PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 72/462/EEC ON HEALTH AND VETERINARY INSPECTION PROBLEMS UPON IMPORTATION OF BOVINE ANIMALS AND SWINE AND FRESH MEAT OR MEAT PRODUCTS FROM THIRD COUNTRIES
Date: 1991-07-19
Institutions: European Commission
Subjects: fresh meat, health control, import, livestock, third country

COMMISSION OF THE EUROPEAN  COMMUNITIES 

C0M(91) 270 final 

Brussels, 19 July  1991 

REPORT FROM THE COMMISSION TO THE COUNCIL 

ON THE CLASSICAL  SWINE FEVER  SITUATION  IN ACCORDANCE 

WITH ARTICLE  4b(2) OF COUNCIL DIRECTIVE 64/432/EEC OF 

26 JUNE  1964 ON ANIMAL  HEALTH PROBLEMS AFFECTING 

INTRA-COMMUNITY  TRADE  IN BOVINE ANIMALS  AND SWINE 

Proposal  for a 

COUNCIL  DIRECTIVE 

amending  Directive 80/217/EEC  introducing Community  measures 

for  the control  of classical  swine  fever 

Proposal  for a 

COUNCIL  DECISION 

amending  Directive 80/1095/EEC and Decision 80/1096/EEC as 

regards certain measures  relating  to classical  swine  fever 

Proposal  for a 

COUNCIL  DIRECTIVE 

amending  Directives 64/432/EEC, 72/461/EEC and 80/215/EEC as 

regards certain measures  relating  to classical  swine  fever 

Proposal  for a 

COUNCIL  DIRECTIVE 

amending  Directive 72/462/EEC on  health  and veterinary  inspection 

problems upon  importation of bovine animals and swine  and  fresh 

meat  or meat  products  from  third  countries 

(presented  by  the  Commission) 

-2 -

EXPLANATORY  MEMORANDUM 

The  Council  by  Decision  80/1096/EEC  In  1980  introduced  Community 
financial  measures  for  the  eradication  of  classical  swine  fever.  The 
measures  were  linked  with  actions  to  be  taken  under  an  accelerated 
eradication plan which  had  the objective  to render  and keep  the  territory 
of  the  Community  free  of  classical  swine  fever  without  the  necessity  of 
recourse  to systematic  vaccination. This action was planned  to run  for a 
period  of  5  years. Member  States, which  were  not  officially  swine  fever 
free,  were  to  prepare  and  present  eradication  plans  which,  subject  to 
certain  conditions,  could  be  implemented  on  a  regional  basis.  Community 
financial  contributions  were  made  available  for  compensation  to  owners 
for  the  slaughter  and  destruction  of  animals,  emergency  vaccination, 
systematic  vaccination  for up to 2 years and  for serological  tests. 

The  5  years  period  initially  allowed  for  disease  eradication  was  later 
extended  to 6  years  and  in  1987  supplementary  measures  were  added  for a 
period  of  4  years  extending  the  total  period  for  implementation  of 
eradication  plans to 10 years. 

At  the  time  that  these  eradication  plans  were  coming  into operation,  an 
epidemic  of  classical  swine  fever  occurred  in  Belgium.  The  disease 
subsequently  appeared  in  the  Netherlands  and  certain  areas  of  Germany. 
The  highest  annual  number  of  outbreaks  recorded  within  the  Community 
during  the  implementation  of  the  accelerated  eradication  plans  was  in 
1984, when  a  total  of  1272 outbreaks  occurred.  Since  then  the  situation 
has gradually  improved  except  for  a period  in 1990, when  an epidemic  was 
experienced  in Belgium.  By  and  large  the  strategy  -  the  non-vaccination 
and  stamping-out  policy  -  has  been  successful  as  8  of  12 Member  States 
now  fulfill  the  requirements  for  recognition  as  officially  swine  fever 
free  Member  States  and  4  Member  States  have  large  areas  which  at  the 
level of  regions comply  with  the conditions  for  recognition. The ultimate 
goal  of  eliminating  classical  swine  fever  virus  from  the Community  is in 
sight  although  the  rather  recently  reported  occurrence  of  the  disease  in 
the  European wild  boar  in two areas  (Hessen, Germany  and  Tuscany,  Italy) 
may  have postponed  the date. 

Experience  gained  during  the  implementation of  the eradication  plans  and 
the completion  of  the single market  justify  the modifications of  existing 
working  procedures  and  amendments  to  existing  legislation  concerning 
disease  eradication  and  trade  in  live  pigs,  fresh  pigmeat  and  pigmeat 
products. 

-  3 -

The  attached  report  describes  the disease  situation,  rules  for  trade and 
measures  applied  to  classical  swine  fever  eradication  since  1980, while 
proposals  for  amending  legislation  are  presented  in  respect  of  Council 
Decision  80/1096/EEC  and  Council  Directive  80/217/EEC,  80/1095/EEC, 
64/432/EEC, 72/461/EEC, 80/215/EEC and 72/462/EEC. 

Finally  it  is the  intention by Commission  Decision  to add classical  swine 
fever  to  the  list  of  diseases  in  Article  3(1)  of  Council  Decision 
90/424/EEC on expenditure  in the veterinary  field. 

-  4 -

Report  from the Commission  to the Council  on  the 

classical  swine fever situation  in accordance 

with Article 4b(2) of Council  Directive 64/432/EEC 

of  26 June 1964 on animal  health  problems 

affecting  intra-Community  trade  in bovine 

animals and swine 

INTRODUCTION 

The  occurrence  of  animal  diseases  has,  since  the  earliest  days  of  the 

Community,  been  an obstacle  to  the  creation of  a  common market  based  on 

freedom  of  trade  in  livestock,  meat  and  products  of  animal  origin. 

Disparities  between  health  standards  in  the  Member  States,  between  the 

methods  used  to  control  animal  diseases  and  between  the  prophylactic 

measures applied on  the farm have restricted  the marketing of  such  goods. 

It  is  indeed  unreasonable  to  jeopardize  the  high  standards  of  health 

achieved  by  a  Member  State  by  obliging  it  to  admit  to  its  territory 

livestock  or  products  which,  if  not  reliably  guaranteed  as  safe,  are 

liable to reintroduce diseases which have been eradicated at  considerable 

technical  and  financial cost. 

Classical  swine  fever  is  regarded  as  one  of  the  economically  most 

important  diseases  affecting  the  pig  industry.  It often  produces  a  high 

mortality  and  causes  further  setbacks  in pig  farming  due  to  abortions, 

retarded  growth,  etc.  The  importance  of  the  disease  was  taken  into 

account  at  the  time  of  the  first  enlargement  of  the  Community  when, 

because  of  exceptional  circumstances  in  the  acceding  Member  States, 

authorization  was  given  for  them  to  maintain  their  national  laws  on 

imports,  namely  the  ban  on  imports  from  countries  with  outbreaks  of 

classical  swine  fever  and a policy of  vaccination. 

-  5 -

In order  to dismantle  these  barriers  to  trade, the Community  decided  in 

1980  to eradicate  classical  swine  fever  from  the whole  of  its  territory 

by  applying  a  common  policy  of  slaughter  and  gradual  abolition  of 

systematic  vaccination  for  the  purposes  of  prevention.  This  kind  of 

common  strategy  was  the only way of  ensuring  the  liberalization of  trade 

and  the  establishment  of  a  true  internal  market  that  might  otherwise 

serve as a network  for  the propagation of  this epidemic disease. 

I.  DISEASE ERADICATION 

1.  Eradication plans  in Member  States 

Plans  for  the eradication of  classical  swine  fever  were  launched  in 

the  early  1980's  to  stamp  out  the  disease  from  those  Member  States 

where  it still  existed.  Likewise, plans were  introduced  for Greece, 

Portugal  and Spain at  the time they  joined  the Community. 

The  final  goal  of  each  plan  was  that  the  Member  State  concerned 

should  obtain  a status  as  "officially  swine  fever  free" based  on  the 

following  health  requirements : 

-  no swine  fever  to be detected during the previous  12 months, 

-  vaccination  against  swine  fever  had  not  been  authorized  for  at 

least  12 months, 

-  holdings not  to contain pigs vaccinated  against  swine  fever during 

the  last  12 months. 

Community  financial  measures  to  support  the  eradication  of  the 

disease, Council  Decision 80/1096/EEC,  include provisions  for payment 

of : 

-  compensation for slaughtered  and destroyed animals, 

-  vaccination  (emergency  vaccinations  and  prophylactic  vaccinations 

for a  limited period only as part of an eradication  plan), 

laboratory  tests for detecting  the disease. 

- 6 -

The  measures  applied  by  individual  Member  States  to  eradicate 
classical  swine  fever  were  in  accordance  with  the  provisions  laid 
and 
down 
Decision 80/1096/EEC, but  the application of  the measures have varied 
in respect of 

Directive 80/217/EEC, 

80/1095/EEC 

Directive 

in 

-  the period allowed  for prophylactic vaccination, 
-  the  priority  given  to  the eradication  of  classical  swine  fever  on 

a regional  level. 

Table  1 provides  information on  the operation of national  eradication 
plans. 

2.  Vaccination 

In  the  past  there  have  been  two  main  strategies  for  the  control  of 
classical  swine  fever. 

be 

might 

which 

The  first  was  based  on  a  systematic  and  comprehensive  vaccination 
indefinitely;  different 
programme 
vaccination  programmes  were  available  and  if  properly  implemented 
vaccination  would  normally  prevent  acute  and  subacute  disease 
outbreaks.  Pig owners knew that  they could  live with  the disease and 
stay  in business.  The  disease  was controlled, but  not  the  infection 
causing  it. 

continued 

The  second  strategy  was  a policy  based  on  the eradication  of  disease 
and  elimination  of  the  infection  without  recourse  to  vaccination. 
This  strategy  calls  for  the  slaughter  of  all  infected  pigs  and  the 
tracing  of  their  contacts.  An  important  tool  in tracing  contacts  is 
the  serological  examination  of  blood  samples  for  antibodies  to 
classical  swine  fever virus. 

Systematic  vaccination  is  Justified  where  the  disease  is endemic  as 
vaccination  reduces  immediate  losses.  Such  situations  occurred  in 
Member  States during  the 1960s  (there were more than 6 000 outbreaks 
in 1961) and  in the 1970s  (more  than 5 000 outbreaks  in  1972). 

- 7 -

Table 1 

Implementation of plans for eradication of classical swine fever 

Member 
State 

Eradication 
plan started 

Vaccination 
stopped 

Status 
obtained 
as O.S.F.(2) 

No. of regions 
recognised 
as O.S.F. 

Belgium 
Denmark 
Germany 

Greece 
Spain 
France 

Ireland 
Italy 
Luxembourg 

1/1/1982 

1/4/1988 

1/1/1982 

1/1/1989 

1/8/1983 

1/6/1982 

1/1/1988 
1/7/1988 
30/4/1983 

1/3/1983 

1/1/1990(1) 

The Netherlands 
Portugal 
United Kingdom 

1/3/1982 
1/7/1987 

15/7/1986 
1/7/1989 

1981 

1990 
1989 

1981 

1981 

1989 
1991 
1981 

8/9(3) 

26/30(4) 

94/96(5) 

0/95(6) 

(1) 
(2) 
(3) 
(4) 

(5) 
(6) 

Except  in Sardinia 
O.S.F. - Officially  swine  fever  free 
Number  of O.S.F.  recognised  regions/total  number  of  regions 
Regions  in  the  territory  of  Germany  which  have  participated  in  the 
eradication programme  since  1982.  The regions  included  in the programme by 
Commission  Decision  90/483/EEC  are  recognised  as  swine  fever  free  regions 
by Council  Decision  90/678/EEC. 
All  regions  (94) on  the mainland  are O.S.F. 
A total  of 87 regions are recognised  as swine  fever  free. 

-  8 -

If  however,  classical  swine  fever  outbreaks  are  sporadic  or  rare, 
vaccination  is an unnecessary  extra cost. 

The  simultaneous  use  of  both  strategies  creates  major  problems  for 
the movement  of  animals  (trade),  and  the  tracing  of  contact  animals 
moved  to and from diseased  herds  (epidemiological  investigations). 

A  Commission  funded  study of  the epidemiology  and economics of  swine 
fever  eradication  within  the  Community  carried  out  during  the  mid-
1970s<1),  concluded  in favour  of  adopting  a non-vaccination policy. 
The decision  to cease vaccination was  taken  in 1985. 

A  number  of  third  countries  such  as  Australia,  Canada,  the 
Scandinavian  countries,  New  Zealand  and  the  USA  have  successfully 
applied  a  non-vaccination  policy  for  a  number  of  years.  Once 
vaccination was prohibited,  it was never  thereafter  utilised. The ban 
on  the use of  vaccine  in these  countries was  linked  to  a  ban  on  the 
importation  of  pigs,  fresh  pigmeat  and  untreated  products  from 
vaccinating  countries.  With  the  establishment  of  the  single  market 
it  is  important  to  continue  with  a  non-vaccination  policy  in  the 
light  of  intra-Community  trade  as  well  as  of  trade  with  third 
countries. 

3.  Disease situation 

Outbreaks  of  classical  swine  fever  during  the  1980s  have  been 
recorded  in  10  out  of  12  Member  States,  Annex  1.  The  recorded 
outbreaks  from  1980-1989 totalled 3 745, compared  to 13 553 outbreaks 
recorded  from  1970-1979.  Two  Member  States,  Belgium  and  Germany, 
have  during  the  1980s  experienced  outbreaks  every  year,  while  two 
Member  States, Denmark  and  Ireland, did not have any outbreaks. 

(1) Studies on  the epidemiology  and economics of swine  fever eradication, 

Commission of  the European Communities, 1977. 

- 9 -

The  relative  large  number  of  outbreaks  recorded  in  Germany  during 

1989 and  1990  is to a great extent  due to the occurrence of  classical 

swine  fever  in  wild  boar;  each  wild  boar,  shot  or  found  dead, 

infected  by  classical  swine  fever  is  recorded  as  an  outbreak. 

Information on  the number  of outbreaks  recorded  in domestic pigs and 

in the wild boar during  1990  is given  in Annex 2. 

An  analysis  of  outbreaks  to  determine  the  sources  of  infections 

during  1990  has  revealed  that  the major  sources  were  :  fomites and 

contacts with neighbouring herds, Annex  3. 

The  main  diagnostic  method  used  to  diagnose  outbreaks  in  Member 

States  is  the  demonstration  of  viral  antigen  by  the  direct 

immunofluosescence technique, Annex  4. 

4.  Financial  consequences 

Community  financial  aid  is made  available  to  the Member  States  from 

the  day  when  the  eradication  plans  are  implemented.  In  accordance 

with  the provisions of  Council  Decision  80/1096/EEC  the aid  has been 

aval table to cover : 

-  up  to 50% of  the cost of  slaughter  and  destruction as paid  by  the 

Member  States  in  compensation  to  the  owners  of  slaughtered 

animals, 

-  up  to  0.125  ECU  per  animal  for  emergency  or  prophylactic 

vaccination, provided  that  it  is part of a plan, 

-  up  to  one  ECU  per  sample  examined  in  a  laboratory  in connection 

with detection tests. 

The  Community  financial  aid  provided  since  the  commencement  of  the 

eradication programmes  is listed below : 

-  10 -

Î  Year of control 
! 

measures 

! 
! 

Payments made of Community 
financial  aid  (reimbursements) 

i 
| 
I 
! 
I 
! 
I 
! 
! 

1982 
1983 
1984 
1985 
1986 
1987 
1988 
1989 
1990* 

!  Total 
i 
I 

! 
i 
| 
! 
', 
! 
! 
! 
i 

! 
i 
I 

4.6MECU 
14.4MECU 
26.4MECU 
13.7MECU 
6.5MECU 
4.1MECU 
1.9MECU 
3.8MECU 

6.07% 
19.12% 
34.95% 
18.16% 
8.61% 
5.40% 
2.62% 
5.05% 

75.4MECU 

100.00% 

*  Applications for  reimbursements not  received May  1991 

5.  Experience gained - measures  for  the future 

I 
! 

I 
! 
! 
i 
! 

! 
! 
! 

i 
_ _ _! 

Outbreaks of  classical  swine  fever  caused  by  highly  virulent  strains 
of  the  virus  are  normally  readily  recognised  as  they  produce  a 
disease  which  is  characterised  by  rise  in  body  temperature, 
depression,  loss of  appetite, purulent  conjunctivitis, stilted gait, 
incoordination,  diarrhoea  and  a  high  mortality.  During  the  1980s  a 
number  of  outbreaks  have  been  caused  by  strains  of  low  virulence, 
which  produce  weak  or  indistinct  signs  of  disease.  This  type  of 
virus  strain  spreads  rather  slowly  through  a  herd  and  the  infection 
may  be  present  in  a  population  for  some  time  (weeks)  before  it  is 
detected.  Virological  and  serological  testing  methods  are  of 
paramount  importance  for  the confirmation of such  infections. 

The  use  of  rapid  serological  testing  methods  (EL ISA-test),  however, 
have  been  faced  with  problems  in  herds  which  recently  have  changed 
from  having  a  vaccination  status  to  a  non-vaccination  status  as 
detected  antibodies  can  be  caused  by  a  field  virus  or  a  vaccine 
antigen.  Verification  of  the  result  requires  additional  laboratory 
tests,  unless  misinterpretation  can  be  ruled  out  by  individual  pig 
identification and vaccination records. 

-  11 -

The  repeated  epidemics  in some  Member  States  can  be  related  to  the 

dense  population  of  pigs  in  the  affected  areas  and  it  seems  likely 

that  the  introduction  of  virus  strain  of  low  virulence  into  densely 

populated  areas will  create major  eradication  problems;  particularly 

if  large numbers of animals are being moved  between herds. 

The  occurrence  of  classical  swine  fever  in  European  wild  boar  as 

recently  reported  from  the  areas  of  Hessen,  Germany  and  Tuscany, 

Italy  has  added  new  dimensions  to  the  disease  situation;  and  this 

represents  a  permanent  source  of  infection  that  will  remain  within 

the  borders  of  the  Community  for  some  time.  The  importance  of  the 

infected  wild  boar  as  a  source  of  infection  of  domestic  pigs  is 

difficult  to assess, but  it  is evident  that  special  attention must  be 

given  to this matter  in the future. 

Measures  for  thg future 

On  balance,  the  Commission  is  of  the  opinion  that  the  eradication 

programmes  have been well  designed  and by and  large well  implemented. 

At  this  moment  in  time,  however,  it  appears  appropriate  to  draw 

attention  to  certain  topics  which  in  the  future  deserve  special 

attention  due  to the nature of  the disease  and  the completion  of  the 

single market. 

1. The  non-vaccination  policy  should 

continue.  If  emergency 

vaccination  is  carried  out  live  animals  should  remain  in  the 

vaccinal  zone.  Meat,  subject  to  appropriate  heat-treatment,  can 

leave the zone. 

- 12 -

2. Measures  for  the control  of  classical  swine  fever  in the European 

wild boar  should be established. 

3. The  diagnostic  methods  for  the  confirmation  of  classical  swine 
fever  have  been  improved  in  recent  years. These  improved  methods 
should be available and used  in all Member States. 

4. All  Member  States  should  have  contingency  plans  to  ensure  rapid 
implementation  of  adopted  legislation  on  control  and  eradication 
measures. 

5. The  adoption  of  Council  Decision  90/424/EEC  of  26 June 1990  on 
expenditure  in  the  veterinary  field  provides  for  Community 
financial  aid,  in  the  event  of  the occurrence  of  classical  swine 
fever,  within  the  framework  of  this  decision;  thus  classical 
swine  fever  will  be  treated  from a  financial  point  of  view  like a 
number  of  the  other  economically  important  diseases  listed  in 
Article 3 of  the said Decision. 

I  Conditions for  trade 

The status "officially swine fever  free" and  "swine fever  free". 

With  the  aim  of  dismantling  trade  barriers  prior  to  the  total 
eradication  of  classical  swine  fever  from  the  Community,  since  1980 
it  has  been  possible  for  geographical  regions  to  obtain  status  as 
"officially  swine  fever  free"  or  as  "swine  fever  free".  The 
conditions  for  obtaining  the  officially  swine  fever  free  status 
include : 
-  no detection of swine fever  for at  least  12 months, 
-  no  vaccination  against  swine  fever  had  been  authorized  for  at 

least  12 months, 

-  holdings  do  not  contain  pigs  which  have  been  vaccinated  against 

swine  fever within  the  last  12 months 

while  the  condition  for  obtaining  a  "swine  fever  free  status"  is no 
detection of swine  fever  for at  least  12 months. 

-  13 -

In principle a Member  State can at any  time within  its territory  have 

three different  types of  regions e.g.  "officially  swine  fever  free", 

"swine  fever  free" and  no  status  regions.  Where  an  outbreak  occurs 

in an  "officially  swine  fever  free" or  "swine  fever  free" region  the 

status  shall  immediately  be  suspended  by  the Member  State  concerned 

in  accordance  with  the  provisions  of  Directive 64/432/EEC  or 

72/461/EEC.  Depending on the evolution of  the disease  the status may 

be reinstated or withdrawn. 

In general  live animals, fresh  pigmeat  and  pigmeat  products  can move 

freely  between  regions/Member  States  having  the  same  status.  The 

system  set  up  for  trade  has  by  and  large worked  satisfactorily, but 

it  has  been  criticized  on  a  number  of  occasions  for  not  providing 

sufficient  protection  to  Member  States,  which  have  obtained  the 

officially  swine  fever  free  status  for  a  large  number  of  regions, 

but not  the whole  territory. 

When  applying  the  regional  approach  to  disease  eradication  and 

control  it  is  appropriate  to  impose  the  measures  on  the  areas 

directly  affected.  The  present  system  does not  follow  this  approach 

in full  as the status of  regions  is fixed prior  to outbreaks;  thus a 

pig  holding  situated  100km  away  from  an  outbreak  may  lose  trading 

opportunities, while  this may  not  be  the case  for  a holding  situated 

in a neighbouring  region only  15km away  from an  infected holding. 

Measures for the future 

The principle of régionalisation should apply  in respect of classical 

swine  fever  as  it applies  for  foot-and-mouth  disease.  In  the  event 

of  an outbreak  a protection  and  surveillance  zone should  immediately 

be  established  around  the  outbreak.  This  will  ensure  an  immediate 

ban  on  the  movement  of  live  pigs  and  fresh  meat  out  of  an  area 

covering  at  least  300km2.  Should  an  epidemic  develop  additional 

protection  measures  can  be  introduced  in  accordance  with  the 

provisions  of  Council  Directive 90/425/EEC  concerning  the veterinary 

and  zootechnical  checks  applicable  to  intra-Community  trade  in 

certain  live  animals  and  products  with  a  view  to  the  completion  of 

the  internal market. 

-  14 -

III RELATIONSHIP BETWEEN DISEASE ERADICATION AND CONDITIONS FOR TRADE 

The  strategy  to eradicate  classical  swine  fever  has  been  reasonably 
successful  as 8 out of  12 Member  States now fulfil  the conditions for 
being  recognized  as officially  swine  fever  free Member  States  and  4 
Member  States have  large areas which  at a  regional  level  comply  with 
the  conditions  for  recognition  as  officially  swine  fever  free. 
Certain  Member  States  have  encountered  difficulties  during  periods 
following the cessation of vaccination. 

The  elimination  of  classical  swine  fever  from  the  Community  before 
1993  is not  likely.  But  free  movement  of  pigs  and  their  products 
without  spread  of  disease  can  be  established  provided  restrictions 
are placed on holdings and areas directly  affected  by  the disease. 

The following proposals, annexed  to this report : 

a) Draft  Proposal  for  a  Council  Directive  amending  Directive 
80/217/EEC  introducing  Community  measures  for  the  control  of 
classical  swine fever 

b) Draft  Proposal  for  a  Council  Decision  amending  Directive 
80/1095/EEC  and  Decision  80/1096/EEC  as  regards  certain  measures 
relating to classical  swine fever 

c) Draft  Proposal  for  a  Council  Directive  amending  Directives 
64/432/EEC, 72/461/EEC  and  80/215/EEC as  regards  certain  measures 
relating  to classical  swine fever 

d) Draft  Proposal  for  a  Council  Directive  amending  Directive 
72/462/EEC  on  health  and  veterinary  problems  upon  importation  of 
bovine  animals  and  swine  and  fresh  meat  or  meat  products  from 
third countries 

have been drawn up for  this purpose. 

-  15 -

ANNEX 

Number of outbreaks of Classical  Swine Fever  In Member  States  1980-1990 

Country 

1980 

1981 

1982 

1983 

1984 

1985 

1986 

1987 

1988 

1989 

1990 

Belgium 

Denmark 

France 

Germany 

Greece 

Spain 

Ireland 

Italy 

Luxembourg 

Netherlands 

Portugal 

7 

0 

19 

18 

40 

0 

0 

0 

0 

37 

102 

26 

67 

80 

83 

9 

0 

0 

13 

17 

0 

8 

0 

2 

19 

535 

1041 

351 

4 

24 

0 

2 

7 

0 

3 

1 

0 

1 

1 

0 

0 

20 

46 

0 

0 

0 

0 

5 

41 

0 

0 

0 

2 

0 

15 

3 

0 

0 

0 

8 

0 

0 

113 

0 

4 

64 

118 

0 

0 

0 

0 

0 

0 

34 

48 

13 

25 

28 

13 

12 

11 

15 

0 

6 

4 

20 

84 

0 

5 

8 

1 

1 

0 

0 

11 

65 

161 

176 

36 

0 

1 

0 

10 

1 

1 

0 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

. 0 

0 

United Kingdom 

0 

0 

0 

0 

171 

43 

16 

9 

0 

3 

0 

Total 

84 

346 

300 

809 

1271 

486 

185 

145 

32 

83 

252 

ANNEX  2 

o 
i 

Annex  3 

C-S-F-EUR12 
ORIGINS OF DISEASE! 

1990 

87 

38 

48 

20 

23 

12 

'01 

'02 

'03 

'04 

'05 

'06 

'08 

'09 

'10 

'13 

'88 

01.UNK-cont. 

02UNK_ FIN 

03.WASTE FOOD 

04. MARKET 

05.Neighb.  C. 

06. Purchase 

08.Transport 

09.Human spr 

lO.Fomite spr 

13. Latent 

88. Other 

- 18 -

ANNEX 4 

The use of diagnostic methods for confirmation of 

Classical Swine Fever, 1988 - 1990 

Codes for notification (82/894/EEC Disease notification) 

DIAGNOSTIC METHODS 

Direct immunofluorescence 

Virus isolation 

Plaque reduction 

Neutralization test (Ni) 

Virus neutralization and Immunofluorescence test (NIFT) 

CI in i caI d i agnosis on I y 

0:1 

0:2 

0:3 

0:4 

0:5 

0:6 

TIME-INTERVAL UNDER REPORT: FROM 1/1-1988 TO 31/12-1990 

DISEASE:  10 CSF 

01 

02 

03 

04 

05 

06 

I 

1 

138 

12 

16 

28 

8 

1 

82 

37 

21 

1 

9 

2 

2 

1 

Country 

Germany 

France 

Italy 

Netherlands 

Be 1g i urn 

Luxembourg 

United Kingdom 

Ireland 

Denmark 

Greece 

Spain 

Portugal 

TOTALS 

264 

58 

22 

13 

*) 

-  19 -

Proposal  for a 
COUNCIL  DIRECTIVE 
amending  Directive 80/217/EEC  introducing 
Community  measures  for  the control  of  classical  swine  fever 

THE COUNCIL  OF THE  EUROPEAN  COMMUNITIES, 

Having  regard  to the Treaty  establishing  the European  Economic  Community, 
and  in particular  Article 43  thereof, 

Having  regard  to the proposal  from  the  Commission, 

Having  regard  to the opinion  of  the European  Parliament, 

Having  regard  to the opinion  of  the Economic  and  Social  Committee, 

Whereas  Council  Directive  80/217/EEC^1),  as  last  amended  by  Directive 
87/486/EEC^2^, 
introduced  Community  measures  for  the  control  of 
classical  swine  fever; 

Whereas  during  the  period  covered  by  Directive  80/217/EEC  the  disease 
has,  thanks  to the measures  adopted  to combat  it, been  eradicated  in most 
Member  States;  whereas,  however,  certain  serious  difficulties  have  been 
experienced  in  eradicating  the  disease  in  areas  with  a  high  density  of 
pigs and  in areas containing  wild  boar; 

Whereas,  in  view  of  the  disease  evolution,  the  availability  of  improved 
diagnostic  methods  and  of  the  completion  of  the  internal  market  for 
1 January  1993,  it  is  necessary  to  amend  the  control  measures  already 
taken  at  Community  level  to control  classical  swine  fever; 

Whereas  these  amendments  are  related  to  cleaning  and  disinfection  of 
infected  farms,  disease  in wild  boar,  the  use  of  crisis  units,  movement 
controls  in protection  and  surveillance  zones, emergency  vaccination  and 
diagnostic  procedures, 

(1) OJ  No L 47, 21.02.1980, p. 11. 
(2) OJ  No L 280, 03.10.1987, p. 21. 

HAS ADOPTED  THIS  DIRECTIVE: 

-  20  -

Article 1 

Directive  80/217/EEC  is hereby  amended  as  follows: 

1.  Article  2  is replaced  by  the  following: 

"Article  2 

For  the  purposes  of  this  Directive  the  following  definitions  shall 
apply: 

(a) "pig": any  animal  of  the  family  suidae; 

(b) "breeding  pig":  a  pig  intended  or  used  for  reproduction  with  a 

view  to multiplication of  the  species; 

(c)  "fattening  pig":  a pig  fattened  and  intended  for  slaughter  at  the 

end  of  the  fattening  period  with  a view  to meat  production; 

(d)  "slaughter  pig":  a  pig  which  is  intended  for  slaughter  without 

undue  delay  in a slaughterhouse; 

(e) "feral  pig":  a pig which  is not  kept  or  bred  in a  holding; 

(f) "holding":  any  establishment  (agricultural  or  other)  situated  in 

the  territory  of  a Member  State,  in which  pigs  are  kept  or  bred; 

(g)  "pig  suspected  of  being  infected  with  classical  swine  fever":  any 
pig  exhibiting  clinical  symptoms  or  showing  post-mortem  lesions 
or  reactions  to  laboratory  tests  carried  out  according  to 
Article  11,  indicating  the  possible  presence  of  classical  swine 
fever ; 

(h) "pig  infected  with  classical  swine  fever": any  pig 

in  which  clinical  symptoms  or  post-mortem 
classical  swine  fever  have  been officially  confirmed,  or 
in  which  the  presence  of  this  disease  has  been  officially 
confirmed  as  the  result  of  a  laboratory  examination  carried 
out  in accordance  with  Article  11; 

lesions  of 

(i)  "owner  or  keeper":  any  person  or  persons,  either  natural  or 
legal,  having  ownership  of  the  pigs, or  charged  with  keeping  the 
said  animals, whether  or  not  for  financial  reward; 

-  21  -

(k) "competent  authority":  veterinary  authority  appointed  for  the 
purpose  by  the  national  administration  for  the  Member  State 
concerned, 
national 
administration  within  the  scope  of  this  Directive,  and  reporting 
through  the national  administration; 

responsible 

directly 

being 

the 

to 

(I) "official  veterinarian":  the  veterinarian  appointed  by  the 

competent  authority of  the Member  State; 

(m) "rendering":  the  processing  of  high-risk  material  in  accordance 
Directive 

in  Council 

laid  down 

with  the  provisions  as 
90/667/EEC*; 

(n) "swill": wast  from  kitchens,  restaurants  or,  as  the  case may  be, 

from  industries using  meat. 

*0J  No L 363, 27.12.1990, p. 51." 

2.  In Article  5 

(a) the  following  is added  to  the seventh  indent  of  paragraph  1: 

"The  reintroduction  of  pigs  shall  start  with  the  introduction  of 
sentinel  piglets, which  have  been  checked  and  found  negative  for 
the  presence  of  antibodies  against  classical  swine  fever  virus. 
The  sentinel  piglets  shall  be  placed  in  accordance  with  the 
requirements  of  the  competent  authority  throughout  the  infected 
holding  and  be  rechecked  after  21  and  42  days  after  placing  on 
the  holding  for  the presence of  antibodies. 

If none of  the piglets  has developed  antibodies against  classical 
swine  fever  virus  and  as  soon  as  the  results  of  the  second  test 
are  available, with  a negative  result,  full  repopulation  may  take 
pI ace." 

(b) paragraph  2  is replaced  by  the  following: 

"2.  The  competent  authority  may  apply  the  measures  provided  for 
in  paragraph  1  to other  holdings  where  pigs  may  have  become 
infected  as a result  of  their  location  and  direct  or  indirect 
contact  with  the  infected  holding." 

3.  The  following Article  6a  is  inserted: 

-  22 -

"ARTICLE 6a 

1.  Immediately  after  the  competent  authority  has  information  that 
feral  pigs  are  suspected  of  being  infected,  it  shall  take  all 
appropriate  measures  to  confirm  the  presence  of  the  disease,  by 
giving  information  to  the  owners  or  keepers  of  pigs  and  the 
hunters,  and  by  investigation  of  all  feral  pigs,  shot  or  found 
dead,  including  laboratory  testing. 

2.  As  soon  as  confirmation  of  infection  in  feral  pigs  has  taken 
place,  the  competent  authority  of  a  Member  State  shall 
immediately  place  under  official  surveillance  holdings  in  the 
defined  infected  area  and  shall  in particular  order  that: 

(a) an official  census shall  be made of  all  categories of  pigs on 
all  holdings;  the census must  be kept  up  to date by  the owner 
or  keeper;  the  information  in  the  census  must  be  produced  on 
request  and may  be checked  at each  inspection; 

(b) all  pigs  on  the  holding  be  kept  in  their  living  quarters  or 
some  other  place  where  they  can  be  isolated  from  feral  pigs. 
The  feral  pigs must  not  have access  to any material  which  may 
subsequently  come  in contact  with  the pigs on  the  holding; 

(c) no pigs shall  enter  or  leave  the holdings; 

(d) appropriate  means  of  disinfection  be  used  at  the  entrances 
and  exits  of  buildings  housing  pigs  and  of  the  holding 
itself; 

(e) all  dead  or  diseased  pigs  on  a  holding  s:.all  be  tested  for 

the presence of  classical  swine  fever; 

(f) no  part  of  any  feral  pig  (shot  or  found  dead)  shall  enter  a 

ho Id i ng; 

(g) persons  engaged  in  hunting  feral  pigs  shall  not  enter  a  pig 

ho Id i ng. 

3.  Without  prejudice  to the measures  laid down  in paragraph  2 Member 
States  shall  present  as  soon  as  possible  a  written  plan  to  the 
Commission  about  the measures  taken  to eradicate  the disease  in a 
defined  infected  area  and  the  measures  applied  to  the  holdings 
situated  in the said  area. 

-  23 -

The  Commission  shall  examine  the  plan  in  order  to  determine 
whether  it permits  the desired objective  to be attained  and shall 
approve  the  plan,  if  necessary  with  amendments,  in  accordance 
with  the procedure  laid down  in Article  16. 

The  plan  may  subsequently  be  amended  or  supplemented,  in 
accordance  with  the  same  procedure,  to  take  account  of 
developments  in the situation. 

4.  After  approval  has  been  given  for  the  measures  provided  for  in 
the  plan,  those  measures  shall  replace  the  initial  measures 
referred  to  in paragraph  2, on  a date which  shall  be decided  upon 
in the course of giving  approval. 

5.  The plan mentioned  in paragraph  3 shall  contain  information on: 

(a) a  defined  infected  area  within  the  territory  of  the  Member 
State  referred  to  in paragraph  2. When  defining  the  infected 
area  the competent  authority  shall  take  into account: 

the geographical  distribution of  the disease, 

(i) 
(ii)  the  feral  pig population  in the area, 
(iii) the  availability  of  natural  and  man-made  borders  of 

importance  for movements of  feral  pigs. 

(b) the approximate number  of  groups of  feral  pigs and  their  size 

in the defined  area; 

(c) specific  efforts  made  to  determine  the  extent  of  the 
infection  in  the  feral  pig  population,  by  investigation  of 
feral  pigs  shot  by  hunters  or  found  dead,  and  by  laboratory 
test ing; 

(d) the  organization  of  close  cooperation  between  biologists, 
hunters,  hunting  organizations,  the  wild  life  services  and 
veterinary  services  (animal  health  and public  health); 

(e) the  reduction  of  the  feral  pig  population,  and  the  licensing 
of  hunting;  the  period  decided  to  be  used  for  reduction  of 
the  feral  pig  population  shall  consist  of  an  Initial 
eradication period  to be  followed  by a surveillance period; 

-  24 -

(f) the  method  of  removal  of  feral  pigs,  found  dead  or  shot.  In 
the  first  phase  (eradication  period)  the  removal  shall  be 
based  on  destruction  under  supervision  of  the  competent 
authority.  In  the  second  phase  (surveillance  period)  the 
removal  shall  be  in  accordance  with  the  requirements  laid 
down by  the competent  authority; 

(g) the  epizootiolog lea I enquiry  which  is  carried  out  on  each 
feral  pig  (shot or  found  dead).  This enquiry must  include  the 
completion  of  a  questionnaire  which  supplies  information 
about : 

-  the  geographical  area  where  the  animal  was  found  dead  or 

shot, 

-  the date when  the animal  was  found  (dead or  shot), 
-  the person who  found or  shot  the animal, 
-  the age and sex of  the pig, 
-  if shot: symptoms  before shooting, 
-  if found dead: the state of  the carcase, 
-  laboratory  findings; 

(h) disease  preventive  measures  applicable  to  the  holdings 
situated  in  the  defined  infected  area,  including  the 
transport  and  movement  of  animals  within,  from  and  to  the 
area*, 

(i) the  criteria  to be  applied  for  lifting  the measures  taken  to 
eradicate  the  disease  in  the  defined  area  and  the  measures 
applied  to holdings  in the area." 

4.  The  following Article 7a  is  inserted: 

"Article 7a 

In  order  to  provide  full  coordination  of  all  measures  necessary  to 
ensure  eradication  of  classical  swine  fever  as  quickly  as  possible 
and  for  the  purpose  of  carrying  out  the  epizootiological  enquiry,  a 
crisis unit  shall  be established. 

The  general  rules  concerning  national  crisis  units  and  Community 
crisis unit  are  laid down by EEC Council  Regulation  ../.../EEC*. 

*0J  No L 

-  25 -

5.  In Article  8  the  second  sentence  of  paragraph  2  is  replaced  by  the 

fol lowing: 

"in  the  event  an  authorization  Is  given  to  remove  pigs  for 
slaughter  the competent  authority  concerned  shall  ensure  that  the 
conditions  for  removal  and  slaughtering  of  pigs  fulfil  the 
requirements  laid down  in Article 9(4)(f)(i) and  the meat  derived 
from  the said  pigs  shall  comply  with  the conditions  laid  down  in 
Article  9(4)(g).M 

6.  Article 9  is replaced  by  the following: 

"Article  9 

1.  Immediately  after  the diagnosis of  classical  swine  fever  has been 
officially  confirmed  in  pigs  on  a  holding,  the  competent 
authorities  shall  establish  a protection  zone with  a radius of at 
least  3  kilometres  around  the  outbreak  site,  which  is  itself 
included  in  a  surveillance  zone  of  a  radius  of  at  least  10 
kiIometres. 

2.  The  competent  authority  must  during  the  establishment  of  zones 

take account  of: 

(a) the  results  of  the  epidemiological  studies  carried  out  in 

accordance with Article 7; 

(b) the available  serological  evidence; 
(c) the geographical  situation  particularly  natural  boundaries; 
(d) the  location  and proximity  of  holdings; 
(e) patterns  of  trade  in  growing  and  slaughter  pigs  and  the 

availability of  slaughterhouses; 

(f) the  facilities  for  control  and  the  nature  of  the  control 
measures  employed,  particularly  whether  or  not  slaughter  is 
carried out on  the  infected  premises. 

3.  In  the  case  that  a  zone  or  zones  include  parts  of  the  territory 
of  several  Member  States, the competent  authorities of  the Member 
States concerned  shall  collaborate  to establish  the zones. 

4.  The  following measures shall  be applied  in the protection zone: 

-  26 -

(a) a  census  of  all  the  holdings  shall  be  made  as  soon  as 
possible;  after  the  establishment  of  the  protection  zone 
these  holdings  shall  be  visited  by  an  official  veterinarian 
within  at  least  7 days; 

(b) the  movement  and  transport  of  pigs  on  public  or  private 
roads,  excluding  the  service  roads  of  holdings,  shall  be 
prohibited.  This  prohibition  shall  not  apply  to  the  transit 
of  pigs by motorway  or  rail  without  unloading  or  stopping-, 

(c) trucks  and  other  vehicles  and  equipment,  which  are  involved 
in the  transport  of  pigs, or  other  livestock  and  in material 
which  may  be  contaminated  (eg.  feedingstuff,  manure,  slurry, 
etc.)  and  which  are  used  within  the  protection  zone,  shall 
not  leave: 

a holding  situated  within  the protection  zone, 

(i) 
(ii)  the protection  zone, 
(iii) a slaughterhouse, 

without  having  been  cleaned  and  disinfected  in  accordance 
with  the procedures  laid down by  the competent  authority. The 
procedures  shall  include  that  no  truck  or  vehicle, which  has 
been  involved  in  the  transport  of  pigs,  can  leave  the  zone 
without  being  inspected  by  the competent  authority; 

(d) no  other  species  of  animals  may  enter  or  leave  a  holding 

without  the authorization of  the competent  authority; 

(e) all  dead  or  sick  pigs  on  a  holding  shall  be  reported  to  the 
competent  authority,  who  shall  carry  out  any  investigations 
necessary  to establish  the presence of  classical  swine  fever; 

(f) pigs may  not  be  removed  from a holding  in which  they  are  kept 
until  21  days  after  the  completion  of  preliminary  cleaning 
and  disinfecting  measures  as  laid  down  in Article  10;  after 
21  days  authorization  may  be  given  to  remove  pigs  from  the 
said  holding: 

(i) 

directly  to  a  slaughterhouse,  designated  by  the 
competent  authority,  preferably  within  the  protection 
or  surveillance zone, under  the  following  conditions: 

5) 

-  27 -

-  an  inspection  of  all  the pigs on  the  holding  has  been 

carried  out; 

-  a  clinical  examination  of  the  pigs  to  be  moved  for 
slaughter, 
the  body 
temperature  of  a proportion  thereof,  has been  carried 
out; 

the  taking 

including 

of 

-  each  pig  has been marked  by ear  marking; 
-  the  pigs  are  transported  in  vehicles  which  are 

sealed  by  the competent  authority. 

competent 

the 
The 
slaughterhouse  shall  be  informed  of  the  intention  to 
send  pigs  to  it. 

responsible 

authority 

for 

On  arrival  at  the  slaughterhouse  these  pigs  shall  be 
kept  and  slaughtered  separately  from  other  pigs.  The 
vehicle  and  equipment  which  have  been  involved  in  the 
transport  of  pigs  shall  immediately  be  cleaned  and 
disinfected. 

During  ante  and  post  mortem  inspection  carried  out  at 
the  designated  slaughterhouse,  the  competent  authority 
shall  take  into  account  the  possible  signs  relating  to 
the  presence  of  the  classical  swine  fever  virus 
infection. 

(ii)  under  exceptional  circumstances  directly  to  other 
premises  located  within  the  protection  zone  under  the 
following  conditions: 

-  an  inspection  of  all  the pigs on  the  holding  has  been 

carrled  out; 

- a  clinical  examination  of  the  pigs  to  be  moved, 
including  the  taking  of  the  body  temperature  of  a 
proportion  thereof,  has been  carried  out; 
-  each  pig  has been marked  by ear  marking. 

(g) Fresh  meat  derived  from  pigs,  referred  to  in  paragraph  4(f) 
shall  be  given  the  mark  as  described  in  the  Annex  of  Council 
Directive  72/461/EEC  of  12 December  1972, on  health  problems 
affecting 
in  fresh  meat*,  and 
subsequently  treated  in  accordance  with  rules  laid  down  in 

intra-Community 

trade 

-  28 -

Article  4(1)  of  Council  Directive  80/215/EEC  of  22  January 
1980  on  animal  health  problems  affecting  intra-Community 
trade  in  meat  products**.  This  shall  be  done  at  an 
establishment  designated  by  the competent  authority. 

The  meat  shall  be  sent  to  the  said  establishment  under  the 
condition  that  the consignment  is sealed  during  transport. 

5.  The  measures  in  the  protection  zone  shall  be maintained  at  least 

until 

(a) all measures  laid down  in Article  10 have been  carried  out, 

(b) pigs on all  holdings  have  undergone 

(i) 

a  clinical  examination  and  have  been  found  to  have  no 
signs of  illness suggesting classical  swine  fever, and 

(ii)  a  serological  examination  in  accordance  with  the 
provisions  of  Annex  I and  IV without  the  detection  of 
antibodies  to classical  swine  fever  virus. 

The  examination  referred  to  in  (i) and  (ii) shall  not  take  place 
before  30  days  have  elapsed  after  the  completion  of  preliminary 
cleaning  and  disinfection measures on  the  infected  holding. 

6.  The  following measures  shall  be applied  in the surveillance zone: 

(a) a census shall  be  taken of  all  pig  holdings; 

(b) the movement  and  transport  of  pigs on  public  roads, excluding 
the  service  roads  of  holdings  shall  be  prohibited,  unless 
licensed  by  the  competent  authority.  This  prohibition  shall 
not  apply  to the  transit  of  pigs by motorway  or  rail, without 
unloading or  stopping; 

(c) trucks  and  other  vehicles  and  equipment,  which  are  involved 
in  the  transport  of  pigs, or  other  livestock  and  in material 
which  may  be  contaminated  (eg.  feedingstuff,  manure,  slurry, 
etc.)  and  which  are  used  within  the  surveillance  zone  shall 
not  leave  the  zone without  having  been  cleaned  or  disinfected 
in  accordance  with  the  requirements  of  the  competent 
authority; 

-  29 -

(d) no  other  species  of  animals  may  enter  or  leave  a  holding 
during  the  first  7  days  after  the  establishment  of  the  zone 
without  the authorization of  the competent  authority; 

(e) all  dead  pigs on a holding  shall  be reported  to the  competent 
authorities  who  shall  carry  out  any  investigations  necessary 
to establish  the presence of  classical  swine  fever-, 

(f) pigs may  not  be  removed  from  a holding on which  they  are kept 
until  7 days after  the completion  of  preliminary  cleaning  and 
disinfection  measures  as  laid  down  in  Article  10;  after  7 
days  authorization may  be given  to  remove  pigs  from  the  said 
ho Id i ng: 

(i) 

directly  to  a  slaughterhouse,  designated  by  the 
competent  authority,  preferably  within  the  protection 
or  surveillance  zone, under  the  following  conditions: 

-  an  inspection of  all  the pigs on  the holding  has been 

carried  out; 

-  a  clinical  examination  of  the  pigs  to  be  moved  for 
the  body 
slaughter, 
temperature  of  a proportion  thereof,  has been  carried 
out; 

the  taking  of 

including 

-  each  pig  has been marked  by ear marking; 
-  the pigs are  transported  in vehicles which  are  sealed 

by  the competent  authority. 

competent 

the 
The 
slaughterhouse  shall  be  informed  of  the  intention  to 
send  pigs  to  it. 

responsible 

authority 

for 

On  arrival  at  the  slaughterhouse  these  pigs  shall  be 
kept  and  slaughtered  separately  from other  pigs. 

During  ante  and  post  mortem  inspection  carried  out  at 
the  designated  slaughterhouse,  the  competent  authority 
shall  take  into account  the  possible  signs  relating  to 
the presence of  the classical  swine  fever  infection. 

(ii)  under  exceptional  circumstances  directly  to  another 
located  within  the  protection  zone  or 

premises 
surveillance  zone under  the  following  conditions: 

-  30 -

-  an  inspection of  all  the pigs on  the holding  has been 

carried out; 

-  a  clinical  examination  of  the  pigs  to  be  moved, 
including  the  taking  of  the  body  temperature  of  a 
proportion  thereof, has been carried out; 
-  each  pig has been marked  by ear  marking. 

Trucks  and  other  vehicles  and  equipment,  which  are 
involved  in  the  transport  of  these  pigs,  shall  be 
cleaned  and disinfected  after  each  transport. 

(g) Fresh  meat  derived  from  pigs,  referred  to  in  paragraph  6(f) 
shall  be  given  the  mark  as  described  in  the  Annex  of 
Directive  72/461/EEC,  and  subsequently  treated  in  accordance 
with  rules  laid down  in Article  4(1) of  Directive 80/215/EEC. 
This  shall  be  done  at  an  establishment  designated  by  the 
competent  authority. 

The  meat  shall  be  sent  to  the  said  establishment  under  the 
condition  that  the consignment  is sealed  during  transport. 

7.  The  measures  in  the  surveillance  zone  shall  be  maintained  at 

least untiI 

(a) all measures  laid down  in Article  10 have been carried  out, 

(b) pigs on all  holdings have undergone 

(i)  a  clinical  examination  and  have  been  found  to  have  no 

signs of  illness suggesting  classical  swine  fever, and 

(ii)  a  serological  examination  in  accordance  with  the 
provisions  of  Annex  I and  IV without  the  detection  of 
antibodies  to classical  swine  fever  virus  infection. 

The  examination  referred  to  In  (i) and  (ii) shall  not  take  place 
before  15  days  have  elapsed  after  the  completion  of  preliminary 
cleaning  and disinfection measures on  the  infected  holding. 

8.  By  derogation  from  the provisions  in paragraph  4(f) and 6(f), the 
competent  authority  may  authorize  that  pigs  are  moved  out  from 
the holding  to be  transported  to a rendering  plant  for  rendering 
or  to a place where  the pigs are killed  in order  to be  burned  or 

-  31  -

buried.  These  animals  shall  be  tested  at  random  for  the  presence 
of  the  classical  swine  fever  virus  and  the  criteria  for 
collecting  blood  samples  given  in  Annex  IV  shall  be  taken  into 
account  during  the  random  testing. 

All  necessary  precautions  shall  be  taken  to  avoid  the  risk  of 
spread  of  the  virus  by  this  transport,  such  as  cleaning  and 
disinfecting  of  the  truck  after  the  transport. 

9.  Where  the  prohibitions  provided  for  in  paragraph  4(f)  and  6(f) 
are  maintained  beyond  30  days  because  of  the  occurrence  of 
further  cases  of  disease  and  as  a  result  problems  arise  in 
keeping  the  pigs,  the  competent  authority  may,  following  an 
application  by  the  owner  explaining  the  grounds  for  such 
application,  authorize  removal  of  pigs  from  a  holding  within  the 
protection  zone,  respectively  the  surveillance  zone,  provided 
that 

(a) the official  veterinarian  has verified  the  facts; 

(b) an  inspection  of  all  pigs  on  the  holding  has  been  carried 

out ; 

(c) a clinical  examination  of  the pigs  to be moved,  including  the 
taking  of  the  body  temperature  of  a  proportion  thereof,  has 
been  carr ied out; 

(d) each  pig  has been marked  by ear  marking; 

(e) the  holding  of  destination  is  located  in  the  protection  zone 

or  within  the surveillance  zone. 

All  necessary  precautions  shall  be  taken  to  avoid  the  risk  of 
spread  of  the  virus  by  this  transport,  such  as  cleaning  and 
disinfecting  the  truck  after  the  transport. 

10. The  competent  authority  shall  take  all  necessary  measures, 
including  the  use  of  prominent  signposts  and  warning  notices  and 
use of media  resources such  as  the press  and  television  to ensure 

-  32 -

that  all  persons  in  the  protection  and  surveillance  zones  are 
fully  aware  of  the  restrictions  in  force,  and  shall  take  such 
measures  as may  be  considered  appropriate  to  ensure  the  adequate 
enforcement  of  these measures. 

*0J  No L 302, 31.12.1972, p. 24. 

**0J  No L 47, 21.2.1980, p. 4." 

7.  Article  10  is replaced  by  the  following: 

"Article  10 

Member  States  shall  ensure  that 

(a) the  disinfectants  to  be  used  and  their  concentrations  are 

officially  approved  by  the competent  authority-, 

(b) the  cleaning  and  disinfection  operations  are  carried  out  under 

official  supervision  in accordance  with 

the  instructions given  by  the official  veterinarian, and 

(i) 
(ii)  the  procedure  for  cleaning  and  disinfecting  of  an  infected 

holding  as  laid down  in Annex  V." 

8.  The  following Article  10a  is  inserted: 

"Article  10a 

In  the  event  classical  swine  fever  is  confirmed  in  a  slaughterhouse 
the competent  authority  shall  ensure  that: 

(a) all  pigs  in the slaughterhouse  are slaughtered  without  delay; 

(b) the  carcases  and  offals  of  infected  and  contaminated  pigs  are 
destroyed  under  official  supervision  in  such  a  way  as  to  avoid 
the  risk of  classical  swine  fever  virus  spreading-, 

(c) cleaning  and  disinfection  of  buildings  and  equipment  including 
vehicles  take  place  under  the  supervision  of  the  official 
veterinarian  in  accordance  with  instructions  laid  down  by  the 
competent  authority; 

-  33 -

(d) an  epidemiological  enquiry  is carried  out  in accordance  with  the 

provisions of Article 7; 

(e) the  re introduction  of  pigs  for  slaughter  does  not  take  place 
until  at  least  24  hours  after  completion  of  the  cleaning  and 
disinfection  operations  carried  out  in accordance  with (c)." 

9.  Article  14  is replaced  by  the  following: 

"Article  14 

1.  Member  States shall  ensure  that: 

(a) the use of  classical  swine  fever  vaccines  is prohibited; 

(b) the manipulation  of  classical  swine  fever  virus  for  research, 
diagnosis  and/or  manufacture of  vaccines  shall  be carried  out 
only  in approved  establishments and  laboratories; 

(c) the storage, supply,  distribution  and  sale of  classical  swine 
fever  vaccines  on  the  territory  of  the  Community  are  carried 
out  under  official  control. 

2.  Notwithstanding  the  provisions  of  paragraph  1 concerning  the  use 
of  classical  swine  fever  vaccine,  it  may  be  decided,  when 
classical  swine  fever  has been  confirmed  and  is tending  to  spread 
alarmingly,  that  emergency  vaccination may  be  introduced.  In this 
case  the Member  State  concerned  sha11  submit  to the Commission  an 
emergency  vaccination plan which  shall  include  information on-. 

(a) the  disease  situation  which  has  resulted  in  the  demand  for 

the emergency  vaccination, 

(b) the  extent  of  the  geographical  area  in  which  emergency 

vaccination  is to be carried  out, 

(c) categories  of  pigs  and  approximate  number  of  pigs  to  be 

vaccinated, 

(d) the vaccine  to be  used, 

-  34 -

(e) the duration of  the vaccination  campaign, 

(f) the  identification  and  registration  of  the  vaccinated 

animals, 

(g) measures  for  the movement  of  pigs and  their  products, 

(h) other matters appropriate to the emergency  situation. 

shall 

Commission 

The 
in 
immediately 
collaboration with  the Member  State concerned.  In accordance with 
the  procedures  laid  down  in Article  16  the emergency  vaccination 
plan may be approved or  amendments and additions may  be  requested 
before approval  is given. 

examine 

plan 

the 

3.  In  the  event  of  emergency  vaccination  a  Member  State  which 

practices emergency  vaccination  shall  ensure  that: 

no  live pigs  leave  the vaccination  area  except  for  immediate 
slaughter  in  a  slaughterhouse  designated  by  the  competent 
authority  and  situated  within  the  vaccination  area  or  close 
to this area-, 

all  fresh  pig  meat  produced  from  pigs  vaccinated  during  the 
emergency  vaccination  shall  bear  the  stamp  provided  for  in 
Article  5a  of  Directive  72/461/EEC  and  be  stored  and 
transported  separately  from meat  not  having  the said  stamp. 

4.  The  provisions  of  paragraph  3  shall  apply  during  the  emergency 
vaccination  period  and  for  a  minimum  of  12  months  following 
completion of  the vaccination operations  in the affected  area. 

5.  If  necessary,  the  Commission  shall  adopt  rules  relating  to  the 
production,  packaging,  distribution  and  state  of  the  stocks  of 
anti  classical  swine  fever  vaccines  in the  Community." 

10. Article  14a  is replaced  by  the  following: 

-  35  -

"Article  14a 

Veterinary  experts  from  the Commission  may,  in collaboration with  the 
authorities  of  the Member  State  concerned,  in so  far  as  is necessary 
to  ensure  uniform  application  of  this  Directive,  make  on-the-spot 
checks;  the  Commission  shall  inform  the Member  States of  the  results 
of  the  investigation. 

A Member  State  in whose  territory  a check  is being  carried  out  shall 
give  all  the  necessary  assistance  to  the  experts  in  carrying  out 
their  duties. 

The  general  provisions  for  implementing  this  Article  shall  be 
determined  in accordance  with  the procedure  laid  down  in Article  16." 

11. Annex  I is replaced  by  the  following: 

-  36 -

"ANNEX 

\ 

DIAGNOSTIC PROCEDURES FOR THE  CONFIRMATION 
OF DIFFERENTIAL  DIAGNOSIS OF CLASSICAL SWINE FEVER 

The  following  guidelines,  standards  and  minimum  criteria  are  laid  down 
for the diagnostic procedures of Classical  Swine Fever  (CSF). 

A.  COLLECTION OF MATERIALS FOR DIAGNOSIS 

should 

tissues 

1.  For  virus  isolation  and  antigen  detection,  tonsil  and  spleen 
tissues are  considered  essential.  Preferably  at  least  two other 
the 
be 
lymphatic 
retropharyngeal,  parotid,  mandibular  or  mesenteric  lymph  nodes 
together  with  ileum or  kidney.  Each  sample of  the  tissue should 
be  placed  in  a  separate  sealed  plastic  bag  and  labelled.  The 
samples  should  be  transported  and  stored 
in  leak-proof 
containers.  They  should  not  be  frozen  but  kept  cool  at 
refrigerator  temperature and tested without  delay. 

collected, 

such 

as 

2.  Blood  samples  for  virus  isolation  from  leucocytes  should  be 
collected  from  pigs  showing  signs  of  fever  or  other  signs  of 
disease.  EDTA or  heparin should  be used  as anticoagulants.  The 
samples  must  be  kept  cool  at  refrigerator  temperature  and 
submitted  to  laboratory  testing without  delay. 

3.  Blood  samples  for  the  detection  of  antibody  as  an  aid  to 
diagnosis  of  clinical  outbreaks  and  for  the  purposes  of 
surveillance,  should  be  taken  from  animals  which  have  recovered 
from  suspect  infection  and  from  pigs  known  to  have  been  in 
contact with  infected or suspect  cases.  In such suspect  holdings 
all of  the first  20 suspect or  in-contact  animals, and  25% of any 
additional  animals, should be sampled.  In order  to ensure a high 
probability of detection of antibody, samples should be collected 
from each unit of  the holding  at this  level. 

B.  THE  LABORATORY  DIAGNOSIS OF  CLASSICAL  SWINE  FEVER 

-  37  -

The  principal  basis  for  the  laboratory  diagnosis  of  CSF  shall  be  the 
demonstration  of  viral  antigen,  virus  or  antibodies  in  organs  or 
tissue  fluids. 

In  the  case  of  inconclusive  results,  the  tests  shall  be  repeated  on 
the  same  samples.  Additional  samples  should  be  collected  from  the 
same  source  if clinical  suspicion  continues. 

Serological  tests  for  the  detection  of  antibodies  may  be  used  as  an 
adjunct  to  diagnosis  in  cases  of  suspect  CSF.  If  the  demonstration 
of  viral  antigen  or  virus  isolation  has  not  been  successful  on 
material  derived  from  animals  giving  rise  to suspicion  of  CSF  or  with 
material  from  holdings which  have  had  contact  with  cases of  CSF,  then 
tests  for  the  detection  of  antibody  shall  be  applied  to blood  samples 
of  animals  which  have  recovered  from  the  suspect  disease  and  from 
those  known  to have  been  in contact  with  the  disease. 

1.  Demonstration of  viral  antigen 

For  the demonstration of  viral  antigen  in organ  tissues, a  direct 
immune  labelling  system  should  be  used  on  thin  cryostat  sections 
(up  to  five  microns)  of  tonsils  and  tissues  of  other  organs  as 
specified  in A  (1).  The  diagnostic  reagent  must  be  a  pestivirus-
specific  polyclonal  antiserum  to  CSF  virus,  labelled  with  a 
fluorochrome,  an  enzyme,  or  biotin,  according  to  the  following 
criter ia: 

(a) hyperimmune  serum  shall  be  prepared  from  pigs  free  from 
infections  or  antibody  which  could  affect  the  specificity  or 
quality of  the  reaction; 

(b)  labelled  immunoglobulin  prepared  from  CSF  hyperimmune  pig 
serum  as  specified  under  (a)  shall  have  a  minimum  working 
titre  of  1/20  as  determined  in  CSF  virus  infected  cell 
cultures  and  confirmed  by  check  tests  on  tissue  sections. 
The working  dilution of  the conjugate  shall  combine  a maximum 
of  signal  with  a minimum  of  background  staining; 

Any  sample  showing  specific  cytoplasmic  reaction  shall  be 
considered  positive  for  pestivirus.  In  such  cases  further  tests 
must  be  carried  out  as described  in B(3). 

-  38 -

2.  Virus  isolation  and  identification  in cell  cultures 

(a) Virus  isolation  from  tissue  samples 

is  performed  on 
susceptible  cell  cultures  of  PK15  or  other  equally 
susceptible  cell  lines.  Organ  suspension  from  a  suspected 
animal  should  be  inoculated  at  a dilution of  1/10. 

(b) Virus  isolation  from  blood  samples,  collected  and  handled  as 
indicated  in paragraph  A(2), is performed  by  the  inoculation 
of  cell  cultures with  buffy  coat  suspension  reconstituted  to 
the original  blood  volume. 

(c) For  detection of  viral  antigen  in the cytoplasm of  Inoculated 
monolayers,  ceil  cultures  shall  be  treated  with  labelled 
polyclonal  antiserum.  The  staining  should  be  applied  at 
intervals from  24 to 72 hours  from  the  time of  inoculation. 

(d) Positive  cultures  should  be  subject 

to  differential 
diagnostic  tests  as  specified  in  B(3).  Negative  results 
after  the  first  cell  culture  passage  may  require  second  or 
even more passages  in order  to  isolate virus. 

3.  Monoclonal  antibody  typing  of pestivirus  isolates 

(a) Duplicates of  tissue cryostat  sections or  cell  cultures which 
give  positive  reactions  with  polyclonal 
antiserum  as 
described  in  B(1)  and  (2)  shall  be  further  examined  by 
labelled  monoclonal  antibodies  to  differentiate  between  CSF 
virus  and  bovine  virus  diarrhoea  (BVD)/border  disease  (BD) 
viruses. 

(b) Only  monoclonal s  which  have  been  officially  recommended  by 
the  EC  Reference  Laboratory  for  Classical  Swine  Fever, 
following extensive characterization, should  be used. 

(c) The  monoclonal s  should  be  grouped  into  four  panels  according 

to the following  criteria: 

Panel  number 

Reactivity 

1 
2 
3 
4 

All  pest iviruses 
All  CSF  viruses 
CSF vaccine  strains 
AI I BVD/BD  viruses 

-  39 -

Each  panel  may  be  represented  either  by  a  single  monoclonal 
or  by  a  mixture  of  the  component  monoclonal  antibodies, 
provided  that  the  spectrum  of  reactivity  corresponds  to  that 
given above. 

(d) The  interpretation of  the  reaction  patterns  is summarised  as 

fol lows: 

Panel 

12  3 4 

Interpretation 

+ + 
+ + + - 
+ 
+ 
+ 
+ + - + 
+ + + + 

CSF  confirmed 
CSF  vaccine  strain 
BVD/BD  virus 

) 
)  Virus unclassified, 
) 
) 

further  tests 
required 

C.  DETECTION OF ANTIBODY TO CLASSICAL  SWINE  FEVER  VIRUS 

The  detection  of  CSF  virus  antibody  in  blood  samples  is carried  out 
to assist  in the diagnosis of  swine  fever  in holdings containing  pigs 
showing  clinical  signs of  the disease or  in pigs believed  to have had 
contact  with  infected  pigs.  It  may  also  be  carried  out  for  the 
purposes of  surveillance or  for  surveys  in herds of  unknown  status. 

For  these  purposes,  blood  samples  should  be  subjected  to  an  approved 
test. 

The  following  tests are approved  for use and must  be carried  out  with 
the  inclusion of  appropriate  positive  and negative  serum  controls. 

The  virus  strains  to  be  used  for  serological  tests  should  be  agreed 
at  a  meeting  of  the  National  Swine  Fever  Laboratories  (NSFL),  and 
issued  as  required  by  the EC Reference  Laboratory  for  Classical  Swine 
Fever  to the NSFL, upon  request. 

All  test  procedures  used  must  be  shown  to  give  satisfactory  results 
with  CSF  reference  sera  supplied  by  the  EC  Reference  Laboratory  for 
Classical  Swine  Fever. 

-  40 -

1.  The virus neutralization  test 

This  test  is  based  on  the  determination  of  the  50%  endpoint. 
Cultures  are  inoculated  with  mixtures  of  diluted  serum  and  a 
constant  amount  of  virus  after  a  specified  incubation  period  at 
37*C.  The  results  are  based  on  the  absence  of  any  viral 
replication  detectable  by  an  immune  labelling  system.  Either 
neutralization-immunofluorescence  (NIF)  or  the  neutralizing 
peroxidase-1 inked  antibody  (NPLA)  assays  may  be  used.  Detailed 
protocols will  be supplied by  the EC Reference Laboratory  for CSF 
as  required. 

For  screening  purposes  the sera  are  initially diluted  1/10.  When 
a  full  titration  is  necessary  two-fold  dilutions  of  serum 
starting  at  1/10  are  prepared.  Each  dilution  is  mixed  with  an 
equal  volume  of  virus  suspension  containing  100  (+/-  0.5  log10) 
infectious  doses  (TCID 50).  At  least  two  cultures  are  used  at 
each  dilution  level.  After  an  appropriate  incubation  period  the 
cell  cultures  are  fixed  and  viral  antigen  is  detected  by  an 
immune  labelling  system.  The  results  are  expressed  as  the 
reciprocal  of  the  initial  serum  dilution  at  which  half  the 
inoculated  cell  cultures  fail  to show any  specific  labelling.  An 
end-point  between  two dilution  levels  is estimated. 

2.  The enzyme-1inked  immunosorbent  assay  (ELISA) 

Competitive,  blocking  and  indirect  techniques may  be  used  on  any 
suitable  support. 

It  is  recommended  that  the  tests  used  should  minimize  cross-
reactions  with  BVDV  and  other  pestiviruses.  However,  the  test 
system  must  ensure  identification  of  all  CSF  infections,  and  at 
all  stages of  the  immune  response  to  infection. 

Ant i gen : 

The  antigen  should  be  derived  from  or  correspond  to  viral 
proteins of one of  the recommended  CSF  virus strains.  Cells used 
to  prepare  antigen  should  be  free  of  any  other  pestivirus 
infection. 

-  41  -

Antisera: 

Polyclonal  antisera  for  competitive  or  blocking  assays  should  be 
raised  in  pigs  or  rabbits  by  infection  with  one  of  the 
recommended  CSF  virus  strains  or  with  the  lapinized  C  strain. 
Monoclonal  antibodies should  be directed  against  or  correspond  to 
an  immunodominant  viral  protein  of  CSF  virus.  Indirect  assays 
should  use  an  anti-porcine  immunoglobulin  reagent  that  detects 
both  IgG and  IgM. 

The  sensitivity  of  the  EL I SA  should  be  high  enough  to  score 
positive  any  serum  recating  In the  neutralization  test,  and  also 
reference  positive  sera  as  issued  by  the  EC Reference  Laboratory 
for  CSF. 

The  EL I SA  may  only  be  used  with  serum  or  plasma  samples  derived 
from  individual  pigs. 

If  the  EL I SA  procedure  used  is  not  CSF  specific,  then  positive 
samples  should  be  further  examined  by  differential  tests  as 
specified  in section E. 

D.  EVALUATION OF  THE RESULTS OF LABORATORY  TESTING 

1.  The  demonstration  of  CSF  virus  antigen  in organ  tissues  or  cell 
cultures  after  virus  isolation  from  tissue  samples  following  the 
techniques  defined  in B  (1), (2) and  (3) shall  form  the  basis of 
confirmation of  the presence of  the disease except  in the case of 
a  reaction  demonstrated  to  be  due  to  vaccinal  virus  specified 
according  to  B  (3).  The  demonstration  of  BVD/BD  antigen 
according  to B  (3) shall  rule out  suspicion of  CSF  provided  there 
are  no  other  grounds  for  such  suspicion.  Following  unusual  or 
unexpected  results  of  monoclonal  typing  according  to  B  (3) 
pestivirus  isolates shall  be considered  unclassified  and  the herd 
of  origin  regarded  as  suspect  pending  further  testing.  This  may 
include  submission  of  the  virus  to  a  reference  laboratory  for 
characterization,  and  serological  investigations  on  the  herd  of 
origin. 

2.  Following  the  detection  of  antibody  reactive  with  CSF  virus,  the 

herd of origin  shall  be  regarded  as  suspect. 

-  42 -

(a)  In  order  to  rule  out  the  suspicion  of  CSF  raised  by  the 
detection  of  antibody,  the  test  described  in Section E below 
shall  be  used  to  distinguish  between  CSF-reactive  antibody 
that  may  have  been  induced  by  other  pestiviruses  and  such 
antibody due to CSF virus  itself.  All original  samples shall 
be retested  by  the differential  test. 

(b)  If  suspicion  cannot  be  ruled  out  on  the  first  differential 
test,  a  further  test  shall  be  carried  out  at  least  30  days 
later  to  follow up  the possible  spread  of  infection.  All  of 
the  first  20 animals on  the suspect  holding  shall  be  sampled 
and 25% of any additional  animals. 

3.  Interpretation of serological  results 

A virus neutralization  titre of >.  1/10  in any  pig  together  with 
clinical  or epizootiological  evidence giving  rise to suspicion of 
disease shall  constitute a positive diagnosis.  A titre of >. 1/10 
in  any  pig  without  clinical  or  epizootiologiaI  evidence  gives 
rise  to  suspicion  of  disease  and  should  be  followed  by 
differential  diagnostic procedures. 

The same criteria should  be applied  for any pig giving  a positive 
EL I SA result. 

E.  SEROLOGICAL  PROCEDURES  FOR  THE  DIFFERENTIAL  DIAGNOSIS  BETWEEN 

CLASSICAL SWINE  FEVER AND OTHER  PEST IVI RUSES 

1.  Tests  for  the differential  diagnosis of  CSF  and other  pestivirus 
infections  are  based  on  parallel  testing  of  the  sera  with  both 
CSF and BVD/BD virus strains using  fully comparable methods. 

The  CSF  and  BVD/BD  virus  strains  for  use  should  have  been 
officially  approved  (see C  above).  To  rule out  the suspicion  of 
CSF  raised  by  the detection of  antibody, blood  samples  should  be 
examined  by  comparative  end-point  titrations  for  neutralizing 
antibody against  CSF virus and BVD/BD virus. 

In blocking  ELISA,  a  comparison  of  percentage  blocking  with  CSF 
and BVD/BD antigens may be used. 

2.  The  results of  the comparative  serological  tests using  reference 
strains  of  CSF  and  other  pestiviruses  shall  be  interpreted  as 
foI Iows: 

-  43 -

(a)  if  the  comparative  tests  show  that  more  than  one  pig  has 
antibody  to CSF  virus with  no antibody  to other  pestiviruses 
the test  result  is considered positive for CSF. 

(b)  if  the  comparative  tests  show  that  the  titres  to  CSF  virus 
are equal  to or  higher  than  the  titres  to other  pest(viruses 
in more  than one of  the pigs  there shall  be suspicion  of CSF 
and differentiation shall  proceed  as follows: 

-  those  pigs  which  shown  neutralizing  titres  against  CSF 
virus which  are  higher  than or  equal  to  the  titres  against 
other  pestiviruses  shall  be  slaughtered.  Their  tissues 
and,  if  pregnant,  their  fetuses,  shall  be  subjected  to 
examination  for  CSF  antigen  or  virus,  following  the 
procedure defined  in B  (1, 2 or 3 ). 

-  if  CSF  viral  antigen  or  virus  is  detected,  CSF  shall  be 

conf irmed, 

-  if the examination  defined  in the second  indent  above  fails 
to reveal  the presence of CSF antigen or  virus, the holding 
shall  be considered  as suspect  until'a  further  set of blood 
samples collected at  least  30 days  later  has been  subjected 
to further  comparative  tests. 

-  if  these  subsequent  comparative  tests  show  all  animals  to 
have  significantly  (four-fold  or  greater)  higher  titres 
against  BVD/BD  virus  than  against  CSF  virus,  suspicion 
shalI  be ruled out, 

-  if one or  more  animals  show  a titre against  CSF  virus  that 
is equal  to or  higher  than  its titre  to BVD/BD  virus, then 
the result  is considered  positive for CSF. 

(c)  if  the  BVD/BD  titres  are  such  as  not  to  exclude  the 
possibility  of  CSF,  the  holding  shall  be  considered  as 
suspect  and be retested  after  at  least  30 days. 

THE DIFFERENTIAL  DIAGNOSIS OF AFRICAN SWINE FEVER  (ASF) 

ASF  cannot  be  differentiated  from  Classical  Swine  Fever  by  either 
clinical  or  post-mortem  examinations  and  both  of  these  diseases 
should  be  considered  in  the  differential  diagnosis  of  any  acute 
febrile haemorrhagic syndrome of pigs. 

-  44 -

Laboratory  tests  are  essential  to  distinguish  between  the  two 
diseases.  A  positive  diagnosis  in  an  ASF-free  country  should  be 
based on  the  isolation and  identification of ASF virus. 

The  principal  basis  for  the  laboratory  diagnosis of  ASF  shall  be  the 
demonstration  of  virus,  viral  antigen  or  antibodies  in  organs  and 
tissue fluids. 

In  case  of  inconclusive  or  negative  results  of  at  least  2  tests  on 
samples  from animals giving  rise  to suspicion of ASF or with material 
from  holdings  which  had  contacts  with  cases  of  ASF,  additional 
material  should  be  collected  in  the  same  holding  and  from  animals 
which  have been  in contact  with  the disease. 

1.  Demonstration of viral  antigen. 

of 

the 

viral 

demonstration 

For 
direct 
immunofluorescence  technique  or  other  suitable  techniques  shall 
be applied  to  thin cryostat  sections of  organ  tissues or  smears, 
or on sediments  from  leucocyte cultures.  The procedures used are 
similar  to  those  described  for  CSF,  except  that  ASF-specific 
reagents are used. 

antigen 

the 

2.  Virus  isolation and  identification 

(a) Haemadsorption  (HAD) test 

The  HAD  test  is  carried  out  by  inoculating  either  prepared 
10%  tissue  suspensions  or  blood  collected  in  the  field  from 
suspect  pigs  into  primary  pig  leucocyte  cultures  or  by 
preparing  leucocyte  cultures  from  the  blood  of  febrile  pigs 
inoculated  at  the  laboratory  or  collected  in  the  field. 
Haemadsorption consists of  the attachment  of  large numbers of 
pig  erythrocytes  to  the  surface  of  infected  cells  and  is 
diagnostic  for ASF. 

(b) Pig  inoculation 

A  pool  is made  with  aliquots  of  each  10%  tissue  suspension 
and  2ml  inoculated  intramuscularly  into  each  of  four  pigs: 
two  of  these  should  be  vaccinated  against  CSF  and  two 
unvaccinated.  Pigs  should  be examined  daily  for  increase of 

-  45 -

rectal  temperature  and  onset  of  clinical  signs  for  up  to 21 
days.  If  fever  develops  blood  samples  should  be  collected 
for  preparation  of  leucocyte  cultures  for  the  HAD  test 
(autorosette  and  inoculation  of  primary  pig  leucocyte 
cultures).  If  no  clinical  signs  develop  blood  should  be 
taken  for  detection  of  antibodies  after  the  21  day 
observation  period. 

DETECTION  OF  ANTIBODY  INDUCED  BY  ASF-VIRUS  IN  BLOOD  SAMPLES  AND 
TISSUE FLUIDS 

The  detection  of  antibody  in  samples  of  serum  or  tissue  fluid  is 
carried  out  to assist  in the diagnosis of ASF  in holdings  containing 
pigs showing clinical  signs suspicious of disease or  in pigs believed 
to  have  had  contact  with  ASF  infected  pigs.  It may  also  be  carried 
out  for  the  purpose  of  surveillance  or  for  surveys  in  herds  of 
unknown status. 

For  these purposes samples should  be subjected  to an approved  test. 

The  following  are  approved  for  use  and  must  be  carried  out  with  the 
inclusion of appropriate positive and negative serum controls. 

(a)  Indirect  immunofluorescence  ( M F)  test 
(b) EL ISA" 

12. The following annexes are added  after  Annex  III 

-  46 -

"ANNEX  IV 

SEROLOGICAL  SCREENING OF PIGS  IN THE PROTECTION ZONE 

AND SURVEILLANCE ZONE FOR DETECTION OF ANTIBODIES AGAINST 
CLASSICAL SWiNE FEVER VIRUS 

The  programme  for  serological  screening  shall  take  into  account  the 
transmission  of  classical  swine  fever  and  the way  pigs  are  kept, e.g.  a 
reference  to whether  pigs are kept  in groups or not. 

1•  Serological  screening of pigs kept  in a group 

A group  is two or more pigs kept  in direct contact. 

Samp Iing of groups 

if 20 or  less than 
20 pigs  in a group -

2  pigs.  In  the  event  the  groups 
consists  of  a  sow  with  piglet, only 
the sow shall  be sampled; 

if more  than 20 

2 pigs  -i- 5% of  the remainder. 

All groups shall  be sampled. 

2.  Serological  screening  of  pigs  kept  individually:  this  Includes  pigs 
kept  in close  proximity  to each  other  but  having  no  direct  contact, 
e.g.  tethered  sows 

Sampling procedure 

No of pigs 

pigs to be tested 

less than 20 
20 - 100 
more than 100 

al I 
20 + 20% of  the remainder 
20 + 10% of  the remainder 
(at  least  36) 

-  47  -

ANNEX V 

PROCEDURE  FOR  CLEANING  AND  DISINFECTING 
AN  INFECTED  HOLDING 

I. Preliminary  cleaning  and  disinfection 

a)  As  soon  as  the  carcases  of  the  pigs  have  been  removed  for 
disposal,  those  parts  of  the  premises  in  which  the  pigs  were 
housed  and  any  parts  of  other  buildings,  yards  etc  contaminated 
during  slaughter  or  post-mortem  examination  should  be  sprayed 
with  disinfectants  approved  for  use  in  accordance  with  Article 
10. 

b)  Any  tissue  or  blood  which  may  have  been  spilled  during  slaughter 
or  post-mortem  or  gross  contamination  of  buildings,  yards, 
utensils  etc  should  be  carefully  collected  and  disposed  of  with 
the  carcases. 

c)  The  used  disinfectant  shall  remain  on  the  surface  at  least  24 

hours. 

II.  Final  cleaning  and  disinfection 

a)  Grease  and  dirt  should  be  removed  from  all  surfaces  by  the 
application  of  a  degreasing  agent  and  washed  with  cold  water. 

b)  After  washing  with  cold  water  as  described  in a)  further  spraying 

with  disinfectant  should  be  applied. 

c)  After  7  days  the  premises  should  be  treated  with  a  degreasing 
agent,  rinsed  with  cold  water,  sprayed  with  disinfectant  and 
rinsed  again  in cold  water. 

d)  Manure  and  used  bedding  should  be  stacked  to  heat,  sprayed  with 
disinfectant  and  left  for  42  days.  Slurry  should  normally  be 
stored  for  42  days  after  the  last  addition  of  infective  material. 
This  period  may  be  extended  if  the  slurry  has  been  heavily 
contaminated." 

-  48 -

Article 2 

Member  States  shall  bring  into  force  the  laws,  regulations  and 
administrative  provisions  necessary  to  comply  with  this  Directive  not 
later  than  31  December  1991. They  shall  forthwith  inform  the  Commission 
thereof. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a 
reference  to this Directive or  shall  be accompanied  by  such  reference at 
the  time  of  their  official  publication.  The  procedure  for  such 
reference shall  be adopted  by Member  States. 

This Directive  is addressed  to the Member  States 

Art icle 3 

Done at Brussels, 

For  the Council 
The President 

-  49 -

Proposal  for a 
COUNCIL  DECISION 
amending  Directive 80/1095/EEC and Decision  80/1096/EEC 
as regards certain measures  relating  to classical  swine fever 

THE COUNCIL OF THE EUROPEAN  COMMUNITIES, 

Having  regard  to the Treaty establishing  the European  Economic  Community, 
and  in particular  Article 43 thereof, 

Having  regard  to the proposal  from  the Commission, 

Having  regard  to the opinion of  the European  Parliament, 

Having  regard  to the opinion of  the Economic  and Social  Committee, 

Whereas  Council  Directive  80/1095/EEC^1),  as  last  amended  by  Directive 
87/487/EEC^2^,  lays  down  conditions  designed  to  render  and  keep  the 
territory of  the Community  free from classical  swine  fever; 

Whereas  Council  Decision  80/1096/EEC^3^,  as  last  amended  by  Decision 
87/488/EEC^4^, 
the 
eradication of classical  swine  fever; 

introduced  Community 

financial 

measures 

for 

Whereas  the  measures  applied  to  eradicate  classical  swine  fever  have 
gradually  improved  the  health  status  of  the  pig  population  on  the 
territory  of  the  Community;  whereas  it  has  been  possible  due  to  this 
improved  status  to  recognize  areas  (regions  or  Member  States)  as 
officially  swine  fever-free or swine  fever-free; 

Whereas  one  of  the  given  objectives  to  keep  the  territory  of  the 
Community  free  from  classical  swine  fever  has  been  reached  in  large 
areas;  whereas  it  is necessary  to  take  this  situation  into  account  and 
consequently  amend  Directive 80/1095/EEC  and Decision  80/1096/EEC, 

HAS ADOPTED THIS DECISION: 

(1) OJ  No L 325, 01.12.1980, p. 1. 
(2) OJ  No L 280, 03.10.1987, p. 24. 
(3) 0J No L 325, 01.12.1980, p. 5. 
(4) 0J  No L 280, 03.10.1987, p. 26. 

-  50 -

Article 1 

In  Article  12(2)  of  Directive  80/1095/EEC  the  date  1  July  1993  is 
replaced  by  1 January 1992. 

Article 2 

The  following  sentence  is added  to Article  2(1) of  Decision  80/1096/EEC: 
"Nevertheless,  the participation of  the Community  is  limited  to measures 
carried out  before  1 January  1992". 

This Decision  is addressed  to the Member  States 

Art icle 3 

Done at Brussels, 

For  the Counci 
The President 

-  51 -

Proposal  for a 
COUNCIL  DIRECTIVE 
amending  Directives 64/432/EEC, 72/461/EEC  and  80/215/EEC 
as regards certain measures  relating  to swine  fever 

THE COUNCIL OF THE EUROPEAN  COMMUNITIES, 

Having  regard  to the Treaty establishing  the European  Economic  Community, 

and  in particular  Article 43 thereof, 

Having  regard  to the proposal  from  the Commission, 

Having  regard  to the opinion of  the European Parliament, 

Having  regard  to the opinion of  the Economic  and Social  Committee, 

Whereas  Council  Directive  64/432/EEC  of  26  June  1964  on  animal  health 
problems  affecting  intra-Community  trade  in bovine  animals  and  swine*1*, 
as  last  amended  by  Decision  91/13/EEC*2*,  defines  in  particular  the 
conditions  which  must  be  satisfied  as  regards  classical  swine  fever  by 
live pigs  intended  for  intra-Community  trade; 

Whereas  Council  Directive  72/461/EEC  of  12  December  1972  on  health 
problems  affecting  intra-Community  trade  in  fresh  meat*3*,  as  last 
amended  by  Directive 89/662/EEC*4*,  defines  the  conditions which  must  be 
satisfied  as regards classical  swine  fever  by  fresh pig meat  intended  for 
intra-Community  trade; 

Whereas  Council  Directive  80/215/EEC of  22 January  1980 on  animal  health 
problems  affecting  intra-Community  trade  in  meat  products*5*,  as  last 
amended  by  Directive  89/662/EEC,  defines  in  particular  the  conditions 
which  must  be  satisfied  as  regards  classical  swine  fever  for  meat 
products  intended  for  intra-Community  trade; 

Whereas  the  measures  applied  to  eradicate  classical  swine  fever  have 
gradually  improved  the  health  status  of  the  pig  population  on  the 
territory of  the  Community; 

(1) OJ No  121, 29.07.1964, p. 1977/64 
(2) OJ No L  8, 11.01.1991, p. 26. 
(3) OJ  No L 302, 31.12.1972, p. 24. 
(4) OJ  No L 395, 30.12.1989, p. 13. 
(5) 0J No L  47, 21.2.1980, p. 4. 

-  52 -

Whereas  one  of  the  given  objectives  to  keep  the  territory  of  the 
Community  free  from  classical  swine  fever  has  been  reached  in  large 
areas;  whereas  it  is necessary  to  take  this  situation  into  account  and 
consequently amend  Directives 64/432/EEC, 72/461/EEC and 80/215/EEC; 

Whereas  in  this  context  it  is  appropriate  not  to  extend  the  type  of 
guarantees  laid  down  in  Article  4b  of  Directive  64/432/EEC  and  of 
Article 13b of  Directive 72/461/EEC  and  to discontinue  the measures  laid 
down  in Article  10 of Directive 80/215/EEC, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 64/432/EEC  is hereby  amended  as follows : 

1.  In Art icle 2 : 

(a) the  words  "swine  fever"  in the  second  line of  (i) of  point  (ii) 

are deleted, 

(b) the definitions  in (p), (q) and  (r) are deleted. 

2.  In Artide  3: 

(a) the  words  "swine  fever"  in  the  introducing  phrase  of  paragraph 

2(b) are deleted, 

(b) the words  "swine fever or"  in paragraph  2(b)(i) are  deleted, 

(c) paragraph  2(b)(ii)  is deleted, 

(d) the words  "swine fever"  in paragraph  2(c)(ii) are deleted. 

-  53 -

e)  the first  sentence of paragraph  4  is replaced  by  the following : 

"Swine  for  breeding  and  production  must  moreover  come  from 

brucellosis  free stock" 

3.  Article 4b  is replaced  by  the  following: 

"Article 4b 

In addition  to the measures provided  for  in this Directive  concerning 
classical  swine  fever  each  Member  State  shall  ensure  that  pigs  sent 
from  its  territory  to  that  of  another  Member  State  shall  not  come 
from  a  holding  or  an  area  which  is  subject  to  restrictions  for 
classical  swine  fever  in  conformity  with  the  provisions  of  Council 
Directive  80/217/EEC  of  22  January  1980  introducing  Community 
measures  for  the control  of classical  swine  fever*. 

*0J  No L 47, 21.2.1980, p. 11." 

4.  In Annex  F,  Form  III, V,  the point  (c)  is deleted.  The points "(d), 

(e) (f) and  (g)" becomes  "(c), (d), (e) and (f)". 

Article 2 

Directive 72/461/EEC  is hereby  amended  as follows: 

In Article  3 the following  point  (e)  is added  after  point (d): 

"(e) 

The  meat  shall  not  be  the  subject  of  animal  health  restrictive 
measures  pursuant  to  the  provisions  of  Council  Directive 
80/217/EEC  of  22 January  1980  introducing  Community  measures  for 
the control  of classical  swine  fever*. 

*0J  No L 47, 21.2.1980, p. 11." 

Art icle 3 

Article  10 of Directive 80/215/EEC  is hereby  deleted. 

-  54 -

Art icle 4 

Member  States  shall  bring  into  force  the  laws,  regulations  and 
administrative  provisions  necessary  to  comply  with  this  Directive  not 
later  than  1  January  1992. They  shall  forthwith  inform  the  Commission 
thereof. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a 
reference  to this Directive  or  shall  be accompanied  by  such  reference at 
the  time  of  their  official  publication.  The  procedure  for  such 
reference shall  be adopted  by Member  States. 

This Directive  is addressed  to the Member  States 

Art icle 5 

Done at Brussels, 

For  the Council 
The  President 

-  55 -

Proposal  for a 
COUNCIL  DIRECTIVE 
amending  Directive 72/462/EEC on health  and veterinary  inspection 
problems upon  importation of bovine animals and swine and 
fresh meat  or meat  products  from  third  countries 

THE COUNCIL OF THE  EUROPEAN  COMMUNITIES, 

Having  regard  to the Treaty establishing  the European  Economic  Community, 
and  in particular  Article 43 thereof, 

Having  regard  to the proposal  from  the Commission, 

Having  regard  to the opinion of  the European Parliament, 

Having  regard  to the opinion of  the Economic  and  Social  Committee, 

Whereas  Council  Directive  72/462/EEC*1*,  as  last  amended  by  Directive 
91/69/EEC*2*,  defines  in  particular  the  conditions  which  must  be 
satisfied  as regards classical  swine  fever  upon  importation  of  live pigs, 
fresh pig meat  and meat  products  from  third countries; 

Whereas  in view of  the  improved  health  situation  within  the  Community  in 
respect  of  classical  swine  fever  and  the  discontinuation  of  systematic 
vaccination  against  the  said  disease,  it  is  necessary  to  amend  the 
conditions  laid  down  for  importation  of  live  pigs,  fresh  pig  meat  and 
meat  products, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 72/462/EEC  is hereby  amended  as follows: 

1.  The  following paragraphs 4, 5 and 6 are added  to Article  6: 

"4.  In  respect  of  classical  swine  fever  pigs  must  come  from  the 

territory  of a third  country which: 

(1) OJ  No L 302, 31.12.1972, p. 28. 
(2) OJ  No L  46, 19.02.1991, p. 37. 

-  56 -

has  been  free  from  classical  swine  fever  for  at  least  12 

months, 
has not  permitted  vaccination  for  the preceding  12 months 
does  not  allow  on  its  territory  pigs  which  have  been 
vaccinated  less than  12 months  previously. 

By  way  of  derogation  from  paragraph  4  it  may  be  decided,  in 
accordance  with  the  procedure  laid  down  in  Article  29,  to 
authorize  the  importation  of  pigs  coming  from  a  part  of  the 
territory  of  a  third  country  provided  that  vaccination  against 
classical  swine  fever  is  prohibited  throughout  the  entire 
territory  of  that  country  and  the  part  of  the  territory  of  the 
third country  fuifiIs the conditions  laid down  in paragraph  4. 

By  way  of  derogation  from  paragraph  4,  in  the  event  classical 
swine  fever  occurs  in  a  third  country  which  fulfils  the 
conditions of  paragraph  4,  it may  be  decided,  in accordance  with 
the  procedure  laid  down  in  Article  29,  that  the  period  of 
12 months  referred  to  in  the  first  Indent  of  paragraph  4 may  be 
reduced  to 6 months  if: 

(a) an  outbreak  or  a  number  of  epizootiologically  interrelated 
outbreaks occur within a geographically  limited  area, and 

(b) the  outbreak  or  outbreaks  have  been  stamped  out,  within  a 
period of  3 months and without  recourse  to vaccination." 

2.  The following subparagraph  (c)  is added  to Article  14(2): 

"(c)  in which  no  classical  swine  fever  has  been  detected  for at 
least  the  preceding  12  months,  vaccination  against 
classical  swine  fever  has  not  been  authorized  for  at  least 
the  preceding  12  months  and  in  which  no  pigs  have  been 
vaccinated  against  classical  swine  fever  in  the  preceding 
12 months." 

The following sentence  is added  to Article 15: 

"In accordance with  the the procedure  laid down  in Article 29,  it may 
be  decided  to  derogate  from  the  provisions  laid  down  in  Article 
14(2)(c)." 

-  57 -

Art icle 2 

Member  States  shall  bring  into  force  the  laws,  regulations  and 
administrative  provisions  necessary  to  comply  with  this  Directive  not 
later  than  1  January  1992.  They  shall  forthwith  inform  the  Commission 
thereof. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a 
reference  to this Directive or  shall  be accompanied  by  such  reference at 
the  time  of  their  official  publication.  The  procedure  for  such 
reference shall  be adopted  by Member  States. 

This Directive  is addressed  to the Member  States 

Article 3 

Done at Brussels, 

For  the Council 
The President 

ISSN 0254-1475 

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