Certification Procedure to Export Embryos

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TAHD-DSAT-IE-2008-1-3
February 21, 2013

Amendments: Minor edits in 7.4, 7.5 and in the Declaration at the end of the document.

Background

Veterinarians who collect embryos for export must be approved by the Canadian Food Inspection Agency (CFIA) according to the Embryo Export Approval Program (EEAP). These approved embryo team (ET) veterinarians are inspected twice a year by specially trained CFIA officers. During inspection, along with other verification, embryo storage, records and document procedures are audited for conformity with the EEAP. Approved ET veterinarians have access to a CFIA secure website application to complete online embryo export certificates. In March 2007, the European Union (EU) conducted an audit concerning bovine embryos exported to the EU; the auditors found that some certification procedures were not acceptable according to international and European standards and recommended changes when embryos are moved within Canada to be exported from a central shipping location. The Canadian Embryo Transfer Association (CETA) also asks the CFIA to ensure that certification procedures are similarly applied throughout Canada. The purpose of this directive is to clearly define the procedures that shall be followed when embryos are presented to the CFIA for export certification.

The following procedures apply to all destinations for embryos exported from Canada.

Note: When an embryo shipment leaves directly for a destination country from an approved initial storage facility of an ET veterinarian, only one copy of the certificate is prepared by the EEAP veterinarian and presented for endorsement to the local district office at the time of shipment. In this case, appropriate procedures should be selected from the information mentioned below. "Approved initial storage facility" is defined as a permanent storage facility approved by the CFIA where an approved ET veterinarian stores frozen embryos after collection.

1. Use of Appropriate Version and Format of the Export Certificate

The approved ET veterinarian is responsible for verifying with the CFIA the validity of the certificate he or she intends to use. When a new version of an export certificate is validated, it may take up to five working days to have the new certificate template available on the CFIA; secure website, but district offices are immediately advised when a new version is validated. There are embryo export certificates for more than 85 destination countries, and each of them has its own particularities and restrictions. Embryo export certificates must be printed on legal-size paper (8.5 x 14) for presentation to the CFIA. Other certificate formats are not endorsed by the CFIA.

2. Completion of the Certificate by the approved ET Veterinarian

The approved ET veterinarian must complete two copies of the export certificate. One copy is endorsed at the CFIA local district office, while the second one, which is not dated, not signed and not stamped by the CFIA local district office, is used when the shipment is finalized at the shipping point. Appropriate sections of the export certificate should be completed by the ET veterinarian, but some information linked to the final shipment may be absent or incomplete.

The sanitary qualification of the herd and the donor cow is the responsibility of the ET veterinarian: this means confirmation of the absence of diseases mentioned on the certificate for the herd of origin or the collection site. The ET veterinarian is responsible for all diseases except those under the control of the CFIA, such as exotic and reportable diseases. The donor cow must fulfil all requirements mentioned on the certificate; test results must be available if they are required. All procedures with relation to the collection, processing, examination, freezing and storage of embryos are the responsibility of the ET veterinarian. The qualification of the semen used to inseminate the donor cow is also the responsibility of the ET veterinarian, including appropriate documentation, if needed. When a deletion is required concerning a statement under his or her responsibility, the ET veterinarian should make the appropriate deletion and initial it, unless otherwise mentioned on the certificate.

The copy of the certificate presented to the CFIA local district office for endorsement must disclose the following supplementary information. This information must not be recorded on the second copy of the certificate that will be used for the final shipment:

  1. the identification of the container used to transport the embryos from the CFIA-approved initial storage facility under the responsibility of the ET veterinarian to the shipping point; and
  2. the private seal number affixed by the ET veterinarian to this transport container. When the transport container is physically moved by the ET veterinarian or his or her staff from the approved initial storage facility to the shipping point, there is no obligation to use a private seal, but the following statement must be recorded on the certificate: "Direct supervised transport."

If there is no specific location on the certificate to disclose this information, it can be placed anywhere on the certificate presented to the CFIA local district office for endorsement. This information is required to maintain the traceability of embryo movements from an approved initial storage facility and to confirm the maintenance of export eligibility of embryos.

3. Minimal Documentation to Be Presented by the ET Veterinarian to the CFIA Local District Office

The copy disclosing information about the transport container and the private seal number is sent by the ET veterinarian to his or her CFIA local district office (defined as the district office of residence of the approved veterinarian) for endorsement. When the certificate does not have a section for the signature of the ET veterinarian, the endorsing district office should request a copy of the certificate signed by the ET veterinarian in order to support the CFIA endorsement.

At the minimum, the following documents must be presented to the local district office by the ET veterinarian in order to obtain endorsement. A copy of these documents must be kept on file by the endorsing district office:

  1. a completed and signed export certificate, as mentioned above;
  2. an embryo collection data document (dam, sire, collection date, number of embryos collected, etc.);
  3. documentation about the semen used, as per the conditions mentioned on the export certificate, if needed; and
  4. a copy of tests performed on donor cows, if tests are required by the certificate.

Note: The ET veterinarian should contact the district office when certification for a new destination is considered; CFIA staff should consult the certificate status page, as specific information about semen eligibility may be available.

4. Verification of the Certificate by the CFIA Local District Office

The local district office verifies the documentation presented and ensures it is complete. Certificates not properly completed should be returned to the ET veterinarian for correction. The local district office is responsible for the confirmation of export requirements mentioned on the certificate that are under the control of the CFIA, such as country and herd freedom of certain regulated diseases (for example, FMD, rinderpest, rabies, anthrax, TB, BR, BT) and other specific official requirements, if required (for example, absence of quarantine measures when embryos were collected). This information is available either at the local district office or at another CFIA district office, depending on where the embryo collection took place. It is the responsibility of the local district office to verify this information before the export certificate is endorsed and to keep it on file for future reference and audit. The verification may also include confirmation of the semen used and appropriate testing, if required by the certificate. Appropriate deletion and initialling on the export certificate in relation to regulated diseases or situations must be done by the CFIA local district office, including statements already crossed out by headquarters on template certificates, if any.

5. Endorsement by the CFIA Local District Office

When verification has been completed by the local CFIA district office, a reference number is given to the certificate that is then dated, endorsed and stamped. The certificate is signed uniquely on the last page, unless otherwise indicated on the certificate (for example, Australia). The export stamp is applied to all pages of the certificate. A photocopy of the endorsed embryo export certificate must be kept on file by the endorsing district office along with the supporting documentation. The fees are invoiced by the CFIA local district office; fee codes 1486 to 1489 are applicable. The endorsed certificate is returned to the ET veterinarian. This endorsed export certificate is not sent to Ottawa for statistical purposes, as this certificate is considered only a pre-certification document.

6. Movement of Embryos and Certificates to the Shipping Point

The ET veterinarian sends the certificate endorsed by his or her local district office and the second copy that is not dated, not signed and not stamped by the CFIA (refer to section 2 above) to the shipping point along with the embryos to be exported. The "shipping point" is defined as the location where the embryos are finally inspected by the CFIA and the shipping container sealed with an official CFIA seal before leaving Canada. The transport of embryos within Canada from a CFIA-approved initial storage facility to a shipping point is under the responsibility of ET veterinarians who must take appropriate transport control measures, either by the use of a private seal placed on transport containers, or by the ET veterinarian or his or her staff maintaining direct control of transport containers during movement. Embryos for export must always remain under the control of an approved ET veterinarian at the shipping point. When a specialized organization is involved in the preparation of an embryo shipment, the location where embryos are prepared for the shipment must be under the supervision of an ET veterinarian. The ET veterinarian responsible for the embryo shipment at a shipping point is also responsible for the final certification of embryos.

7. Finalization of an Embryo Shipment

The information about transport containers and private seals used to move embryos from CFIA-approved initial storage to the shipping point must be maintained by the approved ET veterinarian responsible for the final shipment. This ET veterinarian is responsible for storing embryos to be exported in an approved storage facility. He or she is also responsible for gathering appropriate certification for presentation to the CFIA for the final shipment. The shipping container must be under his or her control. When the shipment is ready to be finalized, the ET veterinarian responsible for the embryo shipment must contact his or her CFIA district office to inform them of an upcoming embryo shipment. A veterinarian of the CFIA district office must go to the shipping point and work with the ET veterinarian to finalize the embryo shipment.

7.1 Documentation Required and Inspection Modalities

The ET veterinarian must present to the CFIA district office both copies of each embryo certificate. The ET veterinarian responsible for the shipping point must provide an embryo movement declaration document showing embryo movement from the initial approved storage to the shipping point. This document ensures the maintenance of export eligibility of embryos when they are moved within Canada for export purposes. The ET veterinarian must have the shipping container, an appropriate source of liquid nitrogen, and appropriate equipment and material needed for the inspection, according to the instructions from the CFIA district office. The ET veterinarian must be present during the container inspection or have delegated one of his or her staff trained in the sanitary manipulation of straws.

7.2 Verification of the Shipping Container

The CFIA district office must confirm that the shipping requirements mentioned on the certificate are fulfilled, such as the use of new or cleaned and disinfected shipping containers and the qualification of liquid nitrogen used for shipment. The examination of the empty container and its filling with liquid nitrogen is at the discretion of the CFIA inspector. The content of the shipping container should be verified according to the certificates previously signed by the CFIA and presented by the ET veterinarian; it is recommended that 10% of straws be verified with the help of the ET veterinarian, but the final decision belongs to the CFIA district veterinarian responsible for the shipment. CFIA staff are not allowed to manipulate straws; all manipulations must be done by the responsible ET veterinarian or his or her staff. After verification, the CFIA veterinarian affixes an official seal to the shipping container.

7.3 Completion of Final Export Certificates

The CFIA veterinarian responsible for the shipment completes each second copy of the certificate mentioned in point 2 above (the one that is not dated, not signed and not stamped) with information concerning the shipping container and official seal number, and uses the same reference number. The CFIA district office may require that this completion be done by the ET veterinarian or his or her staff. Appropriate deletion and initialling on each certificate must be done by the CFIA veterinarian responsible for the shipment, as per the copy of the certificate previously endorsed by the CFIA local district office. It is imperative that final export certificates are properly completed and appropriate deletion and initialling done.

7.4 Endorsement of Final Export Certificates

The CFIA veterinarian responsible for the shipment dates the certificates with the date of inspection of the shipping container, and signs and stamps the final certificates that will accompany the shipment to the destination country. All certificates for embryos included in the shipment container must bear the same date (that is, the final inspection date), and be signed by the CFIA official veterinarian who supervises the final shipment and affixes the official seal to the shipping container. The embryo movement declaration document showing embryo movement from the initial approved storage to the shipping point prepared by the ET veterinarian responsible for the shipment is stamped by the CFIA. When the destination country requires this embryo movement declaration document, the original document is attached to the final export certificates sent along with the embryo shipment. When the destination country does not require the embryo movement declaration document, this document is kept at the final district office. No fee can be invoiced for this final inspection of the shipping tank and issuance of final certificates, as fees have already been invoiced.

7.5 Documentation Retained by the CFIA District Office Responsible for the Shipping Point

The certificates endorsed by the local CFIA district office in point 5 above are retained by the CFIA district office responsible for the shipping point for verification and audit purposes, along with a photocopy of the final export certificate issued and the original or a photocopy of the embryo movement declaration document. A photocopy of the final export certificates is sent to the Terrestrial Animal Health Division (TAHD), Ottawa, for the purpose of collecting export statistics; this information is further included in an export database using the exact number of embryos exported and export date.

8. Consolidation of Export Certificates

Some destination countries allow for consolidation of embryo export certificates. "Consolidation" is defined as the preparation of a new certificate based on previous export certificates issued by CFIA local district offices. When a destination country accepts this procedure (ex: European Union), the ET veterinarian responsible for the shipment may prepare a consolidated export certificate using certificates previously signed by the CFIA. When consolidated certification is used, the CFIA district office responsible for the shipment must be presented with this consolidated certificate along with supporting documentation before or at the time of the finalization of the embryo shipment. (Refer to point 7 above.) A fee applies when a consolidated certificate is presented to the CFIA for endorsement, as this is a new certificate.

9. Certification Flaws

If a question arises from a certificate issued by a local district office, contact should be made immediately to obtain appropriate information through the area export specialist. The area export specialist should follow up with local district offices if they are located in his or her area, or refer to the export specialist of other areas. When appropriate information is not available on time for the shipment, embryos must be removed from the shipment and kept under the control of the ET veterinarian responsible for the shipment. If embryos certified by local CFIA district offices are not included in a shipment, these embryos may be returned under private seal by the ET veterinarian to initial storage with appropriate documentation, or they may be kept in a CFIA-approved storage facility by the ET veterinarian responsible for the shipment for future export. Recurring certification flaws should be communicated to the attention of the TAHD, Ottawa, for appropriate follow-up.

The procedures outlined above must by applied to all embryo shipments, destined to any country. According to international standards applying to semen and embryos, a shipment must be certified by the last official veterinarian in control of the shipment, and official certification must be issued by this official veterinarian on the day that the shipping container is inspected and sealed.

Embryo Movement Declaration From an Initial Approved Storage Facility to an Approved Shipping Point
Export to (insert name of destination country)

Note: This list must be attached to the final shipment documentation provided by the ET veterinarian responsible for the shipping point. This document summarizes movement in Canada of embryos included in the shipment from their initial storage to the shipping point. This document is prepared by the approved Embryo Team veterinarian responsible for the final shipment, and stamped by the CFIA when the shipment is finalized. Embryos shipped directly from the initial storage facility must not be included in this list.

Embryo Permit Number (if any):

Name of Embryo
Collection Team
Name and ET Code of Approved Embryo Collection Team Veterinarian Transfer Date Reason for Transfer Certificate/Document Reference Number Transport Container Serial Number Seal Placed on Container

The embryos suitable for export listed above and coordinated by (insert name of exporter) were identified and stored until export within a storage facility approved by the Canadian Food Inspection Agency (CFIA). All embryos were received and transferred within this approved facility and placed in the shipping tank indicated below at the time of final shipment. Only new liquid nitrogen was added to the shipping tank.

Shipping Tank Identification:

Approved Embryo Team Veterinarian Responsible for the Final Shipment:

Name & ET Code:

Signature:

Date:

Date modified: