S.L. 437.100 Art. 17Offences and penalties. In order to following (a) the (b) it (c) it (d) in (e) it A laboratory to other products Conditions 1. (a) (b) of (c) or the donor or shall be and in present no such risk is disinfected or used for other are stored and that the date of of the donor the team can of this code-

(1) Any person who fails to abide by these rules shall be guilty of an offence in terms of the Act and the provisions and measures rule 3(3) and (4) shall apply to it.

(2) Any right given to the competent authority under these rules to apply all such necessary measures prescribed in rule 3(3) and (4) shall be given to the Authority without prejudice to other criminal procedures which may be taken under the Act or any other law when a person commits an offence by failing to abide by these rules. SCHEDULE A CHAPTER I

Conditions for the approval of an embryo collection team be given approval each embryo collection team shall fulfill the requirements: collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene; shall be placed under the general supervision and authority of the official veterinarian; shall 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; the case of a permanently sited laboratory, it shall 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,

(ii) a room or area equipped for cleansing and sterilizing instruments and equipment used in embryo collection and manipulation; shall have at its disposal, in the case of a mobile laboratory, a specially equipped part of the vehicle consisting of two 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.

mobile laboratory shall always have contact with a permanently sited ensure the sterilization of its equipment and the provision of fluids and necessary for the collection and manipulation of embryos. CHAPTER II

relating to the collection, processing, storage and transport of embryos by the approved embryo collection team

Collection and processing 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 rules. Embryos shall be collected in a place which is isolated from other parts the premises or holding and which shall be in good repair and easy to cleanse and disinfect. 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.

(d) All implements which come into contact with the embryos animal during collection and processing shall be disposable properly disinfected or sterilized prior to use.

(e) Products of animal origin used during collection of the embryos the transport medium shall be obtained from sources which animal health risk or are to be so treated prior to use so that prevented.

(f) Storage flasks and transport flasks shall be properly sterilized before the commencement of each filling operation.

(g) The cryogenic agent used shall not have been previously products of animal origin.

(h) Each embryo container and the containers in which they transported shall be clearly code-marked in such a way collection of the embryos and the breed and identification sire and donor dam, as well as the registration number of be readily established. The characteristics and form marking shall be established in accordance with the down in the definition "Standing Committee on the Food Animal Health or the Committee" in rule 2(2).

(i) Each embryo shall be washed at least ten times in a special embryos which shall be changed each time and which, otherwise under paragraph (m), shall contain trypsin, with internationally recognized procedures. Each wash fold dilution of the previous wash and a sterile micropipette used to transfer the embryo on each occasion.

(j) After the last wash each embryo shall be subjected examination over its entire surface to determine that the is intact and is free from any adherent material.

(k) Each consignment of embryos that has successfully examination provided for in paragraph (j) shall be placed container marked in accordance with paragraph (h) and sealed immediately.

(l) Each embryo shall, where appropriate, be frozen as soon stored in a place which is under the control of the team veterinarian which is subject to regular inspection by an official veterinarian. (m) In accordance with the procedure laid down in the definition Committee on the Food Chain and Animal Health" or "the in rule 2(2) concerning authorised flushing and washing techniques and, where necessary, enzymatic treatments authorized transportation media. Pending the adoption of enzymatic treatments, the national rules on the use of continue to apply, in compliance with the general provisions Treaty.

(n) Each collection team shall submit routine samples of flushing washing fluids, disintegrated embryos, non-fertilized ova from its activities for official examination for bacterial contamination. The procedure for collecting of samples, such examinations, together with the standards to be achieved decided in accordance with the procedure laid down in in "Standing Committee on the Food Chain and Animal Health" Committee" in rule 2(2). If the standards laid down are not achieved the competent authority which granted the official approval to the team shall withdraw that approval. Each collection team shall keep a record of its activities in respect of embryo collection during the twelve months before and twelve months after storage including:

(i) the breed, age and identification of the donor animals concerned,

(ii) the place of collection, processing and storage of embryos collected by the team,

(iii) the identification of the embryos together with details of their destination if known.

collection team shall ensure that the embryos are stored at suitable in premises approved for the purpose by the competent authority. In approved these premises shall:

comprise at least one lockable room intended exclusively for embryo storage; easy to cleanse and disinfect; have permanent records of all incoming and outgoing movements of embryos. The final destination of the embryos in particular shall be specified in such records; subject to inspection by the official veterinarian. competent authority may authorize the storage of semen that fulfils the of the Animal Health Conditions Applicable to Intra-Community Trade from Third Countries of Deep-Frozen Semen of Domestic Animals of Species, Rules 2010 in the approved storage premises. Transport trade shall be transported in satisfactory hygienic conditions in containers from the approved storage premises until their arrival at their containers shall be marked in such a way that the number coincides number on the animal health certificate.

SCHEDULE B Conditions applying to donor animals the purposes of embryo collection donor animals shall meet the requirements: they shall have spent the previous six months within the Community or the third country of collection in at least one herd:

(i) which is officially tuberculosis free; and

(ii) which is officially brucellosis free or brucellosis free;

(iii) which is enzootic bovine leucosis free or which, during the three previous years, has shown no clinical signs of enzootic bovine leucosis;

(iv) which, during the previous year, has shown no clinical infectious bovine rhinotracheitis/infectious pustular vaginitis;

(b) during the six months preceding embryo collection, donor have spent successive periods in a maximum of two meeting the requirements set out above.