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Old May 8th 2013, 08:53 PM   #1
 
  Apr 2009
  TN
THANKS to: Laurie Seale for sending this information so I could post it for the industry.



United States Department of Agriculture

Animal and Plant Health Inspection Service

Veterinary Services



Chronic Wasting Disease

Program Standards



July 2012



Table of Contents



Introduction



Definitions



Part A. Herd Certification Program



(1) Administrative Procedures

(1.1) Supervision

(1.2) Entering Premises

(1.3) Providing Services

(1.4) Reporting Activities

(1.5) Designated Epidemiologist

(1.6) Designated CWD HCP Coordinator

(1.7) Review of Approved State HCP Progress

(1.8) Selection of States for Approved State HCP Review

(1.9) Approved State Review Report



(2) Participation

(2.1) Approving Existing State CWD Herd Certification Programs

(2.2) Provisional Approval

(2.3) Participating Approved State: Requirements

(2.4) Participating Herd: Requirements for Enrollment

(2.5) Herd Owner Enrollment and Advancement

(2.6) Additions of Animals or Genetic Material (Germplasm) to a Herd: Effects on Status

(2.7) Inspections and Inventories

(2.8) Loss of Certification Status

(2.9) Relocation of Herd

(2.10) Cancellation of Participation



(3) Registration, Identification, and Recordkeeping

(3.1) Premises ID

(3.2) Animal Identification

(3.3) Herd Inventory – Records

(3.4) National Herd Inventory Electronic Record Keeping

(3.5) Data Security in the Electronic National CWD Database (PENDING)



(4) Fencing Requirements



(5) Surveillance and Sampling

(5.1) Reportable Disease

(5.2) CWD-Suspect Animals

(5.3) On-Farm Surveillance

(5.4) Shooter Animal Surveillance

(5.5) Slaughter Surveillance

(5.6) Sample Collection: Owner Responsibility

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Old May 8th 2013, 08:54 PM   #2
 
  Apr 2009
  TN
(5.7) Collection and Submission Procedures

(5.8) Quality Control

(5.9) Consequences of Poor Quality and Missing Samples



(6) Diagnostics

(6.1) Testing Authority and Approved Laboratory

(6.2) Official CWD Test

(6.3) Confirmatory Testing

(6.4) Test Results

(6.5) Autolyzed Samples

(6.6) Reporting of Results



(7) National Reports

(7.1) Data Entry and Purpose

(7.2) Regularity

(7.3) Components of Report



(8) Interstate Movement

(8.1) Requirement for Interstate Movement

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

(8.3) Exemption for Interstate Movement



Part B. Guidance on Response to CWD-Affected Herds



(1) Herd Plan

(1.1) Herd Plan: CWD-Positive Herds

(1.2) Herd Plan: CWD Exposed Herds

(1.3) Quarantine 39

(1.4) Release from Quarantine

(1.5) Depopulation



(2) Carcass Disposal

(2.1) Suitable Disposal Methods

(3) Sanitary Precautions/Biosecurity

(4) Epidemiology

(4.1) Responsibility

(4.2) Investigation

(4.3) Trace-Back and Trace-Forward Notifications



Appendix I. Official Animal Identification



Appendix II. Fencing Requirements and References



Appendix III. Sample Collection



Appendix IV Guidelines on Environmental Contamination and Recommended Procedures for Disinfection and Decontamination



Appendix V. Carcass Disposal of Positive Animals or Animals of Unknown Status



Appendix VI. CWD Epidemiology Investigation and Report Template



Appendix VII. Links to Forms and Documents



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Old May 8th 2013, 08:55 PM   #3
 
  Apr 2009
  TN
Introduction 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. By following the methods described in the Program Standards, participants in this voluntary program can achieve herd certification status.



These Program Standards will be reviewed at least annually by representatives of the cervid industry and appropriate State and Federal agencies. A notice may be published in the Federal Register to inform stakeholders of any revisions APHIS plans to the Program Standards. These Program Standards also may be amended in the future by replacing pages or by adding new pages with approval of all stakeholders.



Part A. Herd Certification Program. These Program Standards are the minimum standards optional guidelines adopted and approved by the Deputy Administrator, Veterinary Services (VS), Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA). They were established for three primary purposes:

1. To assist Federal and State agencies in maintaining CWD-certified herds of deer, elk, and moose (all Odocoileus spp. and Cervus spp. and their hybrids and Alces alces).

2. To provide guidance on procedures to certify herds as a low risk for CWD by remaining in continuous compliance with the CWD Herd Certification Program requirements found in 9 CFR Part 55.

3. To provide guidance on complying with the minimum requirements for interstate movement of cervids found in 9 CFR Part 81.



Enrollment and participation by cervid herd owners in the national CWD Herd Certification Program may only occur in states that permit cervid farming.



Approved States may have additional or stricter requirements that exceed the national program minimum requirements.





Part B. Guidance on Response to CWD-Affected Herds. The CWD regulations at 9 CFR part 55 describe minimum requirements in response to the finding of a CWD-affected herd in accordance with the national CWD HCP. This section further provides suggested best management practices that may be used by a State and herd owner to investigate and manage CWD-affected herds, including quarantine, depopulation, cleaning and decontamination, and herd plans.



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Old May 8th 2013, 08:56 PM   #4
 
  Apr 2009
  TN
Definitions



Scope. The definitions in 9 CFR 55 and 9 CFR 81 apply to these Program Standards.



Accredited Veterinarian. A veterinarian approved by the Administrator in accordance with Part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter.



Administrator. The Administrator of APHIS or any employee of APHIS who is authorized to act for the Administrator.



Animal. Any farmed or captive deer, elk, or moose.



Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.



APHIS Employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.



Animal Status. See Program Animal Status



Approved State. A State that the Administrator has determined has an Approved State CWD Herd Certification Program.



Approved State CWD Herd Certification Program. A program operated by a State government for certification of cervid herds with respect to CWD that the Administrator has determined to meet the requirements of 9 CFR Part 55.



Approved Laboratory. A diagnostic laboratory approved by the Administrator to conduct official tests for CWD in accordance with 9 CFR 55.8



Area Veterinarian in Charge (AVIC). The APHIS veterinary official assigned by the Administrator to supervise and perform the official APHIS animal health work in the State concerned.



Certified Herd. A Certified herd is regarded as low risk for CWD because it has attained Certified status as defined in 55.24 and in these Program Standards.



Certified CWD Sample Collector. An individual who has completed appropriate training recognized by his or her State on the collection and preservation of samples for CWD testing and on proper recordkeeping, and who has been certified to perform these activities by his or her State regulatory authority for farmed and captive cervids.



Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species. For the purposes of this part [rule], the term ‘cervid’ refers specifically to cervids susceptible to CWD. These are animals in the genera Odocoileus, Cervus, and Alces and their hybrids, i.e. deer, elk, and moose.



Chronic Wasting Disease, (CWD). A transmissible spongiform encephalopathy of cervids.



Commingled, commingling. Farmed cervids are commingled if they are housed or penned together having direct physical contact with each other, have less than 10 feet of physical separation (except in cases of “limited contact”; see definition) or any activity where uninhibited contact occurs such as sharing an enclosure, a section of a transport vehicle, or sharing equipment, pens or stalls, pasture, or water sources/watershed (i.e., housed in a pen that receives runoff or shares a natural or manmade body of water with another pen), or being grouped together for bottle feeding (such as in fawn rearing facilities),. Commingling includes contact with bodily fluids or excrement from other farmed animals. Farmed cervids



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Old May 8th 2013, 08:57 PM   #5
 
  Apr 2009
  TN
commingled with other farmed cervids assume the status of the lowest program status animal in the group.



Commingled, commingling. Animals are commingled if they have direct contact with each other, have less than 10 feet of physical separation, or share equipment, pasture, or water sources/watershed. Animals are considered to have commingled if they have had such contact with a positive animal or contaminated premises within the last 53 years.



CWD National Database. For the purposes of the CWD rule and the Approved State CWD HCP, a CWD HCP database administered by APHIS or a State database approved by the Administrator as compatible with a “CWD National Database” for the Approved State CWD HCP program.



CWD-Exposed Animal. An animal that is part of a CWD-positive herd, or that has been commingled with a CWD-positive animal or resided on contaminated premises within the 5 3 years before diagnosis.



CWD-Exposed Herd. A herd in which a CWD-positive animal has resided within 5 3years before that animal’s diagnosis as CWD positive, as determined by an APHIS employee or State official.



CWD Herd Certification Program. The Chronic Wasting Disease Herd Certification Program established in 9 CFR 55. This program includes both herds that are directly enrolled in the CWD Herd Certification Program and herds that are included based on their participation in Approved State CWD Herd Certification Programs.



CWD-Positive Animal. An animal that has had a diagnosis of CWD established through official, confirmatory CWD testing conducted by the National Veterinary Services Laboratories (NVSL).



CWD-Positive Herd. A herd in which a CWD-positive animal resided at the time it was diagnosed.



CWD Source Herd. A herd identified through testing, tracebacks, or epidemiological evaluations to be the source of CWD-positive animals identified in other herds.



CWD-Suspect Animal. An animal for which a State official or APHIS employee has determined that preliminary laboratory tests from an approved laboratory or clinical signs suggest a diagnosis of CWD, but for which official confirmatory laboratory results have been inconclusive, or not yet conducted.



CWD-Suspect Herd. A herd for which preliminary laboratory tests from an approved laboratory, or clinical signs, suggest a diagnosis of CWD, as determined by a State official or APHIS employee, but for which official confirmatory laboratory results have been inconclusive, or not yet conducted.



Deer, Elk, and Moose. All animals in the genera Odocoileus, Cervus, and Alces, and hybrids of these species. This includes white-tailed deer (Odocoileus virginianus), mule deer (Odocoileus hemionus) and black-tailed deer (Odocoileus hemionus columbianus) and any associated subspecies. Also includes North American elk or wapiti (Cervus canadensis), red deer (Cervus elaphus), and Sika deer (Cervus nippon).



Deputy Administrator. The VS Deputy Administrator or any other official to whom the Administrator has delegated authority to act as the Deputy Administrator.



Designated Epidemiologist. A State official or Federal veterinarian with epidemiology training or experience who assists in decision-making about the use and interpretation of diagnostic tests, analysis of field investigation data, and the management of CWD-affected herds.



Enrollment Date. With the exceptions listed in 9 CFR 55.22(a)(1), the enrollment date for any herd that joins the CWD Herd Certification Program after the effective date of this rule will be the date the herd is approved for participation.



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Old May 8th 2013, 08:58 PM   #6
 
  Apr 2009
  TN
Farmed or Captive. Privately or publicly maintained or held for economic or other purposes within a perimeter fence or confined area, or temporarily captured from a wild population for interstate movement and release.



Herd. A herd consists of an animal or group of animals that are:

(a) under common ownership, control, or supervision and are grouped on one or more parts of any single premises (lot, farm, or ranch) where commingling of animals occurs; or

(b) A single herd also is considered to be all animals under common ownership, control, or supervision on two or more premises which are geographically separated but on which animals have been commingled or had direct or indirect contact with one another.

If an owner wishes to maintain separate herds, he or she must maintain separate herd inventories, records, working facilities, water sources, equipment, and land use. Herds must be separated by a distance of 30 feet or more. No commingling of animals may occur. If movement of animals does occur between herds, this movement must be recorded as it would if they were separately owned herds.



Herd. One or more animals that are:

(1) Under common ownership or supervision and are grouped on one or more parts of any single premises (lot, farm, or ranch) or

(2) All animals under common ownership or supervision on two or more premises which are geographically separated but on which animals have been interchanged or had direct or indirect contact with one another.



Herd Certification Program (HCP). The Chronic Wasting Disease Herd Certification Program established in 9 CFR 55 Subpart B. A program of surveillance, monitoring, and related actions designed to determine the CWD status of farmed or captive deer, elk, and moose. Herds that successfully complete 5 years of the program with no evidence of disease will be designated as certified and will be allowed to move interstate.



Herd Inventory. A herd owner’s written record of all of the animals belonging to a herd that includes species, date of birth, age, sex of each animal, the date of acquisition and source of each animal that was not born into the herd, the date of disposal and destination of any animal removed from the herd, and all individual identification numbers (from tags, tattoos, electronic implants, etc) associated with each animal. Herd inventory can also refer to the process of reconciling a herd owner’s written record with the animals physically present in the herd.



Herd Plan. A written herd or premises management agreement that sets forth the steps to be taken to eradicate CWD from a CWD-positive herd, to control the risk of CWD in an exposed or suspect herd, or to prevent introduction of CWD into that herd or any other herd. A herd plan will require specified means of identification for each animal in the herd, regular examinations of animals in the herd by a veterinarian for clinical signs of disease, reporting to a State or APHIS representative any clinical signs of central nervous system disease or other signs consistent with CWD, maintaining records of the acquisition and disposition of all animals entering or leaving the herd, including dates and source of acquisition and removal, and reporting mortalities and cause of death, including CWD testing, of all animals in the herd. Additional requirements to prevent or control spread of CWD may include depopulation of the herd, specifying the time for which a premises must not contain cervids (after depopulation), fencing requirements, selective culling of animals, restrictions on sharing and movement of possibly contaminated livestock equipment, premises cleaning and disinfection requirements, or other requirements.

Herd Plan-A signed written agreement between the herd owner, the State Veterinarian, and/or APHIS Administrator. The signed her plan may also include requirements on fencing, decontamination and cleanup of the premise.



Herd plan. A written herd and/or premises management agreement developed by the state veterinarian APHIS in collaboration with the herd owner, APHIS, State representatives, and other affected parties. The herd plan will not be valid until it has been reviewed and signed by the Administrator, the State representative, and the herd owner. A herd plan sets out the steps to be taken to eradicate CWD from a CWD-positive herd, to control the risk of CWD in a CWD-exposed or CWD-suspect herd, or to prevent



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Old May 8th 2013, 08:58 PM   #7
 
  Apr 2009
  TN
introduction of CWD into that herd or any other herd. A herd plan will require specified means of identification for each animal in the herd; regular examination of animals in the herd by a veterinarian for clinical signs of disease; reporting to a State or APHIS representative of any clinical signs of a central nervous system disease or chronic wasting condition in the herd; maintaining records 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. A herd plan may also contain additional requirements to prevent or control the possible

spread of CWD, depending on the particular circumstances of the herd and its premises, including but not limited to depopulation of the herd, specifying the time for which a premises must not contain cervids after CWD-positive, -exposed, or -suspect animals are removed from the premises; fencing requirements; selective culling of animals; restrictions on sharing and movement of possibly contaminated livestock equipment; premises cleaning and disinfection requirements; or other requirements. A herd plan may be reviewed and changes to it suggested at any time by any party signatory to it, in response to changes in the situation of the herd or premises or improvements in understanding of the nature of CWD epidemiology or techniques to prevent its spread. The revised herd plan will become effective after it is reviewed by the Administrator and signed by the Administrator, the State representative, and the herd owner.



Herd Status. See Program Herd Status.



Herd status. The status of a herd assigned under the CWD Herd Certification Program in accordance with Sec. 55.24, indicating a herd's relative risk for CWD. Herd status is based on the number of years of monitoring without evidence of the disease and any specific determinations that the herd has contained or has been exposed to a CWD-positive, -exposed or -suspect animal.



Hold Order. A temporary order issued by a State prohibiting movement of animals from or in to a premises for a given period of time.



Initial Reactor ELISA. 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.



Limited Contact. Any brief contact with a farmed animal such as occurs in sale or show rings and alleyways at fairs, livestock auctions, sales, shows, and exhibitions. Limited contact does not include penned animals having less than 10 feet of physical separation or contact through a fence, or any activity where uninhibited contact occurs such as sharing an enclosure, a section of a transport vehicle, sharing equipment, food, or water sources, or contact with bodily fluids or excrement. Pens at fairs, livestock auctions, sales, shows, and exhibitions must be thoroughly cleaned and all organic material removed after use and before holding another animal.



Location-based numbering system. The location-based number system combines a State or Tribal issued location identification (LID) number or a premises identification number (PIN) with a producer’s unique livestock production numbering system to provide a nationally unique and herd unique identification number for an animal.



National Veterinary Services Laboratories (NVSL). The USDA APHIS National Veterinary Services Laboratories.



Noncompliant Herd. Any source, suspect, exposed, or positive herd whose owner declines to enter into a herd plan agreement once so designated or whose owner is not in compliance with an existing herd plan agreement; any herd whose owner has misrepresented, or who employs a person who has misrepresented, the herd status of an animal or any other information on a certificate, permit, owner statement, or other official document within the last 5 years; or any herd whose owner or manager has moved, or who employs a person who has moved, an animal in violation of 9 CFR Parts 55 or 81 within the last 5 years.



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Old May 8th 2013, 08:59 PM   #8
 
  Apr 2009
  TN
Official Animal Identification. A device or means of animal identification approved by APHIS for use in the CWD Herd Certification Program to uniquely identify individual animals. For the purposes of the CWD rule, and in accordance with the Traceability rule (9 CFR 86.1), the official identification number must be a nationally unique number that is permanently associated with an animal and that adheres to one of the following numbering systems:

(1) National Uniform Eartagging System (NUES).

(2) Animal Identification Number (AIN).

(3) Location-based number system.

(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.



Official CWD Test. A program-approved test method for CWD diagnosis that is approved by the Administrator in accordance with 9 CFR 55.8 using NVSL protocols and conducted at the NVSL, an APHIS-approved laboratory, or another laboratory to which NVSL has referred a case for confirmatory testing. Certain CWD test methods, such as enzyme-linked immunosorbent assay (ELISA) tests, also may require Center for Veterinary Biologics licensure to be used as official CWD tests.



Official CWD test. Any test for the diagnosis of CWD approved by the Administrator and conducted in a laboratory approved by the Administrator in accordance with 55.8 of this part.



Owner. An individual, partnership, company, corporation, or other legal entity that has legal or rightful title to an animal or herd of animals.



Premises. The ground, area, buildings, water sources, and equipment commonly shared by a herd of animals.



Premises Identification Number. A unique number consistent with official animal identification as set forth in USDA’s Animal Disease Traceability framework, used to identify the premises on which a herd resides. This number is recorded in the CWD national database.



Premises Plan. The section of a herd plan which outlines actions to be taken with regard to possible environmental contamination due to a CWD-positive or exposed herd.



Program Animal Status. The status of an animal assigned under the Herd Certification Program indicating the animal’s relative risk for CWD. An animal’s status is equivalent to the status of the herd in which that individual animal resides.



Program Herd Status. The status of a herd assigned under the Herd Certification Program indicating a herd’s relative risk for CWD.



Quarantine. An order issued by a State prohibiting movement of animals from or into a premises for a given period of time.



Research Animal. An animal held captive for research purposes.



SCS- Core One. Surveillance Collaboration Services – Core One is a module of the VS Comprehensive and Integrated Animal Health Surveillance System. SCS –Core One supports routine animal health surveillance and program management under the purview of the VS National Center for Animal Health Programs (VS NCAHP) and the National Surveillance Unit (NSU).



State. Each of the 50 States, the District of Columbia, Puerto Rico, and all territories or possessions of the United States.



State Official. An individual employed in livestock animal health or wildlife activities by a State or a political subdivision of a State who is authorized by the State or political subdivision to perform the activities involved.



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Old May 8th 2013, 08:59 PM   #9
 
  Apr 2009
  TN
State Veterinarian. The veterinary official of a State authorized by the State to supervise and perform the official animal health work of the State concerned.



Status Date. The day, month, and year on which the respective State or APHIS employee approves a change in the status of a herd in regard to CWD.



Suspect Positive ELISA. 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.



Suspect Positive IHC Test. 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.



Trace-back Herd. A herd in which a CWD-positive animal had formerly resided in any of the 60 months before the diagnosis of CWD in the positive herd, or a herd being investigated from which animals were purchased and added to the CWD-infected herd in which the CWD-positive animal was a natural addition.



Trace back herd. A herd in which a CWD-positive animal formerly resided.



Trace-Forward Herd. A herd that has received exposed animals from a CWD-positive herd within 60 months3 years before the diagnosis of CWD in the positive herd or from the identified point of entry of CWD into the positive herd.



Unapproved CWD State. Any State other than an Approved State including a State having a CWD Herd Certification Program that does not meet minimum standards of the national CWD Herd Certification Program, or a State without a CWD Herd Certification Program.



Veterinary Services, (VS). The APHIS unit authorized to conduct prevention, control, and eradication programs for diseases of livestock and poultry.





Part A. Herd Certification Program



(1) Administrative Procedures. The CWD Herd Certification Program (HCP) is a cooperative effort between APHIS, State animal health or wildlife agencies, and farmed/captive deer, elk, or moose owners. Under the program, APHIS reviews State CWD HCPs and approves the programs if they meet Federal standards, monitors them to ensure consistency with Federal standards, and administers the national CWD HCP, subject to the availability of appropriated funds, in States that do not have an approved State CWD HCP. APHIS will execute a Memorandum of Understanding with States having an approved CWD HCP.



(1.1) Supervision Routine supervision is provided by full-time State officials or APHIS employees.



(1.2) Entering Premises In accordance with the MOU, persons working in the program must be authorized by the State to enter premises to carry out program activities. While on those premises, they must use standard sanitary procedures to minimize the risk of disease transmission to other premises.



(1.3) Providing Services Owners may need to engage accredited veterinarians or other appropriate animal health professionals to perform program activities at the owner’s expense. Owners are responsible for assembling, handling, and restraining their animals. If resources are available, program services may be rendered by State and Federal agencies without expense to the herd owner.



(1.4) Reporting Activities All CWD activities shall be reported as directed in 9 CFR 55 the Program Standards.



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Old May 8th 2013, 09:00 PM   #10
 
  Apr 2009
  TN
(1.5) Designated Epidemiologist A State official or Federal veterinarian (where applicable) with epidemiology training or experience to: 1) make decisions about the use of CWD diagnostic test results; 2) participate in field epidemiologic investigations; 3) to manage CWD-infected herds; and 4) ensure data quality and accuracy for the CWD program in his or her State or Area. In each State, a designated epidemiologist may be selected jointly by the State representative with regulatory authority for CWD and the APHIS AVIC. Only persons with the requisite epidemiology training or experience should be selected.



(1.6) Designated CWD HCP Coordinator The State has designated at least one State representative, or has worked with APHIS to designate an APHIS employee, to coordinate CWD HCP activities in the State in accordance with 9 CFR 55.23.



(1.7) Review of Approved State HCP Progress APHIS may periodically review an approved State’s CWD program. Objectives of the review include:

1. Evaluate program activities to verify Approved State status.

2. Identify and provide guidance on State problems in complying with Federal requirements.

3. Review farmed cervid surveillance activities and enrolled herd owner compliance.

4. Review records and documents on enrolled herds, including laboratory reports and herd inventories.

5. Review epidemiological reports submitted by the State designated epidemiologist to the Regional Epidemiologist and national CWD program manager.

6. Assess compliance and completeness with data entered into the national CWD database or equivalent State database.

7. Review educational and outreach efforts to producers.

8. Evaluate personnel and other resource needs.

9. Conduct site visits in accordance with VS Guidance 5509.1.



(1.8) Selection of States for Approved State HCP Review CWD Regional Epidemiologists, with input from Area and Regional leadership and national program staff, will consider States with compliance or program consistency issues, States with varying sizes of cervid industry, Regional balance (selecting States from each Region), and review intervals (at least once every 5 years).



(1.9) Approved State Review Report APHIS will give a State Review report to the Approved State that will include the findings of the review, and a request to the State to develop a response which could include an action plan. The plan will include a list of recommendations or requirements to address specific issues identified and a specified period of time to complete.



(2) Participation. The regulatory authority for the requirements for participation in the national CWD HCP is found in 9 CFR Part 55 Subpart B.



(2.1) Approving Existing State CWD Herd Certification Programs APHIS will accept applications to become an Approved State CWD herd certification program and will review the State’s documentation of the CWD programs already existing within the State to determine if the State meets the program requirements. Existing State CWD programs and farmed or captive elk, deer, and moose owners participating in them will be approved if they meet the minimal requirements of the APHIS national CWD programCFRS. The date that these herds enrolled in a State program that APHIS subsequently determines qualifies as an Approved State CWD herd certification program would be considered their enrollment date in the national CWD HCP. This process will allow herds participating in approved State programs to retain their State status in the APHIS national CWD HCP. A list of Approved State CWD HCPs will be posted on the APHIS CWD Web site.



(2.2) Provisional Approval Provisional approval may be granted to States that do not meet all the national CWD HCP minimum requirements upon application to the program. APHIS and the State will work to develop a plan with appropriate time frame to meet program requirements.



(2.3) Participating Approved State: Requirements States must submit an application, including a completed VS Form 11-2 and supporting documentation, describing their ability to meet the national CWD



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Old May 8th 2013, 09:00 PM   #11
 
  Apr 2009
  TN
HCP requirements. In reviewing a State program's eligibility to be designated as an Approved State, the Administrator or his or her designee will evaluate the State statutes, regulations, and directives pertaining to the State agency responsible for farmed or captive cervids, as well as relevant reports and publications of the State animal health or State wildlife agency. The Administrator or designee will also review a written statement from the State animal health or State wildlife agency describing State CWD control and farmed or captive elk, deer, and moose herd certification activities. In determining whether the State program qualifies, the Administrator or his or her designee determines whether the State:



1. Has the authority, based on State law or regulation, to quarantine and restrict intrastate movement of all CWD-positive, CWD-suspect, and CWD-exposed animals.



2. Has the authority, based on State law or regulation, to require the prompt reporting of any animal suspected of having CWD; and forward test results for any animals tested for CWD to APHIS and State representatives, or State wildlife authorities when they are the appropriate regulatory authority.



3. Has signed a Memorandum of Understanding (MOU) between APHIS and the State that delineates the respective roles of each in CWD HCP implementation. A link to the MOU form can be found in Appendix VIII.



4. Has placed all known CWD-positive, CWD-exposed, and CWD-suspect animals and herds under movement restrictions, with movement of animals from them only for destruction with appropriate carcass disposal, or only under permit.



5. Has effectively implemented policies to:

a. Promptly investigate all animals reported as CWD-suspect animals within 7 days of notification.

b. Designate herds as CWD-positive, CWD-exposed, or CWD-suspect and promptly restrict movement of animals from such herds after an APHIS employee or State official determines that the herd contains or has contained a CWD-positive animal.

c. Remove herd movement restrictions only after completion of a herd plan.

d. Conduct an epidemiological investigation of CWD-positive, CWD-exposed, and CWD-suspect herds that includes the designation of suspect and exposed animals and that identifies animals to be traced in accordance with recommended guidelines.

e. Initiate and conduct trace-backs of CWD-positive animals in affected herds and trace-outs of CWD-exposed animals.

f. Report, within 30 days following notification of a CWD-positive animal, any out-of-State traces to the appropriate State official and APHIS employee.

g. Conduct trace-backs based on slaughter sampling. Investigation should be initiated promptly following notification of a CWD-positive animal at slaughter.



6. Effectively monitors and enforces State quarantines or hold orders and State reporting laws and regulations for CWD, documenting any noncompliance with quarantines, hold orders, or reporting.



7. Has designated at least one State official to coordinate CWD HCP activities in the State.



8. Has programs to educate those engaged in the interstate movement of farmed or captive elk, deer, or moose regarding the identification and recordkeeping requirements of 9 CFR Part 81.



9. Requires, based on State law or regulation, official identification of all animals in herds participating in the CWD herd certification program, effectively enforces this requirement, and documents any noncompliance with this requirement.



10. Maintains the following information in the CWD National Database administered by APHIS (SCS Core One – National Instance), or in a State database recognized by the Administrator as meeting the data requirements in the CWD National Database as outlined below:

a. Premises information and assigned premises numbers.



page 11
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Old May 8th 2013, 09:01 PM   #12
 
  Apr 2009
  TN
b. Individual animal information on all farmed or captive elk, deer, and moose in herds participating in the CWD HCP in the State.

c. Individual animal information on all out-of-State farmed or captive elk, deer, and moose to be traced.

d. Accurate herd status data. See Section A3, “Registration, Identification, and Recordkeeping” for detailed information on data requirements.



11. Requires that tissues from all CWD-exposed and suspect animals from affected herds that die or are depopulated or otherwise killed be submitted to a laboratory authorized by the Administrator to conduct official CWD tests.



12. Requires appropriate disposal of the carcasses of CWD-positive, CWD-exposed, and CWD-suspect animals (Appendix V).



13. Enforces all testing and disposal requirements, and documents any noncompliance.



Further ensures that herds comply with program requirements including physical herd inventories at least every 36 months, annual herd and premises inspections, and verification of required CWD surveillance.

Physical inventories may be conducted on unrestrained animals providing that it is possible to visually inspect and verify one the identification numbers and devices on each animal, and that information is matched to herd records. Animals may be temporarily gathered in pens or other means used for viewing. Any animals in which ID cannot be visually inspected will need some form of restraint for confirmation. States may require more frequent physical inventories for all herds in their Approved State CWD HCP.



Farmed or captive elk, deer, and moose herd owners who do not wish to move their animals interstate or who cannot meet the requirements of the National CWD Herd Certification Program may choose not to participate. Commercial hunt facilities (shooter herds) that receive animals from multiple sources are of particular concern. Such herds provide a unique opportunity for CWD surveillance and, if left unmonitored, present an increased risk of CWD to wild and farmed or captive cervids in the State in which they reside. However, many such herds may see little advantage in participating in the National CWD HCP because they have no need to move live animals interstate or know that they cannot meet the inventory and surveillance requirements of the program. While APHIS cannot require States to institute monitoring programs for these herds, we recommend States develop surveillance monitoring programs for such herds that are not part of the National CWD HCP.



(2.4) Participating Herd: Requirements for Enrollment



A. Herd owners already participating in an Approved State CWD HCP will maintain the same enrollment date for the National CWD HCP as the first date that the herd participated in the Approved State program.



B. Herd owners may be able to enroll directly in the National CWD HCP, subject to the availability of appropriated funds, if they do not have an Approved State CWD HCP in their State. Their enrollment date will be the earlier of:



1. The date APHIS approves enrollment; or



2. A date no more than 3 years before the date APHIS approved enrollment if the owner has demonstrated the herd has been maintained in a manner that substantially meets the requirements listed in Sections A 2.4 (C) and 2.5.



C. Herd owners enrolled in either the Approved State CWD HCP or directly enrolled in the national CWD HCP agree to maintain their herds in accordance with the following requirements:



1. Each animal in the herd must be identified before reaching 12 months of age using means of identification described in Section A 3.2 of these Program Standards.



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Old May 8th 2013, 09:02 PM   #13
 
  Apr 2009
  TN
2. The 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 (See Section 4 – Fencing Requirements).



3. The owner must mustimmediately report in a prompt and timely manner) to a State official of the Approved CWD HCP or to an APHIS employee (where applicable) all deaths of farmed or captive deer, elk, and moose aged 12 months or older (including animals killed on premises maintained for hunting and animals sent to slaughter), and must make the carcasses of such animals available for tissue sampling and testing. The owner must make the carcasses available in accordance with instructions from the State representative (Approved State CWD HCP) or APHIS employee (where applicable). ). States may routinely allow up to 1 week for reporting mortalities. However, State or APHIS employees may approve mortality reporting schedules other than immediate notification when herd conditions warrant it in the opinion of both APHIS and the State. Herd inventory records should be updated and reconciled at least annually for submission to the Approved State official.



4. The owner also must immediately report in a prompt and timely manner of discovery to a State official (Approved State CWD HCP) or an APHIS employee (where applicable) animals that have escaped or disappear, or are otherwise missing from the premises as well as entry of any wild cervids into the facility. States may routinely allow up to 72 hours for reporting such incidents. This also 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).



5. Records, including a complete inventory of animals, must be kept in accordance with Section A 3.3 of these Program Standards. Herd owners must make animals and records available to accredited veterinarians, APHIS employees, or State officials for inspection. Owners are responsible for assembling, handling, and restraining animals for physical inventories or other inspections under conditions that will allow the accredited veterinarian, APHIS employee, or State official to safely read all identification on the animals. The owners are responsible for the costs that may be incurred to present the animals for inspection and must agree that any liability or injury to the animals during handling rests with the owner.



6. If an owner wishes to maintain two or more separate herds, he or she must maintain separate herd inventories, records, working facilities, water sources, equipment, and land use. There must be a buffer zone or geographic zone of at least 30 feet between the perimeter fencing around the separate herds, and no commingling of animals may occur. Movement of animals between herds must be recorded as if they were separately owned herds.



7. New animals may be introduced into the herd only from other herds enrolled in the CWD herd certification plan and under the conditions outlined in Section A 2.6.



Failure to comply with any of the listed HCP requirements will affect the herd status and could result in suspension or removal from the national CWD HCP.



(2.5) Herd Owner Enrollment and Advancement



A. Individual herd owner direct enrollment will be for herds that reside in States that do not have an Approved State HCP. and is subject to availability of appropriated funds. Herd owners wishing to participate in the National CWD HCP must first submit a signed application for enrollment form (VS Form 11-1), a current inventory, documentation showing that all animals in the herd 12 months of age and older were inspected and inventoried within the previous 12 months, and a statement attesting to the requirements listed in Section A 2.4 of the Program Standards.



APHIS will determine the herd enrollment date for HCP participation on receipt and evaluation of the information provided. The enrollment date may include no more than 3 years of credit time if the owner can demonstrate the herd has been maintained in a manner that substantially meets the requirements in Section A 2.3



page 13
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Old May 8th 2013, 09:02 PM   #14
 
  Apr 2009
  TN
The enrollment date will be the day, month, and year in which an owner’s herd is officially enrolled in the HCP. This date is important because it would typically be used to calculate when herds may advance to a higher herd status under the HCP after completing successive years without CWD being diagnosed in the herd. For a herd that only adds animals from herds with the same or greater status, the enrollment and status dates will remain the same. However, for herds that add animals from herds with a lesser status the enrollment and status dates for the receiving herd will reflect the lowest status date. The enrollment date is a fixed date, while the status date may change based on herd additions or status progress.



B. When initially enrolled in an Approved State CWD HCP or directly enrolled in the national CWD HCP, all herds will be placed in First Year status. Each year, on the anniversary of the enrollment date or status date (whichever is later) and of meeting the HCP requirements, the herd status is upgraded by 1 year; i.e., Second Year status, Third Year status, Fourth Year status, and Fifth Year status. One year from the date a herd is placed in Fifth Year status with no findings of CWD in the herd after 5 continuous years of testing, the herd status is changed to Certified, and the herd remains in Certified status as long as continuous enrollment is maintained in the program and the herd continues to meet all of the program requirements.



Herds that are established and sourced solely from other Certified herds will be enrolled as Certified herds and must continue to demonstrate compliance with program requirements to maintain Certified status.



Eligibility for advancement from one status to the next is based on compliance with program requirements, including the submission of samples. Should the herd owner not be in compliance with the standards 9 CFR 55, State officials and APHIS employees will may withhold advancement or lower, suspend, or revoke the status.



(2.6) Additions of Animals or Genetic Material (Germplasm) to a Herd: Effects on Status



A herd may add animals from herds with the same or a greater status in the national CWD HCP with no negative impact on the status of the receiving herd.



If animals are acquired from a herd with a lesser status, the receiving herd reverts to the status of that source herd. If a herd participating in the program acquires animals from a nonparticipating herd, the receiving herd reverts to First Year status with a new status date listed as the date of acquisition of the animal. The enrollment date in the national CWD HCP would remain unchanged but the herd status level would be modified (and modification date recorded).



If a herd acquires animals from herds with a lower or nonparticipating status, the owner must notify a Federal or State official within 5 business days of such acquisition.



At this time there is no scientific evidence that germplasm (embryos or semen) may transmit CWD. However, there is no scientific evidence that embryos or semen from positive animals do not serve as a route of transmission for CWD. Because of the lack of scientific information on transmission potential, APHIS recommends that germplasm from known CWD-positive animals not be used. If more definitive evidence of the role of embryos or semen in the transmission of CWD should become available, this guidance will be changed.



New herds assembled from multiple sources will be assigned the status of the lowest status source herd (i.e., will be given the status date of the lowest status herd).



Other sources of equivalent or higher status animals may include cervid herds enrolled and at an appropriate level in a CWD herd certification program in another country where APHIS recognizes the HCP to be at least equivalent to the APHIS national CWD HCP.



(2.7) Inspections and Inventories



page 14
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Old May 8th 2013, 09:03 PM   #15
 
  Apr 2009
  TN
Inspections are conducted annually and physical inventories are conducted at least every 3 years as described below. Records must be reconciled during inspections and inventories.



An initial complete physical herd inventory in which all animals in the herd are visually inspected and individual identification verified and recorded must be performed on a herd in accordance with this paragraph at the time a herd is initially enrolled in the CWD HCP. APHIS may accept a complete physical herd inventory performed by a State representative, an accredited veterinarian, or an APHIS employee not more than 12 months before the herd's date of enrollment in the CWD HCP as fulfilling the requirement for an initial inventory.



Thereafter, a physical herd inventory must be performed for all herds enrolled in the CWD HCP no more than 3 years after the last complete physical herd inventory for the herd. Physical inventories may be conducted on unrestrained animals providing that it is possible to visually inspect and verify one the identification numbers and devices on each animal, and that information is matched to herd records. Animals may be temporarily gathered in pens or other means used for viewing. Any animals in which ID cannot be visually inspected will need some form of restraint for confirmation. States may require more frequent physical inventories for all herds in their Approved State CWD HCP.



In addition, herd and premises inspections to include record inventories will be conducted and reconciled annually. These annual inspections will ensure compliance with the provisions of this program. Herds may not advance in status until the annual inspections have been completed, submitted, reconciled, and approved.



These inspections and inventories will be conducted by State officials, accredited veterinarians, or APHIS employees (subject to the availability of Federal funding), and will consist of inspections of the herd and facilities as well as inventory verification. Inventory verification includes inspection of the individual animals, verification of identification for each individual, and reconciliation of the animal inspection and identification verification findings to the written records. This section will apply to the 3 year inventory.



(2.8) Loss of Certification Status



Failure to Comply with Program Requirements



Herds may lose national herd certification status if the Administrator or his or her designee, in consultation with the respective Approved State Official, determines that the herd owner failed to comply with the program requirements. The Administrator will determine owner compliance failures for herds enrolled directly in the national CWD HCP in States without an Approved State CWD HCP.



CWD-Positive or Exposed Herd



If a herd is designated a CWD-positive herd or a CWD-exposed herd, it immediately loses its program status may be suspended until an epidemiological investigation is conducted, and may only re-enroll after completing a herd plan.



CWD Suspect, Trace Back, or Trace Forward Herd



If a herd is designated a CWD-suspect herd, a trace back herd, or a trace-forward herd, it will immediately be placed in suspended status pending an epidemiological investigation by the State animal health agency. During suspended status, a herd loses all status related to the CWD herd certification plan and interstate movement. A herd may remain in suspended status until the epidemiological investigation ends and appropriate actions are taken.



If the epidemiological investigation determines that the herd was not commingled with a CWD-positive animal, the herd is reinstated to its former program status, and the time spent in suspended status counts toward its advancement to the next herd status level.



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