Guidance on the Transmissible Spongiform Encephalopathies (TSE) Regulations (NI) 2010

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European Commission legislation lays down rules for the prevention, control and eradication of certain Transmissible Spongiform Encephalopathies (TSE) such as Bovine Spongiform Encephalopathy (BSE) in cattle and scrapie in sheep in the European Union (EU).  These rules have been managed and enforced in Northern Ireland (NI) by a series of TSE Regulations.

The Regulations were first introduced in Northern Ireland in 2002, and were updated and amended in 2006 and 2008.  Since then, there have been a number of amendments made to the EU TSE Regulations which has resulted in the requirement to update the NI 2008 domestic Regulations to reflect these and various operational and technical changes.  These changes also reflect the declining prevalence of BSE in cattle, new controls on milk and milk products derived from sheep and goats in which a TSE is suspected or confirmed and technical advances in line with the European Commission.  The Transmissible Spongiform Encephalopathies (NI) Regulation 2008 are now being replaced by the Transmissible Spongiform Encephalopathies Regulations (NI) 2010.  These Regulations will come into effect 31 December 2010.

This guidance is particularly relevant to the sheep and goat dairy industry, feed industry and meat industries as it provides guidance to those who have to comply with in order to meet the EU Regulation and provides offences for non compliance with the Regulations.  Although this document contains general guidance, further detailed technical guidance is available on the DARD website or from the local DARD Veterinary Office.  This guidance may also be of interest to anyone in the livestock sector, or involved with TSEs.

This guidance is only relevant in Northern Ireland.  England and Scotland have introduced similar TSE Regulations, while Wales anticipate the introduction of their regulations by the end of 2010 or early in 2011.  Links to the English and Scottish TSE Regulations can be found at the bottom of this page.

These guidance notes have been produced by the Department of Agriculture and Rural Development (DARD), to provide informal advice in a user friendly format, to any person or business in complying with the Transmissible Spongiform Encephalopathies (TSE) European Commission Regulations and who may be affected by introduction of the new TSE Regulations (NI) 2010.

The purpose of the Transmissible Spongiform Encephalopathies Regulations (Northern Ireland) 2010 is to amend arrangements for managing and enforcing the European Union (EU) Regulation (EC 999/2001) in Northern Ireland.  It provides the requirements with which those in the livestock, meat and feed industries have to comply with in order to meet the EU Regulation and provides offences for non compliance with the Regulations.

EU requirements are directly applicable to EU countries/ member states and their requirements must be complied with.

There have been a number of amendments to the European Union TSE Regulation since the introduction of the 2008 Regulations.  These include the European Commission Regulations (EC) Nos 956/2008, 103/2009, and 163/2008.  These amendments reflect the declining prevalence of BSE in cattle and new scientific advice and technical advances.

There is an exemption from TSE testing requirements for fallen animals that die on Rathlin Island and the Copeland Islands which have been designated as remote areas under the EU TSE Regulation.

There is a new requirement for BSE testing of over 48 month old animals slaughtered by cattle keepers on their own premises for their own consumption (home-slaughtered).  However, as from the 1 July 2011 the age limit has increased from over 48 to over 72 months for those healthy animals home slaughtered for human consumption.  At ‘risk cattle’ (ante mortem failures, casualties etc) will remain under the TSE Regulations (NI) 2010 to be tested at over 48 months.

The Regulations remove the requirement for slaughterhouses slaughtering animals aged between 30 and 48 months to have a Required Method of Operation (RMOP).  The Food Standards Agency Board has agreed that only plants processing animals eligible for BSE testing should require an approved RMOP in relation to the removal of vertebral column as Specified Risk Material.

The Regulations also remove the requirement to dispose of the milk of a cow suspected of being infected with a TSE.  However, the milk would still be banned from use for human consumption by EC Food Hygiene Regulation 853/2004 which requires that raw milk for human consumption must come from animals which are in a good general state of health.

The Regulations implement the requirements of Regulation (EC) No. 103/2009 which introduced controls to reduce the risk of spreading BSE or classical scrapie to ruminant animals in uninfected flocks and herds through consumption of sheep and goats milk and milk products.  The controls place restrictions on sheep and goat milk and milk products from a holding in which a TSE is suspected or classical scrapie is confirmed.

Provision for payment of compensation by DARD for cases in Northern Ireland for sheep and goat milk compulsorily destroyed where BSE cannot be excluded.

Provision for farmers wishing to take advantage of the derogation which allows member States to delay the killing and destruction of genetically susceptible sheep and all goats following confirmation of scrapie in a flock subject to certain conditions.

Inspectors are empowered to serve a notice to prohibit the movement of sheep or goat milk or milk products from a holding on which a TSE is suspected in sheep or goats, while permitting its use within the holding of origin.

Sheep or goat milk or milk products from a holding on which classical scrapie is confirmed, produced prior to the removal of all goats and genetically susceptible sheep, may not be used as feed for ruminants (except on the holding of origin) or exported as feed for non ruminants requirements regarding storage and transportation must be complied with for national markets.

Inspectors are empowered to serve a notice to destroy sheep or goat milk or milk products produced between the dates of official suspension and killing, on a holding on which BSE cannot be excluded after testing in sheep or goats.  In this case only DARD would pay compensation for milk and milk products which would be valued according to market price for cases in Northern Ireland.  

Farmers will be required to identify sheep and goats on holdings on which atypical scrapie is confirmed, as directed by the Department.

The Regulations allow for a derogation in the EU Regulations allowing Member States to delay the culling of goat herds in which classical scrapie has been confirmed for 5 years or 18 months in respect of dairy flocks/herds, by enabling farmers to apply in writing to the Department setting out the reasons for the application.  The Department would consider applications and an appeals process would apply to applications approved in part or refused.  The Department would also be able to apply the derogation without the need for an application from the farmer.

Provision for the feeding of fishmeal to unweaned ruminants in reconstituted milk replacer in line with Regulation (EC) No. 956/2008, whilst maintaining the existing ban on feeding fishmeal to adult ruminants.

The feeding to all farmed animals, of feed materials of plant origin and feed containing such products, in which insignificant amounts of bone fragments of environmental origin had been detected, would be permitted on the basis of a favourable risk assessment, in line with Regulation (EC) 163/2009.  The export of pet food containing processed animal proteins (PAP) of ruminant origin would be permitted, provided that it is produced and labelled in accordance with the Animal By-Product Regulations.

In the case of cattle and sheep/goat green offal, the occupier of the slaughterhouse as soon as reasonably practicable after post mortem inspection, will be required to consign any offal that has been removed from the carcase and that contains or is attached to specified risk material to an appropriate area of the slaughterhouse.  Once there the specified risk material must be removed as soon as reasonably practicable.

The new offences are as follows:

Inspectors have the power to serve a notice on the owner, keeper or person in possession in relation to any animal, body or parts of the body of any animal, semen, embryo, ovum, animal protein or feeding stuffs that may contain animal protein or the owner in possession of any milk or milk products.  The notice may prohibit movement; require killing or slaughter of animals or disposal of the items.

Serious breaches of the Regulations are liable to prosecution and if found guilty of an offence the penalties are as follows:

The Regulations will be enforced by the Department of Agriculture and Rural Development with the exception of Schedule 7 (Specified Risk Material, Mechanically Separated Meat and slaughtering techniques) and points 1, 3 and 4 of Schedule 8 (Restrictions on placing on the Market and Export).  These will be enforced by the Food Standards Agency.

For the purpose of these Regulations, Transmissible Spongiform Encephalopathies (TSE) are fatal brain diseases suffered by a variety of species most commonly Bovine Spongiform Encephalopathy (BSE) in cattle and Scrapie in sheep and goats.

The Transmissible Spongiform Encephalopathies (TSE) Regulations provide the powers to manage and enforce the requirements of European Commission (EC) legislation on the prevention, control and eradication of TSEs.  There have been a number of amendments to the EC Regulation since the domestic Transmissible Spongiform Encephalopathies Regulations (NI) 2008 came into force; therefore the 2008 Regulations are required to be updated to reflect these.

The main changes are:

If you are a sheep and goat dairy farmer and TSE is suspected or confirmed in your flock/herd you will be unable to move milk or milk products from your farm or premises, but you can use them within the holding.  Where you have a case of classical scrapie confirmed in an animal or flock, you will be unable to use the milk or any milk product you have produced, prior to the removal of affected sheep and all goats, as feed for ruminants (except on the holding of origin).

No, you will be unable to export the milk and milk products as feed for non ruminants and you would have to comply with storage and transport requirements in relation to the milk and milk product for national markets.

Compensation will only be payable to farmers for milk or milk products compulsorily destroyed where BSE cannot be ruled out.

Rathlin and the Copeland Islands have been declared as remote areas in agreement with the European Union (EU) TSE Regulation. Bovine/Cattle over 48 months or ovine/sheep and goats over 18 months which die on Rathlin will not be required to be TSE tested.  However, you will be required to dispose of any dead animals/carcases in compliance with the Animal By-Products (NI) Regulations 2003.

Yes, if the animal is a healthy bovine, it will required to be tested for BSE at over 72 months due to the increase in the EU TSE Testing age change which came into effect from 1 July 2011.  However, if it is an at ‘risk bovine’ (casualty, ante mortem failure etc)  it will require testing under the TSE Regulations at over 48 months.  You will need to arrange delivery of the head of the animal to a Department approved laboratory for the removal of the brainstem sample for testing.  You will need to hold on to the carcase and all body parts (including the blood and hide) until the test has been carried out and a negative result is received.  You will also need to remove Specified Risk Material (SRM), e.g. any tissues most likely to hide BSE infection from the carcase. SRM’s must be disposed of as Category 1 material, in compliance with the Animal By-Product (NI) Regulations 2003.

You will be required to dispose of the carcase and all body parts (including the blood and hide) as category 1 material to AFBI for incineration under Veterinary Service guidance and supervision.  There will also be further controls on your herd regarding potential cohorts and offspring in the event of a positive case.

You can find details of the Department's approved laboratories for BSE testing at Index number 9 below.

You will be required to meet the sampling and disposal costs at an estimated £20 per animal to the cattle keeper and the Department will pay the associated testing costs.

For advice and guidance on the home slaughter for consumption of any bovine animal you should contact your local DARD Veterinary Office.  A list of offices and numbers can be found at the bottom of this guidance.

A guidance leaflet entitled, 'Home Slaughter of Livestock' is also available from the Food Standards Agency (NI) and can be obtained on the FSA Website www.food.gov.uk or by telephoning 028 9041 7700.

In 2008 the EU adopted Regulation 956/2008 which allows the feeding of fishmeal to un-weaned ruminants in reconstituted milk replacer.  This followed the European Food Standards Agency opinion, a Community Reference Laboratory report on significant improvement in performance of tests to detect traces of mammalian meat and bone meal in fishmeal and a scientific assessment of the dietary need of young ruminants.  This concluded that fishmeal is a highly digestible protein source with good amino acid profile and a high calcium/ phosphorus content compared with vegetable protein sources. Scientific Encephalopathy Advice Committee (SEAC) concluded that the risk of BSE infections arising from the feeding of feed containing fishmeal to young ruminants was likely to be very low to negligible.

If you wish to bring milk replacer containing fishmeal onto your farm or premises, you will have to be registered with the Department.  The milk replacer would have to come from mills authorised by the Department and labelled and transported in compliance with EU requirements.  These conditions are similar to those for feed currently for non-ruminant animals.

To register with the Department and receive information to comply with the regulations, you should contact your local DARD Veterinary Office.  A list of offices and numbers can be found at the bottom of this guidance.

In 2009, EU Regulation extended the scope of conditions allowing the use of root crops in which bone fragments have been detected to cover all feed products of plant origin.  However, it only applies were there is an unavoidable presence of insignificant amounts of animal bone fragments arising from e.g. soil, rodents, and birds and is subject to a favourable Veterinary Service risk assessment as to whether the feed would pose a risk of generating new TSE infections.

If you handle only bovine animals under 48 months of age you will no longer be required to have an approved method of operation (RMOP).  The RMOP will apply only to meat plants slaughtering animals over 48 months of age which require to be tested for BSE.

Also, in the case of bovine and ovine green offal you will be required, as soon as reasonably possible after post mortem inspection, to transfer any offal that has been removed from the carcase and that contains or is attached to specified risk material. It is to be removed to an appropriate area of the slaughterhouse and as soon as is reasonably practicable after the offal is consigned there and before it is removed from the slaughterhouse.

For further information and or advice on how the Regulations may affect you and what you need to do to comply, you should contact your Divisional Veterinary / DARD Direct Office.  Details of local offices can be found by visiting the DARD website:  DARDNI Divisional Veterinary Offices.