COLLECTION OF INFORMATION ON ZOONOSES AND ZOONOTIC AGENTS RULES

SUBSIDIARY LEGISLATION 437.57

COLLECTION OF INFORMATION ON

ZOONOSES AND ZOONOTIC AGENTS RULES

18th March,, 2005

LEGAL NOTICE 78 of 2005.

(1) The title of these rules is the Collection of Information

on Zoonoses and Zoonotic Agents Rules.

(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.

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.

For the purposes of these rules -

"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

I.

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.

II.

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.

INSPECTION FOR SALMONELLA

Section 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

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

COLLECTION OF INFORMATION

ON ZOONOSES AND ZOONOTIC AGENTS

Number of faeces samples to be taken in the

Number of birds kept in

building or group of buildings on the

a building

holding

1 - 24

(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

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.

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

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

breedi ng flock, the person responsible for the lab oratory 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

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 paragraph (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 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.

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

(a) surveillance systems based on a serological check at the holding may be

recognized if they offer guarantees equivalent to the system of

COLLECTION OF INFORMATION

ON ZOONOSES AND ZOONOTIC AGENTS

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 to

(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.

(1) The following rules shall be ensured in Malta

(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]/61/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

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

European 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) shall not rule out more frequent reporting for

additional information, where the circumstances warrant.

The systems for tracing the movement of farm animals laid

down in European Commission Decision 89/153/EEC shall be

enforced in relation to the measures for zoonoses and zoonotic

agents laid down in these rules.

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

Government the national measures which are being

taken to achieve the objectives of these rules in respect

of the zoonoses listed in Schedule 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) 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.

(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-

s p o t c h e c k s . To d o t h i s , t h e y m a y v e r i f y b y c h e c k i n g 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.

COLLECTION OF INFORMATION

ON ZOONOSES AND ZOONOTIC AGENTS