Joint Committee on Statutory Instruments Twenty-First Report


Voluntary Memorandum by the Ministry of Agriculture, Fisheries and Food



1  The purpose of this memorandum is to explain why it is considered necessary to lay the above instruments before Parliament less than twenty-one days before they come into force.

2.  The Specified Risk Materials Order 1997 is made under the Animal Health Act 1981 and the Specified Risk Material Regulations under the Food Safety Act 1990. Together they consolidate and extend the existing controls on the use of specified risk material (SRM) - those parts of cattle, sheep and goats which may pose a risk of transmissible spongiform encephalopathy (TSE) infection. Previously, these controls have applied only to cattle slaughtered in the UK and to the heads of sheep and goats. The new legislation extends the controls to SRM from all countries, and to a wider range of sheep and goat offals.

3.  This action is being taken in response to advice given by the Spongiform Encephalopathy Advisory Committee (SEAC), which recommended in May 1997 that it would be prudent in the interests of public health to extend SRM controls to the spleen of sheep and goats, the spinal cord of older sheep and goats, and to imports of SRM or items containing SRM from all countries except those where there was no known risk of BSE.

4.  Agreement was secured in July to European measures to give effect to controls of the kind SEAC were recommending, which was to be implemented by Commission Decision 97/534. This was due to apply from 1 January 1989, and required the removal and destruction of SRM from animals slaughtered in the Community. It also provided that imports of SRM from third countries were banned, and food, feed and cosmetic and pharmaceutical imports would have to be accompanied by a certificate from the veterinary authorities in the country of production, certifying that no SRM had been used in their production.

5.  It has subsequently become clear however that Decision 97/534 will create serious practical difficulties for the cosmetic and pharmaceutical industries. These industries depend on gelatin and tallow - both products which in the absence of controls would usually be derived in part from SRM imported from third countries, particularly, the USA, which do not currently apply such controls. Other industries, such as bone china production which also depend on imported bones which contain SRM, will also be seriously affected. In the light of these problems, the Commission is reconsidering Decision 97/534: a replacement decision was put to the Standard Veterinary Committee on December 8/9, but was not voted on because of various Member States' concerns. It will be discussed by the Committee again on 15 December, and may be referred to the Agriculture Council which is meeting at the same time, but the likely outcome is unclear.

6.  Because of this uncertainty, the UK has now delayed adopting the measures required to give effect to Decision 97/534, and thus to SEAC's advice on last May. As it appears that the Agriculture Council and/or Standing Veterinary Committee will either fail to reach a decision on revising the Decision, or possibly delay implementation until later in 1998, and seven months have elapsed since SEAC gave its original advice, the Minister of Agriculture, Fisheries and Food has concluded that any further delay would pose a sufficiently serious risk to health that unilateral adoption of measures giving effect to SEAC's advice is now justified. The necessary measures are contained in the two instruments to which this memorandum refers.

7.  The Department regrets that it has been necessary to break the twenty-one day rule. However, the proposals contained in the two attached instruments (other than the import ban) were the subject of a consultation in October, so those affected by the measures have been made aware of the substantive requirements. In relation to the import ban, those importing products into the UK would have expected them to be required to be free of SRM by virtue of Decision 97/534.

8.  The Committee will note that the majority of the powers in the Animal Health Act under which the Specified Risk Materials Order is made are not subject to any Parliamentary procedure. Orders under section 10 are however required to be laid after making (although not subject to any further procedure). The Department considers that although it is not normally possible to combine instruments made under different procedures, since general statutory instruments even if they are not required to be laid are nevertheless subject to scrutiny, it was permissible in the circumstances to include all the relevant provisions in a single instrument laid before each House of Parliament.

10th December 1997

Voluntary Memorandum by the Ministry of Agriculture, Fisheries and Food


1.  This memorandum is submitted to explain why the Ministry considers it necessary to lay the Specified Risk Material (Amendment) Regulations 1997 before Parliament less than twenty-one days before they come into force.

2.  The Regulations are being made to amend the Specified Risk Material Regulations ("the Principal Regulations") to remove two unintended burdens which have been identified since those Regulations were made earlier this week. The Principal Regulations were made together with the Specified Risk Material Order 1997 in response to advice given by the Spongiform Encephalopathy Advisory Committee. A copy of the memorandum submitted with the Principal Regulations and that Order is enclosed.

3.  The first unintended burden is the application of the extended specified risk material controls in respect of sheep and goats to carcases of sheep and goats in storage on 1st January 1998 elsewhere than at licensed slaughterhouses or authorised cutting premises. Long term storage of these carcases other than at licensed slaughterhouses or authorised cutting premises was not identified during the consultation on the Principal Regulations, as such long term storage is not customary in the production and marketing to the consumer of sheep and goat meat, and the Ministry has only this week been made aware of one such premises and is now checking for others. The Ministry believes it is therefore necessary to ensure that the new controls do not apply unintentionally to such storage of carcases from animals already slaughtered when the Principal Regulations come into force.

4.  The other unintended burden relates to the prohibition in regulation 7 of the Principal Regulations. It applies unintentionally to food containing specified risk material, derived from animals slaughtered outside the United Kingdom, which is either a food not listed in Schedule 1 to the Specified Risk Material Order 1997 or which is such a food but was, or has ingredients containing specified risk material which were, imported in accordance with article 6 of that Order. Regulation 7 is amended to provide that the prohibitions in it do not apply to such food.

5.  Having identified the representative organisations substantially affected by the amendments the Ministry has consulted them rapidly on the Specified Risk Material (Amendment) Regulations 1997 to ensure that the Regulations can be made, laid before Parliament and brought into force in time to avoid the unintended application of these two burdens in the principal Regulations.

6.  The Ministry regrets that it has been necessary to break the twenty-one day rule in making these Regulations.

7.  The Committee will also wish to be aware of developments at European Community level in relation to SRM controls since the memorandum accompanying the Principal Regulations was prepared. The Commission proposed to the Standing Veterinary Committee on 15 December that application of Decision 97/534 (which was to have applied Community wide controls on the removal, use and import of SRM) be deferred from 1st January until 1st April 1998. This was accepted by a qualified majority of Member States (all save the UK voting for deferment), and the Decision referring the implementation date of 97/534 was adopted by the Commission on []

8.  Speaker's Counsel has raised with Mr Fitch the question of to what extent the SRM Order and Regulations 1997 implement Community obligations. Since the implementation date of Decision 97/534 (imposing Community wide controls on SRM) has been deferred from 1 April 1998, the UK legislation is unilateral (except for the obligation to remove SRM from cattle slaughtered in the UK, which is required by Commission Decision 94/474/EC). The Ministry considers that the UK is entitled to adopt the legislation as an interim protective measure, taken on serious public health grounds, in accordance with the safeguard procedure (article 9(1)) penultimate paragraph) of Council Directive 89/662/EEC (concerning veterinary checks on intra-Community trade in products of animal origin). The Committee may be interested to know that some other Member States (certainly France) are also taking unilateral action. The measures have been notified to the Commission and other Member States in accordance with Article 9(1) of Directive 89/662, and also as technical standards under the Technical Standards Directive 83/189/EC.

19th December 1997

Memorandum by the Ministry of Agriculture, Fisheries and Food




This memorandum is in response to the Committee's request for a memorandum on the following points -

    (1) Explain when these instruments were published, and the reason for any delay in publication. If the instruments were published after they came into force, explain what steps have been taken for the purpose of bringing them to the notice of the public or persons likely to be affected by them.

The earlier explanatory memoranda to the Committee explained why it was not possible to meet the 21-day rule in laying these instruments before Parliament. For the same reasons it was not possible to make early preparations for publication. It is also unfortunate that this coincided with the Christmas period. In addition, the original proof of the Specified Risk Material Order 1997 was mislaid by the printer.

Full texts of the legislation were placed on the Ministry's Internet sit on 17 December. They remain accessible in this form. In addition, copies were sent to enforcement authorities. Comprehensive details of the requirements of the legislation, including detailed guidance notes on the Specified Risk Material Regulations 1997, were sent to interested parties before Christmas.

      (2) Article 10(2) of the Order requires the Minister to approve premises for processing material if he is satisfied that -

      (a)  the operator has in place a [sufficient] tracing system; and

      (b)  does not pose a risk to human or animal health

      Identify the subject of "does not pose a risk".

The subject of the condition in article 10(2)(b) was intended to be the manufacturing process undertaken at the approved premises. Unfortunately (in attempting to improve drafting previously contained in article 21 of the Specified Bovine Material Order 1997) the words "the manufacturing process" were accidentally omitted from the beginning of sub-paragraph (b). The Ministry regrets this error, but considers that a court would be likely to interpret (b) to mean "no risks will be posed to human health". The words occur in a provision which governs approval by the Minister, and this is the interpretation which he will adopt.

It is expected that the SRM Order will be amended or replaced in March or April of this year, after the European Commission have adopted Community-wide measures relating to the control of SRM replacing those in Commission Decision 97/534. If the policy set out in article 10 remains possible in the light of the new Commission Decision, we will ensure that the drafting is corrected at that time.

      (3) Regulation 27(1) and Order article 11(1) impose the same obligations in relation to the carriage in containers of specified risk material. Explain -

      (a) what difference (if any) there is in the scope of "specified risk material" in the Regulations and in the Order;

      (b) What respective criminal penalties would apply for breach of this regulation and this article.

      (4) Regulation 27(2) and Order article 11(2) impose the same obligation as respects the circumstances in which food may be placed in the same part of the vehicle as had carried specified risk material. Explain what respective criminal penalties would apply for breach of this regulation and this article.

      (5) Regulation 28(1)(2) and Order article 12(1)(2) impose the same obligation as respects the separation in storage of specified risk material and food. Explain what respective criminal penalties would apply for breach of this regulation and this article.

      (6) Explain why (to the extent indicated above) the same obligations are imposed by the Regulations and by the Order.

The definitions of Specified Risk Material contained in the Order and the Regulations are identical in all respects save that the Regulations define the carcases of sheep and goats which are removed to be rendered whole from the place where they die or were slaughtered as class II specified sheep and goat material, and hence as SRM. (This provision, which allows for the on-farm disposal of sheep dying there, is not relevant to the SRM Order).

Penalties for breach of the Regulations are set out in regulation 29. Regulation 29(2) provides that contravention of any provision of the Regulations (thus including regulations 27(1), (2) and 28(1)) is an offence, punishable on summary conviction with a fine not exceeding the statutory maximum, and on indictment by a fine and/or up to two years imprisonment. Regulation 29 reflects the penalties set out in Section 35 of the Food Safety Act 1990, save that imprisonment is not stipulated in the Regulations as a penalty available on summary conviction.

The doing of anything in contravention of an order made under the Animal Heath Act 1981 (the legal base for the SRM Order) is an offence by virtue of section 73 of that Act. The maximum penalty prescribed by Section 75 of the Act applicable to breaches of articles 11(1), (2) and 12(1) of the SRM Order is a fine not exceeding level 5 on the standard scale, together with an additional fine not exceeding level 3 of the standard scale in respect of each 508 kg of material in excess of 508 kg, where an offence is committed in relation to more than 508 kg of material. Section 75 provides for summary process only.

Given the potential risk to public and animal health posed by SRM, it is important that nothing likely to be ingested by humans or animals comes into contact with it. For this reason it is important that SRM is stored and transported in an appropriate manner. Since they are made under the Food Safety Act, the SRM Regulations can only impose controls on the storage and transport of SRM in proximity to food. Since BSE has been declared a zoonosis, broader powers exist under the Animal Health Act to take action necessary for the protection of public (as well as animal) health. Hence the controls in the SRM Order relate to food, feeding stuffs, medical, pharmaceutical and cosmetic products.

While regulation 27(1)/article 11(1) and, inasmuch, as they relate to food, regulation 27(2)/article 11(2) and regulation 28(1)/article 12(1) impose the same obligation, it was considered helpful to the reader of legislation that they should do so. Since the Order relates to imports and to the use of SRM in animals feeds, cosmetic and pharmaceutical products, while the SRM Regulations deal with the removal and disposal of SRM from ruminants, and the prohibition of its use in food, an importer would not need to consider the provisions of SRM Regulations, while the operator of a slaughterhouse would not refer to the Order. Thus only by putting substantially the same provision in other sets of legislation could it readily be ensured that all those dealing with SRM were aware of all the obligations relevant to them. While the maximum penalty for contravention of the Regulations is more severe, the likelihood is that contravention of the provision dealing with storage and transport would be dealt with summarily, and would be subject to fines at or below the level set in the Animal Health Act.

27th January 1998

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