Statutory Instruments of the Scottish Parliament

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

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

"cattle identification regulations" means–

(a) if they comply with Part 1 of Schedule 1, as premises for the quarantine of bovine animals (an "EC 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 intra Community trade (an "EC collection centre"); or

(ii) premises for the collection, processing and quarantine of semen not intended for intra Community trade (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 intra Community trade (an "EC storage centre"); or

(ii) premises for the storage of semen not intended for intra Community trade (a "domestic storage centre").

(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.

(a) is approved for that purpose by the Scottish Ministers;

(b) is identified in accordance with the cattle identification regulations;

(c) shows no clinical signs of disease on the day the semen is to be collected;

(d) has not been vaccinated against foot and mouth disease within the 30 days preceding the date of collection;

(e) has not been allowed to serve naturally since the date of the application for its approval for semen collection; and

(f) has, where its semen is to be supplied as fresh semen, been kept at an EC collection centre or a domestic collection centre for a continuous period of at least 30 days preceding the date the semen is collected.

(a) give their reasons in writing; and

(b) explain the right of the applicant to request a review of the decision to refuse to grant an approval or licence, or grant an approval or licence subject to conditions under regulation 36.

(a) have bovine animal housing, including isolation facilities that have no direct communication with the normal bovine animal housing;

(b) be constructed so that the bovine animal housing can be readily cleaned and disinfected; and

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

(a) have–


(i) bovine animal housing, including isolation facilities that have no direct communication with the normal bovine animal housing;

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

(iii) facilities where semen may be processed, which need not be on the same site; and

(iv) a semen quarantine room, which need not be on the same site;



(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.

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

(b) have a semen storage room that can be readily cleaned and disinfected.

(a) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC.

    (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) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC.

    (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–

(a) the date the semen was collected;

(b) the identity of the donor bovine animal under the cattle identification regulations;

(c) the breed of the donor bovine animal; and

(d) the licence number of the centre.

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

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

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

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

(e) for BVD/MD, a serological antibody test applied only to seronegative bovine animals.

    (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–

(a) Campylobacter fetus ssp. venerealis; and

(b) Trichomonas foetus.

    (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–

(a) Campylobacter fetus ssp. venerealis; and

(b) Trichomonas foetus.

    (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–

(a) where the ejaculate is held at the centre, ensure that it is–


(i) discarded; or

(ii) used or supplied only if tested for BVD/MD with negative results; or



(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–

(a) the bovine animal is isolated;

(b) semen collected from that animal since 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) is–


(i) if held at the centre, not supplied for intra Community trade; and

(ii) if supplied to any person from the centre, the subject of notice to that person under paragraph 2;



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



(i) if held at the centre–


(aa) kept in separate storage; and

(bb) not supplied for intra Community trade,



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–

(a) the bovine animal that tested positive shall not be supplied for intra-Community trade; or

(b) any other bovine animal at the centre shall be–


(i) kept in separate storage; and

(ii) not supplied for intra Community trade,



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.

(a) semen processed at the centre is–


(i) collected at an EC collection centre;

(ii) collected at a collection centre approved under the Directive in another part of the United Kingdom; or

(iii) from bovine animals which have been subjected to the tests specified in Schedule 2, paragraph 2(1);



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



(i) processed using separate equipment (which must be cleaned and sterilised after use) or at a different time from the processing of semen intended for intra Community trade; and

(ii) identified by a marking different from that required under sub paragraph (f);



(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–



(i) the date the semen was collected;

(ii) the identity of the donor bovine animal under the cattle identification regulations;

(iii) the breed of the donor bovine animal; and

(iv) the licence number of the centre where the semen was collected (if applicable); and



(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–

(a) the documents specified in regulation 14(4); and

(b) if the semen comes from unlicensed premises, the documents specified in Schedule 7, paragraph 1(c).

     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–

(a) not less than 500 µg streptomycin per ml final dilution;

(b) not less than 500 International Units penicillin per ml final dilution;

(c) not less than 150 µg lincomycin per ml final dilution; and

(d) not less than 300 µg spectinomycin per ml final dilution.

    (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.

(a) foot and mouth disease; and

(b) the bovine diseases listed in Annex E(I) to Directive 64/432/EEC,

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–

(a) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC,

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.

(a) only semen is stored at the centre;

(b) semen is only stored at the centre if it has not come into contact with any other semen and–


(i) it has been collected and processed at EC collection centres, or at centres otherwise approved for semen collection under the Directive; or

(ii) following collection and processing at EC collection centres or at centres otherwise approved for semen collection under the Directive, it has been stored at EC storage centres or at centres otherwise approved for semen storage under the Directive;



(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–



(i) the date the semen was collected;

(ii) the identity of the donor bovine animal under the cattle identification regulations;

(iii) the breed of the donor bovine animal; and

(iv) the licence number of the centre where the semen was collected (if applicable).

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

(a) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC.

    (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–

(a) the date the semen was collected;

(b) the identity of the donor bovine animal under the cattle identification regulations;

(c) the breed of the donor bovine animal; and

(d) the licence number of the centre.

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

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

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

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

(a) the bovine animal is isolated; and

(b) where the semen collected from it is held at the centre–


(i) the semen collected from the bovine animal since the last negative test is destroyed;

(ii) semen collected from all other bovine animals at the centre since the date when the positive test was carried out is held in separate storage; and

(iii) such semen is not used or supplied until the health status of the centre has been restored to the level required by the Directive and these Regulations.

    (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.

(a) semen processed at the centre is semen collected–


(i) at an EC collection centre;

(ii) at a collection centre approved under the Directive in another part of the United Kingdom or another member State;

(iii) at a domestic collection centre;

(iv) at unlicensed premises in accordance with these Regulations; or

(v) lawfully in another part of the United Kingdom;



(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–



(i) the date the semen was collected;

(ii) the identity of the donor bovine animal under the cattle identification regulations;

(iii) the breed of the donor bovine animal; and

(iv) the licence number of the centre where the semen was collected (if applicable).

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

(a) the documents specified in regulation 14(4); and

(b) if the semen comes from unlicensed premises, the documents specified in Schedule 7, paragraph 1(c).

     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–

(a) not less than 500 µg streptomycin per ml final dilution;

(b) not less than 500 International Units penicillin per ml final dilution;

(c) not less than 150 µg lincomycin per ml final dilution; and

(d) not less than 300 µg spectinomycin per ml final dilution.

    (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.

(a) foot and mouth disease; and

(b) the bovine diseases listed in Annex E(I) to Directive 64/432/EEC,

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–

(a) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC,

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.

(a) only semen is stored at the centre;

(b) semen is only stored at the centre if it was collected and processed–


(i) in accordance with these Regulations;

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

(iii) in accordance with the Directive;



(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–



(i) the date the semen was collected;

(ii) the identity of the donor bovine animal under the cattle identification regulations;

(iii) the breed of the donor bovine animal; and

(iv) the licence number of the centre where the semen was collected (if applicable).

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

(a) the accommodation in which the bovine animals from which semen is to be collected are kept, and the collection facilities (if different), are constructed so that they can be readily cleaned and disinfected;

(b) the Scottish Ministers are notified immediately if the result of any test carried out on a bovine animal on the premises, for any disease that must be tested for under these Regulations, indicates a change in the health status of the bovine animal;

(c) semen collected is moved to an EC collection centre or to a domestic collection centre for processing, accompanied by documents certifying–


(i) the bovine animal satisfies the requirements of regulations 19(c), 19(d) and 19(e) on the day of collection;

(ii) the bovine animal satisfies the requirements of Parts 1 or 2 of Schedule 8;

(iii) that the unlicensed premises satisfy the requirements in regulation 20(2); and

(iv) the premises from which the bovine animal came satisfy the requirements in regulation 22(6).

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

(a) did not belong to a herd officially free of enzootic bovine leukosis in accordance with Directive 64/432/EEC; or

(b) was produced by a dam which did not, after removal of the bovine animal from it, test negative to a test carried out in accordance with Annex D (Chapter II) to Directive 64/432/EEC.

    (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.

(a) completed 28 days' quarantine in–


(i) an EC quarantine centre; or

(ii) a quarantine centre approved in accordance with paragraph 1(a) of Chapter 1 of Annex B to the Directive by the competent authority of another member State or part of the United Kingdom,



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–



(i) another EC collection centre; or

(ii) a semen collection centre authorised under the Directive in accordance with paragraph 5 of Chapter 1 of Annex B to the Directive, in the case of movement of a bovine animal kept in a semen collection centre authorised under the Directive in another member State or part of the United Kingdom.

(a) officially tuberculosis free in accordance with Directive 64/432/EEC and the herd must not contain any bovine animals that have suffered a positive reaction, or given an inconclusive result, to a tuberculin skin test carried out in accordance with Directive 64/432/EEC; and

(b) officially brucellosis free in accordance with Directive 64/432/EEC.

     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–

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

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

(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.

     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.

(a) the name and address of the person to whom the semen is supplied;

(b) the date the semen was dispatched and the means of dispatch;

(c) the name of the donor bovine animal and its identity under the cattle identification regulations;

(d) the number of straws or other receptacles supplied and their identification code.

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

(a) the name and address of the person who supplied the semen;

(b) the date the semen was received;

(c) the name of the donor bovine animal and its identity under the cattle identification regulations;

(d) the number of straws or other receptacles supplied and the identification code allocated to each batch of straws;

(e) the number of any straws or other receptacles damaged or destroyed and their identification code.

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

(a) the name of the donor bovine animal and its identity under the cattle identification regulations;

(b) the number of the straw or other receptacle used;

(c) the identification code of the straw or other receptacle;

(d) the ear tag number of the bovine animal inseminated;

(e) the date of insemination.

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

(a) the name of the donor bovine animal and its identity under the cattle identification regulations;

(b) the number of the straw or other receptacle destroyed;

(c) the identification code of the straw or other receptacle;

(d) the date of destruction.