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PART 5
Control of vaccination
Vaccination against foot-and-mouth disease and
administration of hyper-immune serum
33. -(1) No person shall vaccinate an
animal against the disease, or administer hyper-immune
serum to it, except under the authority of a licence
granted by the Scottish Ministers.
(2) The Scottish Ministers shall grant a licence where a
decision is made under Article 50.1 of the Directive that
emergency vaccination shall be carried out in Scotland and,
in any other case, may decide to grant a licence.
(3) When deciding whether to grant a licence under
paragraph (1), the Scottish Ministers shall have regard, in
particular, to-
(a) the risk of an outbreak-
(i) in Scotland becoming widespread in the United
Kingdom,
(ii) outside Scotland spreading to Scotland with
imported susceptible animals, or
(iii) spreading to or from Scotland because of the
prevailing meteorological conditions;
(b) any threat from the disease to animals-
(i) in laboratories, zoos, wildlife parks or
enclosed areas principally used for shooting, and
(ii) in bodies, institutes or centres where animals
are kept for scientific purposes or purposes related to
conservation of species or farm animal genetic resources
and which have been approved under regulation 9 of the
Animals and Animal Products (Import and Export) (Scotland)
Regulations 2000
9; and
(c) the criteria in Annex X of the Directive.
(4) A licence granted under paragraph (1) may be limited
to a particular animal or class of animal, shall require
vaccination to be carried out swiftly and in conformity
with the rules of hygiene and bio-security so as to avoid
the spread of the disease virus, and shall specify-
(a) whether the vaccination licensed is protective
or suppressive,
(b) the place or geographical area in which it is to
be carried out,
(c) the species and age of the animals to be
vaccinated,
(d) the intended duration of the vaccination
programme,
(e) the form of the eartags to be affixed, marks to
be applied and records to be made under regulation 37, and
(f) such other conditions (if any) as the Scottish
Ministers think fit so as to prevent the spread of disease
through vaccination.
(5) No licence granted under paragraph (1) shall
authorise vaccination in a vaccination surveillance zone
declared under regulation 34.
(6) Notwithstanding section 16(1) of the Act, the
Scottish Ministers may cause vaccination of animals which
do not fall within that sub-section where they are in a
vaccination zone declared under regulation 34, and section
16 of the Act shall apply as if such vaccination was
carried out in exercise of the power in section 16(1).
(7) Paragraph (1) shall not apply to-
(a) anything done under the authority of a licence
granted under article 4 of the Specified Animal Pathogens
Order 1998
10; or
(b) administration of a vaccine in accordance with
an animal test certificate issued in accordance with
section 32 of the Medicines Act 1968
11.
Protective vaccination: declaration of vaccination
zones and vaccination surveillance zones
34. -(1) The Scottish Ministers shall
declare any part of Scotland in respect of which they have
granted a licence for protective vaccination to be a
vaccination zone.
(2) A declaration under paragraph (1) shall specify-
(a) the boundaries of the vaccination zone,
(b) the boundaries of a vaccination surveillance
zone which shall extend from the vaccination zone for at
least 10km, and
(c) such other information (if any) as the Scottish
Ministers think necessary to inform those who may be
affected by the vaccination programme.
(3) Any premises which are partly inside and partly
outside a vaccination zone shall be deemed to be wholly
within it.
(4) Any premises which are partly inside and partly
outside a vaccination surveillance zone shall be deemed to
be wholly within it (except premises which are also partly
within a vaccination zone).
(5) The Scottish Ministers may by further declaration
reduce the size of a vaccination surveillance zone and such
declaration shall-
(a) refer to the declaration creating the zone;
(b) specify the new boundaries of the zone and the
date and time at which the boundary change is to take
effect; and
(c) be published in such way as the Scottish
Ministers thinks fit.
(6) An area shall remain a vaccination zone or a
vaccination surveillance zone until the declaration
creating it is revoked.
Suppressive vaccination
35. -(1) The Scottish Ministers may
license suppressive vaccination to be carried out in a
protection zone declared under regulation 28(1).
(2) Where they license suppressive vaccination, the
Scottish Ministers shall serve a notice on the occupier of
each holding where it is to take place communicating that
fact.
Facilitation of vaccination
36. -(1) Any keeper of animals specified
in a licence under regulation 33 shall (where required by
an officer of the Scottish Ministers or a person acting at
the officer's direction)-
(a) state (if required, in writing) the species,
ages, and numbers of the animals for which the keeper is
responsible;
(b) submit any such animals for vaccination by an
officer of the Scottish Ministers or a person acting at the
officer's direction, at such time and in such place as
required;
(c) give any assistance or information which may
reasonably be required for the purposes of vaccination (and
in particular comply with any requirements as to the
collection, penning and securing of the animals to
facilitate vaccination).
(2) Nothing in these Regulations or any licence issued
under them shall be interpreted as requiring any person to
vaccinate any animal.
Identification of vaccinated animals
37. -(1) Any person vaccinating an animal
shall-
(a) identify it immediately after vaccination by
affixing an eartag and applying an indelible mark;
(b) make a written record containing at least the
following-
(i) the date,
(ii) the place,
(iii) a description of the animal and the details of
its eartag and mark,
(iv) the product and dosage administered; and
(c) ensure that an officer of the Scottish Ministers
receives a copy of that record.
(2) Eartags, marks and records shall each be in the form
stated in the licence granted under regulation 33.
(3) The keeper of any animal issued with a cattle
passport under the Cattle Identification Regulations 1998
12 or a registration certificate under the Cattle
(Identification of Older Animals)(Scotland) Regulations
2001
13 shall give it to the person carrying out the
vaccination and that person shall ensure it is sent to the
British Cattle Movement Service with a request to record
the vaccination in the passport or certificate and the
Service's database.
(4) No person shall intentionally remove an eartag or
obscure or erase a mark affixed or applied under this
regulation.
(5) Any person who knows or suspects that-
(a) an animal has been-
(i) vaccinated but is not carrying an eartag, or
(ii) specified for vaccination but has not been
vaccinated at the time when it should have been; or
(b) a carcase is-
(i) from a vaccinated animal but is not identified
as such, or
(ii) from an animal specified for vaccination which
has not been vaccinated,
shall immediately notify an inspector.
(6) If the Scottish Ministers suspect that-
(a) an animal has been vaccinated but is not
carrying an eartag, or
(b) has been specified for vaccination but has not
been vaccinated at the time when it should have been,
they shall arrange for that animal to be vaccinated as
soon as is reasonably practicable (but not sooner than 21
days after the date of any suspected vaccination).
(7) If the Scottish Ministers or an inspector know or
suspect that-
(a) a carcase is from a vaccinated animal but is not
identified as such, or
(b) is from an animal specified for vaccination
which has not been vaccinated
it shall nonetheless be deemed to be from a vaccinated
animal and they shall ensure that it is marked and dealt
with accordingly.
Time phases and measures applicable to the vaccination
zone
38. -(1) Phase 1 shall commence on
declaration of a vaccination zone.
(2) After 30 days have elapsed since all animals in a
vaccination zone specified for vaccination in a licence
granted under regulation 33(1) have been vaccinated, the
Scottish Ministers may declare the end of phase 1 and the
commencement of phase 2 and such declaration shall specify
the date and time it is to take effect.
(3) On completion of all measures in regulation 39(2) in
every depopulation holding in a vaccination zone, the
Scottish Ministers shall declare the end of phase 2 and the
commencement of phase 3 and such declaration shall specify
the date and time it is to take effect.
(4) Notwithstanding paragraph (3), the Scottish
Ministers may, before completion of the measures in
regulation 39(2) in every depopulation holding in a
vaccination zone, serve a notice on any holding classified
as free of disease under regulation 39(1)(b) stating that
it shall enter phase 3 and phase 3 shall be deemed to have
commenced in respect of that holding on such service.
(5) Subject to regulation 39(2), the provisions of
Schedule 2 apply to a vaccination zone without prejudice to
any requirements or restrictions applying in any part of it
because of a protection zone or a surveillance zone
declared under these regulations.
Survey and classification of holdings during phase
2
39. --(1) The Scottish Ministers shall
ensure that during phase 2-
(a) a clinical and serological survey of all holdings
in the vaccination zone keeping susceptible animals is
carried out in accordance with the following method-
(i) all susceptible animals in the vaccination zone
are clinically inspected, and
(ii) either-
(aa) testing for infection with the disease virus by
an assay for antibodies against non-structural proteins of
the disease virus is carried out on a selection of
susceptible animals pursuant to a sampling protocol
suitable to detect 5% prevalence with at least 95% level of
confidence, or
(bb) testing for antibodies against non-structural
proteins of the disease virus is carried out on samples
from all vaccinated animals and their non-vaccinated
offspring; and
(b) each holding in the vaccination zone is classified
according to the outcome of the survey and the criteria in
Schedule 3 either-
(i) where the holding contained at least one
susceptible animal suspected of being infected and where
the presence of the disease virus is confirmed, as infected
premises (and a declaration shall be made under regulation
13); or
(ii) where the holding contained at least one
susceptible animal suspected of being infected but where
further testing including all susceptible animals on the
holding confirmed the absence of circulating disease virus,
as a depopulation holding (and the Scottish Ministers shall
serve a notice on the occupier declaring the holding to be
a depopulation holding); or
(iii) otherwise, as free of disease (and that
classification shall be communicated to the occupier by
notice served on the occupier by the Scottish
Ministers).
(2) The following measures shall apply to a depopulation
holding-
(a) susceptible animals which have tested positive
to at least one of the tests in sub-paragraph (1)(a)(ii)
shall be slaughtered on the holding in accordance with the
written directions of the Scottish Ministers;
(b) other susceptible animals shall be slaughtered
in accordance with the written directions of the Scottish
Ministers;
(c) the carcases of any susceptible animals
slaughtered on the holding shall be disposed of ; and
(d) the holding shall be cleansed and
disinfected.
Measures applying in a vaccination surveillance
zone
40. -(1) No person shall move any
susceptible animal within or out of a vaccination
surveillance zone except-
(a) within the premises on which it is kept, or
(b) under the authority of a licence granted by the
Scottish Ministers.
(2) Paragraph (1) applies without prejudice to any
requirements or restrictions applying in any part of a
vaccination surveillance zone because of a protection zone
or a surveillance zone declared under these
Regulations.
Restocking following protective vaccination
41. -(1) No person shall restock a holding
in the vaccination zone except under the authority of a
licence granted by the Scottish Ministers and-
(a) where it is or has been a depopulation holding,
in accordance with the requirements of paragraph (2) below;
or
(b) where it is not and has not been a depopulation
holding, in accordance with the requirements of either-
(i) paragraphs 1 to 3 of Schedule 10, or
(ii) paragraph (3) below.
(2) The requirements of this paragraph are that the
holding shall be restocked in accordance with Schedule 10
every time it is subjected to the measures in regulation
39(2) but-
(a) this paragraph shall not apply to any other
restocking of that holding, and
(b) the Scottish Ministers may, by notice served on
the occupier of any holding to which this sub-paragraph
applies, exempt that holding from the requirements of
sub-paragraphs 3(b) to 3(d) of Schedule 10 provided that no
infected premises have been declared within 10km of the
holding for at least 3 months before the commencement of
restocking.
(3) The requirements of this paragraph are that-
(a) an officer of the Scottish Ministers has within
the previous 24 hours carried out a clinical examination on
every susceptible animal on every holding of origin of an
animal to be introduced and has not identified signs of the
disease;
(b) no holding of origin of an animal to be
introduced is in a protection zone or a surveillance zone;
and
(c) every animal to be introduced has been tested
for antibodies against the disease after the end of its
incubation period with negative results or a serological
survey has been completed.
Export of vaccinated animals
42. -(1) No person shall export any
vaccinated animal to another Member State or consign any
such animal for export there except under the authority of
a licence granted by the Scottish Ministers.
(2) A licence under paragraph (1) may only be granted in
accordance with specific measures adopted under Article
64(2) of the Directive.
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