Animals, England PART 1 General provisions Citation, commencement, extent and application 1 1 These Regulations may be cited as the Transmissible Spongiform Encephalopathies (England) Regulations 2018 and come into force on 19th July 2018. 2 They extend to England and Wales but apply in England only. Interpretation 2 1 In these Regulations— “ bovine animal ” includes bison and buffalo (including water buffalo); “ BSE ” means bovine spongiform encephalopathy; “ cattle passport ” has the same meaning as in the Cattle Identification Regulations 2007 ; “ Commission Decision 2007/411/EC ” means Commission Decision 2007/411/EC prohibiting the placing on the market of products derived from bovine animals born or reared within the United Kingdom before 1st August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in the EU TSE Regulation ; “cutting plant” (except in paragraph 4(3)(b)(iii) of Schedule 7) has the meaning given to it in paragraph 1(17) of Annex 1 to Regulation (EC) No 853/2004 , and is an establishment that is approved or conditionally approved as such by the Food Standards Agency under Article 148(3) of Regulation (EU) 2017/625 , or operating as such under Article 4(5) of Regulation (EC) No 853/2004 , pending such approval; “ EU TSE Regulation ” means Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies , as read with— Commission Decision 2007/411/EC ; Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk ; and Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programme ; “ holding ” includes— domestic premises if they are being used for any purpose in connection with these Regulations; land and outbuildings; a slaughterhouse; a cutting plant; a game-handling establishment; a place that is, for the purposes of point 4(1)(a) of Annex 5, another place of slaughter; “inspectors” and “veterinary inspectors” are appointed and authorised under regulation 13; “ local authority ” means a county council, a district council, a London borough council, the Common Council of the City of London and the Council of the Isles of Scilly; “ offal ” has the meaning given in point 1.11 of Annex 1 to Regulation (EC) No. 853/2004 ; “ Regulation (EC) No 853/2004 ” means the Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin, as read with— Directive 2004/41/EC of the European Parliament and of the Council repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption ; Commission Regulation (EC) No 1688/2005 implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs ; and Commission Regulation (EC) No 2074/2005 laying down implementation measures for certain products under Regulation (EC) No 853/2004 ; “ slaughterhouse ” has the meaning given in paragraph 1(16) of Annex 1 to Regulation (EC) No 853/2004 , and is an establishment that is approved or conditionally approved as such by the Food Standards Agency under Article 148(3) of Regulation (EU) 2017/625 ; “ specified risk material ” means the tissues specified in Annex 5 of the EU TSE Regulation, and unless otherwise indicated, it does not include products containing or derived from those tissues; “ TSE ” means transmissible spongiform encephalopathy; “ the TSE requirements ” means those requirements set out in regulation 5 and Schedule 1; “ third country ” means any country that is not a member of the EU; “ trained person ” means a person who— has received training to take samples from dead bovine animals, and the site operator is satisfied is competent to carry out such sampling. 2 “Regulation (EU) 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products; 3 References in this instrument to Articles or Annexes are to Articles and Annexes in the EU TSE Regulation unless otherwise stated. 4 Expressions that are not defined in these Regulations and occur in the EU TSE Regulation have the same meaning in these Regulations as they have for the purposes of the EU TSE Regulation. Appointment of competent authority 3 The Secretary of State is the competent authority for the purposes of the EU TSE Regulation except as otherwise specified in paragraph 1 of Schedule 7. Exception for research 4 1 The TSE requirements do not apply in relation to animals kept for the purposes of research in a holding approved for that purpose under this regulation by the Secretary of State. 2 If a bovine, ovine or caprine animal which is kept in an approved research holding dies or is killed, it is a TSE requirement for the occupier to dispose of it as a Category 1 animal by-product in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption , as implemented by Commission Regulation (EU) No. 142/2011 . PART 2 TSE controls The TSE requirements 5 1 For the purposes of Article 11, where a person has in their possession or under their control any animal suspected of being infected with a TSE that person must immediately notify the Secretary of State and detain the animal on the holding until it has been examined by a veterinary inspector. 2 Where a veterinary surgeon examines or inspects an animal and reasonably suspects the animal of being infected with a TSE, the veterinary surgeon must immediately notify the Secretary of State of that suspicion. 3 Where a person examines the carcase of an animal in a laboratory and reasonably suspects the presence of a TSE, that person must immediately notify the Secretary of State, and retain the carcase until a veterinary inspector has authorised disposal. 4 The TSE requirements in Schedule 1 apply. 5 The occupier of a slaughterhouse must comply with the requirement to take samples or to facilitate the taking of samples by an inspector resulting from the Secretary of State's TSE monitoring requirements in Annex 3. 6 In accordance with Article 12, a person with animals placed under an official movement restriction must comply with— a any instructions given by an inspector and co-operate with the Secretary of State in delivering the TSE monitoring requirements in Annex 3; b any instructions given by an inspector and co-operate with the Secretary of State in taking action to control and eradicate a TSE in Annex 7; c the requirements in Annex 4 for the production, use of equipment, packaging, storage and transport of animal feed; d the animal feeding requirements in Annex 4; e the prohibitions concerning animal feeding in Article 7, unless the animal feed products are produced using production and manufacturing processes approved by the Secretary of State ; f the requirements for dealing with specified risk material in Article 8 and Annex 5 and Schedule 7; g the restrictions in Annex 8 and Schedule 8 concerning the placement of animals or products on the market or for export. Application of the Schedules 6 1 The following Schedules apply. 2 Schedule 2 sets out the requirements for TSE monitoring, approval of laboratories and compensation payable to the occupier of the slaughterhouse. 3 Schedule 3 provides for the control of TSE in bovines and the compensation payable to the owner for any bovine animal killed. 4 Schedule 4 provides for the control of TSE in ovines and caprines and the compensation payable to the owner for any ovine or caprine animal killed and for any semen, embyros, ova milk and milk products destroyed. 5 Schedule 5 provides for the control of TSE in animals other than bovines, ovines or caprines and the compensation payable to the owner for any such animal killed. 6 Schedule 6 provides for the slaughter of animals that have had access to unlawful feedingstuffs, the payment of compensation and the restriction and disposal of such feedingstuffs. 7 Schedule 7 sets out the requirements for dealing with specified risk material, mechanically separated meat and slaughtering techniques. 8 Schedule 8 sets out certain restrictions on placing on the market and export. PART 3 Administration and enforcement Approvals, authorisations, licences and registrations 7 1 The Secretary of State must grant an approval, authorisation, licence or registration under these Regulations if satisfied that the relevant TSE requirements will be complied with. 2 An approval, authorisation, licence or registration must be in writing and must specify— a the address of the holding; b the name of the occupier; c the purpose for which the approval, authorisation, licence or registration (as the case may be) is granted. 3 An approval, authorisation, licence or registration may be made subject to such conditions as are necessary to— a ensure compliance with the TSE requirements; b protect public or animal health. 4 The Secretary of State must give written reasons for any refusal to grant an approval, authorisation, licence or registration, and explain that the applicant has the right to make written representations to a person appointed by the Secretary of State in accordance with regulation 11. Occupier's duty 8 The occupier of any holding approved, authorised, licensed or registered under these Regulations must ensure that— a the holding is maintained and operated in accordance with— i any condition of the approval, authorisation, licence or registration (as the case may be), ii the TSE requirements, and b any person employed by them, and any person permitted to enter the holding, complies with those conditions and requirements. Suspension and amendment 9 1 The Secretary of State may suspend or amend an approval, authorisation, licence or registration granted under these Regulations if— a any of the conditions under which it was granted is not fulfilled, or b the Secretary of State is satisfied that the TSE requirements are not being complied with. 2 The Secretary of State may amend an approval, authorisation, licence or registration granted under these Regulations if the Secretary of State considers it necessary in light of technical or scientific developments. 3 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; b otherwise, may have effect after the expiration of at least 21 days. 4 Notification of the suspension or amendment must— a be in writing; b state when the suspension or amendment comes into effect; c give reasons; d explain that the person who has been notified has the right to make written representations to a person appointed by the Secretary of State in accordance with regulation 11. 5 The appeals procedure in regulation 11 applies. 6 If the suspension or amendment does not have immediate effect and representations are made under regulation 11, it must not have effect until the final determination by the Secretary of State of the appeal unless the Secretary of State considers that it is necessary for the protection of public or animal health for the amendment or suspension to have effect before then. Revocations of approvals, authorisations, licences and registrations 10 1 The Secretary of State may revoke an approval, authorisation, licence or registration granted under these Regulations if the Secretary of State is satisfied that the holding will not be operated in accordance with the TSE requirements, and if— a it is currently suspended and the period for appeal under regulation 11 has expired, or the suspension has been upheld following such appeal, b it has been previously suspended and there is further non-compliance with the TSE requirements, or c the Secretary of State is satisfied that the occupier no longer uses the holding for the purpose for which the approval, authorisation, licence or registration (as the case may be) was granted. 2 Notification of the revocation must— a be in writing; b state when the revocation comes into effect; c give reasons; d explain that the person who has been notified has the right to appeal by way of written representations to a person appointed by the Secretary of State in accordance with regulation 11. 3 The appeals process in regulation 11 applies. 4 If the Secretary of State revokes an approval, authorisation, licence or registration under paragraph (1)(b) or (c) and representations are made under regulation 11, the revocation remains in force during that appeals procedure. Appeals 11 1 Where a person in receipt of a notification does not agree with any action taken under these Regulations and wishes to appeal on a matter appealable under this regulation, that appellant may make written representations to a person appointed for the purpose by the Secretary of State concerning any decision of the Secretary of State within 21 days following receipt of the notification of the decision. 2 A person involved with the making of the decision may make written submissions to the appointed person concerning the decision within 21 days of receipt of the appellant's representations. 3 A report of the findings of the appointed person must be submitted in writing to the Secretary of State. 4 The Secretary of State must give to the appellant written notification of the Secretary of State's final determination and the reasons for it. 5 Unless the Secretary of State determines that action under these Regulations must be taken immediately due to a risk to public health or animal health or welfare, no action may be taken by the Secretary of State to kill any animal or destroy any thing under these Regulations until— a the 21 day period has expired without any appeal being lodged; b if there is an appeal, that appeal is determined or withdrawn. Valuations 12 1 This regulation applies when compensation is not fixed in accordance with a procedure laid down in these Regulations and where an individual valuation is required to establish the appropriate market value. 2 The owner and the Secretary of State may agree on an individual valuation. 3 If the owner and the Secretary of State cannot agree on a valuation, they may jointly nominate a valuer to carry out a valuation. 4 If the owner and the Secretary of State cannot agree on such a nomination, the President of the Royal Institution of Chartered Surveyors may nominate the valuer, and both the owner and the Secretary of State must accept that nomination. 5 Both the owner and a representative of the Secretary of State have the right to be present at a valuation meeting. 6 The nominated valuer must carry out the valuation and submit it and any other relevant information and documentation to the Secretary of State, and provide a copy to the owner. 7 The submitted valuation is binding on both the owner and the Secretary of State. 8 In this regulation, “ owner ” means the owner of the animal or product that is disposed of under these Regulations. Appointment and authorisation of inspectors 13 1 Except as specified in paragraph (2)— a a local authority may appoint inspectors, b the Secretary of State may appoint inspectors and veterinary inspectors, for the purposes of enforcing the EU TSE Regulation and these Regulations. 2 The Food Standards Agency may appoint inspectors and veterinary inspectors for the purposes of enforcing Schedules 7 and 8 in relation to a slaughterhouse or cutting plant. 3 The appointment of an inspector (whether under paragraph (1) or (2)) may be limited to powers and duties specified in the notification of appointment. 4 Inspectors may be authorised by the Secretary of State or the Food Standards Agency to carry out functions specified in a letter of authorisation. Powers of entry 14 1 An inspector may, on giving reasonable notice, and on producing a duly authenticated authorisation, enter any holding (except if used wholly or mainly as a private dwelling), vehicle, container, vessel or trailer at any reasonable hour for the purpose of ensuring compliance with the EU TSE Regulation and enforcing these Regulations. 2 The requirement to give notice does not apply where— a the requirement has been waived by the occupier; b reasonable efforts to identify the occupier have failed; c reasonable efforts to agree an appointment have failed; d an inspector has reasonable suspicion of a failure to comply with the TSE requirements. 3 A justice of the peace may sign a warrant to permit an inspector to enter any holding, vehicle, container, vessel or trailer, if necessary by reasonable force, if satisfied on sworn information in writing— a that there are reasonable grounds to enter for the purpose of executing or enforcing the TSE requirements, and b that any of the following conditions are met— i admission has been refused, or a refusal is expected, and (in either case) notification of an application for a warrant has been given to the occupier; ii asking for admission, or the giving of such a notification to the occupier, would defeat the object of the entry; iii entry is required urgently; iv the holding, vehicle, container, vessel or trailer is unoccupied or the occupier is temporarily absent. 4 A warrant under this regulation is valid for one month. 5 An inspector may be accompanied by such other persons as are considered necessary for the visit. 6 If an inspector enters any unoccupied holding, or where the occupier is temporarily absent, the inspector must leave the holding (so far as reasonably practicable) effectively secured against unauthorised entry as it was before entry. Powers of inspectors 15 1 In carrying out any functions under the these Regulations an inspector may— a seize any— i animal, ii body of an animal, and any parts of the body (including the blood and the hide) and any semen, embryo or ovum, iii animal protein or feedingstuffs that may contain animal protein, or iv milk or milk product, and dispose of them as necessary; b carry out any inquiries, investigations, examinations and tests; c collect, pen and inspect any animal and for this purpose may require the keeper of any such animal to arrange for the collection and penning of the animal; d inspect any body of an animal carcase and any parts of the body (including the blood and the hide) and any semen, embryo or ovum; e inspect any part of the holding, any equipment, facility, operation or procedure; f take any samples, including any samples that the Secretary of State requires to be taken in compliance with the United Kingdom's obligations under Annex 3; g seize or detain any cattle passport; h have access to, and inspect and copy any records (in whatever form they are held) in order to determine if these Regulations are being complied with, or remove such records to enable them to be copied; i have access to, inspect and check the operation of, any computer and any associated apparatus or material that is or has been in use in connection with any record; and for this purpose an inspector may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford such assistance as the inspector may reasonably require (including providing them with any necessary passwords) and, where a record is kept by means of a computer, may require the records to be produced in an accessible form; j mark anything (including an animal) whether electronically or otherwise, for identification purposes; k lock or seal any container or store. 2 A person must not deface, obliterate, or remove any mark or seal, or remove any lock, applied under paragraph (1)(j) or (k). 3 An inspector is not personally liable for anything done— a in the execution or purported execution of these Regulations, and b within the scope of their employment, if the inspector acted in the honest belief that their duty under these Regulations required or entitled them to do it; but this does not affect any liability of their employer. Notices 16 1 If it is necessary for any reason connected with the enforcement of the TSE requirements, an inspector may serve a notice on— a the owner or keeper of any animal; b the person in possession of the body or any part of the body of an animal (including the blood and the hide) or any semen, embryo or ovum; c the person in possession, or supplier, of any animal protein or feedingstuffs that may contain animal protein; d the owner, or person in possession, of any milk or milk products; e the occupier or person in charge of any holding, vehicle or container to which the these Regulations apply; f the occupier of a slaughterhouse. 2 A notice may— a require any action that an inspector reasonably believes is necessary for controlling the spread of disease; b prohibit or require the movement of any animal onto or from the holding specified in the notice; c prohibit the movement of any milk or milk products from the holding specified in the notice; d specify those parts of the holding to which an animal may or may not be allowed access; e require the killing of any animal; f prohibit or require the movement onto or from the holding specified in the notice of the body or any part of the body (including the blood and the hide) of any animal, any animal protein or feedingstuffs that may contain animal protein, and any animal semen, embryo or ovum; g require the disposal of the body or any part of the body (including the blood and the hide) of any animal (whether or not it is one that was required to be detained), and any semen, embryo, ovum, milk or milk product as may be specified in the notice; h require the disposal of any animal protein or feedingstuffs that may contain animal protein, or specify how they are to be used; i require that a person does not feed any animal protein or feedingstuffs that may contain animal protein to livestock, or may require that it is recalled; j require that all or any part of the holding, vehicle, vessel or container (and any associated equipment) is cleansed and disinfected where the inspector suspects there is a risk to animal or human health k require an occupier of a slaughterhouse— i to take a sample from bovine animals in accordance with paragraph 6 of Schedule 2, or ii to permit an official veterinarian to take brain stem samples from an ovine animal in accordance with paragraph 6 of Schedule 2. 3 A notice must be in writing, and specify— a the reason for the service of the notice; b the measures which that person must take; c any time limit for taking particular measures. 4 Any notice or licence may be amended, suspended or revoked in writing at any time. 5 A person must comply with the terms of a notice at their own expense, and if there is non-compliance an inspector may arrange to have it complied with at that person's expense. Notices restricting movement 17 1 If a notice is served restricting movements of any animal or product, an inspector may subsequently permit movement under the authority of a licence. 2 Any person transporting a restricted animal or product under the authority of a licence must carry the licence with them during any movement, and produce it on demand to an inspector. Offences and penalties 18 1 It is an offence— a to fail to comply with the TSE requirements; b to fail to comply with the requirements of any notice or licence served or issued under these Regulations; c to intentionally obstruct an inspector carrying out any functions (including the facilitation of samples taken by an inspector in accordance with paragraph 8 of Schedule 2) under the EU TSE Regulation or these Regulations; d without reasonable cause, fail to give to an inspector acting for the purpose of ensuring compliance with the EU TSE Regulation or these Regulations any assistance or information or provide any facilities that the inspector may reasonably require; e to give false or misleading information to an inspector for the purpose of ensuring compliance with the EU TSE Regulation or these Regulations; f to fail to produce a record when required to do so by an inspector acting under these Regulations. 2 A person guilty of an offence is liable on summary conviction to a fine. Corporate responsibility 19 1 If a breach of any TSE requirement is shown to be committed by a body corporate— a with the consent or connivance of an officer, or b attributable to any neglect on their part, the officer as well as the body corporate is liable to prosecution. 2 If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and defaults of a member in connection with their function of management as if they were a director of the body. 3 If a breach of any TSE requirement is shown to be committed by a partnership— a with the consent or connivance of a partner, or b attributable to any neglect on their part, the partner as well as the partnership is liable to prosecution. 4 If a breach of any TSE requirement is shown to be committed by an unincorporated association— a with the consent or connivance of an officer of the association or a member of its governing body, or b attributable to any neglect on the part of such an officer or member, that officer or member as well as the association is liable to prosecution. 5 In this regulation— “ officer ”, in relation to a body corporate or unincorporated association, means a director, member of the committee of management, chief executive, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity; “ partner ” includes a person purporting to act as a partner. Enforcement 20 1 The Secretary of State enforces Schedule 2 TSE monitoring requirements in slaughterhouses and cutting plants. 2 The Food Standards Agency enforces Schedule 7 and paragraph 1 of Schedule 8 in slaughterhouses and cutting plants. 3 Otherwise these Regulations are enforced by the local authority. 4 The Secretary of State may direct, in relation to any particular case that an enforcement duty imposed on the local authority must be discharged by the Secretary of State and not by the local authority. 5 Where the Secretary of State makes a direction under paragraph (4), the Secretary of State may delegate to the Director of Public Prosecutions functions in relation to the prosecution of an offence under these Regulations. Consequential amendments 21 1 In Schedule 3 of the Official Feed and Food Controls (England) Regulations 2009 , in paragraph (a)(viii), for “Transmissible Spongiform Encephalopathies (England) Regulations 2010” substitute “ Transmissible Spongiform Encephalopathies (England) Regulations 2018 ” . 2 The Animal By-Products (Enforcement) (England) Regulations 2013 are amended as follows— a in paragraph (1) of regulation 23 (powers of entry and additional powers)— i at the end of sub-paragraph (a) insert “ , and where the premises are either unoccupied or the occupier is temporarily absent, the authorised person must leave them as effectively secured against unauthorised entry as they were before entry ” ; ii omit sub-paragraphs (j) and (k); b in regulation 29(1) (transitional provisions), omit the words “for the period ending on 31st December 2014,”; c in Schedule 2, omit paragraph 10. Revocations 22 The statutory instruments listed in Schedule 9 are revoked. Transitional provisions 23 Any notice, licence, approval, authorisation, or registration issued, served, made or granted under the Transmissible Spongiform Encephalopathies (England) Regulations 2010 and which has effect at the coming into force of these Regulations remains in force as if it were issued, served, made or granted under these Regulations. Review 24 1 The Secretary of State must from time to time— a carry out a review of the regulatory provisions contained in these Regulations, and b publish a report setting out the conclusions of the review. 2 The first report must be published before 19th July 2023. 3 Subsequent reports must be published at intervals not exceeding 5 years. 4 Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulation must in particular— a set out the objectives intended to be achieved by the regulatory provision referred to in paragraph (1)(a), b assess the extent to which those objectives are achieved, c assess whether those objectives remain appropriate, and d if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision. 5 In this regulation, “ regulatory provision ” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act). Gardiner of Kimble Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs