CELEX: 51992PC0462
Language: en
Date: 1992-11-12
Title: Proposal for a Council Directive amending Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intraCommunity trade in and imports of deep-frozen semen of domestic animals of the bovine species and extending it to cover fresh bovine semen

COMMISSION OF THE EUROPEAN COMVIUNITIES
                                             C0M(92) 462 final
                                             Brussels, 12 November 1992
                       Report from the Commission
                                    on
      the animal health rules to be applied to bovine semen for
    intra-Community trade and imports from the third countries in
          accordance with Article 4 of Directive 88/407/EEC
                                   and
                                proposa I
                                  for a
                           Counc iI D i rect i ve
        amending Council Directive 88/407/EEC of 14 June 1988
                     laying down the animal health
   requirements applicable to intraCommunity trade in and imports
      of deep-frozen semen    of domestic    animals of the bovine
         species and extending it to cover fresh bovine semen
                      (presented by the Commission)
 ---pagebreak---                                    - A -
                              EXPLANATORY MEMORANDUM
Council Directive 88/407/EEC lays down the animal health requirements applicable
to intra-Community trade in and imports of deep-frozen semen of domestic animals
of the bovine species. At the time of adoption, the situation in Member States
with respect to the status of infectious bovine rhinotracheitis/infectious
pustular vulvovaginitis (IBR/IPV) in semen collection centres varied
considerably. Article 4 therefore required the Commission to report on the
situation, with appropriate proposals.
The general IBR/IPV situation in Member States has not changed significantly   :
since the Directive was adopted. There is still a need to allow collection of
semen from bulls which are positive to a blood test for this disease, because of
the long term nature of breeding programmes (typically 10 years). It is therefore
proposed to continue the use of bulls which were positive before vaccination
until the 10-year cycle comes to an end (1998), and to allow vaccination to
continue until such time as Member States make progress in eradication in the
national herd.
Additionally, proposals are made to
- clarify the situation with respect to the brucellosis, enzootic bovine leucosis
  (EBL) and tuberculosis status of the bull on entry to a collection centre,
- discontinue virus isolation testing for foot and mouth disease (FMD) for bulls
  vaccinated more than 12 months prior to collection, and to reduce the number of
  semen straws to be tested from 10 to 5%,
- discontinue the treatment of bulls with streptomycin against leptospirosis,
- remove the requirement for a bull to be on a collection centre for 30 days
  before collection for trade purposes,
- extend the Directive to cover fresh semen and
- allow future amendments to the annexes by the Commission under the Regulatory
  procedure.
 ---pagebreak---                                             - A (r^o
                                        Report from the Commission
                                                    on
                        the animal health rules to be applied to bovine semen for
                    intra-Community trade and imports from the third countries in
                            accordance with Article 4 of Directive 88/407/EEC
 Introduct ion
Council Directive 88/407/EEC laying down the animal health rules applicable to
intra-community trade in and imports from third countries of deep-frozen semen of
domestic animals of the bovine species was adopted by Council on 14 June
1988d).           It w a s subsequently amended in particular by Council Directive
9 0 / 1 2 0 / E E C * 2 ) on 5 March 1990, with respect to rules relating to semen derived
from bulls which were serological I y positive for I BR, either before entry or
following vaccination on the centre. Special rules were introduced in Article 4
to allow Member States to continue trade in semen from such b u l l s , for a
transitional period until 31 December 1992. These rules were required to be
reviewed by 1 January 1992.
The purpose of this report is to made such reviews, and also to identify other
problems found during the implementation of the Directives, in support of
proposals for suitable amendments.
I BR
IBR is a disease of cattle caused by a Herpes virus. It can manifest itself in
either a respiratory form or a urogenital form. It is the respiratory form which
 is most commonly recognised in the Community. The disease may appear             in the acute
or sub acute form, but no serological differences have been identified between
the strains. In the urogenital form, it causes balanoposthitis in the male and
vulvovaginitis in the female. It may be the cause of infertility, particularly in
the female. Vaccines may be used to control              its effects. However, vaccines
probably do not prevent infection by field virus.
(1) OJ No L 194 of 22.07.1988, p. 10
(2) OJ No L 71 of 17.03.1990, p. 37
 ---pagebreak---                                         - 2 -
The presence of virus in the semen is a potential means of spread. This is
complicated by the problem of latency. This means that, after a clinical or
subclinical  infection, the virus may remain latent for the life of the animal. It
may also be reactivated and shed at irregular intervals, particularly   if the
animal  is stressed or has corticosteroids administered to it. Infected bulls must
therefore be regarded as potential   lifelong shedders of virus.
Few countries have attempted to eradicate the disease in their national herd.
Denmark has a national programme, and Ireland has had rules in the past designed
to prevent the introduction of virulent forms which, it was claimed were absent
from the island. In the AI industry, as a general rule, attempts are made to
ensure freedom of the bulls from IBR, in view of its importance as a disease of
breeding. This is done either by exclusion of any seropositive animal from the
centres, or by a policy of vaccination after initial testing (with negative
results). Some countries maintain separate IBR positive and negative studs. In
positive centres, semen from a clinically affected animal would not be used.
Furthermore, there are still some centres which contain bulls which were not
tested prior to entry, and which were vaccinated, before the Directive was
adopted. Their true status is, therefore, unknown. Trade in semen from the latter
category of bulls is permitted until 31/12/92, subject to a negative virus
isolation test being carried out on the semen before export. Trade in semen from
bulls which were seronegative before vaccination is also permitted, without virus
isolation. In both cases, Member States in which all centres are seronegative may
refuse semen from centres which do not have that status.
A major problem with semen is its long storage time after collection. Because of
this, and the length of cattle breeding programmes (typically 5 years to prove a
dairy bull and at least 5 years full use after testing), there will be a great
deal of semen in stores by the end of the transitional period. A limited survey
has been carried out in some Member States. This survey shows that an abrupt
cessation of trade in semen from positive bulls at the end of 1992 wiI be very
costly and will rob the industry of valuable genetic material. (Table 1 ) .
 ---pagebreak---                                        - 3
Similarly, there are bulls of great genetic value in centres in some third
countries. It is important to have access to this genetic material for a further
 limited period. Many breeding programmes started at the time of adoption of the
Directive, i.e. 1988, and the bulls in these programmes will be used at least
until 1998.
It is clear that Council Directive 88/407/EEC gave impetus to the objective of
finally eradicating this disease from AI centres. While this should continue to
be the long-term aim, the practicality of maintaining a bull centre free from IBR
without vaccination in a country where the cattle in the national population are
infected must be questioned. The airborne route of infection is not normally
considered to be a major source of infection, especially over long distances.
However, this route cannot be excluded. Therefore, it is essential to consider
the possible action to be taken if a centre becomes infected.
There are three options:
- slaughter of all stock,
- vaccination of all stock,
- testing with removal of infected animals and vaccination of the remainder.
The first option is unacceptable, in view of the financial and genetic value of
the bulls. The second option would leave infected bulls on the centre; this would
present a hazard to incoming animals, and is not consistent with the long-term
aim. The third option is best, therefore.
The draft proposal attached to this report proposes to maintain the trade in
semen from bulls of unknown status until the end of 1998, and to allow
vaccination of seronegative bulls on the centres where desired by the Member
State concerned. The virus isolation test would continue to be required for all
semen from seropositive bulls which had not been found to be seronegative prior
to vaccination on the centre. Seropositive bulls may not enter a centre at all.
The protocols for the serological and virological tests and the number of straws
to be tested will be established by the Commission.
 ---pagebreak---                                       - 4 -
Foot and Mouth Disease (FMD)
Article 4 of the Directive also makes provisions for virus isolation or animal
innoculation tests on semen from bulls vaccinated against FMD, when going to a
non-vaccinating country. Council Directive 90/423/EEC^ 3 ) banned the use of FMD
vaccine as and from 1/1/92, and, in practice, all Member States had stopped by
August 1991. This requirement should therefore be reviewed. The opinion of the
Scientific Veterinary Committee is that semen produced from bulls vaccinated more
than 12 months before semen collection presents only a negligible risk, assuming
that the centre was free from FMD at the time of collection. Therefore it is
proposed that the testing should apply to trade in semen between all Member
States, but only on semen collected within 12 months of vaccination.
Additionally, the Scientific Veterinary Committee has recommended that the number
of straws to be tested can be reduced to 5% from 10%.
Furthermore, under a non-vaccination policy, there is no further need to keep
fresh semen out of the scope of the Directive. Virus isolation tests would limit
the practicality of trade in fresh semen, but are not needed for all collections
(see preceding paragraph). This applies equally to IBR.
Quarantine of bulls and semen
Annex C requires
- i)   that the bulls are kept on the approved centre for 30 days prior to
       collect ion, and
- ii)  that the semen is stored 30 days prior to dispatch.
This double quarantine is considered to be unnecessary, and one element could be
deleted. The quarantine on semen itself gives the best guarantee that the health
status at the time of collection was satisfactory. Furthermore, the bulls are
subjected to intensive testing before entry into the centre.
(3) OJ No L 224 of 18.08.1990, p. 13
 ---pagebreak---                                        - 5 -
 It is therefore proposed that the requirement for the bull to be in the centre
for 30 days prior to collection can be revoked. To allow trade in fresh semen, it
 is also necessary to remove the quarantine for this category; this can be
justified on the basis of the very low volume of trade in fresh compared with
frozen semen.
Other problems
Other difficulties have been highlighted by Member States. Appropriate amendments
have therefore been proposed.
a)   The double requirement to treat bulls and semen with antibiotics against
     Leptospirosis can be replaced by single treatment of the semen with suitable
     ant ibiot ics.
b)   Currently, a bull must either come from a herd which is free from enzootic
     bovine leucosis or its dam must be tested within 30 days of movement of the
     bull to the centre. This is illogical, as it is the status of the dam at the
     time of weaning which is most relevant. Therefore it is proposed that this
     test on the dam should be done after removal of the bull from its dam. Where
     the bull is born as a result of embryo transfer, the recipient female is
     regarded as the dam.
c)   The current requirement in respect of brucellosis status is that the bull
     must come from an officially free herd and must not have been in any other
     herd of lower status. The latter requirement  is automatic, given the rules
     for movement into officially free herds,.and has lead to confusion of
     interpretation. It is therefore proposed that reference is made directly to
     the definition of an officially free herd in Directive 64/432/EEC* 4 >.
(4) 0J No L 121 of 29.0».1964, p. 2012/64
 ---pagebreak---                                 - 6 -
                               TABLE 1
          IBR - Positive and negative bulls on centre in
                    Belgium and the Netherlands
               Predicted situation on 1 January 1993
    Year of birth            I BR Pos       I BR Neg      Total
THE NETHERLANDS
         1981                    1             0            1
         1982                    3             0            3
         1983                    2             0            2
         1984                    7              1           8
         1985                    5             5           10
         1986                    5             6           11
         1987                   10            22           32
         1988                  61            340          401
         1989                  95            440          535
         1990                    -           450          450
         1991                    -           450          450
      TOTAL                   179           1714         1903
BELGIUM
         1987                  10              1           11
         1988                  89             27          116
         1989                 104             28          132
         1990                  96             37          133
         1991                    -           128          128
      TOTAL                   299            221          510
 ---pagebreak---                                      -3-
                                         proposa I
                                           for a
                                    CounciI Directive
                amending CounciI Directive 88/407/EEC of 14 June 1988
                              laying down the animal health
           requirements applicable to intraCommunity trade in and imports
              of deep-frozen semen     of domestic  animals of the bovine
                species and extending it to cover fresh bovine semen
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^1),
Having regard to the opinion of the European Par Iiament^2),
Having regard to the opinion of the Economic and Social Committee*3^,
Whereas Council Directive 88/407/EEC^4^, as last amended by
Directive 90/425/EEC^5^ rays down the animal health requirements applicable to
intra-Community trade in and imports of deep frozen semen of domestic animals of
the bov i ne spec i es ;
Whereas Article 4 of Directive 88/407/EEC defined provisional measures for trade
in semen from bulIs which are seropositive for Infectious Bovine Rhinotracheitis
(IBR);   whereas these requirements should be reviewed, on the basis of a report
from the Commission;     whereas this report indicates that it is necessary to
phase out bulls which were seropositive or of unknown status      prior to
vaccination on the centre by 1998, and to maintain the possibility to vaccinate
on a centre in the future;      whereas it is necessary to amend Article 4 in this
respect ;
(1) OJ No  C
(2) OJ No  C
(3) OJ No  C
(4) OJ No  L 194, 22.07.1988, p. 10
(5) OJ No  L 224, 18.08.1990, p. 29
 ---pagebreak---                                    -2 -
Whereas routine foot and mouth disease vaccination has been discontinued in the
Community as from August 1991;  whereas therefore it is necessary to amend the
provisions of the Directive to take account of this change in policy;   whereas
this change in policy also permits trade in fresh bovine semen to take place
under harmonised rules;
Whereas it is opportune to make further amendments to the Directive to clarify
certain issues and to take account of changes in technical knowledge,
particularly in respect of treatment of bulls against leptospirosis, and to align
the rules with respect to brucellosis, tuberculosis and leucosis with those laid
down in Council Directive 64/432/EEC^6^;
Whereas it is appropriate to provide for amendments to the Annexes under a
procedure establishing close coopérât ion between Member States and the Commission
within the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
                                    Article 1
Directive 88/407/EEC is hereby amended as follows :
 1. In the title, the words "deep frozen" are deleted.
 2. In Article 1, the words "deep frozen" are deleted.
 3. In Article 3, the existing text is prefixed by the number 1, and the
    following paragraph 2 is added:
    "2. Member States which implement an alternative control system providing
    guarantees equivalent to those laid down in this Directive as regards
    movements within their territory of bovine semen, in particular with regard
    to the certificate, may grant one another derogations from the provisions of
    paragraph 1(d) and Article 6, on a reciprocal basis.
    They shall notify the Commission thereof."
(6) OJ No L 121, 29.09.1964, p. 2012/64
 ---pagebreak---                                    -3-
4. Article 4 paragraph 1 is replaced by the following:
   "1. Without prejudice to paragraph 2, Member States shall authorize the
   admission of semen from bulls giving a negative reaction to the serum
   neutralization test or the Elisa test for infectious bovine rhino-
   tracheit is/infectious pustular vulvo-vaginitis or showing a positive result
   after vaccination in accordance with this Directive.
   Member States may, until 31 December 1998, authorize the admission of semen
   of bulls giving a positive reaction to the serum neutralization test or the
   Elisa test for infectious bovine rhino-tracheitis/infectious pustular vulvo-
   vaginitis and not having been vaccinated in accordance with this Directive.
   In that case, each consignment must pass an examination by inoculation into a
   live animal and/or a virus isolation test.
   This requirement shall not apply in respect of the semen of animals which,
   prior to their first vaccination at the insemination centre, reacted
   negatively to the tests referred to in the first paragraph.
   These examinations can, by bilateral agreement, be carried out either in the
   country of collection or in the country of destination.
   Protocols for tests to be used in accordance with this Article, and the'
   number of straws to be tested for each collection, shall be laid down in
   accordance with the procedure in Articie-18."
5. Article 4 paragraph 3 is replaced by the following:
   "3. Member States may not oppose the admission of semen produced from bulls
   vaccinated against foot and mouth disease. However, where the semen was
   obtained from a bull which had been vaccinated against foot and mouth disease
   during the 12 month period prior to collection, 5% of each collection (with a
   minimum of five straws) intended for sending to another Member State shall be
   subjected to a virus isolation test for foot and mouth disease, with negative
   results."
 ---pagebreak---  6. Article 12 is replaced by the following:
                                      "Article 12
    The rules laid down in Council Directive 90/675/EEC of 10 December 1990
     laying down the principles governing the organization of veterinary checks on
    products entering the Community from third countries^ 7 ) shall apply in
    particular to the organization and follow-up of checks to be carried out by
    the Member States, and the safeguard measures to be applied."
 7. Articles 13 and 14 are deleted.
 8. Article 17 is replaced by the following :
                                      "Article 17
    Amendments to the annexes to this Directive, in particular to adapt them to
    advances in technology, shall be decided in accordance with the procedure
     laid down in Article 18."
 9. In Article 18 at the end of the 4th paragraph, the words "save where the
    Council has decided against the said measure by a simple majority" are
    deleted.
10. In Article 19 at the end of the 4th paragraph, the words "save where the
    Council has decided against the said measures by a simple majority" are
    deleted.
11. In Annex A, chapter ll, the following subparagraph   is added at the end :
    "The competent authority may authorize the storage in the approved semen
    storage premises of embryos which meet the requirements of Directive
    89/556/EEC of 25 September 1989 on animal health conditions governing intra-
    Community trade in and imports from third countries of embryos of domestic
    animals of the bovine species* 8 ^."
(7) 0J No L 373 of 31.12.1990, p.    1
(8) 0J No L 3 r 2 o f 19.10.1989, p. 1
 ---pagebreak---                                     ->M-
12. In Annex B, Chapter  I, paragraph 1, (b) is replaced by :
    "(b) prior to their stay in isolation accommodation described in (a), have
    belonged to a herd which is officially tuberculosis free and officially
    brucellosis free, as defined in Annex A.11 of Directive 64/432/EEC."
13. In Annex B, Chapter I the first sub paragraph of paragraph 1(c) is replaced
    by:
    "have come from an  enzootic bovine leucosis free herd as defined in
    Directive 64/432/EEC, or have been produced by dams which have been subjected
    to an Agar Gel Immunodiffusion test, carried out in accordance with Annex G
    of Directive 64/432/EEC, after removal of the animals from their dam. In the
    case of animals derived by embryo transfer, "dam" means the recipient of the
    embr yo."
14. In Annex B, Chapter I, paragraph 1(e), in the last sentence the words "and
    have treatment against leptospirosis comprising two injections of
    streptomycin at an interval of 14 days (25mg per kilogram of live body
    weight)." are deleted.
15. In Annex B, Chapter II, paragraph 1, (iii) is replaced by:
    "(iii) a serological test for enzootic bovine leucosis, carried out in
    accordance with Annex C to Directive 64/432/EEC, with a negative result."
16. In Annex B, Chapter II, paragraph 1(iv) the words "until 31 December 1992"
    are deleted.
17. In Annex B, Chapter II, paragraph 3 the words "until 31 December 1992" and,
    at the end, the words "under Article 4(1) second, third and fifth
    subparagraphs" are deleted.
18. In Annex C paragraph 1, (b) is replaced by the following:
    "b) (i) were not vaccinated against foot and mouth disease during the
    12 months prior to collection
 ---pagebreak---     or
        (ii) were vaccinated against foot and mouth disease during the 12 months
    prior to collection, in which case 5% (with a minimum of five straws) of the
    collection shall be submitted to a virus isolation/animal   inoculation test
    for foot and mouth disease with negative results,"
19. In Annex C, sub-paragraph 1(d) is deleted and the remaining sub-paragraphs
    are accordingly   renumbered.
20. In Annex C paragraph 3, (i) is replaced by the following:
    "be stored in approved conditions for a minimum period of 30 days prior to
    dispatch. This requirement shall not apply to fresh semen."
21. In Annex D IV, paragraph 4 (iii), the word "consignment" is replaced by the
    word "collect ion".
22. In Annex D IV, paragraph 5 is replaced by:
    "5.   The semen described above was collected from bulls :
          (i) which have not been vaccinated against foot and mouth disease within
          12 months prior to collection(1);
          or
          (ii) which have been vaccinated against foot and mouth disease within
          12 months prior to collection, in which case the semen comes from a
          collection in which 5% of each collection intended for trade (with a
          minimum of 5 straws) has been subjected, with negative results, to a
          virus isolation test for foot and mouth disease in
          laboratory(2)."   .
23. In Annex D IV the following is added:
    "6.   the semen was stored in approved conditions for a minimum period of
          30 days prior to dispatch(3)."
 ---pagebreak---                                  - A 2, -
24. In Annex D, in footnote (2), the words "the second subparagraph of
    Article 4(1)" are replaced by "Article 4".
25. In Annex D, the following footnote (3) is added :
    "(3) may be deleted for fresh semen."
                                    Article 2
 1. Member States shall bring into force the laws, regulations and administrative
    provisions necessary to comply with this Directive by 1 April 1993. They
    shall inform the Commission thereof.
 2. When Member States adopt the measures referred to in paragraph 1, they shall
    contain a reference to this Directive or shall be accompanied by such
    reference on the occasion of their official publication. The methods of
    making such reference shall be laid down by the Member States.
                                    Art icle 3
This Directive is addressed to the Member States.
Done at                                                    For the Council
 ---pagebreak---  ---pagebreak---                                     -4 11-
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                                                              COM(92) 462 final
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