S.I. No. 259/1993 - European Communities (Trade in Bovine Breeding Animals, Their Semen, Ova and Embryos) Regulations, 1993.

S.I. No. 259 of 1993.

EUROPEAN COMMUNITIES (TRADE IN BOVINE BREEDING ANIMALS, THEIR SEMEN, OVA AND EMBRYOS) REGULATIONS, 1993.

I, JOE WALSH, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive No. 77/504/EEC of 25 July 1977⁽¹⁾ (as amended by Council Directive 91/174/EEC of 25 March 1991⁽²⁾), Commission Decision 84/247/EEC of 27 April 1984⁽³⁾, Commission Decision 84/419/EEC of 19 July 1984⁽⁴⁾, Commission Decision 86/130/EEC of 11 March 1986⁽⁵⁾, Commission Decision 86/404/EEC of 29 July 1986⁽⁶⁾, Council Directive 87/328/EEC of 18 June 1987⁽⁷⁾, Commission Decision 88/124/EEC of 21 January 1988⁽⁸⁾, Council Directive 88/407/EEC of 14 June 1988⁽⁹⁾, (as amended by Council Directive 90/120/EEC of 5 March 1990⁽¹⁰⁾) and Council Directive 89/556/EEC of 25 September 1989⁽¹¹⁾, hereby make the following regulations:

⁽¹⁾ OJ No. L206, 12.8.77, p.8

⁽²⁾ OJ No. L85, 5.4.91, p.37

⁽³⁾ OJ No. L124, 12.5.84, p.58

⁽⁴⁾ OJ No. L206, 5.9.84 p. 12

⁽⁵⁾ OJ No. L101, 17.4.86 p.37

⁽⁶⁾ OJ No. L233, 20.8.86 p.19

⁽⁷⁾ OJ No. L167, 26.6.87 p.54

⁽⁸⁾ OJ No. L62, 8.3.88 p.32

⁽⁹⁾ OJ No. L194, 22.7.88 p. 10

⁽¹⁰⁾ OJ No. L71, 17.3.90 p.37

⁽¹¹⁾ OJ No. L302, 19.10.89, p. 1

PART I Preliminary

1 Citation.

1. These Regulations may be cited as the European Communities (Trade in Bovine Breeding Animals, their Semen, Ova and Embryos) Regulations, 1993.

2 Interpretation

2. (1) In these Regulations, save where the context otherwise requires—

"animal health certificate" means a certificate in which the health status of animals, semen, ova or embryos is certified for the purposes of these Regulations by an official veterinarian issuing the certificate;

"approval" means an approval granted under Regulation 6 by the Minister or a competent authority designated under Regulation 5 for the purposes of these Regulations and the Directives and Decisions;

"approved" means approved by the Minister or a competent authority designated under Regulation 5 for the purpose of these Regulations and the Directives and Decisions;

"approved for breeding" means breeding animals or the semen, ova and embryos of such animals approved for breeding;

"approved laboratory" means a laboratory approved to carry out the analytical or diagnostic tests required under these Regulations;

"application for approval" means an application to the Minister or a competent authority designated under Regulation 5 in respect of an approval in relation to any of the matters specified in Regulation 6 (2) for the purposes of these Regulations and the Directives and Decisions;

"authorised officer" means a person appointed by the Minister to be an authorised officer under Regulation 24 or an officer of Customs and Excise;

"breeding animal" means a bovine animal used for breeding;

"breeders' organisation or association" means a breeders' organisation or association which establishes and maintains a herd book for pure-bred breeding animals;

"centre veterinarian" means a veterinarian responsible for the day-to-day supervision of a semen collection centre;

"collection of semen" means a quantity of semen taken from a donor animal at any one time;

"consignment of embryos" means a quantity of embryos removed in one operation from a single donor animal, and covered by the appropriate animal health and zootechnical certificates;

"consignment of semen" means a quantity of semen from a donor animal, which is accompanied by the appropriate animal health and zootechnical certificate;

"Council Directive 64/432/EEC" means Council Directive 64/432/EEC of 26 June, 1964⁽¹²⁾;

⁽¹²⁾ OJ No. L121 of 29.7.64 p.1.

"Council Directive 88/407/EEC" means Council Directive 88/407/EEC of 14 June, 1988⁽⁹⁾;

"the Directives and Decisions" means Council Directive No. 77/504/EEC of 25 July 1977⁽¹⁾ (as amended by Council Directive 91/174/EEC of 25 March 1991⁽²⁾), Commission Decision 84/247/EEC of 27 April 1984⁽³⁾, Commission Decision 84/419/EEC of 19 July 1984⁽⁴⁾, Commission Decision 86/130/EEC of 11 March 1986⁽⁵⁾, Commission Decision 86/404/EEC of 29 July 1986⁽⁶⁾, Council Directive 87/328/EEC of 18 June 1987⁽⁷⁾, Commission Decision 88/124/EEC of 21 January 1988⁽⁸⁾, Council Directive 88/407/EEC of 14 June 1988⁽⁹⁾, (as amended by Council Directive 90/120/EEC of 5 March 1990⁽¹⁰⁾), and Council Directive 89/556/EEC of 25 September 1989⁽¹¹⁾ or any one or more of those Directives and Decisions as the case may be;

"embryo" means an ovum that has been fertilised and is in the initial stage of development while it is suitable for being transferred to a recipient bovine dam;

"herd book" means any book, register, file or data medium—

( a ) which is maintained by a breeders' organisation or association, and

( b ) in which pure-bred breeding animals are entered or registered with mention of their ancestors;

"intra-Community trade" means trade between Member States;

"Member State" means a Member State of the European Communities;

"the Minister" means the Minister for Agriculture, Food and Forestry;

"official veterinarian" means a registered veterinary surgeon, within the meaning of section 1 of the Veterinary Surgeons Act, 1931 (No. 36 of 1931), appointed by the Minister for the purposes of these Regulations;

"officer of Customs and Excise" has the same meaning as in the Customs Act, 1956 (No. 7 of 1956);

"ova/embryo collection centre" means an establishment in which ova or embryos (or both) from breeding animals are collected for use in artificial insemination;

"ova/embryo collection team" means a group of technicians supervised by a team veterinarian, approved to perform the collection, processing and storage of ova or embryos of breeding animals;

"pure-bred breeding animal" means a pure-bred breeding animal entered in the main section of a herd book whose parents and grandparents are entered in a herd book of the same breed;

"semen" means the prepared or diluted ejaculate of a breeding animal;

"semen collection centre" means an establishment in which semen from breeding animals is collected from bulls for use in artificial insemination;

"team veterinarian" means the veterinarian responsible for the supervision of an ova/embryo collection team;

"testing or genetic evaluation" means the testing or genetic evaluation of breeding animals for the purpose of assessing their genetic merit for the purposes of these Regulations and the Directives and Decisions;

"third country" means a country or territory which is not a Member State;

"trade" includes domestic trade and imports and exports;

"working day" means any day other than—

( a ) Saturday or Sunday, or

( b ) a public holiday within the meaning of the Holidays (Employees) Act, 1973 (No. 25 of 1973);

"zootechnical certificate" means a certificate giving the identity, ancestry, blood type, and performance or progeny test results as required by these Regulations issued by a person designated by the Minister.

(2) A word or expression that is used in these Regulations and is also used in the Directives and Decisions has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directives and Decisions.

(3) In these Regulations, unless otherwise indicated—

( a ) a reference to a Regulation or a Schedule is to a Regulation of, or a Schedule to, these Regulations,

( b ) a reference to a paragraph or a subparagraph is a reference to a paragraph or subparagraph of the Regulation or Schedule in which the reference occurs.

3 Scope of Regulations.

3. These Regulations apply to trade in, and approval for breeding of, breeding animals, their semen, ova and embryos.

4 Competent Authority.

4. For the purposes of these Regulations and the Directives and Decisions the Minister shall be the competent authority in the State.

5 Designation of other competent authorities

5. (1) Notwithstanding Regulation 4, the Minister may designate any other person, for such period as he sees fit and specifies in the designation, also to be a competent authority, subject to any limitations or conditions as he decides, to grant approvals in relation to any or all of the matters referred to in these Regulations.

(2) The Minister may at any time revoke a designation made under this Regulation.

(3) Where the Minister makes or revokes a designation made under this Regulation the designation or the revocation shall be published in Iris Oifigiúil and in at least 2 daily newspapers published and circulating in the State.

PART II Approvals

6 ..

6. (1) Subject to these Regulations, the Minister may grant an approval to a person for the purposes of these Regulations and the Directives and Decisions in relation to any of the matters specified in paragraph (2) if he is satisfied that the Directives and Decisions will be complied with.

(2) An approval may be granted by the Minister in respect of—

( a ) a breeders' organisation or association in accordance with Regulation 7,

( b ) a laboratory to carry out the blood typing, analytical or diagnostic tests in accordance with Regulation 8,

( c ) the testing or genetic evaluation or both of breeding animals in accordance with Regulation 9,

( d ) a centre veterinarian in accordance with Regulation 10,

( e ) a semen collection centre in accordance with Regulation 11,

( f ) an ova/embryo collection centre or an ova/embryo collection team in accordance with Regulation 12,

( g ) breeding animals, semen, ova and embryos for breeding purposes in accordance with Regulation 13,

( h ) a scientific and educational research programme involving trade in semen, ova or embryos in accordance with Regulation 14.

(3) An application for approval shall—

( a ) be submitted in writing by the applicant to the Minister,

( b ) be legible and state the name and address of the applicant and where the applicant is a body corporate its principal place of business,

( c ) be accompanied by the fee determined in accordance with Regulation 25, and

( d ) be addressed to—

The Officer in Charge,

Livestock Breeding Division (Cattle),

Department of Agriculture, Food and Forestry,

Farnham Street,

Cavan,

or to such other person or address as the Minister may direct and as published in at least 2 daily newspapers published and circulating in the State.

(4) The Minister may, upon receipt of an application for approval, require such information from the applicant as he considers necessary for him to ensure that the Directives and Decisions will be complied with and to decide whether or not to grant the approval.

(5) A person who in making an application for approval wilfully makes a false or misleading statement shall be guilty of an offence.

(6) An approval with any conditions attached thereto, shall be in writing and signed by an officer of the Minister.

(7) An approval shall be valid for such period as the Minister may determine.

(8) The Minister may attach any condition (including a condition as to the keeping of appropriate records) to an approval at the time it is granted or at any time subsequently and he may amend or revoke a condition attached to the approval and shall notify the person who has applied for or holds an approval in writing of the conditions, amendment or revocation, as the case may be, in relation to that approval; and in relation to any approval, compliance with the relevant provisions of the Directives and Decisions and of these Regulations shall be a condition of such approval.

(9) The Minister may, if he is not satisfied that the relevant provisions of the Directives and Decisions and of these Regulations are being or will be complied with, refuse an application for approval or revoke an approval and shall notify the owner or person in charge of the establishment concerned in writing of the refusal or revocation.

(10) The Minister shall not—

( a ) revoke an approval, or

( b ) refuse an application for approval, or

( c ) amend a condition to an approval,

without—

( d ) notifying the holder of, or applicant for, the approval of his intention to revoke the approval or refuse the application, or amend the condition, as the case may be,

( e ) specifying his reasons for the intended revocation or refusal of the approval, or amendment of the condition, and

( f ) affording the holder of, or applicant for, the approval the opportunity of making representations or having representations made on his behalf to the Minister in relation to the proposed revocation or refusal or amendment of the condition, as the case may be, within 14 days of the receipt by that person of the notification referred to in subparagraph (d) and having had regard to any such representations.

(11) The holder of an approval shall inform the Minister if significant changes are made in the operation or organisation of the activities to which the approval relates.

(12) A person who contravenes an approval or a condition of an approval shall be guilty of an offence.

(13) In this Regulation a reference to the Minister shall be construed as including a reference to any competent authority under Regulation 5.

7 Breeders' Organisations and Associations.

7. (1) A person shall not carry on the activities or any of the activities of a breeders' organisation or association or hold himself out as carrying on such activities unless he is the holder of an approval in respect of such breeders' organisation or association.

(2) An approval in respect of a breeders' organisation or association shall only be granted provided that:

( a ) the applicant for the approval has met the conditions specified in Schedule A, and

( b ) the approval does not endanger the preservation of the breed or jeopardise the zootechnical programme of existing breeders' organisations or associations for the same breed.

(3) The entry of animals in herd books maintained by breeders' organisations or associations shall be in accordance with the conditions specified in Schedule B.

(4) Breeders' organisations or associations shall not refuse the entry into their herd books of pure-bred breeding animals from herd books approved by the competent authorities in other Member States provided such animals comply with the veterinary and zootechnical requirements specified in Regulation 20.

(5) Breeders' organisations or associations shall not have entry standards higher than those applicable to purebred animals produced by natural service for entry into their herd books of pure bred breeding animals which are the result of using semen or embryos which comply with the veterinary and zootechnical requirements specified in Regulation 20 and have been approved for breeding in accordance with Regulation 13.

(6) Breeders' organisations or associations approved by the competent authorities in other Member States or in third countries which meet the conditions specified in Schedules A and B and which maintain herd books for pure bred breeding animals shall be deemed to be approved.

8 Approved Laboratory

8. (1) A laboratory designated by the Minister which in the opinion of the Minister is suitably qualified immediately before the commencement of these Regulations, shall be deemed to be approved to carry out blood typing, analytical or diagnostic tests for the purposes of these Regulations and the Directives and Decisions.

(2) A person shall not carry out or cause to be carried out blood typing, analytical or diagnostic tests for the purposes of these Regulations and the Directives and Decisions save in a laboratory approved or deemed to be approved.

9 Testing or Genetic Evaluation Programme

9. (1) A person who is not the holder of an approval in respect of testing or genetic evaluation programmes shall not purport to be the holder of such an approval.

(2) The holder of an approval to carry out testing or genetic evaluation of breeding animals for the purpose of these Regulations and the Directives and Decisions shall comply with the conditions specified in Part I of Schedule C, and shall comply with the preformance monitoring methods and the methods used for assessing the genetic merit of breeding animals for the traits concerned which are specified in Part II of Schedule C.

10 Centre Veterinarian

10. (1) A person shall not be employed or engaged as, or operate or represent himself to be, a centre veterinarian unless he is the holder of an approval relating to the centre at which he is so employed or engaged, or so operates, or so represents himself, as the case may be.

(2) An approval in respect of a centre veterinarian shall only be granted to a person who in the opinion of the Minister is suitably qualified and has the appropriate expertise.

(3) An approval shall be limited to the centre named in the application.

11 Semen Collection Centres

11. (1) A person shall not engage in the activities of a semen collection centre unless he is the holder of an approval in respect of that centre.

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

( a ) the conditions for the approval of semen collection centres as specified in Schedule D,

( b ) the conditions relating to the supervision of approved semen collection centres as specified in Schedule E,

( c ) the conditions applying to the movement of animals into approved semen collection centres as specified in Schedule F,

( d ) the routine tests and treatment which shall be applied to all bovine animals in an approved semen collection centre as specified in Schedule G, and

( e ) any analysis required under Schedules D to G to be carried out in approved laboratories.

(3) An approved semen collection centre shall be assigned a veterinary registration number and be recorded in a register maintained by the Minister.

(4) Notwithstanding this Regulation, the holder of a licence issued under section 7 of the Live Stock (Artificial Insemination) Act, 1947 , may continue to collect, process and store bovine semen and to trade in the State until 31 December, 1994; provided that after that date any such holder of a licence shall apply for approval in respect of the semen collection centre.

12 Ova/Embryo Collection Team.

12. (1) A person shall not carry on the activities or any of the activities of an ova/embryo collection team except under and in accordance with an approval.

(2) The holder of an approval in respect of an ova/embryo collection team and every member of his ova/embryo collection team the subject of such approval shall comply with the following conditions:

( a ) the conditions for the approval of an embryo collection team as specified in Schedule H,

( b ) the conditions relating to the collection, processing, storage and transport of embryos as specified in Schedule I, and

( c ) the conditions applying to donor animals specified in Schedule J.

(3) Each approved ova/embryo collection team shall be registered with the Minister and shall be given a veterinary registration number.

13 Breeding animals, semen, ova and embryos for breeding purposes

13. A person shall not use—

( a ) a breeding animal for breeding purposes unless the animal complies with the conditions specified in Part I of Schedule Q,

( b ) semen for artificial insemination or fertilisation unless such semen has been approved pursuant to an application for such approval made in accordance with Part II (1) of Schedule Q and complies with the applicable conditions specified in part II (2) of Schedule Q, or

( c ) ova or embryos of breeding animals for breeding purposes unless such ova or embryos (as the case may be) comply with the conditions specified in Part III of Schedule Q.

14 Scientific and Educational Research Programme

14. (1) A person shall not carry out a specific and educational research programme involving trade in semen, ova or embryos except in accordance with an approval.

(2) Notwithstanding paragraph (1), these Regulations shall not apply to Teagasc or an approved scientific and educational institution or a university in the State carrying out a research programme involving semen, ova or embryos of breeding animals which, in the opinion of the Minister, does not involve trade in these products.

(3) An approval in respect of a scientific and research programme involving trade shall be limited to the duration of the programme.

15 Offence

15. A person who contravenes any provision of this Part shall be guilty of an offence.

PART III Trade

16 ..

16. A person shall not trade in pure-bred breeding animals or in semen, ova and embryo of breeding animals except under and in accordance with these Regulations.

17 ..

17. The consignee in the State of pure-bred breeding animals, semen, ova or embryos which are to be imported into the State shall report at least 2 working days in advance of such importation to an officer of the Minister at—

Livestock Breeding Division (Cattle),

Department of Agriculture, Food and Forestry,

Farnham Street,

Cavan.

or to such other person or address as the Minister may direct and as published in at least two daily newspapers published and circulating in the State, stating—

( a ) the nature of the consignment and giving any details required by an officer of the Minister,

( b ) the name and address of the establishment to which it is being consigned,

( c ) the anticipated arrival date, and

( d ) in the case of third country imports, their point of entry into the State.

18 ..

18. Imports of breeding animals, semen, ova, or embryos from third countries may only enter the State at approved entry points.

19 ..

19. Semen, ova, or embryos which are imported into the State, may only be consigned to approved semen or ova/embryo collection centres, as appropriate.

20 ..

20. A person shall not trade in pure-bred breeding animals, semen, ova or embryos unless, such animals, semen, ova or embryos are approved for breeding and the following veterinary and zootechnical requirements in relation to trade in the State or with another Member State or with a third country (as the case may be) are complied with:

( a ) Animals

Pure-bred breeding animals shall:—

(i) meet the veterinary requirements specified in the European Communities (Diseases of Animals Acts, 1966 and 1979, Orders) (General Authorisations for Imports) Regulations, 1985 ( S.I. No. 365 of 1985 ),

(ii) in relation to exports to other Member States, meet the animal health conditions specified in Council Directive 64/432/EEC, as amended,

(iii) in relation to imports from and exports to another Member State or third country be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule K,

(iv) in the case of imports from third countries be accompanied by proof that the animal is either entered or is eligible for entry in a herd book of a Member State.

( b ) Semen

(i) Semen of breeding animals shall—

(I) be collected, processed and stored in an approved semen collection centre as specified in Schedules D, E, F and G,

(II) meet the conditions specified in Schedule N,

(III) be accompanied by an animal health certificate as specified in Schedule O,

(IV) be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule L,

(V) in the case of importation into the state of bovine semen giving a negative reaction to a test specified in paragraph 1 (e) (iv) of Schedule F or showing a positive result after vaccination in accordance with Council Directive 88/407/EEC, be permitted entry into the State, on or before such date as may be determined by the Council of the European Communities,

(VI) in the case of the importation into the State of bovine semen before such date giving a positive reaction to a test specified in paragraph 1 (e) (iv) of Schedule F and not having been vaccinated in accordance with Council Directive 88/407/EEC be prohibited entry into the State unless each collection passes an examination by inoculation into a live animal or a virus isolation test (or both), and

(VII) in the case of importation into the State of bovine semen from a Member State which practices vaccination against food and mouth disease, be subject to a virus isolation test for foot and mouth disease in an approved laboratory in respect of 10 per cent. of the semen from each collection intended for trade (with a minimum of 5 straws) and if the result of such a test is positive, importation of the semen shall be refused and a person shall not import such semen into the State.

(ii) Semen of breeding animals for importation into the State from a third country shall:

(I) originate in a country which appears on an approved list drawn up by the Commission of the European Communities,

(II) in accordance with Article 9 of Council Directive 88/407/EEC, have been collected at a semen collection centre in that third country which appears on an approved list of collection centres from which Member States may authorise the importation of semen originating in third countries,

(III) be accompanied by an animal health certificate drawn up and signed by an official veterinarian of the third country of collection as required in Article 11 of Council Directive 88/407/EEC,

(IV) be accompanied by a zootechnical certificate conforming with the model or the alternative specified in Schedule L, and

(V) in the case of semen imported from third countries, be accompanied by proof that the donor animal is entered or is eligible for entry in a herd book of a Member State.

( c ) Embryos

(i) Embryos of breeding animals shall—

(I) comply with the conditions relating to collection, processing, storage and transport specified in Schedule I,

(II) have been conceived as a result of artificial insemination with semen from a donor sire standing at an approved semen collection centre or as a result of natural service by bulls whose health status complies with Schedule F,

(III) meet the requirements laid down in Schedule J relating to conditions applying to donor animals,

(IV) be accompanied by an animal health certificate as specified in Schedule P,

(V) be accompanied by a zootechnical certificate conforming to the model or alternative specified in Schedule M,

(VI) if there is more than one embryo in a single straw, be accompanied by a certificate to this effect and such embryos shall all have the same parentage,

(VII) in the case of importation of frozen embryos from countries where vaccination against foot and mouth disease is practised,

(A) be obtained from donor animals which come from a holding—

( a ) in which no animal has been vaccinated against foot and mouth disease during the 30 days prior to collection, and

( b ) which is not subject to prohibition or quarantine measures pursuant to Council Directive 64/432/EEC, and

(B) have been stored under approved conditions during a minimum period of 30 days before consignment.

(ii) Embryos of breeding animals for importation into the State from third countries shall—

(I) originate in a country which appears on an approved list drawn up by the Commission of the European Communities and in accordance with Commission Decision 92/471/EEC.

(II) in accordance with Article 8 of Council Directive 89/556/EEC, have been collected by an embryo collection team which appears on an approved list from which Member States may authorise the importation of embryos originating in third countries,

(III) be accompanied by a zootechnical certificate conforming to the model or alternative specified in Schedule M, and

(IV) be accompanied by proof that the donor animals are either entered or eligible for entry in a herd book of a Member State.

If a documentary check reveals that any requirement of this Regulation has not been met, or if for any other reason an officer of the Minister suspects that the animals, semen, ova or embryos may be infected or contaminated by pathogenic organisms, that officer may take the necessary measures, including the storage of such animals, semen, ova or embryos in quarantine, to satisfy himself regarding their actual status.

21 ..

21. The veterinary and zootechnical requirements specified in Regulation 20 shall not apply to consignments of breeding animals or products to which these Regulations apply which arrive in the customs territory of the State and are placed under a customs transit procedure for consignment to a destination situated outside the territory of the European Communities.

22 ..

22. In the case of trade in semen in the State a declaration as specified in Schedule R may be substituted for the zootechnical and veterinary certificates referred to in Regulation 20 (b) above required to accompany semen.

23 ..

23. A person who contravenes any provision of this Part shall be guilty of an offence.

PART IV Other Provisions

24 Powers of Authorised Officers

24. (1) The Minister may appoint in writing such and so many persons as he thinks fit to be authorised officers for the purposes of all or any of the provisions of these Regulations.

(2) Every authorised officer shall be furnished with a warrant of his appointment as an authorised officer stating that he is acting under these Regulations.

(3) An authorised officer, on production of the officer's authorisation, if so required by any person affected, may, for the purposes of these Regulations—

( a ) at all reasonable times enter and search any premises or place, including any land, vehicle, wagon, vessel, aircraft or other means of transport where, he reasonably suspects that any breeding animals or their products or any thing the subject of these Regulations is being used, collected, stored, sold, packaged, transported, imported or exported or any establishment in respect of which an application for any approval under these Regulations has been made to the Minister,

( b ) there or at any other place, carry out such examinations, tests, checks and inspections of the premises or place and any equipment, machinery or plant thereat and any animal, product or thing found thereat as he reasonably considers necessary or expedient for the proposes of his functions under these Regulations,

( c ) take, without payment, such samples of any substance or, if the authorised officer is an official veterinarian, take from any animal a sample, at the premises or place as he may reasonably require for the purposes of such functions and carry out or have carried out on the samples such examination checks and inspections according with any relevant provisions of these Regulations as he considers necessary or expedient for the purposes of such functions,

( d ) require any person at the premises or place or the owner or person in charge thereof and any person employed in connection therewith to give him such information and to produce to him such books, documents and other records within the power or procurement of the person as he may reasonably require for the purpose of such functions,

( e ) examine and take copies of, or extracts from, any such records as aforesaid,

(f ) seize or detain any breeding animals, semen, ova or embryos including any container in which semen, ova or embryos are kept which he reasonably believes have been produced or imported or to be intended for export in contravention of these Regulations,

( g ) if accompanied by a member of the Garda Síochána stop any vehicle which he reasonably suspects to contain any breeding animals, their semen, ova or embryos the subject of these Regulations.

(4) If a judge of the District Court is satisfied by information on oath by an authorised officer that there is reasonable cause for suspecting that—

( a ) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found in any premises,

( b ) there is or was any product or thing the subject of these Regulations in any premises, or

( c ) a document directly or indirectly connected with any product or thing the subject of these Regulations is in the possession or control of a person in any premises,

and such premises or any part thereof consists of a dwelling such judge may issue a search warrant.

(5) A search warrant issued under paragraph (4) shall be expressed and operate to authorise a named authorised officer, accompanied by such authorised officers, members of the Garda Síochána or officers of Customs and Excise as the named officer thinks necessary, at any time or times within one month from the date of issue of the warrant, on production if so requested of the warrant, to enter (if necessary by force) the premises named in the warrant.

(6) A person who obstructs or otherwise interferes with an authorised officer in the performance of his functions under these Regulations or who, in purported compliance with a requirement under subparagraphs (3) (d), gives information to an authorised officer that he knows to be false or misleading in a material respect shall be guilty of an offence.

(7) A person who, with intent to deceive—

( a ) tampers with any breeding animal, product or thing the subject of these Regulations so that a sample of it taken under these Regulations does not accurately represent the aforementioned breeding animal, product, or thing, or

( b ) tampers or interferes with any sample taken under these Regulations, shall be guilty of an offence.

(8) Where an authorised officer finds or comes into possession of any breeding animal, product or thing the subject of these Regulations or any breeding animal, product or thing which he reasonably believes to be evidence of the commission of an offence under these Regulations, he may seize it and detain it for use in evidence in a prosecution for an offence under these Regulations for such period from the date of the seizure as may be reasonable or, if proceedings are commenced in which the breeding animal, product or thing the subject of these Regulations is required for use in evidence, until the conclusion of the proceedings.

(9) An authorised officer may by notice in writing given to the owner or the person who appears to be in charge or control of any breeding animal, product or thing the subject of these Regulations which has been seized and detained in accordance with these Regulations—

( a ) require anything specified in the notice to be done by the person to whom the notice is directed before the breeding animal, product or thing the subject of these Regulations is released by an authorised officer, or

( b ) either—

(i) require the disposal of the breeding animal, product or thing the subject of these Regulations by the person to whom the notice is directed, upon its release by the authorised officer, in the manner specified in the notice and at the expense of the owner, or

(ii) indicate the authorised officer's intention to dispose of the breeding animal, product or thing the subject of these Regulations in a specified manner and at the expense of the owner,

the manner of disposal in either case being such as to prevent the breeding animal, product or thing the subject of these Regulations, being exported, imported or used in contravention of these Regulations, and where a notice under this paragraph requires a specified thing to be done, an authorised officer may retain control of the breeding animal, product or thing the subject of these Regulations to which the notice relates until the requirements of the notice have been complied with.

(10) Where a notice is given under paragraph (9) a person shall not, without the consent of the authorised officer by whom the notice was directed, move, dispose of, interfere with or otherwise deal with the breeding animal, product or thing the subject of these Regulations other than in compliance with the requirements of the notice.

(11) Any person who is aggrieved by a notice under this Regulation may, not later than 21 days after the date of the notice, or such further period (if any) as the District Court may allow, appeal against the notice to the District Court.

(12) Notice of an appeal under paragraph (11) shall be given to the Minister by the person bringing the appeal at least 7 days prior to the hearing of the appeal.

(13) ( a ) Where an appeal is brought under paragraph (11), the District Court shall make such order as it considers just (including an order directing that the breeding animal, product or thing the subject of these Regulations be disposed of, at the expense of the owner, in such manner as it may specify).

( b ) The cost of disposal by an authorised officer under this Regulation or pursuant to an order of the District Court under this Regulation shall be recoverable by the Minister by whom it is incurred as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the breeding animal, product or thing the subject of these Regulations at the time of its seizure and detention under these Regulations.

(14) A notice under this Regulation shall not come into force until—

( a ) in the case where there is an appeal to the District Court against the notice, the appeal and any appeal therefrom has been determined, or

( b ) in any other case, the period during which such an appeal may be brought has expired.

(15) ( a ) The jurisdiction conferred on the District Court by this Regulation shall be exercised by the judge of that court for the time being assigned to the District Court district in which the breeding animal, product or thing that the subject of these Regulations was seized or in which the owner or person then in charge or control thereof ordinarily resides or carries on any profession, business or occupation.

( b ) For the purposes of subparagraph (a) the breeding animal, product or thing the subject of these Regulations shall be deemed to be situated in a district court district as if it is situated on a premises which is situated wholly or partly in such district.

(16) An officer of customs and excise may seize and detain any breeding animal, semen, ova or embryos the subject of these Regulations being exported or imported as respects which he reasonably believes that there is a failure to comply with a provision of these Regulations and may for that purpose open any package containing or suspected by the officer to contain any product or thing the subject of these Regulations.

(17) In this Regulation "thing" includes a substance or a liquid.

25 Fees

25. (1) There may be charged by the Minister such fees in respect of any or all of the applications for approvals, blood typing, analytical or diagnostic tests and testing or genetic evaluations processed or carried out in connection with these Regulations as the Minister, with the consent of the Minister for Finance, from time to time, may determine.

(2) A fee charged under this Regulation shall be payable by the owner or person in charge of the establishment to which the approval relates and the Minister may refuse to grant or may revoke an approval until such fee has been paid.

(3) Fees under this Regulation shall be collected and taken in such manner as the Minister for Finance directs and shall be paid into or disposed of for the benefit of the Exchequer in accordance with the direction of that Minister.

(4) A fee payable under this Regulation may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction.

(5) A fee charged under this Regulation shall not exceed an amount equal to the costs, estimated by the Minister, incurred in respect of any or all of the applications for approvals, blood typing, analytical or diagnostic tests and testing or genetic evaluations processed or carried out in connection with these Regulations.

26 Proceedings for Offences

26. (1) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,000.

(2) An offence under these Regulations may be prosecuted by the Minister.

(3) Where an offence is committed under these Regulations by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.

(4) Where a person is convicted of contravening these Regulations and after conviction of so contravening these Regulations, continues such contravention, he shall be guilty of a further offence on every day on which the contravention continues and for each such offence he shall be liable on summary conviction to a fine not exceeding £200.

SCHEDULE A

Regulation 7.

CONDITIONS FOR APPROVAL OF BREEDERS' ORGANISATIONS AND ASSOCIATIONS

In order to be approved, a breeders' organisation or association shall:

1. Have legal personality in accordance with the legislation in force in the State.

2. Prove to the Minister or another competent authority designated under Regulations 5:

( a ) that it operates efficiently;

( b ) that it can carry out the checks necessary for recording pedigrees;

( c ) that it has a sufficiently large herd to carry out a breed improvement programme or that it has a sufficiently large herd to preserve the breed where this is considered necessary; and

( d ) that it can make use of the livestock performance data necessary for carrying out its breed improvement or preservation programme.

3. Have a set of rules covering:

( a ) the definition of the breed's characteristics;

( b ) the system for identifying animals;

( c ) the system for recording pedigrees;

( d ) the definition of its breeding objectives;

( e ) the systems for making use of livestock performance data;

( f ) the division of the herd-book, if there are different conditions for entering animals or if there are different procedures for classifying the animals entered in the book;

4. Have rules of procedure, adopted in accordance with its articles of association, laying down, in particular, the principle of non-discrimination between the members of the breeders' organisation or association concerned.

SCHEDULE B

Regulation 7.

CONDITIONS FOR ENTERING CATTLE IN HERD-BOOKS

1. To qualify for entry in the main section of the herd-book of its breed an animal shall:

( a ) be descended from parents and grandparents entered in a herd-book of that same breed,

( b ) be identified at birth according to the rules of that herd book, and

( c ) have a pedigree established in accordance with the rules of that herd-book.

2. The main section of a herd-book may be divided into several classes according to the animals' merits. Only cattle meeting the criteria laid down in paragraph 1 may be entered in one of those classes. Where a herd book contains several classes in the main section, an animal from another Member State shall be entered in the class of the book whose criteria it meets.

3. A Breeders' organisation or association may decide that a female, which does not meet the criteria laid down in paragraph 1 may be entered in a supplementary section of that herd-book. In such case the female shall—

( a ) be identified in accordance with the herd-book rules,

( b ) be judged to conform to the breed standard, and

( c ) have a minimum performance criteria as laid down by the herd-book rules.

The requirements mentioned in subparagraphs (b) and (c) of paragraph 3 may be differentiated according to whether the female belongs to the breed although it has no known origin or was obtained from a crossing programme approved by the breeders' organisation or association managing the herd-book.

4. A bovine female whose mother and maternal grandmother are entered in a supplementary section of the herd-book as provided for in paragraph 3 and whose father and two grandfathers are entered in the main section of the herd book in accordance with the criteria laid down in paragraph 1 above, shall be regarded as a pure-bred female and entered in the main section of the herd-book, provided for in paragraph 1.

SCHEDULE C

Regulation 9.

CONDITIONS FOR GRANTING APPROVAL TO CARRY OUT TESTING OR GENETIC EVALUATION

PART I

The person carrying out testing or genetic evaluation—

( a ) shall have adequate resources, facilities and staff, and where necessary commercial industry support, co-operation and involvement to ensure complete, unbiased and accurate evaluations of animals,

( b ) shall ensure that all animals involved in testing or genetic evaluation are properly identified and that complete and accurate records (being open to inspection at all reasonable times by an authorised officer) are kept as required by the Minister or another competent authority designated under Regulation 5,

( c ) shall enable all aspects of the testing or evaluation to be under the effective supervision of the Minister or another competent authority so designated.

PART II

In accordance with Commission Decision 86/130/EEC of 11 March, 1986, the genetic merit of a breeding animal may be calculated using one or a combination of the following methods, and all the data accruing from the test results shall be accessible:

1. Performance Testing

( a ) Performance testing on a station

(i) The name of the person responsible for the station and the name of the competent authority for the calculation and publication of the results shall be given.

(ii) The design of the test and the number of animals involved in it shall be stated.

(iii) The following items shall be clearly stated:

(I) conditions for acceptance into the station,

(II) on farm performance of bulls prior to entry into the station if applicable,

(III) ownership and maximum age of young bulls entering the station at the time of the test and the range of ages of contemporary bulls in the station,

(IV) length of the adaptation period and test period in the station,

(V) type of diet and system of feeding.

(iv) For traits being recorded the minimum traits to be recorded must be liveweight. For beef breeds in addition feed intake and muscle assessment, shall be recorded.

(v) The method used to estimating genetic merit must be unbiased and the results obtained must be directly comparable within the population. The genetic merit of tested bulls shall be stated as a breeding value or contemporary comparison for each trait.

( b ) Performance testing on a farm

A performance test may be carried out outside a station provided that at the end of the test a breeding value can be calculated following established zootechnical principles.

2. Milk recording and assessment of the breeding value of females for milk traits

( a ) Milk yield records used for the assessment of the breeding value of females shall be obtained under an official system of milk recording complying with standards laid down by the International Committee for Animal Recording.

( b ) The name of the body or of the person responsible for the calculation and publication of the results shall be given.

( c ) Milk records used in the determination of the breeding value of females shall:

(i) have a standard length of lactation for calculation purposes of 305 days,

(ii) be adjusted for any important environmental influence by appropriate means.

( d ) The method used for the estimation of genetic merit shall be unbiased. The result shall be expressed as a predicted difference or breeding value with associated accuracy values for all traits concerned and be directly comparable within the population.

( e ) A detailed description of the method used shall be given or referenced. Traits evaluated must be defined, the base reference and standard deviation of the traits must be stated and the date of calculation of the figures shall be given.

3. Progeny Testing

( a ) The name of the person responsible for the testing and the name of the competent authority for the calculation and publication of the results shall be given.

( b ) The genetic merit of the sire shall be calculated by assessing the qualities of a suitable number of its offspring in relation to:

(i) Dairy characteristics:

(A) A detailed description of the progeny test method must be given or referenced.

(B) The daughters should not be selectively procured or selectively treated.

(C) First lactations must be used and later lactations may be used; lactation records used shall have a maximum length of 305 days complying with standards laid down by the International Committee for Animal Recording.

(D) Influences other than the genetic merit of the sire shall be eliminated by appropriate procedures in the determination of its breeding value or predicted differences or predicted transmitting ability.

(E) The quantity and composition of the milk produced and other relevant data shall be included when calculating breeding values.

(F) If data are available concerning fertility and the viability of the progeny they shall be published.

(G) The method used for estimating breeding values or predicted differences must be unbiased and results must be comparable within the population.

(H) Results shall be published in the form of predicted difference or breeding values with associated accuracy values for the main production traits recorded. Traits evaluated shall be defined, the base reference and the standard deviation of the traits shall be stated and the date of calculation of the figures shall be given.

(ii) Beef characteristics:

(I) a detailed description of the progeny test method shall be given or referenced,

(II) the progeny should not be selectively procured or selectively treated,

(III) the following four types of progeny tests are hereby recognised by the Minister:

A. central testing in specialised progeny testing units,

B. planned progeny testing in co-operating commercial beef production units,

C. analysis of data from on-farm recording schemes for pedigree and/or commercial herds. The progeny should be distributed amongst herds in such a way that a valid comparison between bulls is possible,

D. survey type data collected on identified progeny at sale or slaughter premises.

In types A and B animals shall be selected in a random way at a young age, and brought together into contemporary groups balanced with respect to bulls involved. In types C and D all qualifying records shall be used in assessing the breeding value of the bulls.

(IV) bulls for progeny testing shall be used at random in herds from which it is planned to procure progeny for testing,

(V) influences other than genetic merit of the sire shall be eliminated by appropriate procedures in the determination of its breeding value,

(VI) the carcase characteristics (where these are part of a selection programme) and its quality and other relevant data shall be included when calculating breeding values,

(VII) if data are available concerning fertility and the viability of the progeny they shall be published,

(VIII) the method used for estimating breeding values shall be unbiased and results produced shall be comparable within the population,

(IX) results must as far as possible be published in the form of predicted difference or breeding values with associated accuracy values for the main traits recorded. Traits evaluated shall be defined, the base reference and the standard deviation of the traits shall be stated and the date of calculation of the figures shall be given.

SCHEDULE D

Regulation 11.

CONDITIONS FOR THE APPROVAL OF SEMEN COLLECTION CENTRES

1. Semen collection centres shall:

( a ) be placed under the permanent supervision of a centre veterinarian;

( b ) have at least—

(i) animal housing including isolation facilities;

(ii) semen collection facilities including a separate room for the cleaning and disinfection or sterilisation of equipment;

(iii) a semen processing room which need not necessarily be on the same site; and

(iv) a semen storage room which need not necessarily be on the same site;

( c ) be so constructed or isolated that contact with livestock outside is prevented;

( d ) be so constructed that the animal housing and the semen collecting, processing and storage facilities can be readily cleaned and disinfected;

( e ) have isolation accommodation which shall have no direct communication with the normal animal accommodation;

( f ) be so designed that the animal accommodated is physically separated from the semen processing room and both are separated from the semen storage room.

SCHEDULE E

Regulation 11.

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 sterilised 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 7.

2. 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.

3. 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.

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

5. Storage flasks and transport flasks shall be properly disinfected or sterilised before the commencement of each filling operation;

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

7. Each individual dose of semen shall be clearly marked in such a way that the date of collection of the semen and the breed and identification of the donor animal, as well as the name of the centre, which may be in code, can be readily established; the characteristics and form of this marking must be in accordance with that specified by the Minister.

SCHEDULE F

Regulation 11.

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

1. All bovine animals admitted to a semen collection centre shall:

( a ) have been subjected to a period of isolation of at least 30 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 isolation accommodation described in (a) have belonged to herds:

(i) which are officially tuberculosis free;

(ii) which are officially brucellosis free or brucellosis free.

The animals may not previously have been kept in other herds of a lower status;

( c ) have come from a herd free of enzootic bovine leukosis or have been produced by a cow which has been subjected to a serological test for enzootic bovine leukosis with a negative result, not more than 30 days before the animal's admission to the centre.

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

( d ) before the period of isolation specified in (a), and within the previous 30 days, have been subjected to the following tests with negative results:

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

(ii) a serum agglutination test carried out in accordance with the procedure laid down in Annex C to Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per millilitre and in the case of brucellosis free herds a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units);

(iii) a serological test for enzootic bovine leukosis carried out in accordance with the procedure laid down in Annex G to Directive 64/432/EEC.

(iv) a serum neutralisation test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis;

(v) a virus isolation test (fluorescent antibody test or immunoperoxidase test) for bovine viral diarrhoea. In the case of an animal less than 6 months of age the test must be deferred until that age is reached.

However the Minister may give authorisation for the tests referred to in subparagraph (d) to be carried out in the isolation accommodation, provided that the results are known before the commencement of the 30-day isolation period laid down in subparagraph (e);

( e ) during the period of isolation of at least 30 days specified in subparagraph (a) have been subjected to the following tests with negative results:

(i) a serum agglutination test complying with the procedure laid down in Annex C to Directive 64/432/EEC and showing a brucella count lower than 30 IU of agglutination per millilitre and a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units) in the case of animals coming from brucellosis free herds;

(ii) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be carried out;

(iii) a microscopic examination and culture test for trichomonas foetus on a sample of vaginal washings or preputial washings; in the case of female animals a vaginal mucus agglutination test shall be carried out;

(iv) a serum neutralisation test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis;

and have treatment against leptospirosis comprising two injections of streptomycin at an interval of 14 days (25 mg per kilogram of live body weight).

If any of the above tests should prove positive, the animal shall be removed forthwith from the isolation accommodation. In the case of group isolation, it will be necessary to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with this Schedule.

2. All tests must be carried out in an approved laboratory.

3. 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.

4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals shall, without prejudice to paragraph 5, have come from isolation accommodation as referred to in paragraph 1 (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 noticeable in accordance with Annex E to Directive 64/432/EEC.

5. Provided that the conditions laid down in paragraph 4 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 shall not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used shall 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 G

Regulation 11.

ROUTINE TESTS AND TREATMENT 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 shall be subjected at least once a year to the following tests and treatment:

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

( b ) a serum agglutination test for brucellosis, carried out in accordance with the procedure laid down in Annex C to Directive 64/432/EEC, giving a count lower than 30 IU of agglutination per millilitre;

( c ) a serological test for enzootic bovine leukosis, carried out in accordance with the procedure laid down in Annex G to Directive 64/432/EEC, with a negative result;

( d ) for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis, a serum neutralisation test or an Elisa test with a negative result. However, on or before such date as may be determined by the Council of the European Communities

— it is not necessary to carry out these tests on bulls which have already been subjected to such tests and have given a positive result to the serological test carried out in accordance with Directive 88/407/EEC as amended,

— vaccination against these diseases may be practised on seronegative bulls, either with one dose of a temperature-sensitive live vaccine administered intranasally or two doses of an inactivated vaccine separated by an interval of not less than three weeks and not more than 4 weeks; the vaccination must be repeated subsequently at intervals of not more than 6 months.

( e ) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be carried out.

However, bulls which are not used for the production of semen may be exempt from the antibody test or a culture test for campylobacter foetus infection, with the proviso that such bulls may not be re-admitted to semen production until they have been subjected to such a test or culture and given a negative result.

2. All tests must be carried out in an approved laboratory.

3. If any of the above tests should prove positive, the animal shall be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade.

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 re-established.

However, on or before such date as may be determined by the Council of the European Communities

—these provisions shall not apply to sero-positive bulls which, prior to their first vaccination in accordance with Directive 88/407/EEC as amended at the semen collection centre, gave a negative reaction to the serum neutralisation test or the ELISA test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis;

—sero-positive bulls referred to in the second subparagraph of Article 4 (1) of Council Directive 88/407/EEC must be isolated, since their semen may be the subject of intra-Community trade in accordance with the provisions for trade in semen from such bulls under Article 4 (1) of Council Directive 88/407/EEC, second, third, fourth and fifth subparagraphs.

SCHEDULE H

Regulation 12.

CONDITIONS FOR THE APPROVAL OF AN OVA/EMBRYO COLLECTION TEAM

In order to be given approval each embryo collection team must fulfill the following conditions:

( a ) The collection, processing and storage of embryos must be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene.

( b ) The embryo collection team shall be placed under the general supervision and authority of an official veterinarian.

( c ) The embryo collection team shall have at its disposal permanent or mobile laboratory facilities where embryos can be examined, processed and packed, consisting of at least a work surface, a microscope and cryogenic equipment.

( d ) In the case of a permanently sited laboratory, the embryo collection team shall have at its disposal,

(i) a room where embryos can be manipulated which is adjacent to but physically separate from the area used to handle the donor animals during collection, and

(ii) a room or area equipped for cleansing and sterilising instruments and equipment used in embryo collection and manipulation.

( e ) The embryo collection team shall have at its disposal in the case of a mobile laboratory a specially equipped part of the vehicle consisting of two separate sections—

(i) one for the examination and manipulation of embryos which shall be a clean section, and

(ii) the other for accommodating equipment and materials used in contact with the donor animals.

A mobile laboratory shall always have contact with a permanently sited laboratory to ensure the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and manipulation of embryos.

( f ) It is the responsibility of the team veterinarian to ensure the welfare of the breeding female animals concerned. In particular embryo shall only be collected from breeding females to which suitable epidural anaesthesia have been administered which will have effect during the entire process of embryo collection.

SCHEDULE I

Regulation 12.

CONDITIONS RELATING TO THE COLLECTION, PROCESSING, STORAGE AND TRANSPORT OF EMBRYOS BY AN APPROVED EMBRYO COLLECTION TEAM

1. Collection and processing

( a ) Embryos shall be collected and processed by an approved collection team without coming into contact with any other consignment of embryos not meeting the requirements of these Regulations.

( b ) Embryos shall be collected in a place which is isolated from other parts of the premises or holding and which shall be in good repair and easy to cleanse and disinfect.

( c ) Embryos shall be processed (examined, washed, treated and placed in identified and sterile containers) in either a permanent laboratory facility or a mobile laboratory facility, which is not situated in a zone subject to prohibition or quarantine measures.

( d ) All implements which come into contact with the embryos or the donor animal during collection and processing shall be disposable or shall be properly disinfected or sterilised prior to use.

( e ) Products of animal origin used during collection of the embryos and in the transport medium shall be obtained from sources which present no animal health risk or are to be so treated prior to use so that such risk is prevented.

( f ) Storage flasks and transport flasks shall be properly disinfected or sterilised before the commencement of each filling operation.

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

( h ) Each embryo container and the containers in which they are stored and transported shall be clearly code-marked in such a way that the date of collection of the embryos and the breed and identification of the donor sire and donor dam, as well as the registration number of the team can be readily established. The characteristics and form of this marking shall be in accordance with that specified by the Minister.

(i) Each embryo shall be washed at least 10 times in a special fluid for embryos which shall be changed each time and which, unless decided otherwise, shall contain trypsin, in accordance with internationally recognised procedures. Each wash shall be a 100-fold dilution of the previous wash and a sterile micropipette shall be used to transfer the embryo on each occasion.

( j ) After the last wash each embryo shall be subjected to microscopic examination over its entire surface to determine that the 'zona pellucida' is intact and is free from any adherent material.

( k ) Each consignment of embryos that has successfully undergone the examination provided for in subparagraph (j) shall be placed in a sterile container marked in accordance with subparagraph (h) and whichshall be sealed immediately.

(l) Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian and which is subject to regular inspection by an official veterinarian.

( m ) All products in the processing, washing, transportation media must be obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented.

( n ) Each collective team must submit to an approved laboratory specified by the Minister routine samples of flushing fluids, washing fluids, disintegrated embryos, non-fertilised ova etc., resulting from its activities for official examination for bacterial and viral contamination. The procedure for collecting of samples, conducting such examinations, together with the standards to be achieved shall be in accordance with that specified by the Minister. If the standards laid down are not achieved the Minister shall withdraw approval.

( o ) Each collection team must keep a record of its activities in respect of embryo collection during the 12 months before and 12 months after storage including:

(i) the breed, age and identification of the donor animals concerned,

(ii) the place of collection, processing and storage of embryos collected by the team, and

(iii) the identification of the embryos together with details of their destination if known.

2. Storage

Each embryo collection team shall ensure that the embryos are stored at suitable temperatures in premises approved for the purpose by the Minister.

In order to be approved these premises shall:

(i) comprise at least one lockable room intended exclusively for embryo storage;

(ii) be easy to cleanse and disinfect;

(iii) have permanent records of all incoming and outgoing movements of embryos and the final destination of the embryos in particular shall be specified in such records;

(iv) be subject to inspection by the official veterinarian.

The competent authority may authorise the storage of semen that fulfils the requirements of Directive 88/407/EEC in the approved storage premises.

3. Transport

Embryos for trade shall be transported in hygienic conditions in sealed containers from the approved storage premises until their arrival at their destination.

The containers shall be marked in such a way that the number coincides with the number on the animal health certificate.

SCHEDULE J

Regulation 12.

CONDITIONS APPLYING TO DONOR ANIMALS

1. Embryos shall not be collected from animals unless such animals have spent the previous 6 months within the territory of the European Communities or in the third country of collection in a maximum of two different herds, each of which—

( a ) was throughout that period officially tuberculosis free,

( b ) was throughout that period officially brucellosis free or brucellosis free,

( c ) was throughout that period enzootic bovine leukosis free or did not, during the three previous years, show any clinical signs of enzootic bovine leukosis, and

( d ) did not, during the previous year, show any clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis;

2. On the day of embryo collection the donor cow:

( a ) shall be resident in a holding which is not subject to veterinary prohibition or quarantine measures, and

( b ) shall show no clinical signs of disease.

SCHEDULE K

Regulation 20.

ZOOTECHNICAL CERTIFICATE

For trade in pure-bred breeding animals of the bovine species

SCHEDULE L

Regulation 20.

ZOOTECHNICAL CERTIFICATE

For trade in the semen of pure-bred breeding animals

A.

B.

SCHEDULE M

Regulation 20.

ZOOTECHNICAL CERTIFICATE

For trade in embryos of pure-bred breeding animals

SCHEDULE N

Regulation 20

CONDITIONS WHICH SEMEN COLLECTED AT APPROVED CENTRES MUST SATISFY FOR THE PURPOSES OF TRADE

1. Semen must be obtained from animals which:

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

( b ) in the case of semen to be imported—

(i) have not been vaccinated against foot-and-mouth disease; or

(ii) come from a centre where all the animals have been fully protected against types A, O and C;

— and are thus either animals which were not previously vaccinated against foot-and-mouth disease and shall, therefore, have received two doses of inactivated virtus vaccine approved and controlled by the competent authority of the exporting Member State at an interval of not less than 6 weeks and not more than 8 months, or animals which were vaccinated on at least 3 occasions at intervals of not more than one year.

Where vaccination is practised, all animals must receive vaccinations at intervals of not more than 12 months;

( c ) have not been vaccinated against foot-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 collection of the 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, and 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, have been free from those bovine diseases which are compulsorily notifiable in accordance with Annex E to 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 5°C for a period of not less than 45 minutes.

3. Semen shall:

(i) be stored in approved conditions for a minimum period of 30 days prior to dispatch,

(ii) be transported in flasks which have been cleaned and disinfected or sterilised before use and which have been sealed prior to dispatch from the approved storage facilities.

SCHEDULE O

Regulation 20.

ANIMAL HEALTH CERTIFICATION FOR TRADE IN SEMEN

IV. I, the undersigned official veterinarian, certify that:

1. The semen described above was collected, processed and stored under conditions which comply with the standards laid down in Directive 88/407/EEC.

2. The semen described above was sent to the place of loading in a sealed container under conditions which comply with Directive 88/407/EEC.

3. The semen described above was collected in a centre where all bulls gave a negative result to a serum neutralisation test or an Elisa test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis carried out in accordance with Directive 88/407/EEC⁽¹⁾.;

4. The semen described above was collected from bulls:

(i) which gave negative result to a serum neutralisation test or an Elisa test for infectious rhinotracheitis or infectious pustular vulvo-vaginitis carried out in accordance with Directive 88/407/EEC⁽¹⁾; or

(ii) which gave a positive result to the tests referred to at (i) but which had already given a negative reaction to these tests prior to a first vaccination in accordance with the Directive 88/407/EEC⁽¹⁾; or

(ii) which gave a positive result to a serum neutralisation test or an Elisa test for infectious bovine rhinotracheitis or infectious pustular vulvo-vaginitis and have not been vaccinated in accordance with Directive 88/407/EEC⁽¹⁾; and in which case the semen comes from a consignment which has been subjected, with a negative result, to an examination by innoculation or a virus isolation test⁽¹⁾ as referred to in the third subparagraph or Article 4 (1) of Directive 88/407/EEC in laboratory ...⁽²⁾;

5. The semen described above was collected from bulls:

(i) which have not been vaccinated against foot-and-mouth disease⁽¹⁾; or

(ii) which have been vaccinated against foot-and-mouth disease in accordance with Directive 88/407/EEC⁽¹⁾; and in which case the semen comes/does not come⁽¹⁾ from a collection in which 10 per cent. of the semen collected with a view of trade (with a minimum of five straws) has been subjected, with a negative result, to a virus isolation test for foot and mouth disease in laboratory ...^(2).

⁽¹⁾ Delete as necessary.

⁽²⁾ Name of approved laboratory.

SCHEDULE P

Regulation 20

Animal Health Certification for trade in embryos

13 I, the undersigned official veterinarian, certify that:

( a ) the embryos described above were collected, processed and stored under conditions which comply with the standards laid down in Directive No. 89/556/EEC and, where consigned to a Member State which does not vaccinate against foot-and-mouth disease, with the requirements set out in the second indent of Article 4(1) of that Directive;

( b ) the embryos described above were sent to the place of loading in sealed container under conditions which comply with the provision of Directive No. 89/556/EEC.

SCHEDULE Q

Regulation 13

Approval for Breeding

PART I

Breeding Animals:

Breeding animals which comply with the following conditions are approved for breeding:

(1) female breeding animals,

(2) purebred male breeding animals entered in the main section of an approved herd book for natural service,

(3) other male breeding animals for natural service which comply with the following:—

( a ) Control of Bulls for Breeding Act, 1985 ,

( b ) Control of Bulls for Breeding (Permits) Regulations, 1985 ( S.I. No. 333 of 1986 ), and

( c ) Control of Bulls for Breeding (Permits) (Amendment) Regulations, 1990 ( S.I. No. 166 of 1990 ).

PART II

Semen of Breeding Animals for use in artificial insemination/fertilisation:

(1) Applications for approval for breeding of semen of breeding animals shall be accompanied by:—

( a ) a zootechnical certificate in accordance with Schedule L in the case of semen of pure bred breeding animals;

( b ) in the case of semen from other breeding animals the ancestry and zootechnical information similar to that referred to in Schedule L shall be provided. The origin of this information shall be stated and be acceptable to the Minister;

( c ) a declaration that the donor animal is or will be blood typed and that a blood typing certificate will be available from an approved laboratory on request:

( d ) a declaration of known genetic defects in the animal itself or its ancestry;

( e ) in the case of semen for testing and genetic evaluation purposes the name of the holder of an approval in accordance with Regulation 9.

(2) Semen of breeding animals shall comply with the following conditions:—

( a ) Semen for unrestricted use:

The genetic merit of the semen for required traits as specified by the Minister must have been established in accordance with Part II of Schedule C.

( b ) Semen for the testing and genetic evaluation of untested bulls:

Semen from untested breeding animals may only be used for the purpose of testing and genetic evaluation of such breeding animals. The number of inseminations and if necessary the time period for the use of such semen may be specified by the Minister.

( c ) Semen for special breeding purposes:

Notwithstanding paragraph (2) (b) semen from untested breeding animals may be approved for special breeding purposes for use in individual herds at the discretion of the Minister.

In such cases the Minister may attach conditions as he thinks fit to such approvals.

PART III

(1) Ova and embryos of breeding animals which comply with the following are approved for breeding—

( a ) Ova and embryos of pure bred breeding animals;

( b ) Embryos of other breeding animals the result of fertilisation by semen approved for unrestricted use under Part II (2) (a).

SCHEDULE R

Regulation 22

Exemption from accompanying Zootechnical and Veterinary Certification — required under Regulation 20 (b)

Details of semen:

—the following declaration signed by a designated employee of the centre

"The semen referred to above was stored at the above named centre and has been released for supply to the above named consignee"

The above certificate shall accompany delivery of semen to the consignee.

GIVEN under my Official Seal, this 7th day of September, 1993.

JOE WALSH,

Minister for Agriculture, Food and Forestry.

EXPLANATORY NOTE.

These Regulations give legal effect to a number of EC Zootechnical and Veterinary Council Directives and Commission Decisions in the area of trade in and approval for breeding of bovine breeding animals, their semen, ova and embryos.

These Regulations should now, by virtue of the directly applicable rules of Community Law, be considered to be the only regulatory provisions applicable to the matters dealt with by the Regulations and any parallel provisions contained in other domestic legislation are regarded as having been disapplied. These Regulations will be applied by the Minister for Agriculture, Food and Forestry on this basis.

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