(This note is not part of the Regulations)
These Regulations, which extend to Scotland, revoke and remake with amendments the Transmissible Spongiform Encephalopathies (Scotland) Regulations 2006.
These Regulations enforce 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 amended (“the EU TSE Regulation”). They also enforce—
(a) Commission Decision 2007/411 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;
(b) Commission Decision 2009/719 authorising certain Member States to revise their annual BSE monitoring programmes;
(c) Commission Regulations (EC) No. 956/2008 and (EC) No. 163/2009 amending Annex IV to the EU TSE Regulation; and
(d) Commission Regulation (EC) No. 103/2009 amending Annexes VII and IX to the EU TSE Regulation.

The main Regulations
The Regulations provide that the Scottish Ministers are the competent authority for the purposes of the EU TSE Regulation (except in Schedule 7 and paragraphs 1, 3 and 4 of Schedule 8, where the competent authority is the Food Standards Agency) (regulation 3) and provide an exception for research (regulation 4).
Part 2 introduces Schedules 2 to 8.
Part 3 deals with administration and enforcement.
Regulations 6 to 10 deal with approvals, authorisations, licences and registrations, occupier's duties, suspension, amendment and revocations of approvals, etc., and an appeals procedure.
Regulation 11 deals with valuations.
Regulations 12 to 14 give powers to the Scottish Ministers, the local authority and the Food Standards Agency to appoint inspectors, and deal with powers of entry and powers of inspectors. Regulation 15 provides for a notice procedure, and regulation 16 provides for licences permitting movement during a movement restriction.
Regulations 17 to 19 deal with obstruction of an inspector, penalties, and offences by a body corporate. A person guilty of an offence under these Regulations is liable—
(a) on summary conviction, to a fine not exceeding £10,000 (the statutory maximum) or to imprisonment for a term not exceeding twelve months or both; or
(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.
Regulation 20 details who is responsible for enforcing these Regulations.
Regulation 21 introduces Schedule 9 (consequential amendments).
Regulation 22 saves the miscellaneous amendments made by the Transmissible Spongiform Encephalopathies (Scotland) Regulations 2006.
Regulation 23 introduces Schedule 10 (revocations).

Schedule 1
Regulation 2(4) and Schedule 1 set out those EU instruments to which any reference should be construed as references to those instruments as amended from time to time.

Schedule 2
Schedule 2 deals with monitoring for TSEs. Paragraph 1 provides for notification to the Scottish Ministers of fallen stock that must be tested for TSEs under the EU TSE Regulation. Paragraphs 2 to 5 deal with the delivery, testing and retention of bodies of bovine animals for the purposes of monitoring under Article 6 of the EU TSE Regulation. Paragraph 4 makes it an offence to destroy the body of a bovine animal to which paragraph 1 applies before it has been tested. Paragraph 6 provides that paragraphs 1 and 2 do not apply in an island area as defined in that paragraph. Paragraph 7 makes it an offence to consign a bovine animal born or reared in the United Kingdom before 1st August 1996 to a slaughterhouse for human consumption or to slaughter such an animal for human consumption. Paragraphs 8 and 9 provide for brain stem sampling of specified bovine animals. Paragraph 10 provides for the approval of laboratories that test such brain stem samples and includes the following fees—
(a) £29,770 for the initial approval of a laboratory;
(b) £8,834 for annual proficiency testing and a follow-up inspection for the first year after approval;
(c) £4,135 for annual proficiency testing from the second year after approval;
(d) £1,385 for Single proficiency test (in the event of a failure in the annual proficiency testing); and
(e) £87.24 per hour for an inspector (for any additional inspections that are necessary to check for compliance with the terms of the approval).
Paragraph 11 deals with applications for approval as a sampling site.
Paragraph 12 creates a requirement for the occupier of a slaughterhouse (in which bovine animals that require BSE testing are slaughtered for human consumption) to have a Required Method of Operation (“RMOP”).
Paragraph 13 provides for retention of products and their disposal, paragraph 14 provides for TSE sampling of sheep, goats and deer and paragraph 15 deals with compensation.
Paragraphs 16 to 22 specify the minimum requirements that must appear in the RMOP.

Schedule 3
Schedule 3 deals with control and eradication of TSE in bovine animals. Paragraph 1 provides for notification of a suspect animal to the Scottish Ministers. Paragraphs 2 and 3 provide for the restriction and slaughter of notified and suspect animals. Paragraphs 4 and 5 deal with the offspring and cohorts of the suspect. Paragraph 6 provides for the notification and restriction of the carcases of animals that die or are killed while under restriction, and paragraph 7 prohibits the placing on the market of offspring.
Paragraphs 8 to 10 deal with compensation.

Schedule 4
Schedule 4 deals with control and eradication of TSE in sheep and goats. Paragraph 1 provides for notification of a suspect animal to the Scottish Ministers. Paragraphs 2 and 3 provide for the restriction and slaughter of the suspect animal. Paragraphs 4 and 5 deal with movement restrictions. Paragraphs 6 to 10 provide for action following confirmation. Paragraph 11 deals with derogations from the usual requirement of paragraphs 6 to 10. Paragraph 12 provides for time for appeals, and paragraph 13 provides for killing and destruction. Paragraphs 14 to 16 deal with infected animals from another holding, common grazing and multiple flocks on a holding. Paragraph 17 deals with subsequent occupiers of the land.
Paragraphs 18 to 20 set out the procedure to be followed after the killing or destruction. Paragraph 18 restricts the introduction of animals onto a holding. Paragraph 19 regulates the use of ovine germinal products, and paragraph 20 restricts the movement of animals from a holding.
Paragraph 21 requires the Scottish Ministers to establish the dates relating to restrictions. Paragraph 22 provides for notification of animals that die while under restriction. Paragraph 23 deals with placing on the market of first generation progeny, semen, embryo, and ovum of animals that are either suspected of, or confirmed with, a TSE. Paragraph 24 deals with compensation for a sheep or goat slaughtered as a suspect animal. Paragraph 25 sets out a table of compensation for a sheep or goat killed or products destroyed following confirmation of TSE. Paragraph 26 provides a process for dealing with disputed valuations. Paragraph 27 provides for compensation for milk and milk products destroyed as a result of inability to exclude BSE from sheep or goats.

Schedule 5
Schedule 5 deals with the control and eradication of TSE in animals that are not bovine, ovine, or caprine. Paragraphs 1 to 3 concern notification, restriction and slaughter of suspect animals. Paragraph 4 provides for compensation.

Schedule 6
Schedule 6 deals with feedingstuffs. Paragraphs 1 to 3 prohibit feeding specified feedingstuffs to ruminant and non-ruminant animals, and provide for exceptions. Paragraphs 4 and 5 provide for movement restrictions and slaughter of animals suspected of having been fed prohibited feedingstuffs, and paragraph 6 provides for compensation. Paragraph 7 prohibits the slaughter or sale for human consumption of restricted animals.
Paragraphs 8 to 10 regulate the production and use of fishmeal for feeding to non-ruminant animals and unweaned, ruminant farmed animals. Paragraphs 11 and 12 regulate feedingstuffs containing dicalcium phosphate or tricalcium phosphate. Paragraphs 13 and 14 regulate feedingstuffs containing blood products and blood meal.
Paragraph 15 makes provision for changes in use of equipment. Paragraphs 16 and 17 control the manufacture, storage and transport of processed animal protein and products containing it. Paragraph 18 controls exports to third countries, and paragraph 19 regulates fertilisers derived from animal protein. Paragraph 20 deals with records, and paragraph 21 deals with cross-contamination.

Schedule 7
Schedule 7 deals with specified risk material, mechanically recovered meat and slaughtering techniques. Paragraph 1 appoints the Food Standards Agency as the competent authority for this Schedule. Paragraph 2 makes provision for training of staff in slaughterhouses and cutting plants where specified risk material is removed.
Paragraph 3 deals with mechanically separated meat, paragraph 4 with pithing, paragraph 5 with tongue harvesting and paragraph 6 with head meat harvesting.
Paragraph 7 controls the removal of specified risk material. Paragraph 8 deals with bovine animals in a slaughterhouse and paragraph 9 deals with sheep and goats in a slaughterhouse.
Paragraph 10 deals with bovine animals, sheep and goats at other places of slaughter.
Paragraph 11 deals with young lamb and goat stamps.
Paragraph 12 deals with the removal of spinal cord from sheep and goats.
Paragraph 13 provides for the authorisation of cutting plants to remove certain specified risk material and paragraph 14 controls the removal of specified risk material at a cutting plant authorised under paragraph 13(1).
Paragraph 15 deals with meat from other Member States.
Paragraph 16 requires the staining and disposal of specified risk material and paragraph 17 provides for the security of specified risk material.
Paragraph 18 prohibits the sale, supply or possession for sale or supply of specified risk material for human consumption.

Schedule 8
Schedule 8 deals with the export of live bovine animals and products derived from them to other Member States and to third countries. Paragraphs 1 and 2 prohibit the export of bovine animals and products to other Member States and to third countries, paragraph 3 restricts the export of heads and un-split carcases containing specified risk material to other Member States, and paragraph 4 prohibits the export of bovine heads and meat containing specified risk material to third countries. Paragraph 5 provides cross-references to other relevant offence provisions in these Regulations.
Schedules 9 and 10
Schedule 9 makes consequential amendments to other statutory instruments and Schedule 10 contains revocations.
A regulatory impact assessment has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Scottish Government Rural Directorate, Pentland House, 47 Robb's Loan, Edinburgh EH14 1TY and from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.