308. Regulation of the Federal Minister for Health on programmes for the monitoring of certain diseases in sheep and goat stocks (sheep and goat health surveillance regulation)

On the basis of § 2 (1) to (3) of the Animal Health Act (TGG), BGBl. I n ° 133/1999, as last amended by the Federal Law BGBl. I n ° 80/2013, will be arranged in agreement with the Federal Minister for Finance and the Federal Minister for Agriculture, Forestry, Environment and Water Management:

table of contents

Paragraph	Object/Label
1. Main item General provisions
§ 1.	Scope
§ 2.	Definitions
2. Main piece Active monitoring of Scrapie and Brucella melitensis
§ 3.	Investigation requirements and sampling plan
§ 4.	Sampling and traceability
3. Main piece Special provisions for the monitoring of scrapie
§ 5.	Investigation requirements and sampling plan for scrapie
§ 6.	Procedure in the case of sampling
§ 7.	Investigating body and National Reference Laboratory
§ 8.	Data collection
§ 9.	Laboratory examination in the context of scrapie monitoring
§ 10.	Maintenance of animal carcasses, measures at the slaughterhouse
4. Main piece Preservation of the health status with regard to classical scrapie in Austrian companies
§ 11.	Holdings with negligible risk for the classical scrapie
§ 12.	Introduction of animals into Austrian farms
§ 13.	Restrictions on establishments which have brought in animals, semen, ova and embryos of ovine and caprine animals in breach of the existing provisions
§ 14.	Provisions applicable to holdings with animals, semen, ova and embryos of ovine and caprine animals from certain establishments of origin
§ 15.	Derogations for sheep with a certain genotype
§ 16.	Procedure as a result of an outbreak of classical scrapie in Austria
§ 17.	Transport rules
5. Main piece Special provisions for Brucella melitensis
§ 18.	Monitoring program to maintain status
§ 19.	Investigating body and National Reference Laboratory
§ 20.	Procedure in the case of non-negative test results
§ 21.	Ban on vaccination
6. Main piece Duties of animal keepers
§ 22.	Special obligations
§ 23.	Penalties
7. Main piece Final provisions
§ 24.	What to do if you change health status
§ 25.	Investigation Cost
§ 26.	Entry into force and external force
Annexes
Annex 1	Investigation requirements for scrapie
Annex 2	Procedure in the case of sampling
Annex 3	Tasks of the investigative bodies and of the National Reference Laboratory for TSE
Annex 4	Laboratory tests on TSE and genotyping
Annex 5	Examination sites for Brucella melitensis
Annex 6	Tasks of the National Reference Laboratory for Brucellosis with regard to Brucella melitensis

1. Main item

General provisions

Scope

§ 1. This Regulation shall apply to all sheep and goat stocks in Austria and

1.		the implementation of Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ L 145, 31.7.2001, p. 1. with regard to the monitoring of scrapie and the maintenance and recovery of the status of a negligible risk for classical scrapie, as well as the following:
2.		the monitoring of brucellosis (Brucella melitensis).

Definitions

§ 2. For the purposes of this Regulation:

1.		AGES: the Austrian Agency for Health and Food Safety (GmbH;
2.		Stock: the whole of the sheep and goats of a livestock farm, which is an epidemiological unit established by the Authority;
3.		Operation: livestock holding according to § 1 para. 2 Animal Health Act (TGG), BGBl. I n ° 133/1999, as last amended by the Federal Law BGBl. I n ° 80/2013, including insemination stations, collection points, trading facilities and staging points, with the exception of veterinary surgeons and veterinary clinics, as long as there is no superstition there;
4.		Placing on the market: the introduction of an animal
-			on a market, an auction, an exhibition or an animal show, or
-			into another establishment or to the cover business, or
-			on Community pastures and other pastures, with the exception of the direct transfer of the animal to a pasture situated in Austria, where it is possible to exclude with certainty the contact with ovine and caprine animals of other holdings.
5.		OIE: World Organisation for Animal Health (IIE);
6.		OIE Manual: Manual of Diagnostic Tests and Vaccines for Terrestrial Animals;
7.		Sheep: animals belonging to the species Ovis aries familiaris of the genus Ovis from the family of Bovidae, subfamily Caprinae (domestic sheep);
8.		SFU system: according to § 8 Fleischuntersuchungsverordnung 2006, BGBl. II No 109/2006, as last amended by BGBl. II No 156/2012, established abattoir reporting system;
9.		animals: sheep and goats;
10.		Animal keeper: any natural or legal person who, if only temporarily, is responsible for the animals subject to this Regulation, and persons responsible for a holding pursuant to Z 3;
11.		TSE: Transmissible Spongiform Encephalopathy, a form of which is scrapie (classical and atypical scrapie according to the case definition, as defined in Annex I to Regulation (EC) No 999/2001);
12.		TSE rapid test: procedure in accordance with Annex X, Chapter C, Z 4 of Regulation (EC) No 999/2001, which results in results within 24 hours;
13.		VIS: according to § 8 of the Animal Health Act (TSG), RGBl. No 177/1909, as last amended by the Federal Law BGBl. I No 80/2013, established electronic veterinary registers;
14.		Goats: to the species Capra aegagrus familiaris hircus of the genus Capra from the family of the Bovidae, subfamily Caprinae belonging animals (house goats).

2. Main piece

Active monitoring of Scrapie and Brucella melitensis

Investigation requirements and sampling plan

§ 3. (1) The Federal Minister for Health, or the Federal Minister for Health, shall draw up a monitoring programme in the context of which sheep and goats-approved by the AGES and approved by the Federal Minister for Health, and approved by the Federal Minister for Health, and approved by the Federal Minister for Health and sample plan published in the "Official Veterinary Messages" (Official Veterinary News)-an appropriate study to be carried out on the disease. In doing so, account must be taken of the rules of the European Union applicable to these diseases, as well as taking into account all the establishments of a federal state, including the number of operations already carried out in the respective establishment in this respect. Investigations are to be taken into account. establishments whose holdings or stocks have been infected in the last seven years by one of the diseases referred to in § 1, holdings with animal imports, holdings with strong animal transport and trade, and establishments which have Community grazing; are preferably to be provided in the sample design.

(2) The conduct of the investigations referred to in paragraph 1 shall be arranged in the form of random checks according to a risk-based sampling plan drawn up by the AGES, by the provincial governor. In the organisation of the studies, it is important to ensure that, in the course of sampling, investigations can also be carried out on other diseases which are monitored by means of regulations on the basis of the TGG. The Governor of the State has to ensure that the investigations carried out are carried out in accordance with the requirements of the sampling plan.

(3) The studies shall be carried out, taking into account any measures necessary to control animal diseases, the status of the control procedures, the degree of contamination, the respective state of the scientific community, and taking into account the veterinary legislation of the European Union and of the OIE.

Sampling and traceability

§ 4. (1) The animals to be examined in accordance with this Regulation shall be subject to the Animal Identification and Registration Ordinance 2009-TKZVO 2009, BGBl. II No 291/2009, as last amended by BGBl. II No 35/2011, in such a way that the identity of each individual animal can be identified without any doubt.

(2) The data relating to the identity and traceability of the samples taken shall be transmitted to the investigative body. The identity and the traceability of the samples must be given to the establishments and to the individual animals. In the event of a proper submission via the VIS or the SFU system, this requirement is in any case fulfilled.

3. Main piece

Special provisions for the monitoring of scrapie

Investigation requirements and sampling plan for scrapie

§ 5. (1) To monitor the scrapie situation in ovine and caprine animals and to maintain the status of 'negligible risk to classical scrapie', all of the following are: Annex 1 shall be examined within a reasonable period of time.

(2) The sampling plan in accordance with § 3 shall be drawn up for the entire Federal territory under the conditions set out in Annex VIII, Chapter A, Part A, Z 2.1 of Regulation (EC) No 999/2001 of the AGES, and shall be drawn up after approval by the Federal Minister, or The Federal Minister of Health is published in the "Official Veterinary News".

Procedure in the case of sampling

§ 6. (1) The removal of samples shall be, in particular in the case of: Annex 2 -not otherwise regulated, by the competent official veterinarian or from the competent official veterinarian.

(2) The way in which sampling is carried out and the conduct of the investigations and the handling of the investigative material, as well as the relevant rights of the investigative material; of the right of disposal shall be governed by Annex 2 .

Investigating body and National Reference Laboratory

§ 7. (1) The investigations of samples shall be carried out by the AGES, Institute of Veterinary Investigations, Mödling. The way the sample is sent is determined by the Federal Minister for Health and made known in the "Official Veterinary Messages".

(2) National Reference Laboratory for TSE is the Institute of Veterinary Investigations Mödling of the AGES.

(3) The tasks of the investigative body and of the National Reference Laboratory for TSE shall be: Annex 3 listed.

Data collection

§ 8. (1) The responsibilities, nature and content of the data collection and/or data collection shall be used for the entries of samples which cannot be recorded directly in the VIS or in the SFU system. -transmitted by the Federal Minister of Health or the Federal Minister of Health, and published in the "Official Veterinary Messages".

(2) The requirements for the design of reports, declarations of the right of disposal, notifications and, where appropriate, samples-accompanying documents in the course of the TSE investigations shall be submitted by the Federal Minister for Foreign Affairs or the Federal Minister for Foreign Affairs of the Federal Republic of Germany. Public health and published in the "Official Veterinary News".

Laboratory examination in the context of scrapie monitoring

§ 9. (1) Samples to be tested on TSE shall be taken in accordance with the requirements set out in Annex X to Regulation (EC) No 999/2001, as well as the methods and protocols in the current edition of the OIE Manual. Care should also be taken to ensure that sufficient material is available for any test retries. Where appropriate methods and protocols are not available, the sampling shall be carried out in a manner appropriate for the proper conduct of the tests, which shall be provided by the National Reference Laboratory for TSE. The requirements and guidelines of the Community TSE Reference Laboratory shall also be taken into account. Each sample shall be labelled in such a way that the identity of the animal tested is clearly detectable.

(2) More detailed provisions on the carrying out of laboratory tests shall be provided in the Annex 4 ,

(3) The investigative bodies shall have samples which shall be Annex 1 Z 1 to 4 are to be examined as a matter of priority.

(4) The National Reference Laboratory for TSE shall, by means of appropriate studies, have to confirm the identity in accordance with Annex 2 Pkt. VII to determine whether the positive sample of the brain is genetically consistent with the muscle sample and the sample derived from the ear tag associated with the ear tag.

Maintenance of animal carcasses, measures at the slaughterhouse

§ 10. (1) All parts of the body (including the skin and a ear tag) of tested slaughtered sheep and goats which are examined on TSE shall in any case be preserved under official supervision until such time as negative result of the rapid test. The parts of a tried-and-tested animal (including the ear marked by the ear tag) must be kept in such a way that they remain unambiguably capable of being assigned. Specified risk material (SRM), other than an ear tag ear per animal, which is examined on TSE, may not be used in accordance with the relevant provisions of the TMG and Regulation (EC) No 1069/2009 laying down health rules for non-compliance with the requirements of the animal by-products intended for human consumption, and repealing Regulation (EC) No 1774/2002, OJ L 327, 31.12.2002, p. No. OJ L 300 of 14.11.2009 p. 1. Where the animal to be tested is not officially marked by ear tags, appropriate ear tags (identity of the animal and the holding of origin must be able to be erutable) are to be drawn in on the occasion of the test.

(2) Where a slaughtered animal is requested at the request of the for the right of disposal on TSE, the health mark on the carcase shall not be carried out until a negative result of the rapid test has been obtained.

(3) In accordance with Regulation (EC) No 999/2001, Annex III, Chapter A, Part II, Z 7.2., the Governor of the State may, upon request, grant exemptions from paragraph 2 if it has been documented in writing and officially certified in the slaughterhouse and is officially certified in accordance with the provisions of the following: in writing, which ensures that no parts of the animal bodies already marked are left to the slaughterhouse or continue to be processed before a negative result of the rapid test has been obtained. This officially recognised system shall, in particular, take account of the following points:

1.		the definition of the type of dissemination of information with regard to the results of the TSE investigation;
2.		in the refrigeration room, physical checks on the completeness of the number and identity of the animals from which the samples were sent for examination;
3.		Safeguard measures against the unlawful removal of carcasses or by-products;
4.		Release of the carcasses and by-products by the official veterinarian or the official veterinarian and its control for completeness at the time of release and the conformity of the animals ' identity with the results of the investigation;
5.		the steps according to Z 2 to 4 are to be documented continuously and in writing at all times.
The updated list of such companies has to be submitted to the Federal Ministry of Health by the Governor of the Federal State.

4. Main piece

Preservation of the health status with regard to classical scrapie in Austrian companies

Holdings with negligible risk for the classical scrapie

§ 11. (1) An establishment shall be considered to be a negligible risk to the classical scrapie, if:

1.		none of its stocks are considered as suspicious within the meaning of the TSG or are subject to restrictions due to the occurrence of classical scrapie,
2.		it is not subject to the restrictions of § § 13 and 14; and
3.		the conditions laid down in this Regulation and in Annex VIII, Chapter A, Part A, Z 4.1. (b), Z 4.2. and Annex IX, Chapter E, Chapter H of Regulation (EC) No 999/2001 is complied with.

(2) All animals in establishments participating in trade within the European Union, in import or export shall be clinically indicative of any signs of scrapie, at least once a year, in the event of a shipment or of an introduction to the animals. , in order to verify compliance with the provisions of this Regulation and Regulation (EC) No 999/2001. The Federal Ministry of Health shall report annually on the conduct of the investigations. In any case, the guidelines published in the "Official Veterinary News" in accordance with § 8 (2) shall be complied with.

(3) The placing on the market of ovine and caprine animals must be carried out by the keeper or keeper. be certified by the animal keeper of the holding company that the animals come from a holding at negligible risk for the classical scrapie. This has to be done in the accompanying document according to § 17 TKZVO 2009.

Introduction of animals into Austrian farms

§ 12. (1) Animals brought to Austria, with the exception of animals which are transported directly to slaughter, must come from holdings which are subject to the conditions laid down in Annex VIII, Chapter A, Part A, Z 4.1. lit b or Annex IX, Chapter E, of Regulation (EC) No 999/2001.

(2) Seeds, ova and embryos of animals may only be brought into Austrian holdings if they meet the requirements laid down in Annex VIII, Chapter A, Part A, Z 4.2. or Annex IX, Chapter H, of Regulation (EC) No 999/2001.

Restrictions on establishments which have brought in animals, semen, ova and embryos of ovine and caprine animals in breach of the existing provisions

§ 13. (1) If an animal or The holding of semen, ova or embryos of animals contrary to the provisions referred to in § 12 shall no longer be considered as an establishment with negligible risk of classical scrapie for up to seven years after the introduction of the said plant. This is the animal keeper or to be shown to the keeper of the animal by the competent district administration authority and to note it in the VIS. The following special requirements must be complied with until the status of classical scrapie is negligible:

1.		Semen, ova or embryos still present shall be destroyed under official supervision. Animals which have been introduced into the herd against veterinary regulations and animals produced from semen, ova or embryos and in each case parent animals are to be examined clinically.
2.		Animals introduced into the herd or animals produced from semen, ova or embryos, and their respective parent animals may only be released for direct slaughter in an Austrian slaughterhouse. animals or animals produced from semen, ova or embryos and the respective parent animals shall, in any event, be at the expense of the keeper, including the cost of transmission, in the event of the destruction, killing or slaughter of animals; by means of a rapid test on scrapie.
3.		All animals of the holding are regularly, at least twice a year, as far as possible within the framework of other controls, veterinary or one or more of the animals. a veterinarian appointed by the provincial governor pursuant to § 2 para. 6 TGG to investigate the presence of clinical symptoms of scrapie, including all documentation and records required by the veterinary authorities, in particular the register of holdings, and the information referred to in Article 22 (1) (4), check.
4.		All animals slaughtered, dead, dead, killed or killed for animal welfare reasons over 18 months, including the cost of sending them, shall be tested at the expense of the keeper by means of a rapid test for the presence of scrapie.
Animals which are to be subjected to sampling in accordance with Z 2 or 4 and the intended killing or slaughtering of such animals shall be the subject of an appropriate sampling of the authority by the keeper or keeper. to report immediately to the animal keeper.

(2) The investigation pursuant to Section 1 (2) (2) shall give a negative examination result, the operation shall be deemed to be an operation with negligible risk for classical scrapie.

(3) Abs.1 and 2 shall also apply to establishments in which an animal is located which has already been brought before the entry into force of this Regulation contrary to the veterinary provisions which have been in force until that date.

Provisions applicable to holdings with animals, semen, ova and embryos of ovine and caprine animals from certain establishments of origin

§ 14. Without prejudice to the control and eradication required in accordance with Articles 11 to 13 of Regulation (EC) No 999/2001, the measures referred to in Article 13 shall also apply to establishments in which animals or animals produced from semen, ova and embryos are located, in their holding of origin has been confirmed by classical scrapie within seven years after the shipment has been completed.

(2) In this case, the investigation pursuant to Section 13 (1) (2) and (4) shall only be carried out at the expense of the keeper or the holder. the keeper of animals, when animals, semen, ova or embryos have been introduced into the herd, contrary to the veterinary regulations in force.

Derogations for sheep with a certain genotype

§ 15. The measures and restrictions in accordance with § § 13 and 14 shall be repealed if it is established that the sheep concerned have the prion protein genotype ARR/ARR, in the case of egg cells and seeds, if they have been shown to have been derived from sheep with the genotype ARR/ARR or in sheep embryos with an ARR-Allel. In the case of § 13, this proof shall be determined by means of official examination at the expense of the keeper or the keeper. of the keeper.

Procedure as a result of an outbreak of classical scrapie in Austria

§ 16. (1) All Austrian establishments, with the exception of those establishments for which an epidemiological link with this outbreak cannot be excluded in the event of an outbreak of classical scrapie, shall continue to be considered as holdings with: negligible risk for classical scrapie. In any event, the placing on the market of animals and their placing on the market shall be carried out in accordance with the provisions of Regulation (EC) No 999/2001.

(2) In order to maintain this status, the surveillance measures referred to in Annex VIII, Chapter A, Part A, Z 1.2, shall be used. lit. (a) to (i) of Regulation (EC) No 999/2001, at the request of the keeper or of the keeper. Following the occurrence of a case of classical scrapie in Austria, a corresponding request shall be made in writing in accordance with the content and time requirements published in the "Official Veterinary Messages" (Official Veterinary Messages), to which: The competent district administrative authority. The costs for the additionally required laboratory examinations of all over 18 months old have been terminated. on official or animal welfare grounds of the holding, including the cost of transmission, by the keeper or the keeper, of the animal keeper. Where a request has been made to the Authority, the proper implementation of the monitoring measures shall be officially checked in the course of the annual visits to operations.

(3) If the surveillance measures referred to in paragraph 2 have been carried out accordingly, this shall be carried out by the official veterinarian and/or from the official veterinarian in the VIS. In this case, the status of a negligible risk for classical scrapie remains for the holding in question.

(4) The monitoring measures referred to in paragraph 2 have not been carried out accordingly or have not been applied following the occurrence of a case of classical scrapie in Austria (paragraph 2). 2) to the District Administrative Authority, this is also the case by the official veterinarian. from the official veterinarian in the VIS. In this case, the operation loses the status of negligible risk for classical scrapie and is considered not to be classified. As long as Austria has the status of negligible risk for classical scrapie, the placing on the market of animals from establishments that have lost this status shall be prohibited.

(5) The establishments referred to in paragraph 4 shall be free to re-classify, in accordance with Regulation (EC) No 999/2001, an application in accordance with the provisions published in the "Official Veterinary Messages" (Official Veterinary Messages), with the competent district administrative authority. . The costs of the laboratory tests required, including the cost of transmission, shall be borne by the keeper of the animal.

Transport rules

§ 17. In any case, animals from holdings with different health status must be transported separately. This shall not apply to the transport of animals for immediate slaughter, the transport being carried out after loading of animals with a lower health status without any further stopover in the case of an animal holding operation.

5. Main piece

Special provisions for Brucella melitensis

Monitoring program to maintain status

§ 18. In accordance with § 3, sheep and goats are to be subjected to a blood serological examination on brucellosis (Brucella melitensis). In order to maintain the status of Austria as "officially brucellosis-free" in accordance with Annex A, Chapter 1, Part II, Z 2 of Directive 91 /68/EEC on animal health problems relating to intra-Community trade, Ovine and caprine animals, OJ L 327, No. 19. to demonstrate, by means of a representative and risk-based sample of animal husbandry with a 95% confidence level, that less than 0.2% of the stocks are infected.

Investigating body and National Reference Laboratory

§ 19. (1) The blood serological tests provided for in this Regulation shall be carried out by a veterinary medical examination office of the AGES accredited for such investigations. More detailed provisions are available in Annex 5 .

(2) The National Reference Laboratory for Brucellosis is the AGES, Institute of Veterinary Investigations, Mödling. More detailed provisions are available in Annex 6 .

(3) Non-negative samples must be sent to the National Reference Laboratory for Brucellosis for final evaluation.

Procedure in the case of non-negative test results

§ 20. (1) In the event of non-negative results, the Landeshauptmann shall immediately carry out epidemiological surveys as well as additional laboratory tests in accordance with the specifications of the National Reference Laboratory to determine whether a suspicion has been found to be The presence of brucellosis is to be carried out.

(2) The Landeshauptmann has the Federal Ministry of Health

1.		to be notified without delay if the findings of the investigation are not negative, and
2.		in the case of Z 1, immediately announce the results of the epidemiological studies referred to in paragraph 1 and the measures taken, and
3.		to submit an annual report on the results of the investigation referred to in paragraph 1.
These reporting obligations shall also be complied with by the immediate and correct registration of the above information in the VIS.

(3) Where brucellosis or a suspicion of brucellosis is detected on the basis of the result of the measures referred to in paragraph 1 in respect of ovine or caprine animals, the provisions of the Brucellosis Regulation, BGBl, shall apply. No 391/1995. In any case, a suspicion is given when a sample reacts positively in more than one used examination procedure in the National Reference Laboratory.

Ban on vaccination

§ 21. Ovine and caprine animals must not be vaccinated against brucellosis (Brucella melitensis). Sheep and goats who have been vaccinated against the brucellosis in the course of the last two years must not be brought to Austria.

6. Main piece

Duties of animal keepers

Special obligations

§ 22. (1) For the purposes of Section 2 (5) of the TGG, the animal keeper or the animal keeper, in particular,

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,
3.		to provide the necessary assistance free of charge in the administrative surveys and investigations, including the provision of a suitable facility for the purpose of speedy sampling and the protection of limb and life; the fixing of animals and the fixing of animals in a suitable manner,
4.		keep the following documents in an orderly and easily verifiable form for seven years and, at the request of the Authority, to be presented to the Authority:
a)			Accompanying documents from all animals introduced into the holding.
b)			records of shipments,
c)			examination findings of all animals and
d)			confirmations of animals for slaughter and destruction or for slaughter;
		and
5.		to provide the necessary assistance in the event of a disinfection which may be necessary.

(2) The keeper or keeper the keeper has to take all reasonable steps to stop the infection of other animals, in particular the secretion of the sick and suspected animals.

Penalties

§ 23. Infringements of bids or prohibitions of this Regulation shall be punished in accordance with § 15 Z 7 TGG.

7. Main piece

Final provisions

What to do if you change health status

§ 24. (1) Austria's status as a negligible risk for classical scrapie is made by the Federal Minister of Health or the Federal Minister of Health in the "Official Veterinary News".

(2) As long as Austria has the status of negligible risk for classical scrapie, the placing on the market of animals from establishments that have lost this status shall be prohibited. The use of animals may only be carried out by direct transport to slaughter.

(3) If a case of classical scrapie occurs in Austria, the control shall be carried out on the basis of the provisions of Regulation (EC) No 999/2001 within the framework of the TSG.

(4) If a case of brucellosis occurs, the control shall be carried out in accordance with the Brucellosis Regulation, BGBl. No 391/1995, within the framework of the TSG.

Investigation Cost

§ 25. (1) The Federal Government shall bear the costs of TSE studies in ovine and caprine animals in accordance with Annex 1 Z 1, Z 2 lit. a, Z 3, Z 4 lit. a, c, d and f.

(2) The keeper or keeper the animal keeper or the the authorized person has the costs of TSE studies in ovine and caprine animals in accordance with Annex 1 Z 2 lit. b, Z 4 lit. b and e and Z 5.

(3) The cost of genetic identification in accordance with Annex 2 Pkt. VII as well as for the genotyping according to § 15 are subject to the application of the applicant and/or the application. to be borne by the applicant.

(4) The costs of the investigations carried out in accordance with § 19 shall be borne by the Federal Government.

(5) The keeper or keeper the animal keeper or the the authorized person shall also provide the necessary assistance with the official surveys and investigations at his own expense.

Entry into force and external force

§ 26. (1) This Regulation shall enter into force on 1 November 2015.

(2) With the expiry of the 31. October 2015 will be the Scrapie monitoring regulation, BGBl. II No 119/2006, as well as the Brucella melitensis monitoring regulation, BGBl. II No 184/2002, except for force.

Oberhauser

Annex 1

Investigation requirements for scrapie

In order to monitor the situation of scrapie in ovine and caprine animals and to maintain the status of 'negligible risk to classical scrapie', the following animals shall be considered within a reasonable period of time 1 to be examined:

1.		all clinically scrapie-suspect animals that have been diagnosed diagnostically as a result of the TSG, and
2.		all slaughtered animals slaughtered, or slaughtered in a healthy way,
a)			have been brought from holdings in which classical scrapie has been detected within the last 7 years;
b)			have been introduced in breach of existing veterinary regulations and animals which have been produced from semen, ova or embryos, which have been brought against the existing veterinary regulations and which have been introduced in each case, Related parent animals (§ 13 para. 1 Z 2);
3.		all sheep and goats which have been slaughtered,
4.		animals over 18 months, unless they have been killed as part of measures to combat a notifiable epizootic disease (epidemic), in the following cases:
a)			healthy slaughtered animals and animals that have been killed or killed according to the sample plan (§ 5 para. 2),
b)			healthy slaughtered animals from holdings with measures to combat atypical scrapie in accordance with Annex VII, Chapter B, point 2.2.3. of Regulation (EC) No 999/2001,
c)			any dead or killed animals over 18 months from establishments with measures to combat the atypical scrapie referred to in Annex VII, Chapter B, Section 2.2.3. of Regulation (EC) No 999/2001;
d)			Animals slaughtered and slaughtered or killed from holdings with measures referred to in Chapter B of Annex VII to Regulation (EC) No 999/2001 (enhanced monitoring protocol, classical scrapie), other than lit. b,
e)			have been slaughtered and killed or killed animals from holdings which have brought animals and their semen, ova and embryos against the existing veterinary regulations (Article 13 (1) (4)), unless they are found in Z 2 lit. b fall,
f)			healthy slaughtered animals and animals which have been slaughtered or killed from holdings with animals from certain establishments of origin in accordance with § 14, provided that they are not covered by Z 2,
5.		Animals which have been slaughtered and have been killed or killed for 18 months not falling under Z 4 can be tested on TSE if the animals are in a healthy condition, or if they are not killed. the authorized persons have been shown to have taken note of and accepted the conditions laid down for this purpose by the Federal Minister for Health or the Federal Minister for Health and published in the "Official Veterinary Messages" (Investigation at the request of the authorized person).

Annex 2

Procedure in the case of sampling

I. In the case of the slaughter of animals, the official veterinarian or the official veterinarian or the official veterinarian, or the official veterinarian, to proceed as follows:

1.		Animals shall be clinically examined on TSE in the case of ante-mortem inspection. In the case of a clinical disdain, the examination must be documented in detail. In this case, the sampling is carried out by the official veterinarian. carry out the official veterinarian and make the consignment mandatory via the VIS. The documentation shall also be connected to the investigation order to the competent investigative body.
2.		If there is no clinical suspicion of a central nervous disease and there is also no obligation to carry out further studies for other reasons, all animals to be sampled shall be at the earliest in the sampling the possible timing of the corresponding parts of the brain by means of a spoon method in accordance with the relevant EU and OIE rules (Regulation (EC) No 999/2001 and OIE Manual). The sample shall be sent to the veterinary inspection body responsible in accordance with Section 7. In addition, an ear marked by ear tag is to be deposited from the rest of the body and sent with the sample. If it is possible to send it via the SFU system, it must be made mandatory.
3.		If it is not possible to obtain a sufficient quantity of sample material suitable for examination by means of a spoon method in accordance with Z 2, or if the spoon method is not applicable, the whole skull, including an ear tag, shall be Ear-marked ears. The consignment must be accompanied by the accompanying report, in which it should be noted why, in the specific case, the spoon method was not applicable, or why it was not possible to obtain a sufficient quantity of suitable sample material.

II. If the sampling is carried out exclusively at the request of the the person entitled to dispose ( Annex 1 Z 5) is in addition to Pkt. I shall proceed as follows:

1.		The official veterinarian the official veterinarian must, in the case of healthy slaughtered animals, join the sample accompanied by the signed declaration (declaration of the right of disposal) and, where appropriate, the submission form to the log book.
2.		The official veterinarian or official veterinarian the official veterinarian or the official veterinarian must, in the case of animals sent or killed, connect the sample accompanied by the signed declaration (declaration of the right of disposal) and send the sample as far as possible with the use of the VIS.
3.		The sample ehmerin or the sampler shall clarify any questions relating to existing investigative capacities and probable duration of investigation in advance with the investigative body responsible in accordance with § 7.
4.		For the submission of samples, if neither VIS nor SFU system can be used, a form must be used, which has been published in the "Official Veterinary News".
5.		The investigative body shall have the costs of the investigations referred to in Annex 1 Z 5 by invoice. The collection and posting costs shall also be borne by the person entitled to dispose of the product.

III. In the case of all the sheep and goats who have been killed or killed, according to Annex 1 Z 2, 4 and 5 are the appropriate brain samples from the official veterinarian, respectively. from the official veterinarian or the official veterinarian, or the official veterinarian, at the earliest possible date, at the point of collection, respectively, the intermediate treatment operation, in the case of direct delivery to a Federal Law Gazette (TMG) according to § 3 of the Animal Materials Act (TMG), BGBl. I n ° 141/2003, as last amended by the Federal Law BGBl. I n ° 23/2013, approved processing operation in this, and to be sent in as far as possible with the use of the VIS. In addition, an ear marked by ear tag is to be deposited from the rest of the body and must be kept up to the presence of a negative finding. For the submission of samples, if the VIS cannot be used, a form must be used, which has been published in the "Official Veterinary News".

IV. In the case of animals with clinical TSE disease suspicion, the whole head with Atlas and ears, including earmarks, is the official veterinarian. to be sent by the official veterinarian directly and immediately to the National Reference Laboratory for TSE in accordance with § 7. In the sense of the TSG, a detailed description of the animal, including its special features, as well as a detailed clinical preliminary report in the course of the submission via the VIS are to be stated in the comments field.

V. Animals which have been killed or killed shall be subject to the following conditions: Annex 1 , without delay, in accordance with the relevant provisions of the TMG and Regulation (EC) No 1069/2009. If samples were taken by means of a spoon method, the ear marked by ear tag must in any case be kept up to the presence of a negative finding. In the event of a positive finding, the ear marked by ear tag shall be sent to the National Reference Laboratory for TSE in order to identify the identity.

VI. All parts of the body of positively tested animals, including the skin, shall be destroyed in accordance with the relevant provisions of Regulation (EC) No 1069/2009, with the exception of the material used in conjunction with the records referred to in Annex 4 Part 1 Z 6 as well as according to Pkt. VII must be kept.

VII. In order to confirm the identity of the animal in the event of a positive test result, the following shall be taken as follows:

1.		The National Reference Laboratory for TSE has, at the request of the the person entitled to dispose, or the keeper, of the keeper, of the animal holder, the positive animal originates, by means of appropriate tests to confirm the identity, to determine whether the positive sample of the brain is genetically identical to the sample derived from the ear marked by the ear tag. To this end, the investigative bodies shall make available to the National Reference Laboratory for TSE the stored ears, including the earmarks.
2.		In order to determine the genetic identity of the associated carcase, if there is a positive evidence at the request of the carcase, the the person entitled to dispose, or the keeper, of the keeper, of the animal holder, whose holding comes from the positive animal, from the official veterinarian or from the official veterinarian, also to take a muscle sample from the carcase and to send it to the National Reference Laboratory for TSE. The to the right of disposal and to the representative or The representative of the agricultural holding concerned shall be given the opportunity to take appropriate counter-samples.
3.		The corresponding test material must also be kept for seven years.

Annex 3

Tasks of the investigative bodies and of the National Reference Laboratory for TSE

The laboratory tests on TSE shall be carried out in the investigative body referred to in § 7. carry out in the National Reference Laboratory for TSE in accordance with the following requirements:

1.		The investigative body shall comply with the requirements of the National Reference Laboratory for TSE on the implementation of the test procedures, documentation of the results and the modalities of the offsetting in respect of the TSE tests to be carried out by the investigative body. The National Reference Laboratory for TSE shall inform the investigative bodies in writing of these specifications.
2.		The National Reference Laboratory for TSE shall comply with all the functions and tasks set out in Annex X, Chapter A, of Regulation (EC) No 999/2001.
3.		The use of rapid tests shall be permitted only if they are authorised in accordance with Annex X, Chapter C, Z 4 of Regulation (EC) No 999/2001.
4.		All test regulations used in the TSE investigative bodies concerning the performance of TSE investigations shall be approved in writing by the National Reference Laboratory for TSE. Strict compliance with the approved test requirements in the examination bodies shall be verified by the National Reference Laboratory for TSE.
5.		As a result of these reviews, the Federal Ministry of Health is to report annually to the National Reference Laboratory for TSE. This report shall also contain, at least, information on the number and content of TSE-specific training and on the results of ring trials. If a check results in the suspicion that TSE investigations have not been carried out properly, the Federal Minister of Health or the Federal Minster for Health shall be informed without delay and shall report back to the Federal Minister for Health. The review of the investigative bodies entitled to carry out the investigations in accordance with § 7 with a view to complying with the requirements of this Regulation shall be the responsibility of the National Reference Laboratory for TSE. The laboratory operators or the laboratory operators shall, during the operating hours and in the event of danger in default, also allow inspection bodies to enter and re-look at the premises, to supply the information necessary for the checks which are necessary for the checks to be carried out. to provide the necessary documentation for inspection and to provide the assistance required in the context of the audit activity free of charge.
6.		According to § 8 paragraph 3 Z 5 of the Health and Nutrition Security Act, BGBl. I No 63/2002, as last amended by the Federal Law Gazette (BGBl). I n ° 189/2013, the National Reference Laboratory for TSE has a monthly general report as well as an annual report according to the guidelines of the Federal Minister for Health or the Federal Minister of Health, which are listed in the "Official Veterinary News" be published and submitted to the Federal Ministry of Health. For this purpose:
a)			the partial reports of the TSE investigative bodies required by the National Reference Laboratory for TSE, as required for the respective General Report, and
b)			within the deadline set by the National Reference Laboratory for TSE, to the National Reference Laboratory for TSE.
c)			In case of need, and in particular in cases of suspitation, positive cases and emergencies, the data reported by the investigative bodies shall be the National Reference Laboratory for TSE with the competent authorities and the Federal Ministry of Health before the transmission of the data to the Federal Ministry of Health.
d)			The information on which the reports are based shall be kept by the investigative bodies in an orderly manner for seven years and shall be submitted to the Federal Ministry of Health at any time upon request.
7.		The investigative bodies shall be obliged to enter the results of the tests they have carried out on samples into the VIS and, if appropriate electronic systems (VIS and SFU system) are not available during rehearsals. -to transmit, where appropriate, additional data necessary for the correct mapping of the examinations carried out electronically to the VIS.

Annex 4

Laboratory tests on TSE and genotyping

1. Laboratory tests on TSE

Sample material of all ovine and caprine animals to be examined (except for the samples submitted after Z 2) which has been sent for laboratory testing shall be approved in accordance with Annex X, Chapter C Z 4 of Regulation (EC) No 999/2001. To be subjected to a rapid test, with which all known TSE strains are detected.

a)		If the result of the rapid test is not conclusive or positive, the tissues shall be immediately subjected to a confirmation test in the National Reference Laboratory for TSE. The confirmatory test shall be carried out in accordance with a method corresponding to the latest edition of the manual and in accordance with the requirements set out in Annex X, Chapter C, point 3.2 of Regulation (EC) No 999/2001.
b)		If the result of the examination of the histopathological examination is not conclusive or negative, or if the material is autolytic, the tissue in question shall in any case be examined in accordance with a different method referred to in the manual.

An animal is considered to be a TSE-positive if the result of the rapid test is positive or non-conclusive and the result of a further examination (confirmation test) is positive. In any case, until a final result has been obtained, the respective samples must be kept.

Tissues derived from ovine and caprine animals with clinical TSE suspicion and sent for laboratory examination shall be immediately referred to in accordance with the latest edition of the manual and in accordance with the requirements set out in Annex X, Chapter C, Z 3, of the Regulation (EC) No 999/2001 in the National Reference Laboratory for TSE. In any case, a sample is to be subjected to a suitable test procedure (confirmatory test). The studies shall also be carried out in accordance with the guidelines of the Community reference laboratory.

The animal is considered to be positive if the result of at least one confirmation test is positive.

3. Samples of clinical suspected cases and of animals considered to be positive scrapie cases, but not atypical scrapie cases, or features which, in the opinion of the laboratory and the National Reference Laboratory, are considered to be TSE, after consultation with the Community reference laboratory, must be studied in more detail, for further investigation by a method of primary molecular typing, in accordance with Annex X, Chapter C, Z 3.2. lit. (c) (i) the investigative body approved by Regulation (EC) No 999/2001.

Samples of TSE cases in which the presence of BSE may not be excluded by the primary molecular test referred to in Z 3 shall be carried out after consultation with the Community reference laboratory and on the basis of all the relevant tests. Available relevant information shall be forwarded without delay to those investigative bodies which are authorised to carry out further abusive studies in accordance with Annex X, Chapter C, point 3.2. of Regulation (EC) No 999/2001. In the evaluation of the results, the National Reference Laboratory for TSE shall support the Community Reference Laboratory.

5. If the investigating body responsible in accordance with Article 7 finds that there is no sufficient quantity of sample material suitable for the examination, it shall immediately contact the person responsible for the dispatch in order to: Consignment of additional sample material suitable for the examination. If the dispatch of additional sample material is not possible, the reason for this is to be documented in writing in the accompanying report.

6. The investigative bodies shall keep all records of tests, in particular the laboratory books, paraffin blocks and photographs of the Western blots, as well as the evidence of positive evidence, for seven years; the Records shall be submitted to the Federal Ministry of Health on request at any time.

2. Genotyping

1. For each positive TSE case in sheep and goats, the genotype of the prion protein shall be determined. The DNA-containing sample materials necessary for this purpose (e.g. Muscular, CNS or ear tissue, organs, EDTA blood, saliva sample) are to be sent to the AGES, Institute for Veterinary Investigations, Mödling. TSE cases found in resistant genotypes (sheep of a genotype in which Alanin on both alleles of codon 154 and arginine on both alleles of Codons 171 are located) must be reported immediately to the Federal Ministry of Health. Such cases are to be transmitted to a laboratory to be determined by the Federal Minister of Health or the Federal Minister for Health, for a regularisation of the stem.

If a regularisation of these cases is not possible, the herd of origin and all other herds in which the animal was present should be subject to increased surveillance in order to find other cases for a regularisation of the stem. If a positive TSE case is a case of atypical scrapie, the prion protein genotype is to be determined for codon 141.

2. In addition to the studies mentioned in Z 1, the prion protein genotype of Codone 136, 141, 154 and 171 of at least 100 sheep is to be determined annually. This sample is to be representative of the whole sheep population. The samples may be taken from the animals slaughtered or killed or live animals sent to the AGES, the Institute of Veterinary Studies Mödling, to the extent that they are appropriate.

Annex 5

Examination sites for Brucella melitensis

1. The investigative bodies shall be obliged to:

a)		to participate regularly (at least once a year) in a ring trial;
b)		demonstrate that the ring test has been successfully completed and that appropriate corrective measures have been carried out within a time limit set by the National Reference Laboratory;
c)		demonstrate that there are no other significant evidence to indicate that the proper conduct of the investigations is not, or is not, is no longer guaranteed and
d)		to submit the reports and statistics requested by the Federal Ministry of Health or the National Reference Laboratory within a reasonable period of time (from a maximum of 30 working days after receipt of the requirements).

2. The investigative bodies shall be obliged to enter the results of the tests carried out by them from samples into the VIS and, if appropriate electronic systems (VIS and SFU system) are not available for the submission of the sample. -provide, where appropriate, additional data necessary for the correct reproduction of the tests carried out electronically, to the VIS.

If the investigative body does not fulfil one or more of its obligations under Z 1 and 2, the Federal Minister of Health or the Federal Minister of Health may, according to the report of the National Reference Laboratory, be entitled to carry out the Investigations on Brucella melitensis until the restoration of the proper condition is withdrawn.

Annex 6

Tasks of the National Reference Laboratory for Brucellosis with regard to Brucella melitensis

The National Reference Laboratory shall be responsible for the implementation of the following tasks:

a)		the carrying out of validation studies to demonstrate the reliability of the test methods and the determination of the test methods to be applied at the other investigative bodies;
b)		the coordination of diagnostic standards and methods;
c)		the establishment of the maximum number of blood samples which can be pooled as a collection sample with the ELISA test methods used in each case;
d)		Calibration of the secondary national reference sera ("Working Standards") against the primary standard sera;
e)		the quality control and approval of all batches of the respective ELISA test methods prior to use at the investigative bodies;
f)		the storage of isolates;
g)		the organisation and evaluation of the annual ring trials;
h)		cooperation within a European network of National Reference Laboratories for the disease;
i)		regular participation in international ring trials for Brucellosis in relation to Brucella melitensis;
j)		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;
k)		Cooperation with the European reference laboratory for brucellosis in relation to Brucella melitensis;
l)		compliance with all the requirements of Union law or of such rules as those laid down by the OIE;
m)		the clarification of non-negative samples.

2. The National Reference Laboratory shall be responsible for verifying the investigative bodies entitled to carry out the investigations (Article 19 (1)) with a view to complying with the provisions of this Regulation. The laboratory operators or the laboratory operators shall, during the operating hours and in the event of danger in default, also allow inspection bodies to enter and re-look at the premises, to supply the information necessary for the checks which are necessary for the checks to be carried out. to provide the necessary documentation for inspection and to provide the assistance required in the context of the audit activity free of charge.

In the event of the determination of results not clearly negative blood samples,-in order to answer the question of whether there is a suspicion of disease-the use of all suitably validated and scientifically recognised methods of examination, which are European Union (EU) or OIE is permitted. Likewise, additional blood samples may be requested to the extent necessary for a final determination of the result.