310. Regulation of the Federal Minister for health of the veterinary requirements for the national marketing of semen, ova and embryos of certain pets (VetSEE-VO)
On the basis of § 2c of the animal diseases Act (TSG), RGBl. No. 177/1909, as well as section 2 para 1 to 3 of the animal health law (TGG), Federal Law Gazette I no. 133/1999, both as last amended by the Federal Act Federal Law Gazette I no. is 3/2009, in agreement with the Federal Minister of finance and the Federal Minister for agriculture and forestry, environment and water management decreed:
General terms and conditions
1. (1) this regulation lays down tierzucht - and health conditions governing notwithstanding the General veterinary requirements for collection, treatment, storage, placing on the market, distribution and application of semen, ova and embryos of
1. bovine animals (including bison and Buffalo), 2 pigs, 3. sheep and goats as well as 4. equidae (horses, donkey and their intersections) within the Austrian Federal territory.
(2) the provisions do not apply to the intra-Community movement of in paragraph 1 listed products.
§ 2. The purposes of this regulation, the terms mean:
1 tax: the transfer of products from one place to the consumer or the consumer;
2. official veterinarian / official veterinarian: an official veterinarian or an official veterinarian of the competent local authority, or one of the locally competent authority pursuant to § 2 para 6 TGG commissioned freelance veterinarian or by the local competent authority in accordance with § 2 article 6 Commissioner freelance TGG veterinarian;
3. application: the use of sperm for artificial insemination or the use of embryos to embryo transfer;
4. authorized users or authorized users: the veterinarian or the veterinary surgeon, the insemination technician or the Inseminators as well as the Eigenbestandsbesamerin and Eigenbestandsbesamer;
5. insemination certificate: document on the application of seeds on the animal;
6 artificial insemination: an officially approved and officially supervised establishment in the Federal territory, which is under the supervision of a veterinarian responsible and authorised by the agency or a responsible person and the authority authorised veterinarian in the semen for artificial insemination is won and processed, stored, placed on the market, or given;
7 insemination technician or insemination technician: a person according to national animal breeding legislation to carry out artificial insemination;
8 Depot veterinarian or depot veterinarian: the or the responsible for the ongoing monitoring of the compliance with the requirements of this regulation in the seed vault and the district administrative authority having authorised veterinarian or veterinary surgeon;
9 Eigenbestandsbesamerin or Eigenbestandsbesamer: a person according to national animal husbandry law exclusively to the artificial insemination of animals in the (by species);
10 equity extraction to own stock insemination: extraction of fresh semen of animals of the own stock to be applied to animals of the own stock, limited to equidae, pigs, sheep and goats;
11 device: artificial insemination, semen depot or embryo collection team;
12 embryo: the early development stage of an animal of the species referred to in article 1, paragraph 1, as long as it can be transferred to an Empfängertier;
13 embryo collection team: an officially approved and officially supervised establishment in the Federal territory to the production, treatment, storage, and release of ova and embryos;
14 embryo transfer licence: document on the transfer of embryos to recipient animals;
15 products: Semen, ova and embryos of the species referred to in article 1, paragraph 1;
16 yard container: a suitable for the storage of seeds or embryos, marked with the LFBIS number of the main operation container in an animal farm, the content of which is determined; intended for use in animals of this operation including the associated component operations
17 placing: spend between approved bodies;
18 LFBIS number: number according to the agriculture and forestry business information system under the LFBIS Act, Federal Law Gazette No. 448/1980, as last amended by Federal Law Gazette No. 550/1994;
19 seeds: that of an animal pursuant to section 1 para 1 diluted originating or prepared to ejaculate (fresh or frozen);
20th seed Depot: an officially approved and officially supervised institution in the Federal territory, which is the authority and a veterinarian authorised by the authority or by a veterinarian authorised by the authority in the semen for artificial insemination is stored, placed on the market and released under supervision;
21 station veterinarian or veterinarian station: the or the authorized by the authority, responsible for the ongoing monitoring of the compliance with the requirements of this regulation in the artificial insemination and official veterinarian or veterinarian;
22 veterinarian or veterinarian: a veterinarian authorized in accordance with veterinary law to practice or a veterinary surgeon authorised according to the veterinary Act to exercise the profession;
23 TRACES: Integrated computer system which informs veterinary authority responsible for the place of destination on the market of products referred to in Z 15;
24 suspicious products: products which are suspected, that the germ of a notifiable animal disease or other veterinary regulated disease can be dragged through it. These include in particular products, whose Herkunft due to faulty labelling or not given attribution can not clearly be established;
25 responsible embryo collection veterinarian or responsible for embryo collection animal doctor: the or the responsible for the ongoing monitoring of the compliance with the requirements of this regulation in the embryo collection team and authorized by the authority to vet or veterinarian;
26 consumer or consumers: Veterinarian or veterinarian, insemination technician Inseminators, Eigenbestandsbesamerin or Eigenbestandsbesamer or farmer or farmer, a product consumed in which or whose portfolios;
27 approved laboratory: a laboratory by the central veterinary authority in accordance with Regulation (EC) No. 882/2004 of the European Parliament and of the Council on official controls for the verification of compliance with feed and food law and animal health and animal welfare (OJ rules No. L 165 of 30.4.2004 p. 1) is admitted to the examinations required by this regulation.
Approval and regulatory approval
3. (1) semen collection centres, semen deposits and embryo collection teams must receive veterinary regulatory approval (section 3 para 2 TGG). The approval is granted if the applicant or the applicant can prove that meet the requirements in accordance with the annex with notice. After marketing authorization, the authority shall without delay make the acquisition of the institution in the veterinary information system (VIS).
(2) a facility that is approved according to the provisions of § 13 of the Veterinärbehördlichen internal market regulation 2008 - BVO 2008, Federal Law Gazette II No. 473, considered to be approved within the meaning of this regulation.
(3) by way of derogation from paragraph 2 require facilities that bovine embryos national want to spend in accordance with § 12 even an authorisation under this regulation, if they are already approved in 2008 according to § 13 BVO.
(4) a separate regulatory approval is required
1. the storage of embryos in semen and semen deposits, and 2. the storage of frozen semen in embryo collection teams.
(5) a can approval according to paragraph 4 together with the authorisation referred to in paragraph 1 or later.
4. (1) has the district administrative authority by the official veterinarian or the official veterinarian regularly to check the approved bodies, where
1 have at least twice a year to check embryo collection teams at least once a year, and 2. semen and semen deposits.
(2) in the course of official activities or controls in approved facilities, is determined that the conditions for authorisation in accordance with the system or of the separate regulatory approval are no longer given according to § 3 para 4, so TGG, 2008 approved BVO pursuant to § 3 para 3 institutions, which according to section 13 were to proceed BVO 2008 according to section 16.
(3) until end of February of the following year are to submit the results of checks carried out by the Governor at the Federal Ministry of health. This commitment to the annual message goes out as soon as the obligation of the authority is to enter the controls and their results in the electronic register of veterinary (VIS) pursuant to article 8 to TSG.
(4) compliance with the provisions of this regulation can be checked by the authority as far as possible in the context of other veterinary regulatory controls.
(5) the owner or the holder has to take part in the inspections and controls referred to in § 2 para 5 TGG.
Provisions for seeds
Extraction and identification of semen
§ 5 (1) is any single dose of fresh or frozen semen, which is produced by semen to the placing on the market, to identify clearly and permanently at least by the following information:
1 sampling date (lot number) in the format (DD/MM/YYYY), 2nd race, 3. name of the donor animal (optional in sheep, goats and pigs), 4 identification of the donor animal in accordance with the provisions of the animal identification, 5 Veterinärbehördliche approval number of semen, in which the seed was obtained.
(2) fresh seeds, obtained from a Spendertier that is held on the same holding such as the Empfängertier (to besamende) and then the same operation is used, requires no labelling.
(3) the extraction and processing of seeds to freezing must be made only in approved semen collection centres.
Provisions relating to the placing on the market and distribution of seeds
Section 6 (1) must seed only from approved semen collection centres and seed deposits be placed at other accredited institutions in traffic or to consumers.
(2) seed should be only placed on the market within the Federal territory or, if this:
1. in accordance with the provisions of the BVO 2008 or the Veterinärbehördlichen import regulation 2008 - VEVO 2008, Federal Law Gazette II No. 474, in approved facilities after Austria has been spent or introduced or comes 2nd from a facility approved in Austria, was won by animals, that comply with the system requirements and prepares the system according to the requirements, stored and promoted was.
(3) a delivery note must be during the journey seed shipments. The delivery note must include at least information emerges from which the entity with registration number (origin, destination) or the consumer or the consumer (name and address, as well as a possible LFBIS-No.), date of delivery, the total amount of supplied portions, the number of servings per Spendertier and its identification and the date of removal. The verbringende or issuing approved facility (para. 1) has assigned chronologically copies of the delivery notes to be kept for at least five years. These are the authority at any time upon request in the original and in copy and, if they are available in electronic form, also in this form free of charge to present.
(4) the registration of the collection date in the delivery note you can omit with emission of semen to veterinarians and animal doctors, technicians and technicians as well as equity portfolio be same gullies and Eigenbestandsbesamer when traceability through the records by issuing approved establishing is guaranteed. Determined in the framework of regulatory control that traceability requirements due to poorly-run records is not specified, so the authority has anyway, up to the next control to order the registration of the collection date on the delivery note.
(5) a delivery note must be connected seed programmes which are brought within Austria to approved facilities in transport, that has to include also following written confirmation from the station / Depot veterinarian or station / Depot veterinarian:
1. "the undersigned responsible station veterinarian or the undersigned responsible station veterinarian of the approved institution with the registration number... confirmed that the seed meets the requirements of Directive 88/407/EEC as amended"or 2"the undersigned responsible station veterinarian or the undersigned responsible station veterinarian of the approved institution with the registration number... confirmed that the seed meets the requirements of Directive 90/429/EEC as amended"or 3"the undersigned responsible station veterinarian or the undersigned responsible station veterinarian of the approved institution with the registration number... confirms that the seed meets the requirements of Directive 92/65/EEC as amended,".
(6) seed shipments, which are transported within Austria to approved semen collection centres or semen deposit must be accompanied with an intended further movement in the intra-Community trade or export from a prior testimony, that the requirements of Appendix 1 Cape. II BVO 2008 or the requirements of the respective third country must comply with. The prior testimony is by that official veterinarian or by the veterinarian to sign up, or for the establishment, in which the seed was obtained, is responsible.
Ban on the placing on the market and the distribution of seeds
7. (1) every form of marketing and distribution of seeds by others as approved bodies is forbidden.
(2) consumers may use seeds only for the immediate application to the animal (insemination) by authorized users or users. A transfer to third parties is not permitted.
(3) frozen semen, which was delivered to consumers must be returned to facilities only for the purpose of disposal. The institutions are obliged to take back. Delivered frozen sequins a withdrawal notice is to exhibit at the withdrawal. Date of collection, number and identity of the donor animals must emerge from this withdrawal slip. When disposing of the seed no longer for the application the requirements of animal material act - TMG, Federal Law Gazette are through I no. 141/2003, amended the Federal Act Federal Law Gazette I no. 3/2009, to keep in mind. Disposal costs can be transferred from the institution to the person returning the seeds.
Application of seeds
§ 8 (1) may be used seeds only by authorized users and users under the national zootechnical provisions.
(2) seed may only be used without prejudice to the zootechnical requirements on the use of seeds to artificial insemination if this is in accordance with the annex was properly obtained, processed, stored and promoted and is marked in accordance with section 5.
(3) fresh semen of animals of the own fleet, which were held for at least 30 days before the seed production in this stock, may be obtained only in compliance with appropriate hygiene measures and used only for artificial insemination of animals of own stocks, which have been held for at least 30 days prior to the semen collection in this stock (equity extraction to own stock insemination).
Ensuring the traceability of seed
Authorized users or users have § 9 (1) without prejudice to the recording necessary on the basis of other legislation and documentation requirements to exhibit a semen collection licence immediately. The insemination Bill is to pass the holder or the owner of the inseminated animal. The authorized user and the authorized user has to keep a copy.
(2) the insemination licence has at least information on name and address of the authorized user or authorized user, the identity of the donor animal and the inseminated animal to include the withdrawal date (lot number) of semen as far as this is stated on the used portion of the seeds, the operation of the holder or of the holder of the inseminated animal including its LFBIS-No. and the date of insemination in horses and cattle.
(3) insemination tickets can be used on the basis of other legislation that meet the requirements of paragraph 1 or paragraph 2, also for the documentation under this regulation.
(4) Bills and insemination notes are by the user or by the user and by the Tierhalterin or by the keepers have to arrange in chronological order, with consecutive numbers to provide and for so long to keep, how seeds of a certain animal (batch) is stored, however, at least five years.
(5) the records shall at any time upon request - for any electronic recording in electronic form - free to submit the authority.
Provisions for ova and embryos
Marking of eggs and embryos
You are not § 10 (1) in the extraction in an embryo collection team for immediate transmission to label ova provided for and embryos immediately after its production at least through the following information on the containers clearly and permanently:
1 sampling date (DD/MM/YYYY), 2nd race/breeds, 3. name of the donor parents, 4. labeling (identification) of donor animals under the animal identification rules, 5 Veterinärbehördliche approval number of the embryo collection team.
(2) fresh embryos for the immediate transmission require any special labeling.
Requirements for the placing on the market of egg cells and embryos
§ 11 (1) ova and embryos are allowed, if not section 12 to the application arrives, are only placed on the market in Austria, if they
1 in accordance with the provisions of BVO 2008 or the VEVO 2008 in authorised facilities after Austria have been spent or introduced or 2 from an accredited Austrian establishment come and were won by animals, that comply with the system requirements and prepares the system according to the requirements, stored and promoted were.
(2) egg / Embryonensendungen be spent only within Austria between approved bodies, must be accompanied by a delivery note, which has to include the following written confirmation of the responsible veterinarian or the responsible veterinarian:
"The undersigned responsible veterinarian or the undersigned responsible veterinarian of the approved institution with the registration number... confirmed that the ova/embryos meet the requirements of Directive 89/556/EEC as amended"(beef) or 2"the undersigned responsible veterinarian or the undersigned responsible veterinarian of the approved institution with the registration number... confirmed that the ova/embryos meet the requirements of Directive 92/65/EEC as amended"(pig, horse, sheep and goat).
(3) egg / Embryonensendungen be placed within Austria by approved bodies solely for the application, must be accompanied by a delivery note including a copy of the minutes of flushing. This is valid even without confirmation of the veterinary requirements for the introduction of oocytes and embryos.
(4) ova and embryos may be placed by approved establishments only to other approved institutions or a veterinarian or a veterinary surgeon to the direct application on the animal or to store in a container yard.
(5) the delivery note must include at least information set up with approval number, name and address of the veterinarian or veterinary, date stating delivery, total amount and number of embryos per Spendertier, identification of the donor parents and the production date.
(6) the copies of the Bills and embryo transfer certificates are chronologically ordered under the supervision of the veterinarian responsible for the establishment or of the veterinarian responsible for the establishment as long as keep, how certain donor animals (batch) embryos stored at least for five years. These are at any time at the request of the original - and in any electronic recording in electronic form - free to submit the authority.
Exceptions for the national marketing of embryos of bovine animals
§ 12 (1) bovine embryos, which are intended exclusively for use by a veterinarian or a veterinary surgeon in the country may be placed also at accredited institutions in the Austrian Federal territory, authorized users or users and storage in the yard container, if it in an approved embryo collection team were obtained, processed and stored in the stationary laboratory separated from the eggs referred to in article 11 and embryos. The proper identification of such embryos has to be carried out by the additional application of the letter "N" as marking.
(2) the veterinarian responsible for the embryo collection team or the veterinarian responsible for the embryo collection team has this procedure in her or his records to document.
(3) the Embryonensendungen referred to in paragraph 1 must be connected a delivery note is marked clearly with the letter "N", will be accompanied. This is valid even without confirmation of the veterinary requirements by the official veterinarian or the official veterinarian for the shipment of embryos.
Prohibition of in placing of oocytes and embryos
Section 13 (1) veterinarians and veterinarians may use embryos only for the immediate application of the animal (embryo transfer) and not pass it on to others.
(2) embryos are allowed only by approved bodies in traffic. Any other form of placing on the market of embryos (E.g. from yard containers) is prohibited.
(3) embryos, which were transferred to consumers, must be returned to facilities only for the purpose of disposal. The institutions are obliged to take back. A return ticket is to exhibit at the redemption for given containers. Date of collection, number and identity of the donor animals must emerge from this withdrawal slip. The specifications of the TMG are at the disposal of embryos no longer to apply. Disposal costs can be transferred from the facility to the person returning the embryos.
Application of oocytes and embryos
Embryos may 14 (1) only by veterinarians and veterinarians are transferred under the national zootechnical provisions.
(2) ova and embryos is allowed only without prejudice to the zootechnical requirements on the application to artificial insemination or transfer, if this in accordance with the annex were duly won, processed, stored and transported and are marked in accordance with section 10 or fall under the provisions of article 12.
Ensuring the traceability of eggs and embryos
Without prejudice to due to other legal provisions of required recording and documentation obligations veterinarians and veterinarians directly on the occasion of the transfer have section 15 (1) to make an embryo transfer licence.
(2) the embryo transfer licence has at least information on name and address of the doctor or of the veterinarian, the identity of the donor parents and of the recipient animal, date of production, to include the name and address of the holder or of the holder of the recipient animal including the LFBIS number of the operation and the date of transfer in horses and cattle.
(3) embryo transfer tickets can be used on the basis of other legislation that meet the requirements of paragraph 1 or paragraph 2, also for the documentation under this regulation.
(4) the or of performing the embryo transfer veterinarian or animal doctor and the Tierhalterin or the keepers have to arrange the delivery notes and the embryo transfer notes in chronological order, to keep to provide and for at least five years with consecutive numbers.
(5) the records shall at any time upon request in the original - for any electronic recording in this form - free to submit the authority.
Measures in case of risk of disease spread
Prohibition of application and information
Section 16 (1) suspicious products in accordance with § 2 Z 24 may be not placed, not submitted, and not applied. These products must be disposed of TMG immediately in accordance with § 10.
(2) every person or entity that brings products on the market, emits, or applies, has, suggest as soon as she may become aware, that, through them to the transfer of an animal disease agent or an agent of any other veterinary regulated disease, prospect notwithstanding any other display obligations to inform all of its well-known trade and the district administrative authority without delay.
(3) the district administrative authority must inform the Federal Minister for health in the ways of the Governor.
Duty of disclosure if disease is suspected
§ 17. Each outbreak, as well as any reasonable suspicion for the presence of a notifiable disease in the donor insemination of oocytes and embryos is to show TSG pursuant to § 17 of the persons therein; is notified to the existence of the suspicion on other veterinary regulated diseases of the district administrative authority by these people.
Section 18 (1) is about the message of another State or determined on the basis of movement messages in TRACES that suspicious products contrary to § 16 para 1 to Austria were imported, or spent within the community, the competent district administrative authority has to take immediately following measures without prejudice to any other veterinary provisions:
1. Prohibition of the placing, the tax or the use of the suspicious products.
2. collection of all suspect products, located in authorised institutions and authorised users and users.
3. separation of all suspect products still stored in approved facilities.
4. the suspicious products already applied on the animal, are to inform the affected stockbreeders and livestock farmers and the duty of disclosure by Verwerfensfällen according to the relevant veterinary regulations, as well as on the need for the immediate examination of aborted fruit to draw attention to.
(2) is not removed the suspicion that the products a notifiable animal disease or a pathogen of other veterinary regulated disease can be deported, and there is no possibility of the return of the products, these are under official veterinary supervision disease safe to dispose of.
(3) suspicious products that were already transferred to consumers, are disease safe to dispose of under the authority and under the supervision of the locally competent official veterinarian or the competent local veterinarian.
(4) is determined that in a facility suspicious products were won, prepared, stored, placed on the market or traded, the competent district administrative authority has, if not done so already on the basis of other veterinary provisions, to arrange the measures referred to in paragraphs 1 to 3. The suspect is not eliminated, the suspicious products under official veterinary supervision are disease safe to dispose of.
Good hygiene and bio-security measures
Section 19 (1) the owner or the operator of a licensed facility has to lay down hygiene rules for the operation of the equipment, the manufacture of products and their storage (bio-security measures) and has been proven to bring the operating personnel before starting work.
(2) the operating personnel is proven with regard to appropriate methods of disinfection and hygiene regulations for preventing the import and spreading of diseases, to train in particular notifiable animal diseases and zoonoses, as well as their practical implementation prior to the activity.
(3) the owner or the operator of a licensed facility has to adjust the current state of science bio-security measures, within reasonable period of time proven note to bring this to the operating personnel and proven to train this.
(4) if by the Federal Minister of health guidelines of to good practice for hygiene and bio-security measures have been adopted and published in the "official veterinary news" accredited institutions are obliged to comply.
Section 20 (1) the owner or the operator of a licensed facility has to ensure that the required written records of arrivals and departures is carried by animals, semen, ova and embryos, as well as on the health status of farms of origin and donor animals in accordance with the applicable provisions of annex. The veterinarian responsible for the establishment or the veterinary surgeon responsible for the establishment of has these recordings must be checked regularly.
(2) the records are chronological and under the supervision of the veterinarian responsible for the establishment or of the veterinarian responsible for the establishment for and as long as keep, as semen, ova or embryos of certain donor animals (batch) are stored at least for five years. You are at any time upon request - for any electronic recording in electronic form - free to submit the authority.
Control of other measures
§ 21. Adherence to measures referred to in paragraphs 19 and 20 has to be carried out in the framework of official control in accordance with § 4.
Final and transitional provisions and entry into force
section 22. As far as the European Union (EU) is referenced in this Regulation provisions in legislation, these are to apply in their respectively valid version.
section 23. The date of removal on the delivery note can be omitted, if the production date before entry into force of this regulation.
Entry into force
§ 24. This Regulation shall enter into force October 1, 2012.