306. Regulation of the Federal Minister for Health, Family and Youth on the examination of milk and blood samples for the determination of the IBR/IPV in cattle (IBR/IPV examination regulation 2008)

Pursuant to § § 3 (2) and (3), (4), (4), (12), (2) and (19) (2a) of the IBR/IPV Law, BGBl. N ° 636/1989, as last amended by the Federal Law BGBl. I n ° 67/2005 and the Federal Law BGBl. I n ° 6/2007, shall be arranged:

Scope

§ 1. (1) This Regulation regulates the conduct of investigations into the determination of IBR/IPV in all bovine herds covered by the IBR/IPV Act in Austria, as well as the procedures and examination bodies to be applied.

(2) The entire Austrian federal territory is IBR/IPV-free area within the meaning of Section 12 (1) of the IBR/IPV Act.

Definitions

§ 2. For the purposes of this Regulation:

1.		Inventory: the whole of the bovine animals of a livestock farm representing a unit of care established by the authority; the term "livestock holding" means any building, any installation or (in the case of an agricultural holding) Each place where bovine animals are held, reared or treated together.
2.		Suspected stock: a stock in which the milk examination or the blood test or clinical symptoms indicate the presence of the agent or a stock which is not recognised free of IBR/IPV.
3.		Milk sample: single milk sample, milk collection sample or tank milk sample delivered from a stock to an Austrian territorial laboratory or taken from an official sample taker.
4.		Stock investigation:
a)			the examination of blood samples of all bovine animals aged over two years old, but not more than ten years old, and bovine animals suspected of being IBR/IPV suspect bovine animals on IBR/IPV or
b)			the examination of milk samples from all lactating cattle of a herd on IBR/IPV.
5.		Re-examination: a second or third examination of bovine animals in which the result of the blood serological examination was neither positive nor negative to assess.
6.		Diagnostic slaughter: officially ordered slaughtering followed by examination, which is carried out in order to clarify the state of health of a bovine animal.
7.		Investigation: Following a diagnostic slaughter of all bovine animals over six months of age, as well as other IBR/IPV suspected bovine animals of the herd by means of blood sample.
8.		National reference laboratory for IBR/IPV: the Institute of Veterinary Medicine, Mödling of the Austrian Agency for Health and Food Safety GmbH (AGES).
9.		Investigation: in the presence of a non-negative milk sample, the individual animal testing of all bovine animals over six months old as well as of other IBR/IPV suspect bovine animals of the herd by means of blood sample.

Investigative bodies

§ 3. (1) In order to collect the samples, the Governor of the State, unless he/she can be found with the official veterinarians, has to attract professional veterinarians who are technically qualified for this purpose.

For the sampling of milk samples for serological tests and, if necessary, for the detection of lactating animals in the herd, other appropriate persons may also be able to take samples where the animals are not subject to reserved activities. according to § 12 of the Veterinary Act, BGBl. N ° 16/1997, as last amended by the Federal Law BGBl. I No 135/2006.

(3) The institutions referred to in paragraphs 1 and 2 shall be informed by the Governor of the State and shall, if necessary, be trained accordingly. Training courses are to be organized by the governor. It can be one of those according to § 2 of the Animal Health Services Ordination, BGBl. II No 443/2005, recognised animal health service in the country.

Investigative bodies

§ 4. (1) The investigations carried out in accordance with this Regulation shall be carried out by a veterinary medical examination office of the AGES accredited for IBR/IPV investigations.

(2) The investigative bodies shall be obliged to participate regularly (at least once a year) in a ring trial organised by the National Reference Laboratory for IBR/IPV.

(3) The Federal Minister of Health, Family and Youth shall be entitled to withdraw the authorisation to carry out the investigations, if either:

1.		the investigative body does not participate in an carried out ring trial, or
2.		the investigative body does not successfully complete the trials and does not carry out any appropriate corrective measures within a time limit set by the National Reference Laboratory for IBR/IPV; or
3.		whereas there are other important indications which indicate that proper conduct of the investigations is no longer guaranteed; or
4.		the investigative body does not have the reports and statistics requested by the Federal Ministry of Health, Family and Youth or the National Reference Laboratory for IBR/IPV within a reasonable period of time (from a maximum of 30 working days) after receipt of the request).

Tasks of the National Reference Laboratory for IBR/IPV

§ 5. (1) The National Reference Laboratory for IBR/IPV shall be responsible for the implementation of the following tasks:

1.		the carrying out of validation studies to demonstrate the reliability of the test methods and the establishment of the test methods used at the investigative bodies in accordance with § 4;
2.		the determination of the maximum number of blood samples which can be pooled as a collection sample using the ELISA test methods used;
3.		the fixing of the maximum number of lactating animals which can be examined in a milk sample using the ELISA test methods used;
4.		the calibration of the secondary national reference standard sera ("working standards") against the primary international standard sera;
5.		the quality control and approval of all batches of the ELISA test methods prior to use at the investigative bodies in accordance with § 4;
6.		the organisation and evaluation of the annual ring trials;
7.		cooperation within a European network of national reference laboratories for IBR/IPV;
8.		Regular participation in international ring trials for IBR/IPV;
9.		the coordination of the reporting of all investigative bodies on the investigations carried out in accordance with the guidelines of the Federal Ministry of Health, Family and Youth.

(2) The examination of the investigative bodies entitled to carry out the investigations in accordance with § 4 (1) with regard to compliance with the provisions of this Regulation shall be the responsibility of the National Reference Laboratory for IBR/IPV. Laboratory operators shall, during the periods of operation and in the event of a risk in default, also allow inspection bodies to enter and re-look at the premises outside these periods, to provide the information necessary for the checks, which shall be: to provide the necessary documentation for inspection and to provide the assistance required in the context of the audit activity free of charge.

(3) Blood samples, which do not have a clearly negative result, shall be forwarded to the National Reference Laboratory for IBR/IPV and shall be definitively assessed by the IBR/IPV Reference Laboratory in accordance with paragraph 4. In the assessment of non-clear negative blood samples, in order to answer the question of whether the pathogen is present in the herd, the use of all scientifically validated and scientifically recognized methods of examination, which are carried out by the EU or the O.I.E. are provided for. Likewise, additional blood samples may be requested to the extent necessary for a final assessment. The final result of this assessment shall be submitted by the National Reference Laboratory for IBR/IPV to the consignor, and in writing to the sending investigative body, to the competent official veterinarian and to the competent State Veterinary Office.

(4) The final assessment shall be:

1.		"positive" if an infection of the animal is to be concluded with the pathogen of the IBR/IPV or to a vaccination of the animal against IBR/IPV,
2.		"negative" if an infection of the animal with the pathogen of the IBR/IPV or a vaccination of the animal against IBR/IPV is to be excluded and
3.		"doubtful" if an infection of the animal with the pathogen of the IBR/IPV or a vaccination of the animal against IBR/IPV cannot be safely ruled out.

Examination procedures and laboratory methods

§ 6. (1) The Landeshauptmann shall ensure that the blood serological surveys are carried out in the following manner:

1.		The selection of the annually examined stocks of each federal state in which milk sampling is not carried out in accordance with paragraph 2 shall be made taking into account the risk-based sampling plan of the AGES by the regional governor. In these stocks, all bovine animals aged over two years, but not more than ten per herd, shall be examined. This blood sample can also be carried out in the course of slaughter. In principle, all stocks of a federal state must be taken into account, taking into account the number of investigations already carried out. Stocks which have been infected with IBR/IPV in the past, stocks of animal imports or intra-Community shipments, stocks of heavy animal transport and trade, and stocks, which have Community pastures, are preferred in of the sample design. As soon as the sample plans of all countries are available, the sampling plan for the entire federal territory is to be transmitted to the Federal Ministry of Health, Family and Youth by the AGES.
2.		The data relating to the identity and traceability of these blood samples shall be transmitted to the investigative body. The identity of the samples and the traceability of the samples must be given to the flocks and to the individual animals. In any case, in the accompanying report, the LFBIS No. of the farm of origin, the number of cattle in the herd according to the cattle database according to the cattle identification regulation 1998, BGBl. II No 408/1997, as last amended by the Federal Law BGBl. I No 55/2007, and the number of bovine animals from which blood samples have been taken.

(2) The Governor of the Land shall ensure that at least once a year, at least four months, all raw milk producing holdings with lactating bovine animals, in which the number of female bovine animals over 24 months is at least 30%, excluding pure suckler cow herds, shall be examined by means of milk samples in the following manner:

1.		The milk samples required for this purpose shall be obtained from territorial laboratories of the Austrian milk test rings, which have an accredited or certified sampling system or from investigative bodies in accordance with § 3 or from a laboratory, which shall be responsible for the authorized in accordance with the BVD Regulation and processed milk samples.
2.		The milk samples taken are to be forwarded immediately to the AGES investigative body provided for the milk inspection.
3.		The data relating to the identity and traceability of these milk samples shall be submitted to the investigative body. In so doing, the identity of the samples and the traceability of the samples to the stocks and individual animals or, in the case of a milk sample originating from several lactating bovine animals, must be given for the respective stock in the examination of the samples. In any case, the accompanying report is the LFBIS No. the establishment of origin, the number of lactating bovine animals in the herd and the number of cows from which the milk sample comes.
4.		The maximum possible number of lactating animals per milk sample in accordance with Annex A is to be observed
5.		The number of lactating bovine animals shall be determined in stocks of more than 50 bovine animals. The identification of the number of lactating bovine animals may be omitted if, according to the bovine database, no more than 50 bovine animals are in the present herd for more than two years.

(3) sampling and testing shall be carried out in accordance with the procedures and laboratory methods laid down in Annex A.

(4) In the organisation of the present investigations, care should be taken to ensure that the tests on Bang and Leukose can also be carried out during the course of the sampling.

Diagnosis and suspicious stocks

§ 7. (1) The diagnostic position shall be made by the competent official veterinarian, taking into account the laboratory results and the epidemiological situation in the herd.

(2) In the case of periodic analyses of milk samples, there shall be no safe negative laboratory results, immediately in the herd concerned of bovine animals aged over six months and other IBR/IPV bovine animals suspected of being bovine animals. To take blood samples and to study in the National Reference Laboratory on IBR/IPV (reconnaction investigation). The stocks are to be blocked in each case by IBR/IPV-suspicious stocks and in accordance with the relevant provisions until the declaration.

(3) In the case of blood sample investigations, do not safely carry out negative laboratory results according to the prescribed test methods, and the epidemiological circumstances or other test methods suggest that this result should be falsified by: After an unspecific reaction has been achieved, after a stock freeze has taken place, a determination can be initiated by the official veterinarian, taking into account the operating situation, in which case the following shall be taken as follows:

1.		The affected animal shall be immediately notified of the diagnostic slaughter, which is verifiably possible (i.e. within a maximum of two weeks), on the order of the district administrative authority.
2.		Prior to the diagnostic slaughter, the National Reference Laboratory for IBR/IPV is to be contacted. In all cases, blood samples and organs are in accordance with the procedure referred to in Annex B See. Further sampling may be carried out on the recommendation of the National Reference Laboratory for IBR/IPV.
3.		In the case of negative results from the studies after Z 2, the herd concerned shall be examined in a blood serological order at the earliest after four weeks of delivery of the slaughtered animal (determination of the findings).
4.		If the result of the determination is negative, the stock shall be deemed to be IBR/IPV-free.
5.		In the event of a positive or dubious result, as well as the absence of diagnostic slaughter, the relevant provisions of the IBR/IPV Act shall continue to act.

Data collection

§ 8. (1) In the case of milk samples, the Landeshauptmann has data concerning the identity and traceability of the samples (§ 6)-in particular, the LFBIS No. of the holding concerned and, where appropriate, the ear tag number of the animal concerned, by electronic means of the investigative body, in accordance with the provisions of the provisions of this Regulation.

(2) In the case of blood samples, the Landeshauptmann shall have data concerning the identity and traceability of the samples (§ 6), in particular the LFBIS No. of the holding concerned and the ear tag number of the animal concerned, by electronic means of the investigative body, in accordance with the provisions of the provisions of the said body. If an electronic message is not possible, the transmission of the data shall be made in writing to the investigative body. The electronic recording of the data transmitted shall be carried out by the investigative body in this case.

(3) In accordance with organisational possibilities, the investigative body shall transmit the data in accordance with paragraphs 1 and 2, including the findings of the investigation, to a central database of the Federal Ministry of Health, Family and Youth electronically.

Obligations of the animal owner

§ 9. The owner of the animal is obliged to:

1.		to tolerate or permit official measures under this Regulation,
2.		provide the necessary information and make the necessary documents available for the purpose of determining the facts; and
3.		free of charge for the necessary assistance in the administrative surveys and investigations. This includes the provision of a suitable device for the fixing of bovine animals and the fixing of the animals in a suitable way for the protection of life and limb.

Penalties

§ 10. Infringements of this Regulation shall be punished in accordance with the IBR/IPV Act.

Personal names

§ 11. All personal names used in this Regulation shall apply equally to persons of both female and male sex.

Final provisions

§ 12. (1) This Regulation shall enter into force 1. Jänner 2008 in force.

(2) With effect from 31 December 2007

1.		the IBR/IPV investigative bodies-Regulation BGBl. N ° 640/1989,
2.		the IBR/IPV investigation Regulation BGBl. II No 296/1999; and
3.		the IBR/IPV BGBl Regulation. No 425/1993 on blood tests
except for strength.

Kdolsky

Annex A

Procedures for sampling and testing

The examination of the samples (milk samples and blood samples) shall be carried out in accordance with the appropriate laboratory methods according to Directive 64 /432/EEC or the requirements of the Manual of Diagnostic Tests and Vaccines, in accordance with the appropriate state of the scientific knowledge and validated. for Terrestrial Animals " of the International Office for Epizootic Diseases (Organisation Mondiale de la Sante Animale/O.I.E.).

The milk of a maximum of 50 lactating bovine animals may be included in each milk sample, depending on the test system.

For the purpose of carrying out the tests, only tests which have been approved by the manufacturer for the respective sample matrix (milk, blood) and which have been approved by the National Reference Laboratory for IBR/IPV shall be used.

Milk samples are to be preserved in operation in accordance with the specifications of the National Reference Laboratory with a preservative in order to preserve the ELISA test system. that has been developed for these measurement systems (e.g. ProClin). The preservation may be prevented if it is ensured that the milk samples are cooled to below 6 °C immediately after extraction and the samples are stored in such a way during transport to the IBR/IPV examination centres until processing, that no acidification of the samples occurs.

Annex B

Sampling for diagnostic slaughtering

The following organs are to be taken from the meat examination veterinarian in the context of the diagnostic slaughter and are to be transmitted to the National Reference Laboratory for IBR/IPV:

Head including ZNS

Larynx, Trachea, Bronchies and Lung

Oesophagus

Uterus and Ovarian