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
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
19th December 1997
Memorandum by the Ministry
of Agriculture, Fisheries and Food
REGULATIONS 1997 (S.I. 1997/2965)
ORDER 1997 (S.I. 1997/2964)
1997 (S.I. 1997/3062)
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
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
(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
(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
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