7.9 Appendix 3: National Standards for Scrapie Flock Certification Program

Introduction

Participation in the Voluntary Scrapie Flock Certification Program (VSFCP) 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 VSFCP 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 diagnose 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.

There are three separate paths that can be followed for a flock/herd to achieve certified status. Pathway 1 involves limiting acquisitions to animals from similar or higher status flocks/herds and ongoing surveillance through the submission of deadstock for scrapie testing. The program includes six levels, from the entry level (level E) to the highest level (certified). A minimum of five years is necessary to reach the certified level.

Pathway 2 involves genotype screening to identify adults that possess the genotype susceptible to scrapie and then screening these animals by means of the third eyelid test or recto-anal mucosa associated lymphoid tissue (RAMALT) biopsy test. Negative results give a reasonable level of assurance that the disease is not present in the flock/herd. Ongoing surveillance of deadstock continues to monitor for the presence of the disease.

Pathway 3 involves genotype screening and elimination of genetically susceptible animals from the breeding flock.

The VSFCP is carried out in co-operation with producers, accredited veterinarians, provincial governments 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 an official disease control program.

Note: Discrepancies between genotyping results from two laboratories will be subject to final genotype testing by a CFIA laboratory.

The CFIA is responsible for developing and maintaining a publicly accessible report (e.g. published on the website) of all enrolled flocks and herds and their status. 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 VSFCP 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, e.g. 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 VSFCP;
• 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 VSFCP status in the event of reported irregularities;
• investigating flock/herds that are suspended and proceeding with reinstatement or revocation of VSFCP status;
• updating the regional administrator of the VSFCP 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 or a veterinarian who is an employee of a provincial department that is the status assessor or regional administrator. 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, 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 purposes or genotyping 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 no longer do 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 during the mandatory follow-up period for deadstock surveillance, for the pathway joined, up to the point of flock/herd certification, or a maximum of five years (whichever comes first).

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;
• 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).

1.5 Laboratories

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 VSFCP 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 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 suitable; 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.)

1.6 Producers

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 VSFCP 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 VSFCP;
• 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, determine if small ruminants have been contained on the premises in the last 10 years.

2. Administration

2.1 Enrolment Procedure

The flock owner contacts the local CFIA district veterinarian to determine the organizations responsible for the VSFCP in the region in which the flock/herd is located.

The owner contacts the VSFCP regional administrator and requests an application form.

An application 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 form 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; 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 VSFCP may be possible for flocks/herds which have met all program requirements for a number of years prior to application.

A flock/herd that has been subject to the CFIA Scrapie Disease Control Program may be admitted to the certification program at the level at which it meets the certification program requirements.

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 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;
• 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 has previously contained (or it is unknown whether it previously contained) small ruminants, within the last 10 years, 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 VSFCP 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 VSFCP and quitting the VSFCP within the same 24-month period will not be permitted to re-enrol in the VSFCP for a period of three years from their date of departure from the program (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 VSFCP (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.

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 infected with, or a source of scrapie, its certification status will be suspended. The flock/herd will be subject to the scrapie control program governed by the Health of Animals Act and the Health of Animals Regulations. Following completion of the scrapie control program, the flock/herd may be reinstated in the VSFCP at the appropriate pathway and level.

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.

2.4 Reports

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 with their pathway and certification levels.

Records must be kept of feed given to animals, according to the Health of Animals Act and Regulations.

2.5 Review of the Program

The VSFCP 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.

3.1

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 VSFCP removed (revoked).

3.2

All sheep and goats on a premises must be included in the flock/herd enrolled in the certification program, ownership notwithstanding.

3.3

Multiple premises must be listed under the same certification contract if the premises belong to the same owner and are located in proximity to each other.

3.4

The flock/herd owner must arrange for the services of an accredited veterinarian (or equivalent) to deliver the VSFCP. The accredited veterinarian's acceptance of their role in implementation of the VSFCP within the identified flock/herd is reflected by their signature on the application form.

3.5

The owner of a flock/herd must report to their accredited veterinarian any illness in a sheep or goat over 12 months of age lasting longer than two weeks, except a physical injury. 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.

3.6

All animals aged 12 months or more must be identified with two unique identification devices.

3.7

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 (e.g. exhibition, insemination centre, sales barn or auction barn).

3.8

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 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); and
• scrapie testing results for deadstock over 12 months of age.

Additional information that is required for pathway 3 is as follows:

• identifiers of the sire and dam; and
• genotype testing results as required for pathway 3.

Flock/Herd Inventories

3.9

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 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.

Annual Reports

3.10

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;
• the status of the flock/herd of origin for those sheep or goats entering the premises;
• 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; and
• appropriate laboratory results (genotyping or scrapie testing).

The report must be forwarded to the status assessor within the anniversary quarter in which the certified flock/herd was registered.

Deadstock Testing

3.11

The head of the animal or the brain sample may be submitted directly to an approved provincial laboratory by the producer, or the accredited veterinarian may collect samples for submission to either an approved provincial laboratory or to a CFIA district office to be sent to a CFIA laboratory (as part of the national scrapie surveillance program). In all cases, the head (or the sample) 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.

3.12

If moribund animals are humanely destroyed on farm by a gun shot to the head, the recipient lab must sample and test both the brain and one lymph node from the head (mandibular, retro pharyngeal or third eyelid) for scrapie.

3.13

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 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.

3.14

Animals older than 12 months which are submitted for routine post-mortem may be considered as dead submissions if tested for scrapie.

3.15

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.

3.16

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

3.17

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.

C.Theft

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 (e.g. by an accredited veterinarian or laboratory). Recognized laboratories should note on reception of the specimen that the obex 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

3.18

Samples (e.g. blood samples) required for genotyping may be taken by a veterinarian accredited to deliver the VSFCP or a third party under the supervision of a veterinarian accredited to deliver the VSFCP (e.g. a veterinary student, a technician).

3.19

The genotype of 171RR breeding males 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. 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 Canadian laboratory that participates in the national genotyping project or a foreign laboratory approved by the CFIA.

Information Sharing

3.20

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. Program Specific Pathway 1

Note: This pathway is available to sheep and goats.

4.1

The program includes six levels, from the entry level (level E) to the highest level (certified). A minimum of five years (one year at each level E, D, C, B, A) is necessary for an enrolled flock/herd to reach the certified level in pathway 1. Once a flock/herd has reached the certified level, it maintains this level provided that the applicable requirements continue to be met.

4.2

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).

4.3

A brain sample from all sheep or goats over 12 months of age that die or are humanely killed on the farm (deadstock) must be submitted for scrapie testing by a CFIA-approved laboratory.

4.4

One-hundred per cent of animals older than 12 months that die or are humanely killed on the farm 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.

4.5

If no suitable samples have been submitted for testing for a period of time equal to or exceeding 12 months, at least one animal 24 months of age or older, which has resided in the flock/herd for no less than 12 months, is to be killed (in any manner: slaughter, euthanasia) and a sample submitted for testing.

4.6

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 repeat level E for one additional year (allowing time to raise an animal for slaughter and testing).

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 VSFCP 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.

4.7

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.

4.8

Introduction of one or more females or embryos obtained from flocks/herds registered in the VSFCP 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.

4.9

If females 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.

4.10

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).

4.11

Introduction of males from flocks/herds of any status will have no impact on the certification level of the recipient.

However, producers must be aware that the requirement for export to the U.S. and Japan is that scrapie has not existed on any premises on which animals (for export) were located during the 60 months immediately prior to shipment.

4.12

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) or suspected of being affected by scrapie. The semen must meet the requirements of the national artificial insemination program.

4.13

The producer must make an annual request for advancement or maintenance of the flock/herd status within the VSFCP. The request must be accompanied by the annual report including animal inventory, and all supporting documentation must be submitted to the status assessor.

5. Program Specific Pathway 2A – Third Eyelid

Note: This pathway is not available to goats.

5.1

A blood sample is collected from all ewes older than 14 months and submitted for genotyping by a CFIA-approved laboratory. Samples (e.g. blood samples) required for genotyping must be taken by a veterinarian accredited to deliver the VSFCP or a third party under the supervision of a veterinarian accredited to deliver the VSFCP (e.g. a veterinary student, a technician).

5.2

All ewes 14 months of age or older, that are determined to have the 171 QQ genotype, must have a sample of lymphoid tissue collected from the third eyelid by the accredited veterinarian on contract and subjected to testing for scrapie by a laboratory approved by CFIA for that purpose. A minimum of 50 ewes must be biopsied in order to continue in this pathway.

5.3

If all laboratory tests for scrapie are negative, the flock may officially apply to enter the VSFCP and, if accepted, enters level B.

5.4

Commencing upon acceptance into the program, brain samples from all sheep/goats over 12 months of age that die on the farm (deadstock) must be submitted for scrapie testing by a CFIA-approved laboratory.

5.5

Females and embryos acquired from flock of an equivalent or higher status will not have an impact on the status of the recipient flock.

On the other hand, the acquisition of females or embryos from flocks of lower status will result in the lowering of the status of the recipient flock to the status of the flock of origin.

5.6

For application to advance to level A, any breeding females that were purchased from other farms prior to entering the VSFCP but were not 14 months or older (thus did not have third eyelid test) at the time of the first testing must now be subject to genotyping and third eyelid testing as per steps 5.1 and 5.2 above. These results must be submitted along with the annual report and the request to advance to level A.

5.7

The flock may advance to the certified level as per pathway 1. Once a flock has reached the certified level, it maintains this level provided that the requirements for this level (deadstock surveillance, acquisitions) are followed. An annual request, with the accompanying annual report including animal inventory and all supporting documentation, must be submitted to the status assessor.

Program Specific Pathway 2B – RAMALT Biopsy

Note: This pathway is available to goats. Start at 5.10 if dealing with a goat herd on this pathway.

5.8

A blood sample is collected from all ewes older than 12 months and submitted for genotyping by a CFIA-approved laboratory. Samples (e.g. blood samples) required for genotyping must be taken by a veterinarian accredited to deliver the VSFCP, or a third party under the supervision of a veterinarian accredited to deliver the VSFCP (e.g. a veterinary student, a technician).

5.9

All ewes 12 months of age or older that are determined to have the 171 QQ genotype must have a RAMALT biopsy collected by the accredited veterinarian on contract and subjected to testing for scrapie by a laboratory approved by CFIA for that purpose. A minimum of 50 ewes must be biopsied in order to continue in this pathway.

5.10

Any does 12 months of age or older must have a RAMALT biopsy taken by the accredited veterinarian on contract and subjected to testing for scrapie by a laboratory approved by CFIA for that purpose. A minimum of 50 does must be biopsied in order to continue in this pathway.

5.11

If all laboratory tests for scrapie are negative, the flock/herd may officially apply to enter the VSFCP and, if accepted, enter level B.

5.12

Upon acceptance into the program, brain samples from all sheep or goats over 12 months of age that die on the farm (deadstock) must be submitted for scrapie testing by a CFIA-approved laboratory.

5.13

Females and embryos acquired from flocks/herds of an equivalent or higher status will not have an impact on the status of the recipient flock/herd.

On the other hand, the acquisition of females or embryos from flocks/herds of lower status will result in the lowering of the status of the recipient flock/herd to that of the flock/herd of origin.

5.14

In order to apply to advance to level A, any breeding females that were purchased from other farms prior to entering the VSFCP but were not 12 months or older (and thus did not have a rectal biopsy) at the time of the first testing must now be subject to rectal biopsy. These results must be submitted along with the annual report and the request to advance to level A.

5.15

The flock/herd may advance to the certified level as per pathway 1. Once a flock/herd has reached the certified level, it maintains this level provided that the requirements for this level (deadstock surveillance, acquisitions) are followed. An annual request, with the accompanying annual report including animal inventory and all supporting documentation, must be submitted to the status assessor.

6 & 7. Program Specific Pathway 3

Note: This pathway is not available to goats.

There are two distinct ways in which a producer may prepare their flock for application into this pathway.

6. Whole-Flock Screening

6.1

A blood sample is collected from all breeding sheep and submitted for genotyping by a CFIA-approved laboratory.

6.2

Upon receipt of the results, all breeding females and males that are determined to be 171 QQ are removed from the breeding flock.

If any of the breeding stock to be retained have been bred, it will be necessary to determine the genotype of their progeny to determine if they may also be retained.

6.3

After removing 171 QQ sheep from the flock, an updated inventory documenting that all remaining breeding sheep are 171 RR or 171 QR must be conducted under the supervision of a veterinarian accredited to deliver the VSFCP. At this point the producer may officially apply to enter the VSFCP and, if accepted, enter level A.

6.4

Commencing upon acceptance into the program, brain samples from all sheep over 12 months of age that die on the farm (deadstock) must be submitted for scrapie testing by a CFIA-approved laboratory.

6.5

Newly purchased breeding stock must be genotyped 171 QR or 171 RR by a CFIA-approved laboratory. This restriction also applies to semen.

6.6

Offspring (including embryos) from a mating involving at least one 171 RR parent (either ewe or ram) may be retained in the flock for breeding purposes without genotyping.

6.7

Offspring (including embryos) from all other matings (other than one involving at least one 171 RR parent) must be genotyped or removed from flock by 12 months of age. 171 QQ offspring must be removed by 12 months of age.

6.8

After one year of continuing the requirements for restrictions on genotype of introduced animals and deadstock surveillance and the compilation of a second annual inventory that documents the appropriate flock membership, the owner may apply for advancement in the VSFCP to certified level status.

6.9

Once a flock has received the certified level, it maintains this level provided that the requirements for this level (genotyping of offspring from non RR matings and genotype restriction on purchased breeding stock or germplasm; deadstock surveillance) are followed. An annual request, with the accompanying annual report (including animal inventory and all supporting documentation), must be submitted to the status assessor.

7. Rams-Only Screening

7.1

A producer starts by selecting breeding rams that are documented 171 RR.

7.2

Over subsequent breeding cycles, cull the flock such that all remaining sheep can be documented (by flock records) to be offspring of a 171 RR ram.

7.3

All subsequent breeding males, be they natural replacements, purchases or loans, must be 171 RR. Semen must be sourced from rams genotyped 171 RR. All breeding females, other than natural replacements, and embryos must be established by genotyping as 171 QR or RR.

7.4

At this point, an annual inventory documenting the removal of 171 QQ and ungenotyped sheep must be conducted under the supervision of a veterinarian accredited to deliver the VSFCP. At this point, the producer may officially apply to enter the VSFCP and, if accepted, enter level A.

7.5

Commencing upon acceptance into the program, a brain sample from all sheep over 12 months of age that die on the farm (deadstock) must be submitted for scrapie testing by a CFIA approved laboratory.

7.6

After one year of continuing the requirements for restrictions on genotype of introduced animals and deadstock surveillance and the compilation of a second annual inventory that documents the appropriate flock membership, the owner may apply to advance to the certified level of the VSFCP.

7.7

Once a flock has attained the certified level, it maintains this level provided that the requirements for this level (selection of replacement breeding rams genotyped twice and purchased ewes, and deadstock surveillance) are followed. An annual request, with the accompanying annual report including animal inventory and all supporting documentation, must be submitted to the status assessor.

Definitions

Commingled (mixed): animals grouped together with physical contact between the animals. This does not include limited contact (e.g. contact through a fence, pen separation). Commingling includes sharing the same section in a transportation unit where physical contact can occur.

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.

Flock: as defined in the Health of Animals Regulations.

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.

Limited contact: incidental contacts between animals off the premises of the flock/herd such as at fairs, shows, exhibitions and sales. 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.

Unique identification devices: 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.

171 QQ: include all results that do not identify arginine at codon 171 of the scrapie incubation gene (includes glutamine and histidine; QQ, QH, HH).

171 QR: include all results that do not identify the animal as a homozygote for arginine at codon 171 of the scrapie incubation gene, identifying arginine on one allele and the absence of arginine on the other (includes glutamine and histidine; QR or HR).

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