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Chronic Wasting Disease: A Proposed Program For Captive Elk

Chronic Wasting Disease: A Proposed Program For Captive Elk

June, 2001 by Dr Lynn Creekmore with the USDA/APHIS/VS

Please find attached the latest draft of the proposed CWD program. Over the past few months, each of you has expressed interest in receiving a copy of the latest draft. The proposed program has undergone a last round of review by the National CWD Working Group and the VS study group and some revisions to the draft proposed program have been made.

At this point, the proposed program will be turned over to the APHIS' Regulatory Development Staff. The task of this staff is to shepherd these rules through the legal and administrative channels of formal rule making. The person in charge of the program will be Richard Kelly who works with us here in Fort Collins. While this part of the process continues, we will continue our dialogue about the program design and proposed regulations and will continue to seek input on both the rules and program implementation. However, when the "rule" comes out for formal public comment, we will have to suspend our informal dialogue in favor of all groups' formal comments. We expect that this formal comment period will begin in four to six months. We also expect that the latest version of the proposed regulation and UM&R will be discussed at the USAHA meeting in October. Best regards!

(See attached file: Revised Draft CWD Plan in MS Word June 2001.doc) [See below--BSE Coordinator]

Sincerely,

Lynn Creekmore CWD@aphis.usda.gov Staff Veterinarian

Rob Werge Planning Specialist


1. Introduction

This proposal describes a cooperative Federal-State-Private Sector program to eradicate chronic wasting disease (CWD) from captive elk herds in the United States. Captive elk include farmed or domesticated elk as well as elk held in Zoos or other facilities in which animals are contained within a high fence and not used for research purposes. Chronic wasting disease is a type of transmissible spongiform encephalopathy (TSE), in the same class of diseases as bovine spongiform encephalopathy (BSE) in cattle and scrapie in sheep. As of March 30, 2001, it has been found in free-ranging cervids, including mule deer, elk, and white-tailed deer, in Colorado and Wyoming and mule deer in Nebraska and the Canadian province of Saskatchewan. It also has been found in captive elk herds in Colorado, Montana, Oklahoma, South Dakota, Nebraska, and Saskatchewan as well as in captive white-tailed deer in a facility with positive captive elk in South Dakota.

Jurisdiction over farmed elk, a group included within the definition of captive elk, varies from state to state. In some states the regulatory authority over farmed elk resides with the State agricultural or animal health agency, in some with the State wildlife management agency, and in some the authority is shared between agricultural and wildlife management agencies. Also, complicating the issue is the fact that in some states CWD may exist in free-ranging wildlife which poses a risk to farmed elk while in other states CWD is present in farmed elk herds but not in free-ranging cervids thus creating a risk for wildlife. Cooperation between animal health and wildlife resource agencies is critical in constructively dealing with the occurrence of CWD in either captive or free-ranging cervids.

This proposal is the result of a series of discussions and reviews begun in 1998 with an initial program design put forward by the North American Elk Breeders Association and others. The United States Animal Health Association (USAHA) passed resolutions in 1998 and 1999 endorsing the development of a CWD program. In the latter part of 1999 through 2000, representatives of Veterinary Services of USDAís Animal and Plant Health Inspection Service (APHIS) met with State Departments of Agriculture, State Departments of Wildlife, Federal and State university diagnostic laboratories and research agencies, and producer associations to draft key elements of the program. Producer associations included the North American Elk Breeders Association, the Exotic Wildlife Association, the American Sheep Institute, and the North American Deer Farmers Association.

In October 2000, USAHA endorsed the continued development of an earlier version of this program. Informal comments on that program were received from a number of organizations and individuals through the end of 2000. Existing State CWD programs were reviewed. Following a final meeting of APHIS representatives, the following program proposal is being put forward as the basis for a cooperative national CWD program.

Through these discussions, there has been broad agreement that Federal and State agencies and private organizations must work together to solve the problems posed by CWD in cervids. There is also agreement that the presence of CWD in captive elk is only part of a much larger and complex issue. But even with this narrow focus, the devil is in the details. There are aspects of the present proposal which some regard as an onerous burden upon captive elk owners. There are aspects that others regard as not being aggressive enough in eliminating the disease from captive elk herds.

The document is presented in five parts. The first is this introduction. The second is a series of questions and answers concerning the context, intent and substance of the program. The third is a set of definitions used in the proposed program regulations. The fourth is the proposed regulation that would set out the rules for program implementation. The fifth part contains guidelines of carcass disposal and disinfecting of premises.

Taken as a whole, this proposal represents an attempt to apply the best available and current scientific and diagnostic information to the management practices and economics of elk production units. The science of chronic wasting disease, like that of other TSEs, is rapidly evolving. As new information becomes available, the program will change. The current proposal is designed to have the necessary flexibility to respond to new developments.

2. Components of the Program Logic

1. What is the goal of the program?

The goal of the program is the eradication of chronic wasting disease (CWD) from captive elk herds in the United States. Captive elk herds are those elk that are privately or publicly owned and held for economic or other purposes within a perimeter fence or confined space. This includes cervids which are "farmed," "ranched," "game farmed," or owned by zoos and other public or private captive entities. An exception is made for animals being held for CWD research purposes by State or Federal agencies.

Is the program just for elk or for all cervids?

The program is designed for captive elk (Cervus elaphus) or elk hybrids. Elk are one of a number of species, including mule deer, reindeer, white-tailed deer, sika deer, moose, etc., that are classified as cervidae. Aside from animals in research situations, elk and white-tailed deer are the only captive cervid species in which CWD has been reported. The white-tailed deer diagnosed with CWD were housed on a premises that also held positive farmed elk.

Most State CWD programs cover all captive cervids. Some of those States may wish to apply the programís surveillance methods to all cervids. However the monitoring, reporting, certification, and indemnification aspects of this program apply only to captive elk. Should CWD be reported in other cervid species, this program may be used as a model for them to follow.

The program does not apply to free-ranging cervids under the management of Federal, State or Tribal management authorities. The spread of CWD in free-ranging animals in its endemic area (Colorado, Wyoming and Nebraska) and its appearance elsewhere is a major concern. USDA is working as closely as possible with appropriate State and Federal agencies and USAHA to deal with that aspect of the disease and will continue to support surveillance for CWD in free-ranging cervids across the country and urge that CWD be considered in cervid translocation or reintroduction efforts.

2. How would a national program be implemented?

States would design and implement CWD certification programs for their own captive elk owners. State programs would meet minimum USDA/APHIS criteria to ensure that programs were equivalent to one another. States could make program standards more stringent than those minimum criteria and could make the program mandatory if they chose. USDA/APHIS and the States would collaborate on the implementation of this program with American Indian tribal authorities.

Existing State CWD programs and participating owners would be grandfathered into the Federal program if they meet the minimal requirements. A CWD Program Standard Committee will be established to review existing State programs to determine the worthiness of grandfathering.

USDA/APHIS would assist owners in those States that were unable to establish certification programs.

The Federal government, USDA/APHIS, would allow interstate movement of captive elk only from herds participating in certification programs. Owners would have to participate if they wished to move their elk to another State or if the program was mandatory in their State.

The Federal Government would provide indemnity for depopulation. This could be supplemented by payments from States and industry.

In the event that a CWD positive animal is found, the status of the herd in which it resided would change to ìpositiveî. The herdís future status would depend upon the development and the implementation of a herd plan.

Implementation of the national CWD certification program would begin as Federal funding becomes available.

3. What is the rationale for some of the technical elements in Herd Certification?

(I.A.) Fencing is designed to reduce the risk of transmission from captive elk to free-ranging cervids and from free-ranging cervids to captive elk. Double fencing is strongly recommended in areas where CWD is endemic in free-ranging populations and shall be required when a positive captive herd has been identified.

(I.C.) Federal, State, accredited veterinarians or private individuals may be certified as ìapprovedî sample collectors through completion of a USDA or State training course. ìApprovedî status would require a yearly update and submission of acceptable samples. Sample collection guidelines must be carefully followed. Herd status can be jeopardized by improper or poor sample collection.

(I.D.) Herd inventory is central to surveillance. Software applications have been developed by several States to facilitate the maintenance and cross checking of herd inventories. Annual verification may be integrated with TB and/or brucellosis program requirements.

(I.E.) Producers are encouraged to register and maintain as separate herds those subunits within their current herd that are truly managed independent of one another.

(I.G.) Animal identification will consist of two approved forms of identification; it is recommended that one of the forms of identification be an ear tattoo.

(I.H) Possible environmental contamination due to CWD requires precise geographical definition of premises. GPS information would form the basis of spatial analysis for future premises use or potential for exposure of free-ranging animals should a positive diagnosis occur. (I.K.) Laboratories that are certified for CWD testing by the National Veterinary Services Laboratory in Ames, Iowa will conduct diagnostic testing. A standard protocol for CWD diagnosis has been developed. Stringent quality control standards will be followed.

(I.L.) Sixty months is used as a quarantine period as well as the time frame for conducting trace back/trace forward investigations. Given the lack of definitive scientific data on the potential length of preclinical CWD latency, it is believed this period provides a margin of error for uncovering all possible cases related to a CWD positive diagnosis. 4. What do the different herd designations mean?

Because there is limited knowledge of CWD in captive elk, measures for tracing the transmission of the disease and for eliminating all possible cases must be as comprehensive as possible. Program terminology is designed to cover all of those cases in which a CWD herd plan is required. These include:

Herd status - The relationship of a herd in regard to CWD. This should reflect the number of years of monitoring without evidence of the disease or reflect specific experience with the disease (such as a CWD positive, exposed or suspect herd).

Positive herd - A herd in which a CWD positive animal resided at the time it was diagnosed and which has not been released from quarantine.

Suspect herd - A herd for which laboratory evidence or clinical signs suggest a diagnosis of CWD, but for which laboratory results have been inconclusive or not yet conducted

Exposed herd - A herd in which a CWD positive or exposed animal has resided 60 months prior to the diagnosis of CWD.

Trace-back herd - An exposed herd in which a CWD positive animal resided in any of the 60 months prior to the diagnosis.

Trace-forward herd - An exposed herd that has received exposed animals from a positive herd within 60 months prior to the diagnosis of CWD in the positive herd.

In any of these cases, measures must be specifically tailored to eliminate possible further transmission of the disease.

5. What is a herd plan and what does it contain?

(II.) A herd plan is a document written by Federal, State, and Tribal officials in conjunction with the respective owner and his/her veterinarian. A herd plan is based upon a thorough epidemiological investigation and risk assessment conducted by State/Federal officials. It outlines steps to be taken as a response to identification of a suspect, CWD positive, or exposed herd.

6. What are key elements in herd plans?

(II.A-D.) Herd plans must analyze the risk of continued disease transmission by clinical and subclinical animals and/or by environmental contamination. Herd plans set out specific actions to be followed during the quarantine period to eradicate the disease from the herd. Common factors in herd plans include: Whole herd depopulation Quarantine Identification of levels of possible exposure based upon preexisting management patterns Reproductive control Selective culling of animals Continued surveillance Fencing

Herd plans must also contain a premise plan that outlines cleaning and disinfection procedures and further use of the land due to possible environmental contamination from a CWD positive herd. Given current state of knowledge, repopulating of cervids on the same premises may result in reinfection of a new herd. Research is just beginning on steps to ensure adequate decontamination.

7. Why is herd depopulation the preferred option of a herd plan in the event of a positive diagnosis?

(II.A.) Given CWDís long incubation period, absence of a live animal, pre-clinical test and current state of knowledge on transmission, whole herd depopulation with no restocking on contaminated premises presents the least risk of further spread of the disease once a positive diagnosis has been made. However, alternative approaches may be necessary where depopulation is not possible or other overriding factors make depopulation undesirable or impractical. These may reflect limitations on indemnity funding, the desire to increase surveillance and monitoring, and the need for flexibility in order to encourage initial participation and reporting on the part of owners.

8. How would control of interstate movement work?

(III.A-C) Interstate movement would be controlled through the use of certificates of veterinary inspection and Federal enforcement of their use. A number of states have opted for the control of intrastate movement of captive elk through the use of similar certificates. States are requested to consider such controls for documenting animal movements to create consistency among states and to improve ability to trace animals in the event a CWD positive diagnosis is made.

3. Proposed Definitions for Use in CWD Program Regulations

Term

Animal Animal, CWD exposed

Animal, CWD positive

Animal, CWD negative

Animal, CWD suspect

Captive

Certification

Cervid

Chronic Wasting Disease

Commingling

Enrollment date

Elk

Herd

Herd inventory

Herd plan

Herd status

Herd, CWD positive

Herd, suspect

Herd, exposed

Herd, trace back

Herd, trace forward

Hold order

ID, official

Owner

Premises

Premises plan

Quarantine

Status date

Test, official CWDDefinition Any captive elk An animal that is, or has been in the last five years, part of a CWD positive herd. An animal that has had a diagnosis of CWD confirmed by means of an official CWD test conducted by a laboratory certified by USDA/APHIS.

An animal that has had an official CWD test conducted by a laboratory certified by USDA/APHIS and that test results in a negative classification.

An animal for which laboratory evidence or clinical signs suggest a diagnosis of CWD.

Animals that are privately or publicly maintained or held for economic or other purposes within a perimeter fence or confined space. Animals that are held for research purposes are not included.

A program of surveillance, monitoring and related actions designed to provide a status to captive elk herds relative to chronic wasting disease.

All members of the cervidae family and hybrids including deer, elk, moose, caribou, reindeer, and related species. A transmissible spongiform encephalopathy (TSE) of cervids.

Animals that have direct contact with each other or have less than thirty (30) feet of physical separation or that share management equipment, pasture, or water sources/watershed. Animals are considered to have commingled if they have had such contact within the last five years.

The day, month and year in which an owner's herd is officially enrolled in the CWD certification program by the respective State official.

North American wapiti (Cervus elaphus) or elk X red deer hybrids A group of animals that are (a) under common ownership or supervision and are grouped on one or more parts of any single premises (lot, farm or ranch) or (b) 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. An official list of all of the animals belonging to a herd including verification of the official or approved animal identifications.

A written herd management agreement developed by the herd owner, State and Federal veterinarians, and others and approved by the respective Federal, State, and Tribal officials. A herd plan sets out the steps to be taken to eradicate CWD from a CWD positive, exposed, or suspect herd.

The relationship of a herd in regard to CWD. This should reflect the number of years of monitoring without evidence of the disease or reflect specific experience with the disease (such as a CWD positive, exposed or suspect herd).

A herd in which a CWD positive animal resided at the time it was diagnosed and which has not been released from quarantine.

A herd which laboratory evidence or clinical signs suggest a diagnosis of CWD, but for which laboratory results have been inconclusive or not yet conducted. A herd in which a CWD positive or exposed animal has resided 60 months prior to the diagnosis of CWD.

An exposed herd in which a CWD positive animal resided in any of the 60 months prior to the diagnosis.

An exposed herd that has received exposed animals from a positive herd within 60 months prior to the diagnosis of CWD in the positive herd.

A temporary order issued by a State or Federal official prohibiting movement of animals from a premise.

A form of ID approved by the USDA/APHIS administrator and the State chief animal health official.

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

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

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

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

The day, month and year on which the respective State official approves a change in the status of a herd in regard to CWD.

A CWD test approved by the USDA/APHIS administrator

4. Proposed Program Regulations

I. Herd Certification Program Standards

A. States shall have perimeter fencing requirements adequate to prevent ingress or egress of cervids.

B. Surveillance based on testing of all deaths over 16 months of age is required. This includes surveillance at slaughter and surveillance of animals killed in shooter bull operations. C. Good quality sampling is essential for surveillance. Individuals who have passed a USDA ìapprovedî certification training class will be able to submit samples. Approved laboratories will closely monitor sample quality and State and Federal Officials have the authority to adjust herd status if poor quality samples, particularly samples that are from the wrong portion of the brain, are routinely submitted from a premise.

D. Physical herd inventory with annual verification reconciling animals and identifications with records by an accredited veterinarian or state or federal personnel is required. Inventory is to include a crosscheck of all animal identifications with the herd inventory and specific information on the disposition of all animals not present.

E. If an owner wishes to maintain separate herds, he/she must maintain separate herd inventories, records, working facilities, water sources, equipment, and land use. No commingling of animals may occur. Movement of animals between herds must be recorded as if they were separately owned herds.

F. Mandatory death and sold animal reporting and documentation of all interstate movement of captive elk is required.

G. Each animal should have a minimum of two official/approved unique identifiers.

H. Premise locations must be specifically identified by GPS or detailed description during the first herd inventory. A detailed description of the physical facilities also is required.

I. Herd status will be based on the date of official enrollment in the program. Each year following the date of enrollment the owner adds an additional year to the time under surveillance with no evidence of disease. At the end of five years, the owner obtains ìcertifiedî status. Once the herd has received certified status, slaughter surveillance and surveillance of animals killed in shooter operations will no longer be required, but other requirements of the program will remain in force.

J. Herd additions are allowed from herds with equal or greater time in an equivalent State CWD program with no negative impact on the certification status of the receiving herd. If herd additions are acquired from a herd with a later date of enrollment, the receiving herd reverts to the enrollment date of the sending herd. If a herd participating in the certification program acquires animals from a nonparticipating herd, the receiving herd must start over with a new enrollment date based upon the date of acquisition of the animal.

K. A positive diagnosis is based on post-mortem brain testing at a CWD certified laboratory. A positive diagnosis at one laboratory must be confirmed by the National Veterinary Services Laboratories (NVSL) or a second CWD certified laboratory prior to owner notification.

L. If a positive animal is identified in a herd, the State will impose an immediate quarantine and the herd status is changed to positive. Development and implementation of a herd plan will determine future eligibility to reenroll in the program.

II. Disposition of CWD Positive, Exposed, or Suspect Herds

Herd plans will be developed for any CWD positive, exposed, or suspect herds. These plans will be developed by State and Federal officials in conjunction with the owner and will be subject to approval by the State Official. Such plans contain the following options for positive or trace herds and must be adopted within 60 days of a diagnosis of CWD.

CWD Positive Herds

A. Whole herd depopulation with/without repopulation.

Depopulation of the whole herd with payment of indemnity is the preferred option for this program.

CWD positive animals that are depopulated must be disposed of according to USDA guidelines for CWD carcass disposal.

Herd plans for a CWD positive herd must include a premise plan because of possible environmental contamination. Premise plans would include: cleaning and disinfecting actions, future land use in terms of restocking, maintenance of fencing to limit free-ranging cervid access to the land, and the time period for surveillance before interstate animal movement is allowed if restocking occurs.

B. Quarantine with/without selective culling of animals. Euthanasia, testing and disposal of selected animals; CWD positive animals that are culled must be disposed of according to USDA guidelines for CWD carcass disposal. Monthly herd inspection by State or Federal personnel with removal and CWD testing of any suspect animals Inventory with individual animal identification and annual verification of inventory by State or Federal veterinarians Perimeter fencing adequate to prevent fence line contact with captive and free-ranging cervids Quarantine of herd for 60 months from the last case Herd surveillance (mandatory death reporting and CWD testing of all age animals) will be conducted during the quarantine and will continue for 60 months from the last case.

CWD Exposed Herds

A trace-forward exposed herd is a herd that has received an animal from a CWD positive herd within 60 months prior to the diagnosis of CWD in the positive herd. A trace-back exposed herd is a herd in which a CWD positive animal resided in any of the 60 months prior to diagnosis of CWD in the positive herd.

C. Herd plans for trace-forward exposed herds:

1. Removal and testing of the exposed animal traced to the herd with indemnity a. If the animal is CWD positive, the herd is considered to be positive and an appropriate herd plan is to be developed (see II.A-B.) b. If the animal is negative, herd plan would contain: i. Herd inspection by State or Federal personnel with removal and CWD testing of any suspect animals; disposal of CWD positive animals must follow steps outlined in II.A.2 ii. Herd inventory with individual animal identification and annual verification by accredited, State or Federal veterinarian. iii. Herd surveillance (mandatory death reporting and CWD testing of all age animals) for five years from date of removal of the trace animal from the herd. If exposed animal traced to the herd is not removed, steps II.C.1.b.i-ii. would be followed and a. Herd surveillance (mandatory death reporting and CWD testing of all age animals) for five years. b. Quarantine of herd for five years from date of arrival of the exposed animal traced to the herd. However, if the herd has been participating in surveillance as part of the herd certification program, surveillance done after arrival of the exposed animal may count as time in quarantine at discretion of State Animal Health Official.

Herd Plans for trace-back exposed herds:

1. Monthly herd inspection by State or Federal personnel with removal and CWD testing of any suspect animals; disposal of these animals must follow USDA guidelines for CWD carcass disposal.

Herd inventory with individual animal ID and annual verification by a State or Federal veterinarian. Quarantine of herd for 60 months from the last case traced back to the herd. Length of quarantine may be altered by the State Animal Health Official if epidemiology suggests the herd is not the herd of origin of disease for the positive animal traced-back to the herd. Also, if the herd has been participating in surveillance as part of the herd certification program, surveillance done after arrival of the exposed animal may count as time in quarantine at discretion of State Animal Health Official.

Herd surveillance (mandatory death reporting and CWD testing of all age animals) will be conducted during the quarantine and will continue for 60 months from date the CWD positive animal left herd.

III. Minimum Requirements for Interstate Movement of Captive Elk

A. State of origin must require all suspected or confirmed cases of CWD be reported to the State Animal Health Official.

State of origin must have the authority to quarantine CWD positive or exposed herds and to place a quarantine or hold on suspect herds.

C. Animals will be accepted for movement only if they are from herds participating in the CWD herd certification program and the above response measures for positive and trace herds are being followed in the State of origin.  A free-ranging mule deer in Saskatchewan had a confirmed CWD positive test result in early April 10, 2001. Surveillance for CWD in free-ranging cervids has been conducted in over 30 States to date.  In March 2001, indemnity payments are contingent upon Federal funding of a CWD program on the basis of appropriated and/or emergency funding. Implementation assumes that States, USDA/APHIS, and elk owners and others have reached agreement on the outlines of this or a modified program.  It is anticipated that diagnostic procedures will change as research on CWD proceeds. As of March 2001, the current USDA:APHIS approved test for CWD is immunohistochemical (IHC) staining of the brain stem at the level of the obex.


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