The Bovine Embryo (Collection, Production and Transfer) Regulations 1995

Citation and commencement

1.  These Regulations, which implement:

(a)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(1);

(b)Council Directive 93/52/EEC amending 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(2); and

(c)Commission Decision 94/113/EC amending 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 (text with EEA relevance)(3),

may be cited as the Bovine Embryo (Collection, Production and Transfer) Regulations 1995 and shall come into force on 13th October 1995.

Interpretation

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

“approved” means approved by the appropriate Minister for the purposes of these Regulations;

“collect” means remove from a donor cow;

“cow” includes heifer;

“the International Embryo Transfer Society” means the Society of that name founded in Denver, Colorado, United States of America in 1974, incorporated in the State of Nebraska on 7 April 1975 and currently having its headquarters at 309 West Clark Street, Champaign, Illinois 61820, United States of America;

“intra-Area trade” means trade between the United Kingdom and another state of the European Economic Area;

“team veterinarian” means a veterinary surgeon who is responsible for a bovine embryo collection team, a bovine embryo production team or a bovine embryo transfer team;

“transfer” means transfer to a recipient cow;

“veterinary surgeon” means a veterinary surgeon (or veterinary practitioner) registered under the Veterinary Surgeons Act 1966(4).

(2) Subject to paragraph (1) above, any expressions used in these Regulations have the meaning they bear in Council Directive 89/556/EEC;

(3) A reference in these Regulations to a directive is to that directive as amended at the date of coming into force of these Regulations.

(4) Unless the context otherwise requires, any reference in these Regulations to a numbered regulation is to a regulation so numbered in these Regulations, and any reference to a Schedule is a reference to a Schedule to these Regulations.

Exemptions from the Regulations

3.—(1) The provisions of these Regulations relating to the collection, production or storage of bovine embryos shall not apply to bovine embryos produced for the purposes of research carried out in accordance with the conditions of a licence issued under the Animals (Scientific Procedures) Act 1986(5).

(2) Other than regulations 21 and 22, these Regulations shall not apply in relation to embryos derived by transfer of nuclei.

Approvals

4.—(1) An application for approval as a bovine embryo collection team, production team or transfer team, or for any facilities used by such team shall be made in writing to the appropriate Minister and signed by the proposed team veterinarian.

(2) Any approval granted under these Regulations shall be in writing and may be made subject to conditions and may be varied, suspended or revoked by notice in writing at any time.

(3) In particular, any approval of premises and equipment granted under these Regulations may specify that such premises and equipment may be inspected, and may specify the frequency of such inspection.

Approval of bovine embryo collection teams for all purposes including intra-Area trade

5.  The appropriate Minister may, on application, approve a bovine embryo collection team for the purposes of collecting bovine embryos for all purposes, including intra-Area trade, if it complies with Schedule 1.

Approval of bovine embryo collection teams for purposes other than intra-Area trade

6.  The appropriate Minister may, on application, approve a bovine embryo collection team for the purposes of collecting bovine embryos other than for the purposes of intra-Area trade if it complies with Schedule 2.

Approval of bovine embryo production teams

7.  The appropriate Minister may, on application, approve a bovine embryo production team for the purposes of artificial production of bovine embryos if it complies with Schedule 3.

Approval of bovine embryo transfer teams

8.  The appropriate Minister may, on application, approve a bovine embryo transfer team for the purposes of transfer of bovine embryos if it—

(a)is headed by a veterinary surgeon; and

(b)has at its disposal a room or area equipped for cleaning and sterilising instruments and equipment used in bovine embryo transfer.

Registration numbers

9.  Each team approved under regulation 5, 6, 7 or 8 above shall be given a registration number by the appropriate Minister, and if a team is approved for more than one activity shall be given a different number for each activity.

Collection of bovine embryos intended for intra-Area trade

10.  No person shall collect or process any bovine embryo intended for intra-Area trade unless—

(a)he is a member of a collection team approved under regulation 5;

(b)he is the collection team veterinarian or acting under his authority;

(c)the bovine embryo is collected and processed in accordance with Schedule 4;

(d)the donor cow complies with the requirements of Schedule 5; and

(e)the bovine embryo was conceived as a result of artificial insemination with semen from a donor sire which, at the time of semen collection, was standing at a semen collection centre as defined in article 2.b of Council Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species(6).

Collection of bovine embryos not intended for intra-Area trade

11.—(1) No person shall collect or process any bovine embryo not intended for intra-Area trade unless—

(a)he is a member of a collection team approved under regulation 5 or regulation 6;

(b)he is the collection team veterinarian or acting under his authority;

(c)the bovine embryo is collected and processed in accordance with Schedule 4 or Schedule 6;

(d)the donor cow is not subject to any veterinary prohibition or quarantine measures and shows no clinical sign of infectious disease at the date of collection; and

(e)the bovine embryo was conceived either—

(i)from a donor sire (either by natural service or by using raw semen) which, at the date of service, was not subject to any veterinary prohibition or quarantine measures and showed no clinical sign of infectious disease, or

(ii)by artificial insemination using semen which was eligible for distribution or sale in Great Britain at the time of insemination.

(2) A bovine embryo may be collected by either a veterinary surgeon or a member of an approved bovine embryo collection team acting under the authority of the team veterinarian for transfer without being processed in accordance with Schedule 4 or Schedule 6 if—

(a)the bovine embryo is intended for use in the United Kingdom without being frozen or stored and the recipient cow is in the same ownership as the donor cow;

(b)the donor cow is not subject to any veterinary prohibition or quarantine measures at the date of collection; and

(c)in a case where the bovine embryo was conceived by natural service or using raw semen, the donor sire was not subject to any veterinary prohibition or quarantine measures at the date of service.

(3) Where the appropriate Minister thinks fit, he may approve the collection of a bovine embryo produced from a donor animal which does not comply with this regulation provided it is not intended for intra-Area trade.

Production of bovine embryos in vitro

12.  No person shall produce or process a bovine embryo in vitro unless—

(a)he is a member of a production team approved under regulation 7;

(b)he is the production team veterinarian or acting under his authority;

(c)the bovine embryo is produced in accordance with Schedule 7 using semen from a donor sire which, at the time of semen collection, was standing at a semen collection centre as defined in article 2.b of Council Directive 88/407/EEC or, in the case of bovine embryos not intended for intra-Area trade, using semen which was eligible for distribution or sale in Great Britain at the time of fertilisation;

(d)the donor cow complies with the requirements of Schedule 5.

Approval of stores for bovine embryos for use in intra-Area trade

13.—(1) The appropriate Minister may, on application, approve a store for the storage of bovine embryos intended for intra-Area trade if it complies with the conditions of this regulation.

(2) The store shall consist of a lockable room under the supervision of an approved veterinary surgeon who is the team veterinarian for a team approved either as a bovine embryo collection team or as a bovine embryo production team.

(3) The store shall be easy to clean and disinfect.

Storage of bovine embryos for use in intra-Area trade

14.—(1) The person supervising a store approved for the storage of bovine embryos intended for use in intra-Area trade shall ensure that the conditions of this regulation and any other conditions attached to the approval are complied with.

(2) The store shall be locked when not in use.

(3) Nothing shall be stored in the room other than bovine embryos eligible for intra-Area trade or bovine semen eligible for intra-Area trade.

(4) The bovine embryos shall be stored at a suitable temperature.

Prohibition on the storage of bovine embryos for use in intra-Area trade other than at an approved store

15.  No person shall store any bovine embryo for use in intra-Area trade except in a store approved under regulation 13 and in accordance with the conditions of the approval.

Approval of stores for bovine embryos not intended for use in intra-Area trade

16.—(1) The appropriate Minister may, on application, approve a store for the storage of bovine embryos not intended for intra-Area trade if it complies with the conditions of this regulation.

(2) The store shall consist of a lockable room under the supervision, subject to regulation 19, of a veterinary surgeon.

(3) The store shall be easy to clean and disinfect.

Storage of bovine embryos not intended for use in intra-Area trade

17.—(1) The person supervising a store approved under regulation 16 shall ensure that the conditions of this regulation and any other conditions attached to the approval are complied with.

(2) The store shall be locked when not in use.

(3) Nothing shall be stored in the room other than bovine embryos eligible for transfer in Great Britain or bovine semen eligible for use in Great Britain.

(4) The bovine embryos shall be stored at a suitable temperature.

Prohibition on the storage of bovine embryos not intended for intra-Area trade other than at an approved store

18.  No person shall store any bovine embryo for use other than in intra-Area trade except in a store approved under regulation 13 or regulation 16 and in accordance with the conditions of that approval.

Storage of bovine embryos for use on the same premises as the store

19.  In the case of a store used for bovine embryos which will only be used on the same premises as the premises where the store is situate, the store may be supervised by a person who is not a veterinary surgeon, but in this case all the duties placed on the veterinary surgeon shall be placed on the person to whom the approval is granted, and it shall be the duty of the person to whom the approval is granted to ensure that bovine embryos in that store are not removed from the premises on which the store is situate.

Transport of bovine embryos

20.—(1) No person shall transport any bovine embryo except under satisfactory hygienic conditions.

(2) No person shall transport any bovine embryo for the purposes of intra-Area trade except under satisfactory hygienic conditions in a sealed container marked in such a way that the number on the seal is the same as the number on the animal health certificate provided by the competent authority of the exporting member State for the purposes of intra-Area trade.

Transfer of bovine embryos

21.—(1) No person shall transfer any bovine embryo unless he is a member of an approved bovine embryo transfer team or a veterinary surgeon.

(2) If the person carrying out the transfer is not a veterinary surgeon, he shall only do so if he is competent and has been trained in methods and techniques of hygiene by a team veterinarian of a bovine embryo transfer team, and the transfer shall be carried out under the responsibility of the team veterinarian.

(3) If the person carrying out the transfer is a veterinary surgeon, he shall clinically examine the recipient cow before carrying out the transfer and shall satisfy himself—

(a)that the recipient is suitable to receive the bovine embryo; and

(b)that there is no reason of which he knows existing at the time of his examination which would cause him to believe that the animal would not be able to carry to term a normal calf from the breed and type of bovine embryo being transferred and to calve naturally,

and if he cannot so satisfy himself he shall not transfer the embryo.

(4) If the person carrying out the transfer is not a veterinary surgeon, he shall not carry out the transfer unless a veterinary surgeon nominated for this purpose by the team veterinarian has clinically examined the recipient cow within 30 days preceding the transfer and has certified in the form specified in Schedule 8 to these Regulations that—

(a)he has clinically examined the recipient;

(b)the recipient is suitable to receive the bovine embryo; and

(c)he knows of no reason existing at the time of his examination which would cause him to believe that the animal would not be able to carry to term a normal calf of the breed and type specified in the certificate and to calve naturally.

(5) No person shall transfer any bovine embryo unless it has been—

(a)collected, processed and stored in accordance with the provisions of these Regulations or of the Bovine Embryo Collection and Transfer Regulations 1993(7);

(b)imported into Great Britain in accordance with the provisions of the Animals and Animal Products (Import and Export) Regulations 1995(8), or any Regulations which they supersede;

(c)imported into Great Britain in accordance with the provisions of the Products of Animal Origin (Import and Export) Regulations 1992(9) or any Regulations which they supersede;

(d)imported into Great Britain in accordance with the provisions of the Importation of Embryos, Ova and Semen Order 1980(10);

(e)subject to regulation 25, collected in Great Britain before 21 December 1993; or

(f)derived by transfer of nuclei.

(6) In the case of imported bovine embryos, or bovine embryos collected in Great Britain before 21 December 1993, no person shall transfer such embryo unless it has been transported and stored in accordance with these Regulations or any earlier legislation then applicable.

Requirement to use anaesthetics

22.  No person shall collect or transfer any bovine embryo per vaginam unless a general or an epidural anaesthetic has first been administered to the cow.

Records at stores

23.—(1) The person supervising a store for bovine embryos shall keep a record in permanent form of the following—

(a)the identification of each embryo entering the store;

(b)the date of entry of each embryo;

(c)the place of origin of each embryo or the place in which it was last stored, if different;

(d)the date of removal of each embryo from the store; and

(e)the destination of each embryo,

and shall keep the record for the period the embryo remains in the store and for twelve months after the date of removal of the embryo from the store.

(2) In the case of bovine embryos derived by in vitro fertilisation, the identification in the record may be done on the basis of a batch, but must contain details of the date and place of collection of ovaries or oocytes. It must also be possible to identify the herd of origin of the donor animals.

Records other than at stores

24.—(1) The team veterinarian of a bovine embryo collection or production team must keep a record of its activities in respect of bovine embryo collection or production for 12 months after collection or production of each embryo, including—

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

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

(c)the identification of the embryos together with details of their destination if known; and

(d)details of micromanipulation techniques which involve penetration of the zona pellucida or other techniques such as in vitro fertilisation or in vitro culture which have been performed on the embryos.

(2) In the case of bovine embryos derived by in vitro fertilisation, the identification in the record may be done on the basis of a batch, but must contain details of the date and place of collection of ovaries or oocytes. It must also be possible to identify the herd of origin of the donor animals.

(3) The team veterinarian of a bovine embryo transfer team or a veterinary surgeon transferring bovine embryos shall keep a record for twelve months of—

(a)the breed, age and identification of the recipient cow;

(b)the place of transfer; and

(c)the identification of the bovine embryo together with details of its source if known.

Transitional provisions

25.—(1) Subject to paragraph (2) below, after 20 December 1998 no person shall transfer any bovine embryo collected before 21 December 1993, except with the approval of the appropriate Minister.

(2) Notwithstanding the provisions of paragraph (1) above, where a bovine embryo was collected in accordance with the provisions of Council Directive 89/556/EEC in the period between 1 January 1991 and 21 December 1993, a person may use such embryo without an approval.

(3) In the case of bovine embryos collected before 21 December 1993, it shall be a defence for any person charged with an offence relating to record keeping concerning that bovine embryo to show that the information required to be recorded was not available.

Revocation

26.—(1) The Bovine Embryo Collection and Transfer Regulations 1993(11) are hereby revoked.

(2) Any approval granted to a bovine embryo collection or transfer team under those Regulations shall be deemed to be an approval for the same purposes under these Regulations.

(3) Any requirement under those Regulations to keep records shall continue in existence notwithstanding the revocation of those Regulations.