2001/257/EC: Commission Decision of 30 March 2001 laying down the conditions for the control and eradication of foot-and-mouth disease in the United Kingdom in application of Article 13 of Directive 85/511/EEC (Text with EEA relevance) (notified under document number C(2001) 1041)
Date: 2001-03-30
Institutions: European Commission
Subjects: United Kingdom, cattle, disclosure of information, exchange of information, foot-and-mouth disease, slaughter of animals, vaccination

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COMMISSION DECISION

of 30 March 2001

laying down the conditions for the control and eradication of foot-and-mouth disease in the United
Kingdom in application of Article 13 of Directive 85/511/EEC

(notified under document number C(2001) 1041)

(Text with EEA relevance)

(2001/257/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 90/425/EEC of 26 June
1990 concerning veterinary and zootechnical checks applicable
in intra-Community trade in certain live animals and products
with a view to the completion of the internal market (1), as last
amended by Directive 92/118/EEC (2), and in particular Article
10 thereof,

Having regard to Council Directive 85/511/EEC of 18
November 1985 introducing Community measures for the
control of foot-and-mouth disease (3), as last amended by the
Act of Accession of Austria, Finland and Sweden, and in partic-
ular Article 13(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

The control measures for foot-and-mouth disease laid
down in Directive 85/511/EEC are aimed at eradicating
the disease as quickly as possible by stamping out of
infected, contaminated or in-contact herds, applying
strict movement controls on animals of susceptible
species and products derived from such animals and
surveillance in the affected area to substantiate prior to
lifting the control measures the absence of virus circula-
tion.

However,
in Article 13(3) of Directive 85/511/EEC
provisions are made for emergency vaccination where
the disease expands.

The principles provided for in this Article require to
balance the decision on resorting to vaccination against
basic Community interests which must not be endan-
gered.

Following the reports of outbreaks of foot-and-mouth
disease in the United Kingdom, France, the Netherlands
and Ireland, the Commission adopted Decisions 2001/
172/EC (4), 2001/208/EC (5), 2001/223/EC (6) and 2001/
234/EC (7) concerning certain protection measures with

(1) OJ L 224, 18.8.1990, p. 29.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 315, 26.11.1985, p. 11.
(4) OJ L 62, 2.3.2001, p. 22.
(5) OJ L 73, 15.3.2001, p. 38.
(6) OJ L 82, 22.3.2001, p. 29.
(7) OJ L 84, 23.3.2001, p. 62.

(5)

(6)

(7)

(8)

(9)

(10)

(11)

regard to foot-and-mouth disease in the respective
Member State.

In addition to the measures within the framework of
Directive 85/511/EEC, the United Kingdom apply the
pre-emptive killing of susceptible animals in holdings
situated in close proximity to infected or suspect hold-
ings, taking into account the epidemiological situation,
the high density of susceptible animals in certain parts
of the territory and the poor expression of clinical signs
in certain susceptible species.

Killing of animals for disease reasons must be carried
out in accordance with Council Directive 93/119/EEC of
22 December 1993 on the protection of animals at the
time of slaughter or killing (8).

Large scale killing of animals of infected or contami-
nated holdings may quickly exhaust the capacities for
safe destruction of carcasses and thereby unavoidably
delay the pre-emptive killing and this may lead to the
amplification and spread of the virus.

The competent authorities of the United Kingdom have
presented to the Commission a programme to employ
protective vaccination in bovine animals under certain
clearly defined conditions as an additional instrument to
control and eradicate foot-and-mouth disease in connec-
tion with the pre-emptive killing of animals of other
susceptible species in defined densely populated live-
stock areas.

In its report of 10 March 1999 the Scientific Committee
on Animal Health and Animal Welfare made recommen-
dations on the strategy for emergency vaccination
against foot-and-mouth disease, which must be taken
into account (9).

Recourse to any kind of vaccination will inevitably jeop-
ardise the foot-and-mouth disease status in terms of
international trade not only for the Member State or part
of its territory where vaccination is carried out.

The Commission prior to taking a Decision on emer-
gency vaccination must ensure that the measures to be
taken include at least those provided for in Article 13(3)
first to sixth indent of Directive 85/511/EEC.

(8) OJ L 340, 31.12.1993, p. 21.
(9) http://europa.eu.int/comm/food/fs/sc/scah/outcome_en.html

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(12)

It is the purpose of this Decision to define the condi-
tions under which the United Kingdom may apply emer-
gency vaccination and to outline the follow-up measures
applicable to vaccinated animals and products derived
from such animals.

(13)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

HAS ADOPTED THIS DECISION:

Article 1

For the purpose of this Decision the following definitions shall
apply:

1.

‘Pre-emptive killing’ shall mean the killing of susceptible
animals on holdings within a certain radius around holdings
placed under the restrictions laid down in Articles 4 or 5 of
Directive 85/511/EEC.

It is aimed at the urgent reduction of numbers of animals of
susceptible species in an infected area.

2.

‘Protective vaccination’ shall mean emergency vaccination of
bovine animals in identified holdings situated in a defined
area, the ‘vaccination zone’, which is carried out exclusively
in conjunction with pre-emptive killing of certain categories
of sheep and other animals of susceptible species as defined
in paragraph 1.

It is aimed at an urgent reduction of the amount of virus
circulating and the risk of virus spreading beyond the peri-
meters of the area, and is subjected to the condition that
to pre-emptive
such vaccinated animals are not subject
killing.

Article 2

1. Without prejudice to Directive 85/511/EEC, and in
particular Articles 4, 5 and 9 thereof, and without prejudice to
Decision 2001/172/EC, the United Kingdom may decide on
resorting to protective vaccination under the conditions set out
in Annex I.

2.
Before commencing the measures referred to in para-
graph 1, the United Kingdom shall ensure that the Member
States and the Commission are officially and fully informed on
the details concerning the geographical and administrative defi-
nition of
the number of holdings
affected, the time when vaccination will be started and accom-
plished, and of the circumstances motivating the decision to
implement the measures.

the vaccination zone,

Subsequently the United Kingdom shall ensure that the infor-
mation submitted in accordance with the first subparagraph is
completed and updated without undue delay, in particular with
regard to the details concerning the number of holdings and
animals affected, and the modifications of
the restrictions
applied in the areas concerned.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 30 March 2001.

For the Commission

David BYRNE

Member of the Commission

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Conditions for the use of protective vaccination in the control and eradication of foot-and-mouth disease in
application of Article 13(3) of Directive 85/511/EEC

ANNEX I

Extent of the geographical area in which protective
vaccination is to be carried out

The vaccination zone shall be within an area defined in Annex II.

The restrictions applicable in the vaccination zone shall be those in Annex III of this
Decision, without prejudice to the provisions in Article 9 of Directive 85/511/EEC.

Species and age of the animals to be vaccinated

All bovine animals over 1 week of age independently of their sex and gestational or
productive status.

Duration of the vaccination campaign

The vaccination campaign shall be completed within 14 days.

Specific standstill of vaccinated animals and products
of vaccinated animals

Measures laid down in Annex III and the treatments of products derived from
vaccinated bovine animals as laid down in Annexes IV, V, VI-A and VI-B.

identification and special registration of the

Special
vaccinated animals

— Identification of all bovine animals in accordance with Regulation (EC) No

1760/2000 (OJ L 204, 11.8.2000, p. 1),

— on the spot ear-tagging of calves less than 20 days of age and application of an

indelible mark with subsequent issuing of passport,

— marking of vaccination status in the passport,

— entering vaccination details in the database established in accordance with

Regulation (EC) No 1760/2000

Other matters appropriate to the protective vaccination

Adjustment of zones established in accordance with
Article 9 of Directive 85/511/EEC

A surveillance zone of at least 10 km around the vaccination zone referred to in
point 1.

Period for which the measures applied in the zones
established in accordance with Article 9 of Directive
85/511/EEC are maintained

Without prejudice to the provisions in Article 9 of Directive 85/511/EEC and of
Commission Decision 2001/172/EC the measures applied in the vaccination zone
must remain in force until the measures are lifted in accordance with point 6.6.

1.

2.

3.

4.

5.

6.

6.1.

6.2.

6.3.

Execution of the vaccination campaign

6.4.

Vaccine to be used

Vaccination must be carried out under the direction of a veterinary surgeon of the
competent authorities. Necessary measures must be in place to avoid possible
spread of virus. Any residual quantities of vaccine must be returned to the point of
vaccine distribution with a written record on number of animals vaccinated and the
number of doses used.

The inactivated vaccine of at least 100 PD
to be used must be suitably formulated
50
for the species concerned and be effective against the virus type circulating. It shall
be used in accordance with the instructions of the manufacturer.

6.5.

Information on implementation of this programme to
the Commission

A detailed report on the execution of the programme shall be provided to the
Commission and the Member States in the framework of a Standing Veterinary
Committee before the lifting of the restrictions referred to in points 6.1 and 6.2.

6.6.

Lifting of restrictions

In accordance with Article 16 of Directive 85/511/EEC and not earlier than 12
months after the completion of the measures in point 3 and not earlier than 12
months after the last outbreak in the vaccination zone, whichever is the latest.

Vaccination zone:

Administrative areas in the counties of Cumbria and Devon in Great Britain.

ANNEX II

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ANNEX III

MEASURES APPLICABLE IN THE VACCINATION ZONE

1. The United Kingdom shall ensure that the following measures are applied in the vaccination zone during the period
from the beginning of the vaccination until at least 30 days have elapsed following the completion of the vaccination:

(a) Movement of live vaccinated bovine animals is prohibited within and out of the vaccination zone.

Derogating from the prohibition above and after clinical inspection of the animals in question and of the herds of
origin or dispatch, the competent authorities may authorise the direct transport of live bovine animals species for
immediate slaughter in a slaughterhouse designated by the competent authority and situated within the vaccination
zone or in exceptional circumstances to be authorised on a case by case basis by the competent authorities preferably
close to that zone.

(b) Fresh meat produced from vaccinated animals slaughtered during the period referred to in this paragraph shall bear
the stamp provided for in Article 5a of Directive 72/461/EEC, shall be stored and transported separately from meat
not bearing the said stamp, and shall subsequently be transported in sealed containers to an establishment
designated by the competent authorities for treatment in accordance with Annex IV.

(c) Milk and milk products produced from vaccinated animals during the period referred to in this paragraph may be
placed on the market within or out of the vaccination zone, provided that at least one of the treatments referred to
in Annexes VI-A and VI-B has been applied in an establishment located in the vaccination zone or, in exceptional
circumstances to be authorised on a case by case basis by the competent authorities outside that zone. This
treatment shall be certified by the competent veterinary authorities.

(d) The collection of semen for artificial insemination from male bovine animals kept in centres situated within the

vaccination zone shall be suspended.

Derogating from the prohibition above, the competent authorities may authorise the collection of semen from male
bovine animals for the production of frozen semen to be used within the vaccination zone at semen collection centres
within the vaccination zone, if it is ensured that the semen collected during that period is stored separately for at least
30 days and is dispatched only after the following measures have been taken:

the donor males have been vaccinated following a negative test for antibodies against foot-and-mouth disease virus
undertaken prior to vaccination, and

a negative result has been achieved in all susceptible animals present at the time on the semen collection centre, in a
virus isolation test or in an approved test for antibody against non-structural proteins carried out at end of the
quarantine period for the semen.

(e) Collection of ova and embryos from donor female bovines shall be prohibited.

2. The United Kingdom shall ensure that the following measures are applied in the vaccination zone after the completion

of the measures laid down in paragraph 1 and until the restrictions on the vaccination zone are lifted:

(a) Intra-Community trade in bovine animals seropositive against foot-and-mouth disease is prohibited.

(b) Intra-Community trade in semen, ova and embryos of bovine animals vaccinated against foot-and-mouth disease is

prohibited.

(c) Collection of ova shall be prohibited.

(d) Movement of bovine animals may only take place under the following conditions:

Movement out of the vaccination zone of non-vaccinated bovine animals other than those referred to in point (3)
below may be authorised not earlier than 3 months after completion of all vaccination and in accordance with
Directive 85/511/EEC.

Derogating from the provisions in the first subparagraph above, the United Kingdom may authorise the transport of
non-vaccinated bovine animals to a slaughterhouse outside the vaccination zone for immediate slaughter, provided
that the meat shall be subjected to the treatment in Annex V.

Movement out of the vaccination zone of vaccinated bovine animals shall be prohibited, unless 12 months have
elapsed after the completion of the measures referred to in paragraph 1 and not earlier than 12 months after the last
outbreak in the zone, whichever is the latest.

Derogating from the provisions in the first subparagraph, the United Kingdom may authorise the transport of
vaccinated bovine animals to a designated slaughterhouse outside the vaccination zone for direct slaughter, provided
that the meat shall be subjected to the treatment in Annex V.

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Non-vaccinated offspring of vaccinated dams, shall be prohibited from leaving the holding of origin unless being
transported to:

either a slaughterhouse for immediate slaughter, the meat being subject to the treatment in Annex V, or

to another holding within the vaccination zone, or

any holding after obtaining a negative result in a serological test for the detection of antibody against the foot-and-
mouth disease virus.

(e) The restrictions applied to fresh meat produced from vaccinated animals of susceptible species as laid down in
Annex V, and to meat products as laid down in Annex VI, shall continue to apply until the restrictions on
movements of vaccinated animals of susceptible species have been lifted in accordance with Article 16 of Directive
85/511/EEC, and in any case not earlier than 12 months after the completion of vaccination and 12 months after
the last outbreak in the vaccination zone whichever is the latest.

(f) The restrictions applied to fresh milk produced from vaccinated animals of susceptible species and to milk
products produced from such milk as laid down in Annexes VI-A and VI-B shall continue to apply until the
restrictions on movements of vaccinated animals of susceptible species have been lifted in accordance with Article
16 of Directive 85/511/EEC, and in any case not earlier than 12 months after the completion of vaccination and
12 months after the last outbreak in the vaccination zone whichever is the latest.

ANNEX IV

TREATMENT OF MEAT TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH DISEASE VIRUS

Treatment

Food-and-mouth disease

(a) Heat treatment in a hermetically sealed container with an F
0

value of 3,00 or more

(b) Heat

treatment at a minimum temperature of 70 °C, which must be reached

throughout the meat

(c) Heat treatment in a hermetically sealed container to at least 60 °C for a minimum of
4 hours, during which time the core temperature must be at least 70 °C for 30
minutes

(d) Natur fermentation and maturation of not less than 9 months for boneless meat,
resulting in the following characteristics: aw value of not more than 0,93 and a pH
value of not more than 6,0

(e) As (d) above but meat may contain bone. All the necessary measures must be taken

to avoid cross contamination

(f) Heat treatment ensuring a core temperature of at least 65 °C is reached for the time
necessary to achieve a pasteurisation value (pv) equal to or more than 40

‘+’: Effectiveness recognised

+

+

+

+

+

+

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ANNEX V

TREATMENT OF FRESH MEAT

1. De-boned fresh meat:

Meat as described in Article 2(a) of Council Directive 64/433/EEC together with diaphragms but excluding offal, from
which the bone and the main accessible lymphatic glands have been removed.

2. Trimmed offal:

— heart from which lymphatic glands, connective tissue and adhering fat have been completely removed,
— liver from which lymphatic glands, adhering connective tissue and fat have been completely removed,
— whole masseter muscles, incised in accordance with paragraph 41 (A)(a) of Chapter VIII of Annex I to Directive
64/433/EEC, from which lymphatic glands, connective tissue and adhering fat have been completely removed,

— tongues with epithelium and without bone, cartilage and tonsils,
— lungs from which the trachea and main bronchi and the mediastinal and bronchial lymphatic glands have been

removed,

— other offal without bone or cartilage from which lymphatic glands, connective tissue, adhering fat and mucous

membrane have been completely removed.

3. Maturation

— maturation of carcasses at a temperature of more than + 2 °C for at least 24 hours,
— pH value in the middle of Longissimus dorsi muscle recorded as less than 6.0.

4. Effective measures must be applied to avoid cross contamination.

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ANNEX VI-A

TREATMENT OF MILK TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH VIRUS IN MILK FOR HUMAN
CONSUMPTION

Treatment of milk must be carried out in accordance with paragraph 1 below and in any case necessary precautions must
be taken to avoid contact of the milk or milk products with any potential source of foot-and-mouth virus after
processing.

1.

Milk for human consumption must be subject to at least one of the following treatments:

1.1.

1.2.

1.3.

1.4.

1.5.

sterilisation at a level of at least F

03,

single UHT (1) treatment,

double HTST (2) treatment of milk with a pH above 7,0,

single HTST treatment of milk with a pH less than 7,0,

single HTST combined with another physical treatment by:

1.5.1. either a second heat treatment resulting in a negative reaction to the peroxidase test,

1.5.2. or lowering the pH < 6 for at least one hour,

1.5.3. or additional heating to 72 °C or more, combined with desiccation.

2.

Milk based products must be produced from milk after the treatment referred to in paragraph 1.

(1) UHT = Ultra High Temperature treatment at 130 °C for 2-3 sec.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for 15-17 sec or equivalent pasteurisation effect achieving a negative

reaction to a phosphatase test.

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ANNEX VI-B

TREATMENT OF MILK TO ENSURE DESTRUCTION OF FOOT-AND-MOUTH VIRUS IN MILK NOT
INTENDED FOR HUMAN CONSUMPTION AND IN MILK FOR ANIMAL CONSUMPTION

Treatment of milk and milk-based products must be carried out in accordance with paragraphs 1 to 3 below depending
on the intended use of the milk or milk-based products, and in any case necessary precautions must be taken to avoid
contact of the milk or milk based products with any potential source of foot-and-mouth virus after processing.

1.

1.1.

1.2.

1.3.

1.4.

Milk not intended for human consumption and milk intended for animal consumption must be subject to at least
one of the following treatments:

sterilisation at a level of at least F

03,

single UHT (1) combined with another physical treatment referred to in either paragraph 1.4.1. or 1.4.2.

double HTST (2),

single HTST combined with another physical treatment by

1.4.1. either lowering the pH < 6 for at least one hour,

1.4.2. or additional heating to 72 °C or more, combined with desiccation.

2.

3.

4.

Milk-based products not intended for human consumption must be produced from milk after the treatments
referred to in paragraph 1.

Milk-based products intended for animal consumption must be produced from milk after one of the treatments
referred to in paragraph 1.1., 1.2. and 1.4.

Whey to be fed to pigs and produced from milk treated as described in paragraph 1 must be collected at least 16
hours after milk clotting and its pH must be recorded as <6,0 before transport to pig holdings.

(1) UHT = Ultra High Temperature treatment at 130 °C for 2-3 sec.
(2) HTST = High Temperature Short Time pasteurisation at 72 °C for 15-17 sec or equivalent pasteurisation effect achieving a negative

reaction to a phosphatase test.