Chapter 13 – Chronic Wasting Disease Herd Certification Programs

13.1 The disease – September 2020

Etiology

1. Chronic wasting disease (CWD) is a fatal disease that affects the central nervous system of cervids, and occurs in both captive and free-ranging populations. CWD is a naturally occurring member of a unique group of fatal neurological diseases called transmissible spongiform encephalopathies (TSEs). Although the precise cause of these diseases has been the subject of significant debate, the abnormal prion protein hypothesis is now widely accepted. This abnormal prion protein converts normal host prion proteins into the abnormal pathological form, and as this process continues to occur it leads to neurodegeneration and death. The accumulation of this abnormal prion protein in the brain is believed to cause the clinical signs of the disease.

Susceptible species

2. CWD is the only TSE found in free-ranging animals. Susceptible cervid species that have been found to be naturally infected with CWD include Rocky Mountain elk (Cervus elaphus nelsoni), white-tailed deer (Odocoileus virginianus), mule deer (Odocoileus hemionus), red deer (Cervus elaphus elaphus), moose (Alces alces shirasi), reindeer (Rangifer tarandus tarandus), black-tailed deer (Odocoileus hemionus columbianus),sika deer (Cervus nippon), and Manchurian Sika deer (Cervus nippon manchuricus). Muntjac deer (Muntiacus reevesi) are experimentally susceptible to oral CWD infection. Caribou (Rangifer tarandus caribou) are closely related to reindeer and are likely also susceptible to CWD.

Distribution

3. CWD is known to be present in free-ranging and/or captive cervids in 26 states and 3 provinces in North America, in captive cervids in the Republic of Korea, and in free-ranging cervids in Norway, Sweden and Finland. In Canada, CWD has been identified in both free-ranging and captive cervids in Alberta and Saskatchewan, and in captive cervids in Quebec.

Epidemiology

4. CWD is the most contagious of the 3 major TSEs of animals. The primary routes of transmission are direct animal-to-animal contact, and indirect exposure to contaminated environments, feedstuffs and fomites. The shedding of the CWD agent into the environment in excretions and secretions of an infected animal during the pre-clinical or clinical disease, and by its carcass after death (if not properly disposed of), is an important factor in disease transmission.

In areas where CWD is present in free-ranging cervids, direct fence line contact and contaminated wild environments are of particular concern. CWD prion may interact with certain soil types in different ways and may be taken up into roots and leaves which may then be consumed by grazing and browsing cervids.

The CWD prion (and other TSE prions) is highly resistant to both chemical and physical denaturing, and thus can persist in the environment. The agent can survive in soil for extended periods of time and is resistant to dry heat up to 600°C, sunlight, freezing, and desiccation.

Pathogenesis

5. The pathogenesis of CWD involves the conversion of a normal cellular prion protein PrPC to the abnormal disease-associated isoform (PrP^CWD). The lowest dose to cause infection is not definitively known, but has been predicted to be extremely small. The accumulation of PrP^CWD within the central nervous system is the primary event leading to neurodegeneration and the manifestation of clinical signs. During the course of disease PrP^CWD also disseminates to systemic lymphoid tissues and eventually infects all areas of the body. It has been detected in peripheral nervous tissue, lymphoid tissue, feces, urine, saliva, muscle, blood and many internal organs of infected cervids.

There is species variability in the pathogenesis of the disease in deer and elk. In white-tailed deer, the abnormal prion accumulates in cranial lymphoid tissue (such as the retropharyngeal lymph nodes and tonsils) before it can be detected in the brain. In elk, however, the distribution of PrP^CWD in the brain and cranial lymphoid tissue is more variable. Some elk in the preclinical stage of infection will test positive in the obex but do not have detectable levels of PrP^CWD in the retropharyngeal lymph nodes. Many elk show deposits in obex and lymphoid tissue and some in lymphoid tissue only. This variability requires submission of both brain and lymphoid tissue for testing regardless of the species under investigation for CWD.

The typical incubation period of CWD in captive cervids has been observed to be 16 to 36 months. Shedding can occur during the preclinical stage, which may last from a few months to years. The clinical period is generally less than 12 months. CWD-infected cervids can be infectious to other cervids for up to 18 months prior to their death.

CWD is invariably fatal.

Clinical signs

6. CWD should be considered in any cervids over 12 months of age exhibiting clinical signs such as the following:

• excessive salivation
• unusual behaviour (including decreased interactions with other animals)
• listlessness
• depression
• aggressive or violent behaviour
• neurological signs (including paralysis, difficulty in swallowing, head pressing, ataxia, polydipsia/polyuria, proprioceptive deficits, and recumbency)
• weight loss and/or poor body condition
• retention of winter hair coat
• pneumonia

Since many animals do not show overt clinical signs until late in the course of the disease, significant transmission of the CWD prion may occur prior to any visible indications of a disease problem. Signs usually last for weeks or months before the animal dies; however, some animals may not show clinical signs or may succumb to a fatal injury. As there is no treatment for CWD, clinical signs progress until the animal dies.

Differential diagnosis

7. The clinical signs associated with CWD can mimic other diseases of cervids, and may be very subtle in the early stages of the disease. The differential diagnosis of CWD may include the following:

• brain abscesses
• traumatic injuries
• meningitis
• encephalitis
• rabies
• peritonitis
• pneumonia
• arthritis
• parasitism
• starvation and nutritional deficiencies
• dental attrition

Laboratory diagnosis

8. CWD is diagnosed through detection of the abnormal prion protein in brain or lymphoid tissue. Gross pathological lesions are non-specific and our ability to detect CWD in live animals is limited. Therefore, the definitive diagnosis is based on laboratory analysis of post-mortem specimens to detect the abnormal prion protein.

The tissues to submit for diagnosis of CWD are the obex of the medulla oblongata and the retropharyngeal lymph node (RPLN). The primary target tissue tested for all members of the family Cervidae (with the exception of members of the genus Odocoileus), such as elk, red deer, reindeer, sika deer, and fallow deer is the obex of the medulla. The primary target tissue tested for Odocoileus species (including white-tailed deer and mule deer) is the RPLN.

There are 3 tests currently validated by the CFIA for diagnostic use. The CFIA-approved TSE network laboratories are approved to perform the Bio-Rad TeSeE® enzyme-linked immunosorbent assay (ELISA), which is designed as a large-scale screening test. Confirmation of CWD in non-negative samples is performed at the CFIA's National and World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) Reference Laboratory for CWD using a gel electrophoresis immunoassay (Western Blot), and/or immunohistochemistry (IHC). Both Western Blot and IHC confirm ELISA results and are used to differentiate TSE strains.

Immunity

9. No immune response to the CWD prion protein has been detected.

Public health

10. At this time there is no direct scientific evidence that CWD may be transmitted to humans. Health Canada recommends that any tissue which may come from a known CWD-infected animal not be consumed by humans.

13.2 Policy and principles of control – September 2020

Policy statement

1. The national Chronic Wasting Disease Herd Certification Programs (CWD HCP) are voluntary programs that cervid owners/cervid farm operators can choose to join. Any owner or operator of a licenced (where applicable) farmed cervid premises who agrees to comply with CWD HCP requirements may apply to enrol; however, once they are participating in a program, their compliance with the national standards is mandatory. CWD HCP requirements apply to all animals of the family Cervidae (including, but not limited to, animals of the genera Cervus, Odocoileus, Dama, Alces, Rangifer, and any hybrids).
The objectives of the CWD HCPs are to provide owners/cervid farm operators with:

• a means of detecting and preventing introduction of chronic wasting disease (CWD) in their herds
• the opportunity to have their herds identified as participants in Canada's national CWD compartment program of "low risk" animals with respect to CWD
• an opportunity to be eligible for the Canadian Food Inspection Agency's (CFIA) CWD compartment response, including destruction and compensation if eligible, if CWD is confirmed in the herd

There is recognition that the risk of CWD diminishes to low with progressive participation and successful annual advancement in a CWD HCP. Enrolment in a CWD HCP provides reasonable assurance that purchasing cervids from producers enrolled at an equal or higher CWD HCP status level maintains the farm's current level of risk specific to exposure to CWD. Import requirements of other countries for cervids may be based on enrolment or activities under a CWD HCP.

Statutory authority

2. CWD is a reportable disease under the Reportable Diseases Regulations, prescribed pursuant to section 2 of the Health of Animals Act. Any person who suspects an animal is demonstrating signs consistent with CWD must report that animal to a federal veterinarian at a Canadian Food Inspection Agency (CFIA) district office.
The primary role of the CFIA in the CWD HCPs is development of the National Standards, through the use of a consultative process, and audit of third-party administrators for compliance with these standards.

Export certification

3. Animals from herds enrolled in a CWD HCP may be certified and endorsed by the CFIA as participating in a program that meets the National Standards. The CFIA will work to gain international recognition of the National Standards. Certificates documenting participation and CWD HCP status level are obtained from the regional administrator.

Principles for disease control

4. Only a few viable tools exist to deal with CWD. There are currently no validated tests to definitively rule out CWD in live animals, either individually or as a herd. As a result, disease prevention is the most effective control measure. Cervid owners and cervid farm operators can mitigate the risk of CWD by participating in a CWD HCP.

The CWD HCP National Standards are founded on 4 pillars:

1. maintenance of accurate, complete inventory records in which all cervids are accounted for
2. ongoing testing of deaths and slaughter cervids
3. limiting herd introductions to enrolled cervids of a similar or higher CWD HCP level
4. the implementation of the CWD HCP biosecurity measures

A minimum of 5 years is necessary for an enrolled herd to reach the certified level.

The CFIA's CWD disease control program is based on the World Organisation for Animal Health (WOAH) concept of compartmentalization. Compartmentalization identifies a group of animals having a distinct health status based on biosecurity management and husbandry practices. Herds enrolled on a CWD HCP may be recognized as participants in Canada's national CWD compartment program of "low risk" animals with respect to CWD. Promoting compartmentalization in the national disease response program supports cervid owners and cervid farm operators who are taking measures to keep CWD out of their farms.

A CWD suspect is any animal that has CWD as a differential diagnosis. The CFIA implements disease investigation procedures as soon as a clinical suspect is reported.

A CWD-positive animal is any animal in which CWD positive results were reported by the CFIA's National and WOAH Reference Laboratory for CWD using at least 2 CFIA-approved CWD tests applied to lymphoid and/or brain tissues. The current CFIA-approved CWD tests are the Bio-Rad ELISA, immunohistochemistry (IHC) and Western Blot. All confirmed cases of CWD result in immediate suspension from the CWD HCP (if applicable).

Confirmation of CWD in a herd will trigger the CFIA's CWD disease response. Enrolled herds that have achieved level D or higher of a CWD HCP will be eligible for the CFIA's CWD compartment response, which includes movement controls, ordering destruction and disposal of infected herds, ordering cleaning and disinfection of contaminated premises, and providing compensation to producers. For more information on CFIA's CWD disease response, see chronic wasting disease – what to expect if your animals may be infected.

13.3 Accredited veterinarian's responsibilities – December 2021

Preliminary activities

1. Obtain and read chapter 13 Chronic Wasting Disease Herd Certification Programs of the Accredited Veterinarian's Manual, including the National Standards for the Chronic Wasting Disease Herd Certification Programs (CWD HCP).

2. Schedule a meeting with the local Canadian Food Inspection Agency (CFIA) district veterinarian to review the terms and conditions for accreditation, and discuss the duties and procedures that the accredited veterinarian must follow for the delivery of a CWD HCP. This will include a review of the regional CWD HCP requirements.

3. A tutorial or a review of the transmissible spongiform encephalopathy (TSE) brain and lymph node sampling techniques in cervids is suggested at this time. Videos of TSE sampling techniques are available through the Public Health Agency of Canada's training platform. To access the videos:

1. visit the public health training website
2. choose desired language
3. create an account
4. fill in your profile
5. you will receive an email to complete your registration
6. complete the registration using the enrolment key C64A0123
7. go to
   • Courses
   • Learning Communities
   • Canadian Food Inspection Agency (CFIA)
   • Animal Health
   • Transmissible Spongiform Encephalopathies/Encéphalopathie spongiforme transmissible

4. Establish a valid accreditation agreement with the CFIA for the delivery of the CWD HCPs. For more information on the Accredited Veterinarian program, refer to chapter 1 of the Accredited Veterinarian's Manual.

5. Advise the cervid owner/cervid farm operator to contact the regional administrator (RA) to learn the requirements to participate in, advance, and maintain certification in the regional CWD HCP. Contact information for the current regional administrators is found in Appendix A of chapter 13 of the Accredited Veterinarian's Manual.

6. Discuss the requirements of the CWD HCP with the owner/cervid farm operator. Assess the facilities, herd management, and record-keeping practices to gauge the degree to which the producer can be successful, and to identify any changes in record keeping or management that are necessary to meet CWD HCP requirements.

General responsibilities

7. The accredited veterinarian's role in delivery of a CWD HCP is vital. The accredited veterinarian works closely with the owner/cervid farm operator to ensure that all CWD HCP requirements are met. Responsibilities of the accredited veterinarian include:

• reviewing CWD HCP requirements with owners/cervid farm operators, while ensuring the owners/cervid farm operators understand and can meet these requirements
• assessing the facilities, structures and management practices on a premises, and notifying the owner/cervid farm operator of any potential biosecurity concerns
• teaching owners/cervid farm operators to recognize clinical signs of CWD, to understand the epidemiology of CWD, and to prevent CWD through the use of husbandry skills
• ensuring that the owner/cervid farm operator is familiar with obligations to notify CWD as a reportable animal disease under the Health of Animals Act
• supervising approved third parties as necessary (accredited veterinarians engage approved third parties at their discretion)
• performing the annual inspection
• collecting and submitting samples, as may be requested
• checking records and signing any necessary reports, including initial CWD HCP application form and annual reports.
• ensuring that all verifications are true and accurate
• assessing the health of the herd to determine whether any cervid is demonstrating clinical signs of CWD
• notifying the CFIA of the existence of any cervid suspected of having CWD

Refer to section 1.4 Accredited veterinarians, approved third parties and sample collectors of the National Standards for more information on the roles and responsibilities of accredited veterinarians.

8. The CWD HCPs are carried out in co-operation with cervid owners, cervid farm operators, accredited veterinarians, provincial/territorial governments, industry stakeholder organisations, approved laboratories and the CFIA. The roles assumed by each of these organizations may vary in different provinces of Canada. Roles and responsibilities of each of these partners are listed in the CWD HCP National Standards:

• owner/cervid farm operator responsibilities include those listed in section 1.6 Owners/Cervid Farm Operators
• owners/cervid farm operators have overall responsibility for program compliance and ensuring program delivery

Inventories, annual inspection, and annual report

Annual inspection

9. The accredited veterinarian must visit the enrolled herd at least once a year to conduct the annual inspection. The annual inspection must occur within 3 months of the anniversary date, and includes:

• visual inspection of the premises to verify that biosecurity requirements are met
• observation of the general health of the herd
• verification of the implementation of specific regional CWD HCP requirements, as determined by the status assessor
• verification of the inventory reconciliation

Refer to section 4.1.2 Annual Inspection of the National Standards for more information on the annual inspection.

Inventories

10. An inventory must be conducted every year and must occur within 3 months of the anniversary date.

The third-party inventory is conducted at least every 3 years. The third-party inventory is conducted by the accredited veterinarian or by an approved third party (for example, an animal health technician who is registered under the appropriate provincial/territorial licensing body and supervised by an accredited veterinarian, provincial/territorial staff, CFIA inspector/veterinarian). Refer to section 1.4 Accredited veterinarians, approved third parties and sample collectors of the National Standards for more information on approved third parties.

During a third-party inventory, every live cervid in the herd 12 months of age and older must have its identity confirmed and be observed closely enough to check for any clinical signs of CWD.

A producer inventory may be conducted in the years when a third-party inventory is not required.

11. The reconciliation of inventories must be verified by the accredited veterinarian. Reconciliation of the current inventory with the previous year's inventory will account for every cervid 12 months of age or older and include supporting documentation, such as status certificates for introductions of live cervids and embryos, laboratory reports, bills of purchase and sale, and cervid movement permits.

Refer to section 3.9 of the National Standards for more information on documentation requirements and section 4.1.1 for more information on inventories.

Annual report

12. The annual report is the responsibility of both the accredited veterinarian and the owner/cervid farm operator. The annual report contains the annual inspection report, the reconciliation of the inventories with supporting documentation, laboratory reports, and documentation related to biosecurity.

Refer to section 4.1.3 of the National Standards for more information on the annual report.

When the accredited veterinarian is satisfied that the annual report adequately documents all CWD HCP requirements, the report is signed and forwarded to the status assessor. The annual reported must be submitted within 3 months of the anniversary date.

CWD surveillance

13. Testing is the most important CWD HCP pillar. All cervids 12 months of age or greater that die, are humanely euthanized, or are hunted on farm must be tested for CWD. Refer to section 4.2.1 Annual surveillance requirements of the National Standards for more information on the testing requirements.

Laboratories approved by the CFIA for CWD testing are listed in Appendix D of chapter 13 of the Accredited Veterinarian's Manual.

14. The obex of the medulla and the retropharyngeal lymph node must both be submitted for CWD testing. Refer to Appendix B of chapter 13 of the Accredited Veterinarian's Manual for sampling procedures.

15. The head of the cervid may be submitted directly to an approved laboratory by the owner/cervid farm operator or the accredited veterinarian may collect tissue samples for submission to the laboratory. In all cases, heads or tissue samples should be chilled or frozen immediately upon being found. The head of the cervid must bear all identification in situ and all samples must be accompanied by identification.

Sick animals

16. Owners/cervid farm operators are required to report to their accredited veterinarian any illness in a cervid 12 months of age and older lasting longer than 2 weeks that is refractory to treatment, except a physical injury that has lasted longer than two weeks and is improving at the normal or expected rate. The accredited veterinarian is responsible for monitoring progression of the reported cervid illness and for notifying the CFIA veterinary inspector if CWD remains on the rule out list.

Limited entry

17. An enrolled herd may introduce live cervids and embryos only from herds at an equivalent or higher CWD HCP status level with no negative impact on the CWD HCP status level of the recipient herd. Introductions from lower status or unenrolled herds will result in a downgrading of the herd's status level. Appropriate documentation is required for every cervid that is born on or enters the herd.

Refer to section 4.3, Limited Entry of the National Standards for more information regarding the restrictions on introductions to the herd.

Biosecurity

18. The accredited veterinarian will work with the owner/cervid farm operator to review the regional CWD HCP biosecurity plan and identify any facilities or management changes required for successful implementation. The biosecurity plan will address risks posed by inadequate fencing, feed storage, water sources, vehicles, taxidermy and carcasses, and previously owned equipment.

Refer to section 4.4, Biosecurity of the National Standards for more information regarding biosecurity requirements.

13.4 2021 National Standards for the Chronic Wasting Disease Herd Certification Programs (CWD HCP) – December 2021

• Introduction
• 1. Roles and responsibilities
  • 1.1 National administrator
  • 1.2 Regional administrator
  • 1.3 Status assessor
  • 1.4 Accredited Veterinarians, Approved Third Parties and Sample Collectors
  • 1.5 Laboratories
  • 1.6 Owners/cervid farm operators
• 2. Administration
  • 2.1 Enrolment procedure
  • 2.2 Advancement or changes to status
  • 2.3 Suspension/revocation/withdrawal
  • 2.4 Appeals
  • 2.5 Reporting
  • 2.6 Review of the national standards
• 3. General Rules
  • 3.1 Regional CWD HCP recognition
  • 3.2 Enrolment eligibility
  • 3.3 Legislative pre-eminence
  • 3.4 Herd includes all cervids
  • 3.5 Agreements
  • 3.6 Multiple premises
  • 3.7 Facilities
  • 3.8 Identification
  • 3.9 Records
  • 3.10 Prohibited material
• 4. Specific criteria for program pillars
  • 4.1 Inventories, annual inspection and annual report
  • 4.2 CWD surveillance in herd
  • 4.3 Limited entry
  • 4.4 Biosecurity
• 5. Definitions

Introduction

The national Chronic Wasting Disease (CWD) Herd Certification Programs (HCP) will be referred to in this document as CWD HCPs. Participation in a CWD HCP is optional; however, once owners/cervid farm operators are enrolled in a CWD HCP, their compliance with the National Standards and the standard operating procedures (SOP) in their regional CWD HCP is mandatory.

The objectives of the CWD HCPs are to provide owners/cervid farm operators:

• a means of detecting and preventing the introduction of CWD in their herd
• the opportunity to have their herds identified as participants in Canada's national CWD compartment program of "low risk" animals with respect to CWD
• an opportunity to be eligible for the Canadian Food Inspection Agency's (CFIA) CWD compartment response, including destruction and compensation if eligible, if CWD is confirmed in the herd

There is recognition that the risk of CWD diminishes to low with progressive participation and successful annual advancement in a CWD HCP. Enrolment in a CWD HCP provides reasonable assurance that purchasing cervids from owners/cervid farm operators enrolled at the same or higher level of a CWD HCP maintains the farm's current level of risk specific to exposure to CWD. Import requirements of other countries for cervids may be based on enrolment or activities under a CWD HCP. An owner/cervid farm operator of a licensed (where applicable) farmed cervid premises may enroll in a CWD HCP.

The CWD HCP requirements apply to all cervids of the family Cervidae, and involve the 4 CWD HCP pillars:

1. maintenance of accurate, complete inventory records in which all cervids are accounted for
2. ongoing testing of deaths and slaughter cervids
3. limiting herd introductions to enrolled cervids of a similar or higher CWD HCP level
4. implementation of the CWD HCP biosecurity measures

There are 6 levels in a CWD HCP, from the entry level, E, through levels D, C, B, A, to the highest level, "certified". A herd at certified level is not considered "CWD free"; rather, it indicates to potential purchasers that the herd is "low risk" for CWD, as all CWD HCP requirements set out in the National Standards have been followed for a minimum of 5 years. Since the ability to detect CWD in individual live cervids is limited, "low risk" status is maintained by continued adherence to all CWD HCP requirements.

The CWD HCPs are currently used for trade between owners/cervid farm operators within Canada, for export outside of Canada, for individual risk mitigation on enrolled farms, and for the CFIA to determine eligibility for its CWD HCP disease response program.

The CWD HCPs are carried out in co-operation with cervid owners, cervid farm operators, accredited veterinarians, provincial/territorial governments, outside contractors (for example, Canadian Sheep Federation) and the Canadian Food Inspection Agency (CFIA). The roles assumed by each of these organizations may vary in different geographic regions of Canada.

In Canada, CWD is a reportable animal disease as prescribed in the Reportable Diseases Regulations of the Health of Animals Act. Therefore, suspicion of CWD must be notified immediately to a CFIA veterinary inspector.

If the CFIA identifies any cervid in the herd as suspected of being, or confirmed to be, infected with CWD at any time during its enrolment, the herd will automatically be suspended by the status assessor, and may be investigated under any applicable CWD disease control program.

1. Roles and responsibilities

1.1 National administrator

This role and the associated responsibilities will be assumed by the CFIA in all situations. The national administrator oversees the integrity and international recognition of the regional CWD HCPs. The CFIA accomplishes this through the development and maintenance of National Standards for the CWD HCPs, including the following:

• undertaking a review of the CWD HCP National Standards in consultation with provincial/territorial governments, regional program administrators and industry, to modify and update as required
• providing the current National Standards (and any update directives) to the organizations responsible for regional administration (see section 1.2 Regional administrator)
• reviewing any CWD herd certification program proposed for a specific region of Canada and determining equivalency to the published CWD HCP National Standards
• conducting audits of CWD HCP design and implementation to verify that the CWD HCP in a particular region of Canada meets the national standards
• negotiating international recognition of the CWD HCPs and endorsing export certification by the CFIA, which will only be done for those CWD HCP certifications in good standing, and judged by the CFIA to meet the national standards
• assessing the equivalency of foreign CWD herd certification programs
• designing and implementing a quality assurance program for network laboratories performing transmissible spongiform encephalopathy (TSE) testing
• ensuring the maintenance of a publicly accessible list (for example, published on the CFIA website, or links to a status assessor's website) of all enrolled herds and their status levels (this list will be updated at a minimum on a quarterly basis)
• performing all confirmatory testing on non-negative samples at CFIA's National and World Organisation for Animal Health (WOAH) Reference Laboratory for CWD
• reporting confirmed positive results to the cervid owner/cervid farm operator and to the status assessor
• communicating with the regional administrator and/or status assessor when CFIA CWD disease control activities affect enrolled herds, including changes to a herd's CWD categorization (for example, if a CWD-exposed herd becomes a CWD-positive herd) and removal of regulatory controls (for example, when a CWD disease investigation concludes)

1.2 Regional administrator

This role and the associated responsibilities may be assumed by a national or provincial/territorial industry group, or a provincial/territorial government. The regional administrator is responsible for overseeing enrolment in the CWD HCP for a particular region of Canada, including the following:

• developing a CWD HCP that meets the national standards, and outlining all policies and procedures of that regional CWD HCP in a set of standard operating procedures (SOP)
• developing and distributing an agreement (application form) for entry into the CWD HCP, which is signed by the owner/cervid farm operator and the accredited veterinarian (this agreement must include a statement protecting the CFIA from any liability arising from the regional CWD HCP)
• developing and distributing forms required for the CWD HCP, including application, inventory, and annual report forms (the owner/cervid farm operator's annual report form will include a statement or checkbox indicating that there are no significant changes to the cervid operation)
• enrolling owners/cervid farm operators once they have met the requirements of the CWD HCP
• collecting and collating all data on enrolled herds in that region
• producing an inventory report, based on the previous year's inventory, and providing it to the appropriate program delivery person at least 1 month prior to the anniversary date
• upon request, issuing certificates indicating the status level of a herd or the status level of an individual cervid from that herd
• informing the national administrator of the status of all enrolled herds on a quarterly basis
• appointing and training status assessors and program delivery personnel (if a provincial/territorial program for accredited veterinarians is developed, it would need to be reviewed and approved by the CFIA)
• informing all enrolled owners/cervid farm operators, as well as staff of the regional administrator and status assessors, of any updates regarding the CWD HCP
• designing an appeal/review process for decisions made with respect to the CWD HCP that is in compliance with national standards

1.3 Status assessor

The role of assessor of herd status may be assumed by a national or provincial/territorial industry group, or a provincial/territorial government. The status assessor is responsible for the following:

• receiving and reviewing completed applications for enrolment into the CWD HCP
• accepting herds into the appropriate status level of the CWD HCP or informing the owners/cervid farm operators or the responsible veterinarian of any outstanding requirements that prevent enrolment at that time
• annually assessing enrolled herds to ensure each herd has met program requirements, including reviewing the annual report and verifying the reconciliation of the herd inventories, and informing owners/cervid farm operators of the outcome of the assessment
• approving all changes in status level and posting the status publicly (as outlined in sections 2.3 Suspension/revocation/ withdrawal and 2.5 Reporting, and in the regional administrator's SOP)
• investigating non-compliance with CWD HCP requirements, and suspending (and/or revoking) CWD HCP status when required
• communicating suspension to the owner/cervid farm operator
• investigating herds that are suspended and proceeding with reinstatement or revocation of CWD HCP status
• informing the regional administrator of changes in the status of a herd (additions, suspensions, revocations) as they occur
• implementing and conducting the appeal/review process
• developing and implementing a protocol for the reporting and re-introduction of escaped farmed cervids (a decision on the disposition of the escaped cervid(s), when recovered, will depend on a risk assessment of the level of CWD found in wild cervids in the immediate area)

1.4 Accredited veterinarians, approved third parties and sample collectors

1.4.1 Accredited veterinarians

Accredited veterinarians are accredited by the CFIA or the appropriate Regional Administrator's provincial/territorial government (where a provincial/territorial accreditation process exists) to deliver CWD HCP functions. Veterinarians employed within a provincial/territorial department responsible for farmed cervids are qualified to fill the role of the accredited veterinarian by virtue of their position, and do not require CFIA accreditation. Accredited veterinarians are authorized to conduct all aspects of program delivery, including all approved third-party activities.

CFIA-accredited veterinarians must consult module 13.3 of the Accredited Veterinarians' Manual for full details on their role. Veterinarians wishing to become accredited by the CFIA for the CWD HCP function should contact their CFIA district veterinarian.

Accredited veterinarians support owners/cervid farm operators in meeting CWD HCP requirements and verify the implementation of CWD HCP requirements. Accredited veterinarians are responsible for the following:

• reviewing the requirements of the regional CWD HCP with the owner/cervid farm operator and ensuring that the owner/cervid farm operator understands and is able to implement the requirements
• assessing the facilities, structures and management practices on a premises, and notifying the owner/cervid farm operator of any potential biosecurity concerns
• teaching the owner/cervid farm operator to recognize the clinical signs of CWD, and providing information on the epidemiology of the disease and herd management to prevent CWD
• ensuring that the owner/cervid farm operator is familiar with obligations to notify CWD as a reportable animal disease under the Health of Animals Act
• performing the annual inspection
• assessing the health of the herd to determine whether any cervid is demonstrating clinical signs of CWD
• notifying the CFIA of the existence of any cervid suspected of having CWD
• collecting and submitting tissue samples from dead cervids or those that are destroyed, as may be requested
• ensuring that all verifications are true and accurate
• supervising approved third parties as necessary (accredited veterinarians engage approved third parties at their discretion)
• checking records and signing any necessary reports, including initial CWD HCP application form and annual reports

1.4.2 Approved third parties

Approved third parties are approved by the regional administrator as eligible Program deliverers, and are trained and qualified to deliver certain aspects of the CWD HCP. Approved third parties may be staff of a provincial/territorial department or agency, an animal health technician who is registered under the appropriate provincial/territorial licensing body and supervised by an accredited veterinarian, or a CFIA veterinarian or inspector. Approved third parties are trained, qualified and approved for:

• performing initial herd inventories, third-party inventories and producer inventories
• informing the accredited veterinarian of any cervids showing signs of ill - health (see also Section 4.2.6 Reporting of cervid illness)
• collecting samples for CWD testing, only if certified as a CWD sample collector (section 1.4.3);
• assessing the accuracy of site plan;
• assessing premises, facilities, equipment and fences for compliance with biosecurity requirements

1.4.3 Certified CWD sample collectors

A certified CWD sample collector is an individual who has completed appropriate training and is certified by the regional administrator as authorized to collect samples for CWD testing. A certified CWD sample collector may be an approved third party or a cervid farm operator. He/she must operate at arm's length from the owner/cervid farm operator and may not collect samples from his/her own animals. A certified CWD sample collector is responsible for ensuring that, for all cervids presented for sample collection, all identification devices have been verified in situ.

1.5 Laboratories

A network laboratory is part of the National TSE Laboratory Network. Network laboratories are responsible for following the requirements identified in the Inter-laboratory Quality Guidelines for National TSE Network Laboratories. See Accredited Veterinarian's Manual module 13.5 Appendix D for a list of network laboratories. Network laboratories providing diagnostic testing services for the CWD HCPs are responsible for the following:

• receiving, preparing and testing tissue samples in accordance with standard diagnostic methodologies for the diagnosis of CWD as specified by CFIA's National and WOAH Reference Laboratory for CWD
• participating in the Inter-Laboratory Quality Assurance Program under the direction of the CFIA's National and WOAH Reference Laboratory for CWD, as described in the Inter-laboratory Quality Guidelines for National TSE Network Laboratories
• reporting of non-negative test results as outlined by CFIA
• arranging transfer of non-negative samples to CFIA's National and WOAH Reference Laboratory for CWD (in Ottawa) for confirmation
• reporting negative test results to the submitter
• assessing whether a tissue sample is adequate to permit diagnosis of CWD and notifying the submitter of samples that are unsuitable for testing
• ensuring all identification devices have been verified in situ as necessary
• providing the required sample submission forms
• disposing of tissues and carcasses in their possession in accordance with the environmental regulations in force in the province or territory. (Positive carcasses must be disposed of by burial, incineration or approved specified-risk material streams.)

1.6 Owners/cervid farm operators

Owners/cervid farm operators have overall responsibility for program compliance and reporting, and ensuring program delivery.

In these national standards, an owner is an individual, partnership, company, corporation or other legal entity that has legal or rightful title to a cervid or a herd of cervids, regardless of any liens held on the cervid(s). A cervid farm operator is a person who is licensed (where applicable) under the relevant domestic cervid farm regulations (where applicable) to operate a domestic cervid farm; this person may or may not be the owner. Owners/cervid farm operators are persons who have responsibility for the daily care and handling of all cervids on a premises. Owners/cervid farm operators can apply for herd enrolment under a CWD HCP. Individuals who own or lease cervids but do not have responsibility for all cervids on the premises cannot apply for herd enrolment under a CWD HCP.

Owners/cervid farm operators are responsible for:

• ensuring that the premises, the individual cervids and the herd meet the requirements of the National Standards and the regional CWD HCP
• ensuring submission of documentation as required by the regional CWD HCP
• procuring the services of an accredited veterinarian, with or without approved third parties (as in section 1.4 Accredited veterinarians, approved third parties and sample collectors) to deliver the CWD HCP
• maintaining fences that meet any applicable (federal, provincial/territorial) standards in a manner to prevent intrusion (ingress) or escape (egress) of cervids (see section 4.4.2 Fencing)
• providing the necessary facilities and assisting the accredited veterinarian or approved third party with inspection and handling of cervids for inventories and annual inspections
• reporting quarterly, to the status assessor and the appropriate provincial/territorial Ministry, the death of any cervid(s) 12 months of age and older
• reporting immediately to the CFIA district veterinarian any cervid suspected of being clinically affected by CWD
• reporting to the status assessor and the appropriate provincial/territorial Ministry, any cervids that have escaped, disappear or are otherwise missing from the premises as per the protocol outlined in the SOP
• reporting immediately, or with reasonable promptness, to the status assessor and the appropriate provincial/territorial Ministry, the entry of any wild cervids into the premises
• obtaining, maintaining and compiling all relevant documentation of cervid acquisitions, births, and departures (keeping records as per section 3.10)
• agreeing, with reasonable notice, to make the cervids and records available so that the accredited veterinarian, the provincial/territorial regulatory agency, the regional administrator/status assessor and/or the CFIA can inspect them

Any changes to the operation/premises, including the accredited veterinarian, must be reported to the regional administrator and/or status assessor. Documentation must be included in the owner/cervid farm operator's registration file.

2. Administration

2.1 Enrolment procedure

2.1.1 Application

The owner/cervid farm operator contacts the CFIA district veterinarian to determine the organization responsible for the CWD HCP in the region in which the herd is located.

The owner/cervid farm operator contacts the CWD HCP regional administrator and requests an application package.

An application package is completed and submitted to the organization responsible for status assessment. The application must be accompanied by the following:

• a biosecurity plan that provides verification that the biosecurity requirements in section 4.4 are met (the biosecurity plan requirement can be met by regional program verification procedures)
• an initial herd inventory, prepared by the accredited veterinarian or approved third party, within the three-month period immediately prior to acceptance of the application (see section 4.1.1 Inventories)
• confirmation that the record-keeping system enables the records to be reviewed completely and effectively

2.1.2 Assignment of status level

The status assessor reviews the application and assigns a status level upon official acceptance to the CWD HCP.

Accelerated admission up to level C of the CWD HCP may be possible for herds that have met all current CWD HCP requirements for 1 or more years prior to application. Documentation demonstrating that the current CWD HCP requirements were being met for that period of time must be provided. Advancement would only be for the number of years all CWD HCP requirements were being met, and documented, and only for a maximum of 3 years (level C).

2.1.3 Acquired status

CWD HCP status can be transferred to newly formed herds. If an owner/cervid farm operator starts a new herd with acquired cervids of level D or higher, the new farm can inherit the lowest status level of the source animals, provided the following conditions are met:

• the owner/cervid farm operator follows all regular application procedures as above
• the on-farm inventory is completed within 4 months of first arrival of animals on the premises
• the premises where the herd will reside meets the premises history requirements as outlined below in section 2.1.4

2.1.4 Premises history

An owner/cervid farm operator seeking to maintain the acquired status of a newly formed herd must determine if farmed cervids have been contained on the premises in the past and provide a letter stating that the premises where the herd will reside meets 1 of the following conditions:

• the premises has never contained farmed cervids, or
• the farmed cervids previously contained on the premises were enrolled on a CWD HCP, including proof of status level

If there were no farmed cervids on the premises previously, or the previous farmed cervids on the premises were enrolled on a CWD HCP, then the new herd may start at the lowest status level of the cervids being stocked on the premises or of the cervids previously contained on the premises, whichever is lower (following a risk assessment by the status assessor based on the VHCP compliance of the previous cervids).

If it is unknown whether farmed cervids were on the premises previously, or if the farmed cervids were not enrolled on a CWD HCP, the new herd must start at level E. If a CWD-positive herd was previously contained on the premises, the requirements outlined below in section 2.1.5 apply.

2.1.5 Previously infected premises

A herd being established on a premises where a CWD-positive herd has been subject to the CFIA CWD Disease Control Program may only be admitted to a CWD HCP at level E, no sooner than 1 year after cervids have been re-introduced to the premises, provided that:

• the CFIA has classified the premises as minimally contaminated or low risk
• all disease control actions (depopulation, cleaning and disinfection) have been completed, and
• any existing declarations of infected place and quarantines have been removed

Herds contained on premises evaluated as highly contaminated or high risk as defined by CFIA's CWD control program are not eligible for enrolment.

2.1.6 Anniversary date

The status assessor assigns an anniversary date upon official acceptance to the CWD HCP.

When requested by an owner/cervid farm operator, and at the discretion of the status assessor, an anniversary date may be changed if there is a legitimate reason and it doesn't provide an unfair advantage to the owner/cervid farm operator. This may be accomplished by advancing the date by up to 3 months each year until the desired date is reached.

2.1.7 Enrolment of CWD-exposed herd

A herd that has been classified as CWD-exposed or is being investigated under any CWD disease control program is not eligible for immediate enrolment.

A CWD-exposed herd can be accepted into a CWD HCP at level E no sooner than 3 years after the herd has been identified as a CWD-exposed herd unless the herd has been cleared of its CWD suspicion sooner.

CWD suspicion will be eliminated by negative CWD tests results of the individual cervids that are epidemiologically linked to a CWD-positive herd, with oversight as determined by the CFIA, and/or when CWD disease investigations have eliminated the CWD suspicion.

2.2 Advancement or changes to status

2.2.1 CWD HCP status levels

A CWD HCP includes 6 status levels, from the entry level (level E) to the highest level (certified). A minimum of 5 years (1 year each at level E, D, C, B, A) is necessary for an enrolled herd to reach the certified level. Once a herd has reached the certified level, it maintains this level provided all applicable requirements continue to be met.

2.2.2 Advancement

The status level of the herd may be upgraded annually (or maintained at the certified level) if the following conditions are met:

• the premises is not currently subject to any actions related to a CWD disease control program, and
• the herd has met all CWD HCP requirements

2.2.3 Annual report

The owner/cervid farm operator must submit an annual report, as per section 4.1.3 Annual report. All supporting documentation must be submitted to the status assessor for review and approval.

The completed annual report must be signed by the owner/cervid farm operator and the accredited veterinarian. Specific criteria for advancement can be found in section 4 Specific criteria for program pillars.

For all status levels, the status assessor reviews the annual report and approves advancement (or continuation at the certified level), or identifies deficiencies that prevent advancement. The status assessor must document the decision-making rationale.

Criteria for decision-making are to be included in the regional administrator's SOP. Once a decision is made, it is documented to the owner/cervid farm operator.

2.2.4 Delay in submission of annual report

Failure to submit an annual report within 15 months of the anniversary date will result in suspension from the CWD HCP.

Before suspension, the status assessor will undertake an investigation/review. If the delay in submission was due to circumstances beyond an owner's/cervid farm operator's control (for example, emergency, serious illness or death in the family, etc.), the status assessor may, at his or her discretion, grant an extension and has 1 week to decide whether to grant said extension. If an extension is granted, it should be limited to no more than 2 weeks from the original deadline, after which the suspension will take effect.

2.2.5 Deficiencies

When deficiencies are identified, the status assessor may require that the current status level be maintained or the herd be suspended until the deficiencies are addressed. This decision is at the discretion of the status assessor. However, this should be no longer than 1 year, after which the status of the herd will be suspended, downgraded or revoked.

2.3 Suspension/revocation/withdrawal

2.3.1 Suspension

Suspensions are intended to be precautionary measures to temporarily sequester a herd from other enrolled herds when a gap in information obscures the herd's CWD risk status level.

While a herd is suspended, it remains enrolled but has no officially recognized status level (E, D, C, B, A or certified) of risk mitigation for CWD on a CWD HCP. After investigating the situation that led to the suspension, the status assessor must decide on an outcome of the suspension. The 4 possible outcomes of the investigation are:

• 1) the herd is reinstated and advanced to an appropriate level or maintained at the certified level
• 2) the herd is reinstated but is not advanced or is downgraded to a lower level
• 3) the suspension is maintained until the CWD risk status can be more fully understood or
• 4) the herd's enrolment on the CWD HCP is revoked

See section 2.5 Reporting for information on how a suspension is indicated in the published list of enrolled herds.

2.3.2 No issuance of status certificates while suspended

When a herd enrolled in a CWD HCP has its status suspended, status certificates will not be issued until the suspension is lifted and the herd is reinstated in the program. The sale or transfer of a cervid from a suspended herd to an enrolled herd would have a detrimental effect on the CWD HCP status of the purchasing herd. See section 4.3 Limited entry for more information. Any movements are always subject to provincial and territorial regulations where applicable.

2.3.3 Reasons for suspension

Reasons for suspension include the following:

• a biosecurity breach that requires surveillance over time to resolve the CWD risk associated with this breach
• the owner/cervid farm operator does not submit the annual report within 15 months of the anniversary date
• the herd has failed to meet the testing criteria or any other criteria for advancement (and none of the exemptions apply)
• suspicion of CWD, including being subject to a CWD investigation under any CWD disease control program or being identified as a CWD-exposed herd
• any contravention of CWD HCP requirements

2.3.4 Investigation of suspended herds

Suspended herds must be investigated in a timely manner by the status assessor . The cause of the suspension and the requirements for resolution of the suspension will be determined and communicated to the owner/cervid farm operator.

If the suspension has been initiated by deficiencies in the annual report, the investigation should include a discussion with the owner/cervid farm operator to determine the reason for the non-compliance, to ensure that the requirements of the CWD HCP are well understood, and to take steps to help the owner/cervid farm operator comply. Where it has been determined that the herd will not be able to comply with the CWD HCP requirements in the near future, the status assessor revokes the enrolment.

2.3.5 Revocation procedures

An owner/cervid farm operator whose herd is under review for possible revocation from the CWD HCP 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. The status assessor will notify the owner/cervid farm operator in writing of the reasons for the suspension and give the owner/cervid farm operator the opportunity to appeal within the following 60 days. The notice will include the name and address of the lead person responsible for the appeals review committee, as established by the status assessor.

2.3.6 Suspension time limit

A herd that has been suspended due to an annual report deficiency or other non-compliance may only remain suspended for a period of up to 1 year. Herds may be suspended for longer than 1 year if the suspension has been placed due to an investigation under a CWD disease control program or to clear CWD risk following a biosecurity breach.

2.3.7 CWD disease investigation

If an enrolled herd is identified as CWD exposed, the herd will automatically be suspended and investigated under any applicable CWD disease control program. Once the investigation is complete, CFIA will inform the status assessor of the finding and the herd's risk. The status assessor will use this information to determine the outcome of the suspension (reinstate, downgrade or revoke).

2.3.8 Reinstatement following suspension

Once a herd has been cleared of its CWD-exposed status or CWD risk, then the herd will be re-instated and will regain the status level it would have achieved but for the disease investigation, provided all CWD HCP requirements were met during the suspension period.

2.3.9 Revocation of CWD-positive herd

If a participating herd is found to be infected with, or a source of CWD, its enrolment will be revoked.

2.3.10 Re-enrolment following revocation

Re-enrolment following revocation may be considered at the discretion of the status assessor; however, all herds re-enrolling after revocation must do so beginning at level E.

An owner/cervid farm operator whose herd has been removed from a CWD HCP due to contravention of CWD HCP requirements may submit a new application after meeting the conditions stipulated in the CWD HCP. In such an instance, the owner/cervid farm operator must submit satisfactory proof to the status assessor that steps have been taken to ensure that the herd will meet the CWD HCP requirements in the future. Conditions may be imposed by the status assessor during the first year of re-enrolment. In instances where the herd was removed for reasons of information falsification, failure to report to a CFIA veterinary inspector that a cervid might have CWD, or any other action that might expose other cervids to CWD, an owner/cervid farm operator may lose the privilege of registering in a CWD HCP.

2.3.11 Voluntary withdrawal

An owner/cervid farm operator who chooses to withdraw his/her herd from the program must notify the regional administrator of the withdrawal.

2.4 Appeals

2.4.1 Appeals/review eligibility

An owner/cervid farm operator may appeal a decision regarding advancement or downgrading in the event of an incomplete or unsatisfactory submission of the annual report, which includes appealing a decision by the status assessor not to accept an exemption, or sacrifice(s), for missed sample(s). An owner/cervid farm operator may also appeal a suspension or a revocation of registration, but not both. Furthermore, an owner/cervid farm operator may appeal a decision made by the status assessor regarding conditions imposed before the herd is allowed to participate in a CWD HCP after a suspension or revocation.

2.4.2 Appeals/review design

The regional administrator must design an appeals/review process. At the request of the owner/cervid farm operator, the status assessor will implement the appeals/review process to consider the submitted appeals. The appeals/review committee will provide the status assessor with a recommendation as to whether the appeal should be accepted. A representative of the status assessor will be the non-voting chairperson of the committee. A representative of the appropriate cervid organization may assist the committee to provide information related to the cervid industry. In order to ensure consistency in the appeals process between regional programs and provide clarification on the National Standards, it is required that a representative of the CFIA observe the appeal as a non-voting member of the committee.

2.4.3 Appeals/review committee composition

The individuals appointed must each represent 1 or more of the following groups:

• an employee of the provincial/territorial veterinary authority
• an employee of any provincial/territorial department responsible for regulation of the farmed cervid industry
• a professional employee of a college or university who is familiar with the cervid industry
• a producer representative of the small ruminant industry and currently enrolled in the Scrapie Flock Certification Program (SFCP ), or
• a representative of the status assessor from another Canadian regional CWD HCP

2.4.4 Appeals/review procedure

The request for appeal must be made in writing by the owner/cervid farm operator to the status assessor, and set out the reasons why the appeal should be considered.

The committee may consider appeals in written form or via teleconference, and need not meet in person. All references to an owner's/cervid farm operator's personal information are to be removed/hidden from the appeals review documents sent to the committee representatives. An owner/cervid farm operator has the option of being present on a teleconference to present material.

After review and consideration of the appeal/review committee's recommendations, the status assessor makes the final decision regarding the appeal.

2.4.5 Scientific review committee

Where the status assessor believes the recommendation of the appeals review committee would jeopardize the integrity of the CWD HCP, the status assessor may convene a further committee consisting of the CFIA Veterinary Program Specialist responsible for CWD or a delegate, and 2 provincial/territorial government veterinarians from provinces/territories where the government is responsible for regulation of the cervid industry. A representative of the national cervid organization will be an ex-officio (non-voting) member of the committee. Following consultation with these additional individuals, the status assessor makes the final decision regarding the appeal. The decision and associated rationale are documented by the status assessor and placed in the associated herd's file.

2.5 Reporting

Information sharing requires that all herd information relevant to CWD or the population of the herd—including registrations, suspensions, revocations, changes in status, inventories, test results, movement permits, deaths, or sales—be available to the owner/cervid farm operator, the appropriate provincial/territorial department or agency, the regional administrator, the status assessor, the accredited veterinarian and the CFIA.

The regional administrator will maintain a list of all herds enrolled in the CWD HCP, along with their current level, on their website (or on CFIA's website, should the organization not have this capability). The owner/cervid farm operator must agree to allow publication of the herd status level under the CWD HCP at all times. Herds that have been suspended for any reason may be published with the indication of their suspended status or they may be removed entirely from the published list of enrolled herds until the suspension has been resolved, as determined by the policy set in the regional administrator's SOP.

The CFIA will maintain a website that will list and/or provide links to all enrolled herds, along with current status levels.

2.6 Review of the national standards

The national standards will be reviewed, at a minimum, on an annual basis, or sooner as required based on new scientific information or by the consensus of the Review Panel. Along with the national administrator, the Review Panel will include 1 representative from each regional administration and 3 industry representatives and, ideally, will occur in the winter (between January 2 and March 31).

3. General Rules

3.1 Regional CWD HCP recognition

In order for a regional CWD HCP to be eligible for recognition, it must meet or exceed the requirements of the national standards. The regional administrator's SOP must be approved by the national administrator. The regional administrator must submit any updates in the SOP to the national administrator as updates occur.

Implementation of the administration of the regional CWD HCP is subject to CFIA audits at random time intervals.

The regional administrator must ensure adequate training of staff. This training may be audited by the CFIA.

3.2 Enrolment eligibility

The regional CWD HCP must be open to any owner/cervid farm operator of a premises on which cervids are kept, provided that the owner/cervid farm operator and the premises meet the regional CWD HCP requirements, that the owner/cervid farm operator of the premises meets all federal and provincial/territorial requirements that are applicable to cervid farming, including a valid cervid farm licence (where applicable), and that the right to participate in the regional CWD HCP has not been revoked.

3.3 Legislative pre-eminence

The National Standards and requirements of the regional CWD HCPs do not undermine the authority of federal, provincial or territorial legislation. For example, regulations that govern fencing, wildlife, movement permits or waterways will always take precedence over CWD HCP requirements.

3.4 Herd includes all cervids

All cervids on a premises must be included in the herd enrolled in the regional CWD HCP, ownership notwithstanding.

3.5 Agreements

The agreement between the regional administrator and the owner/cervid farm operator must be signed, and the premises must meet the requirements of the regional CWD HCP. The herd owner/cervid farm operator must arrange for the services of an accredited veterinarian to deliver the CWD HCP. The agreement must include a statement protecting the CFIA from any liability arising from the regional CWD HCP.

3.6 Multiple premises

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 or there is co-mingling between the premises. The premises must collectively meet all of the regional CWD HCP requirements. Compliance with the CWD HCP requirements does not negate the requirement to comply with other federal or provincial/territorial programs associated with cervids, such as cervid movement permits.

Multiple premises that are not contiguous may be permitted to be listed under the same certification contract if the premises belong to the same owner/cervid farm operator. The lands and the equipment must be under the same management system and may use the same equipment. The groups of animals are of the same status level and will be considered as 1 herd for the CWD HCP. Whatever happens to 1 premises will happen to the other and the combined premises will hold the status of the lowest premises.

3.7 Facilities

Facilities must be suitable for the safe handling of cervids and, as necessary, for the examination of all cervid identification devices (including CFIA Health of Animals tags, if applicable). Fences must be constructed and adequately maintained to prevent the escape or intrusion of cervids and must meet any provincial/territorial standards and any additional standards as may be stated in this document. All harvested and purchased feed must be stored in a manner that renders it inaccessible to wild cervids.

3.8 Identification

All cervids 12 months of age and older must be identified by at least 2 identification devices, 1 of which is readable from a distance. These devices should allow for unique individual identification of animals with either device.

Cervids less than 12 months of age must be identified in a manner that enables the owner/cervid farm operator to track these cervids in the herd inventory.

Regardless of age, if moved off the premises, all cervids must be identified by at least 2 identification devices, 1 of which is readable from a distance. These devices should allow for unique individual identification of animals with either device.

3.9 Records

The owner/cervid farm operator must keep detailed records of every cervid that is born on or enters the premises, no matter who the owner is or who is responsible for the cervid. The records must be kept for a period of 5 years after the cervid has left the herd or has died. They must be made available to the status assessor, the accredited veterinarian, program delivery personnel or the CFIA inspector at any reasonable time, and must be presented at the time of each annual inspection or inventory.

For all cervids in the herd, the basic data that must be maintained in records and included as part of the annual report includes the following:

• the cervid's species
• the cervid's identification tag/device number(s)
• the cervid's sex
• the date the cervid entered the herd (day if available, month and year)
• the cervid's date of birth (day, month, year)
• the source of the cervid (homegrown, purchased, loaned)
• any cervid movement permits
• if the cervid was not born in the herd, the name and address of the person from whom it was obtained; a copy of the proof of herd status issued for the herd of origin; and the day, month, and year it was issued
• the date the cervid left the herd; the premises to which the cervid was moved; and the name, address, and telephone number of the person to whom the cervid was sold (new owners/cervid farm operators are required to keep bills of sale)
• the reason for the cervid leaving and appropriate documentation (a shipping invoice if shipped, a receipt if sold, a date of death/test result), and
• CWD testing results for all cervids 12 months of age and older that die (including slaughter, as per section 4.2.1 Annual surveillance requirements) or are destroyed for any reason

3.10 Prohibited material

If an owner's/cervid farm operator's farm also has non-ruminants on site, measures must be taken to prevent access of farmed cervids to prohibited material. Where required, copies of all invoices must be kept for an animal food that contains prohibited material (section 171 of the Health of Animals Regulations).

4. Specific criteria for program pillars

4.1 Inventories, annual inspection and annual report

4.1.1 Inventories

4.1.1.1 Initial herd inventory

The initial herd inventory (see Section 2.1.1 Application) is to be conducted by the accredited veterinarian or an approved third party. During the initial herd inventory, the accredited veterinarian or approved third party must verify all identification devices (indicators) and record all identification numbers used for CWD HCP inventory purposes (see section 3.8 Identification).

Every live cervid in the herd 12 months of age and older must be observed closely enough to check for any clinical signs of CWD, and to record all CWD HCP identification devices.

Cervids under 12 months of age must be counted and recorded on the inventory, but they do not require unique identifiers unless moving off the premises prior to the age of 12 months.

The accredited veterinarian or approved third party may observe animals from a distance to allow for assessment of presence of any clinical signs that may be compatible with CWD. If closer observation is deemed necessary to assess ill health, the cervid(s) must be restrained for further examination.

After the initial herd inventory, third-party inventories (see section 4.1.1.2 Third-party inventories) are required at least every 3 years within 3 months of the anniversary date.

If a herd inspection is performed by a CFIA veterinary inspector for the purposes of the CFIA's tuberculosis or brucellosis testing program, this may replace part, or all, of the initial herd inventory. When using a CFIA inventory of the cervids 12 months of age and older, the inventory of the cervids less than 12 months of age may be performed by the owner/cervid farm operator.

4.1.1.2 Third-party inventories

Third-party inventories are to be conducted by the accredited veterinarian or an approved third party at least every 3 years after the initial herd inventory. The third-party inventory must occur within 3 months of the anniversary date.

During a third-party inventory, every live cervid in the herd 12 months of age and older must have its identity confirmed and be observed closely enough to check for any clinical signs of CWD. The accredited veterinarian or approved third party may observe animals from a distance to allow for assessment of presence of any clinical signs that may be compatible with CWD, and to have their identities confirmed (i.e., data recorded in the initial herd inventory can be used to corroborate the CWD HCP identification devices).

If the identity cannot be confirmed or assessment of signs of ill health cannot be made from a distance, or if closer observation is deemed necessary to investigate ill health, the cervid(s) must be restrained for further examination.

Cervids under 12 months of age must be counted and recorded on the inventory, but they do not require unique identifiers.

If a herd inspection is performed by a CFIA veterinary inspector for the purposes of the CFIA's tuberculosis or brucellosis testing program, this may replace part, or all, of the third-party inventory. When using a CFIA inventory of the cervids 12 months of age and older, the inventory of the cervids less than 12 months of age may be performed by the owner/cervid farm operator.

4.1.1.3 Producer inventories

Producer inventories are conducted in the years when third-party inventories are not required. A producer inventory may be completed by confirming the identity of all cervids via identification devices that can be read from a distance (such as dangle tags). If for any reason the identity of a cervid cannot be confirmed by viewing the identification device at a distance, alternate steps must be taken to confirm the identity. The producer inventory may be conducted by the owner/cervid farm operator.

4.1.1.4 Inventory reconciliation

A reconciliation of the inventory findings may be conducted by the owner/cervid farm operator. The reconciliation of records must be verified by the accredited veterinarian, and included in the annual report (see section 4.1.3 Annual report). The reconciliation accounts for all cervids that have entered or left the premises for any reason since the last annual report.

A reconciliation of the inventories lists the following:

• identification of each cervid on the premises at the time of the inventory (all cervids of every age must be on the inventory)
• all CWD HCP identification devices placed on each cervid, including the current calf or fawn crop and any cervids that have lost identification devices
• all cervids that have entered or left the premises (for any reason) since the last inventory
• the status of the herd of origin for those cervids entering the premises
• all deaths, including identification tag/device number(s)
• the destination of every cervid that moved off the premises as established by a bill of sale or, if the cervid has not been sold, a signed document showing the destination of the cervid
• appropriate laboratory results (CWD testing) or, when applicable, exemptions from submission of heads

Official documents produced by provincial/territorial or national identification/traceability programs will be accepted as supporting documentation for cervids that have moved on and off the premises.

All supporting documentation must be verified during the inventory reconciliation and submitted as part of the annual report (see section 4.1.4 Annual report). Required supporting documentation is listed in section 3.9 Records.

4.1.2 Annual inspection

Inspections will be conducted annually by an accredited veterinarian, with the optional assistance of approved third parties within 3 months of the anniversary date. The accredited veterinarian is ultimately responsible for all verifications.

The annual inspection includes:

• visual inspection of the premises to verify that biosecurity requirements are met
• observation of the general health of the herd
• verification of the implementation of specific regional CWD HCP requirements, as determined by the status assessor
• verification of the inventory reconciliation

The annual inspection is required as part of the annual report (see section 4.1.3 Annual Report).

4.1.3 Annual report

The annual report, which is signed by both the owner/cervid farm operator and the accredited veterinarian, is submitted annually within 3 months of the anniversary date to the status assessor, and includes:

• the annual inspection report (see section 4.1.2 Annual inspection)
• a reconciliation of the inventories (see sections 3.9 Records and 4.1.1.4 Inventory reconciliation)
• supporting documentation for cervids that have moved on and off the premises (see section 3.9 Records)
• necessary laboratory reports (see section 4.2.1 Annual surveillance requirements) or, when applicable, exemptions from submission of heads
• perimeter fences report or attestation (see section 4.4.2 Fencing)
• any other relevant supporting documentation (see section 3.9 Records)

In all instances, the owner/cervid farm operator is ultimately responsible for clarifying any inventory or inspection questions or concerns that may arise during the course of the review of the annual report by the status assessor.

4.2 CWD surveillance in herd

4.2.1 Annual surveillance requirements

Testing is the most important program pillar to estimate the CWD status of the herd.

For successful annual advancement or retention in the CWD HCP, owners/cervid farm operators are required to submit samples for CWD testing from 100% of cervids 12 months of age and older that die, are slaughtered, are humanely euthanized, or hunted on farm. The sale of cervids to a hunt farm is similar to any other cervid sale.

If a required sample is missed, an owner/cervid farm operator at levels E–A has the option to sacrifice 2 other adult (12 months of age and older) cervids from the herd for every sample that is missed in order to meet requirements to advance. An owner/cervid farm operator at the certified level has the option to sacrifice 1 other adult (12 months of age and older) cervid from the herd for every sample that is missed in order to meet the requirements to maintain certified level. The sacrificed cervids must be a similar cohort to the sample that was missed. The test result from a cervid of the same cohort that has been slaughtered in the previous 3 months can be used to fulfil the sacrifice requirement.

The sacrifice option may be used only sporadically.

Missed samples that can be neither exempted (as per section 4.2.6) nor replaced by the above sacrifice option may be considered as missed submissions, at the discretion of the status assessor.

4.2.2 Sample submission

The head of the cervid may be submitted directly to an approved laboratory by the owner/cervid farm operator. The head of the cervid must bear all identification in situ. Anything less than the intact head with identification in situ may be submitted so long as there is an ability to demonstrate continuity of identification of the sample. Alternatively, a certified CWD sample collector may collect or supervise the collection of tissue samples for submission to an approved laboratory. All samples must be accompanied by identification.

If the dead cervid is not found immediately, or the certified CWD sample collector or the laboratory are not available within 36 hours of death, the head of the cervid must be frozen and submitted in a timely manner (i.e., as soon as possible and sooner than at the annual assessment) as a frozen specimen. Freezing enables the CWD diagnostic test to be applied to the tissues that otherwise would no longer be suitable for testing.

4.2.3 Unsuitable samples

Specimens must meet the requirements specified in the diagnostic protocol approved by the CFIA, which guarantees the reliability and accuracy of the results. Good-quality samples and complete collection of the obex and the retropharyngeal lymph nodes (RPLN) from dead cervids are essential for successful surveillance. Owners/cervid farm operators are responsible for ensuring that the tissue samples are of good quality, and that all required samples and identification are submitted.

If an unsuitable specimen is received, the receiving laboratory is to notify the submitter. A follow-up of the details of the individual situation will be undertaken by the status assessor. If negligence on the part of the owner/cervid farm operator is identified as the cause, or this occurrence is repeated, then the CWD HCP requirements are considered to have not been met and the herd is to be suspended.

The following are examples of poor-quality, untestable samples:

• the sample/head is severely autolyzed (putrified)
• the wrong portion of the brain was submitted, or something other than the whole brain/obex was submitted
• the skull/head was submitted, but no testable tissue was present
• the sample is not testable for other reasons (that is, no identification, etc.)

When a head is presented to a certified CWD sample collector but there is no brain tissue to sample or no identification, the certified CWD sample collector will provide the owner/cervid farm operator with a letter certifying that the head was submitted but a sample could not be forwarded for testing, with an explanation of why a sample could not be forwarded for testing.

Sacrifices cannot be used to overcome the repeated submission of poor quality samples. If the status assessor determines that there has been negligence on the part of the owner/cervid farm operator, the herd is to be suspended, notwithstanding section 4.2.1 Annual surveillance requirements.

4.2.4 Specimens submitted and tissues tested

The obex and the RPLN must both be submitted for all farmed cervids tested for CWD.

The obex of the medulla is the primary target tissue tested for all members of the family Cervidae, such as elk, red deer, reindeer/caribou, sika deer, fallow deer, moose and any hybrids (with the exception of members of the genus Odocoileus).

The RPLN is the primary target tissue tested for Odocoileus species, including white-tailed deer, black-tailed deer, mule deer and any hybrids.

The additional submitted tissues will be frozen and held by the laboratory until the initial test is completed.

If moribund cervids are humanely destroyed on farm by a gunshot to the head, the recipient lab must sample and test for CWD, both the whole brain and 1 lymph node from the head (mandibular or retropharyngeal) or, if no lymph node is available, the whole brain and 1 tonsil.

4.2.5 Results of analysis on samples submitted

The standard test for the CWD HCP must be the test currently recognized by the CFIA as an appropriate screening test. Currently it is the Bio-Rad ELISA, and reporting must reflect this.

Results of analysis on samples submitted for CWD testing via Bio-Rad ELISA are to be reported as follows:

Tested: CWD not detected

Where the specimen submitted contained the correct target tissue for the species being tested, the sample should be reported as follows: "Bio-Rad ELISA was negative for disease specific PrP (PrPCWD). Based on the tissue available for testing, this cervid was unlikely to have died from CWD."

Tested: CWD not detected in secondary target tissue

Where the specimen submitted did not contain the primary target tissue identified for the species being tested, the sample should be reported as follows: "Bio-Rad ELISA was negative for disease specific PrP (PrPCWD). Based on the tissue available for testing, this cervid was unlikely to have died from CWD."

This may include the following:

• samples from white-tailed deer, black-tailed deer, mule deer and any hybrids where the RPLN was not submitted, but the obex and/or the whole brain is available for testing
• samples from elk, red deer, fallow deer, Sika deer, reindeer/caribou, moose and any hybrids where the obex was not submitted, but the RPLN or other areas of the brain is available for testing

Submitted: Unsuitable for testing

Where the specimen submitted did not have identifiable whole brain/obex or RPLN tissue available for testing, the sample should be reported as "Submitted: Unsuitable for Testing." This should be followed with an explanation as to the cause for this result, as per section 4.2.3 Unsuitable Samples.

4.2.6 Reporting of cervid illness

The owner/cervid farm operator must report to their accredited veterinarian or an approved third party (for subsequent reporting to the accredited veterinarian as per Section 1.4.2) any illness in a cervid 12 months of age and older lasting longer than two weeks that is refractory to treatment, except a physical injury that has lasted longer than two weeks and is improving at the normal or expected rate. The accredited veterinarian will be responsible for monitoring the progression of the reported cervid illness and for notifying the CFIA veterinary inspector if CWD remains on the rule out list.

4.2.7 Exemptions 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 CWD HCP:

• destruction of cervids (including stored heads/samples) by fire: a certificate or letter from an appropriate official must accompany the annual report
• the destruction or carrying away of the head of a cervid 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
• theft: a report from the police officer who investigates the theft must accompany the annual report
• loss or destruction of the head/tissue sample that is no longer in the control of the owner/cervid farm operator (for example, by an accredited veterinarian, courier or laboratory). (Laboratories should note on reception of the specimen that the obex, RPLN or other appropriate tissue samples are 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.)
• any other reason (such as a flood), over which the owner/cervid farm operator could not reasonably be expected to have control that results in the destruction or disappearance of the head/tissue sample: a letter or report by an acceptable third party that sets out the details of the reason for failure to submit the sample must accompany the annual report (the status assessor may accept a picture (when available) of the cervid's head that clearly shows the identification device(s), preferably still in situ)

4.3 Limited entry

4.3.1 Live cervid introductions

An enrolled herd may introduce cervids from herds of equivalent or higher CWD HCP status level with no negative impact on the CWD HCP status of the recipient herd.

Documentation must be provided that enables the status assessor and the owner/cervid farm operator to determine the CWD risk status/CWD HCP status of the herd of origin at the time of transfer of the animal.

4.3.2 Sources of equivalent or higher level of CWD risk

Introduction of cervids from the following sources will have no impact on the status level:

• from Canadian herds registered in a CWD HCP at an equivalent or higher status level, or
• from a country the CFIA recognizes as being free from CWD, or
• from a herd registered (on the date of import) at an equivalent or higher level in a country/region/zone of origin's CWD herd certification program that the CFIA has assessed as meeting or exceeding the National Standards

4.3.3 Downgrading due to introductions

If cervids from herds of a lower status level are introduced, the status level of the recipient herd will be downgraded to that of the herd of origin of the lowest level. If cervids from a non-participating herd are introduced, the status level of the recipient herd will be reduced to level E.

Co-mingling (even temporarily) with cervids from non-participating cervid herds or herds of a lower CWD HCP status will result in downgrading of the status level to that of the lowest level herd (level E if cervids are co-mingled with cervids from a non-participating herd).

4.3.4 Germplasm

Embryos may only be sourced from herds of equivalent or higher status. Semen may be sourced from cervids in non-participating herds or herds of any status level, with no impact on the status level of the recipient herd, provided that, on the date of insemination, the cervid donor is not CWD positive or a CWD-exposed cervid.

4.4 Biosecurity

4.4.1 Site plan

The site plan must have a diagram that identifies all structures and grazing areas on a premises to which cervids are given access, and that are used to store feed for cervids. The location of water sources and location of fences must also be included.

A site plan must be submitted with the initial application when establishing a herd and with the annual report whenever changes to the premises have occurred.

4.4.2 Fencing

Perimeter fencing must be present around the herd. Fences must be maintained in a manner to prevent intrusion (ingress) or escape (egress) of cervids, and must meet any provincial or territorial requirements (if applicable).

As part of the annual inspection, there must be assurance of the integrity of the fences. This assurance can be an inspection of the perimeter fences by the accredited veterinarian or an approved third party. Alternately, the fences can be inspected by the owner/cervid farm operator. When an owner/cervid farm operator attests to the fence integrity they must provide a signed document that they have checked all the fences within the previous 3 months and that the fences meet the requirements of the CWD HCP. The document must be attached to the annual report and include pictures where deemed necessary.

For herds established after May 1, 2017, the fences must be a minimum of 2.4 meters high (8 feet).

4.4.3 Feed storage

All feed must be stored in a manner that renders it is inaccessible to wild cervids. If feed for a CWD HCP herd is grown on a separate area of the premises, bales must be brought inside fences as soon as possible after baling so that wild cervids do not have an opportunity to feed on, salivate in, and defecate or urinate on or near the feed that is going to be fed to CWD HCP herds. Bins for concentrates, such as grain, must be secured and stored in a manner that any feed is inaccessible to wild cervids.

In areas of Canada where CWD exists in the wild, owners/cervid farm operators enrolled in a CWD HCP must take steps that address the highest-risk areas of crop fields that will be used for feed grain. When grain crops in the high-risk areas are swathed, they must be combined as soon as possible to prevent wild cervids from defecating, salivating or urinating on the swaths. This should not be a problem for standing grain crops that are straight combined. Screenings sourced from areas where CWD is known to exist in wild cervids are not to be fed to farmed cervids.

4.4.4 Water sourcing

CWD can potentially be transmitted through contaminated water sources. Standing bodies of water such as ponds, sloughs, dugouts and water troughs which could be used as a source of water for farmed cervids, must be inaccessible to wild cervids. At this time, running water such as streams or spring run-off has not been shown to have infective levels of CWD prion.

4.4.5 Taxidermy and carcasses

Carcasses or parts from wild cervids or farmed cervids with lower or no status under a CWD HCP are not permitted to be brought on to premises enrolled in a CWD HCP for processing or taxidermy. Field-dressed carcasses from wild cervids or farmed cervids with lower or no status may be brought onto the facility for personal use only, and only into areas where farmed cervids do not have access. Exemptions may be allowed on premises on which a separate processing facility (slaughter facility, taxidermy facility, etc.) is located, provided that the facility is physically separate, that live farmed cervids on the premises have no direct or indirect contact with the carcasses or parts, and that waste materials are disposed of in a manner that it is inaccessible to farmed and wild cervids.

4.4.6 Cleaning and disinfection of vehicles

CWD prions adhere readily to surfaces, are very resistant to destruction and disinfection by common procedures, and can remain infectious on vehicle surfaces for long periods of time. Moreover, contamination of vehicles can occur from contact with live or dead cervids, and from contact with contaminated environments. Live cervids may become infected by co-mingling with other cervids during transportation and through contact with contaminated vehicles. Therefore, transportation vehicles used on the premises (trucks, trailers, ATV, etc.) can be a significant source of indirect transmission of CWD to farmed cervids. Owners/cervid farm operators must work with their accredited veterinarians to implement a cleaning and disinfection protocol to mitigate this transmission risk.

Documentation of the protocol and its implementation must be maintained and submitted in the annual report. Photos can be used as a record that a vehicle was properly cleaned, and a statement from the individual who disinfected a vehicle will be a record of disinfection.

The vehicle cleaning and disinfection protocol must detail situations when contamination may occur and which parts of a vehicle must be cleaned and disinfected from potentially CWD-infected material. The following gives some risk factors for contamination to be taken into consideration. This list is not exhaustive.

• Contamination can result from contact with potentially CWD-infected material on a premises of lower or no status.
  • The exterior of vehicles (including wheels, wheel wells, and undercarriage) can become contaminated when moved to and from places with cervids of lower or no status.
  • The interior of vehicles can be contaminated whenever live or dead cervids of lower or no status are transported in the vehicle, or whenever personnel move into a vehicle.

When conducting cleaning and disinfection, vehicles need to first be thoroughly cleaned (to effectively remove all visible organic material, and then they must be properly disinfected to deactivate the CWD prion if present (see "Cleaning and disinfection" in section 5 Definitions).

Mixed loads of farmed cervids of different CWD HCP status (or no status) can only occur if all the cervids are going directly to slaughter. Whenever a vehicle containing cervids of lower or unknown status enters the premises, any organic matter (especially feces and urine) that escapes from the vehicle must be collected and disposed of in a manner that prevents farmed cervids on the premises being exposed to this material.

4.4.7 Movement of previously owned equipment

CWD can potentially be transmitted via contaminated equipment. Any equipment that has been exposed to cervids of a lower or unknown status level must be thoroughly disinfected (see "Disinfection" in section 5 Definitions) before entering the premises. This is especially pertinent when purchasing previously owned equipment, including handling facilities, from a cervid farm. This section applies anytime equipment is moved between cervid premises, regardless of ownership.

Parts of equipment that cannot be thoroughly disinfected must be replaced. Porous materials such as wood, leather, fabric, fibers and foam, must be removed before disinfection and replaced with new materials. Equipment in poor repair may develop features, such as tears and cracks, that could trap organic material. Any such features must be removed or repaired prior to disinfection.

If previously owned equipment has been moved onto the premises, appropriate documentation must be maintained and submitted in the annual report. Examples of relevant documents include bills of sale, documents indicating the nature of the source operation (specifically regarding the presence of cervids on the premises), status level certificates from the herd of origin, and/or disinfection attestations.

The following are additional biosecurity measures that can be used in regional CWD HCPs in areas where CWD has been detected

4.4.8 Record keeping and administration

Keep visitor logs that record the movement of all people and vehicles onto and off the premises.

Provide personnel training (that is, a written and verbal on-farm program to educate, train and re-train all workers and family members), ensuring knowledge of all biosecurity principles and compliance with practices used on-farm.

4.4.9 Minimizing direct (cervid-to-cervid) transmission of CWD

Inspect the perimeter fences at least 4 times per year (or sooner if a problem is noticed) to ensure that they are intact.

Have other mechanisms in place to deter wild cervids from entering the premises (for example, provide protection with dogs, keep feeding and watering stations away from perimeter fences, add 1 strand of electric fence outside the perimeter fences, or install other double-fencing equivalent options).

4.4.10 Minimizing indirect transmission of CWD

Use all disposable equipment only once (for example, needles, syringes, gloves).

Clean and disinfect all other non-disposable equipment that comes into contact with bodily fluids (for example, velveting tools), as per the definition in Section 5 Definitions.

Avoid bringing products or by-products of cervid origin onto the farm (for example, cervid origin supplements for velvet growth, attractants, baits, tissues or carcasses).

Have dedicated equipment for use only on the enrolled farm (for example, dedicated clean boots and coveralls for visitors only and separate ones for employees).

Protect feed from contamination by having a rodent-control program in place. (Rodents can ingest and shed prions.)

Bring in feed from reliable sources only.

5. Definitions

Accredited veterinarian

See section 1.4.1. [Vétérinaire accrédité]

Anniversary date

Date of the official acceptance onto a CWD HCP. The status assessor reviews the application and assigns an anniversary date and a herd level upon official acceptance to a CWD HCP, and will use the same selection criteria for all enrolled owners/cervid farm operators in a region. [Date anniversaire]

Annual inspection

The annual inspection is conducted annually by an accredited veterinarian to inspect, observe, reconcile and verify activities related to the implementation of on-farm CWD HCP requirements. The annual inspection is required as part of the annual report. [Inspection annuelle]

Approved laboratory

A laboratory that is part of the National TSE Laboratory Network or a laboratory approved by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for CWD testing. [Laboratoire approuvé]

Approved third party

An individual who is not the owner/cervid farm operator, is at arm's length with the owner/cervid farm operator and is approved by the regional administrator as an eligible Program deliverer, and who is trained and qualified to deliver certain aspects of a CWD HCP. See section 1.4.2. [Tiers approuvé]

Biosecurity

A set of practices used to minimize the transmission of CWD in farmed cervid populations including its introduction and spread within the population. [Biosécurité]

Certified CWD sample collector

An individual who has completed appropriate training recognized by his or her regional administrator on the collection and preservation of samples for CWD testing and on proper recordkeeping, and is certified by his or her regional administrator to perform these activities for farmed cervids for the purposes of a CWD HCP. A certified CWD sample collector may be an approved third party or a cervid farm operator. He/she must operate at arm's length from the owner/cervid farm operator and may not collect samples from his/her own animals. A certified CWD sample collector is responsible for ensuring that, for all cervids presented for sample collection, all identification devices have been verified in situ. [Personne agréée responsable du prélèvement des échantillons à l'égard de la MDC]

Cervid

Any member of the Cervidae family including any hybrids considered at risk to CWD including, but not limited to, mule deer (Odocoileus hemionus), Rocky Mountain elk (Cervus elaphus nelsoni), red deer (Cervus elaphus elaphus), white-tailed deer (Odocoileus virginianus), black-tailed deer (Odocoileus hemionus columbianus), fallow deer (Dama dama), Sika deer (Cervus nippon), Manchurian Sika deer (Cervus nippon), reindeer/caribou (Rangifer tarandus), Muntjac deer (Muntiacus reevesi), and moose (Alces alces shirasi). [Cervidé]

Cervid farm operator

A person who is licensed (where applicable), under the relevant cervid farm regulations (where applicable) to operate a cervid farm. [Exploitant de ferme de cervidés]

CFIA

Canadian Food Inspection Agency, which serves as the national administrator for the CWD HCPs. [ACIA]

Cleaning and disinfection

Involve the procedures used to inactivate the CWD prion. All visible organic material must first be thoroughly removed by pressure washing or scrubbing with hot water, detergent and brush. After the surface is dry, the disinfectant is applied using low pressure. Surfaces and equipment should be left wet (or soaking) with a solution of sodium hypochlorite (bleach, NaOCI) or sodium hydroxide (NaOH) for at least 1 hour at 20°C, and then thoroughly rinsed with water.

Sodium hypochlorite or sodium hydroxide are proven effective against prions.

NaOCI is used at a concentration of 2% available chlorine. This solution can be prepared from industrial grade or commercially available bleach. For example, most commercially available bleaches have a concentration of 6% available chlorine listed on the label. A mix of 1 part 6% bleach and 2 parts water will provide a concentration of 2% available chlorine.

NaOH is used at a concentration of 2 molar. NaOH may be purchased in crystal form. To make a 2 molar concentration of NaOH, dilute 80 grams NaOH crystals in 1 litre of water, and stir well.

The use of rubber gloves and safety goggles or a full face shield is recommended. [nettoyage et désinfection]

Cohort

A group of cervids with close or similar types of experiences. Animals in the same cohort will be the same age, will have been on the premises for the same length of time, kept in the same enclosures, fed the same feed and accessed the same water supplies. A sacrificed animal should be, as much as possible, from the same cohort as the missed-sample animal. [Cohorte]

Co-mingled cervids

Cervids are considered co-mingled if they have physical contact with each other, including through fences or pen separations, as well as indirect contact such as shared equipment, pasture, or the same water source. Co-mingling also includes sharing the same section in a transportation unit where physical contact can occur. Cervids having had contact with a CWD-positive cervid or CWD-positive premises within the last 60 months are also considered to have co-mingled. [Cervidés regroupés]

Contiguous

Premises which share common boundaries and where co-mingling of farmed cervids can occur between the 2 premises. [Aire contiguë]

CFIA CWD Disease Control Program

The program or policy developed for the control of CWD in farmed cervids and in cervids maintained in zoos and collections, and which is governed by the Health of Animals Act and the Health of Animals Regulations. [Programme de lutte contre la MDC de l'ACIA]

CWD-exposed cervid

A cervid that has co-mingled with any cervid that resided in a CWD-positive herd within the last 60 months. [Cervidé exposé à la MDC]

CWD-exposed herd

A herd that has co-mingled with a CWD-exposed cervid. [Troupeau exposé à la MDC]

CWD-positive cervid

A cervid for which official CWD-positive results were reported by the CFIA's National and WOAH Reference Laboratory for CWD. [Cervidé positif à l'égard de la MDC]

CWD-positive herd

A farmed cervid herd in which 1 or more CWD-positive cervids reside. [Troupeau positif à l'égard de la MDC]

CWD-positive premises

The premises on which a CWD-positive herd resides. [Lieux positifs à l'égard de la MDC]

CWD HCP

Chronic Wasting Disease Herd Certification Programs, regional voluntary programs established and maintained to reduce the occurrence and spread of CWD in farmed cervid herds, and to identify herds that have been free of evidence of CWD over specific time periods. [PCT pour la MDC]

Enrolled herd

A cervid herd enrolled in a CWD HCP. [Troupeau inscrit]

Herd

1 or more cervids that are under common ownership or supervision and are raised on any single premises or on 2 or more premises that are geographically separated (for example by road, stream, etc.), but on which cervids have direct or indirect contact with each other through handling or co-mingling. [Troupeau]

Network laboratory

A laboratory that is part of the National TSE Laboratory Network. [Laboratoire du Réseau]

Non-negative sample

Any CWD sample tested using Bio-Rad ELISA or immunohistochemistry in a network laboratory where a negative test result is not obtained. These samples are then forwarded to CFIA's National and WOAH Reference Laboratory for CWD for confirmatory testing. [Échantillon non négatif]

Obex

The specific area of the brain required for testing using Bio-Rad ELISA or immunohistochemistry for the earliest detection of CWD in all cervids, with the exception of members of the Cervidae family of the genus Odocoileus including mule deer, white-tailed deer, and their hybrids. [Obex]

Official identification device

A provincial/territorial government-approved identification device (where applicable), a CFIA official identification device, or an approved method of identification from a national cervid traceability program. [Dispositif d'identification official]

Owner

An individual, partnership, company, corporation or other legal entity that has legal or rightful title to a cervid or a herd of cervids, regardless of any liens held on the cervid(s). [Propriétaire]

Premises

For the purposes of a CWD HCP, the ground, area, buildings and equipment occupied by, or used for, a farmed cervid herd, and enclosed by perimeter fencing. [Lieux]

Previously CWD-infected premises

A premises that previously contained a CWD-positive herd. Generally, this would be the premises of residence of a depopulated CWD-positive herd. If any cervids of the CWD-positive herd still reside on the premises, the premises is a CWD-positive premises. [Lieux qui ont déjà été contaminés par la MDC]

Prohibited material

No person shall feed prohibited material to a ruminant (Health of Animals Regulations, s.164). Prohibited material includes anything that is, or that contains any, protein that originated from a mammal other than: a porcine or equine; milk or products of milk; gelatin derived exclusively from hides or skins or products of gelatin derived exclusively from hides or skins; blood or products of blood; or rendered fats derived from ruminants, that contain no more than 0.15% insoluble impurities or their products. Prohibited material that has been treated in a manner approved by the Minister to inactivate the agents that cause transmissible spongiform encephalopathies is no longer prohibited material. (HAR, s. 162) [Substances interdites]

Retropharyngeal lymph node (RPLN)

A lymph node of the head that can be used for the earliest detection of CWD in members of the Cervidae family of the genus Odocoileus including mule deer, white-tailed deer, and their hybrids. [Nœuds lymphatiques rétropharyngiens (NLRP)]

Slaughter

Cervids slaughtered on-farm, or slaughtered at a provincial/territorial or federally inspected abattoir. Farmed cervids slaughtered on an emergency basis require sampling. [Abattage]

Status certificate

Document issued by the regional administrator, specifying the location and status of the herd, and indicating the date of issue. [Certificat de statut]

Status level

The level of participation achieved and officially recognized by the status assessor and the CFIA in a CWD HCP. [Niveau de statut]

Suspended herd

A suspended herd retains its enrolment in a CWD HCP, but has no officially recognized status level during the suspension, including for the purposes of export or domestic trade with other herds participating in a CWD HCP. [Troupeau suspend]

Suspension

The removal of the risk-mitigation status of a herd under a CWD HCP. While a herd is suspended, it remains enrolled, but has no officially recognized status level (E, D, C, B, A or certified). All suspensions are intended to be temporary measures. [Suspension]

13.5 Appendices

Appendix A - Program administration and status assessment by region – December 2021

British Columbia and the Atlantic provinces currently have no active program.

Appendix B - Sampling procedures – December 2021

Entire heads may be submitted fresh or frozen to an approved laboratory (see Appendix D).

Samples removed by anyone other than an accredited veterinarian or a certified CWD sample collector (see definition below) or an approved laboratory (or a CFIA veterinarian/inspector) will not be counted as submitted under the requirements of the Chronic Wasting Disease Herd Certification Programs (CWD HCP).

Certified CWD Sample Collector

An individual who has completed appropriate training recognized by his or her regional administrator on the collection and preservation of samples for CWD testing and on proper recordkeeping, and is certified by his or her regional administrator to perform these activities for farmed cervids for the purposes of the CWD HCP. A certified CWD sample collector may be an accredited veterinarian, an official veterinarian, an approved third party (see definition below) or a cervid farm operator. He/she must operate at arm's length from the owner/cervid farm operator and may not collect samples from his/her own animals. A certified CWD sample collector is responsible for ensuring that, for all cervids presented for sample collection, all identification devices have been verified in situ.

Approved third-party

Approved third parties are approved by the regional administrator as eligible Program deliverers, and are trained and qualified to deliver certain aspects of the CWD HCP. Approved third parties may be staff of a provincial/territorial department or agency, an animal health technician who is registered under the appropriate provincial/territorial licensing body and supervised by an accredited veterinarian, and a CFIA veterinarian or inspector. Refer to Section 1.4 Accredited veterinarians, approved third parties and sample collectors of the national standards for more information on approved third parties.

CWD is a reportable disease, and thus if an animal exhibits signs for which CWD is a differential diagnosis, the local CFIA district office can be contacted for sampling.

Both the obex and the retropharyngeal lymph nodes (RPLNs) must be submitted for all farmed cervids tested for CWD under the CWD HCP.

Visualize the approved identification device in situ prior to removing tissues for testing, record all individual animal identification information on the CWD form, and ensure all identification devices (including H of A tags) are submitted with the sample to the laboratory.

Videos of transmissible spongiform encephalopathy (TSE) sampling techniques are available through the Public Health Agency of Canada's training platform. To access the videos:

1. visit the public health training website
2. choose desired language
3. create an account
4. fill in your profile
5. you will receive an email to complete your registration
6. complete the registration using the enrolment key C64A0123
7. go to
   • Courses
   • Learning Communities
   • Canadian Food Inspection Agency (CFIA)
   • Animal Health
   • Transmissible Spongiform Encephalopathies/Encéphalopathie spongiforme transmissible

Obex harvesting technique

Recommended tools:

• knife for disarticulation of the head (if required)
• rat-toothed forceps
• obex removal knife, spoon (plastic or metal). See Figure 1 (the type of plastic spoon available in your area may differ from the one depicted)
• scalpel (optional)
• scissors (optional)

When removing the head from the body, all the flesh, including the spinal cord, should be cut cleanly 15 cm (6 inches) from the head.

1. Place the cervid head upside down (dorsal side down) with the nose pointing away from you and the foramen magnum facing you on a clean, disinfected surface (see Figure 2).

   

2. Using the forceps, grasp the dura mater (which is the thick lining around the spinal cord). With the scissors, make a single cut down the centre line to form 2 flaps.
3. Remove the congealed blood from around the spinal cord.
4. Use the forceps to hold the dura. Sever the cranial nerves from the spinal cord. This can be done with a scalpel, an obex knife, or carefully with scissors (as shown in Figure 3) by moving the instrument gently around the cord.

   

5. This is the most important step in freeing up the spinal cord. The cord must be completely free from attachments by cranial nerves in all directions. If some cranial nerves are left attached, a portion of the obex will remain with that cranial nerve and be pulled off your sample.
6. Once the brain stem and spinal cord are free from cranial nerve attachments, turn the head so that it is dorsal side up on the table. Insert the spoon or spatula into the cerebral canal. Advance it cranially as far as you can until the tip lodges against parts of the skull and comes to rest between the cerebellum and the brain stem (see Figure 4).

   

7. Use your index finger to place downward pressure on the handle of the obex tool, and rotate the tool back and forth to sever the brain stem.
8. Keep the tip of the obex tool down and drag the tool backwards, gently bringing the severed portion of the brain stem with it. The obex is recognizable as a V-shaped depression (see Figure 5).

   

Contact the laboratory to request information on specimen submission (fresh or frozen), and ensure that all the individual animal's identification devices/tags are submitted with the sample to the approved laboratory.

Retropharyngeal lymph node harvesting technique

Recommended tools:

• medium-sized boning knife
• rat-toothed forceps
• scissors (optional)

The following is 1 suggested removal technique to harvest a set of RPLNs. For orientation, the lymph nodes depicted in this Appendix are the medial RPLNs, and lie deep and between the base of the larynx (windpipe) and the floor of the skull. They are "buried" in an area of whitish connective tissue on either side of the pharynx and upper neck and jaw.

1. Place the cervid head upside down (dorsal side down), with the nose pointing away from you, and with the foramen magnum facing you, on a clean, disinfected surface (see Figure 6).

   

2. With a medium-sized boning knife, make the first incision, going straight upwards, from just above the foramen magnum to the surface (and through the skin if not skinned) (see Figure 7).
3. Make a second cut, extending from where the first cut began, staying close to the base of the skull and moving the knife down and to the right as if you were boning out the tissue (see Figure 7).

   

4. Make the third cut, starting at the same spot above the foramen magnum and going down and to the left, staying close to the skull (see Figure 7).
5. After pulling back/reflecting the 2 flaps created, notice an area of white connective tissue and fat on either side of the cut. The RPLNs are fairly large, firm, and encapsulated in the white fibrous tissue (see Figure 8).

   

6. Bluntly dissect out the beige-coloured, firm nodular lymph nodes buried in the white connective tissue, using your gloved fingers and/or a pair of scissors (see Figure 9).

   

Contact the laboratory to request information on specimen submission (fresh or frozen), and ensure the individual animal's identification devices/tags are submitted with the sample to the approved laboratory.

Appendix C - Sanitary precautions and disinfectants – January 2020

Chronic wasting disease (CWD) is not considered a human pathogen; however, normal sanitary precautions against a possible range of pathogens should be taken. Wear protective clothing, gloves, and face protection when collecting brain specimens. Always avoid direct contact with brain tissues. Personnel at tissue harvesting sites should take precautions to avoid ingesting the agent.

It is recommended that you place the animal's head on a disposable plastic drop sheet. This sheet should be large enough to cover the work area.

Chemical decontamination of equipment and work surfaces with sodium hypochlorite (NaOCl) at a concentration of 2% available chlorine, or sodium hydroxide (NaOH) at a concentration of 2 molar, is recommended. Surfaces and equipment should be left wet (or soaking) with NaOCl or NaOH for at least 1 hour at 20°C.

1. NaOH can be purchased from Fisher Scientific in crystal form. To make a 2 molar concentration of NaOH, dilute 80 grams NaOH crystals in 1 litre of water and stir well.

   or

2. NaOCl can be prepared from industrial grade or commercially available bleach (such as Javex/Clorox). Dilute the bleach to provide a final concentration of 2% (20,000 ppm) available chlorine. For example, most commercially available bleaches have 6% available chlorine listed on the label. In this case, mix 1 part bleach and 2 parts water (ratio 1:2) to attain the 2% concentration of available chlorine.

Bury or incinerate used disposable protective clothing, gloves, and animal remains.

It is recommended that neurosurgical tools be soaked in NaOH for 1 hour, removed from the solution, and then wiped with the NaOCl solution for 10 seconds. Dry the tools, as the NaOCl is corrosive.

Appendix D - List of laboratories – September 2020

Approved laboratories for chronic wasting disease testing

An approved laboratory is part of the CFIA National TSE (transmissible spongiform encephalopathy) Laboratory Network or is approved by United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for CWD testing.

National TSE Laboratory Network laboratories for CWD testing

Alberta Agriculture, Forestry and Rural Economic Development
TSE Laboratory
6909 – 116th Street
Edmonton, AB T6H 4P2
Telephone: 780-415-4516
Facsimile: 780-415-4527

Ministère de l'Agriculture des Pêcheries et de l'Alimentation du Québec (MAPAQ) – (French only)
Laboratoire de santé animale
3220 Sicotte Street
Saint-Hyacinthe, QC J2S 2M2
Telephone: 450-778-6542 (ext. 5800)
Facsimile: 450-778-6535

Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) / University of Guelph
Animal Health Laboratory
Laboratory Services Division
University of Guelph
Building 89, 419 Gordon Street,
P.O. Box 3612
Guelph, Ontario, N1H 6R8
Telephone: 519-824-4120 (ext. 54530)
Facsimile: 519-827-0961

Saskatchewan Ministry of Agriculture / University of Saskatchewan
Prairie Diagnostic Services
Rm. 2604 Diagnostic Immunology Laboratory
52 Campus Dr.
Saskatoon, SK S7N 5B4
Telephone: 306-966-7316
Facsimile: 306-966-2488