Key Benefits:
Minister of Agriculture and Fisheries,
Having regard to Council Directive 90/426/EEC of 26 June 1990 on health police conditions governing equine movements and imports of equinees from third countries;
In light of Directive 92/65/EEC of 13 July 1992 defining the conditions of health police governing trade and imports in the Community of Animals, Semen, UFOs and Unsubmitted Embryons, with respect to sanitary police conditions, to the specific EU regulations referred to in Annex A, section 1, of Directive 90/425/EEC;
In view of Book II of the Rural Code, including articles L. 222-1, R. 222.1 to D. 222-5 and R. 222.11;
See?3 May 1994 relating to health police conditions governing intracommunal equine movements and exchanges;
Considering the opinion of the French Food Safety Agency dated 20 March 2007;
Based on the advice of the Animal Health and Protection Advisory Committee dated December 14, 2006,
Stop it!
For the purposes of this Order, the following means:
sperm: the ejaculate of an equine, in the state, prepared or diluted;
- approved sperm collection centre: an officially approved and controlled facility, referenced by a veterinary registration number, in which the semen collection, treatment, conditioning and storage operations for the national market or intra-community exchanges for artificial insemination are carried out;
centre veterinarian: the health veterinarian responsible for animal health monitoring;
- dose: individual conditioning unit, glitter, bottle or any other container containing the sperm of a single donor stallion;
― implementation: female insemination activity.
Is considered to be a registered veterinarian responsible for the collection centre within the meaning of theArticle R. 222-1 of the Rural Code the veterinarian in the establishment department of the health mandate collection centre articles R. 221-4 to R. 221-16 of the rural code and designated by the head of the collection centre to monitor the health of the animals in the centre.
A health approval for placing on the national sperm market or for intra-community sperm exchange is granted by the prefect to the sperm collection centres that comply with the provisions of Annex I to this Order.
Health approval is granted after verification by the departmental director of veterinary services of the conformity of the centres to the sanitary conditions required according to the destination of the collected sperm (national market or intra-community exchange).
Each collection centre thus approved receives a unique registration number issued by the prefect.
The prefect informs the Minister for Agriculture (General Directorate of Food) of the awarding of any new approval of semen collection center by specifying the nature of the approval granted.
In order to apply for medical approval, the head of the centre shall apply to the departmental director of veterinary services with:
- the name or social reason of the centre, the precise address of the establishment and the exact nature of the planned operations;
a commitment to comply with the terms of this Order;
the precise description of the facilities;
- description of the circuits of animals and people;
― the list and qualification of the centre's staff, including the identity of the centre veterinarian and the licensees of the centre's head or inseminator's headArticle L. 653-13 of the Rural Code.
The Departmental Director of Veterinary Services is informed by the officials of the approved centres of major changes to the facilities and equipment of the centres as well as the change of the veterinary centre.
Semen intended for the national market or intra-community exchange must:
- having been collected and processed in a registered collection centre in accordance with the provisions of Article 3 above;
― to have been taken from equinees that have been subject to zootechnical approval provided for in theArticle R. 653. 82 Rural Code and whose health status is in accordance with the provisions of Annex II to this Order;
- having been collected, processed and retained in accordance with the provisions of Annex III to this Order.
Unless immediately installed on the site of the collection center within the hour following the collection of the sperm, each semen sequin or individual dose conditioned in a registered collection center must be identified using an indelible mark to establish:
– French origin;
the date of collection;
- the species, race and identity of the donor stallion (SIRE number, full name of the stallion and, optionally, transponder number);
- the name or registration number of the registered collection centre that collected the sperm.
The characteristics and model of this brand, for individual semen strawttes or doses from an approved collection centre, are specified by instruction of the Minister responsible for agriculture.
Semen intended for intra-community exchanges must be accompanied by a health certificate, in accordance with the model set out in Part III of Annex E to the above-mentioned Directive 92/65/EEC, prepared by an official veterinarian of the Departmental Directorate of Veterinary Services.
The original of the certificate, established at least in French, must:
- accompany sperm doses to their final destination;
be established on a single leaflet;
– to be provided for a single recipient.
Sperm collection centres are regularly monitored during the season by departmental veterinary services to verify compliance with the conditions of accreditation.
The minimum monitoring frequency is as follows:
– at least once a year if the center collects sperm only during the rising season;
– at least twice a year if the center collects sperm throughout the year.
Failure by departmental veterinary services to comply with one or more of the provisions of this Order may result in the suspension of the registered centre's health approval pending corrective actions. In the absence of adequate corrective actions, the prefect shall withdraw the approval of the centre and inform the Minister for Agriculture (General Food Branch).
Sampling for diagnostic tests and vaccinations provided for in this Order shall be carried out by a health veterinarian after prior verification of the identity of the stallion.
The diagnostic tests provided for in this Order may only be carried out by laboratories approved by the Minister for Agriculture.
The list of national reference laboratories and accredited laboratories is prepared by the Minister for Agriculture.
The decision of January 25, 1988 on artificial insemination in kine and asine species and the decree of March 8, 1996 setting the sanitary conditions for intracommunal sperm exchanges of the equine species are repealed.
The Director General of Food at the Ministry of Agriculture and Fisheries and Prefects are responsible, each with respect to it, for the execution of this Order, which will be published in the Official Journal of the French Republic.
A N N E X E I
CONDITIONS OF AGAINST CENTRES
A. ― Conditions of accreditation of semen collection centres
for the national market
Semen collection centres must:
1° Being placed:
- under the health supervision of a centre veterinarian;
―under the technical responsibility of a centre leader who holds a centre chief's licence under section L. 653-13 of the rural code, which may also be a centre veterinarian. However, for centres with semen doses exclusively intended for immediate installation on the centre site within the hour of collection, technical liability may be provided by a holder of an inseminator licence under section L. 653-13 of the rural code.
2° At least:
― facilities for equine housing;
– isolation facilities without direct contact with the usual accommodation of the equine;
- semen collection facilities including a separate site for cleaning and disinfection or sterilization of equipment;
- a semen treatment facility separated from the collection facilities that may be located on another site, if applicable;
- a semen storage facility that can be located on another site, if any;
- an exercise area for equine, if necessary.
The above facilities must be easy to clean and disinfect, with the exception of the exercise area.
3° Being built or isolated so as to avoid contact with animals located outside the centre.
4° Being supervised by the technical manager so that only equidises can stay there, which must be collected and meet the requirements of Schedule II, Part A, and the conditions fixed by the centre veterinarian.
However, other domestic species may be admitted as long as they do not present any risk of infection for equidises whose sperm must be collected.
If natural setting or mounting activities are carried out on the site of the collection centre, the juments, stallions and stallions intended for natural climbing are allowed provided they do not present any clinical signs of infectious disease at the time of their admission to the centre.
5° To be monitored by the technical officer so that the following information is recorded in the livestock register and kept in the centre for a minimum period of five years:
- the species, race, date of birth and identification of each animal present in the centre;
- movements (entrances and exits) of animals;
- the health history and health controls carried out and their results, treatments and vaccinations carried out on detained animals;
- the date of sperm collection and treatment;
– the destination of sperm, including the number, nature (fresh or frozen) and the identification of sent doses, the date of shipment, the identity of the recipient;
– Semen storage, including storage site and stock flows (stock files).
6° Use competent and adequately trained personnel on disinfection and hygiene procedures to prevent the spread of diseases.
7° Benefit from monitoring preventing entry into the centre enclosure to any unauthorized person.
8° To be monitored by the technical manager so that:
― no stallion whose sperm is collected in the center is used at the natural mount at least thirty days before the first sperm collection and throughout the collection period;
- the collection, treatment and storage of sperm shall be carried out exclusively in the premises provided for this purpose;
– all tools in contact with sperm or donor animal during collection or treatment are properly disinfected or sterilized before each use, or are new, for single use, and disposed after use. If natural setting or mounting activities are carried out on the site of the collection centre, the instruments and equipment must be strictly separated and reserved for each activity;
- products of animal origin used in the treatment of sperm, such as diluents and additives, are not a health risk;
- cryogenic agents used in the case of frozen or chilled sperm have not previously been used for other animal products;
any container intended for the storage or transport of the sperm is properly disinfected or sterilized before use, or new, for single use and disposed after use.
9° Ensure indelible identification of each individual sperm dose in accordance with Article 6 of this Order.
B. ― Conditions for accreditation of semen collection centres
for intra-community exchanges
Semen collection centres for intra-community exchanges:
1° Satisfies the conditions of Part A of this Annex I, with the exception of 4°.
2° The technical officer shall be monitored to ensure that only equidises are available for semen that are collected and meet the requirements of Schedule II, Part B, and the conditions established by the centre veterinarian.
However, other domestic species may be admitted as long as they do not present any risk of infection for equidises whose sperm must be collected.
If natural setting or mounting activities are carried out on the site of the collection centre, the juments, stallions and stallions intended for natural climbing are allowed provided they meet the requirements of Appendix II-B, points 1°, 2°, 3° and 4.
A N N E X E I
ALONS ADMISSION CONDITIONS
IN THE COLLECTION CENTERS
A. - Conditions of admission to semen collection centres
for the national market
Only can be allowed to collect sperm intended for the national market stallions which:
1° There are no clinical signs of infectious disease at the time of admission to the centre and day of collection.
2° The following tests were submitted:
(a) For the research of the infectious anemia of the equine, at a immunodiffusion test in chalk (Cogginstest) with negative result achieved during the first climbing season of the stallion in the three months preceding the first collection, then every three years before the start of the climbing season. Additional tests may be required depending on the epidemiological situation and on the instruction of the minister responsible for agriculture;
(b) For the search for equine viral arteritis, a seroeutralization test with a negative result of dilution of 1/4 or any other serologic test authorized by the minister responsible for agriculture with negative result; in the event of a positive result of this serologic test, a viral isolation test or any other virological test authorized by the Minister responsible for agriculture performed on a total sperm sample of the donor stallion with negative result. The search for equine viral arteritis is carried out every year. Sampling must be after December 1 prior to the climbing season.
By derogation, the validly vaccinated standard for equine viral arteritis is not subject to the serologic and virological tests provided for in this c. To be recognized as valid, vaccinations must be carried out by a veterinarian according to the requirements of the marketing authorization of the vaccine used.
Calibons with a positive virological test (research of virus or its components) are recognized excretors and cannot be collected in the registered collection center. However, a waiver may be granted, by the departmental director of veterinary services, under the conditions established by instruction of the minister responsible for agriculture, for the collection of sperm from an excretor stallon provided that the viral strain is not considered pathogenic by the national reference laboratory in this field and subject to compliance with a specific technical protocol that will, in particular, limit the establishment of doses in a closed harem.
(c) For the search for equine contagious metrite at a negative bacteriological diagnostic test conducted each year before the collection period on a swab from the urethral pit. The sampling must be after 1 December prior to the climbing season.
3° Have not been used as a natural rise since the completion of the necessary samplings for the diagnosis of contagious metrite at 2° and throughout the collection period.
4° Are validly vaccinated against equine flu and equine rhinopneumonia. To be recognized as valid, vaccinations must be carried out by a veterinarian according to the requirements of the marketing authorization of the vaccine used.
B. - Conditions of admission to semen collection centres
for intra-community exchanges
Only can be allowed to collect sperm for intra-community exchanges, stallions which:
1° There are no clinical signs of infectious disease at the time of admission to the centre and day of collection.
2° Meet the requirements of thearrested on 3 May 1994 and do not originate from farms that are prohibited because of known contagious disease of equinees within the meaning of section D. 223-21 of the rural code.
3° During the thirty days prior to the sperm collection in one or more farms where no equine had clinical signs of equine viral arteritis during that period.
4° During the sixty days prior to the collection of sperm in one or more farms where no equine has presented clinical signs of equine contagious metritis during this period.
5° Have not been used as a natural mount in the thirty days prior to the first collection and during the collection period.
6° The following tests were tested according to one of the control programs defined at 7° below:
(a) For the research of the infectious anemia of equinees, a gelatin immunodiffusion test (Coggins test) with negative result.
(b) For the search for equine viral arteritis, a seroeutralization test with negative result to dilution of 1/4; in the event of a positive result of this seroeutralization test, at a viral isolation test performed on a total sperm sample of the donor stallion with negative result.
(c) For the search for equigenitalis contagious metritis by isolation of the Taylorella equigenitalis germ with two negative controls carried out at seven days of interval, on the one hand, on swabs from the forepuce (or furnace), the urethral pit and urethra, and on the other hand, on pre-ejaculatory fluid samples or on a sperm sample.
7° One of the following control programs was submitted:
(a) If the sperm is collected for exchange in the form of fresh or chilled sperm:
a-1. If the donor stallion permanently resides in the centre for at least thirty days before the first sperm collection and during the collection period, and if no equidise in the centre comes directly into contact with health-related equidises less than that of the donor stallion, the tests prescribed at 6° above are carried out before the first sperm collection, at the earliest than fourteen days after the entry into the center and
a-2. If the donor stallion does not reside permanently in the centre, or if equines present on the centre have entered direct contact with health status equines below that of the donor stallion, the tests prescribed in 6° above are carried out in the fourteen days prior to the first sperm collection and at least once a year at the beginning of the climbing season.
In addition, during the collection period:
the test referred to in 6° (a) above is repeated every one hundred and twenty days;
― the test referred to in 6° (b) above is performed no later than thirty days before each collection, unless, in the case of positive serologic reaction, the absence of virus excretion is confirmed annually by a viral isolation test.
(b) If the sperm is collected for exchange in the form of frozen sperm:
b-1. The tests prescribed in 6° above shall be carried out during the mandatory period of storage of frozen doses (Appendix III) of thirty days and not earlier than fourteen days after the collection regardless of the status of the stay of the standard;
b-2. Or, the tests prescribed in 6° above shall be carried out according to one of the two control protocols defined in a-1 and a-2 above.
If one of the above tests is positive, the animal must be isolated and its sperm, collected since the date of the last negative examination, cannot be exchanged. The same applies to the sperm collected on other animals affected by the disease and staying in the collection centre since the date the examination was positive. Trade can only resume when the health status of the centre has been restored.
8° Are validly vaccinated against equine flu and equine rhinopneumonia. To be recognized as valid, vaccinations must be carried out according to the requirements of the marketing authorization of the vaccine used.
A N N E X E I I
Sperm
Semen shall be collected, treated and retained in accordance with the following principles:
1° Antibiotics should be added to diluents for sperm according to the rules defined by community decision. This condition is optional for doses put in place immediately on the centre site within the hour of collection;
2° All material used for the collection, processing, retention or freezing of sperm shall be disinfected or sterilized appropriately before each use, or new, for single use and disposed after use;
3° Semen must be placed in duly identified sterile receptacles that contain only the sperm of the same stallion and which are immediately sealed or, for fresh sperm, sealed hermetically;
4° Semen doses shall be identified in accordance with the provisions set out in Article 6 of this Order;
5° In the case of freezing, semen doses must be placed in liquid nitrogen containers that have no risk of contamination of the product. Frozen sperm doses for intracommunity exchanges must be stored for a minimum period of thirty days prior to shipment;
6° Semen should be transported in containers that are properly cleaned, disinfected or sterilized before use, or new, for single use and disposed after use.
Done in Paris, January 24, 2008.
For the Minister and by delegation:
Director General
food,
J.-M. Bournigal
