Veterinary Requirements For The National Marketing Of Semen, Ova And Embryos Of Certain Pets (Vetsee-Vo)

Original Language Title: Veterinärrechtliche Anforderungen beim innerstaatlichen Inverkehrbringen von Samen, Eizellen und Embryonen von bestimmten Haustieren (VetSEE-VO)

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310. Ordinance of the Federal Minister of Health on the veterinary requirements for the national placing on the market of semen, ova and embryos of certain domestic animals (VetSEE VO)

On the basis of § 2c of the Animal Health Act (TSG), RGBl. No. 177/1909, as well as § 2 para. 1 to 3 of the Animal Health Act (TGG), BGBl. I n ° 133/1999, both last amended by the Federal Law of the Federal Republic of Germany (BGBl). I n ° 3/2009, will be in agreement with the Federal Minister for Finance and the Federal Minister for Agriculture, Forestry, the Environment and Water Management:

Section 1

General provisions

Objective scope

§ 1. (1) This Regulation lays down the general veterinary requirements for the collection, preparation, storage, placing on the market, supply and use of semen, ova and embryos of animal origin and embryos of animal origin and animal health requirements, without prejudice to animal health and animal health requirements.

1.

Bovine animals (including bison and buffalo),

2.

Pigs,

3.

Ovine and caprine animals and

4.

Equiden (house horses, domestic donkey and their intersections)

within the Austrian federal territory.

(2) The provisions shall not apply to the intra-Community movement of products referred to in paragraph 1.

Definitions

§ 2. For the purposes of this Regulation, the terms shall mean:

1.

Levy: the release of products from a facility to the consumer or the consumer;

2.

Official veterinarian Official veterinarian: an official veterinarian an official veterinarian of the local competent authority or a freelance veterinarian appointed by the local authority in accordance with Section 2 (6) of the TGG a freelance veterinarian appointed by the local competent authority in accordance with Article 2 (6) of the TGG;

3.

Application: the use of semen for artificial insemination or the use of embryos for embryo transfer;

4.

authorized user and/or authorized user: the veterinarian or the veterinarian, the insemination technician or the inseminator as well as the self-possessed camera or the owner of the property;

5.

Licence: document on the application of semen to animals;

6.

Insemination station: an officially approved and officially supervised establishment in the territory of the Federal Republic, under the supervision of a responsible veterinarian and authorised by the Authority, or a veterinarian responsible and authorised by the Authority, in which semen for artificial insemination are obtained and processed, stored, placed on the market or delivered;

7.

Insemination technician Insemination technician: a person entitled to exercise the artificial insemination in accordance with the right of national animal rights;

8.

Depository veterinarian or Depository veterinarian: the veterinarian responsible for the day-to-day monitoring of compliance with the requirements of this Regulation in the semen depot and authorised by the District Administrative Authority, Veterinarian;

9.

Own-level-obsessed or Own-stock besamer: a person entitled to an artificial insemination of the animals in his own stock (according to animal species), in accordance with the right of national animal breeding law;

10.

self-recuperation for the purpose of self-existence: extraction of fresh seeds from animals of their own stock for use in animals of their own stock, restricted to equidae, pigs, sheep and goats;

11.

Establishment: insemination station, sperm depot or embryo collection unit;

12.

Embryo: the early stage of development of an animal of the animal species referred to in § 1 (1) , as long as it can be transferred to a recipient animal;

13.

Embryo collection unit: an officially approved and officially supervised facility in the federal territory for the collection, treatment, storage and delivery of ova and embryos;

14.

Embryo transfer certificate: document on the transfer of embryos to recipient animals;

15.

products: semen, ova and embryos of the animal species referred to in Article 1 (1);

16.

Yard container: one for the storage of seeds or Embryos more suitable, with the LFBIS No. the main operating vessel in a livestock holding whose content is intended solely for use in animals of that holding, including its sub-holdings;

17.

Placing on the market: bringing in between approved establishments;

18.

LFBIS number: Operating number according to the Agricultural and Forestry Operational Information System, according to the LFBIS Act, BGBl. No 448/1980, as last amended by the Federal Law BGBl. No 550/1994;

19.

seed: the diluted and/or prepared ejaculate (fresh or deep-frozen) originating from an animal in accordance with § 1 (1);

20.

Samendepot: an officially approved and officially supervised establishment in the territory of the Federal Republic, under the supervision of the Authority and a veterinarian empowered by the Authority, or a veterinarian empowered by the Authority, in the semen for: the artificial insemination is stored, placed on the market and delivered;

21.

Hospital doctor or Hospital doctor: the the veterinarian responsible for the day-to-day monitoring of compliance with the requirements of this Regulation at the insemination station, official veterinarian and authorised by the Authority, Veterinarian;

22.

Veterinarian Veterinarian: a veterinarian who is entitled to practise the profession in accordance with the Tierärztegesetz a veterinarian who is entitled to practise the profession in accordance with the Tierärztegesetz;

23.

TRACES: Integrated EDP system to inform the veterinary authority responsible for destination of the introduction of products in accordance with Z 15;

24.

suspicious products: products suspected of being trafficked by the pathogen of a notifiable animal disease or other veterinary-regulated disease. This includes, in particular, products whose origin cannot be clearly identified on the basis of a lack of labelling or of a lack of proper access to the product;

25.

responsible embryo collection veterinarian or Responsible embryo collection veterinarian: the the veterinarian responsible for the day-to-day monitoring of compliance with the requirements of this Regulation in the embryo collection unit and authorised to do so by the Authority, Veterinarian;

26.

Consumer Consumer: veterinarian Veterinarian, insemination technician Besamtechnicians, self-owned and/or self-owned Self-owned or farmer Landlord, in whose the stock of which a product is consumed;

27.

Approved laboratory: a laboratory, carried out by the central veterinary authority concerned, in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls to verify compliance with the food and Animal feed law and animal health and animal welfare rules (OJ L 327, 30.4.2004, No. 1) is authorised for the purposes of carrying out the studies required by this Regulation.

Approval and regulatory approval

§ 3. (1) Besamation stations, seed depots and embryo collection units require a veterinary authorisation (§ 3 para. 2 TGG). The authorisation shall be issued if the applicant or the applicant is responsible for the application. the applicant shall indicate that the requirements laid down in Annex will be met. Once the authorisation has been granted, the Authority shall immediately carry out the collection of the establishment in the veterinary information system (VIS).

(2) A facility that is in accordance with the requirements of § 13 of the Internal Market Regulation 2008-BVO 2008, BGBl. II No 473, shall be deemed to be authorised within the meaning of this Regulation.

(3) By way of derogation from paragraph 2, institutions wishing to spend national bovine embryos at national level in accordance with § 12 shall also require authorisation under this Regulation if they have already been approved in accordance with the provisions of Section 13 of the BVO 2008.

(4) A separate regulatory approval is required

1.

the storage of embryos in insemination stations and seed depots, and

2.

the storage of deep-frozen semen in embryo collection units.

(5) A permit pursuant to paragraph 4 may be granted jointly with the approval pursuant to paragraph 1 or also subsequently.

Regulatory control

§ 4. (1) The District Administrative Authority shall have the official veterinarian. the official veterinarian must regularly check the approved facilities,

1.

Embryo collection units at least once a year, and

2.

Insemination stations as well as seed depots at least twice a year

are to be checked.

(2) In the course of official activities or checks carried out in approved establishments, it is established that the conditions for the authorisation in accordance with the Annex or the separate regulatory approval pursuant to section 3 (4) is no longer granted, according to § 3 (3) of the German TGG (TGG), in the case of entities which have been authorised according to § 13 BVO 2008, pursuant to § 16 BVO 2008.

(3) By the end of February of the following year, the results of the checks carried out by the Landeshauptmann shall be transmitted to the Federal Ministry of Health. This obligation for the annual notification shall be issued as soon as the obligation for the Authority to enter the controls and their results in the electronic veterinary register (VIS) in accordance with § 8 TSG.

(4) Compliance with the provisions of this Regulation shall be reviewed by the Authority as far as possible within the framework of other veterinary checks.

(5) The farmer or the farmer has to participate in the investigations and checks in accordance with § 2 para. 5 TGG.

Section 2

Provisions for seeds

Production and labelling of seeds

§ 5. (1) Each single dose of fresh or deep freeze seed produced by insemination stations for placing on the market shall, at least by the following information, be clearly and permanently marked:

1.

Withdrawal Date (batch number) in format (DD/MM/YYYY),

2.

Race,

3.

the name of the donor animal (optional for sheep, goats and pigs),

4.

Identification of the donor animal in accordance with the animal labelling requirements,

5.

Veterinary approval number of the insemination station in which the seed has been obtained.

(2) Fresh seed obtained from a donor animal which is kept at the same holding as the recipient animal (to be held) and is then used on the same farm, does not require any labelling.

(3) The extraction and preparation of seeds for freezing shall only be carried out in approved semen collection centres.

Provisions governing the placing on the market and distribution of semen

§ 6. (1) Seeds shall be placed on the market or delivered to consumers only by approved semen collection centres and seed depots to other approved establishments.

(2) Seeds may be placed on the market or placed on the market within the territory of the Federal Republic of Germany only if the seed:

1.

in accordance with the provisions of the BVO 2008 or the Veterinary Import Ordinance 2008-VEVO 2008, BGBl. II No 474, has been introduced or imported into approved establishments in Austria, or

2.

from a facility approved in Austria has been obtained from animals which meet the requirements of Annex and to meet the requirements of Annex has been prepared, stored and transported accordingly.

(3) A delivery note must be attached to a consignment note during transport. The delivery note shall contain at least information from which the establishment (s) with the approval number (place of origin, place of destination) or the consumer (name and address, as well as any LFBIS number), the date of delivery, the total number of portions delivered, the number of portions per donor animal and its identification and the date of withdrawal. The authorized body (s) to be provided or donated (para. 1) has to keep copies of the delivery notes chronologically ordered for at least five years. These shall be at any time at the request of the Authority. in a copy and, if available in electronic form, free of charge, even in this form.

(4) The registration of the date of withdrawal in the delivery note may be dispensed with the supply of semen to veterinarians, technicians and technicians, as well as self-insurers, if the traceability is carried out by the The authorised institution shall be kept in keeping with the records. In any event, if it is established, within the framework of official control, that there is no traceability due to the lack of records kept, the Authority shall, in any event, have until the next inspection the entry of the date of withdrawal from the delivery note. ,

(5) Samenets which are placed on the market within Austria must be connected to a delivery note, which also confirms the following written confirmation from the station veterinarian or the depository veterinarian. of the staff/depository veterinary surgeon:

1.

" The signatory in charge of the training physician or the signatory responsible station doctor of the approved establishment with the approval number ..... confirms that the semen complies with the requirements of Directive 88 /407/EEC idgF ", or

2.

" The signatory in charge of the training physician or the signatory responsible station doctor of the approved establishment, with the approval number ....., confirms that the seed meets the requirements of Directive 90 /429/EEC idgF " or

3.

" The signatory in charge of the training physician or the signatory responsible station doctor of the approved establishment with the approval number ..... confirms that the semen complies with the requirements of Directive 92 /65/EEC idgF ".

(6) seed consignments which are sent within Austria to approved insemination stations or seed depots must be accompanied by a certificate in the event of an intended transfer to intra-Community trade or export; the conditions laid down in Appendix 1. II BVO 2008 and must comply with the requirements of the third country concerned. The certificate shall be issued by the official veterinarian. to be signed by the official veterinarian who which is responsible for the establishment in which the seed has been obtained.

Prohibition of the placing on the market and the release of semen

§ 7. (1) Any form of placing on the market and the delivery of semen by other than approved establishments shall be prohibited.

(2) Consumers may only use semen for direct use in animals (insemination) by authorized users, or Use users. A transfer to third parties is not permitted.

(3) Deep freeze seeds delivered to consumers may be returned to facilities only for disposal purposes. The facilities shall be subject to the withdrawal. In the case of the withdrawal, a removal order is to be issued for the released deep freeze paillettes. The date of withdrawal, number and identity of the donor animals must be derived from this withdrawal order. The requirements of the Animal Material Act (TMG), BGBl, are to be found in the disposal of seeds that are no longer used for the purpose of administration. I n ° 141/2003, as last amended by the Federal Law BGBl. I No 3/2009. The disposal costs can be transferred from the device to the person giving back the seed.

Application of seeds

§ 8. (1) Seeds may only be used by authorized users in accordance with the provisions of national law on the law of the country.

(2) Seeds may not be used for artificial insemination without prejudice to the animal rights requirements for the use of semen only if the seed is used in accordance with the Annex has been properly won, processed, stored and transported, and is identified in accordance with § 5.

(3) Fresh seeds of animals of their own stock, which have been kept in this herd for at least 30 days prior to seed production, may only be obtained in accordance with appropriate hygiene measures and only for the artificial insemination of animals of the their own holdings, which have been kept in this stock for at least 30 days prior to the insemination (self-reclamation of their own stock of existence).

Ensuring the traceability of seeds

§ 9. (1) Without prejudice to the recording and documentation requirements required by other legislation, authorised users shall have the right to: The user shall immediately issue an insemination certificate. The insemination certificate is the holder. to the holder of the beamed animal. The authorized user or the authorized user shall keep a copy.

(2) In the case of horses and bovine animals, the insemination certificate shall have at least the name and address of the authorized user. of the authorized user, the identity of the donor animal and the possessed animal, the date of withdrawal (batch number) of the seed as far as such is indicated on the seed portion used, the holding or holding of the holder or of the keeper of the beamed animal, including its LFBIS No. and to include the date of the insemination.

(3) The documentation provided for in this Regulation may also be used for insemination certificates on the basis of other pieces of legislation which comply with the requirements of paragraph 1 or (2).

(4) Delivery notes and insemination certificates shall be issued by the user. by the user and by the keeper or have been chronologically ordered by the keeper of animals, provided with consecutive numbering, and kept for as long as the seeds of a particular animal (batch-related) are stored, but at least five years.

(5) The records shall be provided free of charge to the Authority at any time upon request, in the case of electronic record in any electronic form.

Section 3

Provisions applicable to ova and embryos

Labelling of egg cells and embryos

§ 10. (1) In the case of extraction in an embryo collection unit, the ova and embryos not intended for immediate transfer shall be clearly and durably, immediately after they have been obtained, at least by the following particulars to appear on the containers. mark:

1.

Withdrawal Date (DD/MM/YYYY),

2.

Race/Races,

3.

the names of the donor parents,

4.

Identification of the donor animals in accordance with the animal labelling requirements,

5.

Veterinary approval number of the embryo collection unit.

(2) Fresh embryos for direct transmission do not require any special labelling.

Provisions for the placing on the market of ova and embryos

§ 11. (1) Eizelles and embryos may be placed on the market within Austria unless they are used in § 12, unless they are used for the purpose of:

1.

in accordance with the provisions of the BVO 2008 or the VEVO 2008 in approved establishments, have been or have been introduced into Austria, or

2.

come from an approved Austrian body and have been obtained from animals which meet the requirements of Annex and to meet the requirements of Annex have been prepared, stored and transported accordingly.

(2) Eizelle/Embryon consignments, which are shipped exclusively within Austria between approved establishments, must be accompanied by a delivery note, the following written confirmation from the responsible veterinarian or of the responsible veterinarian has to include:

1.

" The undersigned responsible veterinarian, the signatory responsible veterinarian of the approved establishment with the approval number ..... confirms that the ova/embryos meet the requirements of Directive 89 /556/EEC idgF " (beef), or

2.

" The undersigned responsible veterinarian, the signatory responsible veterinarian of the approved establishment with the approval number ..... confirms that the ova/embryos meet the requirements of the Directive 92 /65/EEC idgF " (pig, horse, sheep and goat).

(3) Eizelle/Embryon consignments which are made exclusively for use within Austria by approved establishments must be accompanied by a delivery note, including a copy of the rinsing protocol. This is also valid without confirmation of the veterinary requirements for the transfer of egg cells/embryos.

(4) ova and embryos may only be used by approved establishments to other approved establishments or to a veterinarian or to a veterinary surgeon. be delivered to a veterinarian for direct application to the animal or to be stored in a court container.

(5) The delivery note shall contain at least information from which the establishment with the registration number, name and address of the veterinarian, or of the veterinarian, the date of delivery, the total number and number of embryos per donor animal, the identification of the donor parents and the date on which the date of production is to be taken.

(6) The copies of the delivery notes and embryo transfer certificates are chronologically ordered under the supervision of the veterinarian responsible for the establishment, respectively. of the veterinarian responsible for the establishment, as long as embryos of certain donor animals (batch-related) are stored, but at least for five years. These shall be submitted to the Authority at any time on request in the original and in electronic form, even in electronic form, free of charge.

Exceptions to the national placing on the market of embryos of bovine animals

§ 12. (1) embryos of bovine animals which are used exclusively for use by a veterinarian or A veterinarian in Austria may be admitted to approved facilities in the Austrian federal territory, authorized users, or Users and for storage in the court container are also delivered if they are obtained in an approved embryo collection unit, prepared and stored in the stationary laboratory separately from the ova and embryos referred to in § 11. The proper identification of such embryos shall be carried out by the additional affixing of the letter "N" as a marking.

(2) The veterinarian responsible for the embryo collection unit the veterinarian responsible for the embryo collection unit has this procedure in her/her/her/her/her/her/her/her to document his records.

(3) The consignment of embryos referred to in paragraph 1 shall be accompanied by a delivery note clearly marked with the letter "N". This is also valid without the confirmation of the veterinary requirements by the official veterinarian or the official veterinarian for the transfer of embryos.

Ban on the placing on the market of ova and embryos

§ 13. (1) Veterinarians may use embryos only for direct use in animals (embryo transfer) and not pass on to others.

(2) embryos may only be placed on the market by approved bodies. Any other form of the placing on the market of embryos (e.g. from court containers) is prohibited.

(3) embryos made to consumers may be returned to facilities only for disposal purposes. The facilities shall be subject to the withdrawal. In the case of the withdrawal, a removal order shall be issued for the delivered containers. The date of withdrawal, number and identity of the donor animals must be derived from this withdrawal order. In the disposal of embryos no longer intended for use, the requirements of the German Telemedia Act (TMG) must be observed. The disposal costs can be transferred from the device to the person giving back the embryos.

Use of egg cells and embryos

§ 14. (1) embryos may only be transmitted by veterinary surgeons in accordance with the provisions of national law on animal law.

(2) Eizelles and embryos may only be used for artificial insemination or fertilisation without prejudice to the animal breeding requirements for use. shall be used if the transmission is carried out in accordance with the Annex have been properly won, processed, stored and transported, and are identified in accordance with § 10 or fall under the provisions of § 12.

Ensuring the traceability of egg cells and embryos

§ 15. (1) Without prejudice to the requirements for recording and documentation requirements required by other legislation, veterinary surgeons must issue an embryo transfer certificate immediately on the occasion of the transfer.

(2) The embryo transfer certificate shall contain at least the name and address of the veterinarian in the case of horses and bovine animals. the veterinarian, the identity of the donor parents and the recipient, the date of the winning date, the name and address of the keeper, of the holder of the recipient, including the LFBIS No of the holding and the date of the transfer.

(3) Embryo transfer certificates may also be used for the documentation provided for in this Regulation, pursuant to other legislation which complies with the requirements of paragraph 1 or paragraph 2.

(4) the veterinarian who is carrying out embryo transmission, or Veterinarian and the animal keeper the keeper has to order the delivery notes and the embryo transfer notes chronologically, to be provided with consecutive numbering and to keep them for a minimum of five years.

(5) The records shall be provided free of charge to the Authority at any time upon request in the original, in the case of any electronic recording in this form.

Section 4

Measures to be taken at the risk of spreading the disease

Prohibition of use and information requirements

§ 16. (1) Suspected products according to § 2 Z 24 may not be placed on the market, not delivered and not applied. These products must be disposed of immediately in accordance with § 10 TMG.

Any person or body placing, supplying, applying or applying products to the market shall have, as soon as it becomes aware of circumstances, that it may indicate that it is intended for the transmission of an animal disease regiment or of a pathogen to an animal , without prejudice to any other obligation to notify, to inform all the known trade participants and the District Administrative Authority of any other veterinary regulated disease without delay.

(3) The district administration authority has to inform the Federal Minister of Health by way of the Governor of the State.

Notification of disease suspicion

§ 17. Any outbreak and any reasonable suspicion of the existence of a notifiable disease in insemination stations and donor establishments of ova and embryos shall be indicated in accordance with Article 17 of the TSG (TSG) by the persons referred to therein; furthermore, the said person shall be informed of the existence of a disease in the semen and embry To notify persons immediately of the existence of the grounds for any other veterinary-regulated diseases of the District Administrative Authority.

Suspicion of products

§ 18. (1) If it is found, by means of the reporting of another State or on the basis of movement reports in TRACES, that suspicious products have been imported into or within the Community in breach of Section 16 (1), the competent authority shall: District managing authority, without prejudice to other veterinary provisions, to take the following measures without delay:

1.

Prohibition of placing on the market, placing on the market or use of suspect products.

2.

Collection of all suspicious products located in approved establishments and authorised users.

3.

Separate all suspicious products which are still stored in the approved establishments.

4.

Where the suspect products have already been applied to the animal, the keepers and keepers concerned shall be informed and shall be informed of the obligation to notify the suspected cases in accordance with the relevant veterinary regulations and the relevant veterinary regulations. Need to draw attention to the need for an immediate examination of the fruit aborted.

(2) If there is no removal of the suspicion that a notifiable epizootic disease or a pathogen may be abducted by the products, there is no possibility of the return of the Products, they must be disposed of under the supervision of veterinary supervision.

(3) Suspected products which have already been delivered to consumers shall be subject to instructions and under the supervision of the local official veterinarian. of the local official veterinary surgeon.

(4) Where it is established that suspect products have been obtained, processed, stored, placed on the market or made available in a facility, the competent district administrative authority shall, where this is not the case under other veterinary legislation, have Whereas provisions have already been made to order the measures provided for in paragraphs 1 to 3; If the suspicion of the disease is not eliminated, the suspected products must be disposed of under the supervision of veterinary supervision.

Section 5

Other measures

Good hygiene practice and biosecurity measures

§ 19. (1) The operator or the operator of an approved body must lay down the health rules for the establishment, production and storage of the products (biosafety measures) and the operating staff before commeninating the activity; to be taken into account.

(2) In order to prevent the entry and spread of diseases, in particular notifiable animal diseases, the operating staff must be shown to have appropriate disinfection methods and hygiene rules prior to the start of the activity. Zoonoses, as well as their practical implementation.

(3) The operator or the operator of an approved establishment has to adapt biosecurity measures to the current state of the scientific community, to demonstrate this to the operating staff within a reasonable period of time and to demonstrate that it has been shown to be appropriate in accordance with the requirements of Schools.

(4) If guidelines for good hygiene practice and biosecurity measures are issued by the Federal Minister of Health and published in the "Official Veterinary Messages", approved bodies shall be obliged to comply with them.

Accounting

§ 20. (1) The operator or the operator of an approved body shall ensure that the necessary written records relating to the supply and departure of animals, semen, ova and embryos, as well as the health status of the establishments of origin and of the Donor animals shall be guided in accordance with the relevant provisions of the Annex. The veterinarian responsible for the establishment the veterinarian responsible for the establishment shall regularly check those records.

(2) The records are arranged chronologically and under the supervision of the veterinarian responsible for the establishment, respectively. of the veterinarian responsible for the establishment shall be kept for and for as long as the semen, ova or embryos of certain donor animals (batch-related) are stored, but at least for five years. They shall be provided free of charge to the Authority at any time upon request, in the case of electronic record in electronic form.

Control of other measures

§ 21. Compliance with the measures referred to in § § 19 and 20 shall be carried out within the framework of the official control according to § 4.

6.

Closure and transitional provisions and entry into force

References

§ 22. Where reference is made in this Regulation to provisions in the European Union (EU) rules, they shall be applied in their respective versions.

Transitional provision

§ 23. An indication of the date of withdrawal on the delivery note may be omitted if the production date is before the entry into force of this Regulation.

entry into force

§ 24. This Regulation shall enter into force 1. October 2012, in force.

Stöger