Chapter 7 - Scrapie Flock Certification Program
7.4 National Standards for the Scrapie Flock Certification Program
This page is part of the Guidance Document Repository (GDR).
Looking for related documents?
Search for related documents in the Guidance Document Repository
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 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 (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.
1. Roles and responsibilities
1.1 National standards development and audit
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 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 voluntary 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 for example published on the website of all enrolled flocks and herds and their status is maintained. This report will be updated on a quarterly basis.
1.2 Regional administrator
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:
- developing a program that meets the national standard;
- developing and distributing a contract (application form) for entry into the program;
- developing and distributing forms required for the program, including application forms, annual reports, inventory reports and flock/herd status certificates;
- collecting and collating all data on enrolled flocks or herds in that region;
- issuing certificates indicating the status of a flock/herd;
- issuing a certificate indicating that a sheep is a member of a herd enrolled in the certification program and indicating the status of the flock/herd;
- informing the CFIA SFCP coordinator of the status of all enrolled flocks/herds on a quarterly basis; and
- designing an appeal process for decisions made with respect to the voluntary flock certification program, for example regarding compliance with national standards.
1.3 Status assessment or status assessor
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:
- receiving and reviewing completed applications for enrolment into the SFCP;
- accepting a flock or herd into the appropriate level of the program or informing the producer or the responsible veterinarian of any outstanding requirements that prevent enrolment at that time;
- verifying that initial and annual flock/herd inventories and additional records for all additions and deletions are complete;
- suspending SFCP status in the event of reported irregularities;
- investigating flock/herds that are suspended and proceeding with reinstatement or revocation of SFCP status;
- updating the regional administrator of the SFCP of changes in the status of a flock or herd (additions, suspensions, revocations) as they occur; and
- implementing the appeal process to determine whether an exemption should be granted for enrolled owners who failed to comply with national standard program requirements.
1.4 Program delivery
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:
- reviewing the requirements of the program and responding to questions from the owner of the premises applying for or enrolled in the program;
- teaching the owner to recognize the clinical signs of scrapie, and providing information on the epidemiology of the disease and flock/herd management;
- conducting or supervising a flock/herd inventory including verifying requirements are met for any males with an individual status level;
- assessing the health of the flock/herd to determine whether any sheep or goat is demonstrating signs of scrapie;
- immediately notifying the CFIA of the existence of any animal suspected of having clinical scrapie;
- reconciling records to ensure that the program requirements are met;
- signing reports, including the annual inventory, and submitting them to the status assessor;
- collecting or supervising the collection of samples, and submitting them for genotyping;
- collecting and submitting tissue samples from deadstock if there is a request from the owner to do so;
- identifying structures on a premises that may have been used to feed, water, contain or birth small ruminants (if necessary);
- being familiar with prionicidal agents and the correct concentration to which they must be made; and
- supervising and approving appropriate cleaning and disinfection of a premises (if necessary).
Laboratory approval is accompanied by training and 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:
- collecting, preparing and testing tissue samples in accordance with the CFIA national protocol for the diagnosis of scrapie or genotyping blood samples for codon 136 and 171 of the scrapie incubation gene;
- participating in the quality assurance program designed by the CFIA Laboratories Directorate;
- forwarding suspect samples to the appropriate CFIA laboratory (Ottawa – Fallowfield) for confirmation (the results not being reportable to the owner or the accredited veterinarian);
- providing required forms;
- providing appropriate shipping containers;
- notifying the owner, the accredited veterinarian responsible for the flock/herd and the status assessor of negative test results;
- assessing whether a tissue sample is adequate to permit diagnosis of scrapie and notifying the owner, accredited veterinarian and status assessor of samples that are not adequate; and
- disposing of tissues and carcasses in accordance with the environmental regulations in force in the province and territory. (Positive carcasses must be disposed of by burial or incineration.)
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:
- identifying animals in the flock/herd;
- providing the necessary facilities and assistance for inspection and handling of the animals;
- obtaining the services of a veterinarian accredited by the CFIA or the province to deliver the SFCP;
- assisting accredited veterinarian in conducting annual inventories;
- obtaining, maintaining and compiling all relevant documentation of animal acquisitions and departures (keeping records);
- depending on the program pathway being followed, submitting the appropriate tissue samples for laboratory analysis with appropriate animal identification;
- immediately reporting to the CFIA district veterinarian any animal suspected of being clinically affected by scrapie;
- agreeing, with reasonable notice, to make the animals and records available so that the accredited veterinarian, the provincial regulatory agency and the CFIA can inspect them; and
- if stocking a new flock/herd on a new premises for purposes of retaining a higher status, determining whether small ruminants have been contained on the premises in the last 10 years.
2.1 Enrolment procedure
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:
- a site plan of all buildings and grazing premises to which the animals are given access;
- the initial flock/herd inventory prepared by the accredited veterinarian within the three-month period immediately prior to submission of the application;Footnote 1 and
- a record-keeping plan (objective: records must be reviewed completely and effectively at each annual inspection).
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:
- the premises has not contained small ruminants for the last 10 years; or
- it is unknown whether the premises contained small ruminants in the last 10 years; or
- the premises has contained small ruminants in the last 10 years.
In cases where owners will be starting a new flock/herd with acquired animals of status D or higher and they intend to keep that status on a premises that, within the last 10 years, has previously contained (or it is unknown whether it previously contained) small ruminants, all regular application form protocols as above will need to be followed, and the owner will agree to follow the approved cleaning and disinfection protocol for the SFCP under the supervision of their accredited veterinarian prior to stocking any animals on the property. To retain the higher status, it will be necessary for the accredited veterinarian to certify to the administrator that the cleaning and disinfection has been done in a satisfactory manner prior to stocking the animals on the premises.
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).
2.2 Advancement and downgrading
An owner may apply to have the certification status of the flock/herd upgraded if the following conditions are met:
- the premises is not currently subject to CFIA actions related to the scrapie program; and
- the flock/herd has met the minimum requirements applicable to its current certification level.
To upgrade the certification status of the flock/herd, the owner must submit a request along with the annual report that would make them eligible for advancement to the status assessor for review and approval. The request must be completed and signed by the owner and the accredited veterinarian on record.
The status assessor reviews the annual report and approves advancement or identifies deficiencies that prevent advancement.
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.
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).
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.
2.3 Suspension/revoking of registration/appeals
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, 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.
2.5 Review of the program
The SFCP will be reviewed on an annual basis and/or as the scientific information becomes available and changes are required.
3. General rules
These requirements must be met by participants in all three certification pathways.
The certification program must be open to any owner of a premises on which sheep or goats are kept, provided that the owner and the premises meet the program requirements and the owner of the premises has not had the right to participate in the SFCP removed (revoked).
All sheep and goats on a premises must be included in the flock/herd enrolled in the certification program, ownership notwithstanding.
Multiple premises must be listed under the same certification contract if the premises belong to the same owner and are located contiguous to each other.
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 (such as 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.
The flock/herd owner must arrange for the services of an accredited veterinarian (or equivalent) to deliver the SFCP. The accredited veterinarian's acceptance of their role in implementation of the SFCP within the identified flock/herd is reflected by their signature on the application form.
The owner of a flock/herd must report to their accredited veterinarian any sheep or goat with any clinical sign associated with scrapie and any illness in a sheep or goat over 12 months of age lasting longer than two weeks, except a physical injury. The owner may not dispose of the animal unless the accredited veterinarian determines the signs are not consistent with scrapie. The accredited veterinarian must maintain a written record of each such determination. The accredited veterinarian will be responsible for monitoring the outcome of the case and for reporting the case to the CFIA if scrapie is a differential diagnosis. If CFIA determines the animal may be a scrapie suspect, then CFIA's scrapie eradication program procedures must be followed. If the flock/herd is found to be infected with scrapie or a source of scrapie, its certification status will be immediately suspended. 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.
All animals aged 12 months or more must be identified with two unique identification devices.
Animals less than 12 months of age must be identified in a manner that enables the owner to track these animals in the flock/herd inventory. All animals aged less than 12 months must be appropriately identified (as required by regulation) when a change in ownership occurs or when the animals are moved outside their usual location (for example to an exhibition, insemination centre, sales barn or auction barn).
The owner must keep detailed flock/herd records of every sheep or goat that is born on or enters the premises, no matter who the owner is or who is responsible for the sheep or goat. The records must be kept for a period of five years after the animal has left the flock/herd or has died. They must be made available to the program delivery person or the CFIA inspector at any reasonable time and must be presented at the time of each annual inventory.
For all animals in the flock/herd, the basic minimum data that must be maintained in records and submitted as part of annual reports includes the following:
- the animal's identifiers;
- the date the animal entered the flock/herd (day if available, month and year);
- the animal's sex;
- the source of the animal (homegrown, purchased, loan);
- if the animal was not born in the flock/herd, the name and address of the person from whom it was obtained along with:
- the flock/herd status certificate issued for the flock/herd of origin of female animals;
- The flock/herd status certificate issued for the flock/herd of origin of male animals or documentation for rams of genotype 136AA 171RR or 136AA or 171QR as required in 4.7;
- a list of males being maintained separate from the flock/herd, their individual status level and documentation as required in 4.7;
- the date the animal left the flock/herd;
- the reason for the animal leaving and appropriate documentation (a shipping invoice if shipped, a receipt if sold, death record);
- the records for slaughter lambs and kids (under 12 months) may be reported in groups;
- scrapie testing results for deadstock over 12 months of age;
- scrapie testing results for any live animal testing required if using the alternative sampling protocol for advancement, or in order to meet the minimum sampling requirements for the certified plus level; and
- genotype testing results as required to show minimum sampling requirements have been met for advancement.
Sheep or goat milk, colostrum or their derived products destined for use in sheep or goats may only be sourced from sheep or goats in the same flock/herd or from a flock/herd on the SFCP of greater or equal status as the recipient flock. Sheep or goat milk, colostrum or their derived products from a lower status flock/herd or a flock/herd not enrolled in the program will result in downgrading in status of the recipient flock /herd. Sheep and goat milk and colostrum or their derived products from a scrapie – positive animal, a scrapie suspect animal or a genetically susceptible exposed animal (136AA 171QQ, 136AV 171QQ, 136VV 171QQ, 136AV 171QR) may not be used. Bovine milk and colostrum and their derived products may be used. Appropriate biosecurity standards should be applied when sourcing milk and colostrum from any source including bovine.
Inventories (initial and annual) will be conducted by the accredited veterinarian or an appropriate third party supervised by the accredited veterinarian. The inventory will identify all sheep and goats on the premises. During the inventory inspection, all animals over 12 months of age in the flock/herd must be identified individually (by tag) and the veterinarian must check for any clinical symptoms of scrapie. For extremely large flocks/herds using electronic inventories, all animals over 12 months of age must be identified individually and their identifiers must be physically verified over the course of the year. However, only a statistically significant random sampling must have their identifiers physically verified during the annual inventory inspection. Sampling tables are available upon request. If a flock/herd inspection is performed by a CFIA veterinary inspector for the purposes of the scrapie disease control program, this may replace part or all of the annual inspection by the accredited veterinarian.
The annual report lists the following:
- all identification of each sheep and goat on the premises at the time of the inventory;
- all identification devices placed on each sheep or goat, including the current lamb or kid crop and any sheep or goats that have lost identification devices;
- all sheep or goats that have entered or left the premises since the last inventory;
- slaughter lambs and kids (under 12 months) movement may be reported in groups;
- the status of the flock/herd of origin for those sheep or goats entering the premises;
- the genotypes for each ram entering the premises where genotyping is required;
- all males maintained separately from the flock/herd and their individual status level;
- all deaths;
- the destination of every sheep or goat that moved off the premises as established by a bill of sale or, if the animal has not been sold, a signed document showing the destination of the sheep or goat;Footnote 2
- appropriate laboratory results (genotyping or scrapie testing); and
- a letter signed by the producer documenting that the sourcing of sheep and goat milk, colostrum and their derived products destined for use in sheep or goats since the last application for advancement, has been sourced from within the flock/herd or from flocks/herds of equal or higher status on the SFCP.
The report must be forwarded to the status assessor within the anniversary quarter in which the certified flock/herd was registered. The status category is effective from the date when the flock/herd is accepted within the program, and the anniversary quarter for subsequent years is the quarter in which the acceptance date falls (Jan. 1-March 31; April 1-June 30; July 1-Sept. 30; Oct. 1-Dec. 31).
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.
A post-mortem sample for the SFCP requires two tissues, a brain sample (that includes the obex) and a retropharyngeal lymph node. The medial retropharyngeal lymph node is targeted as it typically remains with the head when removed and is accessible. One lymph node is required to be tested, but submit both to ensure suitable tissue is available. In situations where retropharyngeal lymph nodes are unavailable the mandibular lymph node or tonsil would be accepted.
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.
A live animal sample for the SFCP requires either a rectal biopsy obtaining a sample of recto-anal mucosal lymphoid tissue (RAMALT) or a third eyelid biopsy obtaining a sample of third eyelid lymphoid tissue. Samples are collected by the accredited veterinarian, or by a trained third party under the supervision of the accredited veterinarian (the responsibility of the sample collection and submission remains with the accredited veterinarian), and subjected to testing for scrapie by a laboratory approved by the CFIA for that purpose. Live animal testing is restricted to animals over 14 months of age and, if sheep, of genotype 171QQ.
If the animal is a scrapie suspect or implicated in a scrapie disease investigation, sampling is done by CFIA and according to National Scrapie Eradication Program procedures.
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.
A brain and lymph node sample from all sheep or goats over 12 months of age owned by the producer that die or are humanely destroyed, other than those sent for routine slaughter, must be submitted for scrapie testing by a CFIA-approved laboratory.
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.
Animals older than 12 months which are submitted for routine post-mortem may be considered as dead submissions for the annual minimum sampling requirements if tested for scrapie.
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.
Specimens must meet the requirements specified in the diagnostic protocol approved by the CFIA, which guarantees the reliability and accuracy of the results. If an unsuitable specimen is received, the receiving laboratory is to notify the status assessor and accredited veterinarian responsible for the flock/herd. A follow-up of the details of the individual situation will be undertaken with the responsible accredited veterinarian or status assessor. If negligence on the part of the producer is identified as the cause, or this occurrence is repeated, then the program's requirements are not considered to have been met and the flock/herd will be suspended.
It is not necessary to submit for testing more than five adult animals from a group of animals that die from a common cause as determined by a veterinarian or veterinary pathologist within the time frame (not to exceed four weeks) of the same epidemiologically linked episode.
Exemption from submission of heads
The status assessor should consider the following as automatic exemptions from the requirement to submit unless the status assessor suspects that the conditions set out were not met or that the exemption is being abused to the detriment of the flock certification program.
A. Destruction of sheep by fire
A certificate or letter from an appropriate fire official must accompany the annual report.
B. The destruction and carrying away of the head of a sheep by a predator
A certificate or letter from an appropriate wildlife officer or other government official responsible for investigating such incidents must accompany the annual report.
A report of the police officer who investigates the theft must accompany the annual report.
D. Loss or destruction of the sample when it is no longer in the control of the owner (for example by an accredited veterinarian or laboratory). Recognized laboratories should note on reception of the specimen that the obex and/or lymph node is not present and the reason why.
A letter setting out the details of the loss of the sample by the individual responsible must accompany the annual report.
E. Any other reason over which the owner could not reasonably be expected to have control which results in the destruction or disappearance of the body, such as a flood
A letter or report by an acceptable third party which sets out the details of the reason for failure to submit the sample must accompany the annual report.
Genotype samples and testing
Samples (for example blood samples) required for genotyping may be taken by a veterinarian accredited to deliver the SFCP or a third party under the supervision of a veterinarian accredited to deliver the SFCP (for example a veterinary student, a technician). Approved identifiers are required on sheep being genotyped and the official identification number (15 digits) included with the sample submission.
The genotype of 136AA 171RR breeding rams must be determined twice: by using a combination of predictive parentage and testing by a laboratory approved by the CFIA, or a combination of testing at any laboratory and at a laboratory approved by the CFIA. Genotype results with only codon 171 for those animals determined to be 171RR are considered acceptable. This is due to the knowledge that R cannot be found at site 171 in combination with V at site 136 (V at site 136 is linked with Q at site 171).
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 laboratory approved by the CFIA.
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.
Information sharing requires all flock/herd information, including inventories, test results, documents related to purchases and sales of animals or embryos, deaths, to be available to the owner, the CFIA, the status assessor, the regional administrator and the accredited veterinarian. The owner must also agree to allow publication of the status of the flock/herd under the program.
4. Advancement in status (levels E, D, C, B, A and certified)
The program includes seven levels (E, D, C, B A, certified, and certified plus). With the entry level being level E and the highest level being certified plus. Advancement through each level from E to certified occurs annually if all program requirements are met. The owner must make an annual request for advancement or maintenance of the flock/herd status within the SFCP. An annual report including animal inventory and all supporting documentation must be submitted to the status assessor.
Advancement to certified status
A 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 status
Two 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.
The status category is effective from the date when the flock/herd is accepted within the program, and the anniversary quarter for subsequent years is the quarter in which the acceptance date falls (January 1-March 31; April 1-June 30; July 1-September 30; October 1-December 31).
A brain and retropharyngeal lymph node sample from all sheep or goats over 12 months of age owned by the producer that die or are humanely destroyed, other than those sent for routine slaughter, must be submitted for scrapie testing by a CFIA-approved laboratory.
One-hundred per cent of animals older than 12 months owned by the producer that die or are humanely destroyed, other than those send for routine slaughter, are to be submitted for scrapie testing. Animals that are unavailable for testing beyond the automatic exemptions detailed in these standards will be considered as per policy detailed by the status assessor. A program participant who does not agree with the decision of the status assessor may appeal the decision.
a) If no suitable samples have been submitted for testing for a period of time equal to or exceeding 12 months, at least one animal 18 months of age or older, which has resided in the flock/herd for no less than 18 months, is to be humanely destroyed (in any manner: slaughter, euthanasia) and a sample (that includes brain and retropharyngeal lymph node), submitted for testing. If the flock is genotyped, then select a genetically susceptible animal to be humanely destroyed for testing. If humanely destroying an animal for deadstock testing will have a significant impact on the flock or herd due to its small size, a producer enrolled on pathway 1 may be able to advance using the alternative live animal sampling protocol detailed in d) below.
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
To be eligible for advancement live animal sampling must include the following:
- All eligible animals in the flock or herd must be sampled and tested by rectal (RAMALT) biopsy or third eyelid biopsy. Exempt animals are those animals with valid test results in the previous 12 months;
- A minimum of three eligible animals must have been tested with valid test results;
- Eligible animals are defined as all 171QQ sheep over 14 months of age for third eyelid biopsy and all 171QQ sheep and all goats over 12 months of age for rectal (RAMALT) biopsy;
- Samples must be taken by an accredited veterinarian or a trained third party under the supervision of the accredited veterinarian and be subjected to testing for scrapie by a laboratory approved by the CFIA for that purpose;
- Animals sampled and tested must have a valid test result which is considered a negative test result or, if the test is inconclusive, sampling and testing must be repeated a second time; and
- If this live animal sampling protocol has been used to meet requirements to advance in the program at any level, then to advance from Level A to Certified, the flock or herd must have accumulated at least as many valid test results as there were test eligible animals present in the foundationFootnote 3 flock/herd or current flock/herd whichever is higher (this can be any combination of live animal and post-mortem test results).
Introduction of female animals or embryos from the following sources, with a supporting zoosanitary health certificate, will have no impact on the certification level:
- flocks/herds registered in the SFCP at an equivalent or higher certification level (anniversary quarter will be taken into consideration); or
- a country the CFIA recognizes as being free from bovine spongiform encephalopathy (BSE) and scrapie; or
- a flock/herd registered (on the date of export or embryo collection) at an equivalent or higher level in a country/region/zone of origin's scrapie flock certification program, that the CFIA has assessed as being equivalent to the Canadian program; or
- In vivo sheep embryos of the 136AA 171RR genotype from donors with records that enable trace back to all flocks and establishments that they have resided and the donors are not known to be scrapie positive, scrapie suspect or scrapie exposed susceptible animals
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:
- flocks/herds registered in the SFCP at an equivalent or higher certification level (anniversary quarter will be taken into consideration); or
- a country the CFIA recognizes as being free from bovine spongiform encephalopathy (BSE) and scrapie; or
- a flock/herd registered (on the date of export) at an equivalent or higher level in a country/region/zone of origin's scrapie flock certification program, that the CFIA has assessed as being equivalent to the Canadian program; or
- rams genotyped 136AA 171RR or 136AA 171QR from sheep flocks of any status, but must not be from flocks currently subject to any scrapie disease control measures. Owner must obtain a letter from the seller attesting that the ram's flock is not currently subject to any scrapie disease control measures and the ram's genotype must be determined twice as per 3.20 and 3.21. Rams genotyped 136AA 171RR or 136AA 171QR are not restricted in their movement in and out of the flock except they must not be on a premises currently subject to any scrapie disease control measures.
B) Introduction of males from any flocks/herds and kept in the following manner will have no impact on the certification level:
- must not be a scrapie positive, scrapie suspect or scrapie exposed susceptible animal. Owner must obtain a letter from the seller attesting that the flock/herd is not currently subject to any scrapie disease control measures;
- must be maintained separateFootnote 4 from the female animals except during the breeding period;
- must be maintained separateFootnote 4 from the lambs/kids and lambing/kidding facilities at all times; and
- these males acquire an individual status level but will start at level E and to advance must not commingle with animals from non-participating flock/herds or a flock/herd of a lower status. These animals are to be identified separately on the annual inventory.
- males imported from the United States under option 2c) of the Requirements for Small Ruminants Imported from the United States for Breeding, Domestic or Captive Purposes import policy are required to meet the conditions of this policy and be maintained separateFootnote 4 from female animals except during the breeding period and from lambs/kids, and from lambing/kidding facilities at all times, and must never leave the importing premises without written permission from the CFIA. Written permission may be given for activities that would fall under the limited contact definition. Written permission may be given for imported male goats to leave temporarily for hand-breeding purposes, however this would be considered commingling and their individual status would be assigned to reflect this upon their return.
The flock/herd status certificate accompanying the purchase of the animals or embryos will be the supporting document required to attest to the certification level of the flock/herd of origin.
Introduction of one or more animals or embryos obtained from flocks/herds registered in the SFCP at the same certification level but registered in a later anniversary quarter will result in the recipient's anniversary quarter being moved to that of the flock/herd of origin. If one or more animals or embryos from a non-participating flock/herd are introduced, the enrolled producer's anniversary quarter will change to the quarter in which the new animal(s) or embryo(s) were introduced, in addition to the penalty to downgrade to or remain at level E. Anniversary quarter will not be affected for flocks where these embryos or males have been introduced and have met the genotype requirement as set out in 4.6 or 4.7. Anniversary quarter will not be affected for flocks or herds where males have been introduced and met the requirements to be maintained separately as set out in 4.7.
If animals or embryos from flocks/herds of a lower certification level are introduced, the status of the recipient flock/herd will be downgraded to that of the flock/herd of origin of the lowest category. If animals or embryos from a non-participating flock/herd are introduced, the status of the recipient flock/herd will be reduced to level E. Anniversary quarter will not be affected for flocks where these embryos or males have been introduced and have met the genotype requirement as set out in 4.6 and 4.7. Anniversary quarter will not be affected for flocks or herds where these males have been introduced and met the requirements to be maintained separately as set out in 4.7.
With the exception of limited contacts (see definitions), commingling of animals from non-participating flock/herds or a flock/herd of a lower status will result in downgrading of the certification level to that of the flock/herd of origin of the lowest category (level E if animals are commingled with animals from a non-participating flock/herd).
Semen may be sourced from males in non-participating flocks/herds or flocks/herds of any certification level, with no impact on the certification level of the recipient flock/herd, provided that, on the date of insemination, the semen donor is not affected by scrapie (positive animal) or suspected of being affected by scrapie or from a scrapie exposed susceptible animal. The semen must meet the requirements of the national artificial insemination program.
The producer must make an annual request for advancement or maintenance of the flock/herd status within the SFCP. The request must be accompanied by the annual report including animal inventory, and all supporting documentation must be submitted to the status assessor.
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.
5. Advancement to certified plus status
All program requirements in the previous sections must continue to be met for advancement to certified plus status and to maintain certified plus status. Additional requirements to be met in order to advance to certified plus status are detailed in this section.
To attain certified plus status a flock/herd must have been enrolled for a minimum of 7 years with a minimum of 30 animals scrapie tested or the equivalent as set out in 5.3.
a) The minimum sampling requirement for the flock/herd to advance to certified plus status is 30 animals scrapie tested or all genetically susceptible animals over 14 months of age scrapie tested whichever is less. This minimum sampling requirement is met by any combination of the following:
- samples obtained according to the sampling requirements in sections 4.3 to 4.5 as the herd/flock advanced through the program.
- samples obtained from genetically susceptible animals over 14 months by live-animal testing or post-mortem testing (culled, slaughtered animals) to make up the balance of the minimum sampling requirement.
- samples are not required from
- genetically susceptible animals with valid live-animal test results in the previous 24 months
- genetically susceptible animals that have been live-animal tested 4 times with at least one valid result.
- genetically resistant animals as evidenced by documented genotype testing as in section 3.20-3.21. These animals are sheep with documented proof of 136AA 171QR or 171RR genotype.
b) In addition to the minimum sampling requirement above, any genetically susceptible female animals not acquired from certified plus flocks in the preceding two years must be sampled by live-animal or post-mortem testing before advancement.
Once certified plus status is achieved, the producer must make an annual request to maintain certified plus status for their herd/flock. The owner must submit an annual report that documents 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.
- Commingled (mixed):
- animals grouped together with physical contact between the animals. This does not include limited contact (for example 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)
- Established flock or herd:
- all animals that are maintained on a single premises and 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)
- Flock or herd:
- as defined in the Health of Animals Regulations. (Troupeau)
- Flock/herd status certificate:
- 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)
- Limited contact:
- incidental contacts between animals off the premises of the flock/herd such as at fairs, shows, exhibitions and 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)
- Scrapie exposed susceptible animal:
- 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 (CFIA). (Animal sensible exposé à la tremblante)
- Scrapie positive:
- 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 (for example ELISA, immunohistochemistry, Western blot) applied to the brain and/or lymphoid tissue. (Animal positif à la tremblante)
- Scrapie suspect:
- Any animal that has scrapie as a differential diagnosis. (Animal suspect à l'égard de la tremblante)
- Unique identification devices:
- permanent, unique, traceable and secure (for example 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)
- Date modified: