98/272/EC: Commission Decision of 23 April 1998 on epidemio-surveillance for transmissible spongiform encephalopathies and amending Decision 94/474/EC (Text with EEA relevance)
Date: 1998-04-23
Institutions: European Commission
Subjects: animal disease, cattle, veterinary inspection

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 23 April 1998

on epidemio-surveillance for transmissible spongiform encephalopathies and
amending Decision 94/474/EC

(Text with EEA relevance)

(98/272/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks in intra-
Community trade with a view to the completion of the
internal market (1),
amended by Directive
last
92/118/EEC (2), and in particular Article 9(4) thereof,

as

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 (3), as last amended by Directive
92/118/EEC, and in particular Article 10(4) thereof,

(1) Whereas new information has been published in
the United Kingdom further supporting the hypo-
thesis that exposure to the bovine spongiform
encephalopathy (BSE) agent is linked to the new
in
variant of Creutzfeldt Jacob Disease (CJD)
humans; whereas on 16 September 1997 the Spon-
giform Encephalopathy Advisory Committee
(SEAC) of
the United Kingdom concluded that
recent research provided compelling new evidence

that the agent which causes BSE is identical to the
agent which causes the new variant of CJD in
humans; whereas on 18 September 1997 the Advi-
sory Committee on Dangerous Pathogens (ACDP)
concluded that the BSE agent should now be classi-
a human pathogen under Directive
fied as
90/425/EEC,
the Member State of origin or
dispatch is required to implement on its territory
the appropriate measures to prevent all situations
likely to constitute a serious hazard to animals or to
human health;

(2) Whereas,

pursuant

Council Directive
to
82/894/EEC (4), as last amended by Commission
Decision 98/12/EC (5), Member States have since
1990 been obliged to notify all cases of BSE to the
Commission and to the other Member States;

(3) Whereas pursuant

to Council Directive 91/68/
EEC (6), as last amended by Commission Decision
94/953/EC (7), since 1993 scrapie must be an offici-
ally notifiable disease in all Member States;

(4) Whereas the Scientific Veterinary Committee has
stated on the basis of its risk assessment that several
including the United Kingdom
Member States

(1) OJ L 395, 30. 12. 1989, p. 13.
(2) OJ L 62, 15. 3. 1993, p. 49.
(3) OJ L 224, 18. 8. 1990, p. 29.

(4) OJ L 378, 31. 12. 1982, p. 58.
(5) OJ L 4, 8. 1. 1998, p. 63.
(6) OJ L 46, 19. 2. 1991, p. 19.
(7) OJ L 371, 31. 12. 1994, p. 14.

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have reported scrapie in native-born sheep, that the
presence of scrapie cannot be excluded in any
Member State where sheep are present and that
only a
investigation
conducted to common standards will give the
necessary information about the scrapie status of
each country;

thorough epidemiological

(5) Whereas inspections were carried out in Member
States in 1996 and 1997 to check the implementa-
tion of Community measures on BSE; whereas the
results of those inspections have revealed certain
and
deficiencies,
implementation of
the prohibition on use of
mammalian protein in ruminant feed;

in surveillance

in particular

(6) Whereas

in view of previous

trade in certain
products, in particular meat and bone meal and live
animals,
transmissible
spongiform encephalopathy (TSE) agents cannot be
ruled out in any of the Member States, subject to
further scientific evaluation;

the possible presence of

(7) Whereas

the World Organisation for Animal
Health (Office International des Epizooties (OIE))
in its international animal health code on bovine
spongiform encephalopathy of May 1997 has
recommended minimum requirements for effective
surveillance; whereas the OIE has adopted guide-
lines for continuous surveillance and monitoring of
bovine spongiform encephalopathy in its Code of
January 1997;

(11) Whereas

for

ante-
investigation requirements
mortem inspection in slaughterhouses of bovine
animals were laid down in Commission Decision
94/474/EC (3), as last amended by Council Decision
98/256/EC (4); whereas those requirements are now
set out in this Decision; whereas, therefore, the
corresponding provisions of Decision 94/474/EEC
should be deleted;

(12) Whereas the measures provided for in this De-
cision are in accordance with the opinion of the
Standing Veterinary Committee,

HAS ADOPTED THIS DECISION:

Article 1

Member States shall ensure that staff of the competent
authority, of diagnostic laboratories and colleges of agri-
culture and veterinary medicine, official veterinarians,
veterinary practitioners,
slaughterhouse personnel and
animal breeders, keepers and handler have the knowledge
of the clinical signs, epidemiology and, as appropriate,
laboratory findings relating to TSEs.

Article 2

1. Member States shall ensure that it is compulsory for
the suspected presence of any TSE in any animal to be
notified immediately to the competent veterinary au-
thority.

(8) Whereas the Scientific Veterinary Committee in its
report on surveillance of transmissible spongiform
encephalopathies of 11 June 1997 has laid down
guidelines taking account of the recommendations
of the OIE;

2.
BSE shall be suspected in bovine animals aged over
20 months displaying behavioural or neurological signs
where the disease cannot be ruled out either on the basis
of response treatment or following laboratory examina-
tion.

(9) Whereas the measures provided for in this De-
cision are in accordance with that opinion and
represent a harmonised approach towards effective
TSE surveillance in the Member States; whereas
more detailed rules will be laid down in Council
legislation based on Article 100a of the Treaty;

3.
Scrapie shall be suspected in ovine and caprine
animals aged over 12 months displaying behavioural or
neurological signs where the disease cannot be ruled out
either on the basis of response to treatment or following
laboratory examination.

(10) Whereas the measures provided for in this De-
cision will be applied in conjunction with Com-
mission Decision 97/534/EC of 30 July 1997 on
the prohibition of the use of material presenting
risks as regards transmissible spongiform enceph-
alopathies (1), as last amended by Council Decision
98/248/EC (2);

Article 3

1.
Any animal which shows clinical signs giving rise to
the suspicion of a TSE shall be placed under official
movement restrictions pending the outcome of a clinical
and epidemiological
investigation by the competent
authority.

(1) OJ L 216, 8. 8. 1997, p. 95.
(2) OJ L 102, 2. 4. 1998, p. 26.

(3) OJ L 194, 29. 7. 1994, p. 96.
(4) OJ L 113, 15. 4. 1998, p. 32.

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2. Where the competent authority decides that
the
possibility of infection with a TSE cannot be ruled out,
the animal shall be killed and its brain and such other
tissues as the competent authority may determine shall be
removed and sent to an approved laboratory for testing for
the presence of TSE using the methods set out in Article
5. The carcase and remaining internal organs of
the
animal shall be retained under official supervision until a
diagnosis has been made or until it has been destroyed in
accordance with Article 4 of Decision 97/534/EC.

Article 4

In order to give early warning of the emergence or
1.
occurrence of BSE or scrapie, each Member State shall
carry out an annual programme of monitoring in ac-
cordance with the conditions laid down in the Annex.

inform the Commission and
2. Member States shall
the Member States, within the Standing Veterinary
Committee, of the results obtained from the monitoring
programme and of the emergence of TSEs other than
BSE or scrapie. The information shall be presented by
way of an annual report, submitted to the Commission
within three months after the end of each year. It shall at
least cover the information referred to in the Annex.

Article 5

1.
Sampling and laboratory testing for the presence of a
TSE shall be carried out using the methods and protocols
laid down in the Manual of Standards for Diagnostic Tests
the World Organisation for Animal
and Vaccines of
Health (Office International des Epizooties), May 1997
edition. The tests performed shall at least comprise histo-

pathology examination of brain tissue. The competent
authority may also require the use of other laboratory tests
such as immunocytochemic and immunodiagnostic tests
for the detection of scrapie associated fibrils (SAFs), where
their use is considered appropriate.

2.
The competent authority shall ensure coordination
of diagnostic methods and protocols between the labora-
tories approved for testing for the presence of TSEs and
verify the use of those diagnostic methods and protocols.

Article 6

Community inspections may be carried out, in particular
where the annual report is not submitted in accordance
with Article 4(2).

Article 7

Article 2 of Decision 94/474/EC is hereby deleted.

Article 8

This Decision shall apply from 1 May 1998.

Article 9

This Decision is addressed to the Member States.

Done at Brussels, 23 April 1998.

For the Commission

Franz FISCHLER

Member of the Commission

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ANNEX

A. MINIMAL REQUIREMENTS FOR A PROGRAMME FOR MONITORING BSE AND

SCRAPIE

Selection of subpopulations

Selection must be by means of a risk assessment of subpopulations of native-born animals displaying clinical
signs compatible with TSEs and, in a decreasing order of relevance, of higher-risk animals. Within each
subpopulation and age group, selection must be random.

1. The following shall be the criteria for the selection of native-born animals displaying clinical signs

compatible with TSEs:

— animals displaying behavioural or neurological signs lasting for at least 15 days and resistant to treat-

ment,

— moribund animals without signs of infectious or traumatic illness,

— animals displaying other progressive disease conditions.

2. The following risks must be taken into account for the selection of higher risk animals:

— animals originating from countries with indigenous TSE,

— animals which have consumed potentially contaminated feedstuffs,

— animals born or derived from TSE infected dams, and/or sires.

Animal species and type of TSE

1. Bovine animals must be examined for the presence of BSE.

2. Ovine and caprine animals must be examined for the presence of scrapie.

Age of the targeted animals

The sample must target the oldest animals in the subpopulation. However, all targeted bovine animals must
be over 20 months of age and all targeted ovine and caprine animals must be over 12 months of age.
Targeted bovine animals displaying progressive disease conditions without showing neurological signs must
be over 4 years of age.

Sample size

The minimum number of animals to be examined on an annual basis must comply with the sample sizes
referred to in the table for animals in subpopulations of native-born animals displaying clinical signs com-
patible with TSEs. Animals in which infection with a TSE cannot be ruled out and as such have to be
examined in accordance with Article 3 may be included within the minimum sample size. Samples from the
subpopulations of higher-risk animals must be collected at the time when the animals are slaughtered or
killed.

Minimum number of annual neurohistological investigations of animals showing clinical signs
compatible with TSE

Table

Native-born cattle
population 20 months
of age or older
or native-born ovine and caprine
population 12 months
of age or older

Minimum number of brains
to be examined

100 000
300 000
500 000
700 000
1 000 000
2 500 000
5 000 000
7 000 000
10 000 000
20 000 000
30 000 000
40 000 000

10
30
50
69
99
195
300
336
367
409
425
433

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B. ANNUAL REPORT

The annual report must contain data on:

1. the total number of animals and age structure examined within the different groups of the respective
populations of bovine, ovine and caprine animals categorised according to epidemiological criteria;

2. the overall mortality and mortality due to neurological diseases per animal species;

3. records of the competent authority on the number and types of animals or carcases placed under move-

ment restrictions in accordance with Article 3;

4. the number and outcome of the clinical and epidemiological investigations carried out in accordance with

Article 3; these records must be kept for seven years;

5. TSEs in animals other than bovine, ovine and caprine animals;

6. training with respect to knowledge referred to in Article 1.