Chronic Wasting Disease

Program Standards
Chronic Wasting Disease Program Standards

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United States Department of Agriculture 

Animal and Plant Health Inspection Service 

Veterinary Services

May 2019

Chronic Wasting Disease (CWD) 

Program Standards

Contents

Introduction....................................................................................................................................................4

Definitions......................................................................................................................................................6

Part A. Herd Certification Program..............................................................................................................13

1. State Participation ...........................................................................................................................13

1.1 Participating Approved State: Application and Requirements.................................................13

1.2 Provisional Approval................................................................................................................15

1.3 Annual HCP Reports from Approved States ...........................................................................15

1.4 Review of Approved State HCP ..............................................................................................16

1.5 Withdrawal of State Approval..................................................................................................16

2. Herd Participation............................................................................................................................17

2.1 Participating Herd: Requirements for Enrollment....................................................................17

2.2 Herd Owner Enrollment and Advancement.............................................................................18

2.3 Additions of Animals to a Herd: Effects on Status...................................................................19

2.4 Additions of Genetic Material (Germplasm) to a Herd: Effects on Status ...............................19

2.5 Inspections and Inventories.....................................................................................................19

2.6 Loss of Certification Status......................................................................................................20

2.7 Relocation of a Herd................................................................................................................20

2.8 Cancellation of Participation....................................................................................................21

3. Registration, Identification, and Recordkeeping..............................................................................22

3.1 Premises Identification ............................................................................................................22

3.2 Animal Identification ................................................................................................................22

3.3 Owner Records: Herd Inventory..............................................................................................23

4. Fencing Requirements ....................................................................................................................25

5. Surveillance and Sampling..............................................................................................................26

5.1 CWD-Suspect Animals............................................................................................................26

5.2 Mortality Reporting and Routine Surveillance .........................................................................27

5.3 Sample Collection and Submission Procedures .....................................................................27

5.4 Consequences of Poor Quality and Missing Samples ............................................................28

5.5 Exceptions...............................................................................................................................30
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5.6 Tissue for DNA Testing ...........................................................................................................30

6. Diagnostics......................................................................................................................32

6.1 Testing Authority and Approved Laboratories .........................................................................32

6.2 Official CWD Tests ..................................................................................................................32

6.3 Approval of Official Diagnostic Tests.......................................................................................34

6.4 Test Results ............................................................................................................................36

6.5 Rejected Samples ...................................................................................................................36

6.6 Reporting of Results................................................................................................................37

7. Interstate Movement........................................................................................................38

Part B. Guidance on Responding to CWD..................................................................................................40

1. Epidemiological Investigations ........................................................................................40

2. Quarantine.......................................................................................................................41

3. Classification of Animals and Herds During an Epidemiological Investigation................................42

3.1 CWD-Positive Herd .................................................................................................................42

3.2 CWD-Exposed Herd(s)............................................................................................................42

3.3 Epidemiologically-Linked Herds ..............................................................................................43

4. Reporting.........................................................................................................................45

5. Herd Plans.......................................................................................................................46

6. Federal Indemnity............................................................................................................48

6.1 Eligible Animals .......................................................................................................................48

6.2 Appraisals................................................................................................................................48

6.3 Indemnity Requests.................................................................................................................48

6.4 Evaluation and Prioritization of Requests for Federal Indemnity Funds .................................48

7. Carcass Disposal ............................................................................................................51

7.1 Incineration..............................................................................................................................51

7.2 Alkaline Hydrolysis ..................................................................................................................51

7.3 Landfill .....................................................................................................................................52

7.4 Onsite Burial............................................................................................................................52

Appendix I: Links to Forms and Documents ...............................................................................................53

Appendix II: Guidelines for Use of Whole Herd Ante-Mortem Testing of Herds that Contain or Contained

CWD-Exposed Animals...............................................................................................................................54

Appendix III: CWD Epidemiology Investigation and Report Templates ......................................................57

Appendix IV: Biosecurity and Decontamination Procedures for Farmed Cervid Facilities..........................67

Appendix V: Sample Collection...................................................................................................................72

Appendix VI: Diagram for Response to a CWD-Positive Case...................................................................86

 Appendix VII: Diagram for DNA Comparison Testing and Interpretation............................................88

 Appendix VIII: Standard Operating Proceedure for Chronic Wasting Disease Sample Collection in Meat

 Processing Facilities...............................................................................................................89
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Introduction

The goal of the CWD Herd Certification Program (HCP) is to provide a consistent, 

national approach to control the incidence of CWD in farmed cervids and prevent the 

interstate spread of CWD. Achieving this goal will ultimately result in several important 

long-term outcomes, including:

1) Healthy cervids (both farmed and wild populations) with a reduced risk of CWD.

2) Increased confidence that HCP-certified herds are low risk for CWD infection.

3) Strong trade of cervid animals and products (increased market confidence).

4) Reduced risk of transmission from, and environmental contamination by, CWDpositive herds.

The HCP is a cooperative effort between the Animal and Plant Health Inspection 

Service (APHIS), regulatory State animal health and wildlife agencies, and farmed 

cervid owners. APHIS coordinates with these State agencies to encourage cervid 

owners to certify their herds and comply with the CWD Herd Certification Program

Standards.

This goal is accomplished through the establishment of the national CWD herd 

certification program and interstate movement requirements for CWD-susceptible 

cervids found in title 9 of the Code of Federal Regulations (CFR) parts 55 and 81. 

These regulations are written as performance-based regulations that describe the 

legally required outcomes.

The Program Standards provide detailed descriptions of acceptable methods for 

complying with the legal requirements in 9 CFR parts 55 and 81:

Part A, Herd Certification Program, describes acceptable methods to meet the 

minimum requirements to certify farmed cervid herds for interstate movement.

Part B, Guidance on Response to CWD, describes acceptable methods to meet the 

minimum requirements to respond to the finding of CWD in farmed cervid herds.

The methods in these Program Standards have been approved by the APHIS 

Administrator. Alternatively, States may propose other methods/approaches to meet the 

regulatory requirements. These alternative proposals should be submitted in writing to 

APHIS for approval. States may also have additional or stricter requirements that 

exceed the minimum requirements described in the CWD regulations and do not need 

to be submitted in writing.

These Program Standards will be reviewed regularly by APHIS and, as appropriate, 

representatives of the cervid industry and State and Federal agencies. A notice will be 

published in the Federal Register to inform stakeholders of any revisions APHIS plans 
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to the Program Standards.
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Definitions

Accredited Veterinarian: A veterinarian approved by the Administrator in accordance 

with 9 CFR part 161 to perform functions required by cooperative State-Federal disease 

control programs specified in title 9 CFR.

Administrator: The Administrator of the Animal and Plant Health Inspection Service, or 

any person authorized to act for the Administrator.

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

Animal Identification Number (AIN): A numbering system for the official identification 

of individual animals in the United States that provides a nationally unique identification 

number for each animal. The AIN consists of 15 digits with the first 3 being the country 

code (840 for the United States or a unique country code for any U.S. territory that has 

such a code and elects to use it in place of the 840 code).

Animal and Plant Health Inspection Service (APHIS): The Animal and Plant Health 

Inspection Service of the United States Department of Agriculture.

Annual Removal Rate: All adults (12 months or older) removed or lost from 

inventory for any reason since the previous annual inventory. For example: If 100 

animals were on the previous year inventory, and 80 of the same animals are on the 

current inventory is equal to a 20% annual removal rate. ((100-80)/100)=20%

APHIS Employee: Any individual employed by APHIS who is authorized by the 

Administrator to do any work or perform any duty in connection with the control and 

eradication of disease.

Approved State: A State determined by the Administrator to have an Approved State 

CWD Herd Certification Program per 9 CFR part 55.

Approved State CWD Herd Certification Program: A program operated by a State 

government for certification of cervid herds with respect to CWD the Administrator has 

determined meets 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.

Assistant District Director (AD): The APHIS veterinary official assigned by the 

Administrator to supervise and perform the official APHIS animal health work in the 

APHIS District and corresponding State or States.

Certified Herd: A herd that has enrolled in a Herd Certification Program and has

attained Certified status as defined in 9 CFR part 55.
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Certified CWD Sample Collector: An individual who has completed appropriate 

training and is certified by his or her State to perform collection, submission, and 

preservation of samples for CWD testing in farmed cervids.

Cervid: All members of the family Cervidae and hybrids, including deer, elk, moose, 

caribou, reindeer, and related species. For the purposes of this document, the term 

“cervid” refers specifically to cervids susceptible to CWD. These are animals in the 

genera Odocoileus, Cervus, Alces, and their hybrids, i.e. deer, elk, and moose.

NOTE: APHIS proposes to amend the CFR in the future by removing the list of 

susceptible species from the definition of “cervid” and instead listing the genera 

APHIS considers susceptible to CWD. In anticipation of this change, we are 

adding a definition of “CWD-susceptible cervid species” to this revision of the 

Program Standards.These changes will give APHIS more flexibility to change the 

list of species considered susceptible to CWD as evidence becomes available.

Chronic Wasting Disease (CWD): A transmissible spongiform encephalopathy of 

cervids. Clinical signs in affected animals include, but are not limited to: Loss of body 

condition, behavioral changes, excessive salivation, increased drinking and urination, 

depression, and eventual death.

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 (i.e., indirect contact). Animals are considered to have 

commingled if they have had such contact with a CWD-positive animal or contaminated 

premises within the last 5 years.

CWD-Exposed Animal: An animal that is part of a CWD-positive herd, or that has been 

exposed to a CWD-positive animal or contaminated premises within the previous 5 

years.

CWD-Exposed Herd: A herd in which a CWD-positive animal has resided within 5 

years prior to that animal’s diagnosis with CWD, as determined by an APHIS employee 

or State representative. 

CWD Herd Certification Program: This program, established in 9 CFR part 55.

CWD-Positive Animal: An animal that has had a diagnosis of CWD established 

through official confirmatory CWD testing conducted by the National VeterinaryServices 

Laboratories (NVSL).

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

diagnosed which has not been released from quarantine.

CWD-Susceptible Cervid Species: APHIS identifies CWD-susceptible species based 
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on scientific evidence of natural infection or experimental infections through intranasal 

and/or oral routes. This includes animals in the genera Odocoileus, Cervus, and Alces 

and their hybrids, i.e. deer, elk, and moose. Specifically, the following are considered to 

be susceptible to CWD: White-tailed deer (Odocoileus virginianus), mule deer 

(Odocoileus hemionus), black-tailed deer (Odocoileus hemionus columbianus), and any 

associated subspecies. It also includes North American elk or wapiti (Cervus 

canadensis), red deer (Cervus elaphus), and Sika deer (Cervus nippon).

NOTE: APHIS proposes to amend the definition of “cervid” in the CFR in the near 

future by removing the list of susceptible species from the definition. To 

accommodate this future change, we are adding the definition of “CWDsusceptible cervid species” to this revision of the Program Standards. In the 

future, APHIS anticipates adding the genera Rangifer and Muntiacus to the list of 

CWD-susceptible species when the CFR is amended.

CWD-Suspect Animal: An animal for which an APHIS employee or State 

representative has determined that unofficial CWD test results, laboratory evidence, or 

clinical signs suggest a diagnosis of CWD, but for which official laboratory results have 

been inconclusive or not yet conducted.

CWD-Suspect Herd: A herd for which unofficial CWD test results, laboratory evidence, 

or clinical signs suggest a diagnosis of CWD, as determined by an APHIS employee or 

State representative, 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, Alces, and 

hybrids of these species.

Deputy Administrator: The Veterinary Services (VS) Deputy Administrator or any 

other official to whom the Administrator has delegated authority to act as the Deputy 

Administrator.

Designated CWD HCP Coordinator: The epidemiology officer designated by the State 

to coordinate CWD HCP activities in the State, in accordance with 9 CFR 55.23. The 

coordinator may be a State representative selected by the State or an APHIS employee 

identified in consultation with APHIS.

Enrollment Date: The enrollment date for any herd that joins the CWD Herd 

Certification Program after August 13, 2012 will be the date the herd is approved for 

participation unless an exception listed in 9 CFR 55.22(a)(1) applies.

Enrolled Herd: A herd that has enrolled in a Herd Certification Program and met 

the minimum requirements defined in 9 CFR part 55.
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Epidemiologically-Linked Herd: Herds are epidemiologically-linked if the 

investigation determines that the CWD-exposed animal(s) have resided with a CWDpositive animal within 5 years prior to the diagnosis of CWD in the positive herd or 

from the identified date of entry of CWD into the positive herd and have since moved 

to or through other herds, Those herds are then considered to be epidemiologically 

linked. An Epidemiological–linked herd can be a Trace-back Epi-linked, Traceforward Epi-linked or Pass-through Epi-linked.

Farmed or Captive: Privately or publicly maintained, or held for economic or other 

purposes, within a perimeter fence or confined area, or captured from a freeranging population for interstate movement and release.

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 (i.e. commingled).

Herd Inventory: A herd owner’s written or electronic record of all of the animals 

belonging to a herd including each animal’s species, date of birth, age, sex, date of 

acquisition and source (for animals not born into the herd), date of disposal and 

destination (for animals removed from the herd), and all individual identification 

numbers (from tags, tattoos, electronic implants, etc.). A physical herd inventory refers 

to the process by which an APHIS employee, State representative, or accredited 

veterinarian reconciles a herd owner’s records with the animals and their identifications 

physically present in the herd.

Herd Plan: A written herd and/or premises management agreement developed by 

APHIS in collaboration with the herd owner, 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 control spread of CWD from a CWD-positive herd, to control the 

risk of CWD in a CWD-exposed or CWD-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 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
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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 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: The status of a herd assigned under the CWD Herd Certification Program 

in accordance with 9 CFR 55.24. 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.

Hunt Facility: A privately owned ranch or other premises selling commercial hunts.

Limited Contact: Any brief, incidental contact between cervids from different herds 

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. 

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.

Official Animal Identification: A device or means of animal identification approved for 

use by APHIS to uniquely identify individual animals. Examples of approved official 

animal identification devices are listed in 9 CFR 55.25. The official animal identification 

must include a nationally unique animal identification number that adheres to one of the 

following numbering systems:

1) NUES (the CWD program allows the use of either the eight-character or nine 

character format for cervids);

2) AIN;

3) Premises-based number system, which combines an official PIN with a producer’s 

livestock production numbering system (both must appear on the official tag) to 

provide a unique identification number; or

4) Any other numbering system approved by the Administrator for the identification of 

animals in commerce.
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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

9 CFR 55.8.

Owner: An individual, partnership, company, corporation, or other legal entity that has 

legal or rightful title to an animal or herd of animals.

Pass -through Epi-linked Herd: A herd in which a CWD-exposed animal has resided 

within the last 5 years but no longer resides.

Premises: A location where livestock or poultry are housed or kept.

Premises identification number (PIN): A nationally unique number assigned by a 

State, Tribal, and/or Federal animal health authority to a premises that is, in the 

judgment of the State, Tribal, and/or Federal animal health authority, a geographically 

distinct location from other premises. The premises identification number is associated 

with an address, geospatial coordinates, and/or location descriptors which provide a 

verifiably unique location. The premises identification number may be used with a 

producer’s own livestock production numbering system to provide a unique identification 

number for an animal. It may also be used as a component of a group/lot identification 

number. The premises identification number may consist of:

1) The State’s two-letter postal abbreviation followed by the premises’ assigned 

number or

2) A seven-character alphanumeric code, with the right-most character being a check 

digit. The check digit number is based on the ISO 7064 Mod 36/37 check digit 

algorithm.

Quarantine (or Hold Order): An order issued by a State restricting movement of 

animals from or onto a premises for a given period of time.

State Representative: A person regularly employed in the animal health work of a 

State and who is authorized by the State to perform the function involved. This could 

include a wildlife agency official.

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 CWD Test: The result of an approved CWD test conducted at an 

approved laboratory in which the presumptive identification of abnormal protease 

resistant prion protein (PrPres) has been detected in the tissue samples and that result 

must be confirmed positive by NVSL.

Suspended Status: A temporary status given to a herd that is being epidemiologically 

assessed for CWD-exposure.
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Veterinary Services (VS): The APHIS unit authorized to conduct prevention, control, 

and eradication programs for diseases of livestock and poultry.
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Part A. Herd Certification Program

1. State Participation

1.1Participating Approved State: Application and Requirements

States must submit an application, including a completed VS Form 11-2 and supporting 

documentation, describing their ability to meet the national CWD HCP requirements. In 

reviewing a State’s eligibility to be designated as an Approved State, the Administrator 

or designee will evaluate the State statutes, regulations, and policies pertaining to the 

State agency responsible for farmed or captive cervids, as well as relevant reports and 

publications of the State animal health and/or wildlife agencies. The Administrator or 

designee will also review a written statement from the State representative describing 

their CWD control and cervid herd certification activities in farmed or captive cervids.

When assessing 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 to forward test results for 

any animals tested for CWD to APHIS employees and State representatives.

3) Has signed a Memorandum of Understanding (MOU) with APHIS that delineates 

the respective roles of each party in CWD HCP implementation. A link to the 

MOU template can be found in Appendix I.

4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect animals 

and herds under movement restrictions, allowing movement only for destruction 

with appropriate carcass disposal, or under permit.

5) Has effectively implemented policies to:

A. Promptly investigate all animals reported as CWD-suspect animals within 7 

business days of official notification to the State.

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 representative determines that the herd contains or has 

contained a CWD-positive animal.

C. Remove herd movement restrictions only after completion of a herd plan.
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D. Conduct an epidemiological investigation of CWD-positive, CWD-exposed, 

and CWD-suspect herds that includes the designation of suspect and 

exposed animals in accordance with 9 CFR part 55 and Part B of these CWD 

Program Standards).

E. Initiate and conduct epidemiological investigations to trace movements of 

CWD-positive animals and CWD-exposed animals in affected herds. 

F. Report, within 45 calendar days following notification of a CWD-positive 

animal, any out-of-State traces to the appropriate State representative and 

APHIS employee.

G. Conduct epidemiological investigations on trace movements 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 representative to coordinate CWDHCP 

activities in the State.

8) Has programs to educate those engaged in the interstate movement of farmed or 

captive cervids 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 a State database recognized by the 

Administrator as meeting the following data requirements in an accurate and 

timely manner:

A. Premises information, assigned premises numbers, and owner information 

(location, address, and contact information) for all farmed or captive cervid 

herds participating in the CWD HCP in the State.

B. Program status of all enrolled herds.

C. Any restrictions to herd statuses including designation as a CWD-positive, 

exposed, suspect or epidemiologically linked to a positive herd.

D. All program actions such as changes to herd status, depopulation, and 

adoption of herd plans.
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E. Individual animal information on all farmed or captive cervid herds 

participating in the CWD HCP in the State.

F. Individual animal information on all out-of-State farmed or captive cervidsto 

be traced.

11)Requires that tissues from all CWD-exposed and suspect animals from affected 

herds that die or are depopulated or are 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.

13)Enforces all testing and disposal requirements, and documents any 

noncompliance.

14)Ensures that herds comply with program requirements including physical herd 

inventories at least every 3 years, annual herd and premises inspections, and 

verification of required CWD surveillance.

1.2 Provisional Approval

Provisional approval may be granted to States that do not meet all the national CWD 

HCP minimum requirements on application to the program. APHIS and the State will 

work to develop a plan with an appropriate time frame to meet program requirements.

1.3 Annual HCP Reports from Approved States

Comprehensive annual reports of HCP status and activities of enrolled herds are 

provided to the respective APHIS District Field Office for review and endorsement for 

the year beginning July1 through June 30. The report will be submitted along with an 

application for Chronic Wasting Disease HCP approval, renewal or reinstatement of a 

state (VS Form 11-2).The annual report and VS 11-2 will be reviewed and signed by the 

Assistant Director and a designated State representative and submitted to the Cervid 

Health program staff. The reports will be used to monitor compliance with HCP program 

requirements and disease control efforts in Approved States.

The Cervid Health Program staff will provide guidance to States on annual reporting 

formats prior to the end of the reporting period. The following data will be included in 

the Annual HCP reports:

1) Enrolled herds–by State and certification status, species, number of animals in 

each herd, and number inspected.

2) CWD samples and tests–number of animals tested during the reporting period, 

species, herd type (breeder, hunting operation, etc.) and test results. CWD-
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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–Intrastate and interstate trace animal movements of 

CWD-exposed animals initiated, pending, and completed.

1.4 Review of Approved State HCP

In addition to annual review of HCP reports, APHIS may also periodically review an 

Approved State’s CWD HCP program. States may be reviewed on request by APHIS or 

the Approved State. Review activities may include:

1) Evaluating State program activities to verify compliance with Federal 

requirements and identifying opportunities for program improvement.

2) Evaluating enrolled herd owner compliance with HCP requirements including 

reviewing laboratory reports, herd inventories, surveillance sampling, and other 

records and documents.

3) Reviewing reports and records related to epidemiological investigations of CWDpositive, CWD-exposed, or CWD-suspect herds.

4) Assessing compliance and completeness of data entered into an approved State 

database.

5) Conducting site visits as necessary.

APHIS will issue a summary report to the Approved State that will include the findings of 

the review including recommendations to achieve compliance with the National HCP 

Program or to improve the overall effectiveness and efficiency of the program in the 

State. APHIS will work with States to develop a plan to respond to the findings, and a 

specified period of time to complete any proposed actions.

1.5 Withdrawal of State Approval

APHIS may withdraw State approval if the State’s action plan to achieve compliance is 

not completed or not completed during the specified period of time agreed on by APHIS 

and the State. The State may reapply for State approval once they can meet all the 

national CWD HCP minimum requirements.
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2. Herd Participation

2.1 Participating Herd: Requirements for Enrollment

The requirements for participation in the national CWD HCP are found in 9 CFR part 55 

subpart B.

1) 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.

2) Herd owners enrolled in the Approved State CWD HCP agree to maintain their 

herds in accordance with the following requirements:

A. 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.

B. 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 Section A 4 of these Program 

Standards.

C. The owner must immediately report all deaths of farmed or captive cervid 

aged 12 months or older (including animals killed on premises maintained for 

hunting, and animals sent to slaughter) to a State or to an APHIS employee.. 

However, State representatives 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.

D. Carcasses of animals must be made available for tissue sampling and testing 

in accordance with instructions from the State representative or APHIS 

employee.

E. Herd inventory records should be updated and reconciled at least annually 

and submitted to the Approved State representative.

F. The owner must immediately report from time of discovery any animals that 

escape, disappear, or are otherwise missing from the premises to a State 

representative or an APHIS employee. 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 or animals. Likewise, entry of any wild 

cervids into the facility should also be reported as above.
Chronic Wasting Disease Program Standards

18

G. 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 representatives for inspection. Owners are responsible 

for assembling, handling, and restraining animals for physical herd inventories 

or other inspections under conditions that will allow the accredited 

veterinarian, APHIS employee, or State representative 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.

Farmed cervids commingled (see definition) with other farmed cervids 

assume the status of the lowest program status animal in the group. If an 

owner wishes to maintain two or more separate herds (see definition), 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.

H. 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 2.3.

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.

2.2 Herd Owner Enrollment and Advancement

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 will 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, if a herd adds animals from a herd 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.

When initially enrolled in an Approved State 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) 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. After 5 continuous years of compliance (the end of the Fifth status year) with no 

findings of CWD in the herd, the herd status is changed to Certified. The herd remains
Chronic Wasting Disease Program Standards

19

in Certified status as long as continuous enrollment is maintained in the program and 

the herd continues to meet all of the program requirements. Enrolled herds that have 

achieved Certified status are eligible to move interstate in accordance with 9 CFR 81.3.

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 surveillance samples. Should the 

herd owner not be in compliance with 9 CFR part 55, State representatives and APHIS 

employees may withhold advancement, lower, suspend, or revoke the status.

2.3 Additions of Animals 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 

lower status. 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 State representative or APHIS employee within 5 business days of such 

acquisition. New herds assembled from multiple sources will be assigned the status 

date of the lowest status herd.

Other sources of equivalent or higher status animals may include cervid herds enrolled,

at an appropriate level, from an CWD HCP in another country where APHIS recognizes 

the HCP to be at least equivalent to the APHIS national CWD HCP.

2.4 Additions of Genetic Material (Germplasm) to a Herd: Effects on Status

There is currently no scientific evidence that germplasm may transmit CWD.

2.5 Inspections and Inventories

Inspections and physical herd inventories ensure herd compliance with HCP 

requirements. Herds may not advance in status until the annual inspections have been 

completed, submitted, reconciled, and approved. Inspections are performed by a State 

official, an APHIS employee, or an accredited veterinarian. Inspections are conducted 

annually and physical herd inventories are conducted at least every 3 years. 
Chronic Wasting Disease Program Standards

20

The inspector will:

At the Initial Inspection:

 Visually observe each cervid, and the herd as a whole, for signs of CWD.

 Verify and record the two unique animal identification numbers for each 

individual, one of which is a nationally unique official animal identification 

present on the date the herd is initially enrolled in the CWD HCP. 

 The herd inventory must be performed not more than 12 months prior to the 

herd’s date of enrollment.

 Confirm that the perimeter fencing is adequate to prevent ingress and egress of 

cervids, is at a minimum 8 feet high, structurally sound, in good repair, and 

complies with any applicable State regulations.

At the Annual Inspection:

 Must be conducted 11 to 13 months after the last inspection.

 The herd is visually observed for signs of CWD.

 Records are examined for completeness and accuracy.

 The herd inventory must be reconciled with the previous year’s inventory and 

all dispositions and acquisitions must be documented.

 Verify that all sampling requirements have been met. If not, then document 

missed or poor quality samples and describe action recommended.

 Inspect the perimeter fencing and document repairs if needed.

At the Physical Herd Inspection:

 Conducted no more than 3 years after the last complete physical herd 

inventory.

 In addition to the items listed under the annual inspection, all identification will 

be visually verified and matched to the herd’s written or electronic 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.

2.6 Loss of Certification Status

Herds will lose national herd certification status when the Administrator or a 

designee, in consultation with the respective Approved State representative, 

determines that the herd owner failed to comply with the program requirements.

2.7 Relocation of a Herd

If a herd moves, either within a State or to another State, it must meet all Approved 

State intrastate or Federal interstate movement requirements. In addition, the 

appropriate State representative or APHIS employee administering the Federal CWD 

rule should be notified of the relocation within 30 days.
Chronic Wasting Disease Program Standards

21

2.8 Cancellation of Participation 

Mandatory Cancellation

The Administrator, in concurrence with the Approved State, may cancel the enrollment 

of a herd by giving written notice to the herd owner. The Administrator may cancel 

enrollment after determining that the herd owner failed to comply with any HCP 

requirements.

Before enrollment is canceled, an Approved State representative or an APHIS 

employee will inform the herd owner of the reasons for the proposed cancellation andof 

the 10-day appeal deadline. The herd owner may appeal the proposed cancellation in

writing to the Administrator within 10 business days after being notified. The appeal 

must include all of the reasons and supportive evidence with documentation needed to 

challenge the proposed cancellation. The Administrator may grant or deny the appeal in 

writing as promptly as circumstances permit, stating the reason for his or her decision. 

If there is a conflict as to any material fact, a hearing will be held to resolve the conflict.

The Administrator sets the rules of practice concerning the hearing.

In the event of cancellation, the herd owner may reapply to enroll in the national CWD 

HCP but will not reach Certified status until 5 years after APHIS approves the herd 

owner’s new application for enrollment regardless of the status of the animals in the 

herd.

Voluntary Cancellation

An owner may decide to cancel participation in the CWD HCP at any time unless 

otherwise required by State regulations or a signed herd plan. The cancellation should 

be in writing to a State representative or APHIS employee. Owners who voluntarily 

cancel their participation may re-enroll at any time as a First-Year status herd and will 

receive a new enrollment and status date.
Chronic Wasting Disease Program Standards

22

3. Registration, Identification, and Recordkeeping

The regulatory authority for registration, recordkeeping, and identification for each 

animal within enrolled herds is found in 9 CFR 55.23.

3.1 Premises Identification

All participating premises must have a unique Premises Identification Number (PIN).

3.2 Animal Identification

In accordance with 9 CFR 55.25, all animals in the herd must be identified with two 

unique animal identification numbers for each individual. One of these animal 

identifications must be a nationally unique official animal identification.

The official animal identification must be a device using an APHIS-approved animal 

identification numbering system that uniquely identifies individual animals. Information 

on official animal identification and devices can be found on the APHIS Traceability

Web site.

The official animal identification device must be approved by APHIS, and must be a 

legible ear tattoo, tamper-resistant ear tag, electronic implant, legible flank tattoo, or 

other approved device. If a microchip is used and the animals are slaughtered under 

State or Federal meat inspection it should be used in compliance with applicable State 

or Federal regulations.

The official animal identification must be linked to that animal and herd in a State 

database. The second animal identification must be unique for the individual 

animal within the herd and also must be linked to the same animal and herd in the 

State database. The unique Animal Identification Number may be used on two 

separate identification devices on the same animal to fulfill the identification 

requirements if desired.

Natural additions to the herd must be identified before 12 months of age. However, all 

animals regardless of age must be properly identified as described in this section to 

move interstate.

If, at the time of enrollment in the Approved State CWD HCP, identification of animals in 

a herd does not meet the above criteria, the herd owner must bring the herd and animal 

identifications into compliance as soon as possible on a schedule specified by the State 

representative or APHIS employee.

APHIS recommends that all animal identification devices be visible on the animal from 

an appropriate distance to allow visual verification of the identification number on the 

device without animal restraint. Any animals in which identification cannot be visually 

inspected will need some form of restraint for confirmation during physical herd 

inventories.
Chronic Wasting Disease Program Standards

23

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

identification for surveillance testing.

In accordance with 9 CFR 86.4, removal of official identification devices is prohibited 

except at the time of slaughter, at any location upon the death of an animal, or as 

otherwise approved by the State or Tribal animal health official, or a VS Assistant 

Director when a device needs to be replaced.

The Food and Drug Administration (FDA) Center for Veterinary Medicine regulates the 

marketing of implantable transponder devices (electronic identification devices/EID) for 

use in animals. Please contact the FDA or the manufacturer or distributor for information 

on approved EIDs. USDA’s Food Safety and Inspection Service (FSIS) should be 

contacted regarding anatomic placement of the EIDs in animals that may be presented 

for slaughter in official slaughter facilities to determine if these devices pose a potential 

physical food safety hazard.

3.3 Owner Records: Herd Inventory

Each owner must maintain a current complete herd inventory which must include, at a 

minimum, the following information and records for each animal:

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

2) Age.

3) Species.

4) Sex.

5) The date of acquisition and source of each animal that was not born into the herd 

(owner name, city, State).

6) The date of removal and destination of any animal removed from the herd (owner 

name, city, State).

7) Birth date.

8) Date of death (and cause, if known) for animals dying within the herd.

9) Date of CWD sample submission, submitter, owner, premises, and animal 

information, and official CWD test results from NVSL or approved laboratory for 

samples required by the program.

All records, electronic or written, must be kept for 5 years after the cervid has left the 

herd or has died. Records must be made available to an APHIS employee or State
Chronic Wasting Disease Program Standards

24

representative at their request and presented at the time of each annual inspection or 

inventory.
Chronic Wasting Disease Program Standards

25

4. Fencing Requirements

The regulatory authority for fencing requirements of enrolled herds is found in

9 CFR 55.23(b)(2). Fencing alone does not delineate individual herds, which must be 

separated by a distance of 30 feet or greater, as described in 9 CFR 55.23(b)(5).

APHIS considers perimeter fencing with the following characteristics to be adequate to 

prevent ingress or egress of cervids:

1) Structurally sound.

2) Maintained in good repair.

3) Of sufficient construction to contain the animals.

4) Compliant with any other existing State regulations or requirements.

NOTE: For herds established after the effective date of the CWD rule (August 13, 

2012), the fence should be a minimum of 2.4 meters (8 feet) high.

Cervid producers enrolled in the HCP may voluntarily elect to use additional barriers 

and/or other biosecurity measures to minimize escapes and/or to mitigate disease 

transmission risks associated with direct contact between free-ranging and farmed 

cervids.

State representatives have the discretion to require the use of additional barriers and/or 

other biosecurity measures deemed necessary to mitigate the risks of CWD 

transmission.

In the case of CWD-positive, suspect, exposed, and epi-linked herds, APHIS and the 

State representative will assess the risk of CWD transmission between farmed and 

free-ranging cervids on a case-by-case basis. They may include requirements for 

additional barriers and/or other biosecurity measures deemed necessary to mitigate 

the risks of CWD transmission in the herd plan.
Chronic Wasting Disease Program Standards

26

5. Surveillance and Sampling

The regulatory authority for surveillance and sampling of animals in enrolled herds is 

found in 9 CFR 55.23(b)(3).

To achieve certified status, farmed cervid herds must conduct CWD 

surveillance on all deaths of cervids aged 12 months or older, including 

animals in the enrolled herd, animals that are slaughtered on premises or 

at a slaughter establishment, and animals from an enrolled breeding herd 

that moves to a hunt facility under the same ownership for at least 5 

consecutive years, unless the herd owner purchases or assembles a herd 

of animals from herdswith certified status and concurrently enrolls the 

resulting herd in a State HCP.

If the enrolled herd does not have any animal deaths meeting surveillance criteria for 

the year, the herd is considered to be in compliance with surveillance requirements for 

the year.

5.1 CWD-Suspect Animals

The owner must immediately report to a State representative, accredited veterinarian, or 

an APHIS employee all suspected cases of CWD. These are to include any animal 

exhibiting signs of a neurological or wasting disease as described below. These animals 

should be euthanized or closely monitored until death and the carcasses must be made 

available for tissue sampling and testing. Clinical CWD suspects that die or are 

euthanized should be tested for CWD regardless of age. Animals with non-negative 

results on an unofficial test are also considered to be CWD-suspect animals and must 

be reported.

The clinical signs associated with CWD are nonspecific and could be caused by other 

diseases affecting farmed or captive cervids; thus, laboratory confirmation is required 

for CWD diagnosis. Not all animals display all clinical signs of disease. Duration of 

clinical signs varies from a few days in unusual cases to as long as a year, but is most 

often 2 to 3 months.

Usually, the earliest clinical signs displayed are behavioral changes which may include 

alterations in interaction with humans and members of the herd. These subtle changes 

are often only recognized by caretakers familiar with the individual animal. With disease 

progression, behavioral and physical changes may be noted including periods of stupor 

and depression, altered stance, and progressive weight loss. At the terminal stage of 

disease, animals are emaciated and may exhibit increased drinking and urination, 

excessive salivation, lack of coordination, and trembling. However, concurrent disease, 

especially aspiration pneumonia, may cause an affected animal to die while still in good 

to fair body condition.

Animals with progressive neurological disease or wasting syndromes that are not 

responsive to treatment should be considered CWD clinical suspects and consequently 
Chronic Wasting Disease Program Standards

27

be euthanized and tested. If an owner of a clinical suspect declines to allow euthanasia, 

the animal should be tested in accordance with program requirements after it dies.

5.2 Mortality Reporting and Routine Surveillance

To achieve and maintain herd certification status, enrolled herd owners are required to

conduct CWD testing as described in 9 CFR 55.23(b)(3). Herd owners must report and 

make the following animals available for sample collection and CWD testing,

1) All on-farm deaths of farmed or captive deer, elk, and moose aged 12 months or 

older,

2) All animals 12 months or older that are slaughtered on the farm,

3) All animals, under their ownership, 12 months or older that are slaughtered 

at a slaughter establishment,

4) All animals, under their ownership, 12 months or older from an enrolled 

breeding herd that move to a hunt facility under the same ownership,

for at least 5 consecutive years, unless the herd owner purchases or assembles 

a herd of animals from herds with certified status and concurrently enrolls the 

resulting herd in a State HCP.

State representatives or APHIS employees may approve mortality reporting schedules 

other than immediate notification when herd conditions warrant it. Herd inventory 

records should be updated at least annually and reconciled to include mortalities and 

testing results for samples submitted.

5.3 Sample Collection and Submission Procedures

It is the owner’s responsibility to ensure complete, good quality tissue samples are 

collected and all required samples are submitted. Failure to comply with the surveillance 

requirements in this section may result in loss of program status or other actions 

applicable under Approved State or Federal regulation.

Tissue samples may only be collected by State officials, APHIS employees, accredited 

veterinarians, or certified CWD sample collectors. Alternatively, owners may remove 

and submit the entire head with all attached identification devices to an approved CWD 

laboratory for tissue collection. Samples should be submitted to an approved laboratory 

within 7 days of collection.

Detailed instructions regarding sample collection and submissions can be found in 

Appendix V.

The obex and retropharyngeal lymph node should be collected regardless of 

sample condition (e.g. autolyzed, frozen, etc.) and submitted to the approved 
Chronic Wasting Disease Program Standards

28

laboratory to comply with the routine herd surveillance requirement. 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. 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.

A positive IHC or ELISA test result on any sample submitted to the approved laboratory 

will be considered a CWD-suspect test result to be confirmed by IHC at NVSL.

5.4 Consequences of Poor Quality and Missing Samples

Surveillance of all animal mortalities in a herd is the key to increasing our confidence 

that HCP-certified herds are at low risk for CWD infection. Poor quality samples and 

missing samples undermine our ability to assess the CWD status of the herd.

Poor quality samples include samples that are severely autolyzed, from the wrong 

portion of the brain, the wrong tissue, or not testable for other reasons. Approved 

laboratories should closely monitor sample quality. They should provide timely feedback 

to the producer, certified sample collector, State officials, and APHIS employees 

regarding the receipt of poor quality samples. Approved State officials should 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.

Missing samples occur when samples from any animal 12 months of age or older in an 

enrolled herd that dies, is slaughtered, escapes, or is lost are not submitted for 

diagnostic testing for CWD.

Approved States (in consultation with APHIS) should develop risk-based assessments 

to implement consequences for poor quality/incomplete samples and recurring missed 

samples of test-eligible animals in enrolled herds. If neither the obex nor the 

retropharyngeal lymph node in a test-eligible animal can be tested due to being missing 

or of poor quality, then consequences may include, but are not limited to

1) A requirement to replace missed or poor quality samples with testable postmortem samples from an equal number of animals of the same sex and species 

that resided in the herd for at least as long as the untested animals; or

2) A reduction in herd status date (with loss, reduction, or delay in herd 

certification); or

3) A direct suspension of herd status for some period of time.

The following tables are provided as examples of adjustments that could be made to 

CWD herd status to account for poor quality, incomplete, or missing samples. This 

example considers the current status of the enrolled herd, the number of poor 

quality/missing samples, and the percentage of annual removals from the herd. Annual 
Chronic Wasting Disease Program Standards

29

Removals are defined as all adult animals (12 months or older) that were removed or 

lost from inventory for any reason since the previous annual inventory. When animals 

are removed from a herd, they are lost to surveillance testing.

NOTE: In the National Animal Health Monitoring Service Cervid 2014: Health and

Management Practices on U.S. Farmed Cervid Operations, 2014, the average removal 

rate (sales, hunt-harvest, slaughter, etc) was 21.3 percent per year, with deer 

operations at 22.3 percent and elk operations at 20.3 percent.

Herds without Certified Status: HCP herd status will be reduced for each poor 

quality or missing sample as follows:

% Annual 

Removal 

Rate from 

Herd

Status 

Reduction

0 to 20% 1 year

21 to 40% 1.5 years

41% or more 2 years

Herds with Certified Status: HCP herd status will be reduced for each animal that 

dies, is slaughtered or hunt-harvested, escapes, or is lost and is not tested for CWD 

(including due to poor quality, incomplete, or missed samples) as follows:

% Annual 

Removal 

Rate from 

Herd

Status 

Reduction

0 to 20% 0.5 year

21 to 40% 1 year

41% or more 1.5 years

Examples:

1) A certified herd with a 10 percent annual removal rate fails to test an animal that 

died in the herd. The owner also declines to euthanize and test a comparable 

animal from the herd as a replacement for the missed sample. In this case, the 

herd would be reduced to uncertified status and would be unable to move 

animals interstate for 0.5 year. The herd inventory would be repeated after the

0.5 year (6 months) and the herd could regain certified status assuming it 

continued to comply with program requirements.

2) A certified herd with a 10 percent annual removal rate fails to test 3 animals that 

died in the herd. They also decline to euthanize and test comparable animals 
Chronic Wasting Disease Program Standards

30

from the herd as a replacements for the missed samples. In this case, the herd 

would be reduced to uncertified status and would be unable to move animals 

interstate for 1.5 years. The herd inventory would be repeated after 1.5 years (18 

months) and the herd could regain certified status assuming it continued to 

comply with program requirements.

3) A certified herd with a 50 percent annual removal rate fails to test an animal that 

died in the herd. They also decline to euthanize and test a comparable animal 

from the herd as a replacement for the missed samples. In this case, the herd 

would be reduced to uncertified status and would be unable to move animals 

interstate for 1.5 years. The herd inventory would be repeated after 1.5 years (18 

months) and the herd could regain certified status assuming it continued to 

comply with program requirements.

4) An enrolled (not yet certified) herd with a 15 percent annual removal rate fails to 

test 2 animals that died in the herd. They also decline to euthanize and test 

comparable animals from the herd as replacements for the missed samples. In 

this case, the herd would be reduced in status by 2 years.

An enrolled (not yet certified) herd with a 15 percent annual removal rate 

fails to test 2 animals that died in the herd. They agree to euthanize and test 

2 comparable animals from the herd as replacements for the missed 

samples. In this case, the herd would retain their status as long as the test 

results are “not detected”.

States may choose to develop and implement their own risk-based approach for 

consequences for poor quality or missing samples.

5.5 Exceptions

Exceptions to the testing requirement may be granted by APHIS or the Approved State 

Official for extenuating circumstances beyond the control of the herd owner as follows:

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 certified sample collector 

will sample the animals believed to be at higher risk for CWD. Higher-risk animals would 

include older animals, males preferentially over females, or those animals having any 

known pre-existing health conditions or in poor body condition.

5.6 Tissue for DNA Comparison Testing

APHIS strongly recommends that a piece of fresh (not in formalin) tissue attached to an 
Chronic Wasting Disease Program Standards

31

official animal identification (ID) be submitted with each sample that is submitted for CWD 

testing. If part of the ear cannot be removed (e.g., for taxidermy purposes), then a new 

identification tag can be affixed to the hide skin and recorded in the animal’s official record, 

and the tagged hide section submitted with the diagnostic specimens.

This will allow APHIS to perform DNA comparison testing (i.e. identity testing) and 

genotyping if the animal tests positive for CWD. APHIS will perform DNA comparison 

testing for all index cases in newly identified CWD-positive herds. 

Confirming the identity of the CWD-positive animal increases confidence that the State is 

implementing the regulatory actions described in 9 CFR 55 and Part B of these Program 

Standards in the appropriate herd. There are four possible outcomes of the DNA 

comparison testing (See also Appendix V):

 Official identification with fresh tissue attached was not submitted with the CWD-positive 

sample -- States should proceed with regulatory actions based on the official identification 

provided on the VS 10-4 form submitted with the sample. 

 The DNA comparison testing does not yield a valid result – States should proceed with 

regulatory actions based on the official identification provided on the VS 10-4 form submitted 

with the CWD-positive sample.

 The CWD-positive tissue matches the tissue submitted with the official identification -- States 

should proceed with regulatory actions. 

 The CWD-positive tissue does not match the tissue submitted with the official identification --

States should further investigate the likely source of the CWD-positive sample before 

proceeding with regulatory actions. If the identity or source of the CWD-positive sample 

cannot be determined with confidence after a thorough investigation, the State may choose 

not to take further regulatory action. The State may choose to implement consequences for 

poor quality samples as described in Program Standards Part A Section 5.4.

An enrolled herd owner may request identity testing for other CWD-positive animals at the 

owner’s expense. The herd owner must request identity testing, in writing, to the Assistant 

Director (AD) and the State veterinarian. The request must include the owner name, 

address, animal and herd information, test information and reason for request. VS will only 

consider the results of DNA comparison testing performed at the request of a herd owner 

for regulatory purposes if the comparison is performed using fresh tissue attached to an ID 

that was submitted with the CWD-positive sample to NVSL.
Chronic Wasting Disease Program Standards

32

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 Laboratories 

Testing Authority

Laboratories will be approved by NVSL, as designated by the APHIS Administrator, to 

conduct official CWD testing in accordance with 9 CFR 55.8. All suspect positive test 

results must be confirmed by NVSL.

Approved Laboratories

Only laboratories that are members of the National Animal Health Laboratory Network 

(NAHLN) will be approved to conduct official CWD diagnostic testing. Requirements for 

laboratory approval and a list of laboratories approved to conduct CWD testing can be 

found on the NAHLN Web Site 

(https://www.aphis.usda.gov/animal_health/nahln/downloads/cwd_elisa_lab_list.pdf).

Not all laboratories are approved to perform all officially recognized types of CWD 

assays. The VS Cervid Health staff, the NVSL Director, and the NAHLN Coordinator will 

maintain a list of officially recognized CWD assays and when appropriate the tissues 

approved for laboratories that conduct these tests for CWD. The list will be available on 

request to all interested parties.

6.2 Official CWD Tests

An official CWD test is approved by the Administrator in accordance with 9 CFR 55.8. 

To be considered as an official test for CWD, a test method must be:

1) Licensed by the Center for Veterinary Biologics (CVB), if required (i.e.,ELISA 

tests, etc).

2) Performed by APHIS-approved laboratories, at NVSL, or at another laboratoryto 

which NVSL has referred a case for confirmatory testing.

3) Performed following NVSL protocols.
Chronic Wasting Disease Program Standards

33

The following are considered official tests for CWD when used as described in these 

Program Standards:

Approved CWD Test

Method

Tissue Tested Approved Use

Immunohistochemistry 

(IHC) test

Medial 

retropharyngeal 

lymph node 

(MRPLN) and obex 

collected postmortem and 

preserved in 

formalin1

 Routine herd surveillance

 Testing in conjunction with 

epidemiological investigations 

and herd plans for CWDpositive, suspect, exposed, and 

epi-linked herds

Immunohistochemistry 

(IHC) test

Ante-mortem biopsy 

of white-tailed deer 

rectoanal-associated 

mucosa-associated 

lymphoid tissue 

(RAMALT)

This is an official test in white-tailed 

deer only when outlined in a herd 

plan and:

 Genotype at codon 96 is 

established

 Used as a whole herd test as 

indicated in herd plans for 

CWD-exposed herds, and epilinked herds as described in 

Part B and

 Performed at NVSL

Immunohistochemistry 

(IHC) test

Ante-mortem biopsy 

of white-tailed deer 

MRPLN

This is an official test in white-tailed 

deer only when outlined in a herd 

plan and:

 Genotype at codon 96 is 

established

 Used as a whole herd or 

individual test as indicated in 

herd plans for , CWDexposed herds, and epilinked herds as described in 

Part B and

 Performed at NVSL

Enzyme-linked 

immunosorbent assay 

(ELISA) by Bio-Rad

Fresh medial 

retropharyngeal 

lymph node 

(MRPLN) and obex 

collected postmortem1

This is an official HCP test only when 

used for:

 Slaughter surveillance in 

farmed cervids; or

 Carcass segregation for 

disposal; or

1 Although medial retropharyngeal lymph nodes (MRPLNs) may be early CWD detection sites in deer and 

elk, it is not uncommon to find elk that are obex-positive and MRPLN-negative. Therefore, confidence in 

CWD detection is increased when both obex and MRPLNs are tested.
Chronic Wasting Disease Program Standards

34

 Other purpose as approved in 

advance by APHIS and

 Is performed at NVSL or at a 

NAHLN laboratory approved to 

conduct the ELISA

Many States use the ELISA to 

conduct wildlife surveillance. This use 

is not subject to APHIS approval.

Western blot Fresh medial This is an official test only when

retropharyngeal performed at NVSL

lymph node

(MRPLN) and obex

collected postmortem1

6.3 Approval of Official Diagnostic Tests

Prior to evaluation for official use, the manufacturer should obtain a product license from 

the CVB, if needed.

Companies/researchers are encouraged to contact the Cervid Health Team to review 

preliminary data and discuss additional data needs for candidate tests prior to 

submission.

The test manufacturer should submit an application package containing the following 

information to the Cervid Health Team:

1) A standardized protocol that includes a description of the test, sample type, all 

methods associated with preparing the sample and conducting the test, reagent 

specifics, required materials and equipment, and control and quality assurance 

measures.

2) A description of the proposed use of the test in the CWD HCP program and the 

suitability of the test for the stated purpose. Specifically include cervid species, 

post- or ante-mortem use, and conditions for use (e.g., whole herd versus 

individual animal, routine surveillance testing versus use in herds under 

epidemiological investigation, etc.).

3) Data/scientific evidence to demonstrate:

A. Diagnostic sensitivity of the test evaluated in a range of infected animals 

including:
Chronic Wasting Disease Program Standards

35

1. Animals early in the clinical progression, such as:

a. Animals that are MRPLN-only positive,

b. Elk that are obex-only positive, or

c. Animals of all three genetic polymorphisms (96 for white-tailed deer, 

132 from elk).

2. Animals late in the clinical progression, such as:

a. Animals that are MRPLN- and obex-positive, or

b. Animals of all three genetic polymorphisms (96 for white-tailed deer, 

132 from elk).

3. Data provided should include the genotype (96 for white-tailed deer, 132 

from elk) and complete post-mortem testing results for IHC on obex and 

MRPLN for each animal.

4. Description of the calculation.

B. Diagnostic specificity in animals believed to be non-infected based on HCP 

herd certification status and results from mortality testing from at least the last 

5 years.

C. Repeatability of the test result. This refers to the ability of a test to 

repeatedly produce the same result on a given sample. Evidence to 

demonstrate repeatability includes detailed information about the collection 

of the data, including controls and control data.

D. Reproducibility of the test results at other laboratories. This refers to the 

ability of a test to repeatedly produce the same result on a given sample 

when the test is performed at multiple laboratories by multiple people. In 

addition to the supporting data, a letter of support and certification of test 

results from participating laboratories is suggested.

4) Other data and documentation, as requested by APHIS.

5) Field trials and/or pilot projects using the test may be recommended/required 

prior to final approval.

The Cervid Health Team will coordinate with NVSL, NAHLN, CVB and other scientific 

experts within APHIS and USDA to review the application package and evaluate the 

test based on, but not limited to, the criteria described in 9 CFR 55.8. APHIS may 

approve the new test methods or request additional data, including results from field 

trials.

APHIS may limit use of the test to certain species or types of animals or for use in 

specific situations. APHIS will clearly describe the conditions for official use of the 

approved test.
Chronic Wasting Disease Program Standards

36

6.4 Test Results

As described in Section A 5.6, sections of brainstem/obex, MRPLN, and RMALT are 

evaluated by an official test in an approved laboratory to demonstrate the presence of 

the infectious CWD prion. Samples in which the infectious CWD prion is detected in 

testing at approved laboratories are considered to be CWD suspect pending 

confirmatory testing at NVSL. All suspect diagnostic test results from an approved 

laboratory must be confirmed by NVSL to establish a diagnosis of a CWD positive 

animal.

Brainstem or lymph tissues from an animal in which CWD prions are not detected by an 

official test does not mean absence of infection, only that prion was not detected in 

those tissues from that animal at the time of testing. Based on current transmissible 

spongiform encephalopathy research and pathogenesis studies, it is possible to have 

CWD prions present at levels below the analytical sensitivity of the test. CWD prions 

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 

infection.

6.5 Rejected Samples

Samples may be rejected as unsuitable for diagnostic purposes for a wide variety of 

reasons. These poor quality samples will not contribute to required herd surveillance 

and may result in the consequences described in Section 5.9. Common examples of 

rejected samples include:

1) No identification submitted with the sample.

2) Incorrect tissue type.

3) Autolyzed (degraded) samples.

4) Samples where the tissue is unidentifiable.

5) Brain samples that do not include the obex.

6) Sample of insufficient size.

7) Sample contains an insufficient number of lymphoid follicles.

The reason for rejected samples can be described on official laboratory reports as 

follows:

1) ISF: Insufficient follicles (<6 follicles and no positive staining present).
Chronic Wasting Disease Program Standards

37

2) LOC: Location (used for CNS exclusively, no DMNV (Dorsal Motor Vagus 

Nucleus) identifiable, wrong brain region).

3) ISF: Loc: (RB (Rectal Biopsy); <6 follicles and >50 percent squamous epithelium, 

rather than rectal mucosa).

4) U: Unsuitable (no significant lymphoid tissue, e.g. salivary gland).

5) S: Suspect (NAHLN lab sees suspicious stain).

6) NT: Not tested (not tested because unnecessary).

7) UNA: Unacceptable (poor quality sample).

6.6 Reporting of Results

Positive test results are to be reported by NVSL to the submitting NAHLN lab, State 

animal health official, the Assistant Director in the State where the herd resides, and 

the National Cervid Health program staff.

All other test 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.
Chronic Wasting Disease Program Standards

38

7. Interstate Movement

The requirements for interstate movement of live cervids with regard to CWD are 

described in 9 CFR 81.2 and 81.3. These requirements apply to both farmed cervids 

and wild-caught cervids that are moved interstate to eventually be released back into 

the wild.

The following conditions must be met for live farmed cervids to be eligible for interstate 

movement:

1) The animals are enrolled and the herd has achieved Certified status in an 

approved State CWD HCP.

2) Each animal in the shipment must have at least two forms of unique identification 

attached, one of which must be an official animal identification with a nationally 

unique identification number, as described above in Section (3.2) Animal 

Identification.

3) A certificate of veterinary inspection (CVI) must be issued for interstate 

movement. It must contain the following information:

A. All identification numbers of each animal in the shipment.

B. Total number of animals covered by the certificate.

C. Purpose for which the animals are to be moved.

D. Consignor and herd of origin with complete addresses.

E. Consignee and point of destination with complete addresses.

F. A statement by the issuing accredited veterinarian or State or Federal 

veterinarian that the animals in the shipment have achieved Certified status in 

the CWD HCP and that the animals were not exhibiting clinical signs 

associated with CWD at the time of examination. The consignor or owner 

should contact the State representative in the State of destination to 

determine if there are any additional requirements.

Cervids eligible to move interstate in accordance with CWD regulations, and meeting 

the conditions specified in 9 CFR 81.5, can transit States en route to their destination. 

The regulations at 9 CFR 81.5 (only) preempt State and local laws or regulations.

1) 9 CFR 81.3 identifies specific exemptions to these requirements, including exemptions 

for Animals moved directly to a recognized slaughter establishment. The 

consignor or owner also should contact the State representative in the State of 
Chronic Wasting Disease Program Standards

39

destination to determine if they meet all import requirements.

2) Research animals.

3) Interstate movements approved by the Administrator on a case-by-case basis.

States or Tribes may transport wild-caught cervids (elk, deer, moose, or other cervidae) 

from one State or Tribal location to another for release to establish new or augment 

existing free-ranging herds. The movement is subject to approval by the animal health 

officials of the receiving State and APHIS. VS Guidance 8000 “Surveillance and Testing

requirements for Interstate Transport of Wild Caught Cervids” establishes a uniform 

process of disease risk assessment and recommended minimum standards for testing 

to help prevent the spread of CWD, bovine tuberculosis (TB) and brucellosis when wild 

cervids are captured for interstate movement and release.

Transport of game meat and other products derived from farmed cervids for purposes of 

interstate commerce is regulated by the Food and Drug Administration and is not 

addressed in the APHIS CWD regulations or these Program Standards. Similarly, 

transport of carcasses and other parts derived from hunt-harvested wild cervids is 

regulated by appropriate State agencies and is not addressed in the APHIS CWD 

regulations or these Program Standards.

:
Chronic Wasting Disease Program Standards

40

Part B. Guidance on Responding to CWD

The CWD regulations in 9 CFR part 55 describe minimum requirements for States in 

response to the finding of a CWD-positive animal. These Program Standards describe 

acceptable methods to meet these minimum regulatory requirements. The methods in 

these Program Standards have been approved by the APHIS Administrator.

Alternatively, States may propose other methods/approaches to meet the regulatory 

requirements. These alternative proposals should be submitted in writing to APHIS for 

approval.

1. Epidemiological Investigations

The purpose of the investigation is to identify animals and herds that were exposed to 

the CWD-positive animal during the last 5 years. Quarantines and/or movement 

restrictions limit the potential for further spread of the infection until the infection status 

of the exposed animal or herd can be assessed.

Upon NVSL confirmation of a CWD-positive animal, the Approved State, in cooperation 

with APHIS, should conduct an investigation to determine the locations where the CWDpositive and the CWD-exposed animal(s) resided during the last 5 years. The 

investigation should start within 7 business days of the laboratory confirmation.

All out-of-State traces should be promptly reported to the appropriate State authorities 

within 45 calendar days following notification of a CWD-positive animal. All notification 

should be provided in writing to the respective State or States and a copy provided to 

the AD in the corresponding District Field Office even if the initial contact was verbal.

In addition to tracing movements of animals, other factors should be considered in the 

epidemiological investigation. These factors are addressed in Appendix III, CWD 

Epidemiology Investigation and Report Templates. They may include, but are not limited 

to: the genetics of CWD-positive animal or animals, the tissue or tissues that tested 

positive, the length of time the CWD-positive animal or animals spent in the herd or 

herds, and the testing history.

Ideally, the investigation will determine the source of infection; however, this is not 

always possible. If the investigation determines the likely source of infection, then the 

statuses and need for quarantine of herds and animals involved in the investigation 

should be re-evaluated. 
Chronic Wasting Disease Program Standards

41

2. Quarantine

The State representative should issue quarantine or hold orders for CWD-positive and 

CWD-exposed herds. Trace-forward Epi-Linked and Trace-back Epi -linked herds will 

be placed under quarantine until the epidemiological investigation determines the 

status of the CWD-exposed animal(s). A Quarantine or hold order is not required for a

Pass-through herd until the status of the CWD-exposed animals that resided in the 

herd is determined. CWD-exposed animals must be quarantined and held on the 

premises where they currently reside unless a State or Federal permit for movement 

(such as VS Form 1-27) has been obtained.

If a quarantined herd is not depopulated, the herd should remain in quarantine for 60 

months (5 years) from the last exposure to the CWD-positive animal or in the case of an 

epi-linked herd the last exposure to a CWD-exposed animal , as otherwise stipulated in 

the herd plan (e.g. following 2 whole-herd ante-mortem tests), or at the discretion of the 

State representative for a period of time as determined by a risk evaluation based on 

the findings of the epidemiological investigation. State representatives may also modify 

a quarantine to permit movement of CWD-exposed animals onto a CWD-positive 

quarantined premises, such as a terminal hunting facility, where all cervids are

harvested within 90 days of introduction and tested for CWD.

Quarantine may be released only after all herd plan requirements have been met and 

completed, or as determined by the State representative.
Chronic Wasting Disease Program Standards

42

3. Classification of Animals and Herds During an Epidemiological 

Investigation

Any CWD-susceptible cervid that has, by definition, commingled with the CWD-positive 

animal in the last 5 years is considered to be CWD-exposed. All herds that contain or 

contained CWD-exposed animals will immediately be placed in Suspended status until 

further epidemiology can be assessed. The Suspended herds will then be classified as 

follows (also see Appendix VI):

3.1 CWD-Positive Herd

The herd where the CWD-positive animal resided upon diagnosis is considered a CWDpositive herd and will immediately lose HCP herd status. The herd may re-enroll in the 

HCP only after entering into a herd plan.

Options for responding to a CWD-positive herd:

1) Complete depopulation and post-mortem CWD testing of the herd. Depopulation 

may include hunter harvesting and/or slaughter with movements under permit,or

2) Quarantine for 5 years since last CWD-positive case, with or without selective 

culling of animals. The herd will remain under Suspended status until a herd plan 

is developed and implemented (see Herd Plan section below). 

3) Ante-mortem CWD testing and genotyping using NVSL protocol and APHISapproved procedures may be included in the herd plan for disease management 

purposes (see Appendix II) and to reduce environmental contamination. 

3.2 CWD Exposed Herd(s)

If the epidemiological investigation determines that the CWD-positive animal resided in 

another herd (or multiple herds) within the last 5 years, then the herds are considered 

CWD-exposed herds and will immediately lose HCP status. The herd may reenroll in 

the HCP only after entering into a herd plan.

Options for responding to a CWD-exposed herd:

1) Complete depopulation and post-mortem CWD testing of the herd. Depopulation 

may include hunter harvesting and/or slaughter with movements under permit,or

2) Quarantine for 5 years since the last exposure to a CWD-positive animal, with or 

without selective culling of animals. The herd will remain under Suspended status 

until a herd plan is developed and implemented (see Herd Plan section below). 

Time in quarantine may be lessened for:

A. If the CWD-exposed herd contains only white-tailed deer – Whole herd antemortem IHC RAMALT CWD testing and genotyping using NVSL protocol and 
Chronic Wasting Disease Program Standards

43

APHIS-approved procedures as included in the herd plan (see Appendix II).

B. If the CWD-exposed herd contains only white-tailed deer – Whole herd antemortem IHC MRPLN biopsy CWD testing and genotyping using NVSL 

protocol and APHIS approved procedures as included in the herd plan (see 

Appendix II).

C. At the discretion of the State representative for a period of time as determined 

by a risk evaluation based on the findings of the epidemiological investigation.

3.3 Trace-Forward, Trace-Back and Pass-Through Epidemiological-Linked Herds

If the epidemiological investigation determines that CWD-exposed animals that resided 

with a CWD-positive animal within 5 years prior to the diagnosis of CWD have since 

moved to or through other herds, then those herds are considered to be 

epidemiologically linked.

Options for responding to a Trace-forward or a Trace-back epidemiologically-linked herd:

1) If all of the CWD-exposed animals have died, were tested for CWD, and had “not 

detected” results, then the epidemiologically-linked herd is removed from 

Suspended status and maintains its original HCP status, including time spent in 

Suspended status.

2) If CWD-exposed animals are still present in the herd, then those animals may be 

euthanized and tested for CWD. If all CWD-exposed animals are accounted for 

and no samples tested positive for CWD, then the herd is removed from 

Suspended status and maintains its original HCP status, including time spent in 

Suspended status.

If any of the CWD-exposed animals have died and were not tested for CWD, or 

if the CWD-exposed animals no longer reside on the premises, or if the CWDexposed animals are still present in the herd, but the owner does not agree to 

euthanasia and testing, then the herd will remain under Suspended status until a 

herd plan is developed and implemented (see Herd Plan section below). The 

herd should be quarantined for 5 years since the exposed animal(s) was 

exposed to a CWD-positive animal, with or without selective culling of animals. 

Time in quarantine may be lessened for:

A. If the herd contains only white-tailed deer – Whole herd ante-mortem CWD 

testing and genotyping using NVSL protocol and APHIS approved procedures 

as included in the herd plan (see Appendix II).

B. If the herd contains only white-tailed deer – Ante-mortem IHC MRPLN biopsy 

testing and genotyping of all CWD-exposed deer using NVSL protocol and 

APHIS approved procedures as included in the herd plan (see Appendix II).
Chronic Wasting Disease Program Standards

44

C. At the discretion of the State representative for a period of time as determined 

by a risk evaluation based on the findings of the epidemiological investigation.

Options for responding to a Pass-through epidemiological linked herd:

1) Response to a Pass-through epidemiological linked herd will be determined by the status of 

the CWD-exposed animal(s) that has passed through the herd.

2) If the status of the CWD-exposed animal(s) that passed through the herd cannot be 

determined for whatever reason then the response will be determined by a risk 

evaluation based on the findings of the epidemiological investigation. 
Chronic Wasting Disease Program Standards

45

4. Reporting

Sharing accurate, timely, complete information about ongoing CWD epidemiological 

investigations among Federal and State animal health officials helps to control the 

spread of CWD by quickly and accurately identifying exposed animals and placing 

movement restrictions on animals and herds. It also provides State animal health 

officials with information they may use to release or reduce quarantines for herds under 

investigation, as appropriate.

Appendix III provides a template that States may use to report findings from their 

epidemiological investigation to APHIS and other State representatives. States are 

required to submit both a preliminary and a final report for herds enrolled in the HCP. 

Additionally, States must submit these reports for any herd that requests Federal 

indemnity. This reporting requirement will be included in the herd plan. States should 

submit a preliminary report for a newly identified CWD-infected herd to APHIS within 7 

business days of NVSL confirmation of the CWD-positive animal. States should submit 

a final report for CWD-positive herds as part of their annual HCP report.

APHIS may request clarification or additional information on CWD-positive herds as 

needed for risk assessments, indemnity requests, or other reasons.
Chronic Wasting Disease Program Standards

46

5. Herd Plans

A herd plan describes in detail the actions to be taken to control the spread of CWD 

from and within CWD-positive, exposed, epi-linked or suspect herds. It is a herd and/or 

premises management agreement based on a risk evaluation of the affected premises 

and herd and developed by APHIS in collaboration with the herd owner, State 

representatives, and other affected parties. The herd plan is not valid until it has been 

signed by the Assistant Director, the State representatives, and the herd owner. Herd 

plans should be signed within 60 days of a confirmed diagnosis of CWD.

A written, signed herd plan is required for herds to receive Federal indemnity. 

Quarantined herds must complete the requirements described in a herd plan before 

quarantines are released.

At a minimum, the herd plan should include:

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, and the cause of death, if the animal died while in the herd.

5) Testing of all mortalities, regardless of age (9 CFR 55.24 (2)(ii)). Records should 

be maintained for all samples submitted for CWD testing.

A 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:

1) Depopulation of the herd if funds for indemnity are available. Depopulationalso 

may be accomplished by moving animals from CWD-positive, suspect, epilinked and exposed herds (by permit and under seal) to a slaughter facility or 

to an appropriate hunt facility at the discretion of the State officials.

2) Specifying the time for which a premises must not contain cervids after CWDpositive, CWD-exposed, or CWD-suspect animals are removed from the 

premises.
Chronic Wasting Disease Program Standards

47

3) Removal of CWD-exposed or CWD-suspect animals from the premises if funds 

for indemnity are available or at the discretion of State officials.

4) Fencing requirements and time period for regular inspection of fences.

5) Selective culling of animals.

6) Restrictions on use and movement of possibly contaminated livestock 

equipment.

7) Procedures for cleaning and decontamination of premises, including the use of 

bleach and/or lye for EPA required reporting.

8) Whole herd ante-mortem CWD testing and genotyping using NVSL protocol and 

APHIS-approved procedures.

9) Requirement to provide information needed to complete the preliminary and final 

epidemiology reports (see Appendix III).

10)Current Centers for Disease Control and Prevention (CDC) guidelines for 

prevention of potential human exposure to CWD.

11) Other requirements.

A herd plan may be reviewed and changes proposed at any time by any signatory party 

in response to changes in the situation of the herd or premises. The plan may also be 

changed if the understanding of the nature of CWD epidemiology, or techniques to 

prevent its spread, improves. However, any proposed changes must be reviewed and 

approved by all signatories before they are adopted.

Additional information on CWD environmental contamination and recommended 

procedures for cleaning and decontamination of premises that may be included in herd 

plans for CWD-positive herds is provided in Appendix IV.
Chronic Wasting Disease Program Standards

48

6. Federal Indemnity

6.1 Eligible Animals

Federal indemnity may be available for the purchase, destruction, and disposal of CWDpositive, exposed, and suspect animals.

APHIS will pay reasonable costs for destruction and carcass disposal for animals that 

are indemnified.

Once the animals are euthanized, the carcasses become the property of APHIS, and 

APHIS may collect tissue samples as desired.

At the State’s discretion, a person may remove the skull plate with antlers attached and 

cleaned of all soft tissue and blood from the premises if the material is being moved to a 

taxidermist for processing and after the animal is tested “not detected” for CWD.

6.2 Appraisals

An appraisal must be conducted by a government or a private appraiser (VS 

Memorandum 534.1). The appraisal report and detailed supporting documentation 

must be submitted to the Cervid Health Team for review.

6.3 Indemnity Requests

The Assistant Director responsible for the State in which the animals reside should 

provide the following to the Cervid Health Team when submitting a request for Federal 

indemnity:

1) Completed indemnity request form signed by the Assistant Director.

2) The appraisal report with detailed supporting documentation, such as:

A. The white-tailed deer appraisal calculator.

B. Pedigrees.

C. Sale receipts or invoices.

D. Documentation of antler scores.

3) VS Form 1-23 and a herd plan signed by the herd owner and the Assistant 

Director.

4) Preliminary epidemiological report (see Appendix III).
Chronic Wasting Disease Program Standards

49

6.4 Evaluation and Prioritization of Requests for Federal Indemnity Funds

Whole-herd depopulation and post-mortem testing of all cervids on the premises is often 

the preferred response to control the spread of CWD within and from CWD-positive and 

exposed herds. A limited amount of Federal indemnity funding is available to 

compensate producers and encourage depopulation. In recent years, the amount of 

available Federal indemnity funding has been insufficient to depopulate all CWDpositive herds identified in a single year. Further, indemnity funds have not been 

available to remove CWD-exposed animals for diagnostic testing to determine their 

infection status and the exposure status of specific herds involved in epidemiological 

investigations.

In light of these financial constraints, it is increasingly important for APHIS to prioritize 

how limited funds are used to provide indemnity in a way that:

1) Reduces the potential for disease transmission and environmental 

contamination.

2) Strategically removes CWD-exposed animals to inform risk evaluation and 

decision making regarding movement restrictions and other risk mitigations.

3) Encourages participation and compliance in the HCP.

APHIS will consider requests for Federal indemnity for CWD-positive, -exposed, and 

suspect animals and herds on a case-by-case basis. APHIS, in consultation with State 

representatives, will consider a number of interrelated factors as we comprehensively 

evaluate each case to make a decision about providing Federal indemnity. The factors 

we will consider and the relative priority of possibilities within each factor include (but 

are not limited to):

1) Availability of funds for indemnity.

2) Herd size (as it is related to the availability of funding).

3) Herd Status (CWD-positive herd >> Whole herd depopulation for herds with only 

CWD-exposed or suspect animals).

4) Type of Herd (Breeding herd >> Hunt preserve).

5) HCP Status (Enrolled and compliant >> Not enrolled or Enrolled but not 

compliant).

6) CWD detection in the local area (CWD not detected in wildlife or farmed cervids

>> CWD detected in farmed cervids only >> CWD detected in wildlife).

7) Cervid density in local area (High >> Moderate >> low density).

8) Value of post-mortem testing of animals to understand epidemiology and inform 
Chronic Wasting Disease Program Standards

50

decision making (Animal removal will likely impact knowledge/decisions about 

multiple herds >> will only inform knowledge/decisions about herd animal is 

residing in).
Chronic Wasting Disease Program Standards

51

7. Carcass Disposal

Destruction or inactivation of infectious prions is difficult and few methods have been 

documented as completely successful. In addition, there are currently no quality 

assurance or quality control methods to ensure prion inactivation.

Carcasses from CWD-positive, suspect, or exposed animals or herds should be 

disposed of in compliance with all Federal, State, and local regulations. Additional 

information about State requirements for carcass disposal is available on the Veterinary

Compliance Assistance Web site. APHIS, upon request, can provide technical support 

and guidance to assist in identifying and implementing a local disposal plan.

Carcasses must be carefully transported to treatment or burial sites to prevent 

environmental contamination. Precautions should be taken to prevent ashes, blood, 

tissues, or feces from leaking from transport vehicles. All vehicles should be cleaned 

and disinfected after each use as described in Appendix IV.

The following list describes acceptable options for the disposal of carcasses from 

animals euthanized as part of a diagnostic or depopulation effort for CWD. Incineration, 

alkaline digestion, disposal of materials in appropriate landfills, and onsite burial, or a 

combination of these methods, are generally the most suitable options. These options 

are based on the available science of CWD inactivation. Changes to the list of options 

may be made as new information becomes available.

7.1 Incineration

Carcasses may be incinerated in an Environmental Protection Agency (EPA)-approved 

conventional incinerator, air curtain incinerator, or cement kiln. Prions can be destroyed 

through incineration provided the incinerator can maintain a temperature of 900° F for 4 

hours. Incineration of animals onsite with a mobile incinerator is an option as it 

presents the least risk of spreading contaminated materials by moving carcasses.

However, mobile incinerators require large amounts of fuel to maintain an even, high 

temperature appropriate for prions.

After incineration, ashes should be buried in an active, licensed landfill at a depth that 

meets local and State regulations to prevent scavenging or contamination of 

groundwater.

7.2 Alkaline hydrolysis

Carcasses of infected animals can be destroyed in a sterile alkaline solution using an 

alkaline hydrolysis digester. This consists of an insulated steam-jacketed stainless steel 

vessel which operates at up to 70 psi and 300° F into which sodium hydroxide and 

water is added, heated, and continuously circulated. This process degrades proteins 

and the temperature, together with alkali concentrations, deactivates prions.

After digestion, treated material may be buried in an active, licensed landfill at a depth 
Chronic Wasting Disease Program Standards

52

that meets local and State regulations.

7.3 Landfill

Carcasses may be buried in a licensed, active landfill that meets local and State 

regulations for animal carcass disposal. However, this method will NOT inactivate the 

prions.

The definition of infectious waste varies among States, which could affect the standards 

associated with collection, handling, and disposal of waste that can include tissue, body 

parts, heads, and carcasses as well as contaminated laboratory materials. Consult with 

local and State authorities when pursuing this option.

In addition, individual animals could be tested for CWD using an ELISA with carcass 

disposal delayed until results are obtained. Subsequently, carcasses from positive 

animals can be disposed of with incineration or alkaline hydrolysis with burial of the 

treated materials. Carcass burial in a landfill in compliance with local and State 

regulations may be used for other animals with “Not Detected” results.

7.4 Onsite Burial

Carcasses may be buried onsite at a depth that meets local and State regulations for 

animal carcass disposal. However, this method will NOT inactivate the prions.

In addition, individual animals could be tested for CWD using an ELISA with carcass 

disposal delayed until results are obtained. Subsequently, carcasses from positive 

animals can be disposed of with incineration or alkaline hydrolysis with burial of the 

treated materials. Carcass burial onsite in compliance with local and State regulations 

may be used for other animals with “Not Detected” results.
Chronic Wasting Disease Program Standards

53

Appendix I: Links to Forms and Documents

Forms and templates for application to the Approved State CWD Herd 

Certification Program include:

 VS Form 11-2 (Application for Chronic Wasting Disease Herd Certification program

(CWD HCP) approval, renewal, or reinstatement of a State)

 MOU Between State and APHIS for CWD HCP

The Final CWD Rule:

 9 CFR part 55

 9 CFR part 81

A list of Approved State CWD HCPs

VS Form 10-4 Laboratory Submission Forms

VS Form 10-4A Additional Page for Sample Submissions

CWD Program – “CWD Sample Collection Guidance”

Additional information about the Cervid Health Program
Chronic Wasting Disease Program Standards

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Appendix II: Guidelines for Use of Whole Herd 

Ante-Mortem Testing of Herds that Contain or 

Contained CWD-Exposed Animals

Biopsy of the medial retropharyngeal lymph node (MRPLN) or the rectal anal mucosal 

associated lymphoid tissue (RAMALT) for the detection of the abnormal prion protein 

(protease resistant misfolded prion) associated with CWD is an official test only in whitetailed deer, and only when:

1) Genotype at codon 96 is established;

2) Used with herd plans for CWD-exposed herds, andepidemiologically- linked 

herds as described in Part B. , and

3) When performed at NVSL.

A case-by-case agreement will outline the specific timing and procedures to be used in 

a particular situation and will be included in the overall herd plan.

The following is a draft herd agreement for ante-mortem RAMALT testing that could be 

modified for the specific situation and incorporated into a herd plan:

Draft Herd Agreement for CWD Exposed Herds to Use Rectal Biopsy Testing as a 

Risk Assessment Herd Management Tool

Preface: Biopsy of rectal anal mucosal associated lymphoid tissue (RAMALT) for the 

detection of the abnormal prion protein (protease resistant misfolded prion) associated 

with CWD has a high specificity but a relatively low sensitivity for the detection of CWD 

in individual animals in comparison to post-mortem testing. Serial, whole-herd testing 

using RAMALT increases the confidence of detecting at least one positive animal in a 

potentially exposed herd. Sampling must be conducted by proficient collectors with 

adequate animal restraint.

The genotype of the animal is known to be associated with the tissue distribution of the 

abnormal prion over time (GG on codon 96 will have earlier and more extensive tissue 

distribution than GS on codon 96). The timing of the second whole herd testing will 

therefore depend on the genetic makeup of the herd. Current research suggests that 

the dose load and route of infection may also impact the time from exposure to 

detection.
Chronic Wasting Disease Program Standards

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Assumptions:

1) Genotype of codon 96 influences the interpretation of the RAMALT results.

2) At least two whole herd CWD tests using RAMALT samples must be conducted 

in series.

3) If more than 10 percent of the animals in a whole herd test have insufficient 

follicles for diagnostic purposes, then those animals must be resampled until a 

minimum of 90 percent of the entire herd is successfully sampled. A minimal 

number of samples with insufficient follicles is inherently accepted as part of the 

RAMALT technique.

APHIS Approved Procedure:

1) Initial whole herd test will be conducted not less than 24 months after the last 

known exposure to a CWD-positive animal. Whole-herd RAMALT biopsy, and 

whole blood samples for codon 96 genotyping, will be collected on all animals 

equal to or greater than 12 months of age as described in Appendix II. Biopsy 

samples will be sent to NVSL and blood samples will be sent to an APHISapproved genetics laboratory.

2) Timing of the second whole herd RAMALT test will be determined by the results 

of the herd genotyping.

A. The second whole herd test for herds with over 70 percent GG animals will be 

at least 3 years after the last known exposure and at least 6 months after the 

initial whole herd test.

B. The second whole herd test for herds with 50 percent to 70 percent GG 

animals will be at least 3.5 years after the last known exposure and at least 

6 months after the initial whole herd test.

C. Herds with fewer than 50 percent GG animals will not be permitted to use 

ante-mortem RAMALT testing.

3) All sample collection shall be done by a State or Federal veterinarian or a 

licensed, accredited veterinarian under the supervision of a State or Federal 

veterinarian, and the samples shall be considered to be the property of USDA.

4) All CWD diagnostics shall be performed by NVSL. Genetic testing of whole blood 

should be performed at an approved laboratory.

5) If more than 10 percent of the animals in a whole herd test have insufficient 

follicles for diagnostic purposes, then those animals must be resampled until a 

minimum of 90 percent of the entire herd is successfully sampled.
Chronic Wasting Disease Program Standards

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6) All costs associated with sample collection, genetic testing, and diagnostic 

testing are the responsibility of the herd owner.

7) The loss of any animal, function, or part of an animal that could arise as a result 

of handling or sample collection associated with this agreement shall be borne by 

the herd owner and not by the State or USDA.

8) Any method of chemical restraint used for testing shall be performed or 

administered by a licensed accredited veterinarian approved by the State and 

USDA.

9) The herd owner agrees to be in, and remain in, compliance with the terms of the 

State CWD HCP, and continue to maintain appropriate licensure with the State. 

In addition, any animal 6 months of age or older, that dies during the period of 

the herd plan, must be made available for sample collection.

10)If a positive result is found on rectal biopsy, the herd will remain under quarantine 

and will bedesignated a CWD-positive herd.

11)Notwithstanding paragraph 9, if the herd is negative on both whole herd tests, the 

State and USDA will evaluate the test results and agreement compliance for 

quarantine release. If the herd has remained in compliance with all terms of the 

herd plan, the quarantine will be released.
Chronic Wasting Disease Program Standards

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Appendix III: CWD Epidemiology Investigation 

and Report Templates

Preliminary Epidemiology Report Worksheet

APHIS requests that States provide the following preliminary information to APHIS 

within 7 business days of NVSL confirmation of a CWD-positive animal in a newly 

identified CWD-positive herd. APHIS may request clarification or additional information 

on CWD-positive herds as needed for risk assessments, indemnity requests, or other 

reasons. Submit the completed worksheet to: VS.SP.Cervid.Health@aphis.usda.gov

State County Herd

Owner

Please complete one form for each CWD-positive herd that you have identified in

your State.

Index Case (defined as the first positive case identified in a herd) Check if traced 

from another positive herd

1. Age at the time of death/euthanasia? Yr Mo

2. Sex? M F

3. Species?

4. Was the index case a natural addition? or a purchased addition? (check 

one)

If natural addition, date of birth / /

If purchased, date added to herd / /

If purchased, from where? (herd/name)

(State)

5. Date of death/euthanasia? / /

6. Date CWD samples were taken? / /

7. Was the index case exhibiting clinical signs at the time of death/euthanasia? 

Y/N/Don’t know

8. Obex test result? Positive Not detected Location Not sampled

Lymph node test result? Positive Not detected Location

Not sampled 

test result? Positive Not detected Location

Genetics testing results? @codon @codon Not tested
Chronic Wasting Disease Program Standards

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Positive Premises (defined as the premises on which the index case resided at the

time of diagnosis)

1. Date cervid herd was established? / /

2. Type of operation (check all that apply)? Breeding Hunting Other

(If Other, specify type )

3. Most recent known/reported captive cervid inventory at the time the index case 

was diagnosed: Date of inventory / /

Cervid Herd Inventory at the Time of Index Case Diagnosis

Species

1 year old and over Under 1 year old Total 

Inventory

Males Females Males Females

Elk

White-tailed deer

Other

( )

4. Total size of the area where captive cervids were held? acres

5. Size of the enclosure where the index case was held? acres

6. Were animals from the index herd housed on more than one location? 

Y/N/Don’t know

If yes, please explain

7. Was the premises double-fenced at the time the index case was diagnosed? 

Y/N/Don’t know

8. Is equipment or vehicles shared by other premises?

9. If it is a breeding operation, is sexed semen, AI, or embryo transfer used?

10. Was/Were the animal/s bottle fed?

11. Was the premises managed as a closed herd at the time of diagnosis? 

Y/N/Don’t know

If yes, for what length of time prior to the index case diagnosis? Yr Mo

If the herd was not managed as a closed herd, how many other herds were 

cervids sourced from in the 5-year period prior to the index case diagnosis?

In-State sources # of premises 

Out-of-State sources # of premises 

# of animals 

# of animals 
Chronic Wasting Disease Program Standards

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(Please include any known details of sources)How many other herds were 

cervids moved to in the 5-year period prior to the index case diagnosis?

In-State departures # of premises 

Out-of-State departures # of premises 

# of animals 

# of animals 
Chronic Wasting Disease Program Standards

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(Please include any known details of departures)

12. Were any ancillary businesses associated with the positive premises? (e.g. urine 

collection, taxidermy, wildlife rehabilitation, fawn raising)? Y/N/Don’t know

(If Yes, specify type(s))

)

13. Was the index herd enrolled in a Herd Certification Program (HCP) at the time 

that the index case was diagnosed? Y/N If yes, date of enrollment?

/ /

If yes, was the herd in compliance with the requirements of the HCP at the time 

the index case was diagnosed? Y/N/Don’t know

If the herd was not in HCP compliance at the time the index case was diagnosed, 

please explain:

14.At the time that the index case was diagnosed, was the index herd located: 

Within 10 miles of known CWD positives in wildlife? Y/N/Don’t know 

Between 11 and 50 miles of known CWD positives in wildlife? Y/N/Don’t know

15.At the time that the index case was diagnosed, was the index herd located: 

Within 10 miles of known CWD positives in other captive cervids? Y/N/Don’t 

know

Between 11 and 50 miles of known CWD positives in other captive cervids? 

Y/N/Don’t know

16. What is the wild cervid population density outside of the positive premises?

17.Any other known risk factors or important information regarding the positive 

herd?

Final Epidemiology Report Worksheet

A final report of the epidemiological investigation is required for all HCP-enrolled CWDinfected herds and for all herds that receive APHIS indemnity funds. Ideally, States will 

submit final epidemiology reports from all CWD-positive herds to facilitate future disease 

mitigation efforts. States should submit the final report for CWD-positive herds as part of 

their annual HCP report.

State County Herd

Owner

Please complete one form for each CWD-positive herd that you have identified in

your State.

Index Case (defined as the first positive case in a herd) Check if traced from 
Chronic Wasting Disease Program Standards

61

another positive herd

1. Age at the time of death/euthanasia? Yr Mo

2. Sex? M F

3. Species?

4. Was the index case a natural addition? or a purchased addition? 

(check one) If natural addition, date of birth / /

If purchased, date added to herd / /

If purchased, from where? (herd/name)

(state)

5. Date of death/euthanasia? / /

6. Date CWD samples were taken? / /

7. Was the index case exhibiting clinical signs at the time of death/euthanasia? 

Y/N/Don’t know

8. Obex test result? Positive Not detected Location Not sampled

Lymph node test result? Positive Not detected Location 

Not sampled 

test result? Positive Not detected Location

Genetics testing results? @codon @codon Not tested

Positive Premises (defined as the premises on which the index case resided at the

time of diagnosis)

1. Date cervid herd was established? / /

2. Type of operation (check all that apply)? Breeding Hunting Other

(If Other, specify type )
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3. Most recent known/reported captive cervid inventory at the time the index case 

was diagnosed: Date of inventory / /

Cervid Herd Inventory at the Time of Index Case Diagnosis

Species

1 year old and over Under 1 year old Total 

Inventory

Males Females Males Females

Elk

White-tailed deer

Other

( )

4. Total size of the area where captive cervids were held? acres

5. Size of the enclosure where the index case was held? acres

6. Were animals from the index herd housed on more than one location? 

Y/N/Don’t know

If yes, please explain

7. Was the premises double-fenced at the time the index case was diagnosed? 

Y/N/Don’t know

8. Was the premises managed as a closed herd at the time of diagnosis? 

Y/N/Don’t know

If yes, for what length of time prior to the index case diagnosis? Yr Mo

If the herd was not managed as a closed herd,

How many other herds were cervids sourced from in the 5-year period prior to 

the index case diagnosis?

In-State sources # of premises

Out-of-State sources # of premises 

# of animals 

# of animals _

(Please include any known details of sources)

How many other herds were cervids moved to in the 5-year period prior to the 

index case diagnosis?

In-State departures # of premises 

Out-of-State departures # of premises 

# of animals 

# of animals 
Chronic Wasting Disease Program Standards

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(Please include any known details of departures)

9. Were any ancillary businesses associated with the positive premises? (e.g. urine 

collection, taxidermy, wildlife rehabilitation, fawn raising)? Y/N/Don’t know

(If Yes, specify type(s))

10. Was the index herd enrolled in a Herd Certification Program (HCP) at the time 

that the index case was diagnosed? Y/N

If yes, date of enrollment? / /

If yes, was the herd in compliance with the requirements of the HCP at the time 

the index case was diagnosed? Y/N/Don’t know

If the herd was not in HCP compliance at the time the index case was diagnosed, 

please explain:

11.At the time that the index case was diagnosed, was the index herd located: 

Within 10 miles of known CWD positives in wildlife? Y/N/Don’t know 

Between 11 and 50 miles of known CWD positives in wildlife? Y/N/Don’t know

12.At the time that the index case was diagnosed, was the index herd located: 

Within 10 miles of known CWD positives in other captive cervids? 

Y/N/Don’t know

Between 11 and 50 miles of known CWD positives in other captive cervids? 

Y/N/Don’t know

13. What is the wild cervid population density outside of the positive premises?

14. Was this herd depopulated? Y/N

If yes, date of depopulation? / /

If no, date quarantined? / /

15. If this herd was depopulated, inventory at the time of depopulation: 

Date of inventory / /

Check box if same as inventory listed in item 12 above:

Cervid Herd Inventory at the Time of Depopulation

Species

1 year old and over Under 1 year old Total 

Inventory

Males Females Males Females

Elk

White-tailed deer
Chronic Wasting Disease Program Standards

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Other

( )

CWD Test results from the depopulated inventory (rows below should add up to 

total inventory in item above):

Obex test results? #Positive 

#Not sampled

#Not detected #Location

Lymph node test result? #Positive 

#Not sampled

test result? #Positive 

#Not sampled

#Not detected

#Not detected

#Location

#Location

16. Did any cervids die prior to depopulation of the herd or while the herd was being 

held under quarantine (including euthanasia deaths)? Y/N/Don’t know

If yes, how many? (please complete the following table):

Number of Cervids that Died or were Euthanized Prior to Depopulation or While

Held under Quarantine

Species

1 year old and over Under 1 year old

Total

Males Females Males Females

Elk

White-tailed deer

Other

( )

CWD Test results (rows below should sum to total above):

Obex test results? #Positive

sampled

#Not detected #Location #Not

Lymph node test result? #Positive 

#Not sampled

test result? #Positive 

#Not sampled

#Not detected

#Not detected

#Location

#Location
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17. For all CWD POSITIVE cervids (TOTAL herd numbers) that died or were 

euthanized following the index case diagnosis (during depopulation orotherwise 

AND including the index case), please provide:

a. TOTAL number of CWD-positive animals:

b. Of the total number of CWD-positive animals above, how many were: 

0-24 months of age? :

25-48 months of age? : 

49+ months of age? :

c. Total number of positive males:

d. Total number of positive females: 

e. Were all positives the same species? Yes / No 

If no, please provide the total number of positive:

Elk White-tailed deer Other ( )

f. Total number of positive natural additions:

g. Total number of positive purchased additions:

Were all positive purchased animals from the same place? Yes/No

1. If yes, total number of animals purchased?

From herd in State 

2. If no, number of facilities from which positive animals were purchased?

Provide number of animals purchased from each herd and the State of 

origin 

h. Total number of animals showing clinical signs at time of death:

i. Genetics testing results on positives? Y/N/Don’t know

If yes (WTD), # GG @ codon 96? 

# SS @ codon 96?

# GS @ codon 96? _

If yes (Elk), # LL @ codon 132? 

# MM @ codon 132?

# LM @ codon 132?
Chronic Wasting Disease Program Standards

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18. How many CWD-exposed cervids were identified in the 

epidemiological investigation?

In-State traces # Out-of-State traces #

Check box if unable to trace due to poor records, etc.

How many of the identified CWD-exposed cervids were tested for CWD? 

Were any exposed cervids diagnosed as positive for CWD? Y/N/Don’t know If 

yes, how many were diagnosed as positive for CWD?

For the most recent years prior to the index case being diagnosed, please 

provide:

Number of 

Years Prior 

to CWD 

Index Case 

Diagnosis

Reported 

Inventory

# Sold or 

Transferred 

from Herd

#Purchases 

(or Other 

Non-Natural 

Additions)

#Slaughtered 

and/or 

Hunter 

Harvested 

(and # CWD 

sampled)

# Natural 

Deaths 

(and # 

CWD

Sampled)

#Valid 

Reported 

CWD Test 

Results 

(i.e. do not

count 

location or 

untestable

results)

1 Year Prior ( ) ( )

2 Yrs. Prior ( ) ( )

3 Yrs. Prior ( ) ( )

4 Yrs. Prior ( ) ( )

5 Yrs. Prior ( ) ( )

Please include a copy of any epidemiological reports conducted on this herd and copies 

of any lab test results or other pertinent findings.
Chronic Wasting Disease Program Standards

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Appendix IV: Biosecurity and Decontamination 

Procedures for Farmed Cervid Facilities

Chronic wasting disease (CWD) is an infectious disease of cervids that can be 

transmitted directly, animal to animal, and indirectly via contact with the environment 

and objects within it. The time between CWD exposure, proliferation in the body, and 

shedding in excreta (saliva, urine, feces, and blood) has yet to be definitively 

determined in cervids. However, studies using highly sensitive amplification assays 

have shown that infectious material is shed into the environment via these pathways at 

levels sufficient to cause significant site contamination over time. Once in the 

environment, prions are highly persistent, and can remain a source of CWD exposure 

for extended periods of time. Studies with scrapie in sheep suggest long environmental 

persistence times, greater than 10 years. Because of these factors it is prudent to use 

basic biosecurity practices, and attempt to decontaminate objects and equipment that 

may have become contaminated. There are currently no means available to 

decontaminate soil.

The recommended decontaminated procedures outlined below are believed to reduce 

the overall CWD burden on objects and equipment on a site. These recommended 

procedures may change as new scientific information becomes available.

1) Biosecurity: General Principles and Approach

Biosecurity refers to measures or management practices taken to try to stop the 

spread of harmful biological agents. Although not guaranteed to prevent disease 

spread, the following suggested measures are believed to reduce potential exposure 

of captive cervids to CWD and other infectious diseases:

A. Direct Contact: Contact with cervids and other wildlife

1. Monitor and maintain perimeter fences. Repair holes and washouts to prevent 

the entry of wildlife.

2. Place feeders away from perimeter fences as to not attract wild cervids to the 

fenceline where direct contact can occur between wild and captive cervids.

3. Reduce or eliminate forage immediately outside the perimeter fence to make 

fence lines less attractive to wild and captive cervids.

4. Consider installing a strand of electric fence along perimeter fences to 

discourage contact between captive and wild cervids.

5. If wild birds are a problem at feeders or waterers consult State wildlife 

agencies to develop deterrent strategies.
Chronic Wasting Disease Program Standards

68

6. Remove dead animals from the landscape as soon as they are discovered. 

Do not form carcass or “dead” piles to dispose of dead animals. The 

carcasses attract scavengers, which can translocate infectious agents. See 

section B of this document for proper disposal methods.

B. Indirect Contact: Contact with potentially contaminated objects or materials

1. Store feed and hay so it is not accessible to wild cervids.

2. Personnel working on the site should have designated boots and outerwear 

that are not worn elsewhere.

3. Delivery vehicles and transport vehicles should be cleaned and 

decontaminated before and after going onto the site. Instructions for 

decontamination can be found below.

4. Producer vehicles such as cars, trucks, transport vehicles, tractors, skid 

loaders, and ATVs should be cleaned and disinfected prior to, and after, use 

on other sites (see recommended procedures in section 2.A. below). A 

pressure washer is useful to remove mud and feces from wheels and 

equipment prior to decontamination.

5. Ideally all veterinary supplies and equipment should be disposable. If that is 

not possible, great care should be taken to try to decontaminate instruments 

between animals and herds. 

6. Equipment (feeders, water troughs, chutes, buckets, antler removal 

equipment, bolus guns, multiple-dose syringes, etc) should not be shared 

between herds.

7. Do not bring cervid carcasses, tissues, or byproducts onto the sites where 

direct or indirect contact with the cervids, or their associated equipment, 

could occur.

2) Decontamination: Principles and Approach

The recommended decontamination procedures outlined below are believed to 

reduce the overall CWD burden on objects and equipment on a site with known 

CWD contamination. Decontamination procedures are directed at items and 

locations within the facility most likely to harbor the agent. Areas where CWDpositive animals have resided will be the most contaminated. These areas should be 

evaluated by:

A. Assessing the facility in detail to document areas of animal congregation or 

particular movement patterns.

B. Characterizing the entire facility in terms of concentration of animals over time. 
Chronic Wasting Disease Program Standards

69

This includes identification of fence lines (past and present), pens, corrals or 

handling facilities, watering and feeding areas (including natural water sources),

points of concentration in a landscape (i.e. sheltered areas, woodlots etc.), 

drainage areas, and calving areas.

C. Identifying where known positive animals resided relative to the areas of animal 

concentration.

3) Recommended Procedures for Decontamination of Premises and Associated 

Equipment

A. Pastures

Small pastures where CWD-positive animals have resided or particular areas ina 

pasture where animals are known to have congregated may be treated as 

follows:

1. If practical, till soil under or do not use area to graze CWD-susceptible 

animals.

2. Organic material (hay, accumulations of manure, etc.) in congregation areas 

should be buried. Congregation areas include animal shelters, feeding 

grounds, and water sources (if applicable).

B. Dry Lot

Where CWD-positive animals have been held should be treated as follows: 

1. Remove organic materials (manure, feed, bedding, and other organic 

material). This material may be buried deeply onsite in areas not accessed by 

farmed or wild animals, incinerated, or digested by alkaline hydrolysis. 

Composting may be used to reduce the volume of organic materials. 

Composted material should be buried deeply, incinerated, or digested by 

alkaline hydrolysis after composting is complete. Composting alone does not 

inactivate prions.

2. In addition, as recommended in Scrapie policy guidance removal of the top 1 

to 2 inches of soil may help to reduce surface contamination. The soil 

removed may be buried deeply or incinerated.

C. Earth Surfaces Inside Structures

1. Remove and dispose of the organic material as described for dry lot.

2. When practical, remove the top 1 to 2 inches of soil to help reduce surface 

contamination. Bury the removed material in areas not accessed by farmed or 

wild cervids.
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D. Non-earth Surfaces

Cement floors, wood, metal, tools, equipment, instruments, grain feeders, hay 

feeders, panels, chutes, working facilities, transport vehicles, skid loaders, and 

ATVs may be treated as follows:

1. Remove all organic material and deeply bury the removed material onsite in 

areas not accessed by farmed or wild cervids.

2. Clean and wash surfaces of items using hot water and detergent to remove 

dirt and debris. A high- pressure washer after initial manual removal of 

organic debris and cleaning surfaces is recommended for thorough 

cleaning of large equipment items.

3. Allow all surfaces, tools, and equipment to dry completely before disinfecting 

using the following suggested methods below for clean dry surfaces:

E. To Clean Dry Surfaces:

1. Apply a solution of 2 percent available chlorine (equivalent to approximately 

20,000 ppm available chlorine at room temperature (at least 18.3° C [65° F]) 

for 1 hour of wet contact time. This can be achieved by mixing 50 ounces [6 

1/4 cups] of household bleach (sodium hypochlorite) with enough water (78 

ounces or 93⁄4 cups) to make 1 gallon of solution. Rinse to remove solution 

after 1 hour. Multiple applications may be required to ensure the 1 hour 

contact time. Due to variations in chlorine bleach concentrations, care must 

be taken to verify that the minimum of 20,000 ppm is achieved.If chlorine 

bleach is not available, a 1 molar or 4 percent sodium hydroxide (5 ounces 

sodium hydroxide dissolved in 1 gallon of water) solution may be used at 

room temperature (at least 18.3° C [65° F]) for at least 1 hour of wet contact 

time. Rinse to remove solution after 1 hour. Multiple applications may be 

required to insure the 1 hour contact time.

2. Synonyms for sodium hydroxide (NaOH) are caustic soda, soda lye, and 

sodium hydrate. Sodium hydroxide is a white, brittle solid that dissolves 

readily in water to form a strong alkaline and caustic solution and is used as 

an alkalinizing agent. Sodium hydroxide is very caustic and in solution is 

extremely corrosive. For environmental reasons, only use this disinfection 

method when the preceding method is not available.

4) Restocking

Generally, restocking with CWD-susceptible species is not recommended. If 

restocking with CWD susceptible species occurs, then additional biosecurity 

practices such as additional fencing or other barriers to minimize CWD exposure 
Chronic Wasting Disease Program Standards

71

should be considered. Cervid herds should immediately enroll in the Approved 

State CWD HCP. All mortalities 12 months of age or older must be reported, 

investigated, and CWD tested.

5) Decontamination Safety Precautions

Professional judgment should be exercised in the choice and use of disinfectants. All 

disinfectants are hazardous to humans, animals, and the environment in varying 

degrees. Label directions should be carefully read and followed. If corrosive 

disinfectants are used directly on metal items, the items must be thoroughly rinsed 

with fresh water to minimize damage.

Disinfectants, especially in concentrated form, may irritate the skin, eyes, and 

respiratory systems. Protective equipment such as coveralls, rubber boots, rubber 

gloves, masks, or respirators as well as eye protection should be worn while mixing 

and applying disinfectants. If areas of the body are exposed directly to a disinfectant, 

they should be washed thoroughly with water. Any employee should notify his or her 

supervisor if excessive human or animal exposure to disinfectants occurs or if there 

is an accidental release into the environment.

6) Required Reporting of Bleach and Lye Use

The EPA requires reporting of bleach and lye use in the environment. To fulfill this 

reporting obligation, APHIS and/or State officials are requested to contact the Cervid 

Health Team to report the amounts of bleach and lye that were used.
Chronic Wasting Disease Program Standards

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Appendix V: Sample Collection

Herd owners are responsible for notifying State representative when animals require 

sampling and for refrigerating the head for sampling.

Instructions for Veterinarians and Certified CWD Sample Collectors

1) Safety Precautions

The collector should take the following safety precautions to minimize exposure to 

pathogens:

A. Wear personal protective equipment (PPE) at all times. (See Section 2 below.)

B. Cover cuts, abrasions, and wounds with waterproof dressing if not covered by 

PPE.

C. Wear gloves while handling specimens and formalin. Optionally, use face and 

respiratory protection, including a well-fitted respiratory mask and face shield or 

goggles to protect from infective droplets or tissue particles.

D. Use 10 percent neutral buffered formalin in a well-ventilated area.

E. Take steps to avoid creating aerosols, splashes, and dusts.

F. Wash hands and exposed skin following collection procedures.

G. Wash and disinfect protective clothing and equipment thoroughly after use. Use 

equal parts bleach and water to make 1 gallon of disinfectant solution; this 

solution needs have a wet contact time of 1 hour to be effective. This may require 

multiple applications. It is best if disposable items are used and then discarded 

after use.

H. If rabies is suspected, do not proceed with any tissue collection. Instead, contact 

the approved laboratory for instructions on submission of the entire head to the 

laboratory for rabies testing. After rabies testing is completed, the laboratory will 

proceed with CWD sampling on rabies-negative brains.

2) Personal Protective Equipment

Personal protective equipment (PPE) is designed to minimize exposure to pathogens 

while collecting samples.

The Occupational Safety and Health Administration defines PPE as “specialized 

clothing or equipment worn by employees for protection against health and safety
Chronic Wasting Disease Program Standards

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hazards.” PPE is designed to protect many parts of the body (i.e., eyes, head, face, 

hands, feet, and ears).

PPE is selected based on the environment, physical hazards, and ability to complete 

the task, and is a balance between protection and comfort and should protect an 

individual from the physical hazards of the collection environment while allowing the 

individual to comfortably collect specimens. The following PPE is recommended for the 

collection of CWD specimens, particularly during post-mortem collections:

A. Skin Protection

Protect your skin from contact with fluids during specimen collection. Wear 

waterproof coveralls, preferably disposable, or coveralls with a waterproof apron 

and forearm protectors.

B. Eye and Face Protection

Protect your eyes and face from any aerosols, splashes, or dusts that may be 

created while collecting specimens. Eye protection includes safety glasses, 

safety goggles, or a face shield.

C. Hand Protection/Gloves

1. Wear metal or mesh gloves. A cut-resistant glove (Hantover, Koch, or 

Packer) on the hand that is not holding the knife is recommended. Find a cutresistant glove that fits against your skin and then wear a rubber glove on top 

of it.

2. Wear latex or nitrile examination gloves or thick rubber gloves on the hand 

holding the knife.

D. Foot Protection

Protect your feet from injuries or exposure, such as spills or splashes, by using 

rubber boots.

E. Respiratory Protection

Face masks or respirators are recommended if the environment includes 

aerosols, splashing, or flying debris as may be encountered with certain methods 

of brain removal or tissue handling. Zoonotic diseases such as rabies and listeria 

may be present in the carcass during CWD collection.

3) Paperwork to be Included with Diagnostic Tissue Submission

Accurately complete the specimen collection form (VS Form 10-4 or electronic 10-4, or 

equivalent submission form). Note: Complete VS Form 10-4 with the approval of the
Chronic Wasting Disease Program Standards

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State official or accredited veterinarian who will in turn obtain the approval of the 

Assistant Director. A link to VS Form 10-4 can be found in in Appendix I.

Suspect and presumptive-positive animals should be submitted on separate VS Form 

10-4s from routine surveillance samples and shipped promptly to allow NVSL to 

prioritize testing these cases.

A. Indicate the reason for submission: Routine herd surveillance, exposed animal, 

suspect herd/animal.

B. Indicate whether the animal was exhibiting clinical signs. If the animal exhibited 

clinical signs, list the signs in the Additional Data Section of the VS Form 10-4 or 

equivalent form.

4) Document the Following:

A. Herd identification, species, breed, and sex of animal.

B. Information from all ID devices, tattoos, and any brands on the animal.

C. Age of animal based on owner records.

5) Make Four Copies of the Completed VS Form 10-4 or Equivalent Form:

A. One for your files (submitter’s copy),

B. One for the animal owner or collection site,

C. One for the VS District Office, and

D. One to be submitted with the specimen.

6) Paperwork to be Included with Blood Samples for Codon 96 Genetic Analysis 

with Ante-mortem Testing of Herds that Contain or Contained CWD-Exposed 

Animals

Blood samples collected with ante-mortem diagnostic assays must be sent to an 

approved genotyping laboratory (see Title 9, Code of Federal Regulations (9 CFR) 

section 54.11 – Approval of laboratories to run official scrapie tests and official genotype 

tests (9 CFR 54.11). Contact the laboratory in advance for submission forms and proper 

tissue collection and shipping protocols.

7) Sample Quality

All samples should be collected and submitted to the lab irrespective of the state of 

autolysis. Approved labs should evaluate the condition of the autolyzed samples to
Chronic Wasting Disease Program Standards

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determine if the samples are of sufficient quality to be reliably tested or if the samples 

should be sent directly to NVSL.

Laboratory diagnosticians will determine the suitability of the samples 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.

8) Sample Labeling

A. Properly label all specimen collection containers. The information on the label 

provides detailed information to the laboratory regarding the specimens. The 

sample number or sample bar code on the container must be the same as on the 

completed VS Form 10-4 (or equivalent form).

B. Clearly label both the top and the sides of the sample container. Identify the 

sample by using a permanent marker, or affixing a bar code label (if available), or 

other printed label.

C. Verify that the sample number that appears on the top and side of the sample 

container is the same as VS Form 10-4.

D. The side label should include the following:

1. Date of collection.

2. Producer name.

3. Species.

4. Type of specimen.

5. Official animal ID number.

6. Sample ID number (number assigned to this sample on the VS Form 10-4 or 

equivalent form).

Correctly package specimens to meet Federal transportation guidelines. For 

Category B (UN3373) packaging and shipping details, contact the receiving 

laboratory, or NVSL.

Ensure that the package containing any fresh tissues for CWD testing will be 

shipped with ice packs for overnight delivery to the laboratory during normal 

business hours.
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9) Tissue Specimens and Preservation

Proper preservation and handling of specimens is critical to ensure accurate CWD test 

results. Specimens are submitted either formalin-fixed or fresh depending on the type 

of diagnostic test being used. It is recommended that samples be submitted for testing 

within 7 days of collection.

A. Formalin-fixed specimens are used for immunohistochemistry (IHC) testing 

and histopathology. Submerge the specimen in 10 percent neutral buffered 

formalin (follow the guideline of 10 parts buffered formalin per 1 part specimen). 

Use a single container for each animal. Do not freeze the formalin-fixed 

specimens.

B. Fresh tissue specimens are used for Western blot, the ELISA assay, and for 

DNA/genetic analysis. Fresh tissue specimens must be kept chilled. Ensure the 

sample container correctly lists all specimens included. Use a single container for 

each animal.

C. Blood samples in EDTA tubes are required for codon 96 genotyping with 

approved antemortem diagnostic testing as described in a herd plan. Blood 

samples must be kept chilled. Ensure each tube is clearly marked with the animal 

ID number.

Ship the chilled tissues overnight on ice packs. If dry ice is used, follow all additional 

shipping regulations associated with using dry ice.

Additional samples may be requested by the State representative or APHIS officials, 

including samples requested for research.

10) Post Mortem Tissue Specimens

The obex and retropharyngeal lymph node should be collected regardless of sample 

condition (e.g. autolyzed, frozen, etc.) and submitted to the approved laboratory to 

comply with the routine herd surveillance requirement. APHIS strongly recommends 

that an eartag with a fresh piece of ear tissue attached be included with each sample 

that is submitted for CWD testing.

Required tissues and preservation methods for post mortem diagnostics can be found in 

the table below.
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Fixed:

10% neutral buffered formalin 

(for histopathology, IHC

testing)

Fresh:

Chilled or Frozen

(for DNA, Western blot, ELISA 

testing)

Tissues to be Submitted Tissues to be Submitted

MRPLN.

Half of each of the left and right 

lymph node

MRPLN*

Half of the left and right nodes

Obex

Obex with 1-2 cm brain stem 

(including the apex of the “V” in 

the obex)

Obex*

Obex with 1-2 cm brain stem

Tonsils

(optional)

Tonsils

(optional)

N/A Skin Sample*

Collect the official ID with a

quarter-sized (aprox 1” x 1”) 

piece of tissue (ear, hide, etc.) 

attached to each device♦. This 

will allow DNA verification and/or 

genotyping if necessary.

*Fresh samples from the same 

animal can be placed into the 

same bag. 

♦

It is critical that consistent documentation and sample security ensure that the samples 

remain appropriately linked to the source animal from the time of sample collection to 

the end of the testing process. 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. If part of the ear cannot be removed (e.g., for taxidermy purposes), then a 

new identification tag could be affixed to the hide skin and recorded in the animal’s 

official record, and the tagged hide section submitted with the diagnostic specimens.

This practice will also allow APHIS to conduct genotype testing associated with 

susceptibility to CWD (e.g., codon 96 testing in white-tailed deer) if the animal tests 

positive.
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11) Ante-mortem Tissue Specimens - White-tailed Deer ONLY

Ante-mortem sampling is done as part of a herd plan for CWD-exposed animals only. 

Required tissues and preservation methods for ante-mortem diagnostics can be found 

in the table below. All ante-mortem tissue and blood samples collected as part of herd 

plans in CWD-positive or exposed herds must be performed or directly monitored by a 

State animal health official (SAHO) or Veterinary Services (VS) representative to verify 

the identity of the animal, the tissues taken for biopsy, and the chain of custody of the 

biopsy and blood samples.

Whole blood collection by a State or Federal veterinarian or a licensed accredited veterinarian is 

required for determining the genetic polymorphism at codon 96 in white- tailed deer. This 

polymorphism has a significant impact on CWD propagation and consequently detection, and is 

used to determine repeat sampling times. Blood samples are to be sent to an approved 

genotyping laboratory and the results reported to the Cervid Health Team.

12) Collection Procedures for Post-Mortem MRPLN

The post-mortem collection of the MRPLNs can be completed using several methods. 

However, these collection procedures describe the preferred methods to prevent 

inadvertent damage to the tissues during collection.

A. The following equipment will help ensure proper specimen collection:

1. Sharp boning knives.

2. Disposable scalpel blades or disposable scalpels (a large scalpel blade is 

acceptable).

Fixed:

10% neutral buffered 

formalin

(for histopathology, 

IHC testing

Fresh:

Chilled or Frozen 

(Avoid repeated 

freeze/thaw; for 

genotyping)

Tissues to be Submitted Tissues to be Submitted

MRPLN Biopsy 

2cm X 1cm X 1cm 

(at least 40 follicles

required)

Blood

3-5 mL of whole blood in 

EDTA tube

Rectal Biopsy

1 cm x 1.5 cm
Chronic Wasting Disease Program Standards

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3. Brown-Adson or rat-tooth forceps.

4. Disposable cutting surfaces such as cardboard, plastic, or Styrofoam.

5. Small hand nippers can be used on the hyoid bones or you may cut through 

at the soft cartilage of the joint using a knife.

6. Sharp stainless steel scissors.

B. MRLPN removal

1. The MRPLNs are medial to the stylohyoid bones on the dorsolateral surface 

of the pharyngeal muscles and dorsal to the carotid artery.

2. With the head positioned upside down, locate the esophagus and trachea in 

relation to the foramen magnum (FM).

3. Lift the trachea and dissect muscles forward of the FM (rostrally). Locate the 

left and right medial retropharyngeal lymph nodes (MRPLN) halfway between 

each corner of the jaw bone and the FM, caudal to the nasopharynx, and 

deep to the salivary gland. Lymph node consistency is much firmer and 

rounder than the surrounding tissue.

4. Remove each left and right medial RPLN and longitudinally incise each LN to 

confirm lymphoid tissue.

For IHC testing: Place the medial RPLNs in the same formalin jar with the 

obex.

For ELISA testing: Place the fresh medial RPLNs in labeled whirl-pak bags 

(do NOT use formalin).

13) Collection Procedures for Ante-Mortem MRPLN

A licensed, accredited, veterinarian must perform the sample collection as described in 

the herd plan. The accredited veterinarian must be monitored by a SAHO or VS 

representative to verify the identity of the animal, the tissues taken for biopsy, and the 

chain of custody of the biopsy and blood samples.

A. Tissue Collection

1. Anesthesia will be administered by a licensed accredited veterinarian or by 

personnel under the direct supervision of a licensed accredited veterinarian.

2. All biopsy collections will be performed using aseptic procedures at the 

surgical site, including surgical gloves, masks, sterile instruments, and other 

aseptic techniques.
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3. Surgical instruments must be sterilized according to prion-specific disinfection 

or be disposed of after each use.

4. Biopsy – a single side or bilateral biopsy – may be performed.

5. With the head positioned upside down, identify the medial retropharyngeal 

lymph node located between the larynx and the floor of the skull. If the lymph 

node is cut through the center an outer layer (the cortex) and an inner layer 

(the medulla) will be visible. The lymph node is about 1-2 cm diameter x 2-3 

cm long.

6. The whole lymph node or a section of the lymph node is surgically removed. 

Typically a biopsy of approximately 2 cm x 1 cm x 1 cm will be large enough

to meet or exceed the required 150 square millimeter of total surface area and 

40 total follicles when the biopsy is sectioned and examined microscopically.

7. The incision is closed with absorbable sutures in a 2-3 layer closure.

8. Place the biopsy in a jar of 10 percent neutral buffered formalin (10:1 ratio of 

formalin to tissue sample).

9. Submit MRPLN biopsies collected from CWD-positive or -exposed herds 

directly to NVSL.

14) Collection Procedures for Post-Mortem Obex (Via Foramen Magnum)

A. The following equipment will help ensure proper specimen collection:

1. Sharp boning knives.

2. Disposable scalpel blades or disposable scalpels (a large scalpel blade is 

acceptable).

3. Brown-Adson or rat-tooth forceps.

4. Meat-cutting bone saw, hacksaw, or electric saw when brain removal is 

required.

5. Disposable cutting surfaces such as cardboard, plastic, or Styrofoam.

6. Small hand nippers can be used or you may cut through at the soft cartilage 

of the joint using a knife.

7. Sharp stainless steel scissors.

8. Brain stem/obex spoon, grapefruit knife, or other brain stem scoop.
Chronic Wasting Disease Program Standards

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B. Obex removal

1. Incise the head of the animal at the atlanto-occipital joint (between skull and 

first vertebra). Cut behind the back of the ears and extend the cut around and 

through the front of the larynx. Sever the brain stem as far to the posterior as 

possible during the removal process.

2. Position the head upside down (ventral side up). Locate the occipital condyles 

and foramen magnum (FM). Locate the brain stem inside the FM. Trim the 

dura mater around the brainstem and cut the attached cranial nerve trunks.

3. Gently lift the brain stem with forceps and insert the spoon into the dorsal

aspect of the FM between the brainstem and dorsal calvarium.

4. Advance the spoon 2-3 inches rostrally until it contacts bone to sever the 

cerebellum.

5. Reposition the spoon in the ventral aspect of the FM between the brainstem 

and the ventral calvarium. Advance the spoon until it contacts bone and 

transversely sever the brain stem.

6. Remove the brain stem using the spoon and forceps. Examine to ensure the 

proper obex sample (bifurcation or “V”) is preserved.

7. Further trim the brain stem section by making a transverse cut 3/4 inch in 

front of the “V” shape bifurcation and an equal distance behind the bifurcation 

for good fixation.

For IHC testing: Place the trimmed obex and brainstem pieces in a jar of 10 

percent neutral buffered formalin (10:1 ratio of formalin to tissue sample).

For ELISA testing: Place the fresh obex sample and trimmed pieces in a conical 

tube (do NOT use formalin). Samples should be placed individually in a labeled 

plastic bag and kept chilled or frozen.

Including official animal identification with a quarter-sized (aprox 1” x 1”) piece of 

tissue (ear, hide, etc.) attached to each device provides verification of sample 

identity and material for DNA analysis, if needed. The owner may observe the 

sampling and labeling procedures to assure his or her sample is properly 

identified.

15) Whole Head Submission

Refrigerated heads may be shipped to an APHIS-approved CWD laboratory. Prior 

notification and approval is required from the laboratory before shipping whole heads. 

Owners must ensure that fresh samples or heads can be refrigerated over weekends 

and holidays prior to shipping. Heads should be double bagged and shipped with ice 
Chronic Wasting Disease Program Standards

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packs overnight. Be sure to properly label shipment as biological specimens as per 

shipper requirements.

Whole heads submitted to a laboratory by the owner must include:

A. The owner’s name, address, and phone number.

B. All animal IDs (official and herd).

C. Age of animal.

D. Sex of animal.

E. Description of any observed clinical signs.

16) Collection Procedures for Ante-Mortem Rectal Biopsy

Collection of rectal biopsies is to be conducted only by trained State, Federal, or 

accredited veterinarians following the recommendations given below to avoid cross 

infection of animals, and to ensure sample quality. The accredited veterinarian must be 

monitored by a SAHO or VS representative to verify the identity of the animal, the 

tissues taken for biopsy, and the chain of custody of the biopsy and blood samples.

CWD can be transmitted between animals through the use of contaminated 

instruments. Gloves and instruments must be changed between each animal. All 

instruments described below should be disposable. After use, instruments should be 

soaked in 1:1 bleach and water solution for 1 hour, then thrown away.

A. The following equipment will help ensure proper sample collection:

1. Nitrile gloves.

2. Disposable toothed Adson forceps.

3. Disposable curved Metzenbaum scissors.

4. Disposable rectal speculum (an extra pair of hands also works).

5. Obstetrical lubricant containing 2 percent lidocaine or 0.5 percent 

proparacaine.

6. Individually labeled tissue cassettes with foam inserts, labeled with pencil, not

marker or pen.

7. Specimen collection containers with 10 percent buffered formalin.

8. Head lamp.
Chronic Wasting Disease Program Standards

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B. Collection of biopsy sample:

1. Animals need to be immobilized safely in a chute or chemically.

2. The rectal speculum is put in place, or the rectum held open.

3. The obstetrical lubricant with lidocaine is inserted approximately 10 cm into 

the rectum.
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4. Five or more seconds after application of lubricant, pull the rectal epithelium 

away from the submucosa with forceps approximately 1 cm anterior to the 

mucocutaneous junction on the lateral wall (fig. 1A, B). Try to avoid sampling 

at 12 (tail) or 6 (feet) o’clock. Quickly snip an 1.5 cm X 1 cm biopsy.

5. Place the biopsy mucosal side down on the one of the foam inserts in the 

tissue cassette, carefully spread the sample out, place the other foam insert 

on top, close the cassette, and drop the cassette into the labeled formalin 

sample container (fig.1C).

6. Rectal biopsy samples collected from CWD-positive or -exposed herds must 

be sent to NVSL.

A.

B.
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C.

Figure 1. Grasping of rectoanal mucosa-associated lymphoid tissue (A.) Collection 

of rectal biopsy (B.) Placement of rectal biopsy in tissue cassette (C.) Photos 

courtesy of Dr. Thomas Gidlewski.

17) Collection Procedures for Blood Sample with Ante-Mortem Testing of Herds 

that Contain or Contained CWD-Exposed Animals

Whole EDTA blood collection is required for determining genetic polymorphisms at 

codon 96 in white-tailed deer together with ante-mortem diagnostic assays. Collection is 

only to be performed by a State or Federal veterinarian or a licensed, accredited 

veterinarian under the supervision of a State or Federal veterinarian. Polymorphism at 

codon 96 has a significant impact on CWD propagation, and consequently detection, 

and is used to determine intervals for sampling times in herds.

A. Collection of blood sample:

1. Animals need to be immobilized safely in a chute or chemically.

2. 3-5 ml of blood is collected into a commercial EDTA blood tube (purple top 

tube), then immediately inverted several times to ensure mixing of EDTA and 

blood.

3. Blood samples should be immediately placed in a cooler with ice or ice packs.

4. Blood samples should be sent overnight with ice or ice packs, with the 

associated sample submission form, to an approved genotyping laboratory.
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Appendix VI: Diagram for Response to a CWDPositive Case

The following diagram may be used to assist in response to a CWD-positive animal. All CWD-exposed 

cervids should be traced forward and back to include the 5 years since the exposure to the CWDpositive animal occurred.
Chronic Wasting Disease Program Standards

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Chronic Wasting Disease Program Standards

88

Appendix VII: Diagram for DNA Comparison Testing and 

Interpretation 

Further action at 

State’s discretion

Proceed with regulatory 

actions

Investigate further to determine source 

of CWD+ animal

Unable to determine 

identity/source of CWD+ 

animal

Determine identity 

and/or source of 

CWD+ animal

Is this the first 

detection of 

CWD in this 

herd?

NO

VS will not 

conduct DNA 

Comparison 

testing. Owner 

may request at 

own expense

Yes 

Was official ID with fresh 

tissue submitted with the 

CWD-positive tissue?

Yes

NVSL forwards tissues 

to laboratory for DNA 

comparison testing at 

APHIS expense

Proceed with 

regulatory 

actions based 

on ID 

provided on 

VS 10-4

Unable to obtain 

valid results 

CWD+ tissue matches 

tissue attached to official ID

CWD+ tissue does not 

match tissue attached to ID

NO
Chronic Wasting Disease Program Standards

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Appendix VIII: Standard Operating Proceedure for 

Chronic Wasting Disease Sample Collection in Meat 

Processing Facilities

1. Background

The Chronic Wasting Disease (CWD) herd certification program requires that all animals sent to slaughter under 

the same ownership are sampled and tested for CWD. Proper sample collection, submission and reporting of 

results ensures the integrity of the testing if animal disease tracing is required. Proper collection also ensures 

compliance with the herd certification program. 

2. Purpose

The purpose of this document is to provide clarification on sampling, submission and reporting procedures for 

cervid CWD samples collected at meat processing facilities. Sample collection, sample shipping, and sample 

testing are the financial responsibility of the herd owner. Adherence to the process described below will improve 

reporting of results thereby reducing carcass retention time at meat processing facilities. This process should 

also provide proper documentation for compliance with the CWD herd certification program.

3. Document Status 

This is a new document

4. Authorities and References

9 Code of Federal Regulations 81.2

NAHLN Laboratories

CWD Program Standards

5. Advance Planning

A. The herd owner should notify the processing facility with the proposed date and number of animals in 

advance. When possible, plan for a Monday or Tuesday processing day.

B. The herd owner must identify and notify the Certified CWD Sample Collector or accredited veterinarian 

in advance.

C. The processing facility management should notify on-site Federal or State food safety inspection 

personnel one week in advance.

D. The Certified CWD Sample Collector or accredited veterinarian must secure and/or order sample 

collection equipment and shipping container at least one week in advance. Collection and shipping 

supplies are not provided by the National Veterinary Services Laboratory (NVSL).

E. The Certified CWD Sample Collector or accredited veterinarian must identify an approved laboratory 

for sample submission. 
Chronic Wasting Disease Program Standards

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F. The lab selected must be approved to conduct the ELISA test. A list of labs approved to conduct the 

CWD ELISA test can be found here:

https://www.aphis.usda.gov/animal_health/nahln/downloads/cwd_lab_list.pdf

G. The Certified CWD Sample Collector or accredited veterinarian must contact the NAHLN lab two 

weeks in advance to confirm test kits will be available on the scheduled sample collection date.

6. Sample collection 

A. The ELISA test will be used for samples collected at slaughter. Required samples to be collected are 

the obex and half of both the left and right medial retropharyngeal lymph node. Samples for ELISA 

testing must be fresh rather than formalin fixed. Use a single sample container for each animal. Place 

the samples in conical tube or suitable container and apply black tape around the lid to prevent 

loosening during shipment. Place the sealed container in a plastic bag – preferably a zip-lock type bag. 

B. A side label, written or affixed, should be applied to each sample container 

 Date of collection.

 Producer name

 Species

 Type of specimen

 Sample number

 Official animal identification (ID) number: collection and recording of official 

 identification is mandatory 

C. Collect all identification devices from the animal and submit with the sample. Collect the official ID with a 

quarter-sized (approximately 1” x 1”) piece of tissue (ear, hide, etc.) attached to each device. Submit 

this tissue fresh rather than formalin fixed. This will allow DNA verification and/or genotyping if 

necessary.

D. Attach an ID device such as a numbered retain tag to the carcass that can be used to correlate to the 

lab report. In many situations, an FSIS gang tag can be applied to the carcass and corresponding tag 

can be listed on the submission form as identification.

7. Laboratory submission form

A. Complete a lab submission form for each producer. Describe clinical findings and history when 

applicable. The following information should be included on the submission form::

1) Ensure email address of submitter

2) Type of test - CWD ELISA test

3) A referral number should be applied as follows:

 (State)(Collector’s initials)(6 digit date of collection) 

 Example OK-BRS-031218

4) If the carcass or meat is being retained by FSIS pending results, enter RETAINED. Include 

email address of submitter. 

8. Sample shipping

A. The submitter must contact the lab on the day of shipment. 
Chronic Wasting Disease Program Standards

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B. Fill void area in the shipping container with paper towel when packing the sample. Include the laboratory 

submission form and ID devices in the shipping container with the sample. Include an ice pack in the 

shipping container to keep the sample cool.

C. Samples should be shipped to NAHLN labs on Monday and Tuesday. This will allow processing of 

samples on Tuesday and Wednesday, respectively.

D. Ship the samples using an overnight courier.

E. Provide the lab with the tracking number from the courier air bill.

F. Inform the lab that animals associated with samples are retained pending results.

9. NAHLN Laboratory reporting

A. The ELISA test will be used for samples collected at slaughter.

B. To reduce retention time by FSIS, NAHLN labs are asked to report results within 2 business days of 

sample receipt.

C. The test results will be reported by the NAHLN lab to the submitter via the email address provided on the 

submission form.

10. Collector/Submitter reporting

The submitter listed on the submission form shall provide a copy of the official results to on-site FSIS personnel 

and plant management immediately upon receipt. It is the responsibility of the submitter to obtain contact 

information for FSIS personnel and plant management.

11. Inquiries

Please direct any inquiries to: 

National Cervid CWD Disease Specialist 

USDA APHIS Veterinary Services 

Sheep, Goat, Cervid, and Equine Health Center 

VS.SP.Cervid.Health@aphis.usda.gov