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SCOTTISH STATUTORY INSTRUMENTS

2007 No. 330
AGRICULTURE
LIVESTOCK INDUSTRIES
The Bovine Semen (Scotland) Regulations 2007

	Made	14th June 2007
	Laid before the Scottish Parliament	15th June 2007
	Coming into force	13th July 2007

The Scottish Ministers make the following Regulations in exercise of the powers conferred by section 10 of the Animal Health and Welfare Act 1984[1] and section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972[2] and of all other powers enabling them to do so.

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

PART 1
General Provisions
Citation, commencement and extent
     1. —(1) These Regulations may be cited as the Bovine Semen (Scotland) Regulations 2007 and shall come into force on 13th July 2007.

    (2) These Regulations extend to Scotland only.

Interpretation
     2. —(1) In these Regulations–

"bovine" includes the species Bubalus bubalis and Bison bison;

"bovine semen centre" means any premises licensed under regulation 4;

"cattle identification regulations" means–

(a) the Cattle Identification (Scotland) Regulations 2007[

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"centre veterinarian" has the meaning given in regulation 5(b);

4

5

"dam", in the case of bovine animals derived from embryo transfer, means the recipient of the embryo;

6

7

"domestic collection centre" has the meaning given in regulation 4(b)(ii);

"domestic storage centre" has the meaning given in regulation 4(c)(ii);

"EC collection centre" has the meaning given in regulation 4(b)(i);

"EC quarantine centre" has the meaning given in regulation 4(a);

"EC storage centre" has the meaning given in regulation 4(c)(i);

"fresh semen" means semen which has not been frozen;

"inspector" means a person authorised in writing by the Scottish Ministers in accordance with section 10(4) of the Animal Health and Welfare Act 1984;

"processing" means one or more of–

"straw" means a receptacle used to contain a single dose of semen;

"teaser animal" means a bovine animal which is used as an aid in the collection of semen;

"unlicensed premises" are premises that do not have a licence under regulation 4; and

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    (2) Unless the context otherwise requires, any expressions used in these Regulations have the same meaning as in the Directive.

    (3) Any reference in these Regulations to anything done in writing or produced in written form includes a reference to an electronic communication, as defined in the Electronic Communications Act 2000[9], which has been recorded and is consequently capable of being reproduced.

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[

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(c) the bovine animal that is inseminated–

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

provided the semen collected is not used for artificial insemination and is not the subject of intra Community trade.

(3) These Regulations do not apply to research authorised under the Animals (Scientific Procedures) Act 1986[11].

(4) These Regulations, in so far as they apply to semen intended for intra Community trade, do not apply to semen collected on or before 31st December 1989.

PART 2
Licensing of bovine semen centres and approval of bovine animals
Licensing of bovine semen centres
4. The Scottish Ministers may grant a licence for the following premises–

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

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 Scottish 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;

(b) protect public or animal health.

Approval of a bovine animal
7. —(1) The Scottish Ministers may approve a bovine animal for use in an EC collection centre, a domestic collection centre, or at unlicensed premises if it has tested negative for–

(a) the tests set out in Schedule 2, paragraph 2(1)(a) to (e), prior to its entry to an EC 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 an EC quarantine centre.

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

    (3) The Scottish Ministers may also approve 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 Scottish 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 of the animal.

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; and

(b) protect public or animal health.

Approval of bovine animals for use at unlicensed premises
10. —(1) The Scottish Ministers may approve the use of a bovine animal for the collection of its semen or for use as a teaser animal at unlicensed premises for a maximum period of 3 months.

(2) The Scottish 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 Scottish Ministers may grant a temporary approval.

(4) Where the Scottish 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 or teaser animal used to collect such semen are confirmed.

Requirement to keep records of bovine animals
13. —(1) This regulation does not apply to an EC 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 on which 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 EC quarantine centres.

    (2) Whenever semen is moved from or to a bovine semen centre or is 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 an EC 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 Scottish 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 an EC quarantine centre are set out in Schedule 2;

(b) of an EC collection centre are set out in Schedule 3;

(c) of an EC storage centre are set out in Schedule 4;

(d) of a domestic collection centre are set out in Schedule 5; and

(e) of a domestic storage centre are set out in Schedule 6.

(2) The duties of the operator of unlicensed premises are set out in Schedule 7.

Taking blood samples and testing for bovine tuberculosis
17. —(1) Taking blood samples for laboratory analysis may only be undertaken by–

(a) a centre veterinarian;

(b) an inspector who is qualified as a veterinary surgeon; or

(c) a person who fulfils the conditions set out in articles 3(2)(a) or 3(2)(b) of the Veterinary Surgery (Blood Sampling) Order 1983[

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(2) Only a veterinary surgeon approved by the Scottish Ministers for that purpose may test for bovine tuberculosis.

Laboratory tests
18. The operator of unlicensed premises or the centre veterinarian must ensure that laboratory tests required under these Regulations are carried out by a laboratory approved by the Scottish Ministers.

PART 4
The collection, processing and storage of semen
Bovine animals from which semen may be collected
19. No person may collect semen from a bovine animal for use in artificial insemination unless the bovine animal–

Places where semen may be collected
20. —(1) No person may collect semen from a bovine animal except at–

(a) an EC collection centre;

(b) a domestic collection centre; or

(c) unlicensed premises,

in accordance with these Regulations.

(2) Such centres or unlicensed premises must–

(a) have been free from foot and mouth disease for at least three months prior to collection of the semen;

(b) be 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 the preceding 30 days; and

(c) have been, for 30 days prior to collection of the semen, free from the bovine diseases listed in Annex E(I) to Directive 64/432/EEC.

Use of teaser animals
21. No person may use a teaser animal to assist in the collection of semen unless it is approved for that purpose by the Scottish Ministers.

Entry of bovine animals to EC quarantine centres, EC collection centres, domestic collection centres or to unlicensed premises
22. —(1) No person may introduce a bovine animal into–

(a) an EC quarantine centre;

(b) an EC collection centre; or

(c) a domestic collection centre,

without the authorisation of the centre veterinarian.

(2) The centre veterinarian may not authorise a bovine animal to enter an EC quarantine centre unless, prior to its entry to the centre, it always belonged to a herd–

(a) officially tuberculosis free; and

(b) officially brucellosis free,

in accordance with Directive 64/432/EEC.

    (3) The centre veterinarian may not authorise a bovine animal to enter an EC collection centre unless the requirements of Part 1 of Schedule 8 are met.

    (4) The centre veterinarian may not authorise a bovine animal to enter a domestic collection centre unless the requirements of Part 1 or 2 of Schedule 8 are met.

    (5) The operator of unlicensed premises may not collect semen from a bovine animal on unlicensed premises unless the requirements of Part 1 or 2 of Schedule 8 are met.

    (6) The centre veterinarian of an EC collection centre or domestic collection centre, or the operator of unlicensed premises, may not admit bovine animals unless on the day of movement the premises of origin–

(a) are 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 the preceding 30 days;

(b) have, for at least the preceding 3 months, been free from foot and mouth disease and brucellosis; and

(c) have, for at least the preceding 30 days, been free from those bovine diseases listed in Annex E(I) to Directive 64/432/EEC.

(7) The centre veterinarian or the operator of unlicensed premises may not authorise the admission of any bovine animal which shows any clinical sign of disease on the day of the proposed admission.

Movement of bovine animals
23. —(1) No person may move a bovine animal to an EC collection centre, a domestic collection centre or to unlicensed premises except–

(a) in means of transport that have been cleansed and disinfected before use in accordance with the Transport of Animals (Cleansing and Disinfection) (Scotland) Regulations 2005[

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(2) No person may move a bovine animal from one collection centre to one in another member State except in accordance with Directive 64/432/EEC.

Processing of semen
24. No person may process semen except at–

(a) an EC collection centre; or

(b) a domestic collection centre.

Instruments for collecting and processing semen
25. No person may–

(a) use any instrument (other than a single use instrument) which comes into contact with semen or with the donor animal during collection or processing unless such instrument has been disinfected or sterilised prior to use; or

(b) re use a single use instrument.

Containers for storing or moving semen
26. No person may store or move semen except in a container used exclusively for that purpose that–

(a) has been disinfected or sterilised prior to use; or

(b) is a single use container that has not been used before.

Storing and moving semen
     27. No person storing or moving semen may allow it to come into contact with material of animal origin (including other germplasm) of a lower health status.

Supply of frozen semen
     28. —(1) This regulation does not apply to the steps necessary to move semen to an EC storage centre or a domestic storage centre.

    (2) No person may supply frozen semen or use it in artificial insemination unless it has been stored–

(a) at an EC storage centre;

(b) at a domestic storage centre; or

(c) in another part of the United Kingdom on premises approved by the competent authority for the storage of bovine semen.

Power of Scottish Ministers to grant exemptions
29. No person may supply or use semen for artificial insemination if that person knows or suspects that it has not been collected, processed or stored–

(a) in accordance with these Regulations;

(b) lawfully in another part of the United Kingdom; or

(c) in the case of semen originating in another member State or in a third country, in accordance with the Directive,

unless the supply or use is authorised by the Scottish Ministers.

Intra-Community trade in semen
30. —(1) No person may supply semen for intra Community trade unless–

(a) it was–

(b) in the case of semen supplied from another member State or imported from a third country in accordance with the Directive, it has been stored at an EC storage centre.

    (2) Any person who supplies semen for intra Community trade must ensure that it is accompanied by the animal health certificate referred to in Articles 3(d) and 6(1) of the Directive.

Duties to keep records of the supply of semen
     31. —(1) This regulation does not apply to the operators of unlicensed premises or to centre veterinarians who are subject to regulation 14.

    (2) Any person who supplies semen must keep a record of the information specified in Schedule 9, paragraph 1.

    (3) Any person who receives semen must keep a record of the information specified in Schedule 9, paragraph 2.

    (4) Any person who uses semen for artificial insemination must keep a record of the information specified in Schedule 9, paragraph 3, in relation to each straw or other receptacle used.

    (5) Any person who destroys semen must keep a record of the information specified in Schedule 9, paragraph 4, in relation to each straw or other receptacle destroyed.

    (6) Any person who is required by this regulation to keep records must ensure that the records are made contemporaneously with the supply, receipt, use or destruction.

    (7) Such records may be in written or electronic form and must be kept for at least two years after the supply, receipt, use, or destruction of the semen, as appropriate.

PART 5
Administration and enforcement
Refusal of an approval or licence
32. If the Scottish Ministers refuse to grant an approval or licence, or grant an approval or licence subject to conditions, they must–

(a) any of the conditions under which it was granted are not fulfilled; or

(b) they are satisfied that the provisions of these Regulations are not being complied with.

(2) A suspension or amendment–

(a) may have immediate effect if the Scottish Ministers consider it necessary for the protection of public or animal health; and

(b) otherwise may not have effect for at least 21 days.

(3) Notification of the suspension or amendment must–

(a) be in writing;

(b) state what it applies to;

(c) state when it comes into effect;

(d) give reasons; and

(e) explain the right of the person who has been notified to request a review of the decision to suspend or amend an approval or licence under regulation 36.

(4) If the suspension or amendment does not have immediate effect or a request for a review is made under regulation 36, it must not have effect until the final determination by the Scottish Ministers of the review unless they consider that it is necessary for the protection of public or animal health for the amendment or suspension to have effect before then.

Revocation of an approval or licence
35. —(1) The Scottish Ministers may revoke an approval or licence granted under these Regulations in whole or in part if–

(a) they have notified their decision to suspend the approval or licence and the period for review under regulation 36 has expired;

(b) they have upheld their decision to suspend following an review under regulation 36;

(c) they have previously suspended the approval or licence and there is further non compliance with these Regulations; or

(d) they are satisfied that the occupier no longer uses the premises for the purpose for which a licence was granted.

(2) Notification of a revocation must–

(a) be in writing;

(b) state what it applies to;

(c) state when it comes into effect;

(d) give reasons; and

(e) in the case of a revocation under paragraph (1)(c) or (1)(d), explain the right of the person who has been notified to request a review of the decision to revoke an approval or licence under regulation 36.

(3) If a person does request a review under regulation 36, the revocation remains in force pending the outcome of the review.

Review
36. —(1) A person may apply in writing to the Scottish Ministers for a review of any decision of the Scottish Ministers concerning–

(a) the grant, refusal, suspension, amendment or revocation of an approval or licence under these Regulations; or

(b) the conditions to which an approval or licence is subject,

within 21 days of notification of the decision to that person.

    (2) On an application under paragraph (1) the Scottish Ministers shall appoint such person as they think fit to consider the decision and make such recommendation (if any) as that person considers appropriate.

    (3) The appointed person may include a member of the staff of the Scottish Administration.

    (4) The applicant and the Scottish Ministers may make written submissions to the appointed person concerning the decision of the Scottish Ministers.

    (5) The appointed person must report in writing to the Scottish Ministers.

    (6) The Scottish Ministers must give to the applicant written notification of their determination of the application for review, and the reasons for it.

Notice prohibiting the use of semen
     37. —(1) If an inspector thinks it necessary for the prevention of the spread of disease, the inspector may serve a notice on the owner of a bovine animal or on anyone the inspector believes to be the owner of the bovine animal or in possession of semen from that bovine animal.

    (2) A notice served under paragraph (1) must–

(a) prohibit the use or trade of semen collected from the bovine animal;

(b) require the destruction of such semen; and

(c) require the identification of any other person who may be in possession of the bovine animal or its semen.

    (3) If a notice served under this regulation is not complied with, an inspector may enter any premises on which the inspector knows or suspects semen, which is the subject of the notice, is kept and may seize the semen and arrange for the requirements of the notice to be met.

Notice concerning illegal consignments
     38. —(1) If an inspector knows or suspects that semen has been imported from another member State in contravention of the Directive, the inspector may serve a notice in accordance with paragraph (2) on the person appearing to the inspector to be in charge of the semen.

    (2) The notice may require that person to–

(a) keep semen at such place as the notice may specify;

(b) destroy semen in accordance with the requirements of the notice; or

(c) take such other action as the inspector may specify.

    (3) If a notice served under this regulation is not complied with, an inspector may enter any premises on which the inspector knows or suspects semen which is the subject of the notice to be kept and may seize the semen and arrange for the requirements of the notice to be met.

Provision of false information
     39. No person shall provide any information or make any statement for the purpose of obtaining an approval or licence under these Regulations which that person knows to be false or misleading.

Examination of bovine semen centres
     40. The Scottish Ministers must examine all bovine semen centres at least twice a year.

Payment of fees
     41. —(1) A fee is payable to the Scottish Ministers, on invoice, for–

(a) an application for an approval of a bovine animal under regulations 7 or 10;

(b) an application for a bovine semen centre licence under regulation 4;

(c) testing of a bovine animal under Part 2 of Schedule 3 and Part 2 of Schedule 5; and

(d) examination of a bovine semen centre under regulation 40.

(2) The fee payable under paragraph (1) is the sum of–

(a) the travel costs of the veterinary officer and any necessary assistant in relation to the relevant application, test or examination;

(b) the costs of officials considering the relevant application, test or examination; and

(c) the costs of laboratory tests on bovine animals.

    (3) The Scottish Ministers shall publish the current fees payable under paragraph (1) on the website of the Scottish Executive[14].

Refund of fees
     42. If an application under these Regulations is withdrawn before its determination, the Scottish Ministers may refund to the applicant all or part of any fee paid under regulation 41 in respect of that application as the Scottish Ministers think fit, having regard to any costs reasonably incurred by them in connection with the application.

Transitional provisions
     43. Licences and approvals granted under the provisions of the Artificial Insemination of Cattle (Animal Health) (Scotland) Regulations 1985[15] listed in the first column of Schedule 10 shall continue to have effect as if they were approvals or licences granted under these Regulations in accordance with the corresponding provisions of these Regulations listed in the second column of that Schedule, provided that, in the case of premises, the premises comply with, and are operated in accordance with, the provisions of these Regulations.

Amendment of the Artificial Insemination (Cattle and Pigs) (Fees) Regulations 1987
     44. In the Artificial Insemination (Cattle and Pigs) (Fees) Regulations 1987[16]–

(c) omit regulation 3(1)(a);

(d) omit regulation 3(1A);

(e) in regulation 4, omit the words "the principal cattle Regulations or"; and

(f) omit Schedule 1.

Revocations
45. —(1) The Regulations in Part 1 of Schedule 11 are revoked insofar as they extend to Scotland.

(2) The Regulations in Part 2 of Schedule 11 are revoked.

RICHARD LOCHHEAD
A member of the Scottish Executive

St Andrew's House, Edinburgh
14th June 2007

SCHEDULE 1Regulation 4

Construction and design of centres

PART 1
EC quarantine centre
The EC quarantine centre must–

PART 2
EC collection centre or domestic collection centre
The EC collection or domestic collection centre must–

(b) be constructed or isolated so that contact with livestock outside the centre is prevented;

(c) be constructed so that the bovine animal housing and the semen collection and processing facilities and the semen quarantine room can be readily cleaned and disinfected; and

(d) be so designed that the bovine animal housing is separated from the processing facilities and both are separated from the semen quarantine room.

PART 3
EC storage centre or domestic storage centre
The EC storage or domestic storage centre must–

SCHEDULE 2Regulations 7 and 16

Duties of the centre veterinarian in EC quarantine centres

1. —(1) The centre veterinarian must make a record of any bovine animals to be admitted that–

(2) The centre veterinarian must pass a copy of any record made under sub paragraph (1) to the centre veterinarian of the collection centre to which the bovine animals move, not later than the date of such move.

2. —(1) The centre veterinarian must ensure that within the 28 days preceding the period of quarantine, the bovine animals are subjected to the following tests, with negative results in each case (except for the BVD/MD antibody test referred to in sub paragraph (1)(e)(ii))–

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

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

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

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

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    (2) If any of the tests listed in sub-paragraph (1)(a) to (e)(i) are carried out on samples collected in the quarantine centre, the period of quarantine may not commence before the date of sampling.

    (3) If any of the tests listed in sub-paragraph (1)(a) to (e)(i) prove positive, the centre veterinarian must ensure that the relevant bovine animal is immediately removed from the quarantine centre.

    (4) In the case of group quarantine, the quarantine period does not commence for the remaining bovine animals until the bovine animal which tested positive has been removed.

     3. —(1) During quarantine, the centre veterinarian must ensure that the bovine animals are tested as follows–

(d) for Trichomonas foetus–

(2) If any bovine animal tests positive following a test under sub paragraph (1), the centre veterinarian must ensure that–

4. —(1) During quarantine, the centre veterinarian must ensure that the bovine animals are tested for BVD/MD as follows–

(2) The centre veterinarian may allow bovine animals to be moved to an EC collection centre or a domestic collection centre only if the serological test finds no seroconversion in any bovine animal which gave a negative result to the serological test under paragraph 2(1)(e)(ii) for BVD/MD antibodies.

(3) If seroconversion occurs in any bovine animal in the quarantine centre, the centre veterinarian must ensure that bovine animals that are seronegative–

(4) The centre veterinarian may allow serologically positive bovine animals to be sent to a semen collection centre after–

5. The centre veterinarian must make a record of those bovine animals that test positive for antibodies for BVD/MD under the serological tests at paragraph 2(1)(e)(ii) or 4(1)(b) and pass a copy of the record to the centre veterinarian of the collection centre to which the bovine animals move, not later than the date of such move.

SCHEDULE 3Regulations 16 and 41

Duties of the centre veterinarian in EC collection centres

PART 1
Records of enzootic bovine leukosis and marking of semen doses
1. —(1) The centre veterinarian must make a record of a bovine animal admitted that–

(2) The centre veterinarian must pass a copy of any record made under sub paragraph (1) to the centre veterinarian of any collection centre to which the bovine animals or their semen may move, not later than the date of such move.

2. The centre veterinarian must ensure that each individual dose of semen collected at the centre is clearly marked in such a way that the following information can be readily established–

PART 2
Routine tests and treatment which must be applied to all bovine animals in EC collection centres
1. —(1) The centre veterinarian must ensure that all bovine animals at the centre are subjected at least once a year to the following tests–

(2) The centre veterinarian must ensure that bovine animals from which semen is being collected and bovine animals having contact with such bovine animals are subjected at least once a year to tests on samples of preputial specimen for–

(3) The centre veterinarian must ensure that bovine animals from which semen is to be collected after an interval of more than six months are tested not more than 30 days prior to collection resuming on samples of preputial specimen for–

(4) Should a bovine animal become serologically positive for BVD/MD, the centre veterinarian shall in respect of every ejaculate of that animal collected between the date of the last negative test (or the date that animal arrived at the centre if the positive result is from the first test carried out there) and the date of the positive test–

(b) where the ejaculate has been supplied to any person, notify that person that it is subject to the requirements of sub-paragraph (4)(a).

    (5) A person given notice under sub-paragraph (4)(b) shall, if the ejaculate is held by or for that person ensure that it is discarded, used or supplied in accordance with sub-paragraph (4)(a).

    (6) Where any person has been supplied with ejaculate, other than from the centre, and that person subsequently supplies that ejaculate to any other person, sub-paragraph (4)(b) shall apply equally to that other person.

     2. —(1) If a test required under paragraph 1 is positive, the centre veterinarian must ensure that–

(c) semen collected from any other bovine animal at the centre since the date of the positive test is–

until the health status of the centre has been restored to the level required by the Directive and these Regulations;

(ii) if supplied to any person, the subject of notice to that person under sub paragraph (2).

(2) Notice shall be given that semen supplied from–

until the health status of the centre has been restored to the level required by the Directive and these Regulations.

    (3) Where any person has been supplied with semen, other than from the centre, and that person subsequently supplies that semen to any other person, sub–paragraph (2) shall apply equally to that other person.

     3. A person given notice under paragraphs 1 and 2 must ensure that semen held by or for that person is kept or supplied in accordance with that notice.

     4. Paragraphs 2 and 3 are subject to the exception that ejaculate from a bovine animal that tested positive under paragraph 1 for BVD/MD may be supplied for intra Community trade if the ejaculate tests negative for BVD/MD.

PART 3
Measures applicable to processing facilities at an EC collection centre
1. The centre veterinarian must ensure that–

(b) any semen referred to at sub paragraph (a)(iii) is–

(c) semen collected, processed and quarantined at EC collection centres and intended for intra Community trade does not come into contact with and is not stored in the same room as any other semen processed at the centre;

(d) products of animal origin used in the processing of semen, including additives and diluents, are obtained from sources which present no animal health risk or are so treated prior to use that such risk is removed;

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

(f) each individual dose of semen is sealed, numbered and clearly marked so that the following information can be readily established–

(g) the format used for identifying semen is notified to the Scottish Ministers.

2. The centre veterinarian may not admit semen not collected at the centre for processing unless it is accompanied by–

3. —(1) Subject to sub paragraph (2), the centre veterinarian must ensure that the antibiotics streptomycin, penicillin, lincomycin and spectinomycin are added to produce the following concentrations in the final diluted semen–

(2) An alternative combination of antibiotics which has an equivalent effect against campylobacters, leptospires and mycoplasmas may be used.

4. The centre veterinarian must ensure that, immediately after the addition of antibiotics, the semen is kept at a temperature of at least 5ºC for a period of not less than 45 minutes.

PART 4
Measures applicable to semen quarantine at an EC collection centre
     1. —(1) Prior to the initial dispatch of semen from bovine animals identified as serologically positive for BVD/MD, the centre veterinarian must ensure that a semen sample from each bovine animal is subjected to a virus isolation or virus antigen ELISA test for the BVD/MD virus.

    (2) In the event of a positive result, the centre veterinarian must ensure that the bovine animal is removed from the collection centre and its semen destroyed.

     2. The centre veterinarian must ensure that frozen semen is kept in the semen quarantine facilities for at least 30 days before it leaves the centre.

     3. The centre veterinarian must not allow any semen to leave the centre unless the premises where it was collected remain clear of–

for 30 days after collection or, in the case of fresh semen, until the date of dispatch of the semen.

4. With regard to a bovine animal that–

the centre veterinarian must not allow its semen to leave the centre until the bovine animal has reached the age of two years and has tested negative for enzootic bovine leukosis, under a serological test carried out in accordance with the procedure described in Annex D (Chapter II) to Directive 64/432/EEC.

5. With regard to a bovine animal vaccinated against foot and mouth more than 30 days before, but within 12 months of, a collection, the centre veterinarian must not allow its semen to leave the centre unless 5% (with a minimum of five straws) of each collection have tested negative to a virus isolation test for foot and mouth disease.

SCHEDULE 4Regulation 16

Duties of the centre veterinarian in EC storage centres

1. Subject to paragraph 2, the centre veterinarian must ensure that–

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

(d) each individual dose of semen is sealed, numbered and clearly marked in such a way that the following information can be readily established–

2. Notwithstanding paragraph 1(a), the centre veterinarian may store deep frozen embryos at the centre if–

(a) such storage is authorised by the Scottish Ministers;

(b) the embryos meet the requirements of Council Directive 89/556/EEC on animal health conditions governing intra Community trade in and importation from third countries of embryos of domestic animals of the bovine species[

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SCHEDULE 5Regulations 16 and 41

Duties of the centre veterinarian in domestic collection centres

PART 1
Records of enzootic bovine leukosis and marking of semen doses
1. —(1) The centre veterinarian must make a record of a bovine animal admitted that–

(2) The centre veterinarian must pass a copy of any record made under sub paragraph (1) to the centre veterinarian of any collection centre to which the bovine animal or semen of that animal may move, not later than the date of such move.

2. The centre veterinarian must ensure that each individual dose of semen collected at the centre is clearly marked in such a way that the following information can be readily established–

PART 2
Routine tests and treatment which must be applied to all bovine animals in domestic collection centres
1. The centre veterinarian must ensure that all bovine animals kept at a domestic collection centre must be subjected at least once a year to the following tests–

2. —(1) If any of the tests in paragraph (1) is positive the centre veterinarian must ensure that–

    (2) Where the semen has been supplied to any person from the centre, the centre veterinarian must notify that person that the semen is subject to the requirements of sub-paragraph (1)(b).

    (3) Any person given notice under sub-paragraph (2) shall, if the semen is held by them, ensure that it is destroyed, held in separate storage or not used or supplied in accordance with sub-paragraph (1)(b).

    (4) Where any person has been supplied with the semen, other than from the centre, and that person subsequently supplies that semen to any other person, paragraph (2) shall apply equally to that other person.

PART 3
Measures applicable to processing at a domestic collection centre
1. The centre veterinarian must ensure that–

(b) semen is not stored with semen of a different health status and semen must be identifiable by a marking different from that used in EC collection or storage centres for semen for intra Community trade;

(c) products of animal origin used in the processing of semen, including additives or dilutents, are obtained from sources which present no animal health risk or are so treated prior to use that such risk is removed;

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

(e) each individual dose of semen is sealed, numbered and clearly marked so that the following information can be readily established–

2. The centre veterinarian may not admit semen not collected at the centre for processing unless it is accompanied by–

3. —(1) Subject to sub paragraph (2), the centre veterinarian must ensure that the antibiotics streptomycin, penicillin, lincomycin and spectinomycin are added to produce the following concentrations in the final diluted semen–

(2) An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and mycoplasms may be used.

4. The centre veterinarian must ensure that, immediately after the addition of antibiotics, the semen is kept at a temperature of at least 5ºC for a period of not less than 45 minutes.

PART 4
Measures applicable to semen quarantine at a domestic collection centre
1. The centre veterinarian must ensure that frozen semen is kept in the semen quarantine unit for at least 30 days before it leaves the centre.

2. The centre veterinarian must not allow any semen to leave the domestic collection centre unless the premises where it was collected remain clear of–

for 30 days after collection or, in the case of fresh semen, until the date of dispatch of the semen.

3. With regard to a bovine animal that–

the centre veterinarian must not allow its semen to leave the centre until the bovine animal has reached the age of two years and has tested negative for enzootic bovine leukosis, under a serological test carried out in accordance with the procedure described in Annex D (Chapter II) to Directive 64/432/EEC.

4. With regard to a bovine animal vaccinated against foot and mouth more than 30 days before, but within 12 months of, a collection, the centre veterinarian must not allow its semen to leave the centre unless 5% (with a minimum of five straws) of each collection have tested negative to a virus isolation test for foot and mouth disease.

SCHEDULE 6Regulation 16

Duties of the centre veterinarian in domestic storage centres

1. Subject to paragraph 2, the centre veterinarian must ensure that–

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

(d) each individual dose of semen is sealed, numbered and clearly marked so that the following information can be readily established–

2. Notwithstanding paragraph 1(a), the centre veterinarian may store deep frozen embryos at the centre provided that–

(a) such storage is authorised by the Scottish Ministers;

(b) the centre meets the requirements of regulations 16, 17 and 18 of the Bovine Embryo (Collection, Production and Transfer) Regulations 1995[

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SCHEDULE 7Regulation 16

Duties of operators of unlicensed premises

1. The operator of unlicensed premises must ensure that–

2. —(1) The operator of unlicensed premises must make a record of a bovine animal to be admitted that–

(2) The operator of unlicensed premises must pass a copy of any record made under sub paragraph (1) to the centre veterinarian of the collection centre to which the bovine animal's semen moves for processing, not later than the date of such move.

SCHEDULE 8Regulations 7 and 22

Movement of bovine animals for semen collection

PART 1
Bovine animals that may move to an EC or domestic collection centre or to unlicensed premises
The bovine animals have–

where only other cloven hoofed animals having at least the same health status were present; or

(b) undergone the tests referred to in Part 2 of Schedule 3 during the previous 12 months and have been kept in–

PART 2
Bovine animals that may move to a domestic collection centre or to unlicensed premises
1. The bovine animals belonged to a herd–

2. The bovine animals have been subjected to the following tests within the 28 days preceding the date of admission to a domestic collection centre or to unlicensed premises, with negative results–

3. As an alternative to paragraphs 1 and 2, the bovine animals have been kept at a domestic collection centre and have undergone the tests referred to in paragraph 2 during the previous 12 months with negative results.

SCHEDULE 9Regulation 31

Information to be recorded

1. The information referred to in regulation 31(2) is–

2. The information referred to in regulation 31(3) is–

3. The information referred to in regulation 31(4) is–

4. The information referred to in regulation 31(5) is–

SCHEDULE 10Regulation 43

Transitional Provisions

Licence and approvals under the Artificial Insemination of Cattle (Animal Health) (Scotland) Regulations 1985	Equivalent approval under these Regulations
Approval for use of a bull (regulation 5)	Approval of a bovine animal (regulation 7)
Processing licence (regulation 7(1)(a))	Processing of semen intended for intra Community trade: licence of an EC collection centre (regulation 4(b)(i)). Processing of semen not intended for intra Community trade: licence of a domestic collection centre (regulation 4(b)(ii)).
Storage licence (regulation 7(1)(b))	Licence of EC storage centre (regulation 4(c)(i)) or licence of domestic storage centre (regulation 4(c)(ii)).

SCHEDULE 11Regulation 45

Revocations

PART 1
Statutory instruments revoked insofar as they extend to Scotland

Instrument	Reference
The Importation of Bovine Semen Regulations 1984	S.I. 1984/1325
The Artificial Insemination of Cattle (Advertising Controls etc.) (Great Britain) Regulations 1987	S.I. 1987/904
The Importation of Bovine Semen (Amendment) Regulations 1993	S.I. 1993/1966

PART 2
Statutory instruments revoked

Instrument	Reference
The Artificial Insemination of Cattle (Animal Health) (Scotland) Regulations 1985	S.I. 1985/1857 (S.138)
The Artificial Insemination of Cattle (Animal Health) (Scotland) Amendment Regulations 1992	S.I. 1992/1192 (S.114)
The Artificial Insemination of Cattle (Animal Health) (Scotland) Amendment Regulations 1995	S.I. 1995/2556 (S.185)
The Artificial Insemination of Cattle (Emergency Licences) (Scotland) Regulations 2001	S.S.I. 2001/179
The Artificial Insemination of Cattle (Animal Health) (Scotland) Amendment Regulations 2002	S.S.I. 2002/191