Participation in the Scrapie Flock Certification Program (SFCP) is optional. The program is designed to give producers a means of detecting and controlling scrapie within their flock/herd, resulting in recognition that the risk of their animals being infected with scrapie diminishes to negligible with progressive participation in the program. A sheep or goat producer can join the SFCP provided that the producer agrees to adhere to the program rules. The program certifies flocks/herds with respect to classical scrapie only, and does not cover “atypical” scrapie which is clinically, pathologically, biochemically and epidemiologically unrelated to classical scrapie. Atypical scrapie may, in fact, be a non-contagious, spontaneous degenerative condition of older sheep. As such, throughout this document, when the term “scrapie” is used, it refers to classical scrapie only.
Since there is no test to rule-out the disease in the individual live animal, “scrapie-negligible-risk” status is based on the results of surveillance testing carried out on deadstock, screening the flock/herd for presence of disease, removing genetically susceptible animals, restricting animals entering the flock/herd, and the absence of clinical signs.
The Program involves limiting acquisitions to animals from similar or higher status flocks/herds and ongoing surveillance through the submission of all deadstock for scrapie testing. The program includes seven levels, from the entry (level E) to the certified level, with the addition of a higher level of certified plus. The certified plus level is for flocks which desire to be recognized as more fully aligned with OIE requirements. A minimum of five years (one year each at level E, D, C, B, A) is necessary to reach the certified level. A minimum of 7 years, along with additional sampling requirements is necessary to reach the certified plus level.
The SFCP is used for trade between owners/ farm operators within Canada, for export outside of Canada, and for individual risk mitigation on enrolled farms.
The SFCP is carried out in co-operation with producers, accredited veterinarians, national stakeholder organizations, provincial governments, approved laboratories and the Canadian Food Inspection Agency (CFIA). The roles assumed by each of these organizations may vary in different regions of Canada.
This role and the associated responsibilities will be assumed by the CFIA in all situations. The CFIA is responsible for the development, using a consultative process, of national (minimum) standards for a scrapie flock certification program. Modifications and updates to these standards will be undertaken as required. The CFIA is responsible for providing the current national standards to the organizations responsible for regional administration. (See point 1.2 below.)
Where the regional administration is assumed by organizations other than the CFIA, it is the CFIA’s responsibility to review any scrapie flock certification program proposed for the specific region of Canada and determine equivalency to the published national scrapie flock certification program standards. International negotiation for recognition of the program and endorsement of export certification by the CFIA will only be done for those scrapie flock certification programs judged by the CFIA to meet the national standards.
The CFIA is responsible for conducting audits of program design and implementation to verify that the scrapie flock certification program in a particular region of Canada meets the national standards.
The CFIA is responsible for the design and implementation of a quality assurance program for non-CFIA laboratories performing transmissible spongiform encephalopathy (TSE) testing, and laboratories providing genotyping for scrapie susceptibility. All confirmatory testing on suspect or positive scrapie tissue samples will be performed by a CFIA laboratory. In the case of a confirmed positive animal, the CFIA will implement the National Scrapie Eradication Program, the official disease control program of Canada.Discrepancies between genotyping results from two laboratories will be subject to final genotype testing by a CFIA laboratory.
The CFIA is responsible for ensuring a publicly accessible report (e.g. published on the website) of all enrolled flocks and herds and their status is maintained. This report will be updated on a quarterly basis.
This role and the associated responsibilities may be assumed by a national or provincial industry group, the provincial government or the CFIA Program Network. The regional administrator is responsible for overseeing enrolment and membership in the scrapie flock certification program for a particular region of Canada, including the following:
The role of assessor of flock/herd status may be assumed by a national or provincial industry group, the provincial government or the CFIA district office. The status assessor is responsible for the following:
Program delivery is carried out by a veterinarian accredited by the CFIA. A CFIA veterinarian or a veterinarian who is an employee of a provincial department that is the status assessor or regional administrator may also carry out program delivery, and can be substituted anywhere the services of an accredited veterinarian is required in the standards. The inventory portion of the initial or annual report may be conducted by an accredited veterinarian, an animal health technician supervised by the accredited veterinarian, a CFIA veterinarian, or staff of a provincial department or agency that is the status assessor or regional administrator.
Veterinary practitioners are authorized (accredited) by the CFIA or the appropriate provincial government to perform inspections, to take samples for diagnostic or genotyping purposes and to check records.
To obtain accreditation, a veterinarian must successfully complete the training indicated in the Accredited Veterinarian’s Manual or its provincial equivalent.
The accredited veterinarian must sign the application form completed by the owner.
If the owner decides to stop doing business with the accredited veterinarian who signed the original application form, the new accredited veterinarian must be asked to sign a copy of the form, or – if the situation has changed – a new application form.
In rare instances where a flock or herd has been subject to CFIA disease control actions as a result of being declared positive for scrapie, a CFIA veterinarian may act as the program delivery person for the SFCP during the CFIA’s mandatory follow-up period for deadstock surveillance.
Program delivery personnel are responsible for the following:
Laboratory approval is accompanied by training and the implementation of a quality assurance program established by the CFIA. A member of the laboratory staff must have taken CFIA training in order to be able to supervise scrapie tests and ensure that the quality assurance program is followed. Laboratories providing diagnostic testing services for the SFCP are responsible for the following:
In this program, an owner is a person who owns the premises and the animals on the premises. A producer is a person who has responsibility for the care and handling of all animals on a premises; this person may or may not be the owner.
The owner of a flock/herd wishing to enrol in the SFCP is responsible for the following:
The flock owner contacts the local CFIA district veterinarian to determine the organizations responsible for the SFCP in the region in which the flock/herd is located.
The owner contacts the SFCP regional administrator and requests an application package.
The owner may only join one pathway to certification at a time. Specifically, any flock/herd and all the individual animals within the flock/herd can only be registered in one pathway to certification at a time.
An application package is completed and submitted to the organization responsible for status assessment. The applicant must indicate which Program Specific Pathway to Certification will be pursued. The application must be accompanied by the following:
Accelerated admission to more advanced levels of the SFCP may be possible for flocks/herds which have met all program requirements for a number of years prior to application or are from a program considered equivalent in terms of risk reduction.
A flock/herd that has been subject to the CFIA’s National Scrapie Eradication Program may be admitted to the certification program at the entry level (level E) of the SFCP provided all scrapie eradication program requirements have been completed, and any declarations of infected place or quarantines have been removed.
Owners who will be starting a new flock/herd with acquired animals of status D or higher and who intend to keep that status will need to follow all regular application form protocols as above, but in addition, provide a letter (written by the owner) stating that the premises where the flock will reside meets one of the following conditions:
Flock/herd owners successfully enrolling in the SFCP and quitting the SFCP within the same 24-month period will not be permitted to re-enrol in the SFCP for a period of three years from their date of departure from the program (subject to appeal).
In addition, flock/herd owners who obtain temporary enrolment and do not complete the requirements for full enrolment in the SFCP will not be permitted to re-enrol in the SFCP for a period of three years from their date of acceptance for temporary enrolment (subject to appeal).
An owner may apply to have the certification status of the flock/herd upgraded if the following conditions are met:
When deficiencies are identified, the status assessor may require that the current level be maintained until the deficiencies are addressed, or that the status of the flock/herd be downgraded or suspended. The decision is documented to the program participant and copied to the accredited veterinarian and the regional administrator.
Once the certified level is reached, an owner may choose to keep the flock/herd at certified level, or may apply for advancement to the certified plus level if the additional requirements are met.
Once a flock/herd has attained the certified level, or certified plus level, annual request for renewal of this level is required. To maintain their status of certified or certified plus, the owner must submit an annual report, documenting that all ongoing requirements have been met, to the status assessor for review and approval. The report must be completed and signed by the owner and the accredited veterinarian responsible for the flock/herd.
Owners successfully participating in the SFCP (at level E or above) who have purchased one or more females from a non-enrolled or level E flock/herd, resulting in downgrading to status E (or penalty to remain at level E), will not be permitted to introduce additional females from non-enrolled or level E flocks/herds for a period of three years from the date of their previous introduction or downgrading within the program (subject to appeal).
Regardless of the certification pathway that is pursued, once a flock/herd has attained the certified level, annual application for renewal of this level is required. The owner must submit a request to maintain the status of certified, along with the annual report that documents the fact that all ongoing requirements have been met, to the status assessor for review and approval. The request must be completed and signed by the owner and the accredited veterinarian responsible for the flock/herd.
If the owner of a registered flock/herd contravenes the program rules, the organization responsible for status assessment will temporarily suspend the certification status of the flock/herd, and after reviewing the situation, may reinstate at the same level, downgrade, or revoke the status of the flock/herd and remove it from the program.
An owner whose flock/herd is under review for possible removal from the program will be given the opportunity to submit any relevant information to the status assessor, provided that this is done no later than 30 days after suspension.
Any owner who fails to submit an inspection report within the month following the end of the anniversary quarter will have their flock/herd automatically suspended.
The status assessor will notify the owner and the accredited veterinarian in writing of the reasons for the decision and give the owner the opportunity to appeal within the following 60 days. The notice will include the name and address of the responsible person within the appeal committee as established by the status assessor.
An owner whose flock/herd has been removed from the program due to contravention of program rules may submit a new application after meeting the conditions stipulated in the program. In such a case, the owner must submit satisfactory proof to the status assessor that steps have been taken to ensure that the flock/herd will meet the program requirements in the future. In the case of a flock/herd that is reinstated in the program, the reinstatement level will depend on the reasons for suspension. The flock/herd will not be automatically reinstated at its previous level. In cases where the flock/herd was removed for reasons of information falsification, failure to report to a veterinary inspector that an animal might have scrapie, or any other action that might expose other animals to scrapie, an owner may lose the privilege of registering in the program.
If a participating flock/herd is found to be either infected with, or a source of scrapie, its certification status will be immediately revoked and it will be removed from the program. The flock/herd will be subject to the CFIA’s scrapie eradication program governed by the Health of Animals Act and the Health of Animals Regulations. The flock/herd may re-enroll at the entry level (level E) of the SFCP provided all scrapie eradication program requirements have been completed, and any declarations of infected place or quarantines have been removed.
If it is determined, as part of a CFIA scrapie disease investigation, that scrapie exposed animals may have resided in a SFCP flock/herd, then the flock/herd will have its status immediately suspended and will be subject to CFIA’s scrapie eradication program. The exposed flock/herd’s status is reinstated only once all requirements of CFIA’s scrapie eradication program are complete and all testing is negative. These requirements include genotyping and scrapie testing all genetically susceptible exposed animals. If it is determined that the exposed animals are no longer in the flock and cannot be located and tested, then the corresponding CFIA’s scrapie eradication program requirements for this situation must be followed. If any of the unavailable exposed animals are genetically susceptible breeding females, then the flock/herd may only re-enroll at the entry level of the SFCP.
A producer may appeal a decision regarding advancement or downgrading in the event of an incomplete or unsatisfactory application for advancement. A producer may also appeal a temporary suspension or a revocation of registration, but not both.
The results of all reports, including information on registrations, tests, suspensions, revocations, and changes in status, are distributed to the owner, the accredited veterinarian and the CFIA district veterinarian.
The regional administrator will maintain a list of all flocks and herds enrolled in the program, along with the pathway and their current level, on the Scrapie Canada website. Flock/herds for which a report is not submitted to the status assessor within the prescribed time will be identified on the website as being suspended.
The quarterly report published by the CFIA will be produced and automatically distributed to all provinces, and/or published on the website. It will list all registered and certified flocks and herds, along with their pathway and certification levels.
Records must be kept of feed given to animals, according to the Health of Animals Act and the Health of Animals Regulations.
The SFCP will be reviewed on an annual basis and/or as scientific information becomes available and changes are required.
Multiple premises that are non-contiguous to each other still need to be included under the same certification contract if the small ruminants on the premises meet the definition of established herd.
Multiple non-contiguous premises may be permitted to be enrolled under different certification contracts (i.e. different flocks/herds with separate statuses) if they are not considered an established herd (see definition), including no exchange of animals, and no direct or indirect (shared use of pasture, facilities, equipment) contact of animals.
For all animals in the flock/herd, the basic minimum data that must be maintained in records and submitted as part of the annual report includes the following:
*Official documents produced by provincial identification/traceability programs will be accepted as supporting documentation for animals that have moved on and off the premises.
In all cases, the owner is ultimately responsible for clarifying any inventory questions/concerns that may arise during the course of the review of the annual report by the status assessor.
The head (containing the brain and medial retropharyngeal lymph nodes) of the animal may be submitted directly to an approved laboratory by the producer, or the accredited veterinarian may collect brain and lymph node samples for submission to either an approved laboratory or to a CFIA district office to be sent to a CFIA laboratory (as part of the national scrapie surveillance program). The brain and lymph node samples may be collected by a trained third party under the supervision of the accredited veterinarian however, the responsibility of the sample collection and submission remains with the accredited veterinarian. In all cases, the head (or the samples) should be chilled or frozen immediately.
The owner must contact the laboratory or the accredited veterinarian must contact the CFIA district office in advance before submitting a head. The head must bear animal identification.
If a submitted sample results in a scrapie positive test result, action on the flock/herd is per section 2.3 Suspension/Revoking of Registration/Appeals.
If the dead animal is not found immediately, or the accredited veterinarian and the laboratory are not available within 36 hours of death, the head (containing the brain and medial retropharyngeal lymph nodes) of the animal must be frozen by the owner and submitted as a frozen specimen. Freezing enables the scrapie diagnostic test to be applied to the tissues which otherwise would no longer be suitable for testing.
Genetically susceptible sheep or goats over 14 months tested by live-animal sampling or post-mortem sampling (culled, slaughtered animals) may be used to meet the minimum sampling requirement for the Certified Plus level.
Accordance between the results of the two separate determinations of genotype is required. In cases of discordance, a separate sample will be taken from the animal and submitted to the CFIA lab for determination of the genotype.
Breeding ewes that require genotyping may have their genotype determined through the use of predictive parentage or laboratory analysis.
Samples for genotyping of female sheep may be submitted to any CFIA-approved laboratory.
Genotyping two different tissues (blood, hair follicle or buccal swab) should be considered especially for confirming genotype in 136AA 171QR animals due to the phenomenon of blood chimerism. There are limitations of the standard blood sample in this rare situation of a chimeric animal.
Advancement to Certified StatusA minimum of five years (one year each at level E, D, C, B, A) is necessary for an enrolled flock/herd to reach the certified level. Once a flock/herd has reached the certified level, it maintains this level provided that the applicable requirements continue to be met. All requirements in section 4 and the previous sections must be met.
Advancement to Certified Plus StatusTwo further years, for a minimum of 7 years, and additional sampling minimums are required to advance to the certified plus level. Section 5 details the requirements to advance to the certified plus level.
b) Alternatively if no suitable samples have been submitted for testing for a period of time equal to or exceeding 12 months, an enrolled producer may be permitted to remain on the program without advancing to the next level for one additional year (allowing time to raise an animal for slaughter and testing). For certified producers, they would incur a one year status penalty dropping them from certified to Level A.
c) The annual sampling minimum is waived for genetically resistant flocks, defined as all sheep in the flock with documented proof of 136AA 171QR or 171RR genotype, and all rams of 171RR genotype. The genotype of 136AA 171RR breeding males must be determined twice and the genotype of breeding females must be determined once as described in sections 3.20 and 3.21 under General Rules. All animals owned by the producer that die or are humanely destroyed, other than those sent for routine slaughter, must still be submitted for scrapie testing as per 4.3 and 4.4.
d. Alternative live animal sampling protocol
This protocol will be accessible when a process for submission, testing and payment in an approved laboratory is available. To be eligible for advancement live animal sampling must include the following:
A) Introduction of males from flocks/herds from the following sources, with supporting documentation, will have no impact on the certification level and these males will acquire the status of the flock/herd:
B) Introduction of males from any flocks/herds and kept in the following manner will have no impact on the certification level:
Once certified status is achieved, the producer makes an annual request to maintain certified status for their herd/flock or, once the additional requirements are met, the producer may make a request for advancement to the certified plus level.
Animals grouped together with physical contact between the animals. This does not include limited contact (e.g. contact through a fence, pen separation during a show/sale). Commingling includes sharing the same section in a transportation unit where physical contact can occur. (Mélangés (mêlés))
Premises which share common boundaries and where co-mingling of small ruminants can occur between the two premises. (Aire contiguë)
all animals that are maintained on a single premises OR all animals under common ownership or supervision on two or more premises with animal interchange between the premises or indirect contact including shared use of housing, facilities or pasture. (Troupeau établi)
as defined in the Health of Animals Regulations. (Troupeau)
document issued by the regional administrator specifying the location and status of the flock/herd, indicating the date of issue, and identifying animals leaving the flock/herd following their sale. (Certificat de statut du troupeau)
incidental contacts between animals off the premises of the flock/herd such as at fairs, shows, exhibitions, sales and semen collection facilities. Limited contact does not include any contact, incidental or otherwise, with an animal during or up to 30 days after she lambed, kidded or aborted or when there is any visible vaginal discharge. Limited contacts do not include any activity where uninhibited contact occurs, such as sharing an enclosure, sharing a section of a transport vehicle, or residing in the other flock/herd for breeding or other purposes. (Contact limité)
Any goat and any sheep of 171QQ or 136AV 171QR genotype that has resided on a premises while it was declared scrapie infected by a competent authority (i.e. CFIA). (Animal sensible exposé à la tremblante)
An animal for which scrapie-positive results were reported by the CFIA’s National and OIE Reference Laboratory for Scrapie, using at least two CFIA-approved scrapie tests (e.g. ELISA, immunohistochemistry, Western blot) applied to the brain and/or lymphoid tissue. (Animal positif à la tremblante)
Any animal that has scrapie as a differential diagnosis. (Animal suspect à l’égard de la tremblante)
permanent, unique, traceable and secure (e.g. electronic identification, tattoo, tamper evident tag). Until the national mandatory identification program for goats is implemented, neck chains and collars are acceptable as one form of identification in goats. (Dispositif d’identification unique (identifiant unique))
includes all results that identify the animal as a homozygote for alanine (A) at codon 136 of the scrapie prion gene. (AA en 136)
includes all results that identify the animal as a heterozygote for valine (V) and alanine (A) at codon 136 of the scrapie prion gene. (AV en 136)
includes all results that identify the animal as a homozygote for valine (V) at codon 136 of the scrapie prion gene. (VV en 136)
includes all results that do not identify arginine (R) at codon 171 of the scrapie prion gene (includes glutamine and histidine; QQ, QH, HH). (QQ en 171)
includes all results that do not identify the animal as a homozygote for arginine (R) at codon 171 of the scrapie prion gene, identifying arginine on one allele and the absence of arginine on the other (includes glutamine and histidine; QR or HR). (QR en 171)
includes all results that identify the animal as a homozygote for arginine (R) at codon 171 of the scrapie prion gene. (RR en 171)