The Bovine Semen (Wales) Regulations 2008

Made: 7 April 2008

Laid before the National Assembly for Wales: 8 April 2008

Coming into force: 30 April 2008

The Welsh Ministers, in exercise of the powers conferred by section 10 of the Animal Health and Welfare Act 1984 and now vested in them , and with the approval of the Treasury; and in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 , makes the following Regulations.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Welsh Ministers that it is expedient for references to European Community (EC) instruments referred to in regulation 2(1) to be construed as references to those instruments as amended from time to time.

PART 1 — General Provisions

Title, application and commencement

1

The title of these Regulations is the Bovine Semen (Wales) Regulations 2008; they apply in relation to Wales and come into force on 30 April 2008.

Interpretation

2

• (1) In these Regulations—

• “bovine” (“buchol”) includes the species Bubalus bubalis and Bison bison;

• “bovine semen centre” (“canolfan semen buchol”) means premises licensed under regulation 4;

• “cattle identification regulations” (“rheoliadau adnabod gwartheg”) means—the Cattle Identification (Wales) Regulations 2007 ; orCouncil Regulation 1760/2000, as amended from time to time (in the case of bovine animals born outside Wales);

• “the centre veterinarian” (“milfeddyg y ganolfan”) has the meaning given in regulation 5(b);

• “Council Regulation 1760/2000” (“Rheoliad y Cyngor”) means Regulation (EC) No. 1760/2000 of the European Parliament and of the Council establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No. 820/97 , as amended from time to time;

• “dam” (“mam”), in the case of bovine animals derived from embryo transfer, means the recipient of the embryo;

• “the Directive” (“y Gyfarwyddeb”) means Council 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 , as amended from time to time;

• “Directive 64/432/EEC” (“Cyfarwyddeb 64/432/EEC”) means Council Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine , as amended from time to time;

• “domestic collection centre” (“canolfan gasglu ddomestig”) has the meaning given in regulation 4(b)(ii);

• “domestic storage centre” (“canolfan storio ddomestig”) has the meaning given in regulation 4(c)(ii);

• “licensed” (“trwyddedig”) means licensed by the Welsh Ministers;

• “licensed collection centre” (“canolfan gasglu CE”) has the meaning given in regulation 4(b)(i);

• “licensed quarantine centre” (“canolfan gwarantîn CE”) has the meaning given in regulation 4(a);

• “licensed storage centre” (“canolfan storio CE”) has the meaning given in regulation 4(c)(i);

• “fresh semen” (“semen ffres”) means semen which has not been frozen;

• “inspector” (“arolygydd”) means a person authorised in writing by the Welsh Ministers in accordance with section 10(4) of the Animal Health and Welfare Act 1984;

• “processing” (“prosesu”) means one or more of—diluting (except in the course of or immediately after semen collection),adding any substance with the intention of prolonging the natural life of the semen (except in the course of or immediately after semen collection),adding any antibiotic,packing into straws or other appropriate receptacles, andfreezing;

• “straw” (“corsen”) means a receptacle used to contain a single dose of semen;

• “teaser animal” (“anifail ymlid”) means a bovine animal which is used as an aid in the collection of semen;

• “unlicensed premises” (“mangre sydd heb ei thrwyddedu”) are premises that do not have a licence under regulation 4;

• “unlicensed processing premises” (“mangre brosesu sydd heb ei thrwyddedu”) means unlicensed premises—for the processing of semen—collected at unlicensed premises or at a domestic collection centre, andnot intended for trade with a member State, andsupervised by the centre veterinarian of a licensed collection centre;

• “veterinary surgeon” (“milfeddyg”) means a veterinary surgeon or veterinary practitioner registered under the Veterinary Surgeons Act 1966 .

• (2) Expressions that are not defined in these Regulations and are used in the Directive have the same meaning in these Regulations as they have for the purposes of the Directive.

Exceptions

3

• (1) These Regulations do not apply where—

• (a) semen is collected for the purpose of the artificial insemination of a bovine animal with fresh semen;

• (b) the bovine animal from which the semen is collected—

• (i) is not, at the time of collection, affected by an Order made under sections 6(c), 8, 17, 23, 25, 26 or 29 of the Animal Health Act 1981 ; or,

• (ii) is so affected, but the use of its semen is authorised by the Welsh Ministers; and

• (c) when the bovine animal is inseminated—

• (i) it is in the same ownership and the same herd as the bovine animal from which the semen was collected; and

• (ii) it is kept on the same premises as that bovine animal.

• (2) These Regulations do not apply where semen is collected for the purpose of—

• (a) assessing the suitability of a bovine animal for use in breeding;

• (b) diagnosing infection or disease in a bovine animal; or

• (c) education or research,

provided the semen collected is not used for artificial insemination and is not the subject of trade with a member State.

• (3) These Regulations do not apply to research authorised under the Animals (Scientific Procedures) Act 1986 .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Licensing of bovine semen centres and approval of bovine animals

Licensing of bovine semen centres

4

The Welsh Ministers may license premises as follows—

• (a) if they comply with Part 1 of Schedule 1, as premises for the quarantine of bovine animals (a "licensed quarantine centre”);

• (b) if they comply with Part 2 of Schedule 1, either as—

• (i) premises for the collection, processing and quarantine of semen intended for trade with a member State (a "licensed collection centre”); or

• (ii) premises for the collection, processing and quarantine of semen not intended for trade with a member State (a “domestic collection centre”); or

• (c) if they comply with Part 3 of Schedule 1, either as—

• (i) premises for the storage of semen intended for trade with a member State (a "licensed storage centre”); or

• (ii) premises for the storage of semen not intended for trade with a member State (a “domestic storage centre”).

Application for a licence to operate a bovine semen centre

5

An application for a licence to operate a bovine semen centre must—

• (a) be made in writing to the Welsh Ministers;

• (b) be signed by the applicant for the licence and by the veterinary surgeon who will have responsibility for veterinary supervision of the centre (“the centre veterinarian”);

• (c) specify the premises for which an application is made; and

• (d) specify the licence applied for.

Bovine semen centre licence

6

• (1) A bovine semen centre licence granted under regulation 4 must specify—

• (a) the address of the centre;

• (b) the licence number of the centre;

• (c) the licence holder;

• (d) the centre veterinarian;

• (e) the type of licence granted; and

• (f) any conditions to which the licence is subject.

• (2) A licence must be in writing and may be made subject to such conditions as are necessary to—

• (a) ensure that the provisions of these Regulations are complied with; or

• (b) protect public or animal health.

Approval of a bovine animal

7

• (1) The Welsh Ministers may grant an approval for a bovine animal for use in a licensed collection centre, a domestic collection centre, or at unlicensed premises if it has tested negative to—

• (a) the tests set out in Schedule 2, paragraph 2(1)(a) to (e) prior to its entry to a licensed quarantine centre; and

• (b) the tests set out in Schedule 2, paragraph 3(1)(a) to (d) and paragraph 4(1)(a) after its entry to a licensed quarantine centre.

• (2) The Welsh Ministers may approve a bovine animal despite a positive result to the serological tests set out in Schedule 2, paragraph 2(1)(e)(ii) or in Schedule 2, paragraph 4(1)(b) or in both.

• (3) The Welsh Ministers may also grant an approval for a bovine animal for use in a domestic collection centre or at unlicensed premises, if it has tested negative to the tests set out in Part 2 of Schedule 8, paragraphs 2(a) to (c).

Application for approval of a bovine animal

8

Any application for approval of a bovine animal for the purpose of collecting its semen, or for use as a teaser animal, must be made to the Welsh Ministers by or on behalf of its owner and must—

• (a) specify the name and breed of the bovine animal;

• (b) specify the number by which it is identifiable in accordance with the cattle identification regulations; and

• (c) be made in writing and signed by or on behalf of the owner.

Form of approval for a bovine animal

9

• (1) An approval for a bovine animal must specify—

• (a) the name and breed of the bovine animal;

• (b) the number by which it is identifiable in accordance with the cattle identification regulations; and

• (c) any conditions to which the approval is subject.

• (2) An approval must be in writing and may be made subject to such conditions as are necessary to—

• (a) ensure that the provisions of these Regulations are complied with; or

• (b) protect public or animal health.

Approval of bovine animals for use at unlicensed premises

10

• (1) The Welsh Ministers may approve the use of a bovine animal for the collection of its semen ... at unlicensed premises for a maximum period of 3 months.

• (2) The Welsh Ministers may renew an approval under paragraph (1) for subsequent periods of up to 3 months if—

• (a) they receive the application for renewal of the approval in writing and signed by or on behalf the owner, at least 28 days before the date on which it is due to expire; and

• (b) the tests referred to in Part 2 of Schedule 8, paragraph 2(a) to (c) have been conducted again, with negative results, on the bovine animal to which the approval relates, no more than 28 days before the date the approval is due to expire.

• (3) If the results of any of the tests carried out on a bovine animal under paragraph 2(b) will not be available until after its approval is due to expire, the Welsh Ministers may grant a temporary approval.

• (4) Where the Welsh Ministers grant a temporary approval under paragraph (3), no person may trade any semen which has been—

• (a) collected from a bovine animal; or

• (b) processed following such collection,

until negative results to the tests on the bovine animal ... are confirmed.

PART 3 — The operation of a bovine semen centre and collection at unlicensed premises

Entry of persons to bovine semen centres

11

• (1) No person may enter, without lawful authority or reasonable excuse, a bovine semen centre without the authority of the centre veterinarian.

• (2) A person authorised by the centre veterinarian to enter a bovine semen centre must comply with any requirements laid down by the centre veterinarian to ensure compliance with these Regulations.

• (3) The centre veterinarian must ensure that unauthorised persons do not enter the bovine semen centre.

Entry of non-bovine animals to bovine semen centres

12

• (1) No person may introduce a non-bovine animal into a bovine semen centre without the express authorisation of the centre veterinarian.

• (2) The centre veterinarian may authorise the admission of domestic animals of non-bovine species into a bovine semen centre provided—

• (a) they are necessary for the operation of the centre;

• (b) they present no risk of infection to those bovine animals whose semen is to be collected; and

• (c) they fulfil the conditions laid down by the centre veterinarian.

Requirement to keep records of bovine animals

13

• (1) This regulation does not apply to a licensed storage centre or domestic storage centre.

• (2) The centre veterinarian or operator of unlicensed premises must make a record for each bovine animal moved into or out of the centre or premises of—

• (a) its breed;

• (b) its date of birth;

• (c) the number by which it is identifiable in accordance with the cattle identification regulations;

• (d) all vaccinations administered to it;

• (e) the tests it has undergone for diseases and their results; and

• (f) any indication of disease it may have.

• (3) The centre veterinarian or operator of unlicensed premises must ensure that these records are kept for at least two years from the date when the bovine animal leaves the centre or premises, or dies at the centre or premises.

Requirement to keep records of semen

14

• (1) This regulation does not apply to licensed quarantine centres.

• (2) Whenever semen is moved from or to a bovine semen centre or destroyed, the centre veterinarian must record—

• (a) the number by which the donor bovine animal is identifiable in accordance with the cattle identification regulations;

• (b) its health status;

• (c) the number of doses of semen;

• (d) the numbers on the receptacles in which the semen is or was contained (as applicable);

• (e) the date the semen was received, dispatched or destroyed (as applicable);

• (f) the premises, or bovine semen centre, of dispatch (if applicable); and

• (g) the destination (if applicable).

• (3) The operator of unlicensed premises must record the information in paragraphs 2(a) to (g) for semen sent to a licensed collection centre or domestic collection centre for processing.

• (4) The operator of unlicensed premises or the centre veterinarian must ensure that each consignment of semen is accompanied by documents containing the information in paragraphs 2(a) to (g).

• (5) The operator of unlicensed premises or the centre veterinarian must ensure that these records are retained for at least two years after the dispatch, receipt, or destruction of the semen.

General duties of centre veterinarians

15

• (1) The centre veterinarian must ensure that—

• (a) the centre is operated in accordance with these Regulations;

• (b) the conditions of the licence under which the centre operates are observed;

• (c) appropriate standards of hygiene are maintained at the centre to prevent the incursion of disease transmissible by semen; and

• (d) the biosecurity of the centre is maintained to prevent the incursion of disease transmissible by semen.

• (2) The centre veterinarian must ensure that staff at the centre are technically competent and have received appropriate training in disinfection procedures and hygiene techniques.

• (3) The centre veterinarian must ensure that the Welsh Ministers are notified immediately if the result of any test carried out on a bovine animal at the centre for any disease that must be tested for under these Regulations indicates a change in the health status of the bovine animal.

Specific duties of centre veterinarians and operators of unlicensed premises

16

• (1) The duties of the centre veterinarian—

• (a) of a licensed quarantine centre are set out in Schedule 2;

• (b) of a licensed collection centre are set out in Schedule 3;