Community
Provisions (Bovine Embryos) (Jersey) Regulations 2010
THE STATES, in pursuance of Article 2
of the European Communities Legislation (Implementation) (Jersey)
Law 1996, have made the following Regulations –
Commencement [see endnotes]
Part 1
introductory
1 Interpretation
In
these Regulations, unless the context otherwise requires –
“animal health
certificate” means a certificate issued under Regulation 14;
“border control
post” means a control post designated for the performance of the official
controls provided for in Article 47(1) of the Official Controls Regulation
or approved by the competent authority of any of the
jurisdictions in the British Islands to receive imports from third
countries;
“bovine embryo
storage facility” means a facility approved under Regulation 11;
“Bovine Semen
Order” means the Artificial Insemination
of Domestic Animals (Bovine Semen) (Jersey) Order 2008;
“Community Provision”
means Council Directive 89/556/EEC of 25 September 1989 on animal health
conditions governing intra-Community trade in and importation from third
countries of embryos of domestic animals of the bovine species (OJ L 302,
19.10.1989, p.1), as amended from time to time;
“consignment of
embryos” means a quantity of embryos removed in one operation from a
single donor and covered by a single animal health certificate;
“country of
collection” means the Member State or third country in which embryos are
produced, collected, processed and, where necessary, stored, and from which
they are sent to Jersey;
“embryo” means
the initial stage of development of a domestic animal of the bovine species
while it is capable of being transferred to a recipient dam;
“embryo collection
team” means a team for the time being approved under Regulation 5;
“embryo production
team” means a team for the time being approved under Regulation 8;
“herd” means
an animal or group of animals kept on a holding as an epidemiological unit and,
if more than one herd is kept on a holding, each of these herds shall form a
distinct unit and shall have the same health status;
“Member State”
means a Member State of the European Community;
“Minister”
means the Minister for the Environment;
“Official Controls
Regulation” means Regulation (EU) 2017/625 of the European Parliament and
of the Council of 15 March 2017 on official controls and other official
activities performed to ensure the application of food and feed law, rules on
animal health and welfare, plant health and plant protection products (OJ L 95,
7.4.2017, p. 1);
“official
veterinarian” means –
(a) the
States Veterinary Officer appointed under Article 5 of the Animal Health (Jersey)
Law 2016; and
(b) any
other veterinary surgeon appointed by the Minister as such for the purposes of
these Regulations;
“premises”
includes land or any means of transport;
“public
slaughterhouse” means the slaughterhouse provided by the States and
administered by a Minister;
“semen collection
centre” means premises licensed under Article 3(2) of the Bovine
Semen Order;
“team
veterinarian” means a veterinary surgeon who is responsible for the
supervision of an embryo collection team or an embryo production team;
“third
country” means a country or territory that is not a Member State or
another place in the British Islands;
“veterinary surgeon” means a recognized veterinary
surgeon, within the meaning of the Veterinary Surgeons
(Jersey) Law 1999.[1]
2 Application
These Regulations do not
apply to embryos derived by transfer of nuclei.
pART 2
TRADE WITH EUROPEAN
COMMUNITY
3 Conditions
for export of bovine embryos to a Member State
(1) A
person shall not export, or consign for export, embryos to another Member State
unless the conditions set out in paragraphs (2) and (3) are complied with.
(2) The
embryos –
(a) must
have been conceived as a result of artificial insemination or in vitro
fertilization with semen –
(i) from a donor sire
standing at a semen collection centre, or
(ii) imported
and stored after importation in accordance with the Bovine Semen Order;
(b) must
have been collected from domestic animals of the bovine species whose health
status complies with Schedule 1;
(c) must
have been collected, processed and stored –
(i) by an embryo
collection team,
(ii) in
accordance with Schedule 2.
(3) The
consignment of embryos must be accompanied, during its transport from its place
of despatch to the Member State of destination, by an animal health
certificate.
4 Conditions for import of bovine embryos from a Member State
(1) A
person shall not import embryos from a Member State (either for entry into
Jersey or by way of transit to a Member State) unless the embryos meet the conditions
imposed by Article 3 of the Community Provision (subject to any
derogations permitted or additional requirements imposed in accordance with the
Community Provision).
(2) Where
embryos are imported from a Member State (either for entry into Jersey or by
way of transit to a Member State) the importer and, if different, the person in
charge of the embryos, shall comply with all the relevant provisions of the
Community Provision until the embryos arrive at their place of destination in
Jersey or leave Jersey, as the case may be.
PART 3
APPROVALS AND CERTIFICATION
5 Embryo
collection teams
(1) An
application for approval as an embryo collection team shall be made to the
Minister.
(2) An
application shall be in writing and contain or be accompanied by such
information as the Minister reasonably requires in order to be satisfied that
the team fulfils the requirements in Schedule 3.
(3) The
Minister shall only give an approval if the Minister is satisfied that the team
fulfils the requirements in Schedule 3.
(4) An
approval shall be in writing.
(5) An
approval shall be subject to –
(a) the
condition that the following occurrences are notified to the Minister as soon
as is practicable –
(i) the replacement
of the team veterinarian,
(ii) any
major change in the organization of the team,
(iii) any
major change in the laboratories at the disposal of the team, or
(iv) any
major change in the equipment at the disposal of the team; and
(b) such
other conditions as the Minister considers are necessary to ensure that these
Regulations are complied with.
(6) On
approving an embryo collection team, the Minister shall assign to the team a
unique veterinary registration number.
(7) The
Minister shall inform an applicant, in writing, of the refusal of an
application under this Regulation, and give reasons for the refusal.
6 Register
of embryo collection teams
(1) The
Minister shall maintain a register of approved embryo collection teams and the
veterinary registration number assigned to each of them.
(2) The
Minister shall make the register available to Member States and to the public.
7 Variation
or withdrawal of approval of embryo collection team
(1) The
Minister may vary the conditions imposed under Regulation 5(5)(b) on the
approval of an embryo collection team.
(2) A
variation under paragraph (1) may in particular be made having regard to
an occurrence described in Regulation 5(5)(a), but is not limited to being
made in those circumstances.
(3) The
Minister shall withdraw the approval of an embryo collection team if the team
ceases to fulfil the requirements in Schedule 3 or fails to comply with
any condition attached to its approval.
(4) The
Minister shall, in writing, notify the holder of the approval of an embryo
collection team of the variation or withdrawal of an approval under this
Regulation.
(5) A
notice under paragraph (4) shall –
(a) give
reasons for the decision; and
(b) specify
the date when the variation or withdrawal takes effect.
(6) Subject
to paragraph (7), a variation or withdrawal shall not take effect less
than 21 days after notice of it is given to the holder of the approval.
(7) Paragraph (6)
shall not apply if the Minister considers that a delay of 21 days in the
variation or withdrawal taking effect would constitute an unacceptable risk to
animal health.
8 Embryo
production teams
(1) An
application for approval as an embryo production team shall be made to the
Minister.
(2) An
application shall be in writing and contain or be accompanied by such
information as the Minister reasonably requires in order to be satisfied that
the team fulfils the requirements in Schedules 3 and 4.
(3) The
Minister shall only give an approval if the Minister is satisfied that the team
fulfils the requirements in Schedules 3 and 4.
(4) An
approval shall be in writing.
(5) An
approval shall be subject to –
(a) the
condition that the following occurrences are notified to the Minister as soon
as is practicable –
(i) the replacement
of the team veterinarian,
(ii) any
major change in the organization of the team,
(iii) any
major change in the laboratories at the disposal of the team, or
(iv) any
major change in the equipment at the disposal of the team; and
(b) such
other conditions as the Minister considers are necessary to ensure that these
Regulations are complied with.
(6) On
approving an embryo production team, the Minister shall assign to the team a
unique veterinary registration number.
(7) The
Minister shall inform an applicant, in writing, of the refusal of an
application under this Regulation, and give reasons for the refusal.
9 Register
of embryo production teams
(1) The
Minister shall maintain a register of approved embryo production teams and the
veterinary registration number assigned to each of them.
(2) The
Minister shall make the register available to Member States and to the public.
10 Variation
or withdrawal of approval of embryo production team
(1) The
Minister may vary the conditions imposed under Regulation 8(5)(b) of the
approval of an embryo production team.
(2) A
variation under paragraph (1) may in particular be made having regard to
an occurrence described in Regulation 8(5)(a), but is not limited to being
made in those circumstances.
(3) The
Minister shall withdraw the approval of an embryo production team if the team
ceases to fulfil the requirements in Schedules 3 and 4 or fails to comply
with any condition attached to its approval.
(4) The
Minister shall, in writing, notify the holder of the approval of an embryo
production team of the variation or withdrawal of an approval under this
Regulation.
(5) A
notice under paragraph (4) shall –
(a) give
reasons for the decision; and
(b) specify
the date when the variation or withdrawal takes effect.
(6) Subject
to paragraph (7), a variation or withdrawal shall not take effect less
than 21 days after notice of it is given to the holder of the approval.
(7) Paragraph (6)
shall not apply if the Minister considers that a delay of 21 days in the
variation or withdrawal taking effect would constitute an unacceptable risk to
animal health.
11 Bovine
embryo storage facilities
(1) An
application for approval of a bovine embryo storage facility shall be made to
the Minister.
(2) An
application shall be in writing and contain or be accompanied by such
information as the Minister reasonably requires in order to be satisfied that
the facility satisfies the requirements of paragraph 2(2) and (3) of Schedule 2.
(3) The
Minister shall only give an approval if the Minister is satisfied that the
facility satisfies the requirements of paragraph 2(2) and (3) of Schedule 2.
(4) An
approval shall be in writing.
(5) An
approval shall be subject to such conditions as the Minister considers are necessary
to ensure that these Regulations are complied with.
(6) The
Minister shall inform an applicant, in writing, of the refusal of an
application under this Regulation, and give reasons for the refusal.
(7) The
approval by the Minister of premises as a bovine embryo storage facility also
approves those premises for the storage of bovine semen.
12 Variation
or withdrawal of approval of bovine embryo storage facility
(1) The
Minister may vary the conditions imposed under Regulation 11(5) of the
approval of a bovine embryo storage facility.
(2) The
Minister shall withdraw the approval of a bovine embryo storage facility if the
facility ceases to fulfil the requirements in paragraph 2(2) and (3) of Schedule 2
or fails to comply with any condition attached to its approval.
(3) The
Minister shall, in writing, notify the holder of the approval of a bovine
embryo storage facility of the variation or withdrawal of an approval under
this Regulation.
(4) A
notice under paragraph (3) shall –
(a) give
reasons for the decision; and
(b) specify
the date when the variation or withdrawal takes effect.
(5) Subject
to paragraph (6), a variation or withdrawal shall not take effect less
than 21 days after notice of it is given to the holder of the approval.
(6) Paragraph (5)
shall not apply if the Minister considers that a delay of 21 days in the
variation or withdrawal taking effect would constitute an unacceptable risk to
animal health.
13 Review
of decision of Minister
(1) An
applicant for an approval under Regulation 5, 8 or 11 may apply to the
Royal Court for a review of the decision of the Minister –
(a) to
refuse an approval; or
(b) to
impose conditions on the approval, in accordance with –
(i) in the case of an
application for approval of an embryo collection team, Regulation 5(5)(b),
(ii) in
the case of an application for approval of an embryo production team,
Regulation 8(5)(b),
(iii) in
the case of an approval of a bovine embryo storage facility,
Regulation 11(5).
(2) The
holder of an approval given under Regulation 5, 8 or 11 may apply to the
Royal Court for a review of the decision of the Minister –
(a) to
vary the conditions imposed on the approval; or
(b) to
withdraw the approval.
(3) An
application under this Regulation must be made within 21 days of the of
the applicant being notified of the decision to be reviewed.
(4) The
Royal Court may extend the period mentioned in paragraph (3).
(5) The
Royal Court may, on an application under this Regulation, make such orders as
it thinks fit.
14 Animal
health certificates
(1) An
official veterinarian may issue an animal health certificate for a consignment
of embryos intended for a single place of destination.
(2) An
animal health certificate –
(a) shall
be in the form set out in Annex C to the Community Provision;
(b) shall
be drawn up in at least the official language of the other Member State that is
the place of destination; and
(c) shall
be made out to a single consignee.
part 4
third country imports
15 Health
rules for importation of embryos from a third country
(1) A
person shall not import embryos from an unlisted third country.
(2) An
unlisted third country is one that does not appear in Annex I to Commission
Decision 2006/168/EC of 4 January 2006 establishing the animal health and
veterinary certification requirements for imports into the Community of bovine
embryos (OJ L 57, 28.2.2006, p.19), as amended from time to time.[2]
(3) A
person shall not import embryos from a third country unless the
embryos –
(a) are
dispatched by an embryo collection team or embryo production team that is on
the list of approved teams communicated by the competent authority of the third
country and made available to the public in accordance with Article 8 of
the Community Provision;
(b) come
from donor animals which, immediately prior to the collection of the embryos,
have remained for at least 6 months in the territory of the third country
concerned, and in a maximum of 2 herds complying with Article 9.2 of
the Community Provision; and
(c) comply
with the animal health requirements adopted in accordance with the procedure
laid down in Article 18 of the Community Provision for imports of embryos
from that country.
16 Checks
required for importation of embryos from a third country
(1) Importation
of embryos from a third country shall be authorized only on submission of an
animal health certificate –
(a) drawn
up and signed by an official veterinarian of the third country of collection;
and
(b) satisfying
the requirements of Article 10 of the Community Provision.
(2) Importation
of embryos from a third country shall be authorized only where –
(a) the
embryos are transported to their place of destination in Jersey after passing
through a border control post and without subsequently entering the territory
of a third country; and
(b) the
veterinary checks required by Official Controls Regulation are conducted at the
border control post.[3]
PART 5
CONTROL MEASURES AND
ENFORCEMENT
17 Checks and powers of entry
(1) An
official veterinarian and any other person authorized by the Minister for the
purposes of this Regulation may, on producing the person’s authority,
enter at all reasonable times any premises occupied by the holder of an
approval given under these Regulations and used for or in connection with any
of the purposes authorized by the approval, for the purpose of checking for
compliance with the conditions attached to the approval and with any conditions
in the Schedules that are relevant to the approval.
(2) An
official veterinarian and any other person authorized by the Minister for the
purposes of this Regulation may, on producing the person’s authority,
enter at all reasonable times any premises on which, or in connection with
which, the person has reasonable grounds for suspecting that an offence under
these Regulations is being or has been committed.
(3) A
person who enters premises in exercise of the powers conferred by paragraph (1)
or (2) may –
(a) inspect
the premises and any equipment and animals on them;
(b) carry
out such tests or other investigations, whether on the premises, equipment on
the premises, or animals or embryos on the premises, or on samples taken from
the premises, equipment, animals or embryos, as the person thinks fit in order
to ascertain whether the provisions of these Regulations, or the conditions
subject to which any approval or licence is given under these Regulations, are
being complied with; and
(c) for
the purposes of any such test or investigation, require the occupier of the
premises, and any person in the employment of such occupier, to furnish such
information as is in that person’s power to give.
18 Power
to obtain information from approved teams
The Minister and any person
authorized by or on behalf of the Minister for the purposes of this Regulation
may require any holder of an approval given under these Regulations to furnish
him or her, within such time and in such manner as he or she specifies, with
such returns and other information as he or she requires for the purpose of
monitoring the operation of these Regulations and checking for compliance with
any condition attached to the approval and with any conditions in the Schedules
that are relevant to the approval.
19 Offences
(1) A
person who contravenes Regulation 3, 4 or 15 is guilty of an offence
and liable to a fine of level 3 on the standard scale.[4]
(2) A
person who –
(a) hinders
or obstructs a person in the exercise of the person’s powers under
Regulation 17; or
(b) refuses
or neglects to furnish, in the time and manner specified, any return or
information when required to do so under Regulation 18,
is guilty of an offence
and liable to imprisonment for a term of 6 months and a fine of
level 3 on the standard scale.[5]
(3) A
person who knowingly or recklessly contravenes any condition subject to which
an approval is given under these Regulations or any condition in the Schedules
that is relevant to the approval is guilty of an offence and liable to a fine
of level 3 on the standard scale.[6]
(4) The
holder of an approval given under these Regulations is guilty of an offence and
liable to a fine of level 3 on the standard scale if any condition subject
to which the approval was given or any condition in the Schedules that is
relevant to the approval is contravened and the holder of the approval did not
take all reasonable precautions and exercise due diligence to avoid the
contravention.[7]
(5) A
person who –
(a) in an
application for approval under these Regulations or for the purpose of
obtaining an animal health certificate makes any statement knowing that, or
reckless as to whether, it is false in a material particular;
(b) furnishes
any return or information when required to do so under these Regulations,
knowing that, or reckless as to whether, the return or information is false in
a material particular; or
(c) fraudulently
alters or uses or permits to be fraudulently used any certificate or approval
given under these Regulations or otherwise issued and required as evidence that
a requirement of these Regulations is satisfied,
is guilty of an offence
and liable to imprisonment for a term of 6 months and a fine of level 3 on
the standard scale.[8]
20 Offences:
general
(1) Where
an offence against these Regulations committed by a limited liability
partnership or body corporate is proved to have been committed with the consent
or connivance of –
(a) a
person who is a partner of the partnership, or director, manager, secretary or
other similar officer of the body corporate; or
(b) any
person purporting to act in any such capacity,
the person shall also be
guilty of the offence and liable in the same manner as the partnership or body
corporate to the penalty provided for that offence.
(2) Where
the affairs of a body corporate are managed by its members, paragraph (1)
shall apply in relation to acts and defaults of a member in connection with the
member’s functions of management as if the member were a director of the
body corporate.
Part 6
closing provisions
21 Orders
amending these Regulations
(1) The
Minister may by Order amend any reference in these Regulations to a
Community instrument.
(2) The
Minister may by Order amend the Schedules.
22 Fees
for certificates, approvals and inspections
(1) The
Minister may, by Order, prescribe fees for the issue of certificates under these
Regulations.
(2) Where
a fee is prescribed under paragraph (1), the certificate shall not be
issued until the fee has been paid.
(3) The
Minister may, by Order, prescribe fees for any application for, or the grant
of, any approval to be given, or given, under these Regulations.
(4) Where
a fee is prescribed under paragraph (3) the Minister shall not consider
the application for the approval until the fee has been paid.
(5) The
Minister may, by Order, prescribe fees for any inspection, test or official examination
carried out by or on behalf of an official veterinarian in the discharge of
functions under these Regulations.
(6) Fees
prescribed by the Minister under this Regulation may be determined by reference
to rates which represent the reasonable costs and expenses incurred in
employing or contracting for an official veterinarian to undertake an
inspection, test or official examination, during any given unit of time,
whether for the purpose of the issue of a certificate or the grant of an
approval or otherwise in the discharge of functions under these Regulations.
(7) Fees
prescribed by reference to a rate for an official veterinarian shall be charged
in units of no more than half an hour.
23 Citation
These Regulations may be
cited as the Community Provisions (Bovine Embryos) (Jersey)
Regulations 2010.
SCHEDULE
1
(Regulation 3(2)(b))
CONDITIONS APPLYING TO
DONOR ANIMALS FOR Embryo collection
1 Health history of donor
animal
For the purposes of
embryo collection, donor animals must meet the following
requirements –
(a) they
must have spent at least the previous 6 months within Jersey;
(b) they
must have been present in the herd of origin for at least 30 days prior to
collection;
(c) they
must come from herds which are –
(i) officially
tuberculosis free,
(ii) officially
brucellosis free or brucellosis free,
(iii) enzootic
bovine leucosis free, or, they may come from a herd which is not, or herds
which are not, leucosis-free but for which certification has been obtained that
there has not been any clinical case of enzootic bovine leucosis during the
past 3 years;
(d) during
the previous year, they must not have been present in a herd (or herds) which
have shown any clinical sign of infectious bovine rhinotracheitis or infectious
pustular vulvovaginitis.
2 Health of donor animal on day of
collection
On the day of embryo
collection the donor cow –
(a) shall
be kept in a holding which is not subject to veterinary prohibition or
quarantine measures;
(b) shall
show no clinical signs of disease.
3 Oocyte donation
Paragraphs 1 and 2 shall
also apply to live animals intended as donors of oocytes by ovum pickup or
ovariectomy.
4 Collection after slaughter
(1) In
the case of donors of ovaries and other tissues to be collected after slaughter
in the public slaughterhouse, they should not have been designated for slaughter
as part of a national disease eradication programme, nor should they have come
from a holding subject to restrictions because of animal disease.
(2) At
the time of collection the public slaughterhouse must not be situated in a zone
subject to prohibition or quarantine measures.
SCHEDULE 2
(Regulations 3(2)(c)
and 11(3))
conditions relating to the
collection, processing, storage and transport of embryos
1 Collection and processing
(1) Embryos shall be collected and processed by an
approved collection team, without coming into contact with any other
consignment of embryos not meeting the requirements of these Regulations
relating to trade in bovine embryos with another Member State.
(2) Embryos
shall be collected in a place which is isolated from other parts of the
premises or holding and which must be in good repair and easy to cleanse and
disinfect.
(3) Embryos
shall be processed (examined, washed, treated and placed in identified and
sterile containers) in either a permanent laboratory facility or a mobile
laboratory facility, which is not situated in a zone subject to prohibition or
quarantine measures.
(4) All
implements which come into contact with the embryos or the donor animal during
collection and processing shall be disposable or shall be properly disinfected
or sterilized prior to use.
(5) Products
of animal origin used during collection of the embryos and in the transport
medium shall be obtained from sources which present no animal health risk or
are to be so treated prior to use so that such risk is prevented. All media and
solutions shall be sterilized by approved methods according to the
recommendations of the manual of the International Embryo Transfer Society
(being the Society founded in Denver, Colorado, United States of America in 1974,
incorporated in the State of Nebraska on 7 April 1975 and currently
having its headquarters at 309 West Clark Street, Champaign,
Illinois 61820, United States of America). Antibiotics may be added to the
media in accordance with that Society’s manual.
(6) Storage
flasks and transport flasks shall be properly disinfected or sterilized before
the commencement of each filling operation.
(7) The
cryogenic agent used shall not have been previously used for other products of
animal origin.
(8) Each
embryo container and the containers in which they are stored and transported
shall be clearly code-marked in such a way that the date of collection of the
embryos and the breed and identification of the donor sire and donor dam, as
well as the registration number of the team can be readily established.
(9) Each
embryo shall be washed at least 10 times in a special fluid for embryos
which shall be changed each time and which shall contain trypsin, in accordance
with internationally recognized procedures. Each wash shall be a 100-fold
dilution of the previous wash and a sterile micropipette shall be used to
transfer the embryo on each occasion.
(10) After
the last wash each embryo shall be subjected to microscopic examination at a
magnification of at least × 50 over its entire surface to determine
that the zona pellucida is intact and is free from any adherent material. Any
micromanipulation which involves penetration of the zona pellucida must be
carried out in the facilities approved for the purpose, and after the last wash
and examination. Such micromanipulation may only be carried out on an embryo
having an intact zona pellucida.
(11) Each
consignment of embryos that has successfully undergone the examination provided
for in sub-paragraph (10) shall be placed in a sterile container marked in
accordance with sub-paragraph (8) and which shall be sealed immediately.
(12) Each
embryo shall, where appropriate, be frozen as soon as possible and stored in a
place which is under the control of the team veterinarian and which is subject
to regular inspection by an official veterinarian.
(13) Each
collection team must, when required to do so by the Minister, submit routine
samples of flushing fluids, washing fluids, disintegrated embryos,
non-fertilized ova etc., resulting from its activities to the Minister for
official examination for bacterial and viral contamination.
(14) Each
collection team must keep a record of its activities in respect of embryo
collection during the 12 months before and 12 months after storage
including –
(a) the
breed, age and identification of the donor animals concerned;
(b) the
place of collection, processing and storage of embryos collected by the team;
(c) the
identification of the embryos together with details of their destination if
known; and
(d) details
of micromanipulation techniques which involve penetration of the zona pellucida
or other techniques such as in vitro fertilization and/or in vitro culture
which have been performed on the embryos. In the case of embryos derived by in
vitro fertilization, the identification may be done on the basis of a batch,
but must contain details of the date and place of collection of ovaries and/or
oocytes. It must also be possible to identify the herd of origin of the donor
animals.
(15) The
conditions laid down in sub-paragraphs (1) to (14) shall apply as
appropriate to the collection, processing, storage and transport of ovaries,
oocytes and other tissues for use in in vitro
fertilization and/or in vitro culture.
(16) The
conditions in sub-paragraphs (17) to (22) shall apply in addition to the
conditions in sub-paragraphs (1) to (14).
(17) When
ovaries and other tissues are to be collected post-mortem, this may only be
done at the public slaughterhouse.
(18) Materials
and equipment coming into direct contact with ovaries and other tissues shall
be sterilized before use and after sterilization, used exclusively for those
purposes. Separate equipment shall be used to handle oocytes and embryos from
different batches of donor animals.
(19) Ovaries
and other tissues shall not be allowed to enter the processing laboratory until
completion of the post-mortem inspection of the batch. If relevant disease is
found in the batch of donors, or in any animals slaughtered in the public
slaughterhouse on that day, all tissues from that batch must be traced and
discarded.
(20) The
washing and examination procedure laid down in sub-paragraphs (9)
and (10) shall be carried out after the culture procedure has been
completed.
(21) Any
micromanipulation which involves penetration of the zona pellucida shall be
carried out in accordance with the provisions of sub-paragraph (10), after
the procedures laid down in sub-paragraph (20) have been completed.
(22) Only
embryos from the same batch of donors should be stored in the same ampoule/straw.
2 Storage
(1) Each
embryo collection or production team shall ensure that the embryos are stored
at suitable temperatures in a bovine embryo storage facility.
(2) In
order to be approved the facility must –
(a) comprise
at least one lockable room intended exclusively for embryo storage;
(b) be
easy to cleanse and disinfect;
(c) have
permanent records of all incoming and outgoing movements of embryos which
shall, in particular, specify the final destination of the embryos; and
(d) be
subject to inspection by an official veterinarian.
(3) If
bovine semen is to be stored in a bovine embryo storage facility, the facility
must satisfy the conditions for the grant of a licence as an EC storage centre
under the Bovine Semen Order.
3 Transport
(1) Embryos
for trade must be transported in satisfactory hygienic conditions in sealed
containers from the approved bovine embryo storage facility until their arrival
at their destination.
(2) The
containers must be marked in such a way that the number coincides with the
number on the animal health certificate.
SCHEDULE 3
(Regulations 5 and
8)
conditions for the approval
of embryo collection and embryo production teams
In order to be given
approval each embryo collection team must fulfil the following requirements –
(a) the
collection, processing and storage of embryos must be carried out either by a
team veterinarian or under his or her responsibility by one or more technicians
who are competent and trained by the team veterinarian in methods and
techniques of hygiene;
(b) the
team must have at its disposal permanent or mobile laboratory facilities where
embryos can be examined, processed and packed, consisting of at least a work
surface, a microscope and cryogenic equipment;
(c) in
the case of a permanently sited laboratory, the team must have at its
disposal –
(i) a
room where embryos can be manipulated which is adjacent to but physically
separate from the area used to handle the donor animals during collection, and
(ii) a
room or area equipped for cleansing and sterilizing instruments and equipment
used in embryo collection and manipulation;
(d) where
micromanipulation of the embryo which involves penetration of the zona
pellucida is to be carried out, this shall be done in suitable laminar-flow
facilities which shall be properly cleaned and disinfected between batches;
(e) the
team must have at its disposal in the case of a mobile laboratory a specially
equipped part of the vehicle consisting of 2 separate
sections –
(i) one
for the examination and manipulation of embryos which shall be a clean section,
and
(ii) the
other for accommodating equipment and materials used in contact with the donor
animals.
A mobile laboratory shall
always have contact with a permanently sited laboratory to ensure the
sterilization of its equipment and the provision of fluids and other products
necessary for the collection and manipulation of embryos.
SCHEDULE 4
(Regulation 8)
additional conditions for
the approval of embryo production teams
In order to be given
approval each embryo production team must fulfil the following requirements, in
addition to the requirements in Schedule 3 –
(a) the
personnel must be trained in appropriate disease control and laboratory
techniques, particularly in procedures for working in sterile conditions;
(b) the
team must have at its disposal a permanently-sited processing laboratory which
must –
(i) have
adequate equipment and facilities, including a separate room for recovering
oocytes from ovaries, and separate rooms or areas for processing oocytes and
embryos, and storing embryos, and
(ii) have
laminar-flow facilities under which all oocytes, semen and embryos must be
processed; however, the centrifugation of semen may be carried out outside the
laminar-flow facility, as long as full hygienic precautions are taken;
(c) where
oocytes and other tissues are to be collected in the public slaughterhouse, the
team must have at its disposal suitable equipment for the collection and
transport of the ovaries and other tissues to the processing laboratory in a
hygienic and safe manner.