 and 19 of the

Veterinary Services Act, must not benefit breeders who have

contravened the requirements of these rules.

The competent authority shall establish rules specifying the

measures to be taken to avoid the introduction of salmonella onto a

farm, taking account of the principles set out in Annex II to European

Union Council Directive 90#539#EEC.

Experts from the European Commission may, in so far as in

necessary for the uniform application of these regulations and in

cooperation with the competent authorities of Malta, make on-the-spot

checks. To do this, they may verify by checking a representative

percentage of holdings whether Malta is ensuring compliance with these

rules. The European Commission shall inform the competent authority

of the results of the checks made. The competent authority shall take

any measures which may prove necessary to take account of the results

of the checks.

The safeguard measures provided for in any European

Community law and in articles 15(5) and 16(3) of the Veterinary Services

Act, concerning veterinary checks to be carried out in trade with Member

States or third countries shall apply for the purposes of these rules.