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

• Citation: S.I. 1995/2478
• Sections: 88

Section 1 Citation and commencement

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 , as last amended by Council Directive 2008/73/EC ;

(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 ; 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) ,

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

Section 2 Interpretation

(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;

“ national trade ” means trade within Great Britain;

“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 .

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

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(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.

Section 3 Exemptions from the Regulations

(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 .

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

Section 4 Approvals

(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.

Section 5 Approval of bovine embryo collection teams for all purposes including intra-Area trade

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Section 6 Approval of bovine embryo collection teams for national trade

The appropriate Minister may, on application, approve a bovine embryo collection team for the purposes of collecting bovine embryos for national trade if it complies with Schedule 2.

Section 7 Approval of bovine embryo production teams

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.

Section 8 Approval of bovine embryo transfer teams

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.

Section 9 Registration numbers

Each team approved under regulation ... 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.

Section 10 Collection of bovine embryos intended for intra-Area trade

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Section 11 Collection of bovine embryos for national trade

(1) No person shall collect or process any bovine embryo for national trade unless—

(a) he is a member of a collection team approved under ... 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 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 ....

Section 12 Production of bovine embryos in vitro

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 ... 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.

Section 13 Approval of stores for bovine embryos for use in intra-Area trade

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Section 14 Storage of bovine embryos for use in intra-Area trade

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Section 15 Prohibition on the storage of bovine embryos for use in intra-Area trade other than at an approved store

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Section 16 Approval of stores for bovine embryos for national trade

(1) The appropriate Minister may, on application, approve a store for the storage of bovine embryos for national 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.

Section 17 Storage of bovine embryos not intended for national trade

(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.

Section 18 Prohibition on the storage of bovine embryos for national trade other than at an approved store

No person shall store any bovine embryo for national trade except in a store approved under ... regulation 16 and in accordance with the conditions of that approval.

Section 19 Storage of bovine embryos for use on the same premises as the store

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.

Section 20 Transport of bovine embryos

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

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Section 21 Transfer of bovine embryos

(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 ;

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(c) imported into—

(i) England in accordance with the provisions of the Trade in Animals and Related Products Regulations 2011 or any Regulations which they supersede;

(ii) Wales in accordance with the provisions of the Trade in Animals and Related Products (Wales) Regulations 2011 or any Regulations which they supersede;

(iii) Scotland in accordance with the provisions of the Trade in Animals and Related Products (Scotland) Regulations 2012 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 ;

(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.

Section 22 Requirement to use anaesthetics

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.

Section 23 Records at stores

(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.

Section 24 Records other than at stores

(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.

Section 25 Transitional provisions

(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.

Section 26 Revocation

(1) The Bovine Embryo Collection and Transfer Regulations 1993 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.

Section 1

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Section 2

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Section 3

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Section 4

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Section 5

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Section 1

In order to be given approval under regulation 6 each bovine embryo collection team must fulfil the requirements of this Schedule.

Section 2

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

Section 3

The team must have at its disposal ...—

(a) a permanent laboratory facility where the team has at its disposal—

(i) a work surface, a microscope and cryogenic equipment,

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

(iii) a room or area equipped for cleansing and sterilising instruments and with equipment used in bovine embryo collection and manipulation, and

(iv) where micromanipulation of the bovine embryo which involves penetration of the zona pellucida is to be carried out, suitable laminar-flow facilities,

(b) a mobile laboratory facility where the team has at its disposal—

(i) a work surface, a microscope and cryogenic equipment, and

(ii) a specially equipped part of the vehicle consisting of two separate sections, one for the examination and manipulation of bovine embryos which is a clean section, and the other for accommodating equipment and materials used in contact with the donor animals, or

(c) a mobile laboratory which:

(i) has separate parts so that there is no contact between used and unused equipment and materials, and

(ii) carries sufficient equipment to enable the examination and manipulation of bovine embryos to be carried out without contaminating them, and

(iii) has contact with a permanently sited laboratory to ensure the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and manipulation of bovine embryos.

Section 1

To be approved as a team for the production and processing of bovine embryos derived by in vitro fertilisation and/or in vitro culture, a bovine embryo production team must fulfil the following requirements.

Section 2

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

Section 3

The production team personnel must be trained in appropriate disease control and laboratory techniques, particularly in procedures for working in sterile conditions.

Section 4

The team must have at its disposal a permanently-sited processing laboratory which must—

(a) have adequate equipment and facilities, including a separate room for recovering oocytes fro ovaries, and separate rooms or areas for processing oocytes and bovine embryos, and storing bovine embryos; and

(b) have laminar-flow facilities.

Section 5

Where oocytes and other tissues are to be collected in an abattoir, the production team must have at its disposal suitable equipment for the collection and transport of the ovaries and other tissues to the processing laboratory in a hygienic and safe manner.

Section 1

Bovine embryos shall be collected and processed by an approved collection team, without coming into contact with any other consignment of bovine embryos not meeting the requirements of these Regulations relating to bovine embryos intended for national trade.

Section 2

Bovine embryos shall be collected in a place which is isolated from other parts of the premises or holding and which must be in good repair and easy to cleanse and disinfect.

Section 3

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

Section 4

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

Section 5

Products of animal origin used during collection of the bovine embryos and in the transport medium shall be obtained from sources which present no animal health risk or are treated prior to use in such a way that such risk is prevented. All media and solutions shall be sterilised by approved methods according to the recommendations of the manual of the International Embryo Transfer Society . Antibiotics may be added to the media in accordance with that manual.

Section 6

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

Section 7

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

Section 8

Each bovine embryo container and the containers in which they are stored and transported shall be clearly code-marked in such a way that the date of collection of the bovine embryos and the breed and identification of the donor sire and donor dam, as well as the registration number of the team can be readily established.

Section 9

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

Section 10

After the last wash each bovine embryo shall be subjected to microscopic examination at a magnification of at least 50× over its entire surface to determine that the zona pellucida is intact and is free from any adherent material. Any micromanipulation which involves penetration of the zona pellucida must be carried out after the last wash and examination in the facilities approved for the purpose. Such micromanipulation may only be carried out on a bovine embryo having an intact zona pellucida .

Section 11

Each consignment of bovine embryos that has successfully undergone the examination provided for in the preceding paragraph shall be placed in a sterile container marked in accordance with paragraph 8 of this Schedule and sealed immediately.