Chronic Wasting Disease Program Standards

national efforts in prevention and control of this disease, and may revise these testing requirements in the future.



States may routinely allow up to 1 week for reporting mortalities. However, State officials or APHIS employees may approve reporting schedules other than immediate notification when herd conditions warrant it in the opinion of both APHIS and the State. Mortalities will be reported to the states on NVSL laboratory reports.



Exceptions to the testing requirement may be made by the appropriate Approved State agency having CWD HCP oversight for extenuating circumstances beyond the control of the herd owner such as extreme weather conditions or mass mortality events not directly related to CWD.







(5.4) Shooter (Hunting Operations) Animal Surveillance on hunting operations.



All shooter (hunting operations) animals on hunting operations 12 months or older harvested by hunters as well as natural mortalities on hunt (shooter) facilities must be made available for testing if the hunt facility is enrolled in the Approved State CWD HCP.



Any cervids 12 months or older that have been sent to hunt facilities from herds enrolled in the Approved State CWD HCP, have not yet achieved certified status, and have remained on the owner’s enrolled herd inventory must be tested for CWD at time of death or harvest in the hunt facility and test results reported to the Approved State. Testing of animals from certified herds that are sent to hunting operations will be at the discretion of the Approved State authorities. APHIS intends to evaluate these CWD surveillance parameters for the purposes of assessing CWD risk in these certified herds and to address national efforts in prevention and control of this disease, and may revise these testing requirements in the future.



In such cases where clinically normal animals are harvested over time on hunt facilities, there may be allowance for reporting groups of animals that have been killed over a specified time period. The delayed notification must include the identification numbers of the animals involved and the actual or estimated time and date of death.



States may consider moving animals from CWD suspect, exposed, or positive herds by permit and under seal to a known CWD positive hunt facility within the same state for purposes of selective culling and continuity of business, and all animals harvested to be tested for CWD as described in the Herd Plan (See Section B1).



See Section A 8.3 for information on approval by the Administrator for interstate movement of animals from CWD suspect, exposed, or positive herds to hunting operations or terminal slaughter facilities, and requirements for CWD testing.



States also may modify a quarantine to permit movement of apparently healthy cervids onto a CWD positive, quarantined premises - such as a hunt facility- and all cervids harvested must be tested for CWD. Other stipulations may apply to the modifications.



All animals from enrolled herds that are sent to hunt facilities must retain official identification.





(5.5) Slaughter Surveillance



Any cervids 12 months or older that are sent to slaughter facilities from herds enrolled in the Approved State CWD HCP, have not yet achieved certified status, and have remained on the owner’s enrolled herd inventory must be tested for CWD at time of death and test results reported to the Approved State. Testing of animals from certified herds that are sent to slaughter facilities will be at the discretion of the Approved State authorities. APHIS intends to evaluate these CWD surveillance parameters for the



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purposes of assessing CWD risk in these certified herds and to address national efforts in prevention and control of this disease, and may revise these testing requirements in the future.



This includes farmed or captive deer, elk, or moose moving interstate for slaughter. Such animals must be moved directly to a recognized slaughter establishment, must have two forms of animal identification, one of which is official animal identification, and must be accompanied by a certificate of veterinary inspection (CVI). See Sections A 8.1 and 8.2 for details.



Samples for CWD testing from animals 12 months or older slaughtered on the farm (custom slaughter) must be submitted as part of the on-farm surveillance required for the Approved State CWD HCP.



APHIS recommends that animals moved by permit and under seal to a slaughter facility from a CWD suspect, exposed, or positive herd shall be tested for CWD as described in the Herd Plan (See Section B1). Owners are responsible for making necessary arrangements for CWD sample collection before moving animals to slaughter. These arrangements could include coordination with an accredited veterinarian, State or Federal animal health official, certified collector, State or Federal meat inspection agency, and the slaughter facility.





(5.6) Sample Collection: Owner Responsibility



Good quality sampling and complete tissue collection of obex and MRPLN from dead animals is essential for successful surveillance. It is the owner’s responsibility to submit good quality tissue for sample collection and ensure that all required samples are collected.



Failure to comply with the provisions of this section may result in loss of program status or other actions applicable under Approved State or Federal regulation and based on review and knowledge of the owner’s compliance with CWD HCP requirements.



Owners may remove and submit the entire head with all attached identification devices to an approved CWD laboratory. Samples will be collected by laboratory personnel.



Samples may not be collected by herd owners unless they are approved by their State authority as a certified or designated CWD sample collector. Samples may only be collected by State officials, APHIS employees, accredited veterinarians, or State certified or designated CWD sample collectors.





(5.7) Sample Collection and Submission Procedures

Approved States and enrolled herd owners should follow 9 CFR Part 55.23 which states that owners must make the carcasses of animals that die available for tissue sampling and testing in accordance with instructions from APHIS and the Approved State representative; and should follow Part 55.8 which refers to using test protocols (including sample submission procedures) provided by NVSL.



The NVSL protocol for CWD testing requires the obex and MRPLN to be submitted and tested from all CWD-susceptible and test-eligible individuals regardless of species. At least one (1) valid CWD test result is necessary on each animal tested to be counted in the required mortality surveillance. Other optional lymphoid tissues such as tonsils and rectoanal mucosa-associated lymphoid tissue (RAMALT) also may be submitted for additional evaluation and at additional cost but are not required tissues. The obex and MRPLN should be submitted in 10 percent buffered formalin or as otherwise instructed by an Approved State official or APHIS employee.



All required tissues should be collected regardless of sample condition (e.g. autolyzed, frozen, etc.) and submitted to the approved laboratory. However, there may be circumstances when only one tissue sample can be collected from an animal. In those circumstances, the producer should notify the Approved State official to explain the reason such as severe tissue autolysis, extensive carcass decomposition, or destruction of tissues at slaughter. The Approved State official may determine on a case-by-case basis, if



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submission of the one tissue is acceptable. If that single sample submission is determined by the laboratory to be unsuitable or untestable, then it will be recorded as a missed sample (not tested) and that animal will not be counted in the mortality surveillance for herd certification status.



Laboratory diagnosticians will determine the suitability of the sample(s) for CWD testing with guidance from NVSL as necessary. Any concerns for sample quality and suitability, and subsequent interpretation of test results, will be discussed on a case-by-case basis with the Approved State CWD HCP official and APHIS (See Section A 5.8).



Approved State officials should follow NVSL protocols for sample testing but will determine on a case-by-case basis, whether consistent patterns of submitting unsuitable samples, submitting only one tissue type, or other non-compliant behavior by the enrolled producer warrant action(s). Actions may include loss/suspension of status or delay in advancement in the HCP,



Approved State officials also will provide oversight on sample collection by certified sample collectors and address any skill inadequacies which may require additional training or loss of certification as a sample collector.

A positive IHC test result on any sample submitted to the approved laboratory will be considered a suspect positive to be confirmed by NVSL.



All samples should be submitted using VS Form 10-4 or an equivalent State form (see Appendix VIII). Samples collected and preserved in 10 percent buffered formalin for immunohistochemistry (IHC) testing should be submitted to an approved laboratory within 7 days. Samples collected as fresh tissue for Western blot testing should be submitted within 24 hours. Detailed instructions regarding sample collection and submissions can be found in Appendices III and VIII.



DNA comparison for verification of animal identity.

Verification of the animal’s identity based on DNA comparison is an option available to enrolled herd owners at the owner’s expense. Ear tag identification devices that are firmly attached to part of the ear, which is kept chilled or frozen, must accompany the formalin-fixed or fresh tissues for CWD testing from the same animal. If part of the ear cannot be removed (eg.-for taxidermy purposes), then a new identification tag could be affixed to the hide skin, recorded in the animal’s official record, and the tagged hide section submitted with the diagnostic specimens. It is critical that the basic principles of chain of custody, such as consistent documentation and sample security, be used to ensure that the samples remain appropriately linked to the source animal from the time of sample collection to the end of the testing process. Chain of custody- type practices must be maintained in order that samples submitted can be used to verify the identity of the animal in question with certainty. All specimen containers must be clearly and permanently marked to include official identification of the animal, name of owner, name of collecting official, and date. Laboratory tracking numbers must be included with all corresponding documents.



All requests for DNA comparison testing must be submitted by the owner, in writing, to the AVIC in the corresponding Area Office of the state. The AVIC will notify NVSL of the request. NVSL will extract DNA from the test specimens and associated skin tissue, and forward the extracts to an APHIS approved laboratory for DNA comparison testing. NVSL will be report results back to the AVIC who, in turn, will forward a copy of the test results report to the owner.



(5.8) Quality Control



Approved State officials or APHIS employees have the authority to adjust herd status if incomplete or poor quality samples are repeatedly submitted from an enrolled herd. Poor quality samples include samples that are severely autolyzed (decomposed), that are from the wrong portion of the brain, the wrong tissue, or not testable for other reasons.



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Approved laboratories should closely monitor sample quality. They are responsible for providing feedback to the producer, State officials, and APHIS employees regarding the receipt of poor quality samples.



(5.9) Consequences of Poor Quality and Missing Samples



Surveillance of all animal mortalities is the key to ensuring valid herd certification status. Owners must report all mortalities to program officials as described in Section A 2.4. Failure to test for CWD of any animal 12 months of age or older in an enrolled herd that dies, is slaughtered, escapes, or is lost resulting in missing samples, or submission of incomplete or poor quality samples, may be cause for delayed advancement, loss of or reduction in status, or cancellation from the program as determined by APHIS or the Approved State Official.



Approved States (in consultation with APHIS) should develop risk-based assessments to address consequences for missed samples of test-eligible animals in enrolled herds. This may include penalties in time by reducing herd status date (with loss, reduction, or delay in herd certification), or a requirement to replace missed animals with an additional percentage of in-kind (test eligible) animals from the herd such as those sent to slaughter or hunt facilities, or a direct suspension of herd status for some period of time.

Examples of penalties that could be imposed by Approved States to address missed samples are provided in Appendix VIII .





Exemptions



Exemptions to the testing requirement and missed samples may be granted by APHIS or the Approved State Official having CWD program oversight for extenuating circumstances beyond the control of the herd owner as described below.

CWD sample collections may be limited to two animals per occasion when APHIS or the Approved State official determines that the animals died from a mass casualty/mortality event (where numerous animals die over a short period of time from the same apparent cause) such as during a natural disaster or an infectious disease outbreak (such as Epizootic Hemorrhagic Disease), or from a known zoonotic disease where sample collection would pose a public health risk. In these cases, the designated sample collector will sample the higher risk animals. Higher risk animals would include older animals, males preferentially over females, and/or those animals having any known pre-existing health conditions or are in poor body condition. CWD testing will be at the owner's expense.



(6) Diagnostics



The regulatory authority for official CWD tests and laboratory approval is found in 9 CFR 55.8.





(6.1) Testing Authority and Approved Laboratory



Laboratories will be approved by NVSL, as designated by the APHIS Administrator, to conduct official CWD testing in accordance with 9 CFR 55.8.





A. General Qualifications



Only State, Federal, and university laboratories that are members of the National Animal Health Laboratory Network (NAHLN) will be approved to conduct official CWD diagnostic testing.



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Only program-approved tests conducted in approved laboratories, at the National Veterinary Services Laboratory (NVSL), or at another laboratory to which NVSL has referred a case for confirmatory testing, are considered to be official diagnostic tests for CWD.

- All suspect positive results must be reported by email to the NVSL within 1 business day after testing is completed.



The approved laboratory must submit all specimens (all remaining fixed or frozen tissues, slides, blocks, homogenates, and tags/IDs) from a suspect positive animals to NVSL for confirmation within 24 hours.





B. Laboratory Approval



Requirements for laboratory approval can be found in the Policy regarding Evaluation of Veterinary Diagnostic Laboratories for Membership in the National Animal Health Laboratory Network. http://www.aphis.usda.gov/animal_health/nahln/downloads/Lab Evaluation Policy.pdf





C. NVSL and National CWD Program Manager Responsibilities



Upon receiving a request for laboratory approval, the NAHLN Coordinator, or his or her designee, will notify the national CWD program manager.



If the application is complete and testing is approved by the CWD program manager, authorized NAHLN personnel will schedule and conduct a site visit of the applicant laboratory if the laboratory has not been previously inspected by NAHLN or third party inspection approved by NAHLN. The AVIC will be notified before the site visit. During the site visit, authorized NAHLN personnel will review the test procedures the laboratory intends to use and determine if the applicant laboratory meets the requirements for approval.



If results of the site visit are found to be unsatisfactory, the laboratory with be notified as such will be provided the reasons for denying approval. The laboratory can address the deficiencies and resubmit the application package.





D. Recommendation for Approval



After review of the application and the site visit (if required), if the laboratory meets all requirements, the NAHLN Coordinator, or his or her designee, will notify the laboratory director and the national CWD program manager that the laboratory is approved to conduct the specific tests. Approval will be granted if the laboratory:



1. Completes proficiency testing for the specific test, as directed by NVSL. Satisfactory performance requires that the laboratory correctly identify the CWD status of all samples in the test panel. If discrepant results are obtained, NVSL, the participating laboratory, and others as required will investigate the cause. If the apparent cause of discrepant results is determined and rectified to the satisfaction of NVSL, no additional corrective actions may be needed.



At the discretion of NVSL, additional proficiency testing or additional training of personnel may be required. A second failure of a proficiency test is grounds to deny the laboratory approval for the specific test.



If the results of a laboratory’s proficiency testing are unsatisfactory, the NVSL Director (or designee) will indicate the deficiencies in writing and send this information to the laboratory director, and the NAHLN program office.





NVSL will forward proficiency test results to the NAHLN program office.



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2. Provide the NAHLN program office with CWD testing numbers and test methods used on a quarterly basis.





E. Changes to Laboratory Approval



A laboratory must notify the NAHLN Coordinator, or his or her designate, of any changes in the information contained in the application package within 30 days of the effective date of the change. Changes in procedures or equipment must be approved by NVSL before they are made. Changes in personnel requiring notification include individuals serving as the responsible laboratory official, laboratory director, or the individual responsible for CWD testing technical issues; or the contact information for these individuals.





F. Maintaining Laboratory Approval



To maintain approval, laboratories must demonstrate satisfactory completion of proficiency tests annually or as deemed necessary by NVSL. A final score of 100 percent correctly identified samples is considered a satisfactory score. The procedure described in this document will be used if discrepant results are obtained.





G. Removal of Laboratory Approval



Testing approval may be withdrawn or suspended for the following reasons:

1. Failure to meet any of the conditions stated in 9 CFR 55.8.

2. Failure to meet one or more criteria for obtaining or maintaining approval.

3. A request by the approved laboratory to withdraw approval.

4. Unsatisfactory performance on regular samples submitted for testing or required proficiency tests.

5. Unsatisfactory conditions or procedures at the laboratory.

6. Failure to report results in the manner and within the timeframes specified in these Program Standards, in the SOP provided by NVSL, or in a contract, blanket purchase agreement, or other binding agreement.



The NVSL Director, acting on behalf of the Administrator, may withdraw or suspend a laboratory’s approval to conduct a specific test kit or method on any or all tissues approved to be tested using the kit or method based on proficiency test failures on any tissue using the kit or method.

The NVSL Director, acting on behalf of the Administrator, will provide written notice of a proposed withdrawal to the laboratory director and will allow the laboratory to respond. Any conflicts concerning the reasons for withdrawal will be resolved through discussions that will include the NVSL director, the requesting laboratory’s director, the NVSL laboratory subject matter expert, the national CWD program manager, and the NAHLN coordinator or their designee.

H. List of Approved Laboratories



The national CWD program manager and the NVSL Director will maintain a list of the types of tests and when appropriate the tissues approved for laboratories that conduct official diagnostic tests for CWD. The list will be available on request to all interested parties.



A list of laboratories approved to conduct CWD testing is available at: http://www.aphis.usda.gov/animal_health/nahln/downloads/cwd_scrapie_lab_list.pdf





(6.2) Official CWD Test



An official CWD test is described in 9 CFR 55.8. Currently the official tests for routine CWD HCP surveillance in farmed or captive cervids is the IHC test and the Bio-Rad ELISA (pending final program



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approval) when following test protocols provided by the National Veterinary Services Laboratories (NVSL) at a laboratory approved to conduct official CWD tests. The western blot is also an official test when performed at NVSL.



An initial reactor ELISA is the result of a CWD ELISA test conducted at an approved laboratory in which the optical density (OD) of the Bio-Rad ELISA test is above the prescribed cut-off OD value.



A suspect positive ELISA diagnosis is the result of a CWD ELISA when either of the duplicate wells from repeat testing at an approved laboratory of the initial reactor ELISA homogenate by the Bio-Rad ELISA is above the prescribed cut-off OD values. These results must be confirmed by NVSL.



A suspect positive IHC test is the result of an approved CWD IHC test conducted at an approved laboratory in which the presumptive identification of PrPres has been detected in the tissue samples and that result must be confirmed positive by NVSL.



The Administrator may approve new official tests for the diagnosis of CWD conducted on live or dead animals, and will base the approval of a new test on criteria described in 9 CFR 55.8. NVSL will provide the protocols including tissues to be tested for all official tests.



Certain CWD test methods, such as ELISA tests, also may require Center for Veterinary Biologics licensure to be used as official CWD tests.





(6.3) Confirmatory Testing



All suspect positive samples (either by IHC or ELISA as defined in 6.2) shall be submitted to NVSL within 24 hours for confirmatory testing.



The following materials are required for confirmation testing.



• All remaining homogenate from grinding tubes and wells (if testing by ELISA)

• Place 1 cm section of brainstem at the obex into formalin with the remaining cranial and caudal ends of the fresh brainstem chilled.

• Place 75% of the lymph tissue into formalin and preserve the remaining 25% fresh chilled.

• All paperwork, identification tags (with tissue attached) and any remaining tissues.

Other optional lymphoid tissues such as tonsils and rectoanal mucosa-associated lymphoid tissue (RAMALT) also may be submitted to NVSL for IHC testing at NVSLs discretion but are not required tissues.



All suspect positive diagnostic test results from an approved laboratory must be confirmed by NVSL to establish a diagnosis of CWD.





(6.4) Test Results



As described in Section A 5.7, sections of brainstem/obex and MRPLN are evaluated by an official test in an approved laboratory to demonstrate the presence of the abnormal protease resistant prion protein (PrPres). PrPres is a molecular marker for the transmissible spongiform encephalopathies (TSE). PrPres must be detected in at least one of those tissues. Detections of PrPres in samples tested at approved laboratories are considered to be suspect positive pending further testing at NVSL.



A CWD-positive animal is an animal that has had a diagnosis of CWD established by means of official confirmatory CWD testing conducted by NVSL. Brainstem or lymph tissues from an animal in which PrPres is not detected by an official test does not mean absence of disease, only that the disease was not detected in those tissues from that animal at that time. Based on current TSE research and



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pathogenesis studies, it is possible to have PrPres present at levels below the sensitivity of the test. PrPres also may be present in tissues other than those that were examined. Hence, “not detected” test results may not indicate the true status of the animal if it is in the early stages of the disease.



Several sample quality control concerns are described in Section A 5.9 that can affect test results. For example, a test result of “unsuitable sample” indicates that the submitted sample was not the correct tissue type (eg. salivary gland collected instead of lymph node). A test result with a “location” statement indicates that the submitted sample was taken from an incorrect area of the brainstem (other than the obex).





(6.5) Autolyzed Samples



Autolyzed samples will be considered to be poor quality samples and may not be acceptable for testing. The sample must be verified as brainstem/obex or peripheral lymphoid tissue by the testing laboratory. Such samples may be tested if in the opinion of the testing laboratory a valid result may still be obtained.





(6.6) Reporting of Results



Positive test results are to be reported by NVSL to the submitter (if a state or federal animal health official), and the AVIC in the State where the herd resides, and the and the National CWD Program manager and/or designees. The Area Office will forward that result to the appropriate State official.



Negative (“not detected”) results are to be reported by the testing laboratory to the submitter with copies provided to the corresponding Approved State official for farmed cervids in the State where the herd resides.





(7) National Reports



This section outlines the recommendations for data entry in the national CWD database (SCS Core One National Instance) or approved State database and the submission of reports. Approved States maintaining data in a State-level database must give CWD HCP information and reports to APHIS on request. The information is critical to ensure that Federal and State personnel responsible for administering the CWD Program have the necessary data to do so effectively and efficiently.





(7.1) Data Entry and Purpose



This data will be used to monitor program performance, monitor disease control efforts, and assist States in completing epidemiological investigations. See Section A 3.4 for details regarding data required to be entered into the CWD National Database or equivalent Approved State database.



(7.2) Regularity



Data on positive and exposed herds will be entered within 5 business days after these designations are made.



Data on enrolled herds and premise identification numbers should be entered within 10 business days after it is available.



Comprehensive annual reports of HCP status and activities of enrolled herds as described in Section A 7.3 will be provided to the APHIS Administrator and correspond to state requirements for reporting by June 30 each year. Quarterly or midyear status reports may be required as appropriate. Reports will be



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submitted to the respective APHIS Area Office and will be routed to the corresponding Regional Office and to the CWD program manager.



(7.3) Components of Report



Reports should include information related to numbers of enrolled herds by State, status summaries, and summary of the level of mortality surveillance. As the reports will be used to monitor program performance and disease control efforts, the following data will be a component of the reports:

1. CWD samples and tests–number of animals tested during the reporting period, species, herd type (breeder, hunting operation, etc.) and test results.

2. CWD-positive herds–under quarantine, depopulated and released from quarantine, not under quarantine, under herd plans, number of animals in each herd.

3. CWD-exposed herds–under quarantine, depopulated and released from quarantine, not under quarantine, under herd plans, number of animals in each herd.

4. Epidemiological information–traceouts initiated, traceouts pending, and traceouts completed.

5. Enrolled herds–by State and certification status, species, number of animals in each herd, number due for inspection during each reporting period, number actually inspected.



Reports are to be submitted using VS Form 11-2 in the format provided by the national CWD program.





(8) Interstate Movement



The requirements for interstate movement of live cervids are described in 9 CFR 81.3. The requirements for issuing certificates for interstate movement are in 9 CFR 81.4. Transport of game meat and other products derived from farmed cervids for purposes of interstate commerce are regulated by the Food and Drug Administration and are not addressed in the USDA APHIS CWD regulation or these Program Standards. Similarly, transport of carcasses and other parts derived from hunter harvested wild cervids are regulated by appropriate State agencies and are not addressed in the USDA APHIS CWD regulation or these Program Standards. However, research has shown that CWD infected carcasses can and do spread CWD, therefore APHIS suggests that state wildlife agencies address this possible source of CWD infection by promulgating rules to prevent the movement of carcasses from CWD endemic areas.







(8.1) Requirement for Interstate Movement



No farmed or captive deer, elk, moose, or other Cervus, Odocoileus, and Alces species or their hybrids may move interstate unless the animals meet the following requirements:



For animals in the national CWD HCP: The animal is enrolled in the national CWD HCP and the herd has achieved Certified status. The animal must also be accompanied by a certificate issued in accordance with 9 CFR 81.4 that identifies its herd of origin and states that the animal has achieved Certified status, and that the animal does not show clinical signs associated with CWD.



For cervids captured from a wild population for interstate movement and release: Each animal must have two forms of animal identification, one of which is official animal identification. The certificate issued in accordance with 9 CFR 81.4 that accompanies the animal must state that the source population has been documented to be low risk for CWD based on a CWD surveillance program in wild cervid populations approved by the receiving State and by APHIS. This should include a summary of CWD surveillance data for the source population including estimated population size and statistical parameters used to assess prevalence. Additional information may include referencing recognized published surveillance strategies for detecting and monitoring CWD in free-ranging cervids upon which the surveillance plan was based and/or a review of the surveillance plan by APHIS Veterinary Services.

See Section A 8.3 for exemptions to interstate movement requirements.



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It is suggested that the following chart be used by state wildlife agencies to facilitate a 95% level of confidence with a 1% prevalence rate.



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????



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(8.2) Issuance of Certificates (CVI) for Interstate Movement



The certificate of veterinary inspection (CVI) issued for interstate movement must contain the following information:

1. Consignor and herd of origin with complete address and premises identification.

2. The CWD HCP status.

3. Total number of animals being moved.

4. Purpose of movement.

5. Consignee and point of destination with complete address.

6. Identification for each animal in shipment.

7. A statement that the animals are not known to be from a CWD-exposed or CWD-suspect herd. The veterinarian must also certify that the animals were not exhibiting clinical signs of disease at the time of examination.



The consignor or owner should contact the State officialState official in the State of destination to determine if there are any additional requirements.



(8.3) Exemption for Interstate Movement



Animals Moved Directly to Slaughter

Farmed or captive deer, elk, moose, or other species of Cervus, Odocoileus and Alces and their hybrids may move interstate directly to a recognized slaughter establishment for slaughter if they meet the import requirements of the state of destination.



Specifically, owners must notify their State official having CWD authority and their APHIS Area Office for approval of their eligibility to transport directly to slaughter (See Section A 5.5 for details). The consignor or owner also must contact the State official in the State of destination to determine if they meet all import requirements.. It is recommended to give prior notification to any States through which these animals may transit en-route to their destination. See Section A 8,4 on transiting.



Research Animals

A research animal permit is required for interstate movement of cervids for research purposes. The VS Form 1-27, “Permit to Move Restricted Animals,” may be used for movements of CWD-exposed, CWD-suspect, and CWD-infected animals.



Interstate Movements Approved by the State Veterinarian and Administrator

Interstate movement of farmed or captive deer, elk, and moose may be allowed on a case-by-case basis when the State Veterinarian and Administrator determines that adequate survey and mitigation procedures are in place to prevent the dissemination of CWD and to issue a permit for the movement. They also must meet the import requirements of the state of destination.



Approved States may request approval by the Administrator on a case-by-case basis for interstate movement under seal and by permit (VS Form 1-27 “Permit to Move Restricted Animals”) of farmed cervids from CWD exposed, suspect, and positive herds to a terminal slaughter facility or to a known CWD positive hunt facility or to a hunt facility located in a CWD endemic region in another state provided the Approved State has considered other intra-state options for disposition, and the receiving state authorities agree to permit entry of these animals. The receiving state authorities must have mitigation measures in place to ensure identification and containment of these animals, to limit their time in residence and termination to less than 6 10 months, and to prevent dissemination of CWD. These animals must be accompanied by a certificate issued by an APHIS or State representative or accredited veterinarian stating the destination of the animals, the purpose for which they are being moved, the number of animals covered by the certificate, the point from which the animals are moved interstate, and the name and address of the owner or shipper. All animals must retain official identification until death and all must be tested for CWD.



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(8.4) Transiting



Cervids eligible to move interstate in accordance with the CWD rule, and meeting the conditions specified in Part 81.5, can transit States en-route to their destination. Further, the rule requires farmed or captive cervids moved interstate to be considered low risk for being infected with CWD based on defined farmed cervid herd and wild cervid population surveillance parameters.



Any state requirements for transiting that are more restrictive than the APHIS requirements set forth in the CWD rule (Part 81.5), such as a requirement for a transit permit, are subject to preemption. Although the CWD rule does not require such transport permits, APHIS intends to advise producers and transporters to provide prior notification to any state through which they may transit en-route to their final destination.







Part B. Guidance on Response to CWD-Affected Herds



The CWD regulations in 9 CFR 55 describe minimum requirements in response to the finding of a CWD-affected herd in accordance with the national CWD HCP. The Program Standards provide detailed descriptions of methods for complying with the legal requirements in the regulations in 9 CFR parts 55 and 81. These methods are suggestions only and are not requirements. These methods have been approved by the APHIS Administrator to meet those requirements. Information in this section further provides suggested best management practices and other mitigation methods recognized as effective that may be used by an Approved State and herd owner to investigate and manage CWD-affected herds. APHIS will serve in an advisory capacity on details presented in this section. Recommended Suggested management procedures include quarantine, depopulation, cleaning and decontamination, epidemiology investigations, and development of herd plans.



In accordance with 9 CFR 55.1, only animals present in the original inventory at the time the herd was determined to be CWD positive or exposed may be eligible for federal indemnity upon depopulation should federal funding be available.



(1) Herd Plan



States should may develop a written herd plan for any CWD-positive, exposed, or suspect herds. These individual plans are based on a risk evaluation of the affected premises and herd by State officials and provided to the owner for agreement. The plans may be reviewed by appropriate VS personnel. Herd plans are to be signed by the herd owner and the appropriate State officials, and should be adopted within 60 days of a confirmed diagnosis of CWD.



In general, a signed herd plan includes:

1. Specified means of identification for each animal in the herd.

2. Regular examination (time period as determined by a State official or APHIS employee) of animals in the herd by a veterinarian for signs of disease.

3. Reporting to a State official or APHIS employee of any signs of central nervous system or wasting disease in herd animals.

4. Maintaining records of births and deaths as well as of the acquisition and disposition of all animals entering or leaving the herd, including the date of acquisition or removal, name and address of the person from whom the animal was acquired or to whom it was disposed, and the cause of death, if the animal died while in the herd.

5. Testing of all mortalities over 12 months of age. Records should be maintained for all samples submitted for CWD testing.



A signed herd plan may also contain additional requirements to prevent or control the possible spread of CWD, depending on the particular condition of the herd and its premises, including but not limited to:



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1. Depopulation of the herd if funds for indemnity are available. Depopulation may be accomplished by moving animals under permit to slaughter or to hunting facilities.

2. Specifying the time for which a premises must not contain cervids after CWD-positive diagnosis.

3. Removal of exposed or suspect animals from the premises if funds for indemnity are available.

4. Fencing requirements.

5. Selective culling of animals.

6. Restrictions on use and movement of possibly contaminated livestock equipment.

7. Cleaning and disinfection requirements, or other requirements. If a positive or exposed herd is depopulated, the written herd plan will consist only of premises cleaning and disinfection and restocking requirements.



A signed herd plan may be reviewed and changes proposed at any time by any party signatory to it in response to changes in the situation of the herd or premises. The plan may also be changed if improvements in understanding of the nature of CWD epidemiology; or techniques to prevent its spread, occur. However, any proposed changes must be reviewed and approved by all signatories before they are adopted.

If a producer does not follow the terms of the herd plan and CWD recurs in animals on the premises, the owner may be responsible for infecting other cervids and herds, and may be subject to any regulatory penalties by the State.



Additional information on CWD environmental contamination and recommended procedures for disinfection and decontamination of premises to be included in herd plans is provided in Appendix IV.



(1.1) SIGNED Herd Plan: CWD-Positive Herds



A. Whole Herd Depopulation With or Without Repopulation



1. If funds for indemnity are available, dDepopulation of the whole herd may be is the preferred option for response to CWD-positive herds.

2. CWD-positive and exposed animals that are depopulated must be tested and disposed of according to VS guidelines for CWD carcass disposal (Section B 2 and Appendix V of these Program Standards) and all applicable Federal, State, and local regulations.

3. If funds for indemnity are available, hSIGNED Herd plans may must also include a premises plan because of possible environmental contamination. Premises plans may include cleaning and disinfecting actions, future land use in terms of restocking, maintenance of perimeter fencing to prevent ingress or egress of cervids, and the time period for surveillance before interstate animal movement is allowed if restocking occurs. The fencing must comply with any applicable State regulations and follow the guidance provided in these Program Standards. Based on studies referenced in Appendix II, APHIS recommends the perimeter fencing to be a minimum of 2.4 meters (8 feet) high.

4. Further herd plan guidelines are located in Appendix IV.



B. Quarantine With or Without Selective Culling of Animals



If long-term quarantine of the affected herd instead of depopulation is implemented by State officials in discussion with the owner, then additional restrictions may will be required on the cervids remaining on the premises.

1. After a risk evaluation of the quarantined herd, this plan may include euthanasia if funds for indemnity are available, testing, and disposal of selected animals dependent on exposure. Any CWD-positive animals must be disposed of according to VS guidelines for CWD carcass disposal (Section B 2 and Appendix V of these Program Standards) and all applicable Federal, State, and local regulations.



2. The herd will remain under quarantine for 60 months from the last case. During this time, the herd may be required to undergo monthly inspections by State personnel with removal and CWD testing of any suspect animals. Exceptions to the inspection schedule may be allowed by the State official after consultation with the AVIC or other appropriate VS personnel.



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3.2. The owner will maintain an inventory complete with the following information for each individual animal:

a. All identification (tags, tattoos, electronic implants, etc.).

b. Date of birth.

c. ***.

d. The date of acquisition and source of each animal that was not born into the herd.

e. The date of removal and destination of any animal removed from the herd (animals in quarantined positive herds may only be removed for destruction or under permit).

f. Mortality date for animals dying within the herd and CWD official test results for all animals tested.

g. Method and location of carcass disposal.

h. Date of submission, submitter, and official CWD test results for samples required by the herd plan.



The inventory for a newly identified positive herd must be verified by a State official or accredited veterinarian and provided to APHIS within 30 days of the notification of the positive diagnosis. The owner will help complete the inventory verification. State or Federal personnel will verify this written (paper) inventory annually.



4. 3.The herd premises must have perimeter fencing adequate to prevent ingress and egress of cervids. This fencing must comply with any applicable State regulations and follow the guidance provided in these Program Standards. The fence must be structurally sound, maintained in good repair, and of sufficient construction to contain the animals. Based on studies referenced in Appendix II, APHIS recommends the perimeter fencing to be a minimum of 2.4 meters (8 feet) high.



In areas where CWD is not known to be present in free-ranging wild cervids, a second barrier is recommended that is adequate to prevent fence line contact of wild cervids with this exposed herd. Examples of barriers are described in Appendix II.

The effectiveness of these fencing requirements for the species included in the CWD rule is being evaluated and requirements may change based on future research findings.



5.4. The owner also must immediately report to an Approved State official or an APHIS employee (where applicable) any quarantined cervids that have escaped or disappear, or are otherwise missing from the premises as well as entry of any wild cervids into the facility. State officials may allow time for the herd owner to recapture the animal and work with the Approved State for decisions on disposition of the animal(s).



6. 5.Herd surveillance (mandatory mortality reporting and CWD testing of animals 12 months of age and older of all ages that die or are euthanized) is to be conducted during the quarantine and continues for 60 months 3years from the last case.



7.6. If CWD continues to be detected and the producer decides that he or she will not be able to successfully manage the herd out of the disease, herd depopulation may should be considered if funds for indemnity are available.



(1.2) SIGNED Herd Plan: CWD Exposed Herds



A trace-forward exposed herd is a herd that has received an animal from a CWD-positive herd within 60 months 3 years before the diagnosis of CWD in the positive herd. A trace-back exposed herd is a herd in which a CWD-positive animal had resided in any of the 60 months 3 years before diagnosis of CWD in the positive herd. If the positive animal was a natural addition, the origins of all purchased animals for the previous 60 months 3 years should be evaluated to locate a possible source herd for introduction of the CWD infection.



Trace-Forward Exposed Herd



A. SIGNEDHerd Plans for Trace-Forward Exposed Herds



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1. APHIS recommends that exposed animals traced to a herd be removed and tested if funds for indemnity are available at the expense of the owner, the State, or both.

a. If the animal is CWD-positive, the herd is considered to be positive and handled as in Section B 1.1.

b. If the animal is negative (not detected), no additional actions are required.



2. If an exposed animal traced to the herd is not removed, the herd plan should stipulate the following:

a. The whole herd in which the trace-forward animals reside will remain under quarantine for a period of time determined by the state animal health official for 60 months from the date of the arrival of the exposed animal into the herd. During this time the herd may undergo monthly inspections by State or Federal personnel with removal and CWD testing of any suspect animals if funds for indemnity are available. Exceptions to the inspection schedule may be allowed by the designated epidemiologist in consultation with the State or the AVIC.

b. If the herd has been participating in surveillance as part of the herd certification program, surveillance performed after arrival of the exposed animal may count as time in quarantine to establish or re-establish herd certification status at the discretion of the State official and APHIS.

c. The owner will maintain an inventory with the following information for each individual animal in the exposed herd:

• All identification (tags, tattoos, electronic implants, etc.).

• Date of birth.

• ***.

• Species.

• The date of acquisition and source of each animal that was not born into the herd.

• The date of removal and destination of any animal removed from the herd (animals in quarantined exposed herds may be removed only for destruction or under permit).

• Mortality date for animals dying within the herd and CWD test results for all animals tested.

• Method and location of carcass disposal.

• Date of submission, submitter, and results for samples required by the herd plan.

The inventory for a trace-forward exposed herd that chooses quarantine must be verified by a State official or accredited veterinarian and provided to APHIS within 30 days of the notification to the producer identification of the trace-forward exposed animals. The owner will provide the necessary assistance to complete the inventory verification. State or Federal personnel will verify this written (paper) inventory record annually.

d. Exposed herd premises must have perimeter fencing adequate to prevent ingress or egress of cervids. This fencing must comply with any applicable State regulations and follow the guidance provided in these Program Standards. The fence must be structurally sound, maintained in good repair, and of sufficient construction to contain the animals. Based on studies referenced in Appendix II, APHIS recommends the perimeter fencing to be a minimum of 2.4 meters (8 feet) high.

In areas where CWD is not known to be present in free-ranging wild cervids, a second barrier is recommended that is adequate to prevent fenceline contact of wild cervids with this exposed herd. Examples of barriers are described in Appendix II. The effectiveness of these fencing requirements for the species included in the CWD rule is being evaluated and requirements may change based on future research findings.

e. Herd surveillance (mandatory mortality reporting and CWD testing of animals 12 months of age and older of all ages which die or are euthanized) is to be conducted during the quarantine.

f. If the producer chooses quarantine and CWD is diagnosed during the quarantine period, herd depopulation should be considered.



3. If an exposed animal traced to a herd has been sold or moved elsewhere, and no longer resides in that herd, a risk evaluation should be conducted to determine level of CWD risk associated with length of time the exposed animal was in residence. This will include a review of all aspects of the producer’s management, compliance, and recordkeeping to determine how best to manage the exposed herd, the extent of restrictions to movement of animals in the herd, and release of quarantines. A herd plan should



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be established to describe required surveillance activities and management practices to re-establish herd status. State officials and epidemiologists should determine if the herd in which the exposed animal currently resides will be subject to any quarantines or movement restrictions.





Trace-Back Exposed Herd



B. SIGNED Herd Plans for Trace-Back Exposed Herds



1. If funds for indemnity are available, tThe preferred action in herds identified as trace-back exposed may be is, in most cases, whole-herd depopulation and testing. However, if the epidemiological investigation is able to pinpoint the likely point of infection of the positive animal, depopulation of herds in which the animal resided before that point may not be necessary. If not already participating, these herds should be encouraged to enroll in the program. If funds for indemnity are not available, movement of exposed animals under permit to slaughter facilities or hunt facilities may be allowed.



Animals that moved from trace-back herds during the time the positive animal was in residence also should be traced.



2. If the herd owner decides against depopulation, the herd will remain under quarantine for a period of time determined by the state animal health official for 60 months from the last case traced back to the herd. The owner must also agree to a herd plan. During this time, the herd plan will include:

a. Periodic Monthly inspections by State or Federal personnel with removal and CWD testing of any suspect animals. Exceptions to the inspection schedule may be allowed by the designated CWD epidemiologist in consultation with the State, the AVIC, or both.

b. If the herd has been participating in surveillance as part of the herd certification program, time in surveillance following the departure from the herd of the animal which becomes CWD positive may count as time in quarantine to establish or re-establish herd certification at the discretion of the designated epidemiologist, APHIS employees and State officials.

c. The owner will maintain an inventory complete with the following information for each individual animal:

All identification (tags, tattoos, electronic implants, etc.)

• Date of birth.

• ***.

• The date of acquisition and source of each animal that was not born into the herd.

• The date of removal and destination of any animal removed from the herd (animals in quarantined exposed herds may be removed only for destruction or under permit).

• Mortality date for animals dying within the herd and CWD test results for all animals tested.

• Method and location of carcass disposal.

• Date of submission, submitter, and results for samples required by the herd plan.

The inventory for a trace-back exposed herd that chooses quarantine must be verified by a State official or accredited veterinarian and provided to APHIS within 30 days of the notification to the producer identification of the herd as a trace-back exposed herd. The owner will help complete the inventory verification. State or Federal personnel will verify this inventory annually.

d. Exposed herd premises must have perimeter fencing adequate to prevent ingress or egress of cervids. This fencing must comply with any applicable State regulations and follow the guidance provided in these Program Standards. The fence must be structurally sound, maintained in good repair, and of sufficient construction to contain the animals. Based on studies referenced in Appendix II, APHIS recommends the perimeter fencing to be a minimum of 2.4 meters (8 feet) high.

In areas where CWD is not known to be present in free-ranging wild cervids, a second barrier is recommended that is adequate to prevent fence line contact of wild cervids with this exposed herd. Examples of barriers are described in Appendix II. The effectiveness of these fencing requirements for the species included in the CWD rule is being evaluated and requirements may change based on future research findings.

e. Herd surveillance (mandatory death reporting and CWD testing of all age animals 12 months of age and older which die or are euthanized) is to be conducted during the quarantine.



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f. If the producer chooses quarantine and CWD is diagnosed during the quarantine period, herd depopulation should be considered.



(1.3) Quarantine



CWD-positive or exposed herds are to be issued quarantines or hold orders by the State officialVeterinarian. Exposed animals in a positive or trace herd must remain on the premises unless a State or Federal permit for movement (such as VS Form 1-27) has been obtained.



APHIS defines quarantine as an order issued by a State official Veterinarian restricting prohibiting movement of animals. from or onto a premises for a given period of time. This should be moved to definitionsIf captive cervid herds in which CWD is confirmed are not depopulated, they will remain under quarantine for a minimum of 60 months after the last case has been confirmed. However, States may modify a quarantine to permit cervid movement onto CWD positive quarantined premises, such as a hunting facility, and all cervids harvested must be tested for CWD. Other stipulations may apply to the modifications.









(1.4) Release from Quarantine



Quarantine may be released only after all herd plan requirements have been met and completed, or as determined by the State official Veterinarian.



(1.5) Depopulation



If funds for indemnity are available, wWhole-herd depopulation and testing of all cervids on the premises may be is the preferred action to be taken in response to a positive herd provided there is a signed herd plan in place. Depopulation activities will be at the cost of the owner, the State, or both.



If funds for indemnity are available, dDepopulation and testing may also be the preferred action for trace-forward exposed animals and trace-back herds that are epidemiologically implicated as source herds or exposed herds. As determined by the State officialVeterinarian, quarantined animals may be moved by permit (such as VS Form 1-27) under seal to a recognized slaughter establishment for slaughter. Quarantined animals moved interstate to slaughter or to a hunting facility must have 2 forms of identification, one of which must be official, in accordance with Part 81.3 of the regulation. Meat and other cervid products derived from commercial slaughter are under FDA jurisdiction.





(2) Carcass Disposal



This section outlines the guidelines that States and herd owners may can use for the disposal of carcasses from positive or exposed herds or from trace-exposed animals.



(2.1) Suitable Disposal Methods



Remains of CWD-positive or exposed animals should be disposed of in compliance with all Federal, State, and local regulations. Incineration, alkaline digestion, disposal of materials in appropriate landfills, and burial onsite are the most suitable options. Detailed disposal guidelines can be found in Appendix V.



(3) Sanitary Precautions and Biosecurity Practices for Herd Plans and Depopulations



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Cleaning, disinfection, and decontamination recommendations for CWD positive herds are located in the Herd Plan guidelines in Appendices IV and VI. The following information on biosecurity should be included as general best management practices and is applicable for CWD infected herds. .



Delivery vehicles, such as feed trucks, should always follow good biosecurity and disinfection practices between premises. Owners should restrict entry of such vehicles onto infected premises and/or provide disinfection stations upon exiting the premises.



Any third-party vehicle used to transport cervids must be cleaned and disinfected before and after transporting cervids. The owner will require the transporter to provide a statement that the truck or trailer was cleaned and disinfected and will keep a copy of the statement.



Producer-owned vehicles such as cars, pickup trucks, and tractors only may be shared among herds or premises under common ownership. Producer-owned equipment for transport of animals must be cleaned and disinfected if it is to be used for multiple herds managed by the same producer. Other farm equipment that tends to be heavily contaminated with soil or feces such as manure spreaders and drags may not be shared among herds or premises unless it is cleaned and disinfected each time. Producers should keep records of these activities which involve commingling of animals in those herds. .



Other equipment that should not be shared unless herds are commingled includes, but is not limited to, feed bunks, water troughs, chutes, buckets, and multiple-use medical equipment (antler removal equipment, bolus guns, multiple-dose syringes, etc.).



For herds managed by the same owner, personnel working with these herds must wear different outerwear (e.g., boots and coveralls) when moving from one herd to another.



(4) Epidemiology



This section is an outline for States on epidemiological investigation methods and responsibilities for determining the source of infection as well as the extent of exposure when an infected animal has been identified.



(4.1) Responsibility



An epidemiological investigation will be conducted by a State representative once an animal has been confirmed to have CWD. When appropriate, and when there are available Federal funds, VS personnel will assist with the investigations. The investigation should be started within 7 business days of the laboratory confirmation by a State official or designee.



Case investigation and reporting information should be entered into the Emergency Management Response System.



Where possible, VS personnel will work with the State and the Area Office to prepare educational materials about CWD that can be provided to owners to mitigate future disease transmission.



(4.2) Investigation



The investigation identifies the source of infection in a herd as well as other animals that may have been exposed to CWD. See Appendix VI for an example of an Epidemiology Report template.

The investigation should identify:

1. Source of infection in a positive herd when the positive animal was a natural addition (born in the infected herd and resided there for its lifetime). The focus should be on how CWD may have been introduced into the herd (e.g., movement of other animals into the herd or potential exposure to infected wild cervids). The origin of all purchased animals into the herd should be evaluated to determine if the source of CWD infection can be identified.



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