Decree No. 125 / 2013 Coll.
Decree amending Decree No 380 / 2003 Coll., on animal health requirements for trade in semen, ova and embryos and on animal health conditions governing their importation from third countries, as amended
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Effective from 01.06.2013
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01.06.2013
27.05.2013
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125
DECLARATION
of 17 May 2013
amending Decree No 380 / 2003 Coll., on animal health requirements governing trade in semen, ova and embryos and on animal health conditions governing their importation from third countries, as amended
The Ministry of Agriculture provides pursuant to § 78 of Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended by Act No. 131 / 2003 Coll., Act No. 316 / 2004 Coll., Act No. 48 / 2006 Coll., Act No. 182 / 2008 Coll., Act No. 227 / 2009 Coll., Act No. 308 / 2011 Coll. and Act No. 359 / 2012 Coll., for the implementation of § 31 (3) (a) and § 34 (5) Act:
Decree No 380 / 2003 Coll., on animal health requirements for trade in semen, ova and embryos and on animal health conditions governing their importation from third countries, as amended by Decree No 155 / 2006 Coll. and Decree No 447 / 2009 Coll., is hereby amended as follows:
1. In Article 1, the words "adapted in accordance with the law of the European Communities (1) 'are replaced by the words" incorporating the relevant provisions of the European Union1) and amended. "
2. In Article 2, at the end of point (o), the dot is replaced by a comma and the following point (p) is added:
"(p) semen storage centre - approved and controlled establishment or other establishment in the territory of the Member State or third country in which the semen of the ovine, caprine or equine species is stored."
3. in Articles 3 (1) (b), 6 (b) and 9 (a) and (b), the words "health status" shall be replaced by the words "health status."
4. In Article 3 (1) (d), the words "on a form issued by the State Veterinary Administration in accordance with the model of this document provided for in these cases by the Commission of the European Community (hereinafter referred to as" the form corresponding to the model laid down ')' are replaced by the words "in accordance with the model laid down by European Union rules'.
5. In Article 4 (2), the words "the Commission of the European Community 'are replaced by the words" the European Commission'.
6. in Sections 4 (2) and 4 (3), 7 (2) and (3), 10 (2) and (3), 13 (2) and (3), 24 (1) and 25, the words "State Veterinary Administration" are replaced by the words "Central Veterinary Administration";
7. in Articles 6 (d), 9 (d), 12 (d) and 14 (1) (d), the words "on a form corresponding to the model laid down" shall be replaced by "in accordance with the model laid down by European Union rules."
8. in Article 12 (a), the words "or at the semen storage centre" shall be inserted after the words "semen collection centre."
9. In Article 13 (1), the words "and semen storage centres' shall be inserted after the words" semen collection centres'.
10. In Article 13 (2), the words "or semen storage centre 'shall be inserted after the words" semen collection centre'.
11. in Article 13 (3), the words "and semen storage centres" shall be inserted after the words "semen collection centres."
12. in Article 14 (1), the words "or produced by an approved embryo production team" shall be added at the end of the text of point (a); the conditions for approval of the embryo collection team and embryo production team are set out in Part A of Annex 9 to this Regulation. ';
13. in Article 15 (1) (a), the words "the territories of the Member States (hereinafter referred to as" the territory of the Community ")" shall read "the territories of the Member States (hereinafter referred to as" the territory of the European Union ")."
14. in Articles 15 (1) (b), 16 (1) (a) and (b), 17 (1) (a), 19 (1) (a) and 23 (2), the word "Community" shall be replaced by "European Union."
15. in Articles 15 (2) (c), 16 (2) (c), 17 (2) (c) and 19 (1) (c), the words "on a form corresponding to the model laid down" shall be replaced by "in accordance with the model laid down by European Union rules."
16. in Paragraph 18 (2), "Annex No 1" is replaced by "Annex No 7";
17. in Article 19 (2), the words "collection of embryos and embryo collection teams" shall be replaced by "collection of semen or semen storage centres, embryo collection teams or embryo production teams."
18. in Articles 23 (2) and 27 (2), the words "the European Communities" shall be replaced by the words "the European Union."
19. Article 26 shall be deleted;
20. In Paragraph 27 (2), the words "in accordance with Paragraph 48 (1) (o) (2) of the Act 'are deleted.
21. in Annex No 1 (B) (f) (i), second and third indents, Annex No 2 (B) (3), Annex No 3 (3) and Annex No 8 (1) (a), the word "Community" is replaced by the words "European Union."
22. in Annex 1, Section B (f), the words "except for disposable instruments" shall be added at the end of the text (iii).
23. In Annex 1 (B) (f), at the end of the text (v), the words "except disposable containers' shall be added.
24. in Annex 1, Section B (f) (viii), the words "semen collection centres referred to in point 2" shall be replaced by "semen banks."
25. In Annex 2 (A) (1) (d) to the introductory part of the provision, the word "examination 'is replaced by" examination'.
26. In Annex 3, the title is replaced by the following: "VETERINARY REQUIREMENTS FOR SPERMA GOODS INTENDED FOR TRADE WITHIN THE EUROPEAN UNION OR IMPORTED INTO THE EUROPEAN UNION '.
27. Annexes 5 and 6 shall read as follows:
"Annex No 5 to Decree No 380 / 2003 Coll.
VETERINARY REQUIREMENTS FOR SWINE GRANTED TO THE MIDDLE FOR THE COLLECTION OF SWINE SPREMATE AND THEIR INVESTIGATION
A
Requirements for pigs entering semen collection centres
(1) All animals entering the semen collection centre must:
(a) be subjected to isolation for at least 30 days in an establishment approved for that purpose by the Regional Veterinary Administration and in which only animals of at least the same health status are present;
(b) be selected from herds or holdings before entering the isolation referred to in (a);
1. which are free from brucellosis in accordance with the Chapter on porcine brucellosis of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE),
2. in which no animal vaccinated against foot-and-mouth disease has occurred during the previous 12 months,
3. in which no clinical, serological, virological or pathological evidence of Aujeszky's disease has been detected in the previous 12 months,
4. which are not located in an area with restrictions defined in accordance with Decree No. 299 / 2003 Coll., Decree No. 389 / 2004 Coll. or Decree No. 202 / 2004 Coll. due to the occurrence of disease in pigs.
The animals should not have been kept in any herd with a lower health status than that described in points 1 to 4;
(c) undergo the following tests with negative results within 30 days prior to entry into the isolation provided for under (a), carried out in accordance with the standards laid down or mentioned in the relevant European Union legislation:
1. as regards brucellosis, buffered brucellosis antigen (Bengal red test) or cELISA or iELISA;
2. as regards Aujeszky's disease,
2.1. In the case of non-vaccinated animals, ELISA tests to detect antibodies to the whole Aujeszky's disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) or to a sero-neutralisation test,
2.2. In the case of animals vaccinated with gE deleted vaccine, an ELISA test to detect antibodies to the Aujeszky's disease virus glycoprotein E (ADV-gE);
3. as regards classical swine fever, an antibody ELISA or a sero-neutralisation test.
If an animal has responded positively to the brucellosis test referred to in point 1, animals that have reacted negatively shall not be taken into isolation from the same holding until the status of the herd or of the holding of origin of the animals with positive results as brucellosis-free has been confirmed.
The Regional Veterinary Administration may allow the tests referred to in this point to be carried out in isolation if the results are known before the start of the isolation provided for in point (a).
As regards Aujeszky's disease, serological tests carried out in accordance with this decree must comply with the standards set out in Annex 3 to Decree No 382 / 2003 Coll.;
(d) be subjected to the following tests carried out on samples taken during the last 15 days of isolation provided for in (a):
1. as regards brucellosis, buffered brucellosis antigen (Bengal red test) or cELISA or iELISA;
2. as regards Aujeszky's disease,
2.1. In the case of non-vaccinated animals, ELISA tests to detect antibodies to the whole Aujeszky's disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) or to a sero-neutralisation test,
2.2. In the case of animals vaccinated with gE deleted vaccine, an ELISA test to detect antibodies to Aujeszky's disease virus glycoprotein E (ADV-gE).
If an animal responds positively to the brucellosis test referred to in point 1 and is not suspected of being brucellosis in accordance with point (e), the animal must be immediately removed from isolation.
If an animal responds positively to the Aujeszky's disease test referred to in point 2, the animal must be immediately removed from isolation.
In case of isolation of a group of animals, the Regional Veterinary Administration shall take all necessary measures to ensure that the remaining animals which reacted negatively in the tests referred to in points 1 and 2 have satisfactory health status before being admitted to the semen collection centre in accordance with this Annex to the Ordinance;
(e) measures taken in the event of suspected brucellosis:
As regards animals that have responded positively to the brucellosis test referred to in point (d) (1), the following procedure shall apply:
1. positive sera shall be subjected to at least one of the alternative tests referred to in point (d) (1) which was not carried out on the samples referred to in point (d);
2. an epidemiological inquiry shall be carried out on the holding of origin of the responding animals;
3. for animals that have responded positively to the tests referred to in (d) (1) and (1), at least one of the following tests shall be carried out on samples taken at least seven days after the sampling referred to in (d):
3.1. Brucelosis test with buffered Brucella antigen (Bengal red test),
3.2. Serumagglutination test,
3.3. complement fixation test,
3.4. CELISA,
3.5. iELISA.
Suspected of being brucellosis shall be excluded if:
(i) either the re-examination referred to in point 1 was carried out with a negative result, the epidemiological inquiry on the holding of origin did not reveal the presence of porcine brucellosis and the examination referred to in point 3 was carried out with a negative result; or
(ii) the epidemiological inquiry at the holding of origin has not revealed the presence of porcine brucellosis and all animals that have responded positively to the examination referred to in points 1 or 3 have been subjected to post-mortem and post-mortem tests to determine the agent of porcine brucellosis in both cases with negative results.
After the suspicion of brucellosis is ruled out, all animals from isolation may be listed in the letters. (d) in the second subparagraph, admitted to the semen collection centre.
(2) All tests must be carried out in an approved laboratory.
(3) Animals may be admitted to the semen collection centre only with the express authorisation of the veterinarian of the centre. All movements of animals to and from the centre shall be recorded.
(4) No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission; without prejudice to the provisions of paragraph 5, all animals shall come directly from the isolation referred to in paragraph 1 (a) which on the day of dispatch fulfilled the following conditions:
(a) it was not located in an area with a restriction defined in accordance with Decree No. 299 / 2003 Coll., Decree No. 389 / 2004 Coll. or Decree No. 202 / 2004 Coll. due to the occurrence of disease in pigs;
(b) there has been no clinical, serological, virological or pathological evidence of Aujeszky's disease in the last 30 days.
(5) Provided that the conditions laid down in paragraph 4 are fulfilled and that the routine tests referred to in Part B have been carried out during the previous 12 months, the animals may be moved from one approved semen collection centre to another with an equivalent health status without isolation or testing in the case of direct transfer. The animal concerned must not come into direct or indirect contact with biungulates of lower health status and the means of transport used must be cleaned and disinfected before use.
(6) For the purposes of paragraph 5 and in the case of trade between Member States, the animals shall be accompanied by a health certificate for breeding pigs in accordance with the model laid down in European Union rules.
B
Compulsory routine tests for pigs in semen collection centres
(1) Mandatory routine tests must be carried out as follows:
(a) all animals kept at an approved semen collection centre shall undergo the following tests with negative results:
1. as regards brucellosis, buffered brucellosis antigen (Bengal red test) or cELISA or iELISA;
2. as regards Aujeszky's disease,
2.1. In the case of non-vaccinated animals, ELISA tests to detect antibodies to the whole Aujeszky's disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) or to a sero-neutralisation test,
2.2. In the case of animals vaccinated with gE deleted vaccine, an ELISA test to detect antibodies to the Aujeszky's disease virus glycoprotein E (ADV-gE);
3. as regards classical swine fever, an antibody ELISA or a sero-neutralisation test;
(b) the tests provided for in (a) shall be carried out on samples taken:
1. from all animals immediately prior to leaving the semen collection centre or immediately upon arrival at the slaughterhouse and in any case no later than 12 months after the date of admission to the semen collection centre; or
2. every three months from at least 25% of the animals at the semen collection centre and the veterinarian of the semen collection centre shall ensure that the animals sampled represent all the population of the centre, in particular as regards age groups and housing;
(c) where tests are carried out in accordance with point (b) (2), the veterinarian of the semen collection centre shall ensure that all animals are examined in accordance with point (a) at least once during their stay at the semen collection centre and at least once every 12 months from the date of acceptance, if they exceed 12 months.
(2) All tests must be carried out in an approved laboratory.
(3) If one of the above tests is positive, the animal must be quarantined and the semen collected from it during the period since the last negative test must not be the subject of trade in the European Union.
The semen of each animal in the centre which has been collected since the last negative test shall be kept separately and shall not be the subject of trade in the European Union until the health status of the centre has been restored by the Regional Veterinary Administration.
Příloha č. 6
Annex No 6 to Decree No 380 / 2003 Coll.
VETERINARY REQUIREMENTS FOR SPERM OF SWINE CARRIED OUT IN THE SPERMATE SECTOR AND INTENDED FOR TRADE IN EUROPEAN UNION
(1) Semen must be obtained from animals which:
(a) show no clinical signs of disease on the day of collection of the semen;
(b) are not vaccinated against foot-and-mouth disease;
(c) meet the requirements set out in Part A of Annex 5 to this Decree;
(d) are not used for natural breeding;
(e) are kept in semen collection centres which must not be located in an area restricted under Decree No. 299 / 2003 Coll., Decree No. 389 / 2004 Coll. or Decree No. 202 / 2004 Coll. due to the presence of a disease in pigs;
(f) are kept in semen collection centres where no clinical, serological, virological or pathological signs of Aujessky's disease have been recorded within 30 days immediately prior to collection.
(2) An effective combination of antibiotics, particularly against leptospira, must be added to the diluent or to the semen after final dilution. In the case of frozen semen, antibiotics must be added before freezing.
(a) the effectiveness of this combination of antibiotics shall be at least equivalent to the following concentration in final dilution of the semen:
at least: 500 μg streptomycin per ml of final dilution,
500 MJ penicillin per ml final dilution,
150 μg lincomycin per ml final dilution,
300 μg spectinomycin per ml final dilution;
(b) immediately after the addition of antibiotics, the diluted semen must be stored at a temperature of at least 15 ° C for at least 45 minutes.
(3) The semen intended for intra-Union trade must be:
(a) until dispatch, stored under the conditions laid down in Part A (2) (d) and Part B (6) (a), (b), (e) and (f) of Annex 4 thereto;
(b) transported to the Member State of destination in containers which have been cleaned and disinfected or sterilised before use and which have been sealed before dispatch from the approved storage place.
(4) The State Veterinary Administration may refuse to accept semen from semen collection centres in the Czech Republic to which boars vaccinated against Aujeszky's disease are admitted. '
28. in Annex 7, Section A (g), first indent, Section B (1) (o), fourth indent, and in the last subparagraph of Section B (1) (o), the word "oocytes" is replaced by "egg cells."
29. In the second indent of point (g) of Section A of Annex 7, the words "oocytes, seed 'are replaced by the words" egg cells, semen' and the words "semen 'are replaced by the words" semen'.
30. In Annex 7, Section A, point (h), "oocytes' is replaced by" egg cells'.
31. in Annex 7, Section B (1) (q), "oocytes" is replaced by "egg cells."
32. In Annex No 7, Section B (2), the word "semen 'is replaced by" semen'.
33. In Annex No 8, paragraph 3, the words "oocytes by capturing egg cells' are replaced by the words" oocytes by rinsing '.
34. Annex 9 reads as follows:
"Annex 9 to Decree No 380 / 2003 Coll.
CONDITIONS FOR THE APPROVAL OF THE SEARCH FOR THE SAMPLING OF SPERMATE OF FRUIT, COOKS OR LEATHER, CULTURE OF SPERMATE OF FRUIT, COOKS OR HORSE, OF THE EMBRY OF FRUIT, OF FRUIT, OF FRUIT, OF FRUIT OR OF HORSE, OF FRUIT AND OF FRUIT, OF FRUIT, OF FRUIT OR OF HORSE, OF FRUIT AND OF FRUIT, OF FRUIT OR OF FRUIT, OF FRUIT, OF FRUIT, OF FRUIT OR OF FRUIT, OF FRUIT, OF FRUIT OR OF FRUIT, OF FRUIT, OF FRUIT, OF FRUIT, OF FRUIT AND OF FRUIT
A
Conditions for approval and surveillance of a semen collection centre for ovine, caprine or equine animals, a semen storage centre for ovine, caprine or equine animals, an embryo collection team for ovine, caprine, porcine or equine animals and an embryo production team for ovine, caprine, porcine or equine animals
I. Conditions for approval of semen collection centres and semen storage centres
semen collection centre
(1) The semen collection centre must be under the supervision of the veterinarian of the centre.
(2) The semen collection centre must have at least:
(a) lockable storage facilities and, where necessary, a separation for equidae, physically separated from the semen collection facility and from the rooms for its treatment and storage;
(b) an establishment for the quarantine of animals without direct connection to normal establishment areas;
(c) a semen collection facility which allows protection against adverse weather effects, with a non-slip floor which protects against serious injuries in the event of a fall at the point of collection of the semen and surrounding area;
(d) a room for cleaning and disinfection or sterilisation of equipment;
(e) a semen treatment room separated from the collection and cleaning facilities referred to in (d), which may not necessarily be in the same place;
(f) a semen storage room which is not necessarily in the same place.
(3) The semen collection centre must be designed or isolated in such a way as to prevent contact with animals from the outside.
(4) The semen collection centre shall be designed in such a way that the whole centre is easily cleaned and disinfected, except in the case of offices and, in the case of equidae, in the case of isolation.
Semen storage centre
(1) The semen storage centre must have a specific registration number for each species the semen of which is stored in the centre, provided that the storage is not restricted to semen of individual species collected in an approved semen collection centre or where embryos are stored in the semen storage centre in accordance with this Decision.
(2) The semen storage centre must be under the supervision of the veterinarian of the centre.
(3) The semen storage centre must have a semen storage room, equipped with the necessary semen storage facilities and, where appropriate, embryos designed to protect these products and equipment against adverse environmental and weather effects.
(4) The semen storage centre shall be so constructed as to prevent contact with economic or other animals from the outside.
(5) The semen storage centre shall be designed in such a way that the whole centre is easily cleaned and disinfected, except in the case of offices and, in the case of equidae, in the case of isolation.
(6) The semen storage centre must be designed in such a way as to effectively avoid access by unauthorised persons.
II. Conditions for surveillance at the semen collection centre and semen storage centre
semen collection centre
(1) The semen collection centre must be supervised in such a way that:
(a) it is ensured that only animals of the species whose semen is collected are present at the centre.
However, other animals may be accepted if they do not pose any risk of disease to animals of the species from which the semen is collected and if they satisfy the conditions laid down by the veterinarian of the centre.
Where, in the case of equidae, the collection centre shares a place with an artificial insemination or admission centre, the mare, stallion and stallion designated for natural breeding shall be accepted if they comply with the requirements of Part B, Section I, paragraphs 1 to 4;
(b) unauthorised persons are prevented from entering. Where a visit is authorised, it may be accepted only under the conditions laid down by the veterinarian of the Centre;
(c) have only been employed by personnel with basic knowledge in the care of animals and have been adequately trained on matters of disinfection and hygiene procedures to prevent the spread of diseases.
(2) Monitoring at the semen collection centre shall ensure that:
(a) keeping records to identify:
1. species, breed, date of birth and identification of each animal present at the centre;
2. any movement of animals entering and leaving the centre;
3. medical history and any diagnostic tests and their results, treatment and vaccination carried out in kept animals;
4. the date of collection and treatment of the semen;
5. the destination of the semen,
6. storage of semen;
(b) that no animal kept in the centre for at least 30 days prior to the first semen collection and during the collection period is used for natural breeding;
(c) that the collection, treatment and storage of semen are carried out only in premises reserved for that purpose;
(d) that all instruments which come into contact with semen or donor animals during the collection or treatment of the semen are either properly disinfected or sterilised prior to use, with the exception of new, one-off and after use, if, in the case of equidae, the collection centre shares a place where artificial insemination or acceptance is carried out, semen and instruments and equipment for artificial insemination or natural breeding must be consistently separated from the instruments and equipment coming into contact with donor animals or other animals kept in the collection centre;
(e) that products of animal origin used in the treatment of semen such as diluents, additives or fillers do not present any animal health hazard or are treated before use in such a way as to avoid such danger;
(f) that the freezing mixtures used for the preservation or storage of semen are not previously used for other products of animal origin;
(g) that storage and transport containers are properly disinfected or sterilised before each filling, except for new, disposable containers and after disposal;
(h) to ensure a clear indication of each single batch of semen or of each ejaculate of fresh semen intended for further processing, enabling the date of collection, species, breed and identification of the donor animal and the veterinary approval number of the approved centre which collected the semen.
(3) The semen collection centre shall be inspected by an official veterinarian during the acceptance period at least once a year in the case of seasonal reproduction animals and twice a year in the case of non-seasonal reproduction in order to assess and verify all matters relating to the conditions of approval and surveillance, on the basis of records, standard operating procedures and internal audits as appropriate.
Semen storage centre
(1) The semen storage centre must be supervised in such a way that:
(a) it has been ensured that the health status of the donor animals whose semen is stored in the centre complies with the requirements of this Decree;
(b) unauthorised persons are prevented from entering. Where a visit is authorised, it may be accepted only under the conditions laid down by the veterinarian of the Centre;
(c) have been employed only by staff with basic knowledge in the care of animals and have been adequately trained on matters of disinfection and hygiene procedures to prevent the spread of diseases;
(d) it is ensured that records are kept of all movements of semen received and leaving the storage centre.
(2) In the semen storage centre, monitoring shall ensure that:
(a) only semen which has been collected and originated from an approved semen collection centre or an approved semen storage centre has been admitted to an approved storage centre, has been transported under conditions which guarantee all animal health guarantees and has not come into contact with semen not complying with the conditions of this order;
(b) the semen has been stored under strict hygiene conditions only in premises reserved for that purpose;
(c) any instruments which come into contact with the semen have been properly disinfected or sterilised before use, except for disposable instruments;
(d) storage and transport containers have been properly disinfected or sterilised before each filling, except for disposable containers;
(e) freezer mixtures used for the preservation or storage of semen have not previously been used for other products of animal origin;
(f) each batch of semen is clearly marked in such a way that the date of collection, species, breed and identification of the donor animal and the veterinary approval number of the approved centre can be easily determined.
(3) By way of derogation from paragraph 2 (a), the semen storage centre may store embryos provided that the embryos comply with the requirements of this Order and are stored in separate containers.
(4) The semen storage centre shall ensure that the semen storage centre is checked by an official veterinarian at least twice each calendar year in order to analyse and verify all aspects relating to the conditions for approval, surveillance and monitoring, on the basis of records, standard operating procedures and internal audits as appropriate.
III. Conditions for approval and supervision of embryo collection teams and embryo production teams
embryo collection team
(1) The collection, treatment and storage of embryos shall be carried out either by the veterinarian of the team or under his responsibility by one or more competent technicians, by the veterinarian trained in hygiene methods and techniques, and in disease control techniques and principles.
(2) The veterinarian of the team shall be responsible for all activities of the team, i.e., inter alia:
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Regulation Information
| Citation | Decree No. 125 / 2013 Coll., amending Decree No. 380 / 2003 Coll., on animal health requirements for trade in semen, ova and embryos and on animal health conditions governing their importation from third countries, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.05.2013 |
|---|---|
| Effective from | 01.06.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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