Animal Health PART I GENERAL PROVISIONS Citation and commencement 1 These Regulations may be cited as the Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2018 and come into operation on 3rd January 2019. 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 Passport Regulations (Northern Ireland) 1999 ; “ 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 Regulation (EC) No. 999/2001 and repealing Decision 2005/598/EC ; “cutting plant” (except in Schedule 7, paragraph 9(3)(b)(iii)) has the meaning given to it in paragraph 1(17) of Annex I to Regulation (EC) No. 853/2004 , and is an establishment which 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; “ the Department ” means the Department of Agriculture, Environment and Rural Affairs; “ 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 programmes ; “ inspector ” means an inspector appointed under regulation 13, and includes a veterinary inspector; “ keeper ” in relation to an animal means any natural or legal person responsible for that animal whether on a permanent or temporary basis including during transportation or at a market; “ market value ” means— in the case of a bovine animal, the price which might reasonably have been obtained for the animal at the time of valuation from a purchaser in the open market if the animal was not required to be killed under Schedule 3; and in the case of an ovine or caprine animal, the price which might reasonably have been obtained for the animal at the time of valuation from a purchaser in the open market if the animal was not from a flock or herd affected by a TSE; “official document” must be construed in accordance with regulation 7(1); “ offal ” has the meaning given to it in point 1(11) of Annex I to Regulation (EC) No. 853/2004 ; “ premises ” includes— domestic premises if they are being used for any purpose in connection with the EU TSE Regulation or these Regulations; land and outbuildings; a slaughterhouse; a place that is, for the purposes of point 4(1)(a) of Annex V, another place of slaughter; and any vehicle, container or structure (moveable or otherwise); “ Regulation (EC) No. 853/2004 ” means Regulation (EC) No. 853/2004 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 and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC ; 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 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No. 854/2004 of the European Parliament and of the Council and Regulation (EC) No. 882/2004 of the European Parliament and of the Council derogating from Regulation (EC) No. 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No. 853/2004 and (EC) No. 854/2004 ; “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; “ Regulation (EC) No. 1069/2009 ” means Regulation (EC) No. 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption as implemented by Commission Regulation EU No. 142/2011 ; “ restriction ” includes any prohibition under these Regulations; “ slaughterhouse ” has the meaning given to it in point 1(16) of Annex I to Regulation (EC) No. 853/2004 , and is an establishment which is approved or conditionally approved as such by the Food Standards Agency under Article 148(3) of Regulation (EU) 2017/625 ; “ specified risk material ” has the meaning given to it in Article 3(1)(g); “ third country ” means any country which is not a member State of the EU; “ TSE ” means transmissible spongiform encephalopathy; and “ veterinary inspector ” means a person appointed by the Department as a veterinary inspector. 2 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, and references in these Regulations to Articles or Annexes are to Articles or Annexes of the EU TSE Regulation. 3 References in these Regulations to the following EU instruments— a The EU TSE Regulation; b Regulation (EC) No. 853/2004 ; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d Commission Decision 2007/411/EC ; e Commission Decision 2007/453/EC ; f Commission Decision 2009/719/EC ; g Regulation (EC) No. 1069/2009 ; and h Commission Regulation (EU) No. 142/2011 ; are references to those EU instruments as amended from time to time. 4 The Interpretation Act (Northern Ireland) 1954 shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly. Appointment of competent authority 3 The Department is the competent authority for the purposes of the EU TSE Regulation except as otherwise specified in these Regulations. Exception for research 4 1 The provisions of Schedules 2 to 8 do not apply in relation to an animal, a carcase or a sample kept for the purposes of research in premises approved for that purpose under this regulation by the Department. 2 If a bovine, ovine or caprine animal, kept in approved research premises under this regulation or its progeny dies or is killed, the occupier must dispose of it as a Category 1 animal by-product in accordance with Regulation (EC) No. 1069/2009 and failure to do so is an offence. PART II TSE CONTROLS TSE requirements 5 1 For the purposes of Article 11, any person who has in their possession or under their control any animal suspected of being infected with a TSE must immediately notify the Department and detain it on such premises as the Department may specify until it has been examined by a veterinary inspector. 2 Any veterinary surgeon who examines or inspects any such animal must, with all practical speed, notify the Department. 3 Any person who examines the carcase of an animal in a laboratory and who reasonably suspects the presence of a TSE must immediately notify the Department and retain the carcase until a veterinary inspector has authorised disposal. 4 Any person must comply with the TSE requirements identified in Schedule 1, and— a any instructions given by an inspector and co-operate with the Department in delivering the TSE monitoring requirements as set out in Annex III; b any instructions given by an inspector and co-operate with the Department in taking action to control and eradicate TSE as set out in Annex VII; c the requirements in Annex IV for the production, use of equipment, packaging, storage and transport of animal feed; d Annex IV animal feeding requirements; e the prohibitions concerning animal feeding contained in Article 7, unless the animal feed products are produced using production and manufacturing processes approved by the EU Commission; f with the requirements for dealing with specified risk material contained in Article 8 and Annex V and Schedule 7; g the restrictions set down in Schedule 8; and h the provisions in Annex VIII concerning the placement of animals or products on the market or for export. 5 Failure to comply with this regulation is an offence. The Schedules 6 The following Schedules have effect— a Schedule 1 (TSE requirements); b Schedule 2 (TSE monitoring); c Schedule 3 (control and eradication of TSE in bovine animals); d Schedule 4 (control and eradication of TSE in ovine and caprine animals); e Schedule 5 (control and eradication of TSE in animals other than bovine, ovine or caprine animals); f Schedule 6 (feedingstuffs); g Schedule 7 (specified risk material, mechanically separated meat and slaughtering techniques); and h Schedule 8 (restrictions on placing on the market and export). PART III ADMINISTRATION AND ENFORCEMENT Approvals, authorisations, licences and registrations 7 1 The Department must grant an approval, authorisation, licence or registration under these Regulations (“an official document”) if it is satisfied that the provisions of the EU TSE Regulation and these Regulations will be complied with. 2 An official document must be in writing, and must specify— a the address of the premises to which it relates; b the name of the occupier; and c the purpose for which it is granted. 3 An official document may be made subject to such conditions as are necessary to— a ensure that the provisions of the EU TSE Regulation and these Regulations will be complied with; or b protect public or animal health. 4 If the Department refuses to grant an official document, or grants one subject to conditions, it must— a give its reasons in writing; and b explain that the applicant has the right to make written representations to a person appointed by the Department. 5 The appeals procedure in regulation 11 then applies. Occupier's duty 8 The occupier of any premises approved, authorised, licensed or registered under these Regulations commits an offence if they do not ensure that— a the premises are maintained and operated in accordance with— i any condition of the approval, authorisation, licence or registration; ii the requirements of the EU TSE Regulation and these Regulations; and b any person employed by them, and any person permitted to enter the premises, complies with those conditions and requirements. Suspension and amendment of official documents 9 1 The Department may suspend or amend an official document if— a any of the conditions under which it was granted are not fulfilled; or b it is satisfied that the provisions of the EU TSE Regulation or of these Regulations are not being complied with. 2 The Department may amend an official document if the Department considers it necessary in the light of technical or scientific developments. 3 A suspension or amendment under this regulation— a may have immediate effect if the Department considers it necessary for the protection of public or animal health; b otherwise it must not have effect for at least 21 days from notification. 4 A suspension or amendment of an official document under this regulation must be notified to the holder thereof and must— a be in writing; b state when the suspension or amendment comes into effect; c give the reasons; and d explain that the person who has been notified has the right to make written representations to a person appointed by the Department. 5 The appeals procedure in regulation 11 then applies. 6 If the suspension or amendment under this regulation does not have immediate effect and representations are made under regulation 11, it must not have effect until the final determination of the appeal by the Department unless the Department 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 official documents 10 1 The Department may revoke an official document if it is satisfied that the premises to which it relates will not be operated in accordance with the EU TSE Regulation or these Regulations, and if— a the document is currently suspended and the period for appeal under regulation 11 has expired or the Department has upheld the suspension following such appeal; b the Department has previously suspended the document and there is further non-compliance with the EU TSE Regulation or these Regulations; or c the Department is satisfied that the occupier no longer uses the premises for the purpose for which the document was granted. 2 Notification of the revocation of an official document must— a be in writing; b state when the revocation comes into effect; c give the reasons; and d explain that the person who has been notified has the right to make written representations to a person appointed by the Department. 3 If the Department revokes an official document under paragraph (1)(b) or (1)(c) the appeals procedure in regulation 11 applies but the revocation remains in force during that appeals procedure. Appeals 11 1 A person may, within 21 days of the date of notification of a decision to which this regulation applies, make written representations concerning the decision to a person appointed for the purpose by the Department. 2 The Department may make written submissions to the appointed person concerning its decision. 3 The appointed person must then report in writing to the Department which must make a final determination in relation to the decision to which the report relates. 4 That final determination may affirm, vary or revoke the decision to which the report relates. 5 The Department must give to the appellant written notification of its final determination and the reasons for it. 6 Unless the Department determines that action under these Regulations must be taken immediately due to a risk to public health or human health or welfare, no action may be taken by the Department 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. 7 A person who is aggrieved by the final determination of the Department under paragraph (5) may, within 21 days of the issuing of the notification of the determination, appeal against that determination to a court of summary jurisdiction. Valuations 12 1 This regulation applies when a valuation is necessary under these Regulations. 2 The value of anything for the purposes of these Regulations must be initially assessed by the Department and notified, in writing, to the owner. Value must be determined by agreement between the owner and the Department and that agreement must be final and binding on both the owner and the Department. 3 If the owner and the Department fail to agree the value, the owner must select a valuer (“the nominated valuer”) from a list of approved valuers provided by the Department and notify the Department of the name and address of the nominated valuer within 2 working days of receipt of the list. 4 The owner must, within 5 working days of notification to the Department under paragraph (3), arrange for the nominated valuer to determine the value of the thing in question and must be liable for any fees or other expenses incurred by the valuer in carrying out the valuation. 5 The nominated valuer must carry out the valuation within 5 working days of appointment and give to the owner and the Department a statement in writing of that valuation. 6 The valuation is binding on both the owner and the Department. 7 Where the owner or the nominated valuer fails to comply with paragraph (3), (4) or (5) as the case may be, the Department must determine the value of the thing in question. 8 In this regulation “ owner ” means the owner of the animal or product in question. Appointment of inspectors 13 1 The Department must appoint inspectors for the purposes of the enforcement of the EU TSE Regulation or these Regulations except as specified in paragraph (2). 2 The Food Standards Agency must appoint inspectors for the purposes of enforcing Schedule 7 and paragraphs 1, 3 and 4 of Schedule 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 the powers and duties specified in the appointment. Powers of entry 14 1 Inspectors have a right to enter any premises for the purpose of ensuring that the EU TSE Regulation or these Regulations are being complied with. 2 They must, if so required, produce some duly authenticated document showing their authority before exercising their right under paragraph (1). 3 They may exercise their right under paragraph (1) at all reasonable hours. 4 They may take with them such other persons as they consider necessary. 5 If inspectors enter any unoccupied premises or (where the premises are occupied) the occupier of the premises is temporarily absent they must leave those premises (so far as reasonably practicable) as effectively secured against unauthorised entry as they found them. 6 If a lay magistrate, on sworn complaint in writing, is satisfied that there are reasonable grounds for entry into any premises for the purposes of the enforcement of these Regulations, and— a admission has been refused, or a refusal is expected, and (in either case) notice to apply for a warrant has been given to the occupier; b asking for admission, or the giving of such a notice, would defeat the object of the entry; c the case is one of urgency; or d the premises are unoccupied or the occupier is temporarily absent, the lay magistrate may by a signed warrant authorise inspectors to enter the premises, if need be by reasonable force. 7 A warrant under this regulation is valid for one month. Powers of inspectors 15 1 Inspectors 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 or arrange their disposal 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 and any parts of the body (including the blood and the hide) and any semen, embryo or ovum; e inspect any part of the premises, any equipment, facility, operation or procedure; f take any samples; g have access to, inspect and copy any records (in whatever form they are held) in order to determine if these Regulations are being complied with, including records kept under the EU TSE Regulation and these Regulations, or remove such records to enable them to be copied; h 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 may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford the inspectors such assistance as they may reasonably require (including the provision of any necessary passwords) and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away; i mark or tag anything (including an animal) whether electronically or otherwise, for identification purposes; and j lock or seal any container or store. 2 Any person who defaces, obliterates, or removes any mark, tag, seal or lock applied under paragraph (1) is guilty of an offence. 3 Inspectors are not personally liable for anything they do— a in the execution or purported execution of these Regulations; and b within the scope of their employment, if they 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 EU TSE Regulation or these Regulations inspectors 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; or d the owner, or person in possession, of any milk or milk products. 2 The notice must be in writing. 3 The notice may— a prohibit or require the movement of any animal onto or from the premises specified in the notice; b prohibit the movement of any milk or milk products from the premises specified in the notice; c specify those parts of premises to which an animal may or may not be allowed access; d require the killing or slaughter of any animal; e prohibit or require the movement onto or from premises, 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; f 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; g require the disposal of any animal protein or feedingstuffs that may contain animal protein or specify how they are to be used; or h require the recall of any animal protein or feedingstuffs that may contain animal protein. 4 If inspectors suspect that any premises, vehicle or container to which the EU TSE Regulation or these Regulations apply constitutes a risk to animal or public health, they may serve a notice on the occupier or person in charge of the premises, vehicle or container requiring that person to cleanse and disinfect all or any part of the premises, vehicle or container and any associated equipment. 5 A notice may specify how it must be complied with and the time limit for compliance. 6 A notice must be complied with at the expense of the person on whom it is served, and if it is not complied with an inspector may arrange to have it complied with at that person's expense. 7 A notice served may be amended, suspended, revoked or withdrawn by a further notice. 8 Failure to comply with a notice is an offence. Notices restricting movement 17 1 If a notice is served restricting movement of any animal or product, inspectors may subsequently permit that movement under the authority of a licence. 2 A person moving anything under the authority of a licence must carry the licence with them during the movement and produce it on demand to an inspector or an officer of the Police Service of Northern Ireland, and failure to do so is an offence. Obstruction 18 A person is guilty of an offence if that person— a intentionally obstructs an inspector acting under these Regulations; b without reasonable cause, fails to give to an inspector acting under these Regulations any assistance or information or to provide any facilities that the inspector may reasonably require that person to give or provide for the performance of the inspector's functions under these Regulations; c gives false or misleading information to an inspector acting under these Regulations; or d fails to produce a record when required to do so by an inspector acting under these Regulations. Penalties 19 A person guilty of an offence under these Regulations is liable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term of three months or both; or b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. Enforcement 20 1 The Food Standards Agency enforces in slaughterhouses and cutting plants— a Schedule 7; and b paragraphs 1, 3 and 4 of Schedule 8. 2 Otherwise these Regulations are enforced by the Department. Consequential amendment 21 In Schedule 3 of the Official Feed and Food Controls Regulations (Northern Ireland) 2009 , in paragraph (a)(viii), for “Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2010” substitute “ Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2018 ” . Revocation 22 The Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2010 are revoked. Transitional Provisions 23 Any notice, licence, approval, authorisation, or registration issued, served, made or granted under the Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2010 and which has effect at the coming into operation of these Regulations remains in force as if it were issued, served, made or granted under these Regulations. Sealed with the Official Seal of the Department of Agriculture, Environment and Rural Affairs on 13th December 2018. Jackie Robinson A senior officer of the Department of Agriculture, Environment and Rural Affairs