STATUTORY INSTRUMENTS.

S.I. No. 499 of 2004 .

EUROPEAN COMMUNITIES (TRADE IN BOVINE BREEDING ANIMALS, THEIR SEMEN, OVA AND EMBRYOS) (AMENDMENT) REGULATIONS 2004.

S.I. No. 499 of 2004 .

EUROPEAN COMMUNITIES (TRADE IN BOVINE BREEDING ANIMALS, THEIR SEMEN, OVA AND EMBRYOS) (AMENDMENT) REGULATIONS 2004.

I, JOE WALSH, Minister for Agriculture and Food, in exercise of the powers conferred on me by section 3 of European Communities Act 1972 (No. 27 of 1972), for the purpose of giving effect to Council Directive No. 77/504/EEC of 25 July 1977¹ , Council Directive 87/328/EEC of 18 June 1987² , Council Directive 88/407/EEC of 14 June 1988³ , Council Directive 89/556/EEC of 25 September 1989⁴ , Council Directive 90/120/EEC of 5 March 1990⁵ , Council Directive 90/425/EEC of 26 June 1990⁶ , Council Directive 91/174/EEC of 25 March 1991⁷ , Council Directive 93/52/EEC of 24 June 1993⁸ , Council Directive 93/60/EEC of 30 June 1993⁹ , Council Directive 94/28/EC of 23 June 1994¹⁰ , Council Directive 2003/43/EC of 26 May 2003¹¹ , Commission Decision 84/247/EEC of 27 April 1984¹² , Commission Decision 84/419/EEC of 19 July 1984¹³ , Commission Decision 86/130/EEC of 11 March 1986¹⁴ , Commission Decision 86/404/EEC of 29 July 1986¹⁵ , Commission Decision 88/124/EEC of 21 January 1988¹⁶ , Commission Decision 94/113/EC of 8 February 1994¹⁷ , Commission Decision 94/515/EC of 27 July 1994¹⁸ , Commission Decision 2002/8/EC of 28 December 2001¹⁹ and Commission Decision 2004/101/EC of 6 January 2004²⁰ hereby make the following regulations:

1.  (1) These Regulations may be cited as the European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) (Amendment) Regulations 2004.

(2)  These Regulations, other than Regulation 2(i), come into operation on 1 July 2004.

(3)  Regulation 2(i) of these Regulations comes into operation on 1 January 2005.

2.  The European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) Regulations 1996 ( S.I. No. 112 of 1996 ) are amended by--

(a) in Regulation 2--

(i)  substituting for the definition of “semen collection centre” the following--

“semen collection centre” means a person in the State approved under Regulation 6(2)(e) or a person outside the State approved under Directives and Decision;”,

(ii) inserting after the definition of “semen collection centre” the following--

“semen storage centre” means a person in the State approved under Regulation 6(2)(ee) or a person outside this State approved under Directives and Decision;”,

(b)  in Regulation 6(2) inserting after subparagraph (e) the following--

“(ee) a semen storage centre in accordance with Regulation 11A”,

(c)  inserting after Regulation 11 the following--

“11A.  (1)  A person shall not engage in an activity of a semen storage centre unless the person is the holder of an approval in respect of that centre.

(2)  The holder of an approval in respect of a semen storage centre shall comply with the following--

(a)  the conditions for the approval of semen storage centres specified in Schedule DD,

(b)  the conditions relating to the supervision of approved semen storage centres specified in Schedule EE.

(3)  An approved semen storage centre shall be assigned an EU approval number and be recorded in a register maintained by the Minister.

(4)  The holder of an approval in respect of a semen storage centre shall cause to be kept at the centre such records as the Minister may reasonably require in relation to animal health as respects semen and deep frozen embryos for a period of 2 years.”,

(d)  In Regulation 20(2), sub-paragraphs (v) and (vi) shall be deleted.

(e)  inserting after Schedule D the Schedule contained in Schedule One to these Regulations,

(f)  substituting Schedule E for the Schedule contained in Schedule Two to these Regulations,

(g)  substituting Schedule F for the Schedule contained in Schedule Three to these Regulations,

(h)  substituting Schedule G for the Schedule contained in Schedule Four to these Regulations,

(i)  substituting Schedule N for the Schedule contained in Schedule Five to these Regulations,

(j)  substituting Schedule O for the Schedule contained in Schedule Six to these Regulations, and

(k)  substituting Schedule R for the Schedule contained in Schedule Seven to these Regulations.

Schedule One

“SCHEDULE DD

CONDITIONS FOR THE APPROVAL OF SEMEN STORAGE CENTRES

1. Semen storage centres shall:

(a)  Be placed under the permanent supervision of a centre veterinarian approved by the Minister

(b)  Be so constructed or isolated that contact with outside livestock is prevented, and

(c)  Be so constructed that the storage facilities can be readily cleaned and disinfected.”

Schedule Two

“SCHEDULE E

CONDITIONS RELATING TO THE SUPERVISION OF SEMEN COLLECTION CENTRES

1. Semen collection centres shall:

(a)  Be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be admitted, provided that they present no risk of infection to those species whose semen is to be collected and they fulfil the conditions laid down by the centre veterinarian;

(b)  Be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried out, giving also information from the disease/health file of each animal;

(c)  Be regularly inspected by an official veterinarian, at least twice a year, at which time standing checks on the conditions of approval and supervision shall be carried out;

(d)  Be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors shall be required to comply with the conditions laid down by the centre veterinarian;

(e)  Employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease; and

(f)  Be so supervised that only semen collected at an approved semen collection centre is processed and stored in approved semen collection centres, without coming into contact with any other consignment of semen. However, semen not collected in an approved collection centre may be processed in approved semen collection centres provided that:

(i) Such semen is produced from bovine animals which fulfil the conditions laid down in paragraph 1 (d)(i), (ii), (iii) and (v) of Schedule F,

(ii) Processing of such semen is carried out with separate equipment or at a different time from semen intended for intra-Community trade, the equipment in the latter case being cleaned and sterlised after such processing,

(iii) Such semen may not be the subject of intra-Community trade and cannot at any time come into contact with or be stored with semen intended for intra-Community trade,

(iv) Such semen is identifiable by a marking different from that provided for in paragraph 8.

2. Deep-frozen embryos may also be stored in approved semen collection centres provided that--

(i) Such storage is authorised by the Minister,

(ii) The embryos meet the requirements on animal health grounds of Council Directive 89/556/EEC, and

(iii) The embryos are stored in separate storage flasks in the premises for storing approved semen.

3. Collection, processing and storage of semen shall take place only on the premises set aside for the purpose and under conditions of the strictest hygiene.

4. All implements which come into contact with semen or the donor animal during collection and processing shall be properly disinfected or sterilised prior to use, except for single-use instruments.

5. Products of animal origin used in the processing of semen, including additives or a diluent, shall be obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented.

6. Storage containers and transport containers shall be properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers.

7. The cryogenic agent used shall not have been previously used for other products of animal origin.

8. Each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the centre can be readily established:

SCHEDULE EE

CONDITIONS RELATING TO THE SUPERVISION OF SEMEN STORAGE CENTRES

Semen storage centres shall:

1. Be so supervised that a record is kept of all movement of semen (in and out of the centre) and of the status of the donor bulls whose semen is stored there, and which must comply with the requirements of Directive 88/407/EEC as amended.

2. Be regularly inspected by an official veterinarian, at least twice a year, in the context of the standing checks on the conditions of approval and supervision.

3. Be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors must be required to comply with the conditions laid down by the centre veterinarian.

4. Employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread of disease.

5. Be so supervised that:

(a)  (i) Only semen collected at collection centres approved in accordance with Directive 88/407/EEC as amended is stored in approved storage centres, without coming into contact with any other semen.

(ii) In addition, only semen coming from an approved collection or storage centre and transported in conditions offering every possible health guarantee, having had no contact with any other semen, may be brought into an approved storage centre.

(iii) Deep frozen embryos may also be stored in approved centres provided that:

--  such storage is authorised by the Minister

--  the embryos meet the requirements of Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-community trade in and importation from third countries of embryos of domestic animals of the bovine species.

--  the embryos are stored in separate storage containers in the premises for storing approved semen.

(b)  (i) storage of semen takes place only on the premises set aside for the purpose and under the strictest conditions of hygiene;

(ii) all instruments which come into contact with the semen are properly disinfected or sterilised prior to use, except for single-use instruments;

(iii) storage containers and transport containers are either properly disinfected or sterilised before the commencement of each filling operation, except for single-use containers.

(iv) the cryogenic agent has not been previously used for other products of animal origin;

(v) each individual dose of semen is clearly marked in such a way that the date of collection of the semen, the breed and identification of the donor animal and the approval number of the collection centre can be readily established; each Member State shall communicate to the Commission and other Member States the characteristics and form of the marking used in its territory.”

Schedule Three

“SCHEDULE F

CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED SEMEN COLLECTION CENTRES

For all bovine animals admitted to a semen collection centre the following requirements shall apply:

(a)  They must have been subjected to a period of quarantine of at least 28 days in accommodation specifically approved for the purpose by the Minister, and where only other cloven-hoofed animals having at least the same health status are present;

(b)  Prior to their stay in the quarantine accommodation described in (a), they must have belonged to a herd which is officially tuberculosis free and officially brucellosis free in accordance with Directive 64/432/EEC. The animals shall not previously have been kept in a herd of a lower status;

(c)  They must come from a herd officially free of enzootic bovine leukosis as defined in Directive 64/432/EEC, or have been produced by dams which have been subjected, with negative results, to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC, after removal of the animals from their dam. In the case of animals derived by embryo transfer, “dam” means the recipient of the embryo;

If this requirement cannot be fulfilled, the semen shall not be the subject of trade until the donor has reached the age of two years and has been tested in accordance with Schedule G.1(c) with a negative result;

(d)  Within the 28 days preceding the period of quarantine specified in (a), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test mentioned at subparagraph (v):

(i) For bovine tuberculosis, an intradermal tuberculin test carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;

(ii) For bovine brucellosis, a serological text carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;

(iii) For enzootic bovine leukosis, a serological test carried out in accordance with the procedure laid down in Annex D (Chapter II) to Directive 64/432/EEC;

(iv) For IBR/IPV, a serological test (whole virus) on a blood sample if the animals do not come from an IBR/IPV free herd as defined in Article 2.3.5.3. of the International Animal Health Code;

(v) For BVD/MD,

--  a virus isolation test or a test for virus antigen, and

--  a serological test to determine the presence or absence of antibodies.

The Minister may give authorisation for the tests referred to in (d) to be carried out on samples collected in the quarantine station. In this case, the period of quarantine referred to in (a) may not commence before the date of sampling. However, should any of the tests listed in (a) prove positive, the animal concerned shall be immediately removed from the isolation unit. In the event of group isolation, the quarantine period referred to in (a) may not commence for the remaining animals until the animal which tested positive has been removed.

(e)  Within the period of quarantine specified in (a), and at least 21 days after being admitted to quarantine (at least seven days after being admitted to quarantine to search for Campylobacter fetus ssp. venerealis and Trichomonas foetus), they have been subjected to the following tests with negative results in each case, except for the BVD/MD antibody test mentioned at subparagraph (iii):

(i) For bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC,

(ii) For IBR/IPV, a serological test (whole virus) on a blood sample; If any animals test positive, these animals shall be removed immediately from the quarantine station and the other animals of the same group shall remain in quarantine and be retested, with negative results, not less than 21 days after removal of the positive animal(s),

(iii) For BVD/MD,

--  A virus isolation test or a test for virus antigen, and

--  A serological test to determine the presence or absence of antibodies. Any animal (seronegative or seropositive) may only be allowed entry to the semen collection facilities if no sero-conversion occurs in animals which tested seronegative before entry into the quarantine station. If sero-conversion occurs, all animals that remain seronegative shall be kept in quarantine over a prolonged time, until there is not more sero-conversion in the group for a period of three weeks. Serologically positive animals may be allowed entry into the semen collection facilities,

(iv) For Campylobacter fetus ssp. venerealis:

--  In the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of artificial vagina washings or preputial specimen;

--  In the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on a sample of articicial vagina washings or preputial specimen,

(v) For Trichomonas foetus:

--  In the case of animals less than six months old or kept since that age in a single sex group prior to quarantine, a single test on a sample of preputial specimen;

--  in the case of animals aged six months or older that could have had contact with females prior to quarantine, a test three times at weekly intervals on sample of preputial specimen,

If any of the above tests is positive, the animal must be removed forthwith from the isolation accommodation. In the case of group isolation, the competent authority must take all necessary measures to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with this Schedule.

(f)  (i) Prior to the initial dispatch of semen from BVD/MD serologically positive bulls, a semen sample from each animal shall be subjected to a virus isolation or virus antigen ELISA test for BVD/MD. In the event of a positive result, the bull shall be removed from the centre and all of its semen destroyed,

(ii) All tests must be carried out in a laboratory approved by the Minister

(iii) Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements both in and out must be recorded.

(iv) No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals must, without prejudice to paragraph (v), have come from the isolation accommodation, as referred to in paragraph (a), which on the day of consignment officially fulfils the following conditions:

(a)  Is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot and mouth disease for at least 30 days,

(b)  Has for at least three months been free from foot and mouth disease and brucellosis,

(c)  Has for at least 30 days been free from those bovine diseases which are compulsorily notifiable in accordance with annex E to Directive 64/432/EEC,

(v)  Provided that the conditions laid down in paragraph (iv) are satisfied and the routine tests referred to in Schedule G have been carried out during the previous 12 months, animals may be transferred from one approved semen collection centre to another of equal health status, without isolation or testing if transfer is direct. The animal in question must not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used must have been disinfected before use. If the movement from one semen collection centre to another takes place between Member States it must take place in accordance with Directive 64/432/EEC.”.

Schedule Four

“SCHEDULE G

ROUTINE TESTS WHICH MUST BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE

1. All bovine animals kept at an approved semen collection centre must be subjected at least once a year to the following tests, with negative results:

(a)  For bovine tuberculosis, an intradermal tuberculin test, carried out in accordance with the procedure laid down in Annex B to Directive 64/432/EEC;

(b)  For bovine brucellosis, a serological test carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC;

(c)  For enzootic bovine leukosis, a serological test carried out in accordance with the procedure described in Annex D (Chapter II) to Directive 64/432/EEC;

(d)  For IBR/IPV, a serological test (whole virus) on a blood sample;

(e)  For BDV/MD, a serological antibody which is applied only to seronegative animals;

Should an animal become serologically positive, every ejaculate of that animal collected since the last negative test shall be either discarded or tested for virus with negative results.

(f)  For Campylobacter fetus ssp. venerealis, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production;

(g)  For Trichomonas foetus, a test on a sample of preputial specimen. Only bulls on semen production or having contact with bulls on semen production need to be tested. Bulls returning to collection after a lay-off of more than six months shall be tested not more than 30 days prior to resuming production.

2. All tests must be carried out in a laboratory approved by the Minister.

3. If any of the above tests is positive, the animal must be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade with the exception, for BVD/MD, of semen from every ejaculate which has been tested BVD/MD virus negative. Semen collected from all other animals at the centre since the date when the positive test was carried out shall be held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has been restored.”.

Schedule Five

“SCHEDULE N

CONDITIONS WHICH SEMEN FOR INTRA-COMMUNITY TRADE OR SEMEN IMPORTED INTO THE COMMUNITY MUST SATISFY

1. Semen must be obtained from animals which:

(a)  show no clinical signs of disease on the day the semen is collected;

(b)   (i) have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection or

(ii) have been vaccinated against foot-and-mouth disease during the 12 months prior to collection, in which case 5% (with a minimum of five straws) of each collection shall be submitted to virus isolation test for foot-and-mouth disease with negative results;

(c)  have not been vaccinated against food-and-mouth disease within 30 days immediately prior to collection;

(d)  have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to the collection of the semen in case of collections of fresh semen;

(e)  are not allowed to serve naturally;

(f)  Are kept in semen collection centres which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection, or, in the case of fresh semen, until the date of dispatch and which are situated in the centre of an area of 10 kilometres radius in which for at least 30 days there has been no case of foot-and-mouth disease.

(g)  have been kept in semen collection centres which, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E (I) to Council Directive 64/432/EEC.

2. Antibiotics as listed below shall be added to produce these concentrations in the final diluted semen:

An alternative combination of antibiotics-with an equivalent effect against campylobacters, leptospires and mycoplasmas may be used. Immediately after their addition the diluted semen shall be kept at a temperature of at least 5C for a period of not less than 45 minutes.

3. Semen for intra-community trade shall:

(i) Be stored in approved conditions for a minimum period of 30 days prior to dispatch. This requirement shall not apply to fresh semen.

(ii) Be transported to the Member State of destination in containers which have been cleaned and disinfected or sterilised before use and which have been sealed and numbered prior to dispatch from the approved storage facilities.”.

Schedule Six

“SCHEDULE O

The following model of certificate is applicable to intra-community trade of semen collected in accordance with Council Directive 88/407/EEC as amended by Directive 2003/43/EC

The following model of certificate is applicable from 1 January 2005 for intra-Community trade in stocks of semen collected, processed and/or stored before 31 December 2004 in accordance with the former conditions of Council Directive 88/407/EEC, and traded after that date in accordance with Article 2(2) of Directive 2003/43/EC.

Schedule Seven

“SCHEDULE R

Exemption from accompanying Zootechnical and Veterinary Certification -- required under Regulation 20(2).

Name and Address of approved

semen collection centre/semen storage centre

Name and Address of Consignee

Details of semen:

“the semen referred to above was stored at the above named semen collection centre/semen storage centre and has been released for supply to the above named consignee”

Signed:

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations implement into national law, insofar as bovine breeding animals are concerned, the provisions of Council Directive 2003/43/EC amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-community trade in and imports of semen of domestic animals of the bovine species.

Copies of the relevant Council Directives and Commission Decisions may be obtained from the Government Publications Sales Office, Molesworth Street, Dublin 2.

¹ O.J. No. L 206, 12.8.77, p.8.

² O.J. No. L 167, 26.6.87, p.54.

³ O.J. No. L 194, 22.7.88, p.10.

⁴ O.J. No. L 302, 19.10.89, p.1.

⁵ O.J. No. L 71, 17.3.90, p.37.

⁶ O.J. No. L 224, 18.8.90, p.29.

⁷ O.J. No. L 85, 5.4.91, p.37.

⁸ O.J. No. L 175, 19.7.93, p.21.

⁹ O.J. No. L 186, 28.7.93, p.28.

¹⁰ O.J. No. L 178, 12.7.94, p.66.

¹¹ O.J. No. L 143, 11.6.03, p.23.

¹² O.J. No. L 125, 12.5.84, p.58.

¹³ O.J. No. L 237, 5.9.84, p.11.

¹⁴ O.J. No. L 101, 17.4.86, p.37.

¹⁵ O.J. No. L 232, 20.8.86, p.19.

¹⁶ O.J. No. L 62, 8.3.88, p.32.

¹⁷ O.J. No. L 53, 24.2.94, p.23.

¹⁸ O.J. No. L 207, 10.8.94, p.30.

¹⁹ O.J. No. L 37, 7.2.02, p.7.

²⁰ O.J. No. L 30, 4.2.04, p.15.

⁽¹⁾ Delete as necessary.

⁽¹⁾ Delete as necessary.

⁽²⁾ Corresponding to the identification of the donor animals and date of collection

⁽³⁾ Name of the laboratory

⁽¹⁾ Delete as necessary

⁽⁴⁾ May be delete for fresh semen

⁽¹⁾ Delete as necessary

⁽¹⁾ Delete as necessary

⁽²⁾ Corresponding to the identification of the donor animals, the breed of the donor animals, the date of collection and the serological status of the donor animal in respect of infectious bovine rhinotracheitis and infectious pustular vulvo-vaginitis.

⁽³⁾ The date of collection must be earlier than 31 December 2004.

⁽¹⁾ Delete as necessary

⁽¹⁾ Delete as necessary

⁽¹⁾ Delete as necessary

⁽⁴⁾ Name of the laboratory.

⁽¹⁾ Delete as necessary

⁽⁵⁾ May be deleted for fresh semen.”.