FOOD SAFETY Citation and commencement 1 These Regulations, which relate to material which may contain the agent causing bovine spongiform encephalopathy and which implement paragraph 3( a ) of Article 3 of Commission Decision 94/474/ EC (concerning certain protection measures relating to bovine spongiform encephalopathy and repealing Decision 89/469/ EEC and 90/200/EEC ) may be cited as the Specified Bovine Material (Treatment and Disposal) Regulations (Northern Ireland) 1997 and shall come into operation on 1st May 1997. Interpretation 2 1 In these Regulations— “approved” means approved by the Department; “the Department” means the Department of Agriculture; “intestines” means that part of the digestive tract of a bovine animal from the junction of the abomasum and the duodenum to (and including) the rectum; “ the Order ” means the Food Safety (Northern Ireland) Order 1991; “pharmaceutical” does not include products intended for veterinary use; “processed” means processed in accordance with the provisions of Article 6 of the SBM Order ; “the SBM Order” means the Specified Bovine Material Order (Northern Ireland) 1997 ; “scheme animal” means a bovine animal— which has been slaughtered pursuant to the purchase, slaughter and disposal scheme introduced under Commission Regulation (EC) No. 716/96 adopting exceptional support measures for the beef market in the United Kingdom; or which, being an animal which has been exposed to the infection of bovine spongiform encephalopathy, the Department has caused to be slaughtered in accordance with the provisions of paragraph 10A of Part I of Schedule 2 to the Diseases of Animals (Northern Ireland) Order 1981 ; “sell” includes have in possession for sale or offer or expose for sale; “slaughterhouse” means any building, premises or place for slaughtering animals the flesh of which is intended for sale for human consumption; “specified bovine material” means— subject to paragraph ( d ) of this definition, the head (including the brain but excluding the tongue), spinal cord, spleen, thymus, tonsils and intestines of a bovine animal six months old or over which has died in the United Kingdom or has been slaughtered there; the thymus and intestines of a bovine animal two months old or over but less than six months old which has died in the United Kingdom or has been slaughtered there; the thymus and intestines of a bovine animal under two months old which has been slaughtered in the United Kingdom for human consumption; subject to paragraph (4), the head (including the brain and the tongue), spinal cord, spleen, thymus, tonsils and intestines of a scheme animal; and specified solid waste, and includes anything left attached to such material after dissection of the carcase and any animal matter which comes into contact with the material after it has been removed from the carcase, but does not include the whole carcase; “specified solid waste” means any solid matter resulting from the slaughter of bovine animals, or from the subsequent processing of their carcases, which is collected in any part of the drainage system draining any place where specified bovine material is handled; “stain” in relation to any material, except in regulation 8(8), means treat (either by immersion, spraying or other application) with a 0.5% weight/volume solution of the colouring agent Patent Blue V (E131,1971 Colour Index No. 42051 ) in such a way that the colouring is clearly visible over the whole surface of the material; “tallow” means fat derived from animal tissues by a process of cooking; and “vertebral column” means the whole or any part thereof and includes the sacrum but does not include the coccygeal vertebrae. 2 In these Regulations the expression “mechanical means” does not include the use of hand powered knives which do not use powered pressure or suction. 3 The provisions of these Regulations shall apply to specified bovine material from a scheme animal, except that the provisions appearing in Column 1 of the Table in the Schedule shall apply only to the extent, and subject to the modifications, specified in Column 2 thereof. Approvals 3 1 The Department may, on application made to it, approve any premises for the purposes of these Regulations if it is satisfied that such premises are properly equipped to carry out the functions to which the approval relates and comply with the requirements of these Regulations. 2 Any approval granted under these Regulations— a shall be in writing; b may be made subject to conditions; and c if the Department is satisfied that the conditions of these Regulations, or any additional conditions in the approval are not being complied with, may be amended, suspended or revoked at any time by notice in writing served on the person to whom the approval was granted. Prohibition of sale of specified bovine material for human consumption 4 1 A person shall not sell any specified bovine material, or any food containing specified bovine material, for human consumption. 2 A person shall not use any specified bovine material in the preparation of food for sale for human consumption. 3 A person shall not sell any specified bovine material for use in the preparation of food for human consumption. 4 For the purposes of this regulation “specified bovine material” includes anything derived from it. Specified bovine material for use in cosmetic, pharmaceutical and medical products 5 1 A person shall not sell any cosmetic, pharmaceutical or medical product containing specified bovine material. 2 A person shall not use any specified bovine material in the preparation of any cosmetic, pharmaceutical or medical product. 3 A person shall not sell any specified bovine material for use in the manufacture of any cosmetic, pharmaceutical or medical product. 4 For the purposes of this regulation, “specified bovine material” includes anything derived from it. Prohibitions applying to the vertebral column 6 1 A person shall not use the vertebral column of a bovine animal in the recovery of meat by mechanical means. 2 A person shall not use, in the preparation of food for sale for human consumption, any meat which has been recovered by mechanical means from the vertebral column of a bovine animal. 3 A person shall not use the vertebral column of a bovine animal from which meat has been cut, to produce food other than fat or gelatin for sale for human consumption. Registration of premises on which meat is recovered by mechanical means from bovine animals 7 1 A person shall not on any premises recover meat by mechanical means from the carcase of a bovine animal unless his name and the address of those premises are registered with the Department. 2 The Department shall keep a register for the purposes of paragraph (1). 3 An application for registration under paragraph (1) shall be in writing and be in such form and manner as the Department may require. 4 The Department shall refuse to register under paragraph (1) the name of any person in respect of any premises unless the following particulars are notified to it in writing, that is to say— a the business name, if any; b the name and address of the person who carries on the business; c the address and telephone number of the business; d the address of each premises at which meat is recovered by mechanical means from a bovine animal in the course of the business. 5 A person whose name is registered under paragraph (1) in respect of any premises shall notify the Department in writing of any change in the particulars previously notified to it under paragraph (4) within 14 days of any such change. Initial treatment of bovine carcases in a slaughterhouse 8 1 When a bovine animal is slaughtered in a slaughterhouse, or slaughtered elsewhere than in a slaughterhouse but brought immediately to a slaughterhouse to be dressed for human consumption, the occupier of the slaughterhouse (in this regulation referred to as “the occupier”) shall ensure that all specified bovine material is removed from the rest of the carcase. 2 Subject to the following provisions of this regulation, the occupier shall ensure that specified bovine material (other than the head) which has been removed from a bovine animal is immediately, and in any event before it is frozen, stained. 3 The occupier shall ensure that the head removed from a bovine animal is stained immediately, except that, if the tongue is to be removed from the head, this shall be done immediately after slaughter of the animal and the head shall be stained immediately after removal of the tongue. 4 The occupier shall ensure that the specified bovine material does not come into contact with any other animal material while in the slaughterhouse and that it is disposed of in accordance with these Regulations. 5 Material which is not specified bovine material may be separated from intestines which have been removed from the carcase before the intestines are stained. 6 In the case of specified bovine material which is intended to be examined by or on behalf of an officer of the Department or a veterinary surgeon, the specified bovine material shall not be stained until after the completion of such examination. 7 The requirement to stain specified bovine material shall not apply in the case of specified bovine material which is intended to be used for a manufacturing purpose in accordance with Article 8 of the SBM Order or regulation 16. 8 In the case of a scheme animal, the occupier shall ensure that, once the specified bovine material has been removed, the remainder of the carcase (excluding the hide) is stained immediately with a 0.5% weight/volume solution of the colouring agent Tartrazine E102, Colour Index No. 19140, in such a way that the colouring is clearly visible over the whole surface. 9 The occupier of any slaughterhouse where specified bovine material is removed from the carcases of bovine animals shall, in consultation with an authorised officer, establish a staff training programme to train persons employed in the slaughterhouse to comply with the requirements of these Regulations which relate to the activities they perform on those premises. 10 The occupier of any slaughterhouse shall permit an authorised officer or a person acting under their responsibility to— a inspect the carcase of any bovine animal slaughtered there, so as he can check whether the requirements of these Regulations have been complied with in relation to it; and b mark each carcase which has been so checked and found to comply with the requirements of these Regulations, and shall give to the authorised officer such reasonable assistance as he may require for the purpose. Initial treatment of specified bovine material elsewhere than at a slaughterhouse 9 1 Subject to the provisions of this regulation, when specified bovine material is removed from the carcase of a bovine animal elsewhere than in a slaughterhouse, the occupier of the premises at which the specified bovine material is removed (in this regulation referred to as “the occupier”) shall ensure that it is stained immediately, and in any event before it is frozen. 2 The occupier shall ensure that the specified bovine material does not come into contact with any other animal material while on the premises and that it is consigned in accordance with Article 9 of the SBM Order and disposed of in accordance with these Regulations. 3 In the case of specified bovine material which is intended to be examined by or on behalf of an officer of the Department or a veterinary surgeon, the specified bovine material shall not be stained until after the completion of such examination. 4 The requirement to stain specified bovine material shall not apply in the case of specified bovine material which is intended to be used for a manufacturing purpose in accordance with Article 8 of the SBM Order or regulation 16. 5 The provisions of this regulation shall not apply in the case of a post-mortem examination carried out by a veterinary surgeon or a veterinary practitioner at a farm provided that he makes arrangements for the disposal of the whole carcase by burial there. Exceptions from the requirement to stain specified bovine material 10 1 The requirements in regulations 8 and 9 to stain specified bovine material shall not apply— a if the specified bovine material is to be sent to a veterinary or medical school, laboratory, hospital or similar institution for instructional, diagnostic or research purposes; or b to specified solid waste, provided that it is stored separately from all other animal materials and is clearly identified as specified bovine material. 2 A person shall not transport specified bovine material to premises specified in paragraph (1)( a ) unless the specified bovine material is in a container marked with— a the words “specified bovine material”; b the place of destination; and c the name of the person to whom it is being sent. 3 Any person delivering specified bovine material to premises specified in paragraph (1)( a ) shall state in writing to the occupier of the premises the place from which the specified bovine material was collected for delivery. 4 The person to whom the specified bovine material is consigned in accordance with this regulation shall record on its arrival— a the weight of the specified bovine material delivered; b the date of delivery; and c the place from which it was consigned, and shall keep such records for two years from the date of arrival. 5 Any person to whom specified bovine material is consigned in accordance with this regulation (in this regulation referred to as the “consignee”) shall not consign that material except to other premises specified in paragraph (1)( a ) or in Article 9(1) of the SBM Order, and where he does so he shall keep a record for two years from the date of consignment of the weight consigned, the date it was consigned and the destination of the specified bovine material. 6 When the specified bovine material is no longer needed for the purposes for which it was consigned under this regulation, the consignee shall— a ensure that it is buried or effectively destroyed on the premises to which it was consigned under this regulation or is consigned to premises specified in Article 9(1) of the SBM Order for destruction; b ensure (where specified bovine material is consigned for destruction in accordance with sub-paragraph ( a )) that the specified bovine material is stained before consignment; and c keep a record for two years of the place and method of burial or destruction. Measures in relation to stained specified bovine material 11 Where specified bovine material has been stained in accordance with regulations 8, 9 and 10 the occupier of any premises at which that specified bovine material is stored or handled and, in the case of a place approved under regulation 14 or Articles 5 or 6 of the SBM Order, the operator of that place shall take appropriate measures to ensure that colouring remains over the whole surface of it until it is incinerated or rendered in accordance with regulation 14 or Article 6 of the SBM Order. Prohibition on the removal of the brain and eyes of a bovine animal 12 1 A person shall not in any premises remove the brain or eyes from the head of a bovine animal over six months except— a for the purposes of veterinary or scientific examination or research; and b in a part of the premises kept free at all times from food intended for human consumption, and any cosmetic, pharmaceutical or medical product, or any ingredient of any such product. 2 The prohibition in paragraph (1) shall not apply to the removal under Article 29 of the Order of the eyeballs of bovine animals at the place of slaughter by a veterinary inspector or other authorised officer of the Department for the purposes of analysis under Article 31(1) of the Order. Prohibition on the removal of the spinal cord of a bovine animal 13 1 A person shall not remove the spinal cord or any part of it from the vertebral column of a bovine animal aged six months or over or longitudinally split the vertebral column of such an animal except in a slaughterhouse or for the purposes of veterinary or scientific examination. 2 If the spinal cord is removed in a slaughterhouse, it shall be disposed of as specified bovine material in accordance with these Regulations. 3 If the spinal cord is removed at any premises other than a slaughterhouse for the purposes of veterinary or scientific examination, after that examination both the spinal cord and the vertebral column shall be disposed of as specified bovine material in accordance with these Regulations. Approved incinerators 14 1 Any person delivering specified bovine material to an approved incinerator shall state in writing to the operator of the incinerator the place from which that specified bovine material was collected for delivery to that incinerator. 2 A person shall not operate an incinerator for incinerating specified bovine material unless— a the incinerator has been approved by the Department as having suitable facilities to incinerate specified bovine material in accordance with paragraph (4); b he disposes of the ash in such a way that it does not pose a risk to human health; and c the incinerator is equipped with a refractory lining and is heated by fuel conveyed into the incinerator during incineration by mechanically forced draught. 3 The operator of an approved incinerator shall record on arrival of specified bovine material at the premises— a the weight of the specified bovine material delivered; b the date of delivery; and c the place from which it was consigned, and shall keep such records for two years from the date of arrival. 4 The operator of an approved incinerator shall— a incinerate all specified bovine material delivered to him to the standard specified in the approval and in such a way that all moisture is removed and the material is reduced to ash; and b ensure that all ash is disposed of in accordance with the terms of the approval. 5 A person shall not remove specified bovine material from an approved incinerator unless it has been completely incinerated. Disposal of processed specified bovine material 15 1 After specified bovine material has been processed and separated into protein and tallow in a rendering plant licensed under Article 6(1) of the SBM Order the operator of the rendering plant shall ensure that— a all protein is placed in a container labelled “specified bovine material” and— i disposed of by burial at a landfill site for which there exists a disposal licence granted under Article 7 of the Pollution Control and Local Government (Northern Ireland) Order 1978 ; or ii sent to premises licensed under Article 8(1) of the SBM Order or approved under regulation 16 for use in a manufacturing process; or iii sent to an approved incinerator for incineration; and b all tallow is placed in a container labelled “specified bovine material” and— i disposed of by burial at a landfill site for which there exists a disposal licence granted under Article 7 of the Pollution Control and Local Government (Northern Ireland) Order 1978; or ii sent to premises licensed under Article 8(1) of the SBM Order or approved under regulation 16; iii sent to an approved incinerator for incineration. 2 Protein and tallow produced from animal material, other than specified bovine material, from scheme animals shall be disposed of by burning in an approved incinerator and for this purpose regulation 14 shall apply in relation to such material as if it were specified bovine material. 3 The operator of any rendering plant licensed under Article 6 of the SBM Order shall keep a record for two years of the weight of protein consigned from the plant in accordance with this regulation and a separate record of the weight of tallow consigned, and in each case the date of such consignment and the place of destination. Approved premises not connected with food, pharmaceuticals, medical products and cosmetics 16 1 Upon the Department being satisfied that— a any premises are suitable to process specified bovine material for use in a manufacturing process; b that such manufacture is not in any way connected with food, pharmaceuticals, medical products or cosmetics and does not pose a risk to human health; and c that the operator of the premises has in place a system for tracing through the manufacturing process of all specified bovine material delivered to him sufficient to demonstrate— i that all specified bovine material delivered is either used in the manufacturing process or disposed of in accordance with conditions specified in the approval; and ii that no product manufactured in the process is used as, in connection with or in the manufacture, of any food, pharmaceutical, medical product or cosmetic, it may approve those premises for the purposes of processing specified bovine material for use in a manufacturing process. 2 A person shall not process specified bovine material at premises approved by the Department in accordance with paragraph (1) except in accordance with the provisions of the licence. 3 A person delivering specified bovine material to premises approved under this regulation shall state in writing to the operator of the premises concerned the place from which that specified bovine material was collected for delivery to those premises. 4 A person shall not process specified bovine material at premises approved under this regulation except in accordance with the conditions of the approval. 5 The operator of premises approved under this regulation shall record on the arrival of specified bovine material at the premises— a the weight of the specified bovine material delivered; b the date of delivery; and c the place from which it was consigned, and shall keep such records for two years from the date of arrival. Powers to give directions 17 1 If the Department is satisfied that specified bovine material cannot be disposed of in accordance with these Regulations, whether for reason of mechanical breakdown of equipment or otherwise, it may give written directions to the owner or person in control of the specified bovine material for its disposal in a safe manner. 2 In the event of any person not complying with directions given to him under paragraph (1), the Department may make arrangements for the disposal of the specified bovine material to which the direction relates at the expense of the owner. Storage 18 1 Subject to paragraph (2), a person shall not store specified bovine material in the same room as food, cosmetics, pharmaceutical or medical products or the ingredients of such products. 2 The prohibition in paragraph (1) shall not apply where an authorised officer or an officer of the Department has approved the storage of specified bovine material in the same room as food, cosmetics, pharmaceutical or medical products or any ingredients thereof on being satisfied that the arrangements for storage will ensure the adequate separation of the specified bovine material from the food, product or ingredient, as the case may be. Offences 19 A person who contravenes these Regulations or any direction given under these Regulations, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 5 on the Standard Scale. Enforcement 20 These Regulations shall be enforced and executed by the Department. Application of the Order 21 1 The provisions of the Order set out in paragraph (2) shall apply for the purposes of these Regulations as they apply for the purposes of the Order and, accordingly, any reference in the provisions set out in paragraph (2) to the Order shall be construed as including a reference to these Regulations. 2 The following are the provisions of the Order mentioned in paragraph (1), that is to say— a Article 2(4) and 3 (extended meaning of “sale” etc. ); b Article 4 (presumptions that food intended for human consumption); c Article 8 (inspection and seizure of suspected food); d Article 19 (Offences due to fault of another person); e Article 20 (Defence of due diligence); f Article 34 (obstruction, etc., of officers); g Article 35 (time limit for prosecutions). Revocations 22 The Specified Bovine Material (Treatment and Disposal) (No. 3) Regulations (Northern Ireland) 1996 and the Specified Bovine Material (Treatment and Disposal) (No. 3) (Amendment) Regulations (Northern Ireland) 1996 are hereby revoked. Sealed with the Official Seal of the Department of Agriculture on P. T. Toal Assistant Secretary 30th April 1997.