SUNDHEDSCERTIFIKAT / HEALTH CERTIFICATE for eksport af in vivo opsamlede kvægembryoner fra MKS-frit EU-medlemsstat til USA for export of in vivo derived bovine embryos from FMD-free Member States of the European Union to the United States of America Certifikatnummer (1): / Importtilladelsesnummer:/ Import permit number: Afsenderland:/ Exporting country: DANMARK DENMARK Kompetent ministerium:/ Competent ministry: MINISTERIET FOR FAMILIE- OG FORBRUGERANLIGGENDER/ MINISTRY OF FAMILY AND CONSUMER AFFAIRS Kompetent central myndighed:/ Competent central authority: FØDEVARESTYRELSEN/ THE DANISH VETERINARY AND FOOD ADMINISTRATION Kompetent udstedende myndighed:/ Competent issuing authority: I EMBRYONERNES OPRINDELSE / ORIGIN OF THE EMBRYOS 1. Embryon teamets godkendelsesnr.:/ Approval number of the embryo collection team: 2. Navn og adresse på embryo opsamlingsteamet:/ Name and address of the embryo collection team: La 23,0-1831 Page 1 of 6 USA 06-2007
3. Afsenders navn og adresse:/ Name and address of consignor/ 4. Medlemsstat, hvor embryonerne er opsamlet:/ Member State where embryos were collected: 5. Transportmiddel:/ Means of transport: (Angiv antal vogne, lastbiler, fly-nummer, navn på skib/ Specify the number of wagons, trucks, flight-number, name of ship) II EMBRYONERNES BESTEMMELSESSTED / DESTINATION OF EMBRYOS 1. Modtagerens navn og adresse:/ Name and address of consignee: 2. Indgangsstedet i USA:/ Port of entry into the United States: III IDENTIFIKATION AF EMBRYONERNE / IDENTIFICATION OF THE EMBRYOS 1. Mærkning af strå (frysekode):/ Identification of straws (freeze code): ID nr. på strå:/ ID# on straws: ID nr. på moderdyr / ID nr. på tyr:/ ID# of dam / ID# of sire: Moderdyrets race / Tyrens race:/ Breed of dam / Breed of sire: Opsamlingsdato:/ Date of embryo collection: Antal strå:/ Number of straws: Om nødvendigt fortsættes der på et vedlagt skema, der er underskrevet og stemplet af embedsdyrlægen eller en godkendt dyrlæge/ Continue if necessary on an attached schedule signed and stamped by the official or approved veterinarian. La 23,0-1831 Page 2 of 6 USA 06-2007
2. Containerens plombe nummer: / Seal number of container: IV SUNDHEDSOPLYSNINGER / HEALTH INFORMATION SEKTION A / SECTION A Jeg, undertegnede embedsdyrlæge i Danmark attesterer herved, enten via egne undersøgelser eller baseret på supplerende dokumentation fra teamdyrlægen på det godkendte embryoopsamlingsteam, at:/ I, the undersigned Official Veterinarian of Denmark certify, based on own observations or supporting documentation from the approved Team Veterinarian of the described embryo collection team, that: 1. I 12 måneder forud for opsamlingen af embryonerne til eksport til USA var der ingen kliniske eller patologiske tegn på brucellose eller tuberkulose (TB) hos donor køerne eller på nogle af de lokaliteter, hvor donor køerne befandt sig i denne tidsperiode/ During the 12 months prior to the collection of embryos for export to the United States, there was no clinical or pathological evidence of brucellosis or tuberculosis (TB) found in the donor dams or on any premises on which the donor dams were located during that time. 2. I 60 dage forud for opsamlingen af embryoner til eksport til USA var donor køerne ikke i fold, på græs eller holdt sammen med dyr med lavere sundhedsstatus eller under restriktioner, som kunne gøre dem uegnede som embryo donorer for eksport til USA/ During the 60 days prior to the collection of embryos for export to the United States, the donor dams were not corralled, pastured, or held with animals of lesser health status or under any restrictions which would make them ineligible as embryo donors for export to the United States. 3. I 60 dage forud for opsamlingen af embryoner til eksport til USA blev donor køerne inspiceret mindst én gang og fremstod sunde og blev fundet klinisk fri for smitsomme eller anmeldepligtige sygdomme/ During the 60 days prior to the collection of embryos for export to the United States, the donor dams were inspected at least once and appeared healthy and were found clinically free of contagious or communicable diseases. 4. Hver donor blev undersøgt på dagen, hvor embryonerne blev opsamlet, og fremstod sunde og var klinisk fri for smitsomme eller anmeldepligtige sygdomme/ Each of the donors were examined on the day of embryo collection and appeared healthy and were clinically free of contagious or communicable diseases. 5. Donor køerne stammer fra flokke, der officielt er fri for tuberkulose/ The donor dams originated from herds officially free of tuberculosis. 6. Sæden, anvendt til befrugtning af embryonerne til eksport til USA, blev opsamlet på et godkendt tyrestation i overensstemmelse med gældende lovgivning, især Rådets direktiv 88/407/EØF med senere ændringer. På tidspunktet for opsamling af sæden, var medlemsstaten, som sæden blev opsamlet i, betragtet af USDA som værende fri for mund- og klovesyge samt kvægpest, som angivet i Title 9 Code of Federal Regulations, Part 94 og andre officielle publikationer/ La 23,0-1831 Page 3 of 6 USA 06-2007
The semen used to fertilize the embryos for export to the United States was collected in an approved semen collection centre (SCC), in accordance with legislation in force, notably Council Directive 88/407/EEC, as amended. At the time of collection of the semen, the Member State in which the semen was collected was considered by the USDA to be free of foot-and-mouth disease and rinderpest, as listed in Title 9 Code of Federal Regulations, Part 94 and other official publications. 7. Embryonerne blev opsamlet med brug af et lukket opsamlingssystem, og ethvert instrument, der kom i kontakt med reproduktionsorganer, væv eller væsker, var enten nyt eller steriliseret før brug/ The embryos were collected using a closed collection system, and any instrument coming in contact with reproductive tract tissue or fluids was either new or equipment sterilized before use. 8. Embryonerne blev vasket mindst 10 gange og behandlet med trypsin i overensstemmelse med sidste udgave af Manual of the International Embryo Transfer Society. Efter sidste vask undersøges hele overfladen af hvert embryo mikroskopisk med ikke mindre end 50x forstørrelse. Zona pellucida på hvert embryon blev fundet intakt og fri for vedhængende materiale efter vask/ The embryos were washed at least 10 times and treated with trypsin in accordance with the latest edition of the Manual of the International Embryo Transfer Society. After the last wash, each embryo was examined microscopically over its entire surface at not less than 50x magnification. The zona pellucida of each embryo was found to be intact and free from any adherent material subsequent to washing. 9. Embryoner fra forskellige donorer blev ikke vasket sammen/ Embryos from different donors were not washed together. 10. Containere til lager og transport var rene, for nylig desinficerede, og tomme forud for anvendelsen i dette projekt, og kun frisk flydende nitrogen er blevet brugt/ The storage and shipping containers were clean, recently disinfected, and empty prior to use for this project, and only fresh liquid nitrogen has been used. SEKTION B / SECTION B 11. Medlemsstaten, i hvilken embryonerne er opsamlet, er af USDA betragtet som værende fri for mundog klovesyge (MKS) og kvægpest som angivet i Title 9 Code of Federal Regulations, Part 94 og andre officielle publikationer, og var fri for disse sygdomme på tidspunktet for embryoopsamlingen/ The Member State in which the embryos were collected is considered by the USDA to be free from foot-and-mouth disease (FMD) and rinderpest as listed in Title 9 Code of Federal Regulations, Part 94 and other official publications, and was free of these diseases at the time of embryo collection. 12. Medlemsstaten, i hvilken embryonerne er opsamlet, er fri for oksens ondartede lungesyge/ The Member State in which the embryos were collected is free from contagious bovine pleuropneumonia. La 23,0-1831 Page 4 of 6 USA 06-2007
13. Donorkøerne var en del af kvægpopulationen i medlemsstaten, i hvilken embryonerne er opsamlet, i mindst 60 dage forud for opsamlingen og var fri for enhver flytning eller karantæne restriktion/ The donor dams were part of the national herd of the Member State in which the embryos were collected for a minimum of 60 days prior to collection and were free from any movement or quarantine restrictions. 14. Embryonerne blev opsamlet fra levende kvæg med dokumenteret sundhedshistorie og behandlet i overensstemmelse med standarderne i The International Embryo Transfer Society (IETS) af et embryoopsamlingsteam godkendt af den kompetente myndighed i medlemsstaten i overensstemmelse med gældende EU lovgivning, især Rådets direktiv 89/556/EØF med senere ændringer/ The embryos were collected from live cattle of documented health history and processed in accordance with the standards of the International Embryo Transfer Society (IETS) by an embryo collection team approved by the competent authority of the Member State in accordance with EU legislation in force, notably Council Directive 89/556/EEC, as amended. 15. Alle diagnostiske undersøgelser af donor køerne og tyrene blev foretaget i laboratorier godkendt af Veterinærinstituttet til at varetage sådanne tests til eksport/ All diagnostic testing of the donor dams and sires were conducted in laboratories approved by the National Veterinary Institute to conduct such tests for export. 16. Bestanddele af animalsk oprindelse, som er tilsat mediet, stammer fra lande, der af USDA betragtes som fri for mund- og klovesyge og kvægpest. Trypsin af svineoprindelse stammer fra lande, der af USDA betragtes som fri for mund- og klovesyge, kvægpest, klassisk svinepest og afrikansk svinepest som anført i 9 CFR Part 94 og andre officielle publikationer. (www.aphis.usda.gov/vs/ncie/countries)/ All media additives of animal origin were sourced from countries considered by the USDA to be free from FMD and rinderpest. Trypsin of porcine origin was sourced from countries considered by USDA to be free from FMD, rinderpest, classical swine fever and African swine fever as listed in 9 CFR Part 94 and other official publications. (www.aphis.usda.gov/vs/ncie/countries). 17. Embryonerne var opbevaret under lås og slå eller i forvaring af teamdyrlægen fra embryoopsamlingsteamet, indtil de bliver forseglet til direkte transport til USA/ The embryos were maintained under lock and key or in the custody of the embryo collection team veterinarian until being sealed for direct transport to the United States. La 23,0-1831 Page 5 of 6 USA 06-2007
V ATTESTERING / CERTIFICATION Udfærdiget i/ Done at: Dato/ Date: Officielt stempel (2) / Official stamp (2) : Embedsdyrlægens underskrift (2) / Signature of the veterinary officer (2) : 1. Navn med blokbogstaver/ Name in block letters: 2. Embedsdyrlægens adresse/ Address of Official Veterinarian: (1) Certfikatnummeret skal anføres på alle certifikatets sider / The certificate number must be applied on all the pages of the certificate. (2) Certifikatet skal stemples og underskrives i en anden farve end det trykte / The certificate must be stamped and signed in colour different to the printing. Noter / Notes: (a) Et separat certifikat må laves for hver forsendelse af embryoner / A separate certificate must be issued for each consignment of embryos. (b) Originalen af dette certifikat skal ledsage transporten / The original of this certificate must accompany the shipment. La 23,0-1831 Page 6 of 6 USA 06-2007