Sheep And Ziegengesundheits Monitoring Regulation

Original Language Title: Schaf- und Ziegengesundheits-Überwachungs-Verordnung

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

On the basis of § 2 para 1 to 3 of the animal health law (TGG), Federal Law Gazette I no. 133/1999, as last amended by Federal Law Gazette I no. 80/2013, is in agreement with the Federal Minister of finance, and directed the Federal Ministry of agriculture and forestry, environment and water management:

Table of contents



Clause





Subject / title







1. main piece of General provisions







§ 1.





Scope of application







§ 2.





Definitions







2. main piece of active surveillance of scrapie and Brucella melitensis







§ 3.





Duties of examination and sampling plan







§ 4.





Sampling and traceability







3. main piece of special provisions for the monitoring of scrapie







§ 5.





Duties of examination and sampling scheme for scrapie







§ 6.





The sampling procedure







§ 7.





Investigative and national reference laboratory







§ 8.





Data acquisition







§ 9.





Laboratory examination in the framework of scrapie monitoring







§ 10.





Detention of animal bodies, measures at the slaughterhouse







4. main piece of maintenance of the health status in terms of classical scrapie in Austrian companies







§ 11.





Companies with negligible risk of classical scrapie







§ 12.





Introduction of animals in Austrian companies







§ 13.





Restrictions for businesses that have brought animals, semen, ova and embryos of sheep and goats against the existing regulations







§ 14.





Provisions for businesses with animals, semen, ova and embryos of sheep and goats from a certain origin holding







§ 15.





Exceptions for sheep with certain genotype







§ 16.





Procedure following an outbreak of classical scrapie in Austria







§ 17.





Transport regulations







5. main piece of special provisions for Brucella melitensis







§ 18.





Monitoring program for the maintenance of the status







§ 19.





Investigative and national reference laboratory







§ 20.





Approach to non-negative findings







§ 21.





Prohibition of vaccination







6 piece of main duties of stockbreeders and livestock keepers







section 22.





Special obligations







section 23.





Sanctions







7 showpiece final provisions







§ 24.





Procedure for change of the status of health







§ 25.





Costs of investigation







section 26.





Entry into force and expiry







Attachments







 





 







Annex 1





Duties of examination for scrapie







Annex 2





The sampling procedure







Annex 3





Tasks of the investigation authorities and of the national of reference laboratories for TSES







Annex 4





Laboratory tests on TSES and genotyping







Annex 5





Inspection posts for Brucella melitensis







Annex 6





Tasks of the national of reference laboratories for brucellosis with regard to Brucella melitensis





1. main piece

General terms and conditions

Scope of application

§ 1. This regulation applies to all sheep and goat stocks in Austria and is used



1. the implementation of Regulation (EC) No. 999/2001 with rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ L No. 147 of the 31.05.2001 S. 1, with regard to the monitoring of scrapie, and to maintain and possibly regaining the status of negligible risk for classical scrapie, and 2. the monitoring of brucellosis (Brucella melitensis).

Definitions

§ 2. Within the meaning of this regulation means:



1. AGES: the Austrian Agency for health and food security GmbH;

2. inventory: all the sheep and goats of animal husbandry operation, which represents a single epidemiological unit, as determined by the authority;

3. animal husbandry operation: in accordance with § 1 para 2 animal health law (TGG), Federal Law Gazette I no. 133/1999, last amended by Federal Law Gazette I no. 80/2013, including semen, collection, trade facilities and locations, with the exception of veterinary physicians and veterinary clinics, as long as there no stabling is carried out;

4. placing on the market: the removal of an animal - on a market, an auction, an exhibition or a menagerie - in other modes to the deck business or or - on community pastures and other pastures, except the direct movement of the animal on a willow located in Austria, if contact with sheep and goats of other companies certainly cannot be ruled out at the grazing.

5th OIE: World Organisation for animal health (International Organisation for animal health);

6 OIE Manual: OIE diagnostic manual (Manual of diagnostic tests and vaccines for terrestrial animals);

7 sheep: the species Ovis aries familiaris the Ovis genus in the family of Bovidae, subfamily Antelope owned animals (domestic sheep);

8. SFU system: in accordance with § 8 meat inspection Regulation 2006, Federal Law Gazette II No. 109/2006, as last amended by Federal Law Gazette II No. 156/2012, furnished slaughterhouse feedback system;

9 animals: Sheep and goats;

10 pet owners: any natural or legal person which, if only temporarily, for this Regulation subject animals is responsible, as well as people who are responsible for an operation pursuant to no. 3;

11 TSE: Transmissible spongiform encephalopathy, a form this is the scrapie (classic and atypical scrapie in accordance with the case-definition according to annex I of to Regulation (EC) No. 999/2001);

12 TSE rapid test: C procedure no 999/2001 that lead to results within 24 hours; no. 4 of Regulation (EC) in accordance with annex X, chapter         

13 VIS: that pursuant to § 8 law on epizootic (TSG), RGBl. No. 177/1909, as last amended by the Federal Act Federal Law Gazette I no. 80/2013, furnished electronic veterinary register.

14 goats: part of familiaris of the species Capra aegagrus hircus Capra, a genus of the family of Bovidae, subfamily Antelope animals (goats).

2. main piece

Active monitoring of scrapie and Brucella melitensis

Duties of examination and sampling plan

3. (1) created the Federal Minister or the Federal Minister of health a surveillance programme, under which sheep and goats, according to one of the packages created and approved by the Federal Minister or the Federal Minister of health and are to undergo published sampling plan - the "official veterinary news" an appropriate investigation on the respective disease. The regulations of the European Union for these diseases are to be observed, as well as to take into account all establishments of a federal State, which is also on the number of inquiries in this regard already carried out in the respective operating carefully to take. Farms, which stock or stocks were companies with animal imports, businesses with strong animal transport and trade, as well as companies which equip community pastures, in the last seven years with one infected diseases referred to in article 1, are preferred to provide in the sampling plan.

(2) the examinations referred to in paragraph 1 must be in the form of spot checks after a risk-based sampling scheme created by the AGES of the Governor. The Organization of the investigations is sure that also tests for other diseases that are monitored with regulations after the TGG, can be performed in the course of sampling possible. The Governor has to ensure that the requirements of the sampling plan be achieved with the investigations.

(3) the studies are taking any necessary measures to combat animal diseases, the level of control methods, the degree of contamination, the respective State of the science and taking to set the veterinary technical regulations of the European Union and the OIE.

Sampling and traceability

4. (1) for animals to examine this regulation must TKZVO in accordance with Tierkennzeichnungs - and Registration Ordinance 2009 - 2009, BGBl. No. 291/2009, amended II by Federal Law Gazette II No. 35/2011, to be marked, that the identity of each individual animal can be established beyond reasonable doubt.


(2) the data regarding the identity and traceability of the samples shall be of the investigative body. The identity and the traceability of the samples to the companies and individuals must be given. This requirement is met in the case of the proper submission of the VIS or the SFU system anyway.

3. main piece

Special provisions for the monitoring of scrapie

Duties of examination and sampling scheme for scrapie

All animals referred to in annex 1 are § 5 (1) for the monitoring of scrapie situation in sheep and goats, as well as to the maintenance of the status of "negligible risk for classical scrapie", within a reasonable period of time to investigate.

(2) the sampling plan pursuant to section 3 is for the entire Federal territory in compliance with the requirements referred to in annex VIII, chapter A, part A-Z 2.1 of Regulation (EC) No 999 / 2001 of the AGES to create and will be published after approval by the Federal Minister or the Federal Minister of health in the "official veterinary news".

The sampling procedure

Section 6 (1) is the collection of samples, provided that the following - in particular in annex 2 - unless otherwise regulated, carried out by the competent official veterinarian or by the competent official veterinarian.

(2) the sampling procedure and the conduct of investigations and dealing with the study material and the rights of or of the designated set down in annex 2.

Investigative and national reference laboratory

The testing of samples should be 7 (1) of the AGES, Institute for veterinary investigations Mödling. The way the sample submission is set by the Federal Minister for health and published in the "official veterinary news".

(2) national reference laboratory for TSE is the Institute for veterinary investigations Mödling of AGES.

(3) the duties of the investigation authority and of the national of reference laboratories for TSES are given in annex 3.

Data acquisition

§ 8 (1) for the submissions of samples that can be collected directly in the VIS or the SFU system, responsibilities, nature and content of the data collection or delivery by the Minister or the Federal Minister of health are set and published in the "official veterinary news".

(2) the requirements for the design of reports, declarations of the designated, messages and, if necessary, samples Begleitscheinen in the course of TSE tests are set by the Minister or the Federal Minister of health and published in the "official veterinary news".

Laboratory examination in the framework of scrapie monitoring

Samples should be evaluated for TSE should be § 9 (1) according to the requirements set out in annex X of to Regulation (EC) No. 999/2001, along with the methods and protocols in the current edition of the OIE Manual. It is also important to ensure that sufficient material is available for any re-test. Appropriate methods and protocols are not available, so have the sampling in a manner appropriate for the proper execution of the tests, which pretend to is by the national reference laboratory for TSE must be. The requirements and guidelines of the community TSE reference laboratories are to be considered. Each sample shall be marked, so that the identity of the sampled animal is clearly noticeable.

(2) further details are laid down in the annex 4 provisions regarding the implementation of laboratory tests.

(3) the investigation authorities have samples which are 1 Z 1 to 4 set out in annex, to examine as a priority.

(4) the national reference laboratory for TSE has by means of appropriate tests to confirm the identity in accordance with Annex 2 pt. VII to determine whether the positive befundete brain test genetically with the muscle sample and the sample, comes the ear associated by the marked with ear-tag, matches.

Detention of animal bodies, measures at the slaughterhouse

10. (1) all parts of the body (including the skin and ear marked with ear tag) tested slaughtered sheep and goats, which are examined for TSE, are to be kept, until a negative result to the rapid test so long under official control in any case. The parts of a sampled animal (including the ear marked with ear tag) must so kept are, they remain clearly relatable. Specified risk material (SRM), except an ear marked with ear tag each animal which will be examined for TSE, may in accordance with the relevant provisions of the TMG and the Regulation (EC) No. 1069/2009 laying down health rules for animal by-products not intended for human consumption and repealing Regulation (EC) No 1774/2002, OJ No. L 300 from November 14, 2009 page 1, harmless eliminated. Unless officially marked the to sampled animal by means of ear tags, suitable are on the occasion of the sampling, (identity of the animal and the origin of operation must be exact) a clearly identifiable earmarks.

(2) a slaughtered animal at the request or the designated on TSE tests, then the health marking of carcasses is only to make, if there is a negative result to the rapid test.

(3) in accordance with the Regulation (EC) No. 999/2001, annex III, chapter A, section II can Z 7.2., the Governor at the request of grant exceptions to paragraph 2, if there is a writing documented and officially tested and approved in writing system in place in the slaughterhouse ensuring that no parts of the already marked carcass left the slaughterhouse or further processed until a negative result to the rapid test is. This officially recognised system has to take into account the following points:



1. defining the type of disclosure with respect to the incoming TSE examination results;

2. physical in cold storage checks of the completeness of the number and identity of animals; submitted by which the samples to investigate

3. safeguards against wrongful removal of carcasses and by-products;

4. release of the carcasses and by-products by the official veterinarian or the official veterinarian and their control to be complete at the time of release, as well as the conformity of the identity of the animals with the investigation results;

5. the steps are to Z 2-4 continuous and traceable in written form to document.

The Governor has the each updated list of such establishments to provide the Ministry of health.

4. main piece

Maintenance of the health status in terms of classical scrapie in Austrian companies

Companies with negligible risk of classical scrapie

§ 11 (1) a company is regarded as operating with a negligible risk for classical scrapie, if



1 none of his stocks is regarded as suspicious in the sense of the TSG or is subject to restrictions because of the occurrence of classical scrapie, 2. he neither the limitations of sections 13 and 14 are subject to and 3. the terms and conditions in accordance with this regulation and of annex VIII, chapter A, part A-Z 4.1. lit. b, Z 4.2., and annex IX, Chapter E or Chapter H of Regulation (EC) No 999/2001 are met.

(2) all animals in establishments that participate in trade within the European Union, the import or export, are at least once a year to examine if at all possible on the occasion of a shipment or an introduction, clinical signs of scrapie; where is the compliance with the provisions of this regulation and of Regulation (EC) to review no. 999/2001. About the conduct of the investigations, report to the Federal Ministry of health is annually by the Governor. In any case, you are in accordance with § 8 par. 2 in the "official veterinary news" to comply with published guidelines.

(3) in the case of the placing on the market of ovine and caprine animals must be identified by the Tierhalterin or by the owners of the transferor company, that the animals come from a holding with a negligible risk of classical scrapie. This has to be TKZVO in the accompanying document in accordance with § 17 2009.

Introduction of animals in Austrian companies

§ 12 (1) animals that are transported to Austria, with the exception of animals, which are immediately transported to the slaughter must companies come from number 999/2001 meeting the requirements of annex VIII, chapter A, part A-Z 4.1. lit b and annex IX, Chapter E, to Regulation (EC).

(2) semen, ova and embryos of animals may only be introduced in Austrian companies, if these meet the requirements set out in annex VIII, chapter A, section (A) Z 4.2. or annex IX Chapter H of Regulation (EC) No. 999/2001.

Restrictions for businesses that have brought animals, semen, ova and embryos of sheep and goats against the existing regulations


Section 13 (1) has been an animal or introduced semen, ova or embryos of animals contrary to the provisions referred to in article 12, the operating no longer as operating with a negligible risk applies to up to seven years after the introduction of classical scrapie. This is to announce the Tierhalterin or the keeper has been proven by the competent district administrative authority and in the VIS. Following special requirements must be negligible risk for classical scrapie to the regaining of the status:



1. remaining seeds, eggs or embryos can be destroyed under official supervision. Contrary to the veterinary regulations introduced in the stock, as well as animals resulting from sperm, eggs or embryos and corresponding mother animals are to examine official veterinary clinical.

2. in the stock or animals resulting from sperm, eggs or embryos and corresponding mother animals may be placed only for direct slaughter in an Austrian slaughterhouse. Introduced animals or animals resulting from sperm, eggs or embryos and the respective mother are anyway, in the case of the is used, the killing or slaughter at the expense of the keeper, including one at the end, to investigate by means of quick test on scrapie.

3. all animals of the operation are regularly, at least twice a year as in other checks, Veterinary Office or by one or one by the Governor pursuant to § 2 para 6 vet ordered TGG or veterinarian to examine for the presence of clinical symptoms of scrapie; These are all veterinary authorities required documents and records, to verify in particular the holding register, as well as the information referred to in article 22, paragraph 1 Z 4.

4. all animals over 18 months of age slaughtered, fallen, official arrangement or animal welfare reasons killed are, including the one at the end, at the expense of the keeper by means of rapid test for the presence of scrapie to investigate.

The death of animals, which are a sampling according to undergo Z 2 or 4, and the intended killing or slaughter of these animals is to report immediately to the instigation of appropriate sampling of the authority of the Tierhalterin or the pet owners.

(2) the investigation referred to in paragraph 1 Z 2 results a negative test results, the operation is considered again operating with a negligible risk for classical scrapie.

(3) ABS 1 and 2 also apply to establishments in which an animal is, already introduced before entry into force of this regulation contrary to the veterinary official rules until then.

Provisions for businesses with animals, semen, ova and embryos of sheep and goats from a certain origin holding

Section 14 (1) without prejudice to the article 11 to 13 of Regulation (EC) are no. 999 / 2001 necessary control and eradication measures pursuant to article 13 to farms where animals or animals, semen, ova and embryos that are, in their holding of origin, classical scrapie has been confirmed within seven years after the movement to apply.

(2) in this case, the investigation in accordance with article 13, paragraph 1 is Nos. 2 and 4 only at the expense of the keeper or the Tierhalterin if animals, semen, ova or embryos have been introduced contrary to applicable veterinary regulatory in the stock.

Exceptions for sheep with certain genotype

§ 15. The measures and restrictions are to sections 13 and 14 to repeal, if it is established that the affected sheep have the ARR/ARR prion protein genotype, in the case of ova and sperm, if they are verifiably of sheep of the ARR/ARR genotype or sheep embryos carrying one ARR allele. In the case of article 13, this evidence by means of official investigation at the expense of the Tierhalterin or of the keeper is to lead.

Procedure following an outbreak of classical scrapie in Austria

Section 16 (1) all Austrian companies, with the exception of those operations for which in the event of an outbreak of classical scrapie an epidemiological connection with this outbreak cannot be ruled out, still apply as holdings with a negligible risk for classical scrapie. The placing on the market of animals, as well as their placement in enterprises has to be carried out in accordance with the requirements of Regulation (EC) No. 999/2001.

(2) in order to maintain this status, the monitoring measures referred to in annex VIII, chapter A, part A are Z 1.2. lit. a to Regulation (EC) No. 999/2001 at the request of the Tierhalterin or of the keeper making. An application is written in accordance with the substantive and temporal specifications which are published in the "official veterinary news", to be directed to the competent district administrative authority following the occurrence of a case of classical scrapie in Austria. The cost of the additional necessary lab tests from all over 18-month-old died or killed on the official order or animal welfare reasons animals of the operation, including one at the end, are to be borne by the owner or the Tierhalterin. Set a corresponding application to the authority, the correct implementation of the monitoring measures is officially part of the annually perform company visits to control.

(3) which conducted in paragraph 2 referred to monitoring measures according to, this is by the official veterinarian or by the veterinarian in the VIS to be noted. In this case, the status remains negligible risk for classical scrapie upright for the relevant operation.

(4) the monitoring measures referred to in paragraph 2 does not properly carried out or no corresponding request (para. 2) to the district administrative authority was made following the occurrence of a case of classical scrapie in Austria, this is also by the official veterinarian or by the veterinarian in the VIS to be noted. In this case, loses the operating negligible risk for classical scrapie status and is considered unclassified. As long as Austria has a negligible risk for classical scrapie status, a placing on the market of animals from farms, which have lost this status, is prohibited.

(5) operating pursuant to subsection 4 is's free, further classification in accordance with Regulation (EC) a request in accordance with the guidelines, which are published in the "official veterinary news", at no. 999/2001 to provide competent district administrative authority. The costs for the necessary laboratory tests, including the one at the end costs, are to be borne by the owner.

Transport regulations

§ Are 17 animals on holdings with varying health status in any case separately to transport. The transport of animals for immediate slaughter, is exempt from taking the transport has to be done after load of animals of lower health status without further stopover in a livestock operation.

5. main piece

Special provisions for Brucella melitensis

Monitoring program for the maintenance of the status

§ 18 sheep and goats are terms of sampling in accordance with § 3 a blood serological investigation on brucellosis (Brucella melitensis) to undergo. This 1 part II is no. 2 of Directive No. 91 / 68 / EEC to maintain Austria's status as "officially recognized brucellose-free" in accordance with Annex A, chapter regulating the animal disease problems affecting the intra-Community trade in ovine and caprine animals, OJ To prove no. L 46 of the 19.02.1991 p. 19, by a representative and risk-based sample in the animal husbandry with a proof of confidence of 95% that less than 0,2% of herds are infected.

Investigative and national reference laboratory

The serological blood tests in accordance with this regulation are section 19 (1) be carried out by a veterinary investigation authority of the AGES, accredited for such studies. Further details are laid down in the annex 5 provisions.

(2) the national reference laboratory for brucellosis is the AGES, Institute for veterinary investigations Mödling. Further details are laid down in the annex 6 provisions.

(3) non-negative samples are to submit the final assessment to the national reference laboratory for brucellosis.

Approach to non-negative findings

The Governor has § 20 (1) if there is no negative findings immediately epidemiological surveys, as well as additional laboratory tests according to the specifications of the national to establish whether there is a suspicion of the presence of brucellosis, carried out reference laboratories.

(2) the Governor has the Federal Ministry of health



1 forthwith, if there are non-negative findings and 2. in the case of no. 1 the results of the epidemiological investigations referred to in paragraph 1, as well as the measures taken immediately to announce, and 3. each year a report on the results of the investigation referred to in paragraph 1 to submit.

Can be conducted also prompt and proper registration of the above information in the VIS this notification and reporting obligations.


(3) based on the result of paragraph 1 for ovine or caprine brucellosis or detected a suspicion of the presence of brucellosis measures referred to in, is so pursuant to the provisions of the brucellosis regulation BGBl. No. 391/1995, proceed. A suspect is anyway if a sample in more than one study methods used in the national reference laboratory responded positively.

Prohibition of vaccination

§ May not be vaccinated (Brucella melitensis) 21 sheep and goats against brucellosis. Ovine and caprine animals which have been vaccinated in the last two years against brucellosis may not be moved to Austria.

6 main piece

Duties of stockbreeders and livestock keepers

Special obligations

TGG is § 22 (1) the Tierhalterin within the meaning of § 2 5 or the pet owners in particular obliged,



to tolerate 1. regulatory measures under this regulation or to allow, the necessary information to give 2. and to provide necessary documentation available to determine the facts of the case, 3 free of charge for the necessary assistance when the governmental surveys and investigations to ensure - that is providing a suitable device for the fixation of animals, as well as the fixing of animals in appropriate manner to ensure of a rapid sampling and for the protection of life and limb -. , 4. the following documents for seven years in orderly fashion and easily verifiable form to preserve and present the authority upon request: a) documents of all animals brought into the operation.

(b) records of shipments, c) investigation findings of all animals and d) confirmations about animals given to the killing and disposal or slaughter, and 5 for a possibly necessary disinfection to provide the necessary help.

(2) the Tierhalterin or the pet owner has to take all measures which are likely to discourage the infection of other animals, in particular the secretion of sick and suspect animals.

Sanctions

§ Be 23 violations of instructions or prohibitions of this regulation according to § 15 Z 7 TGG punished.

7 main piece

Final provisions

Procedure for change of the status of health

24. (1) loses Austria negligible risk for classical scrapie status, this will be announced by the Federal Minister or the Federal Minister of health in the "official veterinary news".

(2) as long as Austria has a negligible risk for classical scrapie status, a placing on the market of animals from farms, which have lost this status, is prohibited. Exploitation of animals may be in this case only by direct shipment to slaughter.

(3) a case of classical scrapie in Austria occurs, is fighting on the basis of the provisions of Regulation (EC) No 999/2001 in the framework of the TSG.

(4) a case of brucellosis occurs, is the fight against the brucellosis regulation, Federal Law Gazette No. 391/1995, part of the TSG.

Costs of investigation

Section 25 (1) the Federal Government bears the costs of TSE tests on ovine and caprine animals in accordance with Annex 1 Z 1, Z 2 lit. a, Z 3 and Z 4 lit. a, c, d and f.

(2) the Tierhalterin or the animal owner or the designated has the costs of TSE tests on ovine and caprine animals in accordance with Annex 1 subpara 2 lit. b, Z 4 lit. b and e and Z to carry 5.

(3) PT. VII as well as for genotyping are in accordance with § 15 in illegal contribution from the applicant or the applicant to bear the costs of the genetic identification in accordance with Annex 2.

(4) the cost of the investigations carried out pursuant to article 19 shall be borne by the Federal Government.

(5) the Tierhalterin or the keepers or the claimant has also to ensure the necessary assistance when the governmental surveys and investigations at its own expense.

Entry into force and expiry

26. (1) this regulation with 1 November 2015 enter into force.

(2) upon expiry of the 31 October 2015 enter the scrapie surveillance regulation, Federal Law Gazette II No. 119/2006, as well as the Brucella melitensis - control regulation, Federal Law Gazette II No. 184/2002, override.

O



Annex 1

Duties of examination for scrapie

For the monitoring of scrapie situation in sheep and goats, as well as to the maintenance of the status of "negligible risk for classical scrapie", following animals within reasonable Frist1 are to examine:



1 all clinical scrapie suspicious animals that were killed as a result of the TSG diagnostically and 2. all dead, killed, or healthy slaughtered animals, the a) were introduced from holdings where classical scrapie has been discovered within the last 7 years

(b) contrary to the existing veterinary regulations were tabled and animals resulting from sperm, eggs or embryos, which have been brought against the existing veterinary regulations, as well as the respective mothers (§ 13 para 1 No. 2);

3. all sheep and goats slaughtered emergency, 4 animals over 18 months, provided they were not killed in the context of measures to combat a notifiable epizootic (epidemic) in the following cases: a) healthy slaughtered and dead or killed animals according to the requirements of the sampling plan (§ 5 para 2), b) healthy slaughtered animals on holdings with measures against the atypical scrapie in accordance with annex VII, chapter B Z 2.2.3. Regulation (EC) No. 999/2001 , c) all died or killed animals over 18 months with measures against the atypical scrapie in accordance with annex VII, chapter B Z plants 2.2.3. Regulation (EC) No. 999/2001;

(d) healthy slaughtered and dead or killed animals on holdings with measures in accordance with annex VII, chapter B of Regulation (EC) No. 999/2001 (enhanced audit log classical scrapie), except by lit. b, e) healthy slaughtered and dead or killed animals from farms, the animals and their semen, ova and embryos brought contrary to the existing veterinary regulatory provisions (article 13, paragraph 1 Z 4), provided that they not see subpara 2 lit. b fall, f) healthy slaughtered and dead or killed animals from herds with animals from certain origin establishments referred to in article 14, if they don't see Z 2 fall, healthy slaughtered and dead or killed animals over 18 months, which are not under no. 4 fall, can 5. on TSE be investigated if the and the were designated the conditions that this set by the Minister or the Federal Minister of health and published in the "official veterinary news" that has demonstrably noted and accepted (investigation at the request of the designated).



Annex 2

The sampling procedure

(I). When the slaughter of animals, the official veterinarian or the official veterinarian or the official veterinarian or the official veterinarian have to proceed as follows:



1. animals must be investigated within the framework of the ante-mortem inspection clinically on TSE. In case of clinical suspicion, the investigation in detail must be documented. In this case is making the sampling by the official veterinarian or the official veterinarian and mandatory to make the submission about the VIS. The documentation is to connect even the fact-finding mission to the competent investigation authority.

2. There is no clinical suspicion for presence of zentralnervalen disease and no obligation to conduct further investigations, also for other reasons the appropriate parts of the brain using the spoon method in accordance with the relevant provisions of the EU and the OIE are all to be sampled animals during the sampling at the earliest possible time (Regulation (EC) No. 999/2001 and OIE Manual) to remove. The sample is to be sent to the veterinary investigation authority competent pursuant to § 7. In addition is to use an ear from the rest of the body marked with ear-tag and submit with the sample. If there is the possibility of a submission about the SFU system, this is mandatory to carry out.

3. If obtaining sufficient amounts of sample material suitable for the examination using the spoon method in accordance with no. 2 is not possible or the spoon method is not applicable, the entire skull including an ear marked with ear-tag, is to be sent. To connect the accompanying report in which is to be noted, why the spoon method was not applicable in the particular case, or why obtaining a sufficient amount of suitable sample material was not possible is the broadcast.

II. the sampling is carried out only upon request of the designated (Appendix 1 Z 5) is in addition to PT. I proceed as follows:



1. the official veterinarian or the official veterinarian the sample document has the signed declaration (Declaration of the possessor) and, where appropriate, the form to close the log book in the case of healthy slaughtered animals.

2. the official veterinarian or official veterinarian or the official veterinarian or the official veterinarian has to connect the signed declaration (Declaration of the designated) the sample document in the case of dead or killed animals and to submit the sample as possible, using the VI.

3.

The sample company or the sampler has to clarify any questions regarding existing research capacities and estimated scan time in advance with the investigation responsible according to § 7.

4. for the submission of samples a form is - if either VIS or SFU system can be used - if necessary use, which was published in the "official veterinary news".

5. the investigating body has the designated to impose the costs of the studies referred to in annex 1 Z 5 calculation. The removal and one end costs are to be borne also by the possessor.

III. in all died or killed sheep and goats, which are to examine 1 Nos. 2, 4 and 5, in accordance with annex the corresponding brain samples from the official veterinarian or the official veterinarian or the official veterinarian or the official veterinarian at the earliest possible date to the local competent collection point or intermediate treatment operation, direct delivery to one according to § 3 are animal materials Act (TMG), Federal Law Gazette I no. 141 / 2003 , as last amended by Federal Law Gazette I no. 23/2013, approved processing plant in this, to remove and to submit as possible making use of the VIS. In addition, is to use an ear from the rest of the body marked with ear-tag and to be kept up to the existence of a negative report. To the submission of samples a form is - if the VIS cannot be used - if necessary use, which was published in the "official veterinary news".

IV. in animals with clinical suspicion of TSE diseases is the whole head with Atlas and ears with ear-tags by the official veterinarian or by the veterinarian directly and immediately in the national competent pursuant to § 7 to submit reference laboratory for TSE. A detailed description of the animal including its special features, as well as a detailed clinical preliminary report in the course of the submission of the VIS in the comment box shall be indicated in the sense of the TSG.

Dead or killed animals are V. after sampling in accordance with Annex 1 in accordance with the relevant provisions of the TMG and the Regulation (EC) 1069/2009 harmless to immediately eliminate No.. If sampled using the spoon method, ear marked with ear tag is in any case until a negative diagnosis to be kept. If there is a positive finding, the ear marked with ear tag in order to proof of identity to the national reference laboratory for TSE is to send.

VI. all parts of the body of animals tested positive, including the skin, in accordance with the relevant provisions of Regulation (EC) No. 1069/2009 harmless are to eliminate part 1 No. 6, with the exception of the material, which in conjunction with the records provided for in annex 4 and must be kept in accordance with PT. VII.

VII. to confirm the identity of the animal if there is a positive result of the investigation is to proceed as follows:



1. the national reference laboratory for TSE has at the request of or the possessor the Tierhalterin or of the keeper, originates from, or whose operation the positive animal, by means of appropriate tests to confirm the identity to determine whether the positive befundete brain test genetically matches the sample, which comes from the ear marked with ear tag. For this purpose, the preserved ears including the earmarks are by the investigation authorities to provide the national reference laboratory for TSE.

2. to determine the genetic identity of the corresponding carcass is to take a sample of the muscle in the presence of a positive finding at the request of the designated the Tierhalterin or of the keeper, from which or whose operation the positive animal originated by the official veterinarian or by the veterinarian from the carcass and to be sent to the national reference laboratory for TSE. Is to give opportunity to take appropriate investigation of the possessor and the representative or the representatives of the affected farm.

3. the relevant investigation material is also for seven years to be kept.

Annex 3

Tasks of the investigation authorities and of the national of reference laboratories for TSES

The laboratory tests on TSE are in the investigating body referred to in article 7 or in the national reference laboratory for TSES carried according to the following:



1. the investigating body has the rules of the national of reference laboratory for TSE concerning the implementation of the test procedures, to comply with documentation of results and modalities of the transfer with regard to the TSE tests carried out by her. The national reference laboratory for TSE has these guidelines in writing to inform the investigative bodies.

2. the national reference laboratory for TSE has to fulfill all the functions and duties referred to in annex X, chapter A, of Regulation (EC) No. 999/2001.

3. the use of rapid tests is only permitted if this Z 4 of Regulation (EC) No. 999/2001 in accordance with annex X, chapter C, are approved.

4. all test specifications used on the TSE investigation authorities relating to the implementation of TSE tests, shall be approved in writing by the national reference laboratory for TSE. Strict adherence to the approved test specifications in the inspection bodies can be checked by the national reference laboratory for TSE.

5. from the results of these checks, reference laboratory for TSE is the Federal Ministry of health by the national to report annually. This report has to contain at least also information on the number and content of TSE-specific training as well as the results of interlaboratory tests. An audit reveals the suspicion that TSE tests were performed improperly, is to put the Federal Minister or the Bundesminster for health informed immediately and in writing to report. The review of investigative bodies authorized according to § 7 to carry out the investigation in regard to compliance with the provisions of this regulation is the national reference laboratory for TSE. The lab operators or the lab operators have during operating hours and at risk of default also outside these hours to allow access and review in the operating areas supervisory bodies, information necessary for the controls, to submit the documents necessary for the inspections for inspection and free of charge to provide assistance within the framework of the review activity.

6. in accordance with article 8 para 3 Z 5 of the health and food safety Act, Federal Law Gazette I no. 63/2002, as last amended by Federal Law Gazette I no. 189/2013, has to submit a monthly report and an annual report in accordance with the requirements of the Minister or the Federal Minister of health, which are published in the "official veterinary news" to create and the Federal Ministry of health the national reference laboratory for TSE. (Hiefür are a) necessary for the overall report part reports of the form above in the by the national reference laboratory for TSE TSE investigation authorities, as well as b) to deliver within the time limit fixed by the national reference laboratory for TSE at the national reference laboratory for TSE.

(c) in case of need and in particular on positive cases, suspected cases and Ausmerzungen are the data reported by the investigative bodies of the national competent authorities and the Federal Ministry of health prior to the transmission of data to the Federal Ministry of health to match the reference laboratory for TSE.

(d) the information underlying the messages are for seven years assigned to store and to present the Federal Ministry for health on demand at any time of the investigation authorities.

7. the investigative bodies are obliged to enter the results of tests of samples in the VIS undertaken by them and, if appropriate electronic systems (VIS and SFU system) not available to assist the samples submission - to submit any additional required data to the correct figure of made investigations electronically to the VIS.

Annex 4

Laboratory tests on TSES and genotyping

1. laboratory tests on TSE

1. specimens of all to be sheep and goats (except for the samples submitted after no. 2), which was sent for laboratory testing, is a referred to in annex X, chapter C, Z 4 of Regulation (EC) to take no. 999 / 2001 approved rapid test, which all known TSE strains are detected.



(a) the result of the rapid test is inconclusive or positive, the tissues shall immediately a confirmatory test in the national reference laboratory for TSE, to undergo. The confirmation test has to be Z 3.2 of Regulation (EC) No. 999/2001 by a method according to the latest edition of the manual, as well as in accordance with the specifications in annex X, chapter C.

(b) the examination result of the Histopathological examination is inconclusive or negative or where the material is autolytisch, the tissues is anyway, so using a method referred to in the manual to investigate.


An animal is considered to be positive for TSE, if the result of the rapid test is positive or inconclusive, and a further investigation (confirmation test) the result is positive. The respective samples are to be kept anyway, pending a final outcome.

2. tissue, which comes from sheep and goats with clinical suspicion of TSE and was sent for laboratory testing, is immediately according to the latest edition of the manual, as well as in accordance with the specifications in annex X, chapter C, to investigate Z 3 of Regulation (EC) No. 999/2001 in the national reference laboratory for TSE. In any case, a sample is a suitable test procedures (confirmation test). The investigations are carried out according to the guidelines of the Community reference laboratory.

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

3. samples from clinical suspect cases and from animals that are valid, but not atypical scrapie cases, or exhibit the characteristics which should be examined more closely, according to the investigating laboratory and of the national of reference laboratories for TSES in consultation with the Community reference laboratory as positive scrapie cases are for further examination by an approved method to the primary molecular typing to a referred to in annex X, chapter C, Z 3.2. lit. c) i) of Regulation (EC) to route No. 999 / 2001 approved examination body.

4. samples of TSE cases, where also the presence of BSE through the primary molecular testing indicated under no. 3 cannot be excluded, are forward after consultation with the Community reference laboratory, and on the basis of all available the relevant information without delay to the investigation authorities, in accordance with annex X, chapter C, Z 3.2 of Regulation (EC) No 999 / 2001 for the implementation of further investigations explaining off are permitted. When evaluating the results, the national reference laboratory for TSE has to support the Community reference laboratory.

5. the notes in accordance with § 7 competent investigation authority that no sufficient amount of the examination is suitable sample material available, it has immediately with the person responsible for the submission to contact, to encourage the submission of additional, suitable for the investigation of samples. The submission of additional samples is not possible, the reason for that purpose in the accompanying report to document in writing.

6. the investigation authorities have all records of testing, for seven years to keep a particular laboratory workbooks, paraffin blocks and photographs of Westernblots and the positive befundete specimens; the corresponding records are to submit the Federal Ministry for health on demand at any time.

2. genotyping

1. for each positive TSE case in sheep and goats, the prion protein genotype shall be determined. The DNA-containing sample materials for this purpose necessary (e.g. muscle, CNS - or ear tissue, organs, EDTA blood, saliva sample) are at the AGES, Institute for veterinary investigations Mödling, to submit. TSE cases detected in resistant genotypes (sheep of genotypes which are alanine on both alleles of the codon 154 and Arginin on both alleles of the codon 171) are immediately to report the Federal Ministry of health. Such cases are one by the Minister or to the Federal Minister of health laboratory, for strain-typing, to submit.

The herd of origin and all other herds where the animal was a reinforced monitoring to undergo to find other cases for strain-typing are strain-typing these cases is not possible. A positive TSE case is a case of atypical scrapie, the prion protein genotype of codon 141 shall be determined.

2. in addition to the investigations referred to in subpara 1 of the prion protein genotype of Codone is 136 annually to determine 141, 154 and 171 of at least 100 sheep. This sample should be representative of the entire population of sheep. The samples can be taken by the investigating the AGES, Institute for veterinary investigations Mödling, submitted slaughtered or dead or live animals, according to the appropriate amount.



Annex 5

Inspection posts for Brucella melitensis

1. the investigative bodies are obliged



(a) regularly (at least annually) to take part in an attempt to ring;

b) to demonstrate that the round robin test was successfully completed and at most within a period set by the national reference laboratory corresponding corrective actions conducted.

c) prove that no other significant evidence exists for speaking, ensure a proper conduct of investigations do not or no longer is) and (d) that on the part of the Federal Ministry of health or the national of reference laboratories requested reports and examination statistics within a reasonable period (of no more than 30 working days after receiving the requests) to present.

2. the investigation authorities are obliged to enter the results of tests of samples in the VIS undertaken by them and, if appropriate electronic systems (VIS and SFU system) not available to assist the samples submission - to submit any additional required data to the correct figure of made investigations electronically to the VIS.

3. the inspection entity does not meet one or more of its obligations pursuant to Nos. 1 and 2 so the Federal Minister or the Federal Minister of health may revoke melitensis permission to carry out investigations on Brucella after report of the national of reference laboratories until the restoration of the proper condition.

Annex 6

Tasks of the national of reference laboratories for brucellosis with regard to Brucella melitensis

1. the national reference laboratory responsible for carrying out the following tasks:



(a) the conduct of validation studies to prove of the reliability of the test methods, as well as establishing the applicable test methods on the other investigation authorities;

(b) the coordination of diagnostic standards and methods;

(c) the fixing of the maximum number of blood samples, which can be pooled as aggregate sample with the ELISA test methods used;

(d) the calibration of secondary national reference Sera ('working standards') against the primary Labora;

(e) the quality control and certification of all batches of the ELISA test methods prior to use at the investigative bodies;

(f) the storage of isolates;

(g) the Organization and evaluation of the annual interlaboratory tests.

h) co-operation within a European network of national reference laboratories for the relevant disease;

(i) the regular participation in international interlaboratory tests for brucellosis with regard to Brucella melitensis;

(j) the coordination of reporting of all investigation authorities about investigations carried out in accordance with the requirements of the Federal Ministry of health;

(k) cooperation with the European reference laboratory for brucellosis with regard to Brucella melitensis;

(l) the fulfilment of all requirements of Union regulations or these regulations specified by the OIE;

(m) the clarification of non-negative samples.

2. the national reference laboratory is the review of the inspection bodies authorised to carry out the investigation (article 19 ABS. 1) in compliance with the provisions of this regulation. The lab operators or the lab operators have during operating hours and at risk of default also outside these hours to allow access and review in the operating areas supervisory bodies, information necessary for the controls, to submit the documents necessary for the inspections for inspection and free of charge to provide assistance within the framework of the review activity.

3. when determining result not clearly negative blood samples, is allowed to answer the question, whether a suspect is - the use of all according to validated and scientifically recognised methods, which are provided by the European Union (EU) or the OIE. As well, additional blood samples to the extent can be requested as necessary for a final determination of the outcome.