Department of Agriculture

Directorate Animal Health

Notice No.VPN/31/2009
To:STATE VETERINARY OFFICERS

Subject:Standard for the registration and maintenance of quarantine facilities for collection of bovine / ovine semen and embryos for export.

Content:
Definitions
PART I:Registration process of a semen/embryo collectioncentre for export status
PART II:Standards applicable to semen/embryo exportcollection centre
PART III:Requirements of collection, handling, processing and storage
PART IV: Approval of Embryo Collection Team Leaders
Annex A: Application form for registration with the Directorate Animal Health
Annex B: Inspection report for approval of a collection centre
Annex C: Statement of owner of farm of origin
Annex D:Certificate of origin of donors
Annex E: Health status of donor animals in pre-quarantine
Annex F: Health requirements of donor animals during quarantine
Annex G: Post mortem Record

…………………………………..………………………

Director: Animal Health Date

VPN 31.Semen/embryo export centres.May 2009

DEFINITIONS

For the purposes of this Standard document, the following definitions apply:

Authorised person / means any person authorised to exercise or perform any power or duty, or requested to render any service, by the Controlling Authority.
Controlling Authority / means the authority which is directly responsible for the application of animal health measures.
Identification / means any electronic device (micro-chip), mark or stamp approved by the Controlling Authority and also includes any tag or label bearing a corresponding mark or stamp.
Manager / in relation to a farm includes any person for the time being responsible for the management of the farm.
Official veterinary control / means that the Controlling Authority knows the location of the animals and the identity of their owner or responsible keeper and is able to apply appropriate animal health measures, as required
Owner / means the person in whom the ownership in respect of animal, thing or property is vested.
PSV / ProvincialState Veterinarian
Registered exportembryocollection centre / means an officially supervised agricultural, industrial or commercial undertaking on which embryos are being collected and kept for export.
State Veterinarian
Genetic material (or ‘germ plasm’) / A veterinarian authorised by the Controlling Authority to perform animal health inspections.
Embryos, semen, oocytes, stem cells, or any other cell type which may be used to generate offspring.
Note: The definitions used in the South African Animal Diseases Act (No 35 of 1984) should be used in case of uncertainty.

PART I

REGISTRATION PROCESS OF A SEMEN / EMBRYO COLLECTIONCENTRE FOR EXPORT STATUS

  1. APPLICATION FOR REGISTRATION OF COLLECTION CENTRE FOR EXPORT

1.1All centres for collection of genetic materialmust be registered with the ProvincialVeterinary Services and theDirectorateAnimal Improvement, regardless of whether or not they intend to export genetic material. Centres which intend to export genetic material must additionally be registered for export with the National Directorate Animal Health. The centre must first be registered at the Directorate Animal Improvement and then registered for export at the National Directorate Animal Health.

1.2The owner of the centre or his authorized signatory/person responsible for the management of the centremust apply in writing if he/she wishes to register or re-register a centre with the intent to collect caprine/ovine/bovine embryos for export.

1.3The application form together with the minimum requirements for a veterinary approved facility is obtainable at a regional State Veterinary Office and included in this VPN.

1.4Having acquainted him/herself with the requirements of the VPN, the application must be completed and submitted to the Provincial Executive Officer through the State Veterinarian(s) office in whose area the centre is located.

1.5Only the owner or his authorized signatory/person responsible for the centre may sign the application.

1.6A veterinary official must explain to the owner what the implications are regarding the commitments and obligation the owner undertakes to do/not to do in the application.

  1. OFFICIAL INSPECTION, APPROVAL AND REGISTRATION OF COLLECTION CENTRES

2.1.Having received the application the Provincial State Veterinarian (PSV) or a veterinary official delegated by him/her will inspect the centre for export approval.

2.2.The basis for export approval will be the requirements set by the importing countries as well as the minimum requirements for a veterinary approved facility, as specified in Standards Applicable to Export Facilities in Part II of this document.

2.3.A sketch plan of the centre, indicating camps, pens, restraining and handling facilities, buildings, fences, surrounding structures and activities should be available. Aerial photographs may help in this regard.

2.4.The PSV or the veterinary official delegated by him/her will be responsible for the following actions/procedures:

a)Acquaint himself/herself with the minimum requirements in Standards Applicable to Export Facilitiesfor a veterinary approved facility, as well as other applicable VPN’s.

b)Inspect the centre and complete an inspection report (Annex B) with appropriate comments.

c)If the centre does not comply with the requirements the PSV or the veterinary official delegated by him/her must provide the owner with a report stating the reasons why the centre can not be approved.

d)Arrange for another inspection when the owner notifies the PSV that all the requirements recorded have been met.

e)The PSV or the official delegated by him/her must verify that the centre, animals and biosecurity practices meet the Standards Applicable to Export Collection Centres. Export approval will only be considered if the standards and prescribed management systems are in place.

f)The following forms must be submitted to the National Directorate Animal Health for approval:

  • Annex A – Application form completed by official veterinarian at the centre
  • Annex B – Inspection report completed by official veterinarian at the centre
  • Site plan of the centre, indicating donor camps, fences, gates, pre-quarantine area, surrounding structures and neighbouring activities
  • Detailed plan of the centre, particularly the collection area, laboratory and related buildings.
  • A copy of the registration certificate from the Registrar of Animal Improvement
  • A copy of the registration certificate of the Team Leader

g)The National Directorate Animal Health will evaluate the information supplied and, if it meets the required standard, a registration certificate will be issued.

h)The registration certificate will be sent to the PSV, who will keep a copy thereof and provide the original certificate to the owner of the centre.

i)The PSV must keep record of all documents relating to the registration of centres on file.

j)The PSV must recommend de-listing ofcentres that no longer comply with the requirements for a veterinary approved facility following the same procedure. Notification of such de-listing must be sent to the Provincial Director and the National Director Animal Health.

  1. LISTING OF REGISTERED COLLECTION CENTRES

3.1.All approved centres must be listed by the PSV for his/her area. The PSV must notify the Provincial Director of each new centre registered, who will keep a central database for all centres registered in the province.

3.2.The list and notification to the Provincial Director must (as a minimum) contain the following information for each registered centre:

  • Registration number
  • Name of owner
  • Name of centre
  • Postal address
  • Telephone number
  • Fax number
  • Province
  • District
  • Map co-ordinates
  • Current registration date (void if de-listed)
  • Expiry date of export approval

3.3.The National Director Animal Health will maintain a National database of registered semen/embryoexport centres.

3.4.The registration of a centre is not transferable to new management or between different centres under control of one management.

3.5.The approval is subject to the maintenance of prescribed standards. The Provincial State Veterinarian may at any time cancel approval if the centre does not conform to export requirements and must inform the owner /manager of the centre in writing.

4.MAINTENANCE OF EXPORT REGISTRATION

4.1.At least one inspection report per centre per annum must be submitted by the Provincial State Veterinarian to the National Directorate Animal Health to maintain registration and listing.

4.2 The PSV must determine the frequency of additional inspections based on the animal health status in the Province or the area, as well as his/ her previous findings on the centre in particular. At least four visits per annum should be conducted. Regular documented visits by private practicing veterinarians must be encouraged.

4.3 Centres that no longer comply with the requirements for an export registered centre must be de-listed following the same procedure and the owner/manager of the centre must be informed in writing.

4.4 Applications for annual re-registration must reach the National Directorate Animal Health before the expiry date of the previous registration certificate. Failing this, the centre will be de-listed.

4.5 It is the responsibility of the manager/owner of the centre to contact the state veterinarian timeously in order to do the annual re-inspection.

PART II

STANDARDS APPLICABLE TO EXPORT COLLECTION CENTRES

A:REQUIREMENTS FOR THE APPROVAL OF COLLECTION CENTRES

A1:STRUCTURAL REQUIREMENTS

1.1The premises must not be under any veterinary restrictions and must not be situated in an infected zone, created for the following diseases:

In the case of cattle:Foot and Mouth Disease, Vesicular Stomatitis, Rinderpest, Contagious Bovine Pleuropneumonia, Brucellosis, Tuberculosis, Paratuberculosis, BSE

In the case of pigs: Foot and Mouth Disease, Rinderpest, Swine Vesicular Disease, African Swine Fever, Classical Swine Fever and Enterovirus encephalomyelitis.

In the case of sheep and goats:Foot and Mouth Disease, Rinderpest, Peste des petits Ruminants and Sheep and Goat Pox

1.2The centre must be suitable isolated to ensure that continued health status of the donor herd. Any adjacent animal holdings should only house animals of an acceptable disease status and these animals should not pose a significant threat to the health status of the animals in the export centre. Care should be taken to ensure that fluid run-off from pens with different/lower disease status does not drain through quarantine pens.

1.3The entire centre must be enclosed in a 1,8 meter high animal proof fence and an additional fence to create an animal free zone of at least 3m wide around the facility. There must be only one entrance with lockable gates, which are locked when not in use.

1.4Donor isolation camps, which consist of facilities conducive to humane housing and handling of the species concerned, must be provided. This area must be dedicated to the donor herd only and must be constructed so that contact with animals of a lesser health status is prevented.

1.5There must also be a separate area where animals can be kept in pre-quarantine with facilities to isolate animals of different health status. This must preferably be outside the perimeter fence, or if inside, it must have separate handling facilities and personnel and must be separated from the donor camps by at least 2 barriers and a 3m animal free zone. In cases where there are no animals resident in the donor camps, the donor camps can also be used for pre-quarantine and a separate area will not be required.

1.6There must be a dedicated semen and/or embryo collection area, complete with the necessary handling facilities. Such an area must be washable and protected from the weather.

1.7There must be a laboratory, mobile or permanent in nature, which is separated from the collection area, so as to prevent entry by collection personnel into the laboratory. There must be closable hatch through which to pass semen and/or embryos. All surfaces in the laboratory must be impermeable and washable.

1.8A washing and sterilisation area for equipment should be provided, separate from the laboratory, with all surfaces impermeable and washable.

1.9Changing and ablution facilities must be provided for personnel.

1.10An office must be available for the storage and production of records and any other necessary paperwork.

1.11There must be a Quarantine Notification Sign on the entrance to the facility.

A2: MANAGEMENT REQUIREMENTS

2.1 The site and location must be approved by the National Directorate of Animal Health. A plan, indicating surrounding structures and a detailed plan of the centre must accompany the application for approval, as well as this form completed by either the Provincial State Veterinarian or an inspector from the National Directorate Animal Health.

2.2The centre must also be registered with the Registrar of Animal Improvement in terms of current legislation (Act 25 of 1977 or Act 62 of 1998).

2.3The facility must have a documented specie specific insect and rodent control program.

2.4All donor animals must be individually identified and recorded in a register. All dates of arrival, certificate of origin, treatment dates, illness and/or death dates and details as well as departure dates must be recorded. All deaths must be submitted for post mortem by a veterinarian and the results recorded.

2.5All donor animals must arrive with Certificates of Origin, attesting to the health status of the herd of origin. This certificate must also stipulate the residency period within the herd of origin. This certificate may be issued by the state veterinarian or private veterinarian at the farm of origin. The herd of origin may also not be within an infected zone, created for the diseases listed in paragraph 4. This must be confirmed by the state veterinarian completing this inspection report.

Exceptions to this requirement can be made:

a)Where the farm of origin is in the same state veterinary area as the centre.

b)Where the protocol of the importing country do not require statements regarding the farm of origin

2.6All certificates and records must be made available to the Provincial Official Veterinarian, as well as any other authorised inspector.

2.7The management of the facility must be evaluated by the state veterinarian to confirm that they understand the concept of biosecurity and that the necessary disease control measures will be applied at the centre.

2.8The centre must be inspected on a quarterly basis by a State Veterinarian. A report for re-registration must be submitted on an annual basis. The onus to arrange timeously for inspection for re-approval rests with the owner.

2.9The owners ofartificial insemination facilities and/or collection facilities are ultimately responsible for the genetic quality of the semen and embryos sold.

B.RESPONSIBILITIES OF INVOLVED PARTIES

B.1OBLIGATIONS AT THE FARM(S) OF ORIGIN

B.1.1ACCOUNTABILITY OF OWNERS OF FARMS OF ORIGIN

1.1.1Owners of farms of origin, of the semen/embryo donors, are responsible for the health status of the flock/herd on their farm,because only they can guarantee exactly what was brought from where.

1.1.2The integrity of the owners and/or managers of farms of origin are essential to the whole process of quality assurance for export germ plasm. The responsible person at the farm of origin must undertake in writing to comply with the clauses in Annex C.

B.1.2DUTIES OF PRIVATE VETERINARIANS AT FARMS OF ORIGIN

1.2.1The private veterinarian at the farm(s) of origin is responsible to verify the health status of the flock/herd during the last 5 years (if flock/herd has not been in existence for this long then the health status of the origins must be investigated.), paying particular attention to insidious diseases like Tuberculosis and Brucellosis. This verification process should at least involve the following:

  • obtaining a detailed flock/herd history from the responsible person/owner of the farm
  • analysis of the reasons given for stock losses in the stock register
  • revision of post mortem results
  • cross checking diagnoses made with the veterinarian who was supposedly

responsible for the diagnosis

  • establishing the safety, origin and residency period of all new introductions
  • observation of the general clinical appearance of the flock/herd and hygienic

standards applied on the farm.

1.2.2All potential donors should be clinically examined for any signs of disease, heredity defects or gross pathology of the genital organs. Only donors free of the above symptoms should be selected for use in semen and embryo programs.

1.2.3The veterinarian must ensure all tests and treatments required by the export centrefor the farm of origin are performed on these identified and selected potential donors.

1.2.4 Sections A – D of Annex D must then be certified by the private veterinarian.

B.1.3:OBLIGATIONS OF THE OFFICIAL VETERINARIAN AT THE FARM OF ORIGIN

1.3.1This official veterinarian will usually work for the local Veterinary Authority. The main responsibility of this veterinarian is to endorse the certification of the private veterinarian. The farm of origin and the surrounding area of 50 km must be certified free from notifiable diseases to which the species in question is susceptible.

1.3.2In order to do this, the official veterinarianmust apply official veterinary controlat the farmand promote active surveillance of notifiable diseases in his/her area. This surveillance includes annual Tuberculosis and Brucellosis testing. The Tuberculosis and Brucellosis status of the flocks/herds of origin must be known, only then can Section E of Annex D be certified.

B2:OBLIGATIONS AT THE SEMEN/EMBRYO COLLECTION CENTRE

B.2.1OBLIGATIONS OF THE PRIVATE VETERINARIAN (TEAM LEADER) AT THE CENTRE

2.1.1A centre must have a private veterinarian responsible for all aspects of disease control at that facility. This Veterinarian must be registered as a Team Leader and he/she is responsible to perform certain functions with respect to quality assurance of semen and embryos for export. In terms of the Code and IETS guidelines for embryo trade this is the status described by the term “team veterinarian”.

2.1.2The embryo collection team leadermust:

a)Have an accurate and detailed knowledge of the protocols prescribed by the countries to which the commodity is going to be exported. This knowledge must be used to identify the most stringent protocol clauses and include these in the requirements which must be certified in addition to those already stipulated in Annex F of this document.

b)Develop and commit to writing management procedures for the facility. These management procedures must ensure all animals in the quarantine section of the facility have the same health status, unless the facility is big enough to have separate units catering for specific countries. The management procedures must be organized so as to facilitate auditing by official veterinarians responsible for certification.