L.S. 437.99(R) Regoli dwar il-Kondizzjonijiet tas-Saħħa tal-Annimali Applikabbli għall-Kummerċ Intra-Komunitarju u għall-Importazzjonijiet ta’ Deep Fr

(1)The title of these rules is the Animal Health Conditions Applicable to Intra-Community Trade and Imports from Third Countries of Deep-Frozen Semen of Domestic Animals of the Bovine Species Rules. Citation and scope.

(2)The scope of these rules is to transpose Directive 88/407/ EEC laying down animal health conditions applicable to intraCommunity trade and imports from third countries of deep-frozen semen of domestic animals of the bovine species, and shall apply without prejudice to the provisions adopted pursuant to other regulations and community rules and other national legislation regarding domestic animals which may apply in this regard.

(3)These rules are being made for the safeguarding of the public interest and public safety. Any requirements and safeguard measures contained therein including those relating to authorisations are made for overriding reasons relating to public interest. 2.

(1)Unless stated otherwise in these rules, the definitions in the Act, those contained under the Animal Health Requirements Governing Trade and Imports into the Community of Animals, Semen, Ova and Embryos not Subject to Animal Health Requirements laid down in Specific Community Acts Rules and those contained under the Animal Health Problems Affecting IntraCommunity Trade in Bovine Animals and Swine Regulations shall continue to apply. Interpretation. S.L. 437.98 S.L. 437.48

(2)For the purpose of these rules and unless the context otherwise requires the following definitions shall apply: "the Act" means the Veterinary Services Act; Cap.

1. "animals of the bovine species" means bovine animals whose semen is subject to intra-Community trade and imports from third countries to be produced for use in artificial insemination; "Appeals Board" shall have the same meaning as that provided under the Services (Internal Market) Act, designated in accordance *These rules have been repealed by Legal Notice 77 of
2. †see rule 1

(4)as originally promulgated. Cap. 500. 2 [ S.L.437.99 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES with article 12(f) thereof; "approved laboratory" means a laboratory situated in Malta or a third country designated by the competent authority to carry out the tests laid down in these rules; "authorisation" means any authorisation granted under these rules and in relation to authorised providers and services means a permit, licence, warrant, appointment, concession or any decision concerning access to a service activity or the exercise thereof; S.L. 437.98 "authorised provider" shall have the same meaning as that provided under the Animal Health Requirements Governing Trade and Imports into the Community of Animals, Semen, Ova and Embryos not Subject to Animal Health Requirements laid down in Specific Community Acts Rules; "centre veterinarian" means the veterinarian responsible for dayto-day compliance in the centre with the requirements laid down in these rules; "collection" means a quantity of semen taken from a donor at any time; "the Commission" means the European Commission; "the Community" means the European Community as established by the Treaty of the European Union; "the competent authority" means the Department responsible for veterinary services in Malta as established by the Act; "consignment" means a quantity of semen covered by a single certificate; "country of collection" means the Member State or third country in which semen is collected and from which it is sent either directly from the third country or indirectly to another Member State; "the Director" means the Director responsible for veterinary services or any veterinarian officer nominated by him; "donor" means a domestic animal of the bovine species whose semen is used for artificial insemination; S.L. 437.98 "final consumer" shall have the same meaning as that provided for under the Animal Health Requirements Governing Trade and Imports into the Community of Animals, Semen, Ova and Embryos not Subject to Animal Health Requirements laid down in Specific Community Acts Rules; "health certificate" means a certificate properly issued by the competent authority in accordance with Schedule IV, as a means of guaranteeing and monitoring compliance with animal health requirements as regards animals and products of animal origin subject to trade for the purpose of these rules; "M embe r Sta te" m ea ns a State which i s a member t o the European Union; "Member State of destination" means such Member State to ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 3 which semen is transported either indirectly from the Member State of collection where the semen collection centre or establishment of origin is situated, or directly from a semen collection centre or storage of a third country; "official veterinarian" shall have the same meaning as that provided for under the Animal Health Requirements Governing Trade and Imports into the Community of Animals, Semen, Ova and Embryos not Subject to Animal Health Requirements laid down in Specific Community Acts Rules; S.L. 437.98 "the product" means any product of animal origin subject to trade and trading purposes; "semen" means the prepared or diluted ejaculate of a domestic animal of the bovine species; "semen collection centre" or "centre" means an officially approved and supervised establishment situated in Malta, a Member State or third country, in which semen is produced for use in artificial insemination; "Standing Committee on the Food Chain and Animal Health" or "the Committee" means a Committee made up of Member States’ representatives named committee members, who assist and consult the Com mission by delivering an Opinion regarding safety measures with respect to animal health issues to be then formally adopted by the Commission in accordance with the appropriate procedure. Such committee procedure covers the entire food supply chain, ranging from animal health issues on the farm to the product which arrives to the final consumer, therefore significantly enhancing its ability to target risks to health wherever they arise in the production of food; "third country" means a country which is not a member of the European Community; "trade" means, for the purpose of these rules, trade between Member States or between a Member State and a third country in animals and their products, a business or occupation to make profit or gain, particularly in wholesale or retail and includes dealings in a particular business activity; "the Treaty" means the treaty as established by the European Union; "veterinary checks" means for the purpose of these rules, veterinary checks or import controls carried out on semen imports from third countries via border inspection posts in accordance with the procedure laid down in terms of rule 13, provided that import controls between Member States shall be carried out in conformity to the procedure determined for veterinary checks in intraCommunity trade as provided in rule 3

(2)of the Animal Health Requirements Governing Trade and Imports into the Community of Animals, Semen, Ova and Embryos not Subject to Animal Health Requirements laid down in Specific Community Acts Rules. 3.

(1)These rules shall apply to: S.L. 437.98 Applicability. 4 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 (

1. a)national animal health provisions governing intraCommunity trade in animals and animal products, in order to create a harmonized system for intraCommunity trade and imports into the Community of semen of bovine animals; (
2. b)intra-Community trade in semen, whereby the competent authority ensures that semen has been collected and processed at approved and supervised semen collection centres, and that it has been obtained from animals whose health status is such as to ensure that the risk of spread of animal diseases is eliminated; (
3. c)semen which has been collected, processed, stored and transported in accordance with rules which preserve its health status and is accompanied during transport to the country or member state of destination by an animal health certificate in order to ensure that this obligation has been fulfilled; (
4. d)policies pursued within the Community with regard to vaccination against certain diseases, authorising the competent authority, in respect of certain diseases, to impose the requirement of additional protection against those diseases; (
5. e)imports of semen into the Community from third countries whereby a list of third countries should be drawn up taking into account animal health criteria; (
6. f)authorisation by the competent authority to the importation of semen only from semen collection centres which reach certain standards and which are officially supervised without prejudice to the list mentioned in paragraph (e); (
7. g)specific animal health conditions in respect of countries on such list which should be laid down according to circumstances; (
8. h)the verification of compliance with the standards mentioned in paragraph (f), by means of on-spot checks which may be carried out; (
9. i)the procedure which should be provided for the purpose of settling of disputes which may arise between Member States as to whether approval of a collection centre is justified; and (
10. j)the prevention of transmission of certain contagious diseases, whereby import controls should be carried out when a consignment of semen arrives and is placed on the market of the Community, and the measures to be taken by Member States after such controls have been defined, in case of internal transit.

(2)The competent authority shall take emergency measures in the event of an outbreak of a contagious disease in another Member State or in a third country, which in case of internal transit such ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 5 measures which shall be defined, and shall assess the dangers associated with such diseases and the protective measures required in this regard, in conformity with the procedure mentioned in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" defined under rule 2

(2).

(3)The competent authority may refuse a consignment of semen where it has been established that it does not comply with the provisions of these rules, and return such semen, if this is not contrary to considerations of animal health, and if the consignor or his representative so requests, it shall give a reasoned opinion to such consignor or his representative for such prohibition or restriction and the consignor or his representative shall be allowed to obtain the opinion of an expert.

(4)The Director shall apply all such necessary administrative m e a s u r e s c o n f o r m i n g t o t h e r e q u i r e m e n t s o f t h e St a n d i n g Committee on the Food Chain and Animal Health according to the requirements of these rules, to ensure that there is no breach of these rules and also to reduce the risk for final consumers and any additional risk to animals and to the environment.

(5)These measures shall include the direct confiscation of the product, the suspension of the activities carried out by the auth orised provi der wh en t hese are c reating a risk to final consumers and to the environment, and the forfeiture of any authorisation, licence or permit in addition to the application of any other administrative penalty in terms of article 61 of the Act. 4. The competent authority ensures that only semen meeting the following general conditions is sent from Malta to another Member State: Measures to be adopted by the authority. (a) it shall have been collected and processed, for the purpose of artificial insemination, in a semen collection centre approved from an animal health point of view for the purposes of intra-Community trade in accordance with rule 6

(1); (

1. b)it shall have been collected from domestic animals of the bovine species whose health status complies with Schedule II; (
2. c)it shall have been collected, processed, stored and transported in accordance with Schedules I and III; and (
3. d)it shall be accompanied, during transport to the Member State of destination, by an animal health certificate complying with rule 7

(1). 5.

(1)In the case where all collection centres in Malta or part of its territory, contain only animals giving a negative reaction to the serum neutralization test or the Elisa test for infectious bovine rhino-tracheitis or infectious pustular vulvo-vaginitis or showing a positive result after vaccination in accordance with these rules, the Competent Authority may refuse admission of semen from centres which do not have such status. Laboratory tests carried out by semen collection centres. 6 [ S.L.437.99 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES

(2)Without prejudice to other Community laws and regulations, a Member State of destination which do not practise vaccination against foot-and-mouth disease may not oppose the admission of semen from animals vaccinated in accordance with these rules. In such event, up to 10% of the semen from each collection intended for trade, may be subjected to a virus isolation test for foot-and-mouth in a laboratory in the Member State of destination or in a laboratory specified by such Member State. If the result is positive, admission of the semen may be refused. Semen collection centres. 6.

(1)The competent authority ensures that, with regard to the semen collection centre, the approval provided for in rule 4(a) is granted only where the conditions set out in Schedule I are observed and where the semen collection centre is able to satisfy the other provisions contained in these rules.

(2)The competent authority also ensures that the official veterinarian supervises the observance of these rules and shall w it h d r a w i t s ap p r ov a l w he n o n e o r m o r e o f t h e p r ov i s i o ns contained in these rules are no longer observed.

(3)All approved semen collection or storage centres shall be registered, each centre given a veterinary registration number. The competent authority shall draw up and keep up to date a list of semen collection or storage centres and their veterinary registration numbers and make it available to other Member States and to the public.

(4)Detailed rules for the uniform application of this rule may be adopted in accordance with the procedure referred to in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" under rule 2

(2), where matters relating to semen collection centres shall be referred without delay to the Committee. Admission of semen from Member States subject to an animal health certificate. 7.

(1)The competent authority shall make the admission of semen from other Member States subject to an animal health certificate drawn up by the official veterinarian in such Member State in accordance with Schedule IV.

(2)This certificate shall: (

1. a)be drawn up in at least one of the official languages of the Member State of collection and one of those of the Member State of destination; (
2. b)accompany the consignment to its destination in its original form; (
3. c)be drawn up on a single sheet of paper; and (
4. d)be made out to a single consignee.

(3)The competent authority, where Malta is the Member State of destination may: (

1. a)prohibit the admission of consignments if a documentary check or health certificate reveals that rule 4 has not been observed; ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 7 (
2. b)take the necessary measures, including storage in quarantine, in order to obtain definite proof in cases where semen is suspected of being infected or contaminated by pathogenic organisms.

(4)Decisions taken under sub-rule

(3)(

1. a)or (
2. b)shall, at the request of the consignor or his representative, authorise the return of the semen, provided this is not contrary to considerations of animal health.

(5)If the admission of semen has been prohibited on any of the grounds set out in sub-rule

(3)(

1. a)and (
2. b)and the Member State of collection does not within thirty days authorise the return of the semen, the competent authority may order it to be destroyed.

(6)Except in the case of the granting of an authorisation, a decision taken by the competent authority under sub-rules

(3)and

(5), including refusal or destruction of semen, shall be communicated to the consignor or his representative, and shall be fully reasoned and be open to challenge before the Appeals Board. 8.

(1)The reasoned decisions taken pursuant to rule 7 shall, on request, be communicated to the consignor or his representative in writing, with a reference to what rights of appeal are provided for in the current national legislation, and of the form and time limits in which proceedings shall be initiated by the Member State of collection against whom such decisions were taken. The decisions shall also be communicated to the competent veterinary authority of the Member State of collection. Right of appeal from decisions taken by the competent authority.

(2)The competent authority shall grant to consignors in respect of whose consignments of semen such measures as are provided for in rule 7

(3)have been taken, the right to obtain, before other measures are taken by the competent authority, the opinion of a veterinary expert to determine whether rule 7

(3)has been complied with. The veterinary expert shall be a national of a third party Member State, other than Malta or the Member State of collection.

(3)The rights of appeal and the set-up of proceedings initiated by the Member State of collection as referred to in sub-rule

(1)shall be made subject to the provisions laid down article 15

(10)of the Arbitration Act. 9.

(1)The competent authority may authorise importation of semen only from those third countries which appear on a list drawn up in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health or the Committee" provided under rule 2

(2), and which list may also be amended in accordance with the same procedure.

(2)In deciding whether a third country may appear on the list referred to in sub-rule

(1), particular account shall be taken of: (

1. a)the state of health of the livestock, other domestic animals and wildlife in the third country, with particular reference to exotic animal diseases, and of the environmental health situation in that country, Cap. 387. Importation of semen from third countries. 8 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 which might endanger animal health in Malta; (
2. b)the regularity and rapidity of the information supplied by the third country concerning the existence of contagious animal diseases in its territory, in particular those diseases mentioned in lists A and B of the International Office of Epizootic Diseases; (
3. c)that country’s rules on animal disease prevention and control; (
4. d)the structure of the veterinary services in the country and their powers; (
5. e)the organization and implementation of measures to prevent and control contagious animal diseases; and (
6. f)Conditions relating to semen collection or storage centres. the guarantees which the third country can give with regard to compliance with these rules. 10.

(1)The competent authority shall only authorise imports of semen dispatched from a semen collection or storage centre situated in one of the third countries appearing on the list referred to in rule 9, and for which the competent authority of the third country concerned is able to give the guarantees that the following conditions are met: (

1. a)it meets the conditions: (
2. i)for approval of semen collection centres or storage centres set out in Chapter I of Schedule I; (
3. ii)relating to the supervision of such centres set out in Chapter II of Schedule I; (
4. b)it has been officially approved by the competent authority of the third country for exports to the Community; (
5. c)it is placed under the supervision of a centre veterinarian; (
6. d)it is subject to inspections by an official veterinarian of the third country at least twice a year.

(2)The list of semen collection or storage centres which the competent authority of the third country appearing on the list referred to in rule 9 has approved, in accordance with the conditions set out in sub-rule

(1), and from which semen may be dispatched to the Community, shall be communicated to the Commission.

(3)The approval of a semen collection or storage centre shall be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions set out in sub-rule

(1)and the Commission shall be immediately informed thereof.

(4)Detailed rules for the uniform application of this rule may be adopted in accordance with the procedure referred to in the ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 9 definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2), where matters relating to such authorisation and approval mentioned in this rule shall be referred without delay to the Committee. 11.

(1)Semen shall come from animals which, immediately prior to collection of their semen, have remained for at least six months in the third country on the list drawn up in accordance with rule 9

(1). Conditions relating to semen from a third country.

(2)Without prejudice to sub-rule

(1)and rule 9

(1), the competent authority shall not authorise the importation of semen from a third country on the list, unless the semen complies with the animal health requirements adopted for imports of semen from that country, in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2).

(3)In adopting the requirements referred to in the preceding sub-rule, special account shall be given to: (

1. a)the health situation in the area surrounding the semen collection centre, with particular reference to the diseases appearing on list A of the International Office of Epizootic Diseases; (
2. b)the state of health of the herd in the semen collection centre, including testing requirements; (
3. c)the state of health of the donor animal and testing requirements; and (
4. d)the testing requirements in relation to semen.

(4)The reference basis for fixing animal health conditions in accordance with sub-rule

(2)for bovine tuberculosis and brucellosis shall be the standards laid down in Schedule A to the Animal Health Problems Affecting Intra- Community Trade in Bovine Animals and Swine Regulations.

(5)The competent authority may decide, in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health or the Committee" provided under rule 2

(2), on a case-by-case basis, to waive these conditions where the third country concerned provides similar animal health guarant ees. In such case, ani mal h ealth con di tio ns at least equivalent to those in Schedule A to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations shall be laid down in accordance with the same procedure in order to permit the entry of such animals into semen collection centres. Rule 4 shall mutatis mutandis apply. 12.

(1)The competent authority shall authorise the importation of semen only on submission of an animal health certificate drawn up and signed by an official veterinarian of the third country of collection.

(2)This certificate shall: S.L. 437.48 S.L. 437.48 Certification of semen imported from a third country of collection. 10 [ S.L.437.99 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES (

1. a)be drawn up in at least one of the official languages of the Member State of destination and one of those of the Member State where the import control provided for in rule 13 is carried out; (
2. b)accompany the semen in the original; (
3. c)be drawn up on a single sheet of paper; and (
4. d)be made out to a single consignee.

(3)The certificate shall correspond to a specimen drawn up in a c c o r d a n c e wi t h th e p r o c e d u r e l a id d o w n i n t h e d e f i n i t i o n "Standing Committee on the Food Chain and Animal Health or the Committee" provided under rule 2

(2). Veterinary checks carried out by the competent authority. S.L. 437.41

1. The provisions laid down in the Principles Governing the Organisation of Veterinary Checks on Products Entering the Territory of Malta from Third Countries Regulations shall apply, in particular to the organisation of, and follow-up to the checks to be carried out by the competent authority, when Malta is the Member State of destination, and the safeguard measures to be applied in accordance with the procedure referred to in regulation 19 of the said regulations, regarding a disease or any other phenomenon or circumstance liable to present a serious threat to animal or public health which manifests itself or spreads. Consignment of semen.
2. Each consignment of semen authorised for introduction into the Community by the Member State of destination on the basis of the import control referred to in rule 13 shall, when sent to another Member State, be accompanied by the original certificate or an authenticated copy thereof, suitably endorsed, in either case, by the competent authority responsible for controls carried out in accordance with rule
3. Costs relating to destruction measures.
4. If, pursuant to rule 13, it is decided that destruction measures should be taken by the competent authority, any costs incurred shall be chargeable to the consignor or its agent or representitive, without any compensation thereto by the competent authority. Measures in case of danger of an animal desease. 16.

(1)The competent authority may take the following measures if there is a danger of an animal disease spreading as a result of the introduction of semen in Malta from another Member State: (

1. a)in the event of an outbreak of an epizootic disease in the other Member State, it may temporarily prohibit or restrict the introduction of semen from the areas of that Member State where the disease has occurred; (
2. b)if an epizootic disease becomes widespread, or if there is an outbreak of a further contagious animal disease of a serious nature, it may temporarily prohibit or restrict the introduction of semen from the whole of the territory of that Member State.

(2)The competent authority shall immediately inform the other Member States and the Commission of the outbreak of any disease ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 11 in Malta covered by sub-rule

(1)(a), and of the measures which it ha s t a k e n t o c o nt r o l th a t d i s e a s e . I t s ha l l a ls o n o t if y t h e m immediately of the disappearance of the disease.

(3)Without prejudice to rules 9, 10 and 11, if in a third country a contagious animal disease which can be carried by semen and is liable to endanger the health of the livestock in Malta breaks out or spreads or if any other reason connected with animal health so justifies, the competent authority shall prohibit the importation of that semen, whether imported indirectly through another Member State, or directly from a third country as a whole or from only part thereof.

(4)Measures taken by the competent authority on the basis of sub-rules

(1)and

(2)and the repeal of such measures shall be communicated immediately to the other Member States and the Commission together with the reasons for taking such measures.

(5)In accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2), it may be decided that those measures shall be amended, in particular in order to coordinate them with measures adopted by the other Member States, or that they shall be repealed.

(6)If the situation envisaged in sub-rules

(1)and

(2)arises, and if it is necessary that other Member States also apply the measures taken under such sub-rules as amended where necessary in accordance with sub-rules

(4)and

(5), appropriate steps shall be taken in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2).

(7)Resumption of importation from the third country concerned shall be authorised in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2). 17.

(1)Veterinary experts from the Commission may in cooperation with the competent authority and competent authorities of third countries, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of these rules. Veterinary experts.

(2)The country of collection within whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The country of collection concerned shall take any measures which may prove necessary to take account of the results of the investigation.

(3)The general provisions for implementing this rule, especially as regards the frequency and method of carrying out the checks referred to in sub-rule

(1)shall be laid down in accordance with the procedure set out in in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2). 18.

(1)Any person who fails to abide by these rules shall be Offences and penalties. 12 [ S.L.437.99 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES guilty of an offence in terms of the Act and the provisions and measures of rule 3

(4)and

(5)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

(4)and

(5), 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. ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 13 SCHEDULE I CHAPTER I CONDITIONS FOR THE APPROVAL OF SEMEN COLLECTION CENTRES Semen collection centres shall: (

1. a)be placed under the permanent supervision of a centre veterinarian; (
2. b)have at least: (
3. i)animal housing including isolation facilities; (
4. ii)semen collection facilities including a separate room for the cleaning and disinfection or sterilization of equipment; (iii) a semen processing room which need not necessarily be on the same site; (
5. iv)a semen storage room which need not necessarily be on the same site; (
6. c)be so constructed or isolated that contact with livestock outside is prevented; (
7. d)be so constructed that the animal housing and the semen collecting, processing and storage facilities can be readily cleaned and disinfected; (
8. e)have isolation accommodation which shall have communication with the normal animal accomodation; (
9. f)no direct be so designed that the animal accommodation is physically separated from the semen processing room and both are separated from the semen storage room. CHAPTER II CONDITIONS RELATING TO THE SUPERVISION OF SEMEN COLLECTION CENTRES The collection centres shall: (
10. a)be so supervised that they contain only animals of the species whose semen is to be collected. Other domestic animals which are strictly necessary for the normal operation of the collection centre may nonetheless also be admitted, provided that they present no risk of infection to those species whose semen is to be collected and they fulfill the conditions laid down by the centre veterinarian; (
11. b)be so supervised that a record is kept of all bovine animals at the centre, giving details of the breed, date of birth and identification of each of the animals, and also a record of all checks for diseases and all vaccinations carried out, giving also information from the disease/health file of each animal; (
12. c)be regularly inspected by an official veterinarian, at least twice a year, at which time standing checks on the conditions of approval and supervision shall be carried out; (
13. d)be so supervised that the entry of unauthorised persons is prevented. Furthermore, authorised visitors shall be required to comply with the conditions laid down by the centre veterinarian; (
14. e)employ technically competent staff suitably trained in disinfection procedures and hygiene techniques relevant to the control of the spread [ S.L.437.99 14 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES of disease; (
15. f)be so supervised that: (
16. i)only semen collected at an approved centre is processed and stored in approved centres, without coming into contact with any other consignment of semen. However, semen not collected in an approved centre may be processed in approved collection centres provided that: - such semen is produced from bovine animals which fulfill the conditions laid down in Chapter I, 1(d)(i), (ii), (iii) and (
17. v)of Schedule II, - processing is carried out with separate equipment or at a different time from semen intended for intra-Community trade, the equipment in the latter case being cleaned and sterilized after use, - such semen may not be the subject of intra-Community trade and cannot at any time come into contact with or be stored with semen intended for intra-Community trade, - such semen is identifiable by a marking different from that provided for in point (vii); (
18. ii)collection, processing and storage of semen takes place only on the premises set aside for the purpose and under conditions of the strictest hygiene; (iii) all implements which come into contact with the semen or the donor animal during collection and processing are properly disinfected or sterilized prior to use; (
19. iv)products of animal origin used in the processing of semen including additives or a diluent - are obtained from sources which present no animal health risk or are so treated prior to use that such risk is prevented; (
20. v)storage flasks and transport flasks are properly disinfected or sterilized before the commencement of each filling operation; (
21. vi)the cryogenic agent used has not been previously used for other products of animal origin; (vii) each individual dose of semen is clearly marked in such a way that the date of collection of the semen and the breed and identification of the donor animal, as well as the name of the centre, possibly in code, can be readily established; the characteristics and form of this marking will be established in accordance with the procedure laid down in the definition "Standing Committee on the Food Chain and Animal Health" or "the Committee" provided under rule 2

(2). ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 15 SCHEDULE II CHAPTER I CONDITIONS APPLYING TO THE MOVEMENT OF ANIMALS INTO APPROVED SEMEN COLLECTION CENTRES 1. All bovine animals admitted to a semen collection centre shall: (

1. a)have been subjected to a period of isolation of at least thirty days in accommodation specifically approved for such purpose by the competent authority, and where only other cloven-hoofed animals having at least the same health status are present; (
2. b)prior to their stay in the isolation accommodation described in paragraph (
3. a)have belonged to herds: (
4. i)which are officially tuberculosis free; (
5. ii)which are officially brucellosis free. The animals may not previously have been kept in other herds of a lower status; (
6. c)have come from a herd free of enzootic bovine leukosis or have been produced by a cow which has been subjected to a serological test for enzootic bovine leukosis with a negative result, not more than thirty days before the animal’s admission to the centre. If this requirement cannot be fulfilled, the semen may not be the subject of trade until the donor has reached the age of two years and has been tested in accordance with Chapter II, 1(iii) with a negative result; (
7. d)before the period of isolation specified in paragraph (a), and within the previous thirty days, have been subjected to the following tests with negative results: (
8. i)an intradermal tuberculin test carried out in accordance with the procedure laid down in Schedule B to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations; (
9. ii)a serum agglutination test carried out in accordance with the procedure laid down in Schedule C to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations, and showing a brucella count lower than 30 IU of agglutination per millilitre and in the case of brucellosis free herds a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units); (iii) a serological test for enzootic bovine leukosis carried out in accordance with the procedure laid down in Schedule D to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations; (
10. iv)a serum neutralization test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis; (
11. v)a virus isolation test (fluorescent antibody test or immunoperoxidase test) for bovine viral diarrhoea. In the case of an animal less than six months of age the test shall be deferred until that age is reached. The competent authority may give authorisation for the tests referred to in paragraph (
12. d)to be carried out in the isolation accommodation, provided that the results are known before the commencement of the thirty-day 16 [ S.L.437.99 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES isolation period laid down in paragraph (e); during the period of isolation of at least thirty days specified in paragraph (a), have been subjected to the following tests with negative results: (
13. i)a serum agglutination test complying with the procedure laid down in Schedule C to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations, and showing a brucella count lower than 30 IU of agglutination per millilitre and a complement fixation test showing a brucella count lower than 20 EEC units per millilitre (20 ICFT units) in the case of animals coming from brucellosis free herds; (
14. ii)either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be carried out; (iii) a microscopic examination and culture test for trichomonas foetus on a sample of vaginal washings or preputial washings; in the case of female animals a vaginal mucus agglutination test shall be carried out; (
15. iv)a serum neutralization test or an Elisa test for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis; and have treatment against leptospirosis comprising two injections of streptomycin at an interval of fourteen days (25 mg per kilogram of live body weight). If any of the above tests should prove positive, the animal shall be removed forthwith from the isolation accommodation. In the case of group isolation, the Competent Authority shall take all necessary measures to re-establish the eligibility of the remaining animals for entry into the collection centre in accordance with this Schedule. (
16. e)2. All tests shall be carried out in a laboratory approved by the competent authority. 3. Animals may only be admitted to the semen collection centre with the express permission of the centre veterinarian. All movements, both in and out, shall be recorded. 4. No animal admitted to the semen collection centre may show any clinical sign of disease on the day of admission. All animals shall, without prejudice to paragraph 5, have come from isolation accommodation as referred to in paragraph 1(
17. a)which, on the day of consignment, officially fulfils the following conditions: (
18. a)is situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least thirty days; (
19. b)has for at least three months been free from foot-and-mouth disease and brucellosis; (
20. c)has for at least thirty days been free from those bovine diseases which are compulsorily notifiable in accordance with Schedule E (II) to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations. 5. Provided that the conditions laid down in paragraph 4 are satisfied and the routine tests referred to in Chapter II have been carried out during the previous ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 17 twelve months, animals may be transferred from one approved semen collection centre to another of equal health status without isolation or testing if transfer is direct. The animal in question shall not come into direct or indirect contact with cloven-hoofed animals of a lower health status and the means of transport used shall have been disinfected before use. If the movement from one semen collection centre to another takes place between Member States it shall take place in accordance with the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations. CHAPTER II ROUTINE TESTS AND TREATMENT WHICH SHALL BE APPLIED TO ALL BOVINE ANIMALS IN AN APPROVED SEMEN COLLECTION CENTRE 1. All bovine animals kept at an approved semen collection centre shall be subjected at least once a year to the following tests and treatment: (
21. i)an intradermal tuberculin test for tuberculosis, carried out in accordance with the procedure laid down in Schedule B to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations, with a negative result; (
22. ii)a serum agglutination test for brucellosis, carried out in accordance with the procedure laid down in Schedule C to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations, giving a count lower than 30 IU of agglutination per millilitre; (iii) a serological test for enzootic bovine leukosis, carried out in accordance with the procedure laid down in Schedule D to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations, with a negative result; (
23. iv)for infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis, a serum neutralization test or an Elisa test with a negative result; (
24. v)either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings; in the case of female animals a vaginal mucus agglutination test shall be carried out. 2. All tests shall be carried out in a laboratory approved by the competent authority. 3. If any of the above tests should prove positive, the animal shall be isolated and the semen collected from it since the last negative test may not be the subject of intra-Community trade. Semen collected from all other animals at the centre since the date when the positive test was carried out shall be held in separate storage and may not be the subject of intra-Community trade until the health status of the centre has been re-established. [ S.L.437.99 18 ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES SCHEDULE III CONDITIONS WHICH SEMEN COLLECTED AT APPROVED CENTRES SHALL SATISFY FOR THE PURPOSES OF INTRA-COMMUNITY TRADE 1. Semen shall be obtained from animals which: (
25. a)show no clinical signs of disease on the day the semen is collected; (
26. b)(
27. i)have not been vaccinated against foot-and-mouth disease; or (
28. ii)come from a centre where all the animals have been fully protected against types A, O and C; - and are thus either animals which, before entering the centre, were not previously vaccinated against foot-and-mouth disease and shall, therefore, have received two doses of inactivated virus vaccine approved and controlled by the competent authority of the exporting Member State at an interval of not less than six weeks and not more than eight months, - or animals which, before entering the centre, were vaccinated on at least three occasions at intervals of not more than one year. When vaccination is practised, all animals shall receive repeat vaccinations at intervals of not more than twelve months; (
29. c)have not been vaccinated against foot-and-mouth disease within thirty days immediately prior to collection; (
30. d)have been kept at an approved semen collection centre for a continuous period of at least thirty days immediately prior to collection of the semen; (
31. e)are not allowed to serve naturally; (
32. f)are kept in semen collection centres which have been free from footand-mouth disease for at least three months prior to collection of the semen and thirty days after collection, and are situated in the centre of an area of ten kilometres radius in which for at least thirty days there has been no case of foot-and-mouth disease; (
33. g)have been kept in semen collection centres which, during the period commencing thirty days prior to collection and ending thirty days after collection of the semen, have been free from those bovine diseases which are compulsorily notifiable in accordance with Schedule E (II) to the Animal Health Problems Affecting Intra-Community Trade in Bovine Animals and Swine Regulations. 2. Antibiotics as listed below shall be added to produce these concentrations in the final diluted semen: not less than: 500 IU per ml streptomycin, 500 IU per ml penicillin, 150 mg per ml lincomycin, 300 mg per ml spectinomycin. An alternative combination of antibiotics with an equivalent effect against campylobacters, leptospires and mycoplasmas may be used. Immediately after their addition the diluted semen shall be kept at a temperature of at least 5°C for a period of not less than forty-five ANIMAL HEALTH CONDITIONS APPLICABLE TO INTRA-COMMUNITY TRADE AND IMPORTS FROM THIRD COUNTRIES OF DEEP-FROZEN SEMEN OF DOMESTIC ANIMALS OF THE BOVINE SPECIES [ S.L.437.99 19 minutes. 3. Semen for intra-Community trade shall: (
34. i)be stored in approved conditions for a minimum period of thirty days prior to dispatch; (
35. ii)be transported to the Member State of destination in flasks which have been cleaned and disinfected or sterilized before use and which have been sealed prior to dispatch from the approved storage facilities. SCHEDULE IV ANIMAL HEALTH CERTIFICATE NO: Country of collection: Competent Authority: I. Identification of semen: Number of doses: Date(
36. s)of collection: Identification of donor animal: Breed: Date of birth: II. Origin of semen: Address of semen collection centre(s): Approval number of semen collection centre(s): III. Destination of semen: The semen will be sent from: (name of consignor) The semen will be sent from: (place of loading) The semen will be sent to: (country and place of destination) The semen will be sent by: (means of transport) Name and address of consignee: IV. I, the undersigned official veterinarian, certify that: 1. the semen described above was collected, processed and stored under conditions which comply with the standards laid down in these rules; 2. the semen described above was sent to the place of loading in a sealed container under conditions which comply with these rules. Done at ............................................ on ........................................... . Signature: Name and qualification (in block letters): Stamp