agriculture, england PART 1 General Provisions Title, application and commencement 1 These Regulations— a may be cited as the Bovine Semen (England) Regulations 2007; b apply in England only; and c come into force on 22nd May 2007. Interpretation 2 1 In these Regulations— “ bovine ” includes the species Bubalus bubalis and Bison bison ; “ bovine semen centre ” means premises licensed under regulation 4; “ cattle identification regulations ” means— the Cattle Identification Regulations 2007; Council Regulation 1760/2000, as amended from time to time (in the case of bovine animals born outside England); “ centre veterinarian ” has the meaning given in regulation 5(b); “ Council Regulation 1760/2000 ” means Regulation (EC) No 1760/2000 of the European Parliament and of the Council establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 , as amended from time to time; “dam”, in the case of bovine animals derived from embryo transfer, means the recipient of the embryo; “ the Directive ” means Council Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species , as amended from time to time; “ Directive 64/432/EEC ” means Council Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine , as amended from time to time; “ domestic collection centre ” has the meaning given in regulation 4(b)(ii); “ domestic storage centre ” has the meaning given in regulation 4(c)(ii); “ licensed collection centre ” has the meaning given in regulation 4(b)(i); “ licensed quarantine centre ” has the meaning given in regulation 4(a); “ licensed 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 Secretary of State in accordance with section 10(4) of the Animal Health and Welfare Act 1984; “ licensed ” means licensed by the Secretary of State; “ processing ” means one or more of— diluting (except in the course of or immediately after semen collection), adding any substance with the intention of prolonging the natural life of the semen (except in the course of or immediately after semen collection), adding any antibiotic, packing into straws or other appropriate receptacles, and freezing; “ 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; “unlicensed processing premises” means unlicensed premises— for the processing of semen— collected at unlicensed premises or at a domestic collection centre, and not intended for trade with a member State , and supervised by the centre veterinarian of a licensed collection centre; “ veterinary surgeon ” means a veterinary surgeon or veterinary practitioner registered under the Veterinary Surgeons Act 1966 . 2 Expressions that are not defined in these Regulations and are used in the Directive have the same meaning in these Regulations as they have for the purposes of the Directive. Exceptions 3 1 These Regulations do not apply where— a semen is collected for the purpose of the artificial insemination of a bovine animal with fresh semen; b the bovine animal from which the semen is collected— i is not, at the time of collection, affected by an Order made under sections 6(c), 8, 17, 23, 25, 26 or 29 of the Animal Health Act 1981 ; or, ii is so affected, but the use of its semen is authorised by the Secretary of State; and c when the bovine animal is inseminated— i it is in the same ownership and the same herd as the bovine animal from which the semen was collected; and ii it is kept on the same premises as that bovine animal. 2 These Regulations do not apply where semen is collected for the purpose of— a assessing the suitability of a bovine animal for use in breeding; b diagnosing infection or disease in a bovine animal; or c education or research, provided the semen collected is not used for artificial insemination and is not the subject of trade with a member State . 3 These Regulations do not apply to research authorised under the Animals (Scientific Procedures) Act 1986 . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 2 Licensing of bovine semen centres and approval of bovine animals Licensing of bovine semen centres 4 The Secretary of State may license premises as follows— a if they comply with Part 1 of Schedule 1, as premises for the quarantine of bovine animals ( a “ licensed quarantine centre”); b if they comply with Part 2 of Schedule 1, either as— i premises for the collection, processing and quarantine of semen intended for trade with a member State ( a “licensed collection centre”); or ii premises for the collection, processing and quarantine of semen not intended for trade with a member State (a “domestic collection centre”); or c if they comply with Part 3 of Schedule 1, either as— i premises for the storage of semen intended for trade with a member State ( a “licensed storage centre”); or ii premises for the storage of semen not intended for trade with a member State (a “domestic storage centre”). Application for a licence to operate a bovine semen centre 5 An application for a licence to operate a bovine semen centre must— a be made in writing to the Secretary of State; b be signed by the applicant for the licence and by the veterinary surgeon who will have responsibility for veterinary supervision of the centre (“the centre veterinarian”); c specify the premises for which an application is made; and d specify the licence applied for. Bovine semen centre licence 6 1 A bovine semen centre licence granted under regulation 4 must specify— a the address of the centre; b the licence number of the centre; c the licence holder; d the centre veterinarian; e the type of licence granted; and f any conditions to which the licence is subject. 2 A licence must be in writing and may be made subject to such conditions as are necessary to— a ensure that the provisions of these Regulations are complied with; or b protect public or animal health. Approval of a bovine animal 7 1 The Secretary of State may grant an approval for a bovine animal for use in a licensed collection centre, a domestic collection centre, or at unlicensed premises if it has tested negative to— a the tests set out in Schedule 2, paragraph 2(1)(a) to (e) prior to its entry to a licensed quarantine centre; and b the tests set out in Schedule 2, paragraph 3(1)(a) to (d) and paragraph 4(1)(a) after its entry to a licensed quarantine centre. 2 The Secretary of State may approve a bovine animal despite a positive result to the serological tests set out in Schedule 2, paragraph 2(1)(e)(ii) or in Schedule 2, paragraph 4(1)(b) or in both. 3 The Secretary of State may also grant an approval for a bovine animal for use in a domestic collection centre or at unlicensed premises, if it has tested negative to the tests set out in Part 2 of Schedule 8, paragraphs 2(a) to (c). Application for approval of a bovine animal 8 Any application for approval of a bovine animal for the purpose of collecting its semen, or for use as a teaser animal, must be made to the Secretary of State by or on behalf of its owner and must— a specify the name and breed of the bovine animal; b specify the number by which it is identifiable in accordance with the cattle identification regulations; and c be made in writing and signed by or on behalf of the owner. Form of approval for a bovine animal 9 1 An approval for a bovine animal must specify— a the name and breed of the bovine animal; b the number by which it is identifiable in accordance with the cattle identification regulations; and c any conditions to which the approval is subject. 2 An approval must be in writing and may be made subject to such conditions as are necessary to— a ensure that the provisions of these Regulations are complied with; or b protect public or animal health. Approval of bovine animals for use at unlicensed premises 10 1 The Secretary of State may approve the use of a bovine animal for the collection of its semen ... at unlicensed premises for a maximum period of 3 months. 2 The Secretary of State may renew an approval under paragraph (1) for subsequent periods of up to 3 months if— a he receives the application for renewal of the approval in writing and signed by or on behalf of 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 Secretary of State may grant a temporary approval. 4 Where the Secretary of State grants a temporary approval under paragraph (3), no person may trade any semen which has been— a collected from a bovine animal; or b processed following such collection, until negative results to the tests on the bovine animal ... are confirmed. PART 3 The operation of a bovine semen centre and collection at unlicensed premises Entry of persons to bovine semen centres 11 1 No person may enter a bovine semen centre without the authority of the centre veterinarian. 2 A person authorised by the centre veterinarian to enter a bovine semen centre must comply with any requirements laid down by the centre veterinarian to ensure compliance with these Regulations. 3 The centre veterinarian must ensure that unauthorised persons do not enter the bovine semen centre. Entry of non-bovine animals to bovine semen centres 12 1 No person may introduce a non-bovine animal into a bovine semen centre without the express authorisation of the centre veterinarian. 2 The centre veterinarian may authorise the admission of domestic animals of non-bovine species into a bovine semen centre provided— a they are necessary for the operation of the centre; b they present no risk of infection to those bovine animals whose semen is to be collected; and c they fulfil the conditions laid down by the centre veterinarian. Requirement to keep records of bovine animals 13 1 This regulation does not apply to a licensed storage centre or domestic storage centre. 2 The centre veterinarian or operator of unlicensed premises must make a record for each bovine animal moved into or out of the centre or premises of— a its breed; b its date of birth; c the number by which it is identifiable in accordance with the cattle identification regulations; d all vaccinations administered to it; e the tests it has undergone for diseases and their results; and f any indication of disease it may have. 3 The centre veterinarian or operator of unlicensed premises must ensure that these records are kept for at least two years from the date when the bovine animal leaves the centre or premises, or dies at the centre or premises. Requirement to keep records of semen 14 1 This regulation does not apply to licensed quarantine centres. 2 Whenever semen is moved from or to a bovine semen centre or destroyed, the centre veterinarian must record— a the number by which the donor bovine animal is identifiable in accordance with the cattle identification regulations; b its health status; c the number of doses of semen; d the numbers on the receptacles in which the semen is or was contained (as applicable); e the date the semen was received, dispatched or destroyed (as applicable); f the premises, or bovine semen centre, of dispatch (if applicable); and g the destination (if applicable). 3 The operator of unlicensed premises must record the information in paragraphs 2(a) to (g) for semen sent to a licensed collection centre or domestic collection centre for processing. 4 The operator of unlicensed premises or the centre veterinarian must ensure that each consignment of semen is accompanied by documents containing the information in paragraphs 2(a) to (g). 5 The operator of unlicensed premises or the centre veterinarian must ensure that these records are retained for at least two years after the dispatch, receipt, or destruction of the semen. General duties of centre veterinarians 15 1 The centre veterinarian must ensure that— a the centre is operated in accordance with these Regulations; b any 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 Secretary of State is notified immediately if the result of any test carried out on a bovine animal at the centre for any disease that must be tested for under these Regulations indicates a change in the health status of the bovine animal. Specific duties of centre veterinarians and operators of unlicensed premises 16 1 The duties of the centre veterinarian— a of a licensed quarantine centre are set out in Schedule 2; b of a licensed collection centre are set out in Schedule 3; c of a licensed 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. 1A The duties of the centre veterinarian of a licensed collection centre which are specified in paragraph (1B) must also be performed by that veterinarian when supervising unlicensed processing premises. 1B The duties are those set out in the following provisions of Part 3 of Schedule 3— a sub-paragraphs (d), (e) and (f) of paragraph 1; and b sub-paragraph (b) of paragraph (2). 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 and for whom the relevant qualified person described in those articles is a centre veterinarian or an inspector who is qualified as a veterinary surgeon. 2 Only a veterinary surgeon approved by the Secretary of State 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 Secretary of State. 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— a is approved for that purpose by the Secretary of State; 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 (where its semen is to be supplied as fresh semen) has been kept at a licensed collection centre or a domestic collection centre for a continuous period of at least 30 days preceding the date the semen is collected. Places where semen may be collected 20 1 No person may collect semen from a bovine animal except— a at a licensed collection centre; b at a domestic collection centre; or c at 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 1 No person may use a teaser animal to assist in the collection of semen unless it is approved for that purpose by the Secretary of State. 2 But no such approval is required in respect of a teaser animal used to assist in the collection of semen at unlicensed premises. Entry of bovine animals to licensed quarantine centres, licensed collection centres, domestic collection centres, or to unlicensed premises 22 1 No person may introduce a bovine animal into— a a licensed quarantine centre; b a licensed collection centre; or c a domestic collection centre, without the express authorisation of the centre veterinarian. 2 The centre veterinarian may not authorise a bovine animal to enter a licensed 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 a licensed 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 a licensed 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 a licensed 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) (England) (No. 3) Order 2003 ; and b under conditions that ensure that it does not come into contact with cloven-hoofed animals that are not authorised to enter the centre or premises of destination. 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— a at a licensed collection centre; b at a domestic collection centre; or c at unlicensed processing premises. 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 a licensed storage centre or a domestic storage centre. 2 No person may supply frozen semen or use it in artificial insemination unless it has been previously stored— a at a licensed 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 Secretary of State to grant exemptions 29 No person may supply or use semen for artificial insemination if he knows or suspects that it has not been collected, processed or stored in accordance with the requirements of— a these Regulations, b lawfully in another part of the United Kingdom; or c in the case of semen originating outside of the United Kingdom , the Directive, unless authorised by the Secretary of State. Trade in semen to a member State 30 1 No person may supply semen to a member State unless— a it was— i collected, processed and quarantined at a licensed collection centre; and ii stored at a licensed storage centre; or b in the case of semen supplied from outside the United Kingdom , it has been stored at a licensed storage centre. 2 Any person who supplies semen with a member State must ensure that it is accompanied by the animal health certificate as published by the Secretary of State from time to time . 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. 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 Secretary of State refuses to grant an approval or licence, or grants one subject to conditions, he must— a give his reasons in writing; and b explain the right of the applicant to make written representations under regulation 36(1) to a person appointed by the Secretary of State. Provision of information to the Secretary of State 33 1 The Secretary of State may require an applicant for approval of a bovine animal, the holder of such an approval or the owner of a bovine animal to provide such information and to permit the bovine animal to be subjected to such tests and examinations as the Secretary of State considers necessary to enable him to decide whether the approval should be granted or maintained. 2 The previous owner of an approved bovine animal must notify the Secretary of State of the name and address of the new owner within 21 days of transferring ownership to him. 3 The owner of an approved bovine animal must, within 21 days of its death, notify the Secretary of State of the death, the circumstances in which it occurred and the results of any post mortem examination. 4 The Secretary of State may require an applicant for a bovine semen centre licence, or the holder of such a licence, to provide such information and to permit such tests and examinations as the Secretary of State considers necessary to enable him to decide whether the licence should be granted or maintained. Suspension and amendment 34 1 The Secretary of State may suspend or amend an approval or licence granted under these Regulations in whole or in part if— a any of the conditions under which it was granted are not fulfilled; or b he is satisfied that the provisions of these Regulations are not being complied with. 2 A suspension or amendment— a may have immediate effect if the Secretary of State considers 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 the reasons; and e explain the right of the person who has been notified to make written representations under regulation 36(1) to a person appointed by the Secretary of State. 4 If the suspension or amendment does not have immediate effect and representations are made under regulation 36, it must not have effect until the final determination by the Secretary of State of the appeal unless he considers 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 Secretary of State may revoke an approval or licence granted under these Regulations in whole or in part if— a he has notified his decision to suspend the approval or licence and the period for appeal under regulation 36 has expired; b he has upheld his decision to suspend following an appeal under regulation 36; c he has previously suspended the approval or licence and there is further non-compliance with these Regulations; or d he is 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 the 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 make written representations under regulation 36(1) to a person appointed by the Secretary of State. 3 If a person does make written representations under regulation 36(1), the revocation remains in force pending the outcome of the appeal. Appeals 36 1 A person may make written representations to a person appointed for the purpose by the Secretary of State concerning any decision of the Secretary of State concerning— a the grant, suspension or revocation of an approval or licence under these Regulations, b the conditions to which an approval or licence is subject, or c any fees charged under these Regulations, within 21 days of notification of the decision to him. 2 The Secretary of State may also make written submissions to the appointed person concerning his decision. 3 The appointed person must report in writing to the Secretary of State. 4 The Secretary of State must give to the appellant written notification of his final determination and the reasons for it. Notice prohibiting the use of semen 37 1 If he thinks it necessary to prevent the spread of disease, an inspector may serve a notice on the owner of a bovine animal or on anyone he 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 he knows or suspects semen the subject of the notice to be 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 a member State in contravention of the Directive, he may serve a notice in accordance with paragraph (2) on the person appearing to him to be in charge of the semen. 2 The notice may require that person— a to detain semen at such place as the notice may specify; b to destroy semen in accordance with the requirements of the notice; or c to 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 he knows or suspects semen 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 may provide any information or make any statement for the purpose of obtaining an approval or licence under these Regulations which he does not believe and have reasonable grounds to believe to be true. Examination of bovine semen centres 40 The Secretary of State must examine all bovine semen centres at least twice a year. Payment of fees 41 The fees payable to the Secretary of State are as provided by regulation 6(1) of the Animal Health (Miscellaneous Fees) (England) Regulations 2018 . Refund of fees 42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transitional provisions 43 Licences and approvals granted under the Artificial Insemination of Cattle (Animal Health) (England and Wales) Regulations 1985 shall continue to have effect as if they were approvals or licences granted under these Regulations in accordance with the following table, provided that, in the case of premises, the premises comply with, and are operated in accordance with, the provisions of these Regulations— Licence and approvals under the Artificial Insemination of Cattle (Animal Health) (England and Wales) 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 a licensed 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 licensed storage centre (regulation 4(c)(i)) or licence of domestic storage centre (regulation 4(c)(ii)). Amendment of the Artificial Insemination (Cattle and Pigs) (Fees) Regulations 1987 44 In the Artificial Insemination (Cattle and Pigs) (Fees) Regulations 1987 — a in regulation 2(1), omit the definition of “the principal cattle Regulations”; b in regulation 3(1), for the words “Subject to paragraph (1A) below, there” substitute “ There ” and omit the words “the principal cattle Regulations and”; 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 10 are revoked insofar as they apply in England. 2 The Regulations in Part 2 of Schedule 10 are revoked. Ben Bradshaw Minister of State Department for Environment, Food and Rural Affairs We approve Dave Watts Kevin Brennan Two of the Lords Commissioners of Her Majesty's Treasury