7.9 Appendix 3 - National Standards for Scrapie Flock Certification Program

Introduction

As there is no test to diagnose the disease in the individual live animal, "scrapie-free" status is determined based on the results of surveillance testing carried out on dead stock, screening the flock for presence of disease, removing genetically susceptible animals, restricting animals entering the flock, and the absence of clinical signs.

There are three separate paths that can be followed for a flock to achieve certified status. Pathway 1 involves limiting acquisitions to animals from similar or higher status flocks and ongoing surveillance through the submission of dead stock 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 for a registered flock to reach the Certified Level.

Pathway 2 involves genotype screening to determine adults who possess the genotype susceptible to scrapie and then screening these animals by the third eyelid test. Negative results gives a reasonable level of assurance that the disease is not present in the flock. Ongoing surveillance of dead stock continues to monitor for the presence of the disease.

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

The SFCP is carried out in cooperation 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 geographic regions of Canada.

1. Roles and Responsibilities

1.1 National Standards Development and Audit

Where the regional administration is assumed by organizations other than CFIA, it is CFIA’s responsibility to review any scrapie flock certification program proposed for the specific geographic region of Canada and determine equivalency to the published national scrapie flock certification 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 auditing program design and implementation to verify that the scrapie flock certification program in a particular geographic 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 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. Discrepancies between genotyping results from two laboratories will be subject to final genotype testing by CFIA genotyping laboratory.

The CFIA is responsible for developing and maintaining a publically accessible report (e.g. on Web site) of all enrolled flocks and their status. This report will be updated quarterly.

1.2 Regional Administrator

• 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 status certificates;
• collecting and collating all data on enrolled flocks in that region;
• issuing certificates indicating the status of a flock;
• 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;
• informing the CFIA SFCP co-ordinator of the status of all enrolled flocks on a quarterly basis; and
• designing an appeal process for decisions made with respect to the voluntary flock certification program, for example with regard to compliance with national standards.

1.3 Status Assessment or Status Assessor

• receiving and reviewing completed application for enrollment into SFCP;
• accepting flock into the appropriate level of the program or informing the producer/responsible veterinarian of outstanding requirements that prevent flock enrollment at that time;
• verifying initial and annual flock inventories and additional records for all additions and deletions are complete;
• suspending SFCP status in the event of reported irregularities;
• investigating flocks that are suspended and proceeding with reinstatement or revocation of SFCP status;
• updating the regional administrator of the SFCP of changes in flock status (additions, suspensions, revocations) as they occur;
• 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

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 Accredited Veterinarian’s Manual of Procedures module or provincial equivalent. The accredited veterinarian must sign the application form completed by the flock owner.

If the owner decides to no longer do business with the accredited veterinarian who signed the original application form, a new accredited veterinarian must be asked to sign a copy of the form, or if the situation has changed, a new application form.

Program delivery personnel are responsible for the following:

• reviewing the requirements of the program and responding to questions of the owner of premises applying for or enrolled in the program;
• teaching the owner to recognize the clinical signs of scrapie, providing information on the epidemiology of the disease and flock management;
• conducting or supervising a flock inventory;
• assessing the health of the flock 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 assure that the flock meets the program requirements;
• signing and submitting reports, including the annual inventory to the status assessor;
• collecting or supervising collection and submitting samples for genotyping; and
• collecting and submitting tissue samples from deadstock if the owner requests.

1.5 Laboratories

• 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 are not reported to the owner or the accredited veterinarian);
• providing required forms;
• providing appropriate shipping containers;
• notifying the owner, accredited veterinarian responsible for the flock, and 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 which 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

The owner or shepherd of a flock wishing enrollment in the SFCP is responsible for the following:

• identifying animals in the flock;
• providing the necessary facilities and assistance for inspection and handling of the animals;
• obtaining the services of a veterinarian accredited by the CFIA to deliver the SFCP;
• assisting the 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; and
• agreeing, on reasonable notice, to make the animals and records available so that the accredited veterinarian, the provincial regulatory agency, and the CFIA can inspect them.

2. Administration

2.1 Enrollment Procedure

The flock owner contacts the SFCP regional administrator and requests an application form to participate.

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:

• site plan of all buildings and grazing premises to which the animals are given access;
• the initial flock 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 SFCP may be possible for flocks which have met all program requirements for a number of years prior to application.

A flock 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.

2.2 Advancement/Downgrading

• the premises is not currently subject to CFIA actions related to the scrapie program; and,
• the flock has met the minimum requirements applicable to its current certification level.

To upgrade the flock’s certification status, the owner must submit a request, along with the annual report that would make the flock 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 responsible for the flock.

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, downgraded to a lower status or that the flock status is suspended. The decision is documented to the program participant and copied to the accredited veterinarian and the regional administrator.

Regardless of the certification pathway that is pursued, having 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 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.

2.3 Revoking Registration

An owner whose flock 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 the flock is suspended.

Any flock whose owner fails to submit an inspection report within the month following the end of the anniversary quarter will be automatically suspended.

The status assessor will notify the owner and the accredited veterinarian in writing of the reasons for the decision and will give the owner the opportunity to appeal within 60 days. The notice will include the name and address of the responsible person on the appeal committee as established by the status assessor.

An owner whose flock has been removed from the program because of a contravention of program rules may submit a new application after meeting the conditions stipulated in the program. In such cases, the owner must submit satisfactory proof to the status assessor that steps have been taken to ensure that the flock will continue to meet the program requirements in the future. In the case of a flock that is reinstated in the program, the reinstatement level will depend on the reasons for suspension. The flock will not be automatically reinstated at its previous level. In cases in which the flock 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 flocks to scrapie, an owner may lose the privilege of registering a flock in the program.

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

2.4 Reports

The status assessor will submit a summary report, which will be sent to the regions and to CFIA headquarters so that the information can be included in the CFIA’s quarterly report and posted on the CFIA Web site (Levels E, D, C, B, A, and Certified). Flocks whose report is not submitted to the status assessor within the prescribed time will be identified on the Web site as being suspended.

The quarterly report published by the CFIA will be produced and automatically distributed to all provinces, and/or published on the Web site. It will list all registered and certified flocks 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

3. General Rules

For all animals in the flock, the basic minimum data that must be maintained in the flock records includes the following:

• the animal’s identifiers;
• date the animal entered the flock (day if available, month and year);
• sex;
• source of the animal (homegrown, purchased, loaned);
• if the animal is not born in the flock the name and address of the person from whom it was obtained along with the flock status certificate issued for the flock of origin of female animals;
• date the animal left the flock;
• reason for leaving flock and appropriate documentation (shipped - shipping invoice, sold - receipt, died);
• scrapie testing results for deadstock > 12 months of age.

Additional information that is required for pathway 3:

• identifiers of the sire and dam;
• genotype testing results as required by the pathway specific requirements.

• all identification of each sheep and goat on the premises at the time of the inventory;
• all identification devices placed on each sheep/goat, including the current lamb/kid crop and any sheep or goats that have lost identification devices;
• all sheep/goats that have entered or left the premises since the last inventory;
• the status of the flock of origin for those sheep/goats entering the premises;
• all deaths;
• the destination of every sheep/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/goat; and,
• appropriate laboratory results (genotyping or scrapie testing).

The report must be forwarded to the status assessor within the anniversary quarter of when the certified flock was registered.

The status assessor should consider the following as automatic exemptions from the requirement to submit, unless the status assessor suspects the conditions set out were not met or that the exemption is being abused to the detriment of the flock certification program.

Breeding ewes that are required to be genotyped 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 CFIA.

4. Specific Program Pathway 1

• from flocks registered in the SFCP at an equivalent or higher certification level (anniversary quarter will be taken into consideration); or

• from a country the CFIA recognizes as free from bovine spongiform encephalopathy and scrapie; or,

• from a flock 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 equivalent to the Canadian program.

5. Program Specific Pathway 2

6 & 7 Program Specific Pathway 3

6. Whole Flock Screening

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

7. Ram Only Screening

• 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.

• 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.

• A flock as defined in the Health of Animals Regulations.

• Certificate issued by the status assessor specifying the flock’s location and status, indicating the date of issue, and identifying animals leaving the flock following their sale.

• Incidental contacts between animals off the flock’s premises, e.g. fairs, shows, exhibitions and sales. Limited contacts do 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 other flocks for breeding or other purposes.

• Permanent, unique, traceable and secure (e.g. electronic identification, tattoo, tamper proof tag).

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

• Include all results that do not identify the animal as a heterozygote 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).