TPWD proposes the repeal of §§65.90 -65.94 and new §§65.90 -65.99 Concerning Chronic Wasting Disease - Movement of Deer Singeltary Comment Submission

TPWD proposes the repeal of §§65.90 -65.94 and new §§65.90 -65.99 Concerning Chronic Wasting Disease - Movement of Deer Singeltary Comment Submission

 

 

News Release Media Contact: TPWD News, news@tpwd.texas.gov, 512-389-8030

 

May 3, 2016

 

TPWD Taking Public Comment on Proposed Deer Movement Rules

 

AUSTIN — The Texas Parks and Wildlife Department (TPWD) is taking public comment on proposed rules that would implement the department’s comprehensive chronic wasting disease (CWD) management plan with respect to the artificial movement of deer under TPWD permits, including Triple T (trap, transfer and transplant), DMP (deer management permit), TTP (trap, transport and process) and deer breeder.

 

Current deer movement rules (proposed for repeal) were intended to function on a temporary basis for the 2015-16 deer season and the period immediately thereafter. As stated in previous rulemakings and numerous press releases, TPWD’s intent was to review the current rules following the hunting season and, based on additional information from ongoing epidemiological investigations, disease surveillance data collected from captive and free ranging deer herds, guidance from the Texas Animal Health Commission (TAHC) and input from stakeholder groups, present proposed changes to the TPW Commission at the May 25-26 commission meeting for possible adoption.

 

To ensure that the concerns and interests of all stakeholders were fully understood and considered, TPWD engaged the Center for Public Policy Dispute Resolution at the University of Texas School of Law to provide facilitation services for the spectrum of interested groups, including landowners and land managers, hunters, veterinarians, wildlife enthusiasts, deer breeders, TAHC and TPWD. The facilitator’s official report is available on TPWD’s website http://tpwd.texas.gov/huntwild/wild/diseases/cwd/ .

 

In addition to the facilitated process, the proposed new rules are also a result of extensive cooperation between TPWD and TAHC to protect susceptible species of exotic and native wildlife from CWD. TAHC is the state agency authorized to manage any disease or agent of transmission for any disease that affects livestock, exotic livestock, domestic or exotic fowl, regardless of whether the disease is communicable, even if the agent of transmission is an animal species that is not subject to the jurisdiction of TAHC.

 

Proposed rules are available for review in the April 22, 2016 issue of the Texas Register http://sos.state.tx.us/texreg/pdf/backview/0422/0422is.pdf and public comment may be made online at http://tpwd.texas.gov/business/feedback/public_comment/ , in writing to TPWD Public Comment/Wildlife, 4200 Smith School Rd., Austin, TX 78744 or in person at the same address during the TPW Commission meeting on May 26 at 9 a.m.

 

2016-05-03

 

http://tpwd.texas.gov/newsmedia/releases/?req=20160503a

 

Greetings TPWD, Director Big Game Mitch Lockwood et al,

 

I would kindly like to comment and submit the following pertaining to the ;

 

TPWD proposes the repeal of §§65.90 -65.94 and new §§65.90 -65.99 Concerning Chronic Wasting Disease - Movement of Deer

 

MY comments follow this ;

 

 CHAPTER 65. WILDLIFE SUBCHAPTER B. DISEASE DETECTION AND RESPONSE DIVISION 2. CHRONIC WASTING DISEASE MOVEMENT OF DEER

 

The Texas Parks and Wildlife Department (the Department, or TPWD) proposes the repeal of §§65.90 -65.94 and new §§65.90 -65.99, concerning Chronic Wasting Disease -Movement of Deer. The rules proposed for repeal were intended to function as interim rules (Interim Deer Breeder Rules) in order to maintain regulatory continuity for the duration of the 2015-2016 deer season and the period immediately thereafter. As stated in previous rulemakings, the department's intent was to review the interim rules and, based on additional information from the ongoing epidemiological investigation, disease surveillance data collected from captive and free-ranging deer herds, guidance from the Texas Animal Health Commission, and input from stakeholder groups, present the results of that review to the Parks and Wildlife Commission (Commission) in the spring of 2016 for possible modifications.

 

To ensure that the concerns and interests of the regulated community were fully understood and considered, the Department engaged the Center for Public Policy Dispute Resolution at the University of Texas School of Law to provide facilitation services for the spectrum of stakeholders (including deer breeders, landowners and land managers, hunters, veterinarians, wildlife enthusiasts, the Texas Animal Health Commission (TAHC), and the Department), the purpose of which was to negotiate and develop a consensus concerning the essential components of eventual regulations to comprehensively address and implement effective chronic wasting disease (CWD) management strategies. The stakeholder group convened three times during February and March at which time apparent consensus was reached. The stakeholders also participated in a final phone conference on March 21. The official report of the facilitator is available on the department's website at http://tpwd.texas.gov/huntwild/wild/diseases/cwd/.

 

At the March 23, 2016, meeting of the Texas Parks and Wildlife Commission (Commission), Department staff briefed the Commission on the process and results of the facilitation and presented a synoptic overview of the substantive regulatory provisions being recommended for proposal by staff to address both the consensus issues that emerged from the facilitation and additional regulatory components necessary to operationalize consensus decisions, as well as other regulatory components deemed necessary but on which there was no consensus.

 

In addition to the facilitated process, the new rules are also a result of extensive cooperation between the department and TAHC to protect susceptible species of exotic and native wildlife from CWD. TAHC is the state agency authorized to manage "any disease or agent of transmission for any disease that affects livestock, exotic livestock, domestic fowl, or exotic fowl, regardless of whether the disease is communicable, even if the agent of transmission is an animal species that is not subject to the juris-diction" of TAHC. Tex. Agric. Code §161.041(b).

 

Regulatory Authority

 

Under Parks and Wildlife Code, Chapter 43, Subchapter E, the department may issue permits authorizing the trapping, trans-porting, and transplanting of game animals and game birds for better wildlife management (popularly referred to as "Triple T" permits). In addition, the department may issue permits au-thorizing the trapping, transporting and processing of surplus white-tailed deer (popularly referred to as TTP permits) and per-mits for the removal of urban white-tailed deer.

 

Under Parks and Wildlife Code, Chapter 43, Subchapter L, the department regulates the possession of captive-raised deer within a facility for breeding purposes and the release of such deer into the wild. A deer breeder permit affords deer breeders certain privileges, such as (among other things) the authority to buy, sell, transfer, lease, and release captive-bred white-tailed and mule deer, subject to the regulations of the Commission and the conditions of the permit. Breeder deer may be purchased, sold, transferred, leased, or received only for purposes of propagation or liberation. There are currently 1,275 permitted deer breeders (operating more than 1,300 deer breeding facilities) in Texas.

 

Under Parks and Wildlife Code, Chapter 43, Subchapters R and R-1, and Deer Management Permit (DMP) regulations for white-tailed deer at 31 TAC Chapter 65, Subchapter D, the department may allow the temporary possession of free-ranging white-tailed or mule deer for propagation within an enclosure on property surrounded by a fence capable of retaining deer. At the current time, there are no rules authorizing DMP activities for mule deer.

 

In addition the department regulations authorize the introduction of a deer from a deer breeding facility into a DMP facility for prop-agation. Deer breeders are permitted under Parks and Wildlife Code, Chapter 43, Subchapter L and 31 TAC Chapter 65, Sub-chapter T.

 

Background Regarding CWD

 

CWD is a fatal neurodegenerative disorder that affects some cervid species, including white-tailed deer, mule deer, elk, red deer, sika, and their hybrids (susceptible species). It is clas-sified as a TSE (transmissible spongiform encephalopathy), a family of diseases that includes scrapie (found in sheep), bovine spongiform encephalopathy (BSE, found in cattle), and variant Creutzfeldt-Jakob Disease (vCJD) in humans. Currently, the only test certified by the U.S. Department of Agriculture (USDA) for CWD must be conducted post-mortem by extracting and test-ing the obex (a structure in the brain) or medial retropharyngeal lymph node, although the department in this rulemaking pro-poses to allow certain ante-mortem tests to be valid.

 

Much remains unknown about CWD. The peculiarities of its transmission (how it is passed from animal to animal), infection rate (the frequency of occurrence through time or other com-parative standard), incubation period (the time from exposure to clinical manifestation), and potential for transmission to other species are still being investigated. There is no scientific evidence to indicate that CWD is transmissible to humans. What is known is that CWD is invariably fatal to cervids, and is transmitted both directly (through deer-to-deer contact) and indirectly (through environmental contamination). Moreover, a high prevalence of the disease correlates with deer population

 

PROPOSED RULES April 22, 2016 41 TexReg 2853

 

decline in at least one free-ranging population, and human dimensions research suggests that hunters will avoid areas of high CWD prevalence. Additionally, the apparent persistence of CWD in contaminated environments represents a significant obstacle to eradication of CWD from either farmed or free-ranging cervid populations. The potential implications of CWD for Texas and its annual, multi-billion dollar ranching, hunting, real estate, tourism, and wildlife management-related economies could be significant, unless it is contained and controlled.

 

Discovery of CWD

 

The department has been concerned for over a decade about the possible emergence of CWD in free-ranging and captive deer populations in Texas. Since 2002, more than 50,000 "not detected" CWD test results have been obtained from free-ranging (i.e., not breeder) deer in Texas, and deer breeders have submitted approximately 20,000 "not detected" test results as well. The intent of the proposed new rules is to reduce the probability of CWD being spread from facilities where it might exist and to increase the probability of detecting and containing CWD if it does exist.

 

On June 30, 2015, the department received confirmation that a two-year-old white-tailed deer held in a deer breeding facility in Medina County ("index facility") had tested positive for CWD. Under the provisions of the Agriculture Code, §161.101(a)(6) CWD is a reportable disease and requires a veterinarian, veterinary diagnostic laboratory, or person having care, custody, or control of an animal to report the existence of CWD to TAHC within 24 hours after diagnosis. Subsequent testing confirmed the presence of CWD in additional white-tailed deer at the index facility. The source of the CWD at the index facility is unknown at this time. Within the last five years, the index facility accepted deer from 30 other Texas deer breeders and transferred 835 deer to 147 separate sites (including 96 deer breeding facilities, 46 release sites, and two DMP facilities in Texas, as well as two destinations in Mexico). The department estimates that more than 728 locations in Texas (including 384 deer breeders) either received deer from the index facility or received deer from a deer breeder who had received deer from the index facility. At least one of those locations, a deer breeding facility in Lavaca County, was also confirmed to have a CWD positive white-tailed deer acquired from the index facility.

 

Heightened testing requirements resulted in additional discoveries. A total of 10 white-tailed breeder deer have now been confirmed positive at four facilities (including the index facility). A total of four CWD positive deer were found in the in the index facility. Three CWD positive deer that originated from the index facility were discovered in the Lavaca County facility. A CWD positive deer was harvested from a Medina County release site and another CWD positive deer was sampled in the associated Uvalde County breeding facility located on the same ranch. While the Uvalde County breeding facility is epidemiologically linked to the index facility, neither positive deer at this location originated from the index facility. More recently, another CWD positive deer was reported in a Medina County deer breeding facility and a free-ranging hunter-harvested mule deer in Hartley County was confirmed to have CWD.

 

Previous CWD Rulemaking

 

The department has engaged in several rulemakings over the years to address the threat posed by CWD. In 2005, the department closed the Texas border to the entry of out-of-state captive white-tailed and mule deer and increased regulatory requirements regarding disease monitoring and record keeping. (The closing of the Texas border to entry of out-of-state captive white-tailed and mule deer was updated, effective in January 2010, to address other disease threats to white-tailed and mule deer (35 TexReg 252).)

 

On July 10, 2012, the department confirmed that two mule deer sampled in the Texas portion of the Hueco Mountains tested positive for CWD. In response, the department and TAHC convened the CWD Task Force, comprised of wildlife-health professionals and cervid producers, to advise the department on the appropriate measures to be taken to protect white-tailed and mule deer in Texas. Based on recommendations from the CWD Task Force, the department adopted new rules in 2013 (37 TexReg 10231) to implement a CWD containment strategy in far West Texas. The rules (31 TAC §§65.80 -65.88), among other things, require deer harvested in a specific geographical area (the Containment Zone), to be presented at check stations to be tested for CWD.

 

In response to the first discovery of CWD in a deer breeding facility in Medina County, the department adopted emergency rules on August 18, 2015 (40 TexReg 5566) to address deer breeding facilities and release sites for breeder deer. The department followed the emergency rulemaking with the "interim" rules that are proposed for repeal as part of this rulemaking, which were published for public comment in the October 2, 2015, issue of the Texas Register, adopted by the Commission on November 5, 2015, and published for adoption in the January 29, 2016, issue of the Texas Register (41 TexReg 815). The department also adopted emergency rules governing DMP and Triple T activities (effective October 5, 2015, published in the October 23, 2015, issue of the Texas Register (40 TexReg 7305, 7307) and followed with interim DMP rules published for public comment in the December 18, 2015, issue of the Texas Register (40 TexReg 9086), adopted by the Commission on January 21, 2016, and published for adoption in the February 19, 2016, issue of the Texas Register (41 TexReg 1250).

 

Consensus Rule Components

 

As mentioned previously, the proposed new rules contain provisions that represent a consensus resulting from facilitation. Early in the facilitation process, representatives of the regulated community stated that two important goals for the regulatory community were that new rules allow live-animal testing and that the new rules allow for the transfer of breeder deer without requiring testing at the release site. At a subsequent facilitation meeting, stakeholders suggested the creation of several regulatory components, the most important of which was the creation of four new subcategories of "TC 1" deer breeding facilities (in the rubric of the interim rules, those facilities representing the least amount of risk of spreading CWD), each with a different testing regime. The proposed TC 1 testing regime would allow ante-mortem testing, and would allow the transfer of breeder deer without requiring CWD testing at the release site. After extended discussion and refinement over the remaining facilitation meetings, all stakeholders agreed that the structure was suitable for attaining the goals of both the regulated community, the other stakeholders, and the department.

 

The major consensus provisions emerging from the facilitation process are:

 

1. TC 1 breeding facility testing plans which require no release site testing for recipients of breeder deer; 41 TexReg 2854 April 22, 2016 Texas Register

 

2. The requirements for TC2 breeding facilities and Class II re-lease sites;

 

3. The requirements for TC 3 breeding facilities and Class III release sites;

 

4. Standards for valid ante-mortem testing;

 

5. Standards for post-mortem testing;

 

6. The definition for "eligible-aged deer" to provide for breeder deer 12 months and older, provided the breeding facility is en-rolled in the TAHC Herd Certification Program;

 

7. The stipulation that breeding facilities and release sites that accept breeder deer assume the lowest facility status of all orig-inating facilities;

 

8. The provisions allowing breeding facilities to maintain MQ authorization or facility status by making up for missed tests;

 

9. The allowance of ante-mortem tests to be submitted in lieu of post-mortem tests;

 

10. Stipulation that failure to test a release site make the site ineligible for future releases;

 

11. Testing requirements for DMP sites;

 

12. Testing requirements for Triple T and TTP permits;

 

13. Testing requirements at Triple T release sites;

 

14. Tagging requirements for Class III release sites; and

 

15. Testing requirements and prohibitions for release sites that failed to comply with the interim rules and release sites that fail to comply with the new rules.

 

Non-consensus Rule Components

 

The stakeholders at the facilitation were unable to reach consen-sus on the following:

 

1. The release of breeder deer to sites not surrounded by a 7-foot high fence; which is a provision of the interim rules and which the department has retained in the proposed new rules.

 

2. Standardized ear tagging requirements were a part of the stakeholder discussions. There was no consensus on this issue nor do the proposed rules prescribe a change to the standard for ear tagging requirements for all breeder deer, with the exception of Class III release sites.

 

Description of the Rules

 

Definitions

 

Proposed new §65.90, concerning Definitions, would set forth the meanings of specialized words and terms in order to elimi-nate ambiguity and enhance compliance and enforcement. Proposed new §65.90(1) would define "accredited testing facil-ity" as "a laboratory approved by the United States Department of Agriculture to test white-tailed deer or mule deer for CWD." The definition is necessary in order to provide a standard for testing facilities.

 

Proposed new §65.90(2) would define "ante-mortem" testing as "a CWD test performed on a live deer." The definition is nec-essary because the proposed new rules allow or require ante-mortem testing in addition to post-mortem testing.

 

Proposed new §65.90(3) would define "breeder deer" as "a white-tailed deer or mule deer possessed under a permit is-sued by the department pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Subchapter T of this chapter." The definition is necessary to establish a shorthand term for a phrase that is used frequently in the proposed new rules but cumbersome to repeat.

 

Proposed new §65.90(4) would define "confirmed" as "a CWD test result of "positive" received from the National Veterinary Service Laboratories (NVSL) of the United States Department of Agriculture." The definition is necessary in order to provide a definitive standard for asserting the presence of CWD in a sample. Samples collected from breeder deer are sent initially to an accredited testing facility, such as the Texas Veterinary Medical Diagnostic Laboratory (TVMDL). A test result of "suspect" is returned when CWD is detected, and a tissue sample is forwarded to the NVSL for confirmation.

 

Proposed new §65.90(5) would define "CWD" as "chronic wasting disease." The definition is necessary to provide an acronym for a term that is used repeatedly in the rules.

 

Proposed new §65.90(6) would define "CWD-positive facility" as "a facility where CWD has been confirmed." The definition is necessary because the proposed new rules contain provisions that are predicated on whether or not CWD has been detected and confirmed in a given deer breeding, DMP, nursing, or other facility authorized to possess white-tailed deer or mule deer.

 

Proposed new §65.90(7) would define "deer breeder" as "a person who holds a valid deer breeder's permit issued pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Sub-chapter T of this chapter." As with several other definitions in the proposed new rules, the definition is necessary to establish a shorthand term for a phrase that is used frequently in the proposed new rules but cumbersome to repeat.

 

Proposed new §65.90(8) would define "deer breeding facility (breeding facility)" as "a facility permitted to hold breeder deer under a permit issued by the department pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Subchapter T of this chapter." As with several other definitions in the proposed new rules, the definition is necessary to establish a shorthand term for a phrase that is used frequently in the proposed new rules but cumbersome to repeat.

 

Proposed new §65.90(9) would define "department (department)" as "Texas Parks and Wildlife Department." The definition is necessary to avoid confusion, since the proposed new rules contain references to another state agency.

 

Proposed new §65.90(10) would define "Deer Management Permit (DMP)" as "a permit issued under the provisions of Parks and Wildlife Code, Subchapter R or R-1 and Subchapter D of this chapter (relating to Deer Management Permit (DMP)) that authorizes the temporary detention of deer for propagation purposes. The proposed new rules would regulate certain aspects of activities conducted under a DMP and a definition is necessary to avoid any confusion as to what is meant by the term.

 

Proposed new §65.90(11) would define "eligible-aged deer" as "if the deer is held in a breeding facility enrolled in the TAHC CWD Herd Certification Program, 12 months of age or older or for any other deer, 16 months of age or older." CWD is difficult to detect in deer younger than 12 months of age. The department's previous CWD testing rules at §65.604(e) of this title provided for testing of mortalities that were 16 months or older. The department is retaining that standard but is also recognizing that the TAHC and USDA use a standard of 12 months.

 

PROPOSED RULES April 22, 2016 41 TexReg 2855

 

Proposed new §65.90(12) would define "eligible mortality" as "an eligible-aged deer that has died." The proposed new rules stipulate CWD testing requirements. As mentioned earlier, CWD is difficult to detect in younger animals; therefore, the proposed new rules would require that all deer tested be of eligible age.

 

Proposed new §65.90(13) would define "exposed deer." This definition would replace the former definition for "Tier 1," which proved to be easily confused with other terms such as "TC 1." The definition would provide that "unless the department determines through an epidemiological investigation that a specific breeder deer has not been exposed to CWD, an exposed deer is a white-tailed deer or mule deer that is in a CWD-positive facility or was in a CWD-positive facility within the five years preceding the confirmation of CWD in that facility." The definition is necessary to distinguish the circumstances under which certain provisions of the proposed new rules are applicable. The five-year timeframe was selected because a deer infected with CWD could shed prions (the infectious agent believed to cause CWD) and infect other animals during this period before exhibiting clinical symptoms of the disease. However, if an epidemiological investigation concludes that any part of the five-year window is unnecessary, the status of "exposed" could be altered.

 

Proposed new §65.90(14) would define "facility" as "any location required to be registered in TWIMS under a deer breeder permit, Triple T permit, or DMP, including release sites and/or trap sites." The definition is necessary to provide a shorthand term for the locations to which the proposed new rules apply, rather than having to enumerate a cumbersome list of sites.

 

Proposed new §65.90(15) would define "hunter-harvested deer" as "a deer required to be tagged under the provisions of Sub-chapter A of this chapter (relating to Statewide Hunting Proclamation)." The definition is necessary because the proposed rules in some instances require deer harvested by hunters (as opposed to other types of mortality) to be tested for CWD.

 

Proposed new §65.90(16) would define "hunting year." Because the proposed new rules would stipulate the testing of deer harvested by lawful hunting it is necessary to create a term that covers hunting under the normal seasons and bag limits established for each county by the Commission and hunting that occurs during the period of validity of Managed Lands Deer Permits; therefore, "hunting year" would be defined as "that period of time between September 1 and August 31 of any year when it is lawful to hunt deer under the provisions of Subchapter A of this chapter (relating to Statewide Hunting Proclamation)."

 

Proposed new §65.90(17) would define "landowner (owner)" as "any person who has an ownership interest in a tract of land, and includes a landowner's authorized agent." The definition is necessary because the proposed new rules set forth testing requirements and other obligations for persons who own land where breeder deer are released.

 

Proposed new §65.90(18) would define "landowner's authorized agent" as "a person designated by a landowner to act on the landowner's behalf." The definition is necessary for the same reason set forth in the discussion of proposed new §65.90(17).

 

Proposed new §65.90(19) would define "liberated deer" as "a free-ranging deer that bears evidence of a tattoo (including partial or illegible tattooing) or of having been eartagged at any time (holes, rips, notches, etc. in the ear tissue)." The definition is necessary because the proposed new rules would in certain circumstances require the testing of hunter-harvested deer that could be identified as breeder deer that had been liberated.

 

Proposed new §65.90(20) would define "Movement Qualified (MQ)." Because the proposed new rules require deer breeding facilities to maintain a minimum level of testing over specified time period in order to be authorized by the department to transfer breeder deer to other deer breeders or for purposes of release, it is necessary to create a shorthand term to reference that ability. Therefore, "Movement Qualified (MQ)" would be defined as "a designation made by the department pursuant to this division that allows a deer breeder to lawfully transfer breeder deer."

 

Proposed new §65.90(21) would define "Not Movement Qualified (NMQ)" as "a designation made by the department pursuant to this division that prohibits the transfer of deer by a deer breeder." Because the proposed new rules would prohibit the movement of deer from any facility that is not MQ, a definition for that condition is necessary.

 

Proposed new §65.90(22) would define "NUES tag" as "an ear tag approved by the United States Department of Agriculture for use in the National Uniform Eartagging System (NUES)." The definition is necessary because the proposed new rules require certain breeder deer and Triple T deer released to a release site to be tagged with either a RFID or NUES tag.

 

Proposed new §65.90(23) would define "originating facility" as "any facility from which deer have been transported, transferred, or released, as provided in this division or as determined by an investigation of the department, including for breeder deer, the source facility identified on a transfer permit and for deer being moved under a Triple T permit, the trap site.

 

Proposed new §65.90(24) would define "post-mortem test" as "a CWD test performed on a dead deer," which is necessary in order to delineate the situations in which the proposed new rules require post-mortem testing as opposed to ante-mortem testing.

 

Proposed new §65.90(25) would define "properly executed." Because the proposed new rules would require the submission of electronic reports and forms that provide critical information to the department, it is necessary to make clear that all information on such a form or report must be provided. Therefore, the proposed new rules would define "properly executed" as "a form or report required by this division on which all required information has been entered." Proposed new §65.90(26) would define "reconciled herd" as "the deer held in a breeding facility for which the department has determined that the deer breeder has accurately reported every birth, mortality, and transfer of deer in the previous reporting year." The definition is necessary because the proposed rules require a deer breeder to have a reconciled herd in order to transfer or release breeder deer.

 

Proposed new §65.90(27) would define "release site" as "a specific tract of land that has been approved by the department for the release of deer under this division." The definition is necessary because the proposed new rules impose CWD testing and other requirements for certain tracts of land where breeder deer are liberated or transferred.

 

Proposed new §65.90(28) would define "reporting year" as "the period of time from April 1 of one calendar year to March 31 of the next calendar year." Deer breeders are required to file annual reports with the department. The proposed new rules condition the eligibility of deer breeders to transfer and release deer on the completeness and accuracy of those reports.

 

41 TexReg 2856 April 22, 2016 Texas Register

 

Proposed new §65.90(29) would define "RFID tag" as "a button-type ear tag conforming to the 840 standards of the United States Department of Agriculture's Animal Identification Number system." The definition is necessary because the proposed new rules require certain breeder deer and Triple T deer released to release sites to be tagged with either an RFID or NUES tag.

 

Proposed new §65.90(30) would define "status" as "the level of testing required by this division for any given deer breeding facility or release site." The definition also clarifies that the highest status for a Transfer Category is 1 and the lowest status is Transfer Category 3. Similarly, Class I is the highest status for release sites and Class III is the lowest. As noted previously, the proposed new rules categorize breeding facilities and release sites based on relative risk. The definition is necessary because the proposed new rules include regulatory requirements that are predicated upon the status of a breeding facility or release site.

 

Proposed new §65.90(31) would define "submit." In order to eliminate lengthy repetition throughout the proposed new rules, "submit" is defined as "when used in the context of test results, provided to the department, either directly from a deer breeder or via an accredited testing laboratory."

 

Proposed new §65.90(32) would define "suspect." The testing process for determining that a deer is in fact infected with CWD is two-fold. If the initial test on a sample indicates the presence of the disease, the sample or another sample from the same animal is re-tested. Because the proposed new rules would make any facility NMQ pending confirmation (i.e., the re-test), it is necessary to create a term for the initial test result that causes the re-test. Therefore, "suspect" would be defined as "an initial CWD test result of "detected" that has not been confirmed."

 

Proposed new §65.90(33) would define "TAHC" as "Texas Animal Health Commission."

 

Proposed new §65.90(34) would define "TAHC CWD Herd Certification Program" as "the disease-testing and herd management requirements set forth in 4 TAC §40.3 (relating to Herd Status Plans for Cervidae)." The proposed new rules have provisions specific to deer breeders who participated in the TAHC herd certification program. The definition makes it clear that references to herd certification are references to the herd certification program administered by TAHC.

 

Proposed new §65.90(35) would define "TAHC Herd Plan" as "a set of requirements for disease testing and management developed by TAHC for a specific facility." The proposed new rules in some cases make eligibility to transfer or receive breeder deer contingent on compliance with a herd plan developed by TAHC. The definition makes it clear that references to herd plans are references to herd plans developed by TAHC.

 

Proposed new §65.90(36) would define "Test, Test Result(s), or Test Requirement" as "a CWD test, CWD test result or CWD test requirement as provided in this division," for the same reasons described in the explanation of the definition for "submit."

 

Proposed new §65.90(37) would define "trap site" as "a specific tract of land approved by the department for the trapping of deer under this chapter and Parks and Wildlife Code, Chapter 43, Subchapters E, L, R, and R-1," which is necessary because the proposed new rules would impose testing and reporting requirements on trap sites under various permits.

 

Proposed new §65.90(38) would define "Triple T permit." Because the proposed new rules would affect certain activities conducted under Triple T permits, the term is defined in order to eliminate any confusion. A Triple T permit is "a permit issued under the provisions of Parks and Wildlife Code, Chapter 43, Subchapter E, and Subchapter C of this chapter (relating to Permits for Trapping, Transporting, and Transplanting Game Animals and Game Birds)." In the context of the proposed new rules, a reference to Triple T permit is limited to a Triple T permit for activities involving white-tailed and mule deer.

 

Proposed new §65.90(39) would define "Trap, Transport and Process (TTP) permit"-as "a permit issued under the provisions of Parks and Wildlife Code, Chapter 43, Subchapter E, and Sub-chapter C of this chapter (relating to Permits for Trapping, Transporting, and Transplanting Game Animals and Game Birds), to trap, transport, and process surplus white-tailed deer (TTP permit)." The proposed definition is necessary to clarify and distinguish TTP and Triple T permit requirements.

 

Proposed new §65.90(40) would define "TWIMS" as "the department's Texas Wildlife Information Management Services (TWIMS) online application." TWIMS is the system that all deer breeders are required to use to file required notifications and reports required by current rule.

 

General Provisions

 

Proposed new §65.91, concerning General Provisions, would set forth a number of provisions that are applicable to the transfer or release of deer.

 

Proposed new §65.91(a) would stipulate that in the event that a provision of the proposed new rules conflicts with any other provision of 31 TAC Chapter 65, the new rules (if adopted) would apply. In order to avoid confusion resulting from a conflict between regulations, the proposed new rules with the agency's existing rules governing white-tailed deer and mule deer. Therefore, the proposed new rules would clarify that the proposed new rules govern in the event of conflict.

 

Proposed new §65.91(b) would prohibit the transfer of live breeder deer or deer trapped under a Triple T permit, TTP permit or DMP for any purpose except as provided by the proposed new rules. Because deer breeders, landowners, and wildlife managers frequently transfer deer under various permits, it is necessary in light of the emergence of CWD in Texas deer breeding facilities as well as in free-ranging deer to prohibit the movement of breeder deer except as authorized by the proposed rules.

 

Proposed new §65.91(c) would prohibit the movement of deer to or from any facility where CWD has been detected, beginning with the notification that a "suspect" test result has been received from an accredited testing laboratory, irrespective of how the sample was obtained or who collected the sample and would stipulate that such prohibition would take effect immediately upon the notification of a CWD "suspect" test result and continue in effect until the department expressly authorizes the resumption of permitted activities at that facility. The proposed new provision is necessary because CWD is an infectious disease, which makes it necessary to prohibit certain activities in order to contain the potential spread of the disease while test results are confirmed.

 

Proposed new §65.91(d) would provide that a facility (including a facility permitted after the effective date of this division) that receives breeder deer from an originating facility of lower status automatically assumes the status associated with the originating facility and becomes subject to the testing and release requirements of the division at that status for a minimum of two years, if

 

PROPOSED RULES April 22, 2016 41 TexReg 2857

 

the facility is a breeding facility, or for the period specified for release sites in §65.95(c)(1)(D) of this title (relating to Movement of Breeder Deer). The proposed new rules create a tiered system of testing requirements based on the level of risk of transmission of CWD for each deer breeding facility or release site. The level of risk is based on the degree to which the facility has been monitored for the presence of CWD, or contains or is connected to exposed animals. Epidemiological science dictates that a population receiving individuals from a higher risk population is itself at greater risk; therefore, the proposed new rules would address such transfers from higher risk to lower risk populations by requiring the receiving facility or release site to comply with the testing requirements associated with the originating facility, and would stipulate a duration for the application of continued testing requirements.

 

Proposed new §65.91(e) would provide that a deer breeding facility that was initially permitted after March 31, 2016, will assume the lowest status among all originating facilities from which deer are received. The proposed new subsection is necessary for the same reasons addressed in the discussion of proposed new §65.91(d).

 

Proposed new §65.91(f) would provide that the designation ofstatus by the department in and of itself does not authorize thetransfer or movement of deer and prohibit any person from re-moving or causing the removal of deer from a facility that hasbeen designated NMQ by the department. The provision is nec-essary because a breeding facility of any status can be desig-nated NMQ. Proposed new §65.91(g) would require all applications, notifica-tions, and requests for change in status required by this divi-sion shall be submitted electronically via TWIMS or by anothermethod expressly authorized by the department. To providegreater regulatory efficiency, it is necessary to require the use of an automated system.

 

Proposed new §65.91(h) would provide that in the event that technical or other circumstances prevent the development or implementation of automated methods for collecting and submitting the data required by this division via TWIMS, the department may prescribe alternative methods for collecting and submitting the data required by this division, which is necessary to provide for continuity of administration in the event of technical disruptions.

 

CWD Testing

 

Proposed new §65.92, concerning CWD Testing, would establish the general provisions regarding the collection and submission of CWD test samples.

 

Proposed new §65.92(a) would require all CWD test samples at the time of submission for testing to be accompanied by a properly executed, department-prescribed form provided for that purpose. The technical response being developed by the department would provide for the accredited laboratories that perform CWD testing notify the department of test results electronically. Requiring persons who submit test samples to those laboratories to use a department-supplied form that contains data fields that can be entered by the laboratory, the process of notification and the sharing of records is enhanced by eliminating the need for manual data entry by the department after the test results have been received.

 

Proposed new §65.92(b) would set forth the requirements for valid ante-mortem testing, including the identification of the specific tissues that may be used, the requirement that tissue samples be collected by a licensed veterinarian, that the testing be done by an accredited laboratory, that samples be submitted within six months of submission from a live deer that is at least 16 months of age, has been in the facility for at least 16 months; and has not been the source of a "not detected" ante-mortem test result submitted within the previous 36 months. Under the Texas Veterinary Practices Act (Occupations Code, Chapter 801) only a licensed veterinarian is authorized to perform the procedures that the proposed new rules would allow for purposes of meeting ante-mortem testing requirements. Additionally, in order to be minimally accurate and epidemiologically valuable, tissue samples must be extracted from deer older than 16 months of age that have been in one environment long enough to be expected to have contracted CWD if it were present (which also allows epidemiologists to determine where the disease was acquired). Finally, the most significant epidemiological distinction between ante-mortem testing and post-mortem testing is that the testing of animals that have died provides a much higher likelihood of detecting the presence of disease, since diseased animals are more likely to die than healthy animals. In order to prevent the repeated use of tissues from an animal that has produced "not detected" results in the recent past, it is necessary to stipulate a minimum frequency that an animal may be used to provide tissue samples. The department has chosen the 36-month interval because it is approximately half the amount of the known maximum incubation period for CWD (five years). It should also be noted that although ante-mortem testing has not yet been acknowledged as an official test protocol by the USDA, the submission of a "suspect" ante-mortem test would cause the subject animal to be euthanized and subjected to post-mortem testing for confirmation.

 

Proposed new §65.92(c) would stipulate that ante-mortem tests submitted by a deer breeder for purposes of attaining a higher status would have to be collected and submitted between October 15 of one year and March 15 of the following year. This time period was chosen because it encompasses the time period when breeder deer are most likely to be handled by deer breeders for other reasons (affording the opportunity to take tissue samples at convenient times) and because it is necessary for the department to impose a "window" for logistical and administrative purposes.

 

Proposed new §65.92(d) would set forth the requirements for post-mortem testing, stipulating that a post-mortem CWD test is not valid unless it is performed by an accredited testing laboratory on the obex of an eligible mortality, which may be collected only by a qualified licensed veterinarian or other person certified by TAHC to perform that procedure. The provision also would stipulate that a medial retropharyngeal lymph node collected from the eligible mortality by an qualified licensed veterinarian or other person approved by the department could be submitted to an accredited testing facility for testing in addition to or in lieu of the obex (if the obex cannot be obtained) of the eligible mortality. Obviously, the department's efforts to detect and contain CWD depend on the quality of the testing itself. At the current time, USDA will not certify herd plans for cervidae unless post-mortem CWD testing is performed by laboratories that have been approved by USDA. The standard for approval is compliance with 9 CFR §55.8, which sets forth the specific tests, methodology, and procedure for conducting post-mortem CWD tests. Therefore, in order to ensure that post-mortem CWD tests are performed in accordance with uniform standards, the proposed new rules would require all CWD tests to be performed by

 

41 TexReg 2858 April 22, 2016 Texas Register

 

a laboratory approved by USDA. Additionally, the proposed new subsection would specify which tissues must be submitted and who is authorized to collect those tissues. At the current time, the only CWD testing approved by USDA must be performed on certain tissues from eligible mortalities, such as the obex (a structure in the brain) or certain lymph nodes. Laypersons can be trained to remove an obex, but the successful extraction of appropriate lymph nodes requires an experienced veterinarian, technician, or biologist. Therefore, the proposed new subsection also stipulates that to be valid, a CWD test must be performed on an obex, which can be collected by anyone. If a lymph node is to be tested in addition to the obex, it must be a medial retropha-ryngeal lymph node collected from the eligible mortality by an accredited veterinarian or other person approved by the depart-ment.

 

Proposed new §65.92(e) would allow ante-mortem tests to be substituted for required post-mortem tests at a ratio of 2:1, pro-vided at least two eligible mortalities have occurred in the facility in the corresponding report year; and the number of "not de- tected" post-mortem test results is equal to at least 50 percent of the total test results required have been submitted. The department acknowledges that natural mortality is unpredictable and that therefore there will be time periods when test results for a sufficient number of mortalities cannot be submitted; therefore, the proposed new rule allows limited substitution of ante-mortem tests for post-mortem tests. For reasons discussed earlier, test results from natural mortalities have a higher epidemiological value than ante-mortem tests and the department believes that ante-mortem testing should not replace more than half of the total required post-mortem testing.

 

Proposed new §65.92(f) would prohibit the use of a single antemortem test result more than once to satisfy any testing requirement of the division. From an epidemiological perspective, the use of one test result to satisfy more than one testing requirement (especially if the submissions take place in more than one reporting year) creates a weakness because the test result is then not unique.

 

Proposed new §65.92(g) would stipulate that the testing requirements of the division cannot be altered by the sale or subdivision of a property to a related party if the purpose of the sale or subdivision is to avoid the requirements of this division. The department believes that a person subject to the provisions of the proposed new rules should not be able to avoid compliance simply by selling, donating, or trading property to another person related to the seller.

 

Proposed new §65.92(h) would provide that the owner of a release site agrees, by consenting to the release of breeder deer on the release site, to submit all required CWD test results to the department as soon as possible but not later than May 1 of each year for as long as CWD testing is required at the release site under the provisions of this division. The proposed new rules contemplate a disease management strategy predicated on the results of CWD testing. Incomplete, inadequate, or tardy reporting of test results confound that strategy. For this reason, the proposed new rule would establish a date certain for reporting test results to the department.

 

Harvest Log

 

Proposed new §65.93, concerning Harvest Log, would set forth the elements and requirements for on-site harvest documentation. The proposed new rules require a harvest log to be maintained on Class II and Class III release sites and Triple T release sites. For each deer harvested from a Class II or Class III release site for which a harvest log is required, the proposed new rules would require the hunter's name and hunting license number (or driver's license number, if the daily harvest log is also being used as a cold storage/processing book) to be entered into the harvest log, along with the date of kill, type of deer killed, any alphanumeric identifier tattooed on the deer, the tag number of any RFID or NUES tag affixed to the deer; and any other identifier and identifying number on the deer. The proposed new provision would enable the department to identify all deer harvested at a given release site (including deer that were released breeder deer) if an epidemiological investigation becomes necessary. The proposed new paragraph also would require the daily harvest log to be presented to any department employee acting within the scope of official duties and for the contents of the daily harvest log to be reported to the department via TWIMS by no later than April 1 of each year, and would also provide for the format and retention of the harvest.

 

Breeding Facility Minimum Movement Qualification

 

Proposed new §65.94, concerning Breeding Facility Minimum Movement Qualification, would set forth the testing requirements necessary for a breeding facility to be able to transfer deer to other deer breeders or for purposes of release. The proposed new provision would cause any breeding facility to be NMQ (prohibited from transferring breeder deer anywhere for any purpose) if the breeding facility was not in compliance with MQ requirements in effect prior to the new rules, if the breeding facility is not in compliance with the testing requirements of the new rules as of their effective date and moving forward, if the facility is prohibited from transferring deer by order of TAHC, if the facility does not have a reconciled herd inventory, or if the facility was not in compliance with reporting and recordkeeping requirements. Among the requirements for achieving the movement qualification standard in proposed new §65.94(a) is a requirement to submit CWD "not detected" test results for at least 50% of eligible mortalities occurring in the facility during each reporting year beginning April 1, 2016. However, the department recognizes that if a breeding facility has unusually low eligible mortalities, this provision would result in the submission of very few test results. Therefore a provision is included to require that beginning April 1, 2021, the number of "not detected" test results submitted during the previous five consecutive years must be equal to or greater than the sum of the eligible-aged population in the breeding facility at the end of each of the previous five consecutive reporting years, plus the sum of the eligible mortalities that occurred within the breeding facility for each of the previous five consecutive reporting years, multiplied by 2.25 percent. This provision is intended to provide a minimum number of tests that must be submitted in a five-year period. To develop this number, the department considered that the average natural mortality in a deer breeding facility is 4.5 percent of the eligible-aged deer population in the breeding facility each year. Therefore, if a deer breeding facility with an average natural mortality rate among eligible-aged deer and tested 50% of those mortalities, the breeding facility would test 2.25 percent (i.e., 50% of 4.5%) of the eligible-aged population each year. In order to calculate this number over a five-year period, the eligible-aged population of the breeding facility (the eligible-aged population of the breeding facility plus eligible-aged mortalities) for each of the previous five years is added together. That number is multiplied by 2.25 percent. The resulting number is 50 percent of the average eligible-aged mortality for a deer breeding facility over a five-year period.

 

PROPOSED RULES April 22, 2016 41 TexReg 2859

 

Proposed new §65.94(b) would provide that a breeding facility that has been designated as NMQ for failure to comply with testing requirements would be restored to MQ when sufficient "not detected" test results are submitted. The department has determined that once a breeding facility is compliant with applicable testing requirements, MQ authority should be restored, so long as the other requirements being MQ are met.

 

Proposed new §65.94(c) would require a facility designated NMQ to report all mortalities within the facility to the department immediately upon discovery. From an epidemiological perspective, once a breeding facility cannot provide the minimum assurance that adequate disease surveillance is being maintained, there is an increased risk that if CWD is present it could be spread. Therefore, the proposed new rule requires noncompliant facilities to report all mortalities immediately, rather than at the end of the reporting year.

 

Proposed new §65.94(d) would require that immediately upon the notification that a facility has received a "suspect" test result, all facilities that received deer from or provided deer to the suspect facility within the previous five years would be designated NMQ until a determination that the facility is not epidemiologically linked to the suspect deer or upon further testing the "suspect" deer is determined not to be positive. The proposed new rules are intended to detect CWD if it is present and prevent the spread of CWD once it is detected; therefore, the department has determined that it is prudent, once a "suspect" test result has been returned, to stop all movement to and from all connected facilities until the "suspect" test is either confirmed or determined to be non-positive.

 

Movement of Breeder Deer

 

Proposed new §65.95, concerning Movement of Deer, would establish the various status levels and attendant testing requirements for breeding facilities and release sites.

 

Proposed new §65.95(a) would allow a TC 1 or TC 2 breeding facility designated MQ and in compliance with the applicable provisions of the divisions to transfer breeder deer under existing rules to another breeding facility, an approved release site, a DMP facility, or to another person for nursing purposes.

 

Proposed new §65.95(b) would establish three categories of breeder facilities based on level of epidemiological risk. The TC 1 category represents the lowest risk of transmitting CWD, based on the provenance of the deer within the facility and the testing regimen performed at the facility on annual and five-year time periods. The proposed new rule would establish TC 1 status for breeding facilities that have "fifth-year" or "certified" status in the TAHC CWD Herd Certification Program. The proposed new rule would also establish TC 1 status for breeding facilities that have submitted "not detected" post-mortem test results equivalent to one the following testing regimes (discussed in greater detail later in this preamble: 1) results equivalent to at least 80 percent of the total number of eligible mortalities that occurred in the breeding facility in each reporting year of the immediately preceding five-year period and each year thereafter, as well as a five-year record of minimum post-mortem testing based on the facility population; 2) ante-mortem tests of at least 80 percent of eligible-aged deer in the facility's inventory at the time the testing is conducted and post-mortem tests of at least 80 percent of all eligible mortalities during each reporting year thereafter, as well as a five-year record of minimum post-mortem testing based on the facility population; or 3) annual ante-mortem tests of at least 25 percent of eligible-aged deer in the facility's inventory at the time the testing is conducted and annual post-mortem tests of at least 50 percent of eligible mortalities. These categories were developed during the facilitation effort discussed earlier in this preamble. The department is confident that the testing requirements provide an increased potential to detect and contain CWD compared to the interim rules.

 

Among the options provided in proposed new §65.95(b) for obtaining TC 1 status is an option to test at least 80 percent of the total number of eligible mortalities that occurred in the breeding facility in each reporting year of the immediately preceding five-year period and each year thereafter. Another option is to conduct ante-mortem tests of at least 80 percent of eligible-aged deer in the facility's inventory at the time the testing is conducted and post-mortem tests of at least 80 percent of all eligible mortalities during each reporting year thereafter. For both of those options, the department recognizes that if a breeding facility has an unusually low number of eligible mortalities, the requirement to submit post-mortem tests for 80 percent of all eligible mortalities during year could result in a lower number of post-mortem tests. Therefore, both provisions contain a minimum number of post-mortem tests to be submitted over a five-year period. That number is calculated as the sum of the eligible-aged population in the breeding facility at the end of each of five consecutive reporting years, plus the sum of the eligible mortalities that have occurred within the breeding facility for each of the five consecutive years, multiplied by 3.6 percent. To develop this number, the department considered that the average natural mortality in a deer breeding facility is 4.5 percent of the eligible-aged deer population in the breeding facility each year. Therefore, if a deer breeding facility with an average number of natural mortalities among eligible-aged deer and tested 80% of those mortalities, the breeding facility would test 3.6 percent (i.e., 80% of 4.5%) of the eligible-aged population each year. In order to calculate this number over a five-year period, the eligible-aged population of the breeding facility (the eligible-aged population of the breeding facility plus eligible-aged mortalities) for each of the previous five years is added together. That number is multiplied by 3.6 percent. The resulting number is 80 percent of the average eligible-aged mortality for a deer breeding facility over a five-year period.

 

Proposed new §65.95(b) also would stipulate consequences for breeding facilities that have failed to comply with the testing requirements for TC 1 breeding facilities, providing for reduction in status to TC 2, provisions for re-attaining TC 1 status if testing compliance is achieved within 60 days of being reduced in status, the stipulation of a minimum time period of two years at TC 2 status if TC 1 status is not re-attained within 60 days, and a provision for ineligibility to regain TC 1 status if breeder deer from a lower status facility are accepted during the 60-day re-attainment period. The department believes that failure to comply with testing requirements is problematic from an epidemiological point of view and should result in demotion to a lower status, but recognizes that it is not necessarily possible to observe or locate mortalities in a timely manner; therefore, the proposed new rules would offer a limited time period for delinquent facilities to "catch up" before being reduced in status for a two-year period. Proposed new §65.95(b)(2) would establish testing requirements for TC 2 breeding facilities, which would be the minimum testing requirements for MQ status stipulated in §65.94, relating to Breeding Facility Minimum Movement Qualification. A TC 2 breeding facility is a facility that is neither a TC 1 breeding facility nor a TC 3 facility.

 

41 TexReg 2860 April 22, 2016 Texas Register

 

Proposed new §65.95(b)(2) also would establish provisions regarding classification and requirements for TC 3 breeding facilities. A TC 3 facility is any breeding facility registered in TWIMS that is under a TAHC hold order and/or herd plan and received an exposed deer within the previous five years, transferred deer to a CWD-positive facility within the five-year period preceding the confirmation of CWD in the CWD-positive facility, or possessed a deer that was in a CWD-positive facility within the previous five years. As such, TC 3 breeder facilities are the facilities with the highest risk of harboring and spreading CWD. Therefore, the proposed new rule prohibits the transfer of deer from any TC 3 facility unless such transfer is expressly authorized in a TAHC herd plan and then only in accordance with the provisions of this division and the TAHC herd plan, and requires all transferred deer to be tagged in one ear with a NUES tag or button-type RFID tag approved by the department.

 

Proposed new §65.95(c) would set forth provisions governing release sites.

 

Proposed new §65.95(c)(1) would provide that an approved release site consists solely of the specific tract of land to which deer are released and the acreage designated as a release site in TWIMS, require that liberated breeder deer have complete, unrestricted access to the entirety of the release site, and stipulate that all release sites onto which breeder deer are liberated be surrounded by a fence of at least seven feet in height that is capable of retaining deer at all times (and make the owner of the release site responsible for ensuring that the fence and associated infrastructure retain deer). In order to provide a measure of confidence that CWD is not spread from those places where breeder deer are released, it is necessary to identify the specific location where breeder deer are authorized to be released. Similarly, it is necessary to establish a level of vigilance sufficient to give reasonable assurance that breeder deer are not allowed to leave the specific premise where they were released. It is also necessary to ensure that released deer are not confined in smaller enclosures within a permitted release site, which have the effect of creating unnatural densities that could encourage the spread of disease if present.

 

Proposed new §65.95(c)(1) also would provide that any testing requirements of the division continue in effect until "not detected" test results are submitted for five consecutive hunting years following the last date on which breeder deer were liberated on the release site, that a release site not in compliance with the testing requirements of this subsection is ineligible to receive deer, prohibit any intentional act that allows any live deer to leave or escape from a release site, and require a harvest log to be maintained. In addition, the owner of a Class II or Class III release site would be required to maintain a harvest log. The proposed new rule would establish that a Class I release site is a release site that has received deer only from TC 1 facilities and is in compliance with the applicable provisions of the division. On that basis, Class I release sites represent the lowest risk of harboring or spreading CWD and are therefore not required to perform CWD testing. A Class II release site is a release site that receives deer from a TC 2 breeding facility (but not a breeding facility of lower status). The proposed new rule would require that for each year a Class II release site receives deer from any TC 2 breeding facility, the owner of the release site must, for a period of five consecutive hunting years immediately following the release, submit "not detected" post-mortem test results for 50 percent of liberated deer that are harvested at the release site or, if no liberated deer are harvested at the release site in any hunting year, 50 percent of hunter-harvested deer. Because a Class II release site receives breeder deer that represent a higher risk of harboring and spreading CWD than breeder deer from a TC 1 facility, the department has determined that some level of testing is prudent. The 50 percent value for hunter-harvested deer provides an additional level of surveillance from an epidemiological perspective, as does the alternative of testing 50 percent of liberated deer (deer that were previously breeder deer). The five-year period for testing represents the approximate time period during which CWD could be expected to be detected. The proposed new rule would also provide that once the testing requirements have been met, the site becomes a Class I release site (no testing required).

 

Finally, proposed new §65.95 would provide that a Class III release site is any release site that has received deer from an originating facility that is a TC 3 facility, received an exposed deer within the previous five years, transferred deer to a CWD-positive facility within the five-year period preceding the confirmation of CWD in the CWD-positive facility, and has not been released from a TAHC hold order. The proposed new rule would require the landowner of a Class III release site to submit post-mortem CWD test results for 100 percent of all hunter-harvested deer or one hunter-harvested deer per liberated deer released on the release site between the last day of lawful hunting on the release in the previous hunting year and the last day of lawful hunting on the release site during the current hunting year, whichever is greater and condition the minimum harvest and testing provision on terms prescribed in a TAHC herd plan. The proposed new rule also would prohibit the transfer of a breeder deer to a Class III release site unless the deer has been tagged in one ear with a NUES tag or button-type RFID tag.

 

Movement of DMP Deer

 

Proposed new §65.96, concerning Movement of DMP Deer, would set forth the movement and testing requirements associated with DMP activities. The proposed new rule would require a DMP release site to which breeder deer from a TC 2 breeding facility are released, or if the DMP property from which deer are trapped for DMP purposes is a Class II release site, to submit "not detected" test results equivalent to 50 percent of the number of hunter-harvested deer in each hunting year for five consecutive hunting years, beginning with the hunting year immediately following the liberation. As discussed elsewhere in this preamble, a TC 2 breeding facility or Class II release site represents a higher risk of transmitting CWD than a TC 1 breeding facility or Class I release site; therefore some level of testing is appropriate. The department has determined that testing half the hunter-harvested deer each year for five years (the approximate time period during which CWD could be expected to be detected) provides a reasonable assurance that CWD would be detected if it were present. The proposed new rule would prohibit the transfer of deer from a TC 3 breeding facility to a DMP facility because breeder deer in a TC 3 breeding facility are presumed to be exposed and therefore present an unacceptable risk of spreading CWD to free-ranging populations. The proposed rules would not impose testing requirements on any DMP facility that either does not receive breeder deer or receives breeder deer solely from TC 1 deer breeding facilities.

 

Testing and Movement of Deer Pursuant to a Triple T or TTP Permit

 

Proposed new §65.97, concerning Testing and Movement of Deer Pursuant to a Triple T or TTP Permit, would set forth

 

PROPOSED RULES April 22, 2016 41 TexReg 2861

 

general provisions and testing requirements applicable to the movement of deer under a Triple T or TTP permit.

 

Proposed new §65.97(a) would stipulate that the disease detection provisions of §65.102 cease effect upon the effective date of the proposed new section, if adopted. This is necessary to prevent regulatory conflict.

 

Proposed new §65.97(a) also would provide that the department may require a map of any prospective Triple T trap site to be submitted as part of the application process, which is necessary to address situations in which the exact nature of a prospective Triple T site and its relationship to nearby or adjoining tracts of land is unclear with respect to previous releases.

 

Proposed new §65.97(a) would further enumerate the criteria under which the department will not authorize deer to be trapped at a specific site, including a release site that has received breeder deer within five years of the application for a Triple T permit, a release site that has failed to fulfill testing requirements, any site where a deer has been confirmed positive for CWD, any site where a deer has tested "suspect" for CWD, or any site under a TAHC hold order. Further, proposed §65.97(a) would provide that in addition to the reasons for denying a Triple T permit listed in §65.103(c) (concerning Trap, Transport, and Transplant Permit), the department will not issue Triple T permit if the department determines, based on epidemiological assessment and consultation with TAHC that to do so would create an unacceptable risk for the spread of CWD. Each of the enumerated criteria for permit refusal represents an unacceptable risk of spreading CWD to free-ranging populations.

 

In addition, proposed new §65.97(a) would require all Triple deer to be tagged prior to release in one ear with a button-type RFID tag approved by the department and for the RFID tag information to be submitted to the department. The proposed new provision would enable the department to identify all deer harvested at a given release site (including deer that were released breeder deer) if an epidemiological investigation becomes necessary.

 

Proposed new §65.97(a) would further stipulate that a Triple T permit does not authorize the take of deer except as authorized by applicable laws and regulations, including but not limited to laws and regulations regarding seasons, bag limits, and means and methods as provided in Subchapter A of this chapter (relating to Statewide Hunting Proclamation), which is necessary to ensure that all deer are harvested by hunters under the regulations established for lawful hunting.

 

Proposed new §65.97(a) also would require all test samples to be collected or tested after the Saturday closest to September 30 (the first day of lawful hunting in any year), which is necessary to ensure that test samples are temporally linked to the year for which activities of the permit are authorized; however, this requirement would not apply to permits issued for the removal of urban deer, for which test samples could be collected between April 1 and the time of application.

 

Additional provisions of proposed new §65.97(a) include a harvest log requirement, the stipulation that a Triple T release site consist solely of the specific tract of land to which deer are released and the acreage designated as a release site in TWIMS, the requirement that deer released pursuant to a Triple T permit must have complete, unrestricted access to the entirety of the release site, the requirement that the testing requirements of the section continue in effect until "not detected" test results have been submitted for five consecutive hunting years following the last date on which deer were released, and the provision that a Triple T release site that does not comply with the testing requirements of the subsection becomes ineligible to be a release site in the future.

 

Proposed new §65.97(b) would establish the testing requirements for Triple T trap and release sites. At the trap site, the proposed new rule would require 15 "not detected" post-mortem test results to be submitted prior to permit issuance. For release sites, the proposed new provision would require the landowner of a Triple T release site to submit "not detected" post-mortem test results for a period of five consecutive hunting years immediately following the release for either 50 percent of liberated deer that are harvested at the Triple T release site, or if no liberated deer are harvested at the Triple T release site in any hunting year, 50 percent of hunter-harvested deer.

 

Proposed new §65.97(b) also would stipulate that CWD testing is not required for deer trapped on any property if the deer are being moved to adjacent, contiguous tracts owned by the same person who owns the trap site property.

 

Proposed new §65.97(c) would set forth the testing requirements for TTP permits. The proposed new provision would require "not detected" test results for at least 15 eligible-aged deer from the trap site to submitted and would require the landowner of a Class III release site where TTP deer are trapped to submit CWD test results for 100% of the deer trapped. The proposed new rule also would require test results related to a TTP permit to be submitted to the department by the method prescribed by the department by the May 1 immediately following the completion of permit ac-tivities.

 

Transition Provisions

 

Proposed new §65.98, concerning Transition Provisions, would set forth provisions to clarify enforcement of regulations with respect to the effective dates of various provisions and would stipulate that the department's executive director develop a transition plan and issue appropriate guidance documents to facilitate an effective transition to this division from previously applicable regulations.

 

Violations and Penalties

 

Proposed new §65.99, concerning Violations and Penalties, would prescribe the penalties and sanctions for violations of a condition of a permit or a provision of the division.

 

Clayton Wolf, Wildlife Division Director, has determined that for each of the first five years that the rules as proposed are in effect, there will initially be no fiscal implications to state and local governments as a result of enforcing or administering the rules as proposed, as department personnel currently allocated to the administration and enforcement of the permit programs affected will administer and enforce the rules as part of their current job duties and resources already in place will be reallocated for purposes of program administration, primarily to address programming costs. However, if administering the program following the initial transition requires continued reallocation of staff and resources, there may be a need for additional personnel to assist in administering the program.

 

Mr. Wolf also has determined that for each of the first five years the new rules as proposed are in effect, the public benefit anticipated as a result of enforcing or administering the rules as proposed will be a reduction of the probability of CWD being spread from facilities where it might exist and an increase in the probability of detecting CWD if it does exist, thus ensuring the public of continued enjoyment of the resource and also ensuring the

 

41 TexReg 2862 April 22, 2016 Texas Register

 

continued beneficial economic impacts of hunting in Texas. Additionally, the protection of free-ranging deer herds will have the simultaneous collateral benefit of protecting captive herds, and maintaining the economic viability of deer breeding operations.

 

There will be adverse economic impact on persons required to comply with the rules as proposed. For deer breeders, those impacts are the same as the adverse economic impacts to small and micro-businesses, which are addressed later in this preamble.

 

For persons who obtain breeder deer for purposes of release (including under a DMP permit) or trap free-ranging deer under a Triple T or TTP permit, the adverse economic impacts of the proposed new rules consist of the CWD testing requirements that the proposed new rules would impose, based on the source and history of the deer being released.

 

The current cost of a CWD test administered by the Texas Veterinary Medicine Diagnostic Lab (TVMDL) is a minimum of $46, to which is added a $6 submission fee (which may cover multiple samples submitted at the same time). If a whole head is submitted to TVDML there is an additional $20 sample collection fee, plus a $20 disposal fee. Thus, the fee for submitting an obex or obex/medial retropharyngeal lymph node pair would be $52, plus any veterinary cost (which the department cannot quantify) and the fee for submitting an entire head for testing would be $92. Therefore, for any Class II or Class III release site owner, the cost of compliance with the testing requirements of the proposed new rules would be approximately $92 per animal required to be tested.

 

There are no adverse economic impacts for persons who obtain and release breeder deer from solely from TC 1 breeding facilities because under the rules as proposed, a release site that receives breeder deer only from TC 1 facilities is a Class I release site and no CWD testing is required.

 

For persons who obtain breeder deer from TC 2 breeding facilities or facilities of higher status (making the release site a Class II release site), the proposed new rules would require the landowner to test either 50 percent of the liberated deer (deer that were ever held under a deer breeder permit) harvested by hunters or, if no liberated deer are harvested, 50 percent of the deer harvested by hunters. Thus, the adverse economic impacts would be a function of the number and type of deer harvested, which could be as low as the cost of testing one deer (i.e., if only two liberated deer were part of the harvest, one would have to be tested and the testing requirement would be met).

 

For Class III release sites, the proposed new rules would require the landowner to test 100% of hunter-harvested deer. Therefore, the cost of compliance would be the cost of a CWD test for every deer harvested. Historically there have been liberations of up to 175 deer; however, the vast majority of releases involve fewer than 10 deer.

 

For a person trapping deer under a Triple T or TTP permit, the adverse economic impact would be would be the cost of complying with the requirement to submit 15 valid CWD test results of "not detected" to the department prior to permit issuance.

 

The proposed new rules will result in adverse economic impacts to landowners of Class II and Class III release sites, who would be required to comply with certain testing requirements. Only those landowners who receive breeder deer from TC 2 and/or TC 3 breeding facility would be subject to the testing requirements imposed by the proposed rules.

 

For a Class II release site, if deer are hunter-harvested, a number of deer equivalent to 50 percent of the number of liberated breeder deer that are harvested at the site or 50 percent of all hunter-harvested deer if not liberated deer are harvested.

 

For a Class III release site, the proposed new rules would require 100 percent of all hunter-harvested deer to be tested or one hunter-harvested deer per breeder deer released between the last day of lawful deer hunting at the site in the previous year and the last day of lawful deer hunting at the site in the current year.

 

Also, because the proposed new rules require all release sites for breeder deer to be enclosed by a fence of at least seven feet in height, a landowner desiring to have breeder deer released on a tract that is not surrounded by such a fence would incur the cost of building one. The cost of fence construction varies by terrain and region, but anecdotal information suggests that it is $10,000 per linear mile or more. The department notes that only 610 breeder deer were released to low-fence environments in 2014 (the last year that such releases were allowed), and that the practice is extremely rare because the breeder deer purchased for liberation represent a significant purchase cost and once they are released they become free-ranging deer and may be legally killed on an adjoining property should they wander from the release site.

 

Small and Micro-business Impact Analysis

 

Under the provisions of Government Code, Chapter 2006, a state agency must prepare an economic impact statement and a regulatory flexibility analysis for a rule that may have an adverse economic effect on small businesses and micro-businesses. As required by Government Code, §2006.002(g), in April 2008, the Office of the Attorney General issued guidelines to assist state agencies in determining a proposed rule's potential adverse economic impact on small businesses. These guidelines state that "[g]enerally, there is no need to examine the indirect effects of a proposed rule on entities outside of an agency's regulatory jurisdiction." The guidelines state that an agency need only consider a proposed rule's "direct adverse economic impacts" to small businesses and micro-businesses to determine if any further analysis is required. The guidelines also list examples of the types of costs that may result in a "direct economic impact." Such costs may include costs associated with additional record-keeping or reporting requirements; new taxes or fees; lost sales or profits; changes in market competition; or the need to purchase or modify equipment or services.

 

Parks and Wildlife Code, §43.357(a), authorizes a person to whom a breeder permit has been issued to "engage in the business of breeding breeder deer in the immediate locality for which the permit was issued" and to "sell, transfer to another person, or hold in captivity live breeder deer for the purpose of propagation." As a result, deer breeders are authorized to engage in business activities; namely, the purchase and sale of breeder deer. The same is not true of DMP or Triple T permit holders, who are authorized only to trap, temporarily detain, and release deer and are not authorized by those permits to buy or sell deer, or to exchange deer for anything of value.

 

Government Code, §2006.001(1), defines a small or micro-business as a legal entity "formed for the purpose of making a profit" and "independently owned and operated." A micro-business is a business with 20 or fewer employees. A small business is defined as a business with fewer than 100 employees, or less than $6 million in annual gross receipts. Although the department

 

PROPOSED RULES April 22, 2016 41 TexReg 2863

 

does not require deer breeders to file financial information with the department, the department believes that most if not all deer breeders would qualify as a small or micro-business. Since the rules as proposed would impact the ability of a deer breeder to engage in certain activities undertaken to generate a profit, the proposed rules may have an adverse impact on deer breeders.

 

Impact on Sales

 

The variety of business models utilized by deer breeders makes meaningful estimates of potential adverse economic impacts dif-ficult. Although a deer breeder has the permit privilege to buy and sell breeder deer and many deer breeders participate in a market for breeder deer, other deer breeders are interested only in breeding and liberating deer on their own property to provide hunting opportunity. Once a breeder deer is liberated, it cannot be returned to a breeding facility and assumes the same legal status as all other free-ranging deer. Thus, if a person who is a deer breeder is engaged primarily in buying and selling deer, the potential adverse economic impact is greater than that for a deer breeder who engages in deer breeding activities primarily for purposes of release onto that person's property. The department does not require deer breeders to report the buying or selling prices of deer. However, publicly available and anecdotal information indicates that sale prices, especially for buck deer, may be significant. The sale price for a single deer may range from hundreds of dollars to many thousands of dollars.

 

It should also be noted that some aspects of this analysis are based on anticipated marketplace behavior which cannot be accurately predicted. In addition, to the extent that any marketplace analysis can be conducted, it is difficult, if not impossible, to accurately separate and distinguish marketplace behavior that is the result of the proposed new rules from marketplace behavior that is the result of the discovery of CWD. For reasons unrelated to the proposed new rules, it is possible, perhaps even likely, that breeders and release site owners will be reluctant to purchase a breeder deer from a facility with a close relationship to a facility at which CWD has been detected.

 

The proposed new rules would not completely prohibit the transfer of deer except facilities that are not movement qualified or TC 3 facilities that are not otherwise authorized to transfer deer pursuant to a TAHC herd plan (in addition to facilities that were not allowed to transfer deer under previous regulations due to failure to test a minimum number of deer or failure to comply with record-keeping requirements). All TC 1 and TC 2 facilities would be allowed to transfer deer, provided certain conditions are met.

 

For TC 1 facilities, the department has determined that there will likely be no adverse economic impact on sales as a result of the proposed new rules. Since transfers of breeder deer from TC 1 facilities are subject to the fewest restrictions under the proposed new rules, breeder deer from a TC 1 facility can more easily be sold to other breeders or to landowners for purposes of liberation. In addition, TC 1 facilities are subject to monitoring and testing at a higher level. Since classification as a TC 1 facility requires certain actions by deer breeders as provided in the proposed rules, the Department cannot accurately identify the number of deer breeders willing to undertake the obligations required to be classified as a TC 1 facility. One category of TC 1 facilities are facilities with "fifth" year or "certified" status in the TAHC CWD Herd Certification Program.

 

For TC 2 and TC 3 facilities, the adverse economic impact of the proposed new rules would consist of testing costs and the possible loss of sales to TC 1 facilities and Class I release sites. The proposed new rules would not prohibit the transfer of breeder deer by TC 2 facilities, but because the proposed new rules would cause any TC 1 facility or Class I release site that accepts deer from a TC 2 (or TC 3) facility to assume the status (and regulatory obligations, such as testing) of the TC 2 (or TC 3) facility, and because TC 2 facilities carry a greater risk of exposure to CWD, it can be assumed that TC 1 facilities or Class I release sites will be less likely destinations for breeder deer coming from facilities of lower status. Historically there have been liberations of up to 175 deer; however, the vast majority of releases involve fewer than 10 deer.

 

As noted above, since the proposed rules would provide a mechanism for more breeder facilities to be classified as a TC 1 facility, many facilities classified as TC 2 under the Interim Rules may elect to undertake the requirements of the proposed rule necessary to attain TC 1 status. Since such decisions are personal and business decisions to be made by each breeder, the Department cannot accurately identify the number of deer breeders willing to undertake the obligations required to be classified as a TC 1 facility.

 

As noted above, if a release site is unwilling to obtain deer from a TC 2 facility, the impact of the proposed rules to a TC 2 deer breeder would be the loss of sales and any attendant profit from the sale of deer. Similarly, a TC 1 facility that acquires a breeder deer from a TC 2 facility would assume the lower TC 2 status. As previously mentioned in this analysis, the department does not require holders of deer breeder permits to disclose the dollar values of sales and purchases of breeder deer; therefore, an exact quantification of the possible impact of the proposed new rules on TC 2 facilities cannot be accurately calculated. However, based on public and anecdotal information, such impact could be from few hundred dollars or less per deer or to thousands of dollars per deer.

 

The proposed new rules would prohibit the introduction to or removal of deer from TC 3 breeder facilities unless authorized by a TAHC herd plan and then only in compliance with the requirements of this division. TC 3 facilities are breeder facilities that received an exposed deer within the previous five years, transferred deer to a CWD-positive facility within the five-year period preceding the confirmation of CWD in the CWD-positive facility; or possessed a deer that was in a CWD-positive facility within the previous five years. The proposed rules would result in an adverse economic impact to deer breeders whose facilities are TC 3 facilities. The extent of such adverse economic impact would consist of loss of revenue as a result of being unable to introduce or remove deer from the breeding facility and thus being unable to deliver or accept deer that have been bought or sold. The dollar value of the adverse economic impact is dependent on the volume of deer produced or acquired by any given permittee, which can vary from a few deer to hundreds of deer. However, as noted above, it is difficult, if not impossible, to accurately determine whether and how much any adverse economic impact is due to the presence of CWD in a facility (or a related facility) or attributable to the proposed new rules. Department records indicate that there are currently 304 TC 3 facilities in the state; if the proposed new rules are adopted, that number will be less than 100. The department notes that with the exception of breeding facilities that are CWD-positive, the proposed new rules allow "exposed" facilities (which would be classified as TC 3 facilities) to transfer breeder deer following successful compliance with the testing and other provisions of the proposed new rules.

 

Testing Costs

 

41 TexReg 2864 April 22, 2016 Texas Register

 

The proposed new rules would cause an adverse economic impact to deer breeders who must undertake disease-testing requirements to continue certain activities. As a result, deer breeders and owners of release sites that are not Class I release sites would incur costs related to the increased testing and monitoring requirements of the proposed new rules.

 

The cost of a CWD testing administered by the Texas Veterinary Medicine Diagnostic Lab (TVMDL) on a sample collected and submitted by a deer breeder is a minimum of $46, to which is added a $6 submission fee (which may cover multiple samples submitted at the same time). If a whole head is submitted to TVDML there is an additional $20 sample collection fee, plus a $20 disposal fee. Thus, the fee for submitting an obex or obex/medial retropharyngeal lymph node pair would be $52, plus any veterinary cost (which the department cannot quantify) and the fee for submitting an entire head for testing would be $92.

 

A significant factor that differentiates the proposed new rules from the interim rules is that the proposed new rules either require or allow ante-mortem (live animal) tests for CWD to be submitted by deer breeders seeking to maintain or increase status. Under the Veterinary Practice Act, the samples necessary for ante-mortem testing can only be obtained a licensed veterinarian. Because veterinary practice models vary significantly (flat rates, graduated rates, included travel costs, herd call rates, sedation costs, etc.) in addition to pricing structures determined by the presence or absence of economic competition in different parts of the state, the cost of ante-mortem testing is difficult to quantify; however, based on anecdotal information and an informal survey of knowledgeable veterinarians, the department estimates the cost of tonsillar or rectal biopsies at approximately $30-70 per head and the cost of ante-mortem lymph node biopsies at approximately $700 per head (these costs are in addition to the estimated $92 lab fee per sample for the actual CWD test). It is important to note that ante-mortem procedures for CWD testing are very new and at the current time there are very few veterinarians with the training and expertise to perform them reliably; thus, the fee structure for such procedures can best be described as still evolving.

 

Additionally, deer breeders who seek "certified" or "fifth year" facilities are also required to obtain an annual inventory by an accredited veterinarian. The cost of an annual inventory by an accredited veterinarian is estimated by TAHC to be approximately $250. However, it should be noted that the requirements for obtaining "certified" or "fifth year" status are not imposed by the proposed rules, but rather by existing TAHC regulations.

 

The department notes that because CWD has been proven to be transmissible by direct contact (including through fences) and via environmental contamination, there may be adverse economic impacts unrelated to the proposed new rules in the event that CWD is confirmed in a breeding facility due to the possible reluctance of potential customers to purchase deer from a facility that accepted deer from a CWD-positive facility. Additionally, in the absence of the proposed new rules, if CWD is detected within a facility or breeder deer that have been in a facility that accepted deer from a CWD-positive facility, there could be lost revenue to the permittee since potential purchasers who are aware of CWD would likely refrain from purchasing deer from such a facility. Therefore, the proposed new rules, by providing a mechanism to minimize the spread of CWD, could also protect the economic interests of the regulated community.

 

The department also notes that for any given deer breeder that is currently not qualified to move or release deer, compliance with the proposed new rules could be achieved in five years or less and at the additional direct economic cost of CWD testing requirements imposed by the proposed new rules.

 

Loss of Sacrificed Deer

 

The proposed new rules would allow for the testing of additional deer (compared to the previous testing requirements) for some deer breeders who desire to move to a higher status. If deer are sacrificed for testing (in order to reach the required number of post-mortem tests to be movement qualified, maintain status, or in increase in status), there could be an economic impact from the loss of the deer and any revenue that might have been realized from the sale of the deer to another breeder or to a release site for liberation. As noted previously, the department does not require that breeders report financial data. The economic impact on a deer breeder would depend on whether the deer breeder sacrifices deer to achieve testing requirements, and the number and type of deer sacrificed. As noted above, the lost revenue from the sacrificed deer could range from few hundred dollars or less per deer to thousands of dollars per deer. However, it should also be noted that the option in the proposed rules for ante-mortem testing should result in fewer deer being sacrificed for purpose of testing.

 

Alternatives Considered

 

In the development of the proposed rules, including through discussions among stakeholders and through the facilitated rulemaking process, several alternatives were raised, discussed and/or considered to achieve the goals of the proposed new rules while reducing potential adverse impacts on small and micro-businesses and persons required to comply.

 

One alternative was to allow the interim rules to expire on their own terms on August 31, 2016. If the interim rules expired, the CWD testing and deer movement requirements would revert to those that existed prior to the 2015 discovery of CWD in Medina County. This alternative was rejected because the presence of CWD in breeding facilities and free-ranging populations presents an actual, direct threat to free-ranging and farmed cervid populations and the economies that depend upon them. Although the previous rules provided some level of monitoring and containment, the 2015 discovery of CWD in a white-tailed deer in Medina County and the subsequent discovery of CWD in additional white-tailed deer warrants a more comprehensive approach. Therefore, because the department has a statutory duty to protect and conserve the wildlife resources of the state, the previous rules would not achieve the necessary level of vigilance needed to detect the presence and/or spread of CWD. Therefore, this alternative was rejected. Another alternative would have been to propose rules identical or very similar to the interim rules. This alternative was rejected for several reasons. The interim rules were intended to be an interim regulatory response to the 2015 discovery of CWD in white-tailed deer, and were not intended to be a long-term response. The interim rules were developed to implement requirements necessary to protect deer herds through the 2015-2016 hunting season, and facilitate continuation of activities by deer breeders. As a result, the interim rules did not provide for a fuller universe of options, such as live-animal (ante-mortem) testing of breeder deer. Therefore, this alternative was rejected.

 

PROPOSED RULES April 22, 2016 41 TexReg 2865

 

♦ ♦ ♦

 

Another alternative would be an absolute prohibition on the movement of deer within the state for any purpose. While this alternative would significantly reduce the potential spread of CWD, it would also have the simultaneous effect of preventing landowners and land managers from implementing popular management strategies involving the movement of deer, and would deprive deer breeders of the ability to engage in the business of buying and selling breeder deer. Therefore, this alternative was rejected because the department determined that it placed an avoidable burden on the regulated community.

 

Another alternative would be imposing less stringent testing requirements. This alternative was rejected because the testing requirements in the proposed new rules reflect mathematical models aimed at higher confidence than is possible under current disease-testing requirements that CWD is or is not present. Less stringent testing requirements would reduce confidence and therefore impair the ability of the department to respond in the event that CWD actually is present. The department also believes that a higher testing intensity is necessary to provide assurance to the hunting public, private landowners, and the regulated community that wildlife resources are safe and reliable.

 

The department has not drafted a local employment impact statement under the Administrative Procedure Act, Government Code, §2001.022, as the agency has determined that the rules as proposed will not result in direct impacts to local economies.

 

The department has determined that there will not be a taking of private real property, as defined by Government Code, Chapter 2007, as a result of the proposed new rules. Any impacts resulting from the discovery of CWD in or near private real property would be the result of the discovery of CWD and not the proposed rules.

 

Comments on the proposed rule may be submitted to Mitch Lockwood, Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas 78744; (830) 792-9677 (e-mail: mitch.lockwood@tpwd.texas.gov); or via the department's website at www.tpwd.texas.gov. 31 TAC §§65.90 -65.94

 

The repeals are proposed under the authority of Parks and Wildlife Code, Chapter 43, Subchapter L, which authorizes the commission to make regulations governing the possession, transfer, purchase, sale, of breeder deer held under the authority of the subchapter; Subchapter R, which authorizes the commission to establish the conditions of a deer management permit, including the number, type, and length of time that white-tailed deer may be temporarily detained in an enclosure; Subchapter R-1, which authorizes the commission to establish the conditions of a deer management permit, including the number, type, and length of time that mule deer may be temporarily detained in an enclosure (although the department has not yet established a DMP program for mule deer authorized by Subchapter R-1); and §61.021, which provides that no person may possess a game animal at any time or in any place except as permitted under a proclamation of the commission.

 

The proposed repeals affect Parks and Wildlife Code, Chapter 43, Subchapters E, L, R, and R-1.

 

§65.90. Definitions.

 

§65.91. General Provisions.

 

§65.92. Transfer Categories and Requirements.

 

§65.93. Release Sites -Qualifications and Testing Requirements.

 

§65.94. Chronic Wasting Disease -Deer Management Permit Provisions.

 

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

 

Filed with the Office of the Secretary of State on April 11, 2016.

 

TRD-201601677 Ann Bright General Counsel Texas Parks and Wildlife Department Earliest possible date of adoption: May 22, 2016 For further information, please call: (512) 389-4775

 

31 TAC §§65.90 -65.99

 

The new rules are proposed under the authority of Parks and Wildlife Code, Chapter 43, Subchapter L, which authorizes the commission to make regulations governing the possession, transfer, purchase, sale, of breeder deer held under the authority of the subchapter; Subchapter R, which authorizes the commission to establish the conditions of a deer management permit, including the number, type, and length of time that white-tailed deer may be temporarily detained in an enclosure; Subchapter R-1, which authorizes the commission to establish the conditions of a deer management permit, including the number, type, and length of time that mule deer may be temporarily detained in an enclosure (although the department has not yet established a DMP program for mule deer authorized by Subchapter R-1); and §61.021, which provides that no person may possess a game animal at any time or in any place except as permitted under a proclamation of the commission.

 

The proposed new rules affect Parks and Wildlife Code, Chapter 43, Subchapters E, L, R, and R-1. §65.90. Definitions.

 

The following words and terms shall have the following meanings, except in cases where the context clearly indicates otherwise.

 

(1) Accredited testing laboratory--A laboratory approved by the United States Department of Agriculture to test white-tailed deer or mule deer for CWD.

 

(2) Ante-mortem test--A CWD test performed on a live deer.

 

(3) Breeder deer--A white-tailed deer or mule deer possessed under a permit issued by the department pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Subchapter T of this chapter.

 

(4) Confirmed--A CWD test result of "positive" received from the National Veterinary Service Laboratories of the United States Department of Agriculture.

 

(5) CWD--Chronic wasting disease.

 

(6) CWD-positive facility--Any facility in or on which CWD has been confirmed.

 

(7) Deer breeder--A person who holds a deer breeder's per-mit issued pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Subchapter T of this chapter. 41 TexReg 2866 April 22, 2016 Texas Register

 

(8) Deer breeding facility (breeding facility)--A facility authorized to hold breeder deer under a permit issued by the department pursuant to Parks and Wildlife Code, Chapter 43, Subchapter L, and Subchapter T of this chapter (Deer Breeder's Permit).

 

(9) Department (department)--Texas Parks and Wildlife Department.

 

(10) Deer Management Permit (DMP)--A permit issued under the provisions of Parks and Wildlife Code, Subchapter R or R-1 and Subchapter D of this chapter (relating to Deer Management Permit (DMP)) that authorizes the temporary detention of deer for the purpose of propagation.

 

(11) Eligible-aged deer-( A) if the deer is held in a breeding facility enrolled in the TAHC CWD Herd Certification Program, 12 months of age or older; or (B) for any other deer, 16 months of age or older.

 

(12) Eligible mortality--An eligible-aged deer that has died.

 

(13) Exposed deer--Unless the department determines through an epidemiological investigation that a specific deer has not been exposed, an exposed deer is a white-tailed deer or mule deer that:

 

(A) is in a CWD-positive facility; or

 

(B) was in a CWD-positive facility within the five years preceding the confirmation of CWD in the CWD-positive facility.

 

(14) Facility--Any location required to be registered in TWIMS under a deer breeder's permit, Triple T permit, or DMP, including release sites and/or trap sites.

 

(15) Hunter-harvested deer--A deer required to be tagged under the provisions of Subchapter A of this chapter (relating to Statewide Hunting Proclamation).

 

(16) Hunting year--That period of time between September 1 and August 31 of any year when it is lawful to hunt deer under the provisions of Subchapter A of this chapter (relating to Statewide Hunting Proclamation).

 

(17) Landowner (owner)--Any person who has an owner-ship interest in a tract of land and includes landowner's authorized agent.

 

(18) Landowner's authorized agent (agent)--A person des-ignated by a landowner to act on the landowner's behalf.

 

(19) Liberated deer--A free-ranging deer that bears evidence of having been liberated including, but not limited to a tattoo (including partial or illegible tattooing) or of having been eartagged at any time (holes, rips, notches, etc. in the ear tissue).

 

(20) Movement Qualified (MQ)--A designation made by the department pursuant to this division that allows a deer breeder to lawfully transfer breeder deer.

 

(21) Not Movement Qualified (NMQ)--A designation made by the department pursuant to this division that prohibits the transfer of deer by a deer breeder.

 

(22) NUES tag--An ear tag approved by the United States Department of Agriculture for use in the National Uniform Eartagging System (NUES).

 

(23) Originating facility--Any facility from which deer have been transported, transferred, or released, as provided in this definition or as determined by an investigation of the department, including:

 

(A) for breeder deer, the source facility identified on a transfer permit; and

 

(B) for deer being moved under a Triple T permit, the trap site.

 

(24) Post-mortem test--A CWD test performed on a dead deer.

 

(25) Properly executed--A form or report required by this division on which all required information has been entered.

 

(26) Reconciled herd--The breeder deer held in a breeding facility for which every birth, mortality, and transfer of breeder deer in the previous reporting year has been accurately reported.

 

(27) Release site--A specific tract of land to which deer are released, including the release of deer under the provisions of this chapter or Parks and Wildlife Code, Chapter 43, Subchapters E, L, R, or R-1.

 

(28) Reporting year--For a deer breeder's permit, the period of time from April 1 of one calendar year through March 31 of the next calendar year.

 

(29) RFID tag--A button-type ear tag conforming to the 840 standards of the United States Department of Agriculture's Animal Identification Number system.

 

(30) Status--A level assigned under this division for any given facility on the basis of testing performance and the source of the deer. For the transfer categories established in §65.95(b) of this title (relating to Movement of Breeder Deer), the highest status is Transfer Category 1 (TC 1) and the lowest status is Transfer Category 3 (TC3). For the release site classes established in §65.95(c) of this title, Class I is the highest status and Class III is the lowest.

 

(31) Submit--When used in the context of test results, provided to the department, either directly from a deer breeder or via an accredited testing laboratory.

 

(32) Suspect--An initial CWD test result of "detected" that has not been confirmed.

 

(33) TAHC--Texas Animal Health Commission.

 

(34) TAHC CWD Herd Certification Program--The disease-testing and herd management requirements set forth in 4 TAC §40.3 (relating to Herd Status Plans for Cervidae).

 

(35) TAHC Herd Plan--A set of requirements for disease testing and management developed by TAHC for a specific facility.

 

(36) Test, Test Result(s), or Test Requirement--A CWD test, CWD test result, or CWD test requirement as provided in this division.

 

(37) Trap Site--A specific tract of land approved by the department for the trapping of deer under this chapter and Parks and Wildlife Code, Chapter 43, Subchapters E, L, R, and R-1.

 

(38) Triple T permit--A permit to trap, transport, and trans-plant white-tailed or mule deer (Triple T permit) issued under the provi-sions of Parks and Wildlife Code, Chapter 43, Subchapter E, and Sub-chapter C of this chapter (relating to Permits for Trapping, Transport-ing, and Transplanting Game Animals and Game Birds),

 

(39) Trap, Transport and Process (TTP) permit--A permit issued under the provisions of Parks and Wildlife Code, Chapter 43, Subchapter E, and Subchapter C of this chapter (relating to Permits for Trapping, Transporting, and Transplanting Game Animals and Game PROPOSED RULES April 22, 2016 41 TexReg 2867 Birds), to trap, transport, and process surplus white-tailed deer (TTP permit).

 

(40) TWIMS--The department's Texas Wildlife Information Management Services (TWIMS) online application. §65.91. General Provisions.

 

(a) To the extent that any provision of this division conflicts with any other provision of this chapter, this division prevails.

 

(b) Except as provided in this division, no live breeder deer or deer trapped under a Triple T permit, TTP permit or DMP may be transferred anywhere for any purpose.

 

(c) Except as provided in this division, no person shall introduce into or remove deer from or allow or authorize deer to be introduced into or removed from any facility for which a CWD test result of "suspect" has been obtained from an accredited testing laboratory, irrespective of how the sample was obtained or who collected the sample. The provisions of this subsection take effect immediately upon the notification of a CWD "suspect" test result, and continue in effect until the department expressly authorizes the resumption of permitted activities at that facility.

 

(d) A facility (including a facility permitted after the effective date of this division) that receives breeder deer from an originating facility of lower status automatically assumes the status associated with the originating facility and becomes subject to the testing and release requirements of this division at that status for:

 

(1) a minimum of two years, if the facility is a breeding facility; or

 

(2) for the period specified in §65.95(c)(1)(D) of this title (relating to Movement of Breeder Deer), if the facility is a release site.

 

(e) A deer breeding facility that was initially permitted after March 31, 2016 will assume the lowest status among all originating facilities from which deer are received.

 

(f) The designation of status by the department in and of itself does not authorize the transfer or movement of deer. No person may remove or cause the removal of deer from a facility that has been designated NMQ by the department pursuant to this division.

 

(g) Unless expressly provided otherwise in this division, all applications, notifications, and requests for change in status required by this division shall be submitted electronically via TWIMS or by another method expressly authorized by the department.

 

(h) In the event that technical or other circumstances prevent the development or implementation of automated methods for collecting and submitting the data required by this division via TWIMS, the department may prescribe alternative methods for collecting and submitting the data required by this division.

 

§65.92. CWD Testing.

 

(a) All CWD test samples at the time of submission for testing shall be accompanied by a properly executed, department-prescribed form provided for that purpose.

 

(b) For the purposes of this subchapter, an ante-mortem CWD test is not valid unless it is performed by an accredited laboratory on retropharyngeal lymph node, rectal mucosa, or tonsillar tissue collected by or under the supervision of a qualified licensed veterinarian within six months of submission from a live deer that:

 

(1) is at least 16 months of age;

 

(2) has been in the facility for at least 16 months; and

 

(3) has not been the source of a "not detected" ante-mortem test result submitted within the previous 36 months.

 

(c) Ante-mortem tests submitted by a deer breeder for pur-poses of attaining a higher status under the provisions of this section shall be collected and submitted between October 15 of one year and March 15 of the following year.

 

(d) A post-mortem CWD test is not valid unless it is performed by an accredited testing laboratory on the obex of an eligible mortal-ity, which may be collected only by a qualified licensed veterinarian or other person certified by TAHC to perform that procedure. A medial retropharyngeal lymph node collected from the eligible mortality by an qualified licensed veterinarian or other person approved by the depart-ment may be submitted to an accredited testing facility for testing in addition to or in lieu of the obex (if the obex cannot be obtained) of the eligible mortality.

 

(e) To meet the requirements of §65.94(a)(1)(B) and (C) of this title (relating to Breeding Facility Minimum Movement Qualifi-cations), or §65.95 of this title, ante-mortem test results may be sub-stituted for post-mortem test results at a ratio of two "not detected" ante-mortem test results for each required "not detected" post-mortem test result, provided:

 

(1) at least two eligible mortalities have occurred in the fa-cility in the corresponding report year; and

 

(2) "not detected" post-mortem test results equal to at least 50 percent of the total test results required have been submitted.

 

(f) Except as provided in this section, an ante-mortem test re-sult may not be used more than once to satisfy any testing requirement of this division.

 

(g) The testing requirements of this division cannot be altered by the sale or subdivision of a property to a related party if the purpose of the sale or subdivision is to avoid the requirements of this division.

 

(h) The owner of a release site agrees, by consenting to the release of breeder deer on the release site, to submit all required CWD test results to the department as soon as possible but not later than May 1 of each year for as long as CWD testing is required at the release site under the provisions of this division. §65.93.

 

Harvest Log.

 

(a) When a release site is required by this division to maintain a harvest log, the harvest log shall be maintained daily and shall meet the requirements of this section.

 

(b) For each deer harvested on the release site the landowner must, on the same day that the deer is harvested, legibly enter the fol-lowing information in the daily harvest log:

 

(1) the name and hunting license of the person who har-vested the deer;

 

(2) the date the deer was harvested;

 

(3) the species (white-tailed or mule deer) and type of deer harvested (buck or antlerless);

 

(4) any alphanumeric identifier tattooed on the deer;

 

(5) any RFID or NUES tag number of any RFID or NUES tag affixed to the deer; and (6) any other identifier and identifying number on the deer, including a description of any evidence or indication that the deer was a liberated deer including, but not limited to evidence of having been eartagged at any time (holes, rips, notches, etc. in ear tissue).

 

41 TexReg 2868 April 22, 2016 Texas Register

 

(c) The daily harvest log shall be made available upon request to any department employee acting in the performance of official du-ties.

 

(d) By not later than April 1 of each year, the owner of a release site shall submit the contents of the daily harvest log to the department via TWIMS or via another method specified by the department.

 

(e) The daily harvest log shall be on a form provided or ap-proved by the department and shall be retained for a period of one year following submission and acceptance by the department. §65.94.

 

Breeding Facility Minimum Movement Qualification.

 

(a) Notwithstanding any other provision of this division, a breeding facility is designated NMQ and is prohibited from transfer-ring breeder deer anywhere for any purpose if the breeding facility:

 

(1) has not complied with the following testing require-ments:

 

(A) submitted CWD "not detected" test results for at least 20% of the total number of eligible mortalities that occurred in the facility since May 23, 2006;

 

(B) submitted CWD "not detected" test results for at least 50% of eligible mortalities occurring in the facility during each reporting year beginning April 1, 2016; and

 

(C) beginning April 1, 2021, the number of "not detected" test results submitted during the previous five consecutive years must be equal to or greater than the following number: the sum of the eligible-aged population in the breeding facility at the end of each of the previous five consecutive reporting years, plus the sum of the eligible mortalities that occurred within the breeding facility for each of the previous five consecutive reporting years, multiplied by 2.25 percent; tests submitted pursuant to subparagraph (B) of this paragraph may be used to satisfy the testing requirements of this subparagraph;

 

(2) is not authorized pursuant to a TAHC Herd Plan associated with a TAHC hold order or TAHC quarantine;

 

(3) does not have a reconciled herd inventory;

 

(4) is not in compliance with the provisions of §65.608 of this title (relating to Annual Reports and Records).

 

(b) A facility that has been designated as NMQ for failure to comply with the testing requirements specified in subsection (a) of this section, will be restored to MQ when sufficient "not detected" test results as described in subsection (a) of this section are submitted.

 

(c) A facility designated NMQ shall report all mortalities within the facility to the department immediately upon discovery of the mortality.

 

(d) Immediately upon the notification that a facility has received a CWD suspect" test result (a CWD suspect facility), all facilities that received deer from or provided deer to the CWD suspect facility within the previous five years shall be designated NMQ by the department until it is determined that the facility is not epidemiologically linked to the CWD suspect deer, or it is determined upon further testing that the "suspect" deer is not a confirmed positive.

 

§65.95. Movement of Breeder Deer.

 

(a) General. Except as otherwise provided in this division, a TC 1 or TC 2 breeding facility may transfer breeder deer under a transfer permit that has been activated and approved by the department as provided in §65.610(e) of this title (relating to Transfer of Deer) to:

 

(1) another breeding facility;

 

(2) an approved release site as provided in paragraph (3) of this subsection;

 

(3) a DMP facility; or

 

(4) to another person for nursing purposes.

 

(b) Breeder Facilities.

 

(1) TC 1.

 

(A) Except as may be otherwise provided in this division, a breeding facility is a TC 1 facility if:

 

(i) it has "fifth-year" or "certified" status in the TAHC CWD Herd Certification Program;

 

(ii) has submitted "not detected" post-mortem test results equivalent to:

 

(I) at least 80 percent of the total number of eligible mortalities that occurred in the breeding facility in each reporting year of the immediately preceding five-year period and each year thereafter; and

 

(II) a number of "not detected" post-mortem test results submitted during the previous five consecutive years equal to or greater than the following number: the sum of the eligible-aged population in the breeding facility at the end of each of the previous five consecutive reporting years, plus the sum of the eligible mortalities that occurred within the breeding facility for each of the previous five consecutive reporting years, multiplied by 3.6 percent; tests submitted pursuant to subclause (I) of this clause may be used to satisfy the testing requirements of this subclause.

 

(iii) has submitted the following "not detected" test results:

 

(I) ante-mortem tests of at least 80 percent of eligible-aged deer in the facility's inventory at the time the testing is conducted;

 

(II) post-mortem tests of at least 80 percent of all eligible mortalities during each reporting year thereafter; and

 

(III) beginning April 1, 2021, the number of "not detected" post-mortem test results submitted within the previous five consecutive years must be equal to or greater than the following number: the sum of the eligible-aged population in the breeding facility at the end of each of five consecutive reporting years, plus the sum of the eligible mortalities that have occurred within the breeding facility for each of the five consecutive years, multiplied by 3.6 percent; tests submitted pursuant to subclause (II) of this clause may be used to satisfy the testing requirements of this subclause; or

 

(iv) "not detected" test results are submitted on an annual basis for:

 

(I) ante-mortem tests of at least 25 percent of eligible-aged deer in the facility's inventory at the time the testing is conducted; and

 

(II) post-mortem tests of at least 50 percent of eligible mortalities.

 

(B) Failure to Comply with TC 1 Testing Requirements.

 

(i)

 

Upon processing of the annual report, a TC 1 facility that has not met the post-mortem testing requirements of this section becomes a TC 2 facility.

 

(ii)

 

If the deer breeder seeks to regain TC 1 status, the deer breeder must, within 60 days from the date the breeder is notified by the department of the change in status, furnish the test results

 

PROPOSED RULES April 22, 2016 41 TexReg 2869

 

necessary to be in full compliance with the applicable TC 1 testing re-quirements in order to be returned to TC1 status.

 

(iii) If after 60 days the department has not received test results sufficient to achieve compliance with the applicable TC 1 testing requirements, the breeding facility is not eligible to regain TC 1 status for a period of two years.

 

(iv) A breeder will not be eligible to regain TC 1 sta-tus, if breeder deer from a lower status breeding facility are transferred to the breeding facility during the 60 days in which the breeder is seek-ing to regain TC 1 status.

 

(2) TC 2.

 

(A) A breeding facility is a TC 2 facility if:

 

(i) it is not a TC 1 facility; and

 

(ii) it is not a TC 3 facility.

 

(B) The testing requirements for a TC 2 facility are the minimum testing requirements established for MQ designation in §65.94(a)(1) of this title (relating to Breeding Facility Minimum Movement Qualification).

 

(3) TC 3.

 

(A) A TC 3 facility is any breeding facility registered in TWIMS that is under a TAHC hold order and/or herd plan and meets any of the following criteria:

 

(i) received an exposed deer within the previous five years;

 

(ii) transferred deer to a CWD-positive facility within the five-year period preceding the confirmation of CWD in the CWD-positive facility; or

 

(iii) possessed a deer that was in a CWD-positive facility within the previous five years.

 

(B) No deer from a TC 3 facility may be transferred or liberated unless expressly authorized in a TAHC herd plan and then only in accordance with the provisions of this division and the TAHC herd plan.

 

(C) A TC 3 breeding facility remains a TC 3 breeding facility until the TAHC hold order in effect at the breeding facility has been lifted.

 

(D) A TC3 breeding facility may not transfer a breeder deer for any purpose unless the deer has been tagged in one ear with a NUES tag or button-type RFID tag approved by the department.

 

(c) Release Sites.

 

(1) General.

 

(A) An approved release site consists solely of the spe-cific tract of land to which deer are released and the acreage designated as a release site in TWIMS.

 

(B) Liberated breeder deer must have complete, unre-stricted access to the entirety of the release site.

 

(C) All release sites onto which breeder deer are liber-ated must be surrounded by a fence of at least seven feet in height that is capable of retaining deer at all times. The owner of the release site is responsible for ensuring that the fence and associated infrastructure retain deer.

 

(D) The testing requirements of this subsection con-tinue in effect until "not detected" test results have been submitted for five consecutive hunting years following the last date on which breeder deer were liberated on the release site. A release site that is not in compliance with the testing requirements of this subsection is ineligible to receive deer.

 

(E) No person may intentionally cause or allow any live deer to leave or escape from a release site onto which breeder deer have been liberated.

 

(F) The owner of a Class II or Class III release site shall maintain a harvest log at the release site that complies with §65.93 of this title (relating to Harvest Log).

 

(2) Class I Release Site.

 

A release site that is in compli-ance with the applicable provisions of this division and receives deer only from TC 1 facilities is a Class I release site and is not required to perform CWD testing, unless it becomes a Class II or Class III release site.

 

(3) Class II Release Site.

 

(A) A release site that receives deer from a TC 2 breed-ing facility is a Class II release site unless it becomes a Class III release site.

 

(B) Each year that a Class II release site receives deer from any TC 2 breeding facility, the owner of the release site must, for a period of five consecutive hunting years immediately following the release, submit "not detected" post-mortem test results for:

 

(i) 50 percent of liberated deer that are harvested at the release site; or

 

(ii) if no liberated deer are harvested at the release site in any hunting year, 50 percent of hunter-harvested deer.

 

(C) Upon the satisfaction of the provisions of paragraph (3)(B) of this subsection, a Class II release site becomes a Class I re-lease site.

 

(4) Class III Release Site.

 

(A) A release site is a Class III release site if:

 

(i) it has:

 

(I) received deer from an originating facility that is a TC 3 facility; or

 

(II) received an exposed deer within the previous five years or has transferred deer to a CWD-positive facility within the five-year period preceding the confirmation of CWD in the CWD-positive facility; and

 

(ii) has not been released from a TAHC hold order related to activity described in clause

 

(i) of this subparagraph.

 

(B) The landowner of a Class III release site must sub-mit post-mortem CWD test results for one of the following values, whichever represents the greatest number of deer tested:

 

(i) 100 percent of all hunter-harvested deer; or

 

(ii) one hunter-harvested deer per liberated deer re-leased on the release site between the last day of lawful hunting on the release in the previous hunting year and the last day of lawful hunting on the release site during the current hunting year; provided, however, this minimum harvest and testing provision may only be substituted as prescribed in a TAHC herd plan.

 

(C) No breeder deer may be transferred to a Class III release site unless the deer has been tagged in one ear with a NUES tag or button-type RFID tag approved by the department. §65.96. Movement of DMP Deer.

 

41 TexReg 2870 April 22, 2016 Texas Register

 

This section applies to the movement of deer under a DMP.

 

(1) Testing Requirements.

 

(A) There are no CWD testing requirements for a DMP facility that:

 

(i) does not receive breeder deer; or

 

(ii) receives breeder deer solely from TC 1 deer breeding facilities.

 

(B) A release site onto which deer are liberated from the following is required to submit "not detected" test results equivalent to 50 percent of the number of hunter-harvested deer in each hunting year for five consecutive hunting years, beginning with the hunting year immediately following the liberation of:

 

(i) deer from a DMP facility that receives breeder deer from a TC 2 deer breeding facility; or

 

(ii) deer from a DMP facility that receives deer trapped deer from a Class II release site.

 

(2) The department will not authorize the transfer of deer to a DMP facility from a TC 3 breeding facility. §65.97. Testing and Movement of Deer Pursuant to a Triple T or TTP Permit.

 

(a) General.

 

(1) The provisions of §65.102 of this title (relating to Disease Detection Requirements) cease effect upon the effective date of this section.

 

(2) The department may require a map of any Triple T trap site to be submitted as part of the application process.

 

(3) The department will not issue a Triple T permit authorizing deer to be trapped at a:

 

(A) release site that has received breeder deer within five years of the application for a Triple T permit;

 

(B) release site that has failed to fulfill testing requirements;

 

(C) any site where a deer has been confirmed positive for CWD;

 

(D) any site where a deer has tested "suspect" for CWD; or

 

(E) any site under a TAHC hold order.

 

(4) In addition to the reasons for denying a Triple T per-mit listed in §65.103(c) of this title (relating to Trap, Transport, and Transplant Permit), the department will not issue Triple T permit if the department determines, based on epidemiological assessment and con-sultation with TAHC that to do so would create an unacceptable risk for the spread of CWD.

 

(5) All deer released under the provisions of this section must be tagged prior to release in one ear with a button-type RFID tag approved by the department. RFID tag information must be submitted to the department.

 

(6) Nothing in this section authorizes the take of deer ex-cept as authorized by applicable laws and regulations, including but not limited to laws and regulations regarding seasons, bag limits, and means and methods as provided in Subchapter A of this chapter (relat-ing to Statewide Hunting Proclamation).

 

(7) Except for a permit issued for the removal of urban deer, a test result is not valid if the sample was collected or tested after the Saturday closest to September 30 of the year for which activities of the permit are authorized.

 

(8) For permits issued for the removal of urban deer, test samples may be collected between April 1 and the time of application.

 

(9) The owner of a Triple T release site shall maintain a harvest log at the release site that complies with §65.93 of this title (relating to Harvest Log).

 

(10) A Triple T release site consists solely of the specific tract of land to which deer are released and the acreage designated as a release site in TWIMS.

 

(11) Deer transferred pursuant to a Triple T permit must have complete, unrestricted access to the entirety of the release site.

 

(12) The testing requirements of this subsection continue in effect until "not detected" test results have been submitted for five consecutive hunting years following the last date on which deer were transferred to the site pursuant to a Triple T permit. A Triple T release site that is not in compliance with the testing requirements of this subsection will be ineligible as a release site.

 

(b) Testing Requirements for Triple T Permit.

 

(1) The department will not issue a Triple T permit unless "not detected" post-mortem test results have been submitted for 15 eligible-aged deer from the trap site.

 

(2) The landowner of a Triple T release site shall submit "not detected" post-mortem test results for a period of five consecutive hunting years immediately following the release for:

 

(A) 50 percent of liberated deer that are harvested at the Triple T release site; or

 

(B) if no liberated deer are harvested at the Triple T release site in any hunting year, 50 percent of hunter-harvested deer.

 

(3) CWD testing is not required for deer trapped on any property if the deer are being moved to adjacent, contiguous tracts owned by the same person who owns the trap site property.

 

(c) Testing Requirements for TTP Permit.

 

(1) "Not detected" test results for at least 15 eligible-aged deer from the trap site must be submitted.

 

(2) The landowner of a Class III release site must submit CWD test results for 100% of the deer harvested pursuant to a TTP permit, which may include the samples required under paragraph (1) of this subsection.

 

(3) Test results related to a TTP permit must be submitted to the department by the method prescribed by the department by the May 1 immediately following the completion of permit activities. §65.98. Transition Provisions.

 

(a) This division does not apply to an offense committed be-fore the effective date of this division. An offense committed before the effective date of this division is governed by the regulations that existed on the date the offense was committed, including, but not lim-ited to the following:

 

(1) Deer Breeder: published in the Texas Register Septem-ber 4, 2015 (40 TexReg 5566); January 1, 2016 (41 TexReg 9); January 29, 2016 (41 TexReg 815); (2) DMP: published in the Texas Register October 23, 2015 (40 TexReg 7305); February 12, 2016 (41 TexReg 1049); February 19, 2016 (41 TexReg 1250); and

 

PROPOSED RULES April 22, 2016 41 TexReg 2871

 

♦ ♦ ♦

 

(3) Triple T/TTP: published in the Texas Register October 23, 2015 (40 TexReg 7307); January 1, 2016 (41 TexReg 9).

 

(b) A release site that was in compliance with the Interim Deer Breeder Rules (41 TexReg 815) shall be not subject to testing requirements until deer are liberated or released onto the release site under the provisions of this division.

 

(c) A release site that was not in compliance with the Interim Deer Breeder Rules (41 TexReg 815) shall:

 

(1) be required to comply with the applicable provisions of this division regarding Class II or Class III sites for a period of five years beginning on the first day of lawful hunting for the 2016-2017 hunting year; and

 

(2) be ineligible to be a release site for breeder deer or deer transferred pursuant to a Triple T permit until the release site has complied with paragraph (1) of this subsection.

 

(d) The department's executive director shall develop a transition plan and issue appropriate guidance documents to facilitate an effective transition to this division from previously applicable regulations. The transition plan shall include, but is not limited to, provision addressing a mechanism for classifying facilities that have obtained "not detected" ante-mortem test results at a level that meets or exceeds that required in this division prior to the effective date of this division.

 

§65.99. Violations and Penalties.

 

(a) A person who violates a provision of this division or a condition of a deer breeder's permit, DMP, Triple T permit, or TTP permit commits an offense and is subject to the penalties prescribed by the applicable provisions of the Parks and Wildlife Code.

 

(b) A person who possesses or receives white-tailed deer or mule deer under the provisions of this division and/or Subchapters C, D, or T of this chapter is subject to the provisions of TAHC regulations at 4 TAC Chapter 40 (relating to Chronic Wasting Disease) that are applicable to white-tailed or mule deer.

 

(c) A person who fails to comply with a provision of this division or a condition of a deer's breeder permit, DMP, Triple T permit, or TTP permit may be prohibited by the department from future permit eligibility or issuance.

 

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

 

Filed with the Office of the Secretary of State on April 11, 2016.

 

TRD-201601678 Ann Bright General Counsel Texas Parks and Wildlife Department Earliest possible date of adoption: May 22, 2016 For further information, please call: (512) 389-4775

 

http://sos.state.tx.us/texreg/pdf/backview/0422/0422is.pdf

 

***Comments on the proposed rule may be submitted to Mitch Lockwood, Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas 78744; (830) 792-9677 (e-mail: mitch.lockwood@tpwd.texas.gov); or via the department's website at www.tpwd.texas.gov. ***

 

Greetings TPWD, Director Big Game Mitch Lockwood et al,

 

I would kindly like to comment and submit the following pertaining to the ;

 

TPWD proposes the repeal of §§65.90 -65.94 and new §§65.90 -65.99 Concerning Chronic Wasting Disease - Movement of Deer

 

My comments and source reference pertaining to my comments are as follows;

 

If we don’t get serious about the TSE Prion disease, all of them, and what we really need to do, and do it, it may be too late.

 

some of the industry claims that cwd has been here a long time and will just die out.

 

I don’t believe that, and how did that work our for Scrapie (same as cwd). if we continue to ignore the CWD TSE prion, it will only get worse.

 

all hunter kill cervid must be tested for CWD, this should be mandatory in every state, and it should say it on your tags.

 

you can’t have one state making up a set of cwd tse prion rules based on how they might read the science and policy there from, and not have the rest of the states reading the science the same way and making the same policy making decisions for the cwd tse prion, and then import and export between them. it just does not work.

 

the states must get on the same page, and the only way that will happen is to have it mandatory and regulated by the feds, however, we must make sure the feds are on the same page with sound science, and in doing this, we must have sound cwd tse prion policy making, from science by scientist, not by paid lobbyist, politicians, or scientist they have in their pockets$

 

stop all transport of cervid and cervid carcasses from state to state, any and all parts, and even between counties in one state where cwd risk factor is.

 

trucking cwd tse prion around is a real risk factor, down to the dirt on the tires, and dirt on the clothes or shoes of any person or animal that has been exposed to cwd tse prion.

 

cwd tse prion has the capabilities of exposing water tables, land, the surrounding environment, fence line, furniture, and plants, down to the knife and equipment you use to clean a deer or elk.

 

stop baiting period. the congregation of cervid by unnatural means whether or not it’s a pile of corn or a field of planted lettuce and such, bottom line, you congregate cervid in one place, and over time, the shedding of the CWD TSE Prion will load up the environment, and given enough time, everything will be exposed or contaminated.

 

stop urine use for scents.

 

stop the use of mineral blocks.

 

stop the feeding grounds at state parks.

 

stop the loophole that still allows animal protein being fed to cervid.

 

cwd tse prion testing must be enhanced in all states, with a large increase in all cwd tse prion testing across the board.

 

scorched earth policy must be adhered to. kill everything, and test it with validated cwd tse prion test, until a live validated test is ready, one that can guaranty without any doubt, to be 100% in all cervid, of all age groups.

 

killing and field dressing a cervid in the wild has it’s risk factors for the cwd tse prion to spread, due to environmental risk factors, if that cervid is infected with CWD tse prion. proper carcass disposal is critical.

 

game farms help spread cwd, simple fact. it’s been proven. game farms are not the only risk factor though, however, they are a big part of the problem, history shows this.

 

the quarantine of cwd tse prion infected game farms must be extended to 16 years now.

 

the CWD LOTTO ENTITLEMENT of captive game farms where the states pays game farms for CWD MUST BE STOPPED. if the cwd infected farm does not buy insurance for any and all loss from CWD for them and any party that does business with them, and or any loss to the state, and or any products there from, that’s to bad, they should never be allowed to be permitted. in fact, for any state that does allow game farming, urine mills, sperm mills, antler mills, velvet mills, big high fence ranch, little low fence farm, in my opinion, it’s that states responsibility to protect that state, thus, any states that allow these farms and business there from, it should be mandatory before any permit is allowed, that game farm must have enough personal insurance that would cover that farm, any farm that does business with them, and or any products there from, and the state, before such permit is issued. personally, I am sick and tired of all the big ag entitlement programs, and that’s all cwd indemnity is. in fact, the USDA CWD INDEMNITY PROGRAM, should read, THE USDA CWD ENTITLEMENT PROGRAM.

 

we cannot, and must not, let the industry regulate itself, especially with the junk science they try to use. it’s just not working, and it’s been going on long enough.

 

if they are not going to be science based, they must be banned.

 

science has told us for 3 decade or longer, that these are the things that _might_ work, yet thanks to the industry, and government catering to industry, regulations there from have failed, because of catering to the industry, and the cwd tse prion agent has continued to spread during this time. a fine example is Texas.

 

>>>Another alternative would be an absolute prohibition on the movement of deer within the state for any purpose. While this alternative would significantly reduce the potential spread of CWD, it would also have the simultaneous effect of preventing landowners and land managers from implementing popular management strategies involving the movement of deer, and would deprive deer breeders of the ability to engage in the business of buying and selling breeder deer. Therefore, this alternative was rejected because the department determined that it placed an avoidable burden on the regulated community.<<<

 

Thursday, April 07, 2016

 

What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016

 

Sheep and cattle may be exposed to CWD via common grazing areas with affected deer but so far, appear to be poorly susceptible to mule deer CWD (Sigurdson, 2008).

 

***In contrast, cattle are highly susceptible to white-tailed deer CWD and mule deer CWD in experimental conditions but no natural CWD infections in cattle have been reported (Sigurdson, 2008; Hamir et al., 2006). It is not known how susceptible humans are to CWD but given that the prion can be present in muscle, it is likely that humans have been exposed to the agent via consumption of venison (Sigurdson, 2008). Initial experimental research, however, suggests that human susceptibility to CWD is low and there may be a robust species barrier for CWD transmission to humans (Sigurdson, 2008). It is apparent, though, that CWD is affecting wild and farmed cervid populations in endemic areas with some deer populations decreasing as a result.

 

snip...

 

For the purpose of the qualitative risk assessment developed here it is necessary to estimate the probability that a 30-ml bottle of lure contains urine from an infected deer. This requires an estimate of the proportion of deer herds in the USA which are infected with CWD together with the within herd prevalence.

 

The distribution map of CWD in US shows it is present mainly in central states (Figure 1). However, Virginia in the east of the country has recorded seven recent cases of CWD (Anon 2015a). Some US manufacturers claim to take steps to prevent urine being taken from infected animals eg by sourcing from farms where the deer are randomly tested for CWD (Anon 2015a). However, if disease is already present and testing is not carried out regularly, captive populations are not necessarily disease free (Strausser 2014). Urine-based deer lures have been known to be collected from domestic white-tailed deer herds and therefore there is a recognised risk. This is reflected by 6 US States which have

 

14

 

banned the use of natural deer urine for lures, as the deer urine may be sourced from CWD-endemic areas in the USA as well as from areas free of CWD. For example, the US State of Virginia is banning the use of urine-based deer lures on July 2015 and Vermont from 2016 due to the risk of spread of CWD. Alaska banned their use in 2012 (Anon 2015a). Pennsylvania Game Commission has banned urine-based deer lures and acknowledged that there is no way to detect their use (Strausser 2014). On the basis of unpublished data (J. Manson, Pers. Comm.) it appears that up to 50% of deer herds can be infected with 80-90% of animals infected within some herds.

 

*** It is therefore assumed that probability that a 30-ml bottle of deer urine lure imported from the USA is sources from an infected deer is medium.

 

SNIP...

 

In the USA, under the Food and Drug Administration’s BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients.

 

***For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system.

 

***However, this recommendation is guidance and not a requirement by law.

 

***Animals considered at high risk for CWD include:

 

***1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and

 

***2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.

 

***Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants. The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB cannot be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the very low tonnage of non-fish origin processed animal proteins that were imported from US into GB.

 

*** Overall, therefore, it is considered there is a greater than negligible risk that (non-ruminant) animal feed and pet food containing deer and/or elk protein is imported into GB. There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.

 

SNIP...

 

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/514401/qra-chronic-wasting-disease.pdf

 

Summary and MORE HERE ;

 

What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016

 

http://chronic-wasting-disease.blogspot.com/2016/04/what-is-risk-of-chronic-wasting-disease.html

 

Sunday, March 20, 2016

 

Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

http://chronic-wasting-disease.blogspot.com/2016/03/docket-no-fda-2003-d-0432-formerly-03d.html

 

Tuesday, March 15, 2016

 

Docket No. FDA-2016-N-0321 Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin; Request for Comments, Scientific Data, and Information Singeltary Submission

 

http://animalhealthreportpriontse.blogspot.com/2016/03/docket-no-fda-2016-n-0321-risk.html

 

PRION 2016 TOKYO

 

Zoonotic Potential of CWD Prions: An Update

 

Ignazio Cali1, Liuting Qing1, Jue Yuan1, Shenghai Huang2, Diane Kofskey1,3, Nicholas Maurer1, Debbie McKenzie4, Jiri Safar1,3,5, Wenquan Zou1,3,5,6, Pierluigi Gambetti1, Qingzhong Kong1,5,6

 

1Department of Pathology, 3National Prion Disease Pathology Surveillance Center, 5Department of Neurology, 6National Center for Regenerative Medicine, Case Western Reserve University, Cleveland, OH 44106, USA.

 

4Department of Biological Sciences and Center for Prions and Protein Folding Diseases, University of Alberta, Edmonton, Alberta, Canada,

 

2Encore Health Resources, 1331 Lamar St, Houston, TX 77010

 

Chronic wasting disease (CWD) is a widespread and highly transmissible prion disease in free-ranging and captive cervid species in North America. The zoonotic potential of CWD prions is a serious public health concern, but the susceptibility of human CNS and peripheral organs to CWD prions remains largely unresolved. We reported earlier that peripheral and CNS infections were detected in transgenic mice expressing human PrP129M or PrP129V. Here we will present an update on this project, including evidence for strain dependence and influence of cervid PrP polymorphisms on CWD zoonosis as well as the characteristics of experimental human CWD prions.

 

PRION 2016 TOKYO

 

In Conjunction with Asia Pacific Prion Symposium 2016

 

PRION 2016 Tokyo

 

Prion 2016

 

http://prion2016.org/dl/newsletter_03.pdf

 

LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$

 

*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***

 

http://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249

 

PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS

 

*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE ***

 

O18

 

Zoonotic Potential of CWD Prions

 

Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA

 

*** These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.

 

==================

 

***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***

 

==================

 

P.105: RT-QuIC models trans-species prion transmission

 

Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA

 

Conversely, FSE maintained sufficient BSE characteristics to more efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was competent for conversion by CWD and fCWD.

 

***This insinuates that, at the level of proteinrotein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.

 

================

 

***This insinuates that, at the level of proteinrotein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***

 

================

 

http://prion2015.files.wordpress.com/2015/05/programguide1.pdf

 

*** PRICE OF CWD TSE PRION POKER GOES UP 2014 ***

 

Transmissible Spongiform Encephalopathy TSE PRION update January 2, 2014

 

*** chronic wasting disease, there was no absolute barrier to conversion of the human prion protein.

 

*** Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype.

 

http://wwwnc.cdc.gov/eid/article/20/1/13-0858_article.htm

 

http://chronic-wasting-disease.blogspot.com/2014/01/molecular-barriers-to-zoonotic.html

 

*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***

 

http://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249

 

*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.

 

http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf

 

Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online

 

Taylor & Francis

 

Prion 2016 Animal Prion Disease Workshop Abstracts

 

WS-01: Prion diseases in animals and zoonotic potential

 

Juan Maria Torres a, Olivier Andreoletti b, J uan-Carlos Espinosa a. Vincent Beringue c. Patricia Aguilar a,

 

Natalia Fernandez-Borges a. and Alba Marin-Moreno a

 

"Centro de Investigacion en Sanidad Animal ( CISA-INIA ). Valdeolmos, Madrid. Spain; b UMR INRA -ENVT 1225 Interactions Holes Agents Pathogenes. ENVT. Toulouse. France: "UR892. Virologie lmmunologie MolécuIaires, Jouy-en-Josas. France

 

Dietary exposure to bovine spongiform encephalopathy (BSE) contaminated bovine tissues is considered as the origin of variant Creutzfeldt Jakob (vCJD) disease in human. To date, BSE agent is the only recognized zoonotic prion. Despite the variety of Transmissible Spongiform Encephalopathy (TSE) agents that have been circulating for centuries in farmed ruminants there is no apparent epidemiological link between exposure to ruminant products and the occurrence of other form of TSE in human like sporadic Creutzfeldt Jakob Disease (sCJD). However, the zoonotic potential of the diversity of circulating TSE agents has never been systematically assessed. The major issue in experimental assessment of TSEs zoonotic potential lies in the modeling of the ‘species barrier‘, the biological phenomenon that limits TSE agents’ propagation from a species to another. In the last decade, mice genetically engineered to express normal forms of the human prion protein has proved essential in studying human prions pathogenesis and modeling the capacity of TSEs to cross the human species barrier.

 

To assess the zoonotic potential of prions circulating in farmed ruminants, we study their transmission ability in transgenic mice expressing human PrPC (HuPrP-Tg). Two lines of mice expressing different forms of the human PrPC (129Met or 129Val) are used to determine the role of the Met129Val dimorphism in susceptibility/resistance to the different agents.

 

These transmission experiments confirm the ability of BSE prions to propagate in 129M- HuPrP-Tg mice and demonstrate that Met129 homozygotes may be susceptible to BSE in sheep or goat to a greater degree than the BSE agent in cattle and that these agents can convey molecular properties and neuropathological indistinguishable from vCJD. However homozygous 129V mice are resistant to all tested BSE derived prions independently of the originating species suggesting a higher transmission barrier for 129V-PrP variant.

 

Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions.

 

http://www.tandfonline.com/na101/home/literatum/publisher/tandf/journals/content/kprn20/2016/kprn20.v010.sup01/19336896.2016.1163048/20160418/19336896.2016.1163048.fp.png_v03

 

Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

 

Title: Transmission of scrapie prions to primate after an extended silent incubation period

 

Authors

 

item Comoy, Emmanuel - item Mikol, Jacqueline - item Luccantoni-Freire, Sophie - item Correia, Evelyne - item Lescoutra-Etchegaray, Nathalie - item Durand, Valérie - item Dehen, Capucine - item Andreoletti, Olivier - item Casalone, Cristina - item Richt, Juergen item Greenlee, Justin item Baron, Thierry - item Benestad, Sylvie - item Hills, Bob - item Brown, Paul - item Deslys, Jean-Philippe -

 

Submitted to: Scientific Reports Publication Type: Peer Reviewed Journal Publication Acceptance Date: May 28, 2015 Publication Date: June 30, 2015 Citation: Comoy, E.E., Mikol, J., Luccantoni-Freire, S., Correia, E., Lescoutra-Etchegaray, N., Durand, V., Dehen, C., Andreoletti, O., Casalone, C., Richt, J.A., Greenlee, J.J., Baron, T., Benestad, S., Brown, P., Deslys, J. 2015. Transmission of scrapie prions to primate after an extended silent incubation period. Scientific Reports. 5:11573.

 

Interpretive Summary: The transmissible spongiform encephalopathies (also called prion diseases) are fatal neurodegenerative diseases that affect animals and humans. The agent of prion diseases is a misfolded form of the prion protein that is resistant to breakdown by the host cells. Since all mammals express prion protein on the surface of various cells such as neurons, all mammals are, in theory, capable of replicating prion diseases. One example of a prion disease, bovine spongiform encephalopathy (BSE; also called mad cow disease), has been shown to infect cattle, sheep, exotic undulates, cats, non-human primates, and humans when the new host is exposed to feeds or foods contaminated with the disease agent. The purpose of this study was to test whether non-human primates (cynomologous macaque) are susceptible to the agent of sheep scrapie. After an incubation period of approximately 10 years a macaque developed progressive clinical signs suggestive of neurologic disease. Upon postmortem examination and microscopic examination of tissues, there was a widespread distribution of lesions consistent with a transmissible spongiform encephalopathy. This information will have a scientific impact since it is the first study that demonstrates the transmission of scrapie to a non-human primate with a close genetic relationship to humans. This information is especially useful to regulatory officials and those involved with risk assessment of the potential transmission of animal prion diseases to humans. Technical Abstract: Classical bovine spongiform encephalopathy (c-BSE) is an animal prion disease that also causes variant Creutzfeldt-Jakob disease in humans. Over the past decades, c-BSE's zoonotic potential has been the driving force in establishing extensive protective measures for animal and human health.

 

*** In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS.

 

*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated.

 

*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains.

 

http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160

 

Saturday, April 23, 2016

 

Prion 2016 Tokyo

 

SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016

 

Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online

 

http://scrapie-usa.blogspot.com/2016/04/scrapie-ws-01-prion-diseases-in-animals.html

 

Thursday, April 07, 2016

 

 What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016

 

 Sheep and cattle may be exposed to CWD via common grazing areas with affected deer but so far, appear to be poorly susceptible to mule deer CWD (Sigurdson, 2008).

 

 ***In contrast, cattle are highly susceptible to white-tailed deer CWD and mule deer CWD in experimental conditions but no natural CWD infections in cattle have been reported (Sigurdson, 2008; Hamir et al., 2006). It is not known how susceptible humans are to CWD but given that the prion can be present in muscle, it is likely that humans have been exposed to the agent via consumption of venison (Sigurdson, 2008). Initial experimental research, however, suggests that human susceptibility to CWD is low and there may be a robust species barrier for CWD transmission to humans (Sigurdson, 2008). It is apparent, though, that CWD is affecting wild and farmed cervid populations in endemic areas with some deer populations decreasing as a result.

 

 snip...

 

 For the purpose of the qualitative risk assessment developed here it is necessary to estimate the probability that a 30-ml bottle of lure contains urine from an infected deer. This requires an estimate of the proportion of deer herds in the USA which are infected with CWD together with the within herd prevalence.

 

 The distribution map of CWD in US shows it is present mainly in central states (Figure 1). However, Virginia in the east of the country has recorded seven recent cases of CWD (Anon 2015a). Some US manufacturers claim to take steps to prevent urine being taken from infected animals eg by sourcing from farms where the deer are randomly tested for CWD (Anon 2015a). However, if disease is already present and testing is not carried out regularly, captive populations are not necessarily disease free (Strausser 2014). Urine-based deer lures have been known to be collected from domestic white-tailed deer herds and therefore there is a recognised risk. This is reflected by 6 US States which have

 

 14

 

 banned the use of natural deer urine for lures, as the deer urine may be sourced from CWD-endemic areas in the USA as well as from areas free of CWD. For example, the US State of Virginia is banning the use of urine-based deer lures on July 2015 and Vermont from 2016 due to the risk of spread of CWD. Alaska banned their use in 2012 (Anon 2015a). Pennsylvania Game Commission has banned urine-based deer lures and acknowledged that there is no way to detect their use (Strausser 2014). On the basis of unpublished data (J. Manson, Pers. Comm.) it appears that up to 50% of deer herds can be infected with 80-90% of animals infected within some herds.

 

 *** It is therefore assumed that probability that a 30-ml bottle of deer urine lure imported from the USA is sources from an infected deer is medium.

 

 SNIP...

 

 In the USA, under the Food and Drug Administration’s BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. ***For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system. ***However, this recommendation is guidance and not a requirement by law.

 

 ***Animals considered at high risk for CWD include:

 

 ***1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and

 

 ***2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.

 

 ***Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants. The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB cannot be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the very low tonnage of non-fish origin processed animal proteins that were imported from US into GB.

 

 *** Overall, therefore, it is considered there is a greater than negligible risk that (non-ruminant) animal feed and pet food containing deer and/or elk protein is imported into GB. There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.

 

 SNIP...

 

 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/514401/qra-chronic-wasting-disease.pdf

 

 Summary and MORE HERE ;

 

 What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016

 

 http://chronic-wasting-disease.blogspot.com/2016/04/what-is-risk-of-chronic-wasting-disease.html

 

 Tuesday, April 12, 2016

 

The first detection of Chronic Wasting Disease (CWD) in Europe

 

http://chronic-wasting-disease.blogspot.com/2016/04/the-first-detection-of-chronic-wasting.html

 

Saturday, January 31, 2015

 

 European red deer (Cervus elaphus elaphus) are susceptible to Bovine Spongiform Encephalopathy BSE by Oral Alimentary route

 

 http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0116094

 

 http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html

 

 I strenuously once again urge the FDA and its industry constituents, to make it MANDATORY that all ruminant feed be banned to all ruminants, and this should include all cervids as soon as possible for the following reasons...

 

 ======

 

 In the USA, under the Food and Drug Administrations BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system.

 

 ***However, this recommendation is guidance and not a requirement by law.

 

 ======

 

 31 Jan 2015 at 20:14 GMT

 

 *** Ruminant feed ban for cervids in the United States? ***

 

 31 Jan 2015 at 20:14 GMT

 

 see Singeltary comment ;

 

 http://www.plosone.org/annotation/listThread.action?root=85351

 

 Monday, March 28, 2016

 

 National Scrapie Eradication Program February 2016 Monthly Report

 

 http://scrapie-usa.blogspot.com/2016/03/national-scrapie-eradication-program.html

 

 Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

 Greetings again FDA and Mr. Pritchett et al,

 

 I would kindly like to comment on ;

 

 Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

 #158

 

 Guidance for Industry

 

 Use of Material from Deer and Elk in Animal Feed

 

 This version of the guidance replaces the version made available September15, 2003.

 

 This document has been revised to update the docket number, contact information, and standard disclosures. Submit comments on this guidance at any time.

 

 Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket No. FDA-2003-D-0432 (formerly 03D-0186).

 

 For further information regarding this guidance, contact Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-6276, E-mail: burt.pritchett@fda.hhs.gov.

 

 Additional copies of this guidance document may be requested from the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov.

 

 U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine March 2016

 

 Contains Nonbinding Recommendations

 

 2

 

 Guidance for Industry Use of Material from Deer and Elk in Animal Feed

 

 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

 

 I. Introduction

 

 Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer and elk is prohibited for use in feed for ruminant animals. This guidance document describes FDA’s recommendations regarding the use in all animal feed of all material from deer and elk that are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD. The potential risks from CWD to humans or non-cervid animals such as poultry and swine are not well understood. However, because of recent recognition that CWD is spreading rapidly in white-tailed deer, and because CWD’s route of transmission is poorly understood, FDA is making recommendations regarding the use in animal feed of rendered materials from deer and elk that are CWD-positive or that are at high risk for CWD.

 

 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

 

 II. Background

 

 CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for CWD that can be used to test for the disease in live animals.

 

 Contains Nonbinding Recommendations

 

 III. Use in animal feed of material from CWD-positive deer and elk

 

 Material from CWD-positive animals may not be used in any animal feed or feed ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act, animal feed and feed ingredients containing material from a CWD-positive animal would be considered adulterated. FDA recommends that any such adulterated feed or feed ingredients be recalled or otherwise removed from the marketplace.

 

 IV. Use in animal feed of material from deer and elk considered at high risk for CWD Deer and elk considered at high risk for CWD include: (1) animals from areas declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that at some time during the 60-month period immediately before the time of slaughter were in a captive herd that contained a CWD-positive animal.

 

 FDA recommends that materials from deer and elk considered at high risk for CWD no longer be entered into the animal feed system. Under present circumstances, FDA is not recommending that feed made from deer and elk from a non-endemic area be recalled if a State later declares the area endemic for CWD or a CWD eradication zone. In addition, at this time, FDA is not recommending that feed made from deer and elk believed to be from a captive herd that contained no CWD-positive animals be recalled if that herd is subsequently found to contain a CWD-positive animal.

 

 V. Use in animal feed of material from deer and elk NOT considered at high risk for CWD FDA continues to consider materials from deer and elk NOT considered at high risk for CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk include: (1) deer and elk from areas not declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some time during the 60-month period immediately before the time of slaughter in a captive herd that contained a CWD-positive animal.

 

 3

 

 http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052506.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

 Greetings again FDA and Mr. Pritchett et al,

 

 MY comments and source reference of sound science on this very important issue are as follows ;

 

 Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

 I kindly wish to once again submit to Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed.

 

 Thank you kindly for allowing me to comment again, ...and again...and again, on a topic so important, why it is ‘NON-BINDING’ is beyond me.

 

 this should have been finalized and made ‘BINDING’ or MANDATORY OVER A DECADE AGO.

 

 but here lay the problem, once made ‘BINDING’ or ‘MANDATORY’, it is still nothing but ink on paper.

 

 we have had a mad cow feed ban in place since August 1997, and since then, literally 100s of millions of pounds BANNED MAD COW FEED has been sent out to commerce and fed out (see reference materials).

 

 ENFORCEMENT OF SAID BINDING REGULATIONS HAS FAILED US TOO MANY TIMES.

 

 so, in my opinion, any non-binding or voluntary regulations will not work, and to state further, ‘BINDING’ or MANDATORY regulations will not work unless enforced.

 

 with that said, we know that Chronic Wasting Disease CWD TSE Prion easily transmits to other cervid through the oral route.

 

 the old transmission studies of BSE TSE floored scientist once they figured out what they had, and please don’t forget about those mink that were fed 95%+ dead stock downer cow, that all came down with TME. please see ;

 

 It is clear that the designing scientists must also have shared Mr Bradleys surprise at the results because all the dose levels right down to 1 gram triggered infection.

 

 http://web.archive.org/web/20061003022720/http://www.bseinquiry.gov.uk/files/ws/s145d.pdf

 

 it is clear that the designing scientists must have also shared Mr Bradleys surprise at the results because all the dose levels right down to 1 gram triggered infection.

 

 http://web.archive.org/web/20030526212610/http://www.bseinquiry.gov.uk/files/ws/s147f.pdf

 

 Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle

 

 Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.

 

 snip...

 

 The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...

 

 http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/mb/m09/tab05.pdf

 

 *** PLEASE SEE THIS URGENT UPDATE ON CWD AND FEED ANIMAL PROTEIN ***

 

 Sunday, March 20, 2016

 

 Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed ***UPDATED MARCH 2016*** Singeltary Submission

 

 http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052506.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 http://chronic-wasting-disease.blogspot.com/2016/03/docket-no-fda-2003-d-0432-formerly-03d.html

 

*** Infectious agent of sheep scrapie may persist in the environment for at least 16 years ***

 

Gudmundur Georgsson1, Sigurdur Sigurdarson2 and Paul Brown3

 

http://jgv.sgmjournals.org/content/87/12/3737.full

 

 Using in vitro prion replication for high sensitive detection of prions and prionlike proteins and for understanding mechanisms of transmission.

 

Claudio Soto

 

Mitchell Center for Alzheimer's diseases and related Brain disorders, Department of Neurology, University of Texas Medical School at Houston.

 

Prion and prion-like proteins are misfolded protein aggregates with the ability to selfpropagate to spread disease between cells, organs and in some cases across individuals. I n T r a n s m i s s i b l e s p o n g i f o r m encephalopathies (TSEs), prions are mostly composed by a misfolded form of the prion protein (PrPSc), which propagates by transmitting its misfolding to the normal prion protein (PrPC). The availability of a procedure to replicate prions in the laboratory may be important to study the mechanism of prion and prion-like spreading and to develop high sensitive detection of small quantities of misfolded proteins in biological fluids, tissues and environmental samples. Protein Misfolding Cyclic Amplification (PMCA) is a simple, fast and efficient methodology to mimic prion replication in the test tube. PMCA is a platform technology that may enable amplification of any prion-like misfolded protein aggregating through a seeding/nucleation process. In TSEs, PMCA is able to detect the equivalent of one single molecule of infectious PrPSc and propagate prions that maintain high infectivity, strain properties and species specificity. Using PMCA we have been able to detect PrPSc in blood and urine of experimentally infected animals and humans affected by vCJD with high sensitivity and specificity. Recently, we have expanded the principles of PMCA to amplify amyloid-beta (Aβ) and alphasynuclein (α-syn) aggregates implicated in Alzheimer's and Parkinson's diseases, respectively. Experiments are ongoing to study the utility of this technology to detect Aβ and α-syn aggregates in samples of CSF and blood from patients affected by these diseases.

 

=========================

 

***Recently, we have been using PMCA to study the role of environmental prion contamination on the horizontal spreading of TSEs. These experiments have focused on the study of the interaction of prions with plants and environmentally relevant surfaces. Our results show that plants (both leaves and roots) bind tightly to prions present in brain extracts and excreta (urine and feces) and retain even small quantities of PrPSc for long periods of time. Strikingly, ingestion of prioncontaminated leaves and roots produced disease with a 100% attack rate and an incubation period not substantially longer than feeding animals directly with scrapie brain homogenate. Furthermore, plants can uptake prions from contaminated soil and transport them to different parts of the plant tissue (stem and leaves). Similarly, prions bind tightly to a variety of environmentally relevant surfaces, including stones, wood, metals, plastic, glass, cement, etc. Prion contaminated surfaces efficiently transmit prion disease when these materials were directly injected into the brain of animals and strikingly when the contaminated surfaces were just placed in the animal cage. These findings demonstrate that environmental materials can efficiently bind infectious prions and act as carriers of infectivity, suggesting that they may play an important role in the horizontal transmission of the disease.

 

========================

 

Since its invention 13 years ago, PMCA has helped to answer fundamental questions of prion propagation and has broad applications in research areas including the food industry, blood bank safety and human and veterinary disease diagnosis.

 

https://prion2015.files.wordpress.com/2015/05/programguide1.pdf

 

see ;

 

with CWD TSE Prions, I am not sure there is any absolute yet, other than what we know with transmission studies, and we know tse prion kill, and tse prion are bad. science shows to date, that indeed soil, dirt, some better than others, can act as a carrier. same with objects, farm furniture. take it with how ever many grains of salt you wish, or not. if load factor plays a role in the end formula, then everything should be on the table, in my opinion. see ;

 

***Recently, we have been using PMCA to study the role of environmental prion contamination on the horizontal spreading of TSEs. These experiments have focused on the study of the interaction of prions with plants and environmentally relevant surfaces. Our results show that plants (both leaves and roots) bind tightly to prions present in brain extracts and excreta (urine and feces) and retain even small quantities of PrPSc for long periods of time. Strikingly, ingestion of prioncontaminated leaves and roots produced disease with a 100% attack rate and an incubation period not substantially longer than feeding animals directly with scrapie brain homogenate. Furthermore, plants can uptake prions from contaminated soil and transport them to different parts of the plant tissue (stem and leaves). Similarly, prions bind tightly to a variety of environmentally relevant surfaces, including stones, wood, metals, plastic, glass, cement, etc. Prion contaminated surfaces efficiently transmit prion disease when these materials were directly injected into the brain of animals and strikingly when the contaminated surfaces were just placed in the animal cage. These findings demonstrate that environmental materials can efficiently bind infectious prions and act as carriers of infectivity, suggesting that they may play an important role in the horizontal transmission of the disease.

 

Since its invention 13 years ago, PMCA has helped to answer fundamental questions of prion propagation and has broad applications in research areas including the food industry, blood bank safety and human and veterinary disease diagnosis.

 

https://prion2015.files.wordpress.com/2015/05/programguide1.pdf

 

see ;

 

http://www.tandfonline.com/doi/pdf/10.4161/pri.28467

 

Oral Transmissibility of Prion Disease Is Enhanced by Binding to Soil Particles

 

Author Summary

 

Transmissible spongiform encephalopathies (TSEs) are a group of incurable neurological diseases likely caused by a misfolded form of the prion protein. TSEs include scrapie in sheep, bovine spongiform encephalopathy (‘‘mad cow’’ disease) in cattle, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease in humans. Scrapie and chronic wasting disease are unique among TSEs because they can be transmitted between animals, and the disease agents appear to persist in environments previously inhabited by infected animals. Soil has been hypothesized to act as a reservoir of infectivity and to bind the infectious agent. In the current study, we orally dosed experimental animals with a common clay mineral, montmorillonite, or whole soils laden with infectious prions, and compared the transmissibility to unbound agent. We found that prions bound to montmorillonite and whole soils remained orally infectious, and, in most cases, increased the oral transmission of disease compared to the unbound agent. The results presented in this study suggest that soil may contribute to environmental spread of TSEs by increasing the transmissibility of small amounts of infectious agent in the environment.

 

https://www.aphis.usda.gov/emergency_response/downloads/tools/johnson%20et%20al%20prions%20in%20soil.pdf

 

tse prion soil

 

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058630

 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567181/pdf/ppat.1003113.pdf

 

http://www.nature.com/srep/2015/150210/srep08358/full/srep08358.html?WT.ec_id=SREP-639-20150217

 

http://www.cell.com/cell-reports/pdfExtended/S2211-1247(15)00437-4

 

Wednesday, December 16, 2015

 

Objects in contact with classical scrapie sheep act as a reservoir for scrapie transmission

 

http://journal.frontiersin.org/article/10.3389/fvets.2015.00032/full

 

The sources of dust borne prions are unknown but it seems reasonable to assume that faecal, urine, skin, parturient material and saliva-derived prions may contribute to this mobile environmental reservoir of infectivity. This work highlights a possible transmission route for scrapie within the farm environment, and this is likely to be paralleled in CWD which shows strong similarities with scrapie in terms of prion dissemination and disease transmission. The data indicate that the presence of scrapie prions in dust is likely to make the control of these diseases a considerable challenge.

 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4397813/pdf/13567_2015_Article_176.pdf

 

>>>Particle-associated PrPTSE molecules may migrate from locations of deposition via transport processes affecting soil particles, including entrainment in and movement with air and overland flow. <<<

 

Fate of Prions in Soil: A Review

 

Christen B. Smith, Clarissa J. Booth, and Joel A. Pedersen*

 

Several reports have shown that prions can persist in soil for several years. Significant interest remains in developing methods that could be applied to degrade PrPTSE in naturally contaminated soils. Preliminary research suggests that serine proteases and the microbial consortia in stimulated soils and compost may partially degrade PrPTSE. Transition metal oxides in soil (viz. manganese oxide) may also mediate prion inactivation. Overall, the effect of prion attachment to soil particles on its persistence in the environment is not well understood, and additional study is needed to determine its implications on the environmental transmission of scrapie and CWD.

 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160281/

 

P.161: Prion soil binding may explain efficient horizontal CWD transmission

 

Conclusion. Silty clay loam exhibits highly efficient prion binding, inferring a durable environmental reservoir, and an efficient mechanism for indirect horizontal CWD transmission.

 

https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf

 

>>>Another alternative would be an absolute prohibition on the movement of deer within the state for any purpose. While this alternative would significantly reduce the potential spread of CWD, it would also have the simultaneous effect of preventing landowners and land managers from implementing popular management strategies involving the movement of deer, and would deprive deer breeders of the ability to engage in the business of buying and selling breeder deer. Therefore, this alternative was rejected because the department determined that it placed an avoidable burden on the regulated community.<<<

 

Wednesday, December 16, 2015

 

Objects in contact with classical scrapie sheep act as a reservoir for scrapie transmission

 

Objects in contact with classical scrapie sheep act as a reservoir for scrapie transmission

 

Timm Konold1*, Stephen A. C. Hawkins2, Lisa C. Thurston3, Ben C. Maddison4, Kevin C. Gough5, Anthony Duarte1 and Hugh A. Simmons1

 

1 Animal Sciences Unit, Animal and Plant Health Agency Weybridge, Addlestone, UK, 2 Pathology Department, Animal and Plant Health Agency Weybridge, Addlestone, UK, 3 Surveillance and Laboratory Services, Animal and Plant Health Agency Penrith, Penrith, UK, 4 ADAS UK, School of Veterinary Medicine and Science, University of Nottingham, Sutton Bonington, UK, 5 School of Veterinary Medicine and Science, University of Nottingham, Sutton Bonington, UK

 

Classical scrapie is an environmentally transmissible prion disease of sheep and goats. Prions can persist and remain potentially infectious in the environment for many years and thus pose a risk of infecting animals after re-stocking. In vitro studies using serial protein misfolding cyclic amplification (sPMCA) have suggested that objects on a scrapie affected sheep farm could contribute to disease transmission. This in vivo study aimed to determine the role of field furniture (water troughs, feeding troughs, fencing, and other objects that sheep may rub against) used by a scrapie-infected sheep flock as a vector for disease transmission to scrapie-free lambs with the prion protein genotype VRQ/VRQ, which is associated with high susceptibility to classical scrapie. When the field furniture was placed in clean accommodation, sheep became infected when exposed to either a water trough (four out of five) or to objects used for rubbing (four out of seven). This field furniture had been used by the scrapie-infected flock 8 weeks earlier and had previously been shown to harbor scrapie prions by sPMCA. Sheep also became infected (20 out of 23) through exposure to contaminated field furniture placed within pasture not used by scrapie-infected sheep for 40 months, even though swabs from this furniture tested negative by PMCA. This infection rate decreased (1 out of 12) on the same paddock after replacement with clean field furniture. Twelve grazing sheep exposed to field furniture not in contact with scrapie-infected sheep for 18 months remained scrapie free. The findings of this study highlight the role of field furniture used by scrapie-infected sheep to act as a reservoir for disease re-introduction although infectivity declines considerably if the field furniture has not been in contact with scrapie-infected sheep for several months. PMCA may not be as sensitive as VRQ/VRQ sheep to test for environmental contamination.

 

snip...

 

Discussion

 

Classical scrapie is an environmentally transmissible disease because it has been reported in naïve, supposedly previously unexposed sheep placed in pastures formerly occupied by scrapie-infected sheep (4, 19, 20). Although the vector for disease transmission is not known, soil is likely to be an important reservoir for prions (2) where – based on studies in rodents – prions can adhere to minerals as a biologically active form (21) and remain infectious for more than 2 years (22). Similarly, chronic wasting disease (CWD) has re-occurred in mule deer housed in paddocks used by infected deer 2 years earlier, which was assumed to be through foraging and soil consumption (23).

 

Our study suggested that the risk of acquiring scrapie infection was greater through exposure to contaminated wooden, plastic, and metal surfaces via water or food troughs, fencing, and hurdles than through grazing. Drinking from a water trough used by the scrapie flock was sufficient to cause infection in sheep in a clean building. Exposure to fences and other objects used for rubbing also led to infection, which supported the hypothesis that skin may be a vector for disease transmission (9). The risk of these objects to cause infection was further demonstrated when 87% of 23 sheep presented with PrPSc in lymphoid tissue after grazing on one of the paddocks, which contained metal hurdles, a metal lamb creep and a water trough in contact with the scrapie flock up to 8 weeks earlier, whereas no infection had been demonstrated previously in sheep grazing on this paddock, when equipped with new fencing and field furniture. When the contaminated furniture and fencing were removed, the infection rate dropped significantly to 8% of 12 sheep, with soil of the paddock as the most likely source of infection caused by shedding of prions from the scrapie-infected sheep in this paddock up to a week earlier.

 

This study also indicated that the level of contamination of field furniture sufficient to cause infection was dependent on two factors: stage of incubation period and time of last use by scrapie-infected sheep. Drinking from a water trough that had been used by scrapie sheep in the predominantly pre-clinical phase did not appear to cause infection, whereas infection was shown in sheep drinking from the water trough used by scrapie sheep in the later stage of the disease. It is possible that contamination occurred through shedding of prions in saliva, which may have contaminated the surface of the water trough and subsequently the water when it was refilled. Contamination appeared to be sufficient to cause infection only if the trough was in contact with sheep that included clinical cases. Indeed, there is an increased risk of bodily fluid infectivity with disease progression in scrapie (24) and CWD (25) based on PrPSc detection by sPMCA. Although ultraviolet light and heat under natural conditions do not inactivate prions (26), furniture in contact with the scrapie flock, which was assumed to be sufficiently contaminated to cause infection, did not act as vector for disease if not used for 18 months, which suggest that the weathering process alone was sufficient to inactivate prions.

 

PrPSc detection by sPMCA is increasingly used as a surrogate for infectivity measurements by bioassay in sheep or mice. In this reported study, however, the levels of PrPSc present in the environment were below the limit of detection of the sPMCA method, yet were still sufficient to cause infection of in-contact animals. In the present study, the outdoor objects were removed from the infected flock 8 weeks prior to sampling and were positive by sPMCA at very low levels (2 out of 37 reactions). As this sPMCA assay also yielded 2 positive reactions out of 139 in samples from the scrapie-free farm, the sPMCA assay could not detect PrPSc on any of the objects above the background of the assay. False positive reactions with sPMCA at a low frequency associated with de novo formation of infectious prions have been reported (27, 28). This is in contrast to our previous study where we demonstrated that outdoor objects that had been in contact with the scrapie-infected flock up to 20 days prior to sampling harbored PrPSc that was detectable by sPMCA analysis [4 out of 15 reactions (12)] and was significantly more positive by the assay compared to analogous samples from the scrapie-free farm. This discrepancy could be due to the use of a different sPMCA substrate between the studies that may alter the efficiency of amplification of the environmental PrPSc. In addition, the present study had a longer timeframe between the objects being in contact with the infected flock and sampling, which may affect the levels of extractable PrPSc. Alternatively, there may be potentially patchy contamination of this furniture with PrPSc, which may have been missed by swabbing. The failure of sPMCA to detect CWD-associated PrP in saliva from clinically affected deer despite confirmation of infectivity in saliva-inoculated transgenic mice was associated with as yet unidentified inhibitors in saliva (29), and it is possible that the sensitivity of sPMCA is affected by other substances in the tested material. In addition, sampling of amplifiable PrPSc and subsequent detection by sPMCA may be more difficult from furniture exposed to weather, which is supported by the observation that PrPSc was detected by sPMCA more frequently in indoor than outdoor furniture (12). A recent experimental study has demonstrated that repeated cycles of drying and wetting of prion-contaminated soil, equivalent to what is expected under natural weathering conditions, could reduce PMCA amplification efficiency and extend the incubation period in hamsters inoculated with soil samples (30). This seems to apply also to this study even though the reduction in infectivity was more dramatic in the sPMCA assays than in the sheep model. Sheep were not kept until clinical end-point, which would have enabled us to compare incubation periods, but the lack of infection in sheep exposed to furniture that had not been in contact with scrapie sheep for a longer time period supports the hypothesis that prion degradation and subsequent loss of infectivity occurs even under natural conditions.

 

In conclusion, the results in the current study indicate that removal of furniture that had been in contact with scrapie-infected animals should be recommended, particularly since cleaning and decontamination may not effectively remove scrapie infectivity (31), even though infectivity declines considerably if the pasture and the field furniture have not been in contact with scrapie-infected sheep for several months. As sPMCA failed to detect PrPSc in furniture that was subjected to weathering, even though exposure led to infection in sheep, this method may not always be reliable in predicting the risk of scrapie infection through environmental contamination. These results suggest that the VRQ/VRQ sheep model may be more sensitive than sPMCA for the detection of environmentally associated scrapie, and suggest that extremely low levels of scrapie contamination are able to cause infection in susceptible sheep genotypes.

 

Keywords: classical scrapie, prion, transmissible spongiform encephalopathy, sheep, field furniture, reservoir, serial protein misfolding cyclic amplification

 

http://journal.frontiersin.org/article/10.3389/fvets.2015.00032/full

 

Wednesday, December 16, 2015

 

*** Objects in contact with classical scrapie sheep act as a reservoir for scrapie transmission ***

 

http://scrapie-usa.blogspot.com/2015/12/objects-in-contact-with-classical.html

 

*** Infectious agent of sheep scrapie may persist in the environment for at least 16 years ***

 

Gudmundur Georgsson1, Sigurdur Sigurdarson2 and Paul Brown3

 

http://jgv.sgmjournals.org/content/87/12/3737.full

 

>>>Another alternative would be an absolute prohibition on the movement of deer within the state for any purpose. While this alternative would significantly reduce the potential spread of CWD, it would also have the simultaneous effect of preventing landowners and land managers from implementing popular management strategies involving the movement of deer, and would deprive deer breeders of the ability to engage in the business of buying and selling breeder deer. Therefore, this alternative was rejected because the department determined that it placed an avoidable burden on the regulated community.<<<

 

Circulation of prions within dust on a scrapie affected farm

 

Kevin C Gough1, Claire A Baker2, Hugh A Simmons3, Steve A Hawkins3 and Ben C Maddison2*

 

Abstract

 

Prion diseases are fatal neurological disorders that affect humans and animals. Scrapie of sheep/goats and Chronic Wasting Disease (CWD) of deer/elk are contagious prion diseases where environmental reservoirs have a direct link to the transmission of disease. Using protein misfolding cyclic amplification we demonstrate that scrapie PrPSc can be detected within circulating dusts that are present on a farm that is naturally contaminated with sheep scrapie. The presence of infectious scrapie within airborne dusts may represent a possible route of infection and illustrates the difficulties that may be associated with the effective decontamination of such scrapie affected premises.

 

snip...

 

Discussion

 

We present biochemical data illustrating the airborne movement of scrapie containing material within a contaminated farm environment. We were able to detect scrapie PrPSc within extracts from dusts collected over a 70 day period, in the absence of any sheep activity. We were also able to detect scrapie PrPSc within dusts collected within pasture at 30 m but not at 60 m distance away from the scrapie contaminated buildings, suggesting that the chance of contamination of pasture by scrapie contaminated dusts decreases with distance from contaminated farm buildings. PrPSc amplification by sPMCA has been shown to correlate with infectivity and amplified products have been shown to be infectious [14,15]. These experiments illustrate the potential for low dose scrapie infectivity to be present within such samples. We estimate low ng levels of scrapie positive brain equivalent were deposited per m2 over 70 days, in a barn previously occupied by sheep affected with scrapie. This movement of dusts and the accumulation of low levels of scrapie infectivity within this environment may in part explain previous observations where despite stringent pen decontamination regimens healthy lambs still became scrapie infected after apparent exposure from their environment alone [16]. The presence of sPMCA seeding activity and by inference, infectious prions within dusts, and their potential for airborne dissemination is highly novel and may have implications for the spread of scrapie within infected premises. The low level circulation and accumulation of scrapie prion containing dust material within the farm environment will likely impede the efficient decontamination of such scrapie contaminated buildings unless all possible reservoirs of dust are removed. Scrapie containing dusts could possibly infect animals during feeding and drinking, and respiratory and conjunctival routes may also be involved. It has been demonstrated that scrapie can be efficiently transmitted via the nasal route in sheep [17], as is also the case for CWD in both murine models and in white tailed deer [18-20].

 

The sources of dust borne prions are unknown but it seems reasonable to assume that faecal, urine, skin, parturient material and saliva-derived prions may contribute to this mobile environmental reservoir of infectivity. This work highlights a possible transmission route for scrapie within the farm environment, and this is likely to be paralleled in CWD which shows strong similarities with scrapie in terms of prion dissemination and disease transmission. The data indicate that the presence of scrapie prions in dust is likely to make the control of these diseases a considerable challenge.

 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4397813/pdf/13567_2015_Article_176.pdf

 

>>>Another alternative would be an absolute prohibition on the movement of deer within the state for any purpose. While this alternative would significantly reduce the potential spread of CWD, it would also have the simultaneous effect of preventing landowners and land managers from implementing popular management strategies involving the movement of deer, and would deprive deer breeders of the ability to engage in the business of buying and selling breeder deer. Therefore, this alternative was rejected because the department determined that it placed an avoidable burden on the regulated community.<<<

 

Monday, April 25, 2016

 

Arkansas AGFC Phase 2 sampling reveals CWD positive deer in Madison and Pope counties

 

http://chronic-wasting-disease.blogspot.com/2016/04/arkansas-agfc-phase-2-sampling-reveals.html

 

Tuesday, April 19, 2016

 

Arkansas First Phase of CWD sampling reveals 23 percent prevalence rate in focal area With 82 Confirmed to Date

 

http://chronic-wasting-disease.blogspot.com/2016/04/arkansas-first-phase-of-cwd-sampling.html

 

 Friday, April 08, 2016

 

Arkansas AGFC Chronic Wasting Disease CWD TSE Prion Confirms 23 Additional Cases Total At 79 To Date

 

http://chronic-wasting-disease.blogspot.com/2016/04/arkansas-agfc-chronic-wasting-disease.html

 

Friday, April 01, 2016

 

ARKANSAS CHRONIC WASTING DISEASE CWD TSE PRION CASES EXPLODE BY 27 NEW CASES WITH 50 CASES TOTAL TO DATE

 

http://chronic-wasting-disease.blogspot.com/2016/04/arkansas-chronic-wasting-disease-cwd.html

 

Tuesday, May 03, 2016

 

*** Arkansas Chronic Wasting Disease CWD TSE Prion and Elk Restoration Project and Hunkering Down in the BSE Situation Room USDA 1998 ***

 

http://chronic-wasting-disease.blogspot.com/2016/05/arkansas-chronic-wasting-disease-cwd.html

 

Friday, April 22, 2016

 

COLORADO CHRONIC WASTING DISEASE CWD TSE PRION SURVEILLANCE AND TESTING PROGRAM IS MINIMAL AND LIMITED

 

http://chronic-wasting-disease.blogspot.com/2016/04/colorado-chronic-wasting-disease-cwd.html

 

Friday, April 22, 2016

 

Missouri MDC finds seven new cases of Chronic Wasting Disease CWD during past season testing

 

http://chronic-wasting-disease.blogspot.com/2016/04/missouri-mdc-finds-seven-new-cases-of.html

 

Wednesday, April 20, 2016

 

UTAH CHRONIC WASTING DISEASE CWD TSE PRION SURVEILLANCE AND TESTING PROGRAM 70 mule deer and two elk have tested positive

 

http://chronic-wasting-disease.blogspot.com/2016/04/utah-chronic-wasting-disease-cwd-tse.html

 

WISCONSIN CWD CASES OUT OF CONTROL

 

Wednesday, March 16, 2016 Wisconsin CWD sample survey 2015 confirms 290 cases of Chronic Wasting Disease TSE Prion

 

http://chronic-wasting-disease.blogspot.com/2016/03/wisconsin-cwd-sample-survey-2015.html

 

KANSAS CWD CASES ALARMING

 

Wednesday, March 02, 2016 Kansas Chronic Wasting Disease CWD TSE Prion 52 cases 2015 updated report 'ALARMING'

 

http://chronic-wasting-disease.blogspot.com/2016/03/kansas-chronic-wasting-disease-cwd-tse.html

 

Tuesday, February 02, 2016

 

Illinois six out of 19 deer samples tested positive for CWD in the Oswego zone of Kendall County

 

http://chronic-wasting-disease.blogspot.com/2016/02/illinois-six-out-of-19-deer-samples.html

 

Friday, April 22, 2016

 

*** Texas Scrapie Confirmed in a Hartley County Sheep where CWD was detected in a Mule Deer

 

http://scrapie-usa.blogspot.com/2016/04/texas-scrapie-confirmed-in-hartley.html

 

Monday, April 25, 2016

 

TEXAS Nilgai Exotic Antelope Let Loose for Trophy Hunts Blamed for Spreading Cattle Tick Fever, and what about CWD TSE Prion Disease ?

 

http://chronic-wasting-disease.blogspot.com/2016/04/texas-nilgai-exotic-antelope-let-loose.html

 

Saturday, April 02, 2016

 

TEXAS TAHC BREAKS IT'S SILENCE WITH TWO MORE CASES CWD CAPTIVE DEER BRINGING TOTAL TO 10 CAPTIVES REPORTED TO DATE

 

http://chronic-wasting-disease.blogspot.com/2016/04/texas-tahc-breaks-its-silence-with-two.html

 

Friday, February 26, 2016

 

TEXAS Hartley County Mule Deer Tests Positive for Chronic Wasting Disease CWD TSE Prion

 

 http://chronic-wasting-disease.blogspot.com/2016/02/texas-hartley-county-mule-deer-tests.html

 

Friday, February 05, 2016

 

TEXAS NEW CHRONIC WASTING DISEASE CWD CASE DISCOVERD AT CAPTIVE DEER RELEASE SITE

 

 http://chronic-wasting-disease.blogspot.com/2016/02/texas-new-chronic-wasting-disease-cwd.html

 

 Saturday, January 23, 2016

 

Texas new interim rule governing Deer Management Permit (DMP) activities as part of the state’s response to the detection of chronic wasting disease (CWD) in captive deer populations

 

http://chronic-wasting-disease.blogspot.com/2016/01/texas-new-interim-rule-governing-deer.html

 

Sunday, January 17, 2016

 

Texas 10,000 deer in Texas tested for deadly disease CWD TSE, but not tested much in the most logical place, the five-mile radius around the Medina County captive-deer facility where it was discovered

 

http://chronic-wasting-disease.blogspot.com/2016/01/texas-10000-deer-in-texas-tested-for.html

 

Friday, January 15, 2016

 

TEXAS PARKS & WILDLIFE CWD Ante-Mortem Testing Symposium Texas Disposal Systems Events Pavilion January 12, 2016

 

http://chronic-wasting-disease.blogspot.com/2016/01/texas-parks-wildlife-cwd-ante-mortem.html

 

Sunday, January 10, 2016

 

TEXAS MEDIA REPORTING A BIT OF GOOD NEWS ON CWD TESTING SO FAR INSTEAD OF TAHC which is still mum, still refusing timely updates to the public TSE PRION DISEASE

 

http://chronic-wasting-disease.blogspot.com/2016/01/texas-media-reporting-bit-of-good-news.html

 

Tuesday, December 29, 2015

 

*** TEXAS MONTHLY CHRONIC WASTING DISEASE CWD JANUARY 2016 DEER BREEDERS STILL DON'T GET IT $

 

Chronic Wasting Unease

 

*** The emergence of a deadly disease has wildlife officials and deer breeders eyeing each other suspiciously. ***

 

http://chronic-wasting-disease.blogspot.com/2015/12/texas-monthly-chronic-wasting-disease.html

 

Monday, November 16, 2015

 

*** TEXAS PARKS AND WILDLIFE DEPARTMENT EXECUTIVE DIRECTOR ORDER NO. 015-006

 

*** Chronic Wasting Disease (CWD) immediate danger to the white-tailed deer and mule deer resources of Texas

 

 http://chronic-wasting-disease.blogspot.com/2015/11/texas-parks-and-wildlife-department.html

 

Saturday, November 14, 2015

 

TEXAS CAPTIVE BREEDER CHRONIC WASTING DISEASE CWD 2 MORE SUSPECTS DECTECTED BRINGING NUMBER TO 7 DETECTED IN CAPTIVE BREEDER (if/when the last two are confirmed).

 

http://chronic-wasting-disease.blogspot.com/2015/11/texas-captive-breeder-chronic-wasting.html

 

Thursday, November 05, 2015

 

*** TPW Commission Adopts Interim Deer Breeder Movement Rules

 

http://chronic-wasting-disease.blogspot.com/2015/11/tpw-commission-adopts-interim-deer.html

 

Friday, October 09, 2015

 

Texas TWA Chronic Wasting Disease TSE Prion Webinars and Meeting October 2015

 

http://chronic-wasting-disease.blogspot.com/2015/10/texas-twa-chronic-wasting-disease-tse.html

 

Saturday, October 03, 2015

 

TEXAS CHRONIC WASTING DISEASE CWD TSE PRION GOD MUST NOT BE A TEXAN 2002 TO 2015

 

 http://chronic-wasting-disease.blogspot.com/2015/10/texas-chronic-wasting-disease-cwd-tse.html

 

Thursday, September 24, 2015

 

TEXAS Hunters Asked to Submit Samples for Chronic Wasting Disease CWD TSE Prion Testing

 

*** I cannot stress enough to all of you, for the sake of your family and mine, before putting anything in the freezer, have those deer tested for CWD. ...terry

 

http://chronic-wasting-disease.blogspot.com/2015/09/texas-hunters-asked-to-submit-samples.html

 

***raw and uncut

 

Sunday, August 23, 2015

 

TAHC Chronic Wasting Disease CWD TSE Prion and how to put lipstick on a pig and take her to the dance in Texas

 

http://chronic-wasting-disease.blogspot.com/2015/08/tahc-chronic-wasting-disease-cwd-tse.html

 

Friday, August 07, 2015

 

*** Texas CWD Captive, and then there were 4 ?

 

http://chronic-wasting-disease.blogspot.com/2015/08/texas-cwd-captive-and-then-there-were-4.html

 

Thursday, August 06, 2015

 

*** WE HAVE LOST TEXAS TO CWD TASK FORCE CATERING TO INDUSTRY

 

http://chronic-wasting-disease.blogspot.com/2015/08/we-have-lost-texas-to-cwd-task-force.html

 

Tuesday, July 21, 2015

 

*** Texas CWD Medina County Herd Investigation Update July 16, 2015 ***

 

http://chronic-wasting-disease.blogspot.com/2015/07/texas-cwd-medina-county-herd.html

 

Thursday, July 09, 2015

 

TEXAS Chronic Wasting Disease (CWD) Herd Plan for Trace-Forward Exposed Herd with Testing of Exposed Animals

 

http://chronic-wasting-disease.blogspot.com/2015/07/texas-chronic-wasting-disease-cwd-herd.html

 

Wednesday, July 01, 2015

 

TEXAS Chronic Wasting Disease Detected in Medina County Captive Deer

 

http://chronic-wasting-disease.blogspot.com/2015/07/texas-chronic-wasting-disease-detected.html

 

Wednesday, March 18, 2015

 

Chronic Wasting Disease CWD Confirmed Texas Trans Pecos March 18, 2015

 

http://chronic-wasting-disease.blogspot.com/2015/03/chronic-wasting-disease-cwd-confirmed.html

 

Wednesday, March 25, 2015

 

Chronic Wasting Disease CWD Cases Confirmed In New Mexico 2013 and 2014 UPDATE 2015

 

http://chronic-wasting-disease.blogspot.com/2015/03/chronic-wasting-disease-cwd-cases.html

 

Thursday, May 02, 2013

 

*** Chronic Wasting Disease (CWD) Texas Important Update on OBEX ONLY TEXTING

 

http://chronic-wasting-disease.blogspot.com/2013/05/chronic-wasting-disease-cwd-texas.html

 

Monday, February 11, 2013

 

TEXAS CHRONIC WASTING DISEASE CWD Four New Positives Found in Trans Pecos

 

http://chronic-wasting-disease.blogspot.com/2013/02/texas-chronic-wasting-disease-cwd-four.html

 

Tuesday, July 10, 2012

 

Chronic Wasting Disease Detected in Far West Texas

 

http://chronic-wasting-disease.blogspot.com/2012/07/chronic-wasting-disease-detected-in-far.html

 

Monday, March 26, 2012

 

Texas Prepares for Chronic Wasting Disease CWD Possibility in Far West Texas

 

http://chronic-wasting-disease.blogspot.com/2012/03/texas-prepares-for-chronic-wasting.html

 

2011 – 2012

 

Friday, October 28, 2011

 

CWD Herd Monitoring Program to be Enforced Jan. 2012 TEXAS

 

Greetings TAHC et al,

 

A kind greetings from Bacliff, Texas.

 

In reply to ;

 

Texas Animal Health Commission (TAHC) Announcement October 27, 2011

 

I kindly submit the following ;

 

 http://chronic-wasting-disease.blogspot.com/2011/10/cwd-herd-monitoring-program-to-be.html

 

http://chronic-wasting-disease.blogspot.com/2013/02/texas-chronic-wasting-disease-cwd-four.html

 

***for anyone interested, here is some history of CWD along the Texas, New Mexico border, and my attempt to keep up with it...terry

 

snip...

 

see history CWD Texas, New Mexico Border ;

 

Monday, March 26, 2012

 

3 CASES OF CWD FOUND NEW MEXICO MULE DEER SEVERAL MILES FROM TEXAS BORDER

 

http://chronic-wasting-disease.blogspot.com/2012/03/3-cases-of-cwd-found-new-mexico-mule.html

 

Sunday, October 04, 2009

 

CWD NEW MEXICO SPREADING SOUTH TO TEXAS 2009 2009 Summary of Chronic Wasting Disease in New Mexico New Mexico Department of Game and Fish

 

http://chronic-wasting-disease.blogspot.com/2009/10/cwd-new-mexico-spreading-south-to-texas.html

 

 I could go on, for more see ;

 

Thursday, March 31, 2016

 

*** Chronic Wasting Disease CWD TSE Prion Roundup USA April 1, 2016 ***

 

http://chronic-wasting-disease.blogspot.com/2016/03/chronic-wasting-disease-cwd-tse-prion.html

 

 http://chronic-wasting-disease.blogspot.com/

 

 Saturday, April 16, 2016

 

APHIS [Docket No. APHIS-2016-0029] Secretary's Advisory Committee on Animal Health; Meeting May 2, 2016, and June 16, 2016 Singeltary Submission

 

http://animalhealthreportpriontse.blogspot.com/2016/04/aphis-docket-no-aphis-2016-0029.html

 

Tuesday, April 19, 2016

 

Docket No. FDA-2013-N-0764 for Animal Feed Regulatory Program Standards Singeltary Comment Submission

 

http://madcowfeed.blogspot.com/2016/04/docket-no-fda-2013-n-0764-for-animal.html

 

Sunday, March 20, 2016

 

*** UPDATED MARCH 2016 URGENT Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission

 

http://chronic-wasting-disease.blogspot.com/2016/03/docket-no-fda-2003-d-0432-formerly-03d.html

 

Monday, April 11, 2016

 

*** DECLARATION OF EXTRAORDINARY EMERGENCY DUE TO A FOREIGN ANIMAL DISEASE TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION CHRONIC WASTING DISEASE CWD IN THE UNITED STATES AND NORTH AMERICA ?

 

http://chronic-wasting-disease.blogspot.com/2016/04/declaration-of-extraordinary-emergency.html

 

From: Terry S. Singeltary Sr.

 

Sent: Saturday, February 06, 2016 12:11 PM

 

To: SACAH.Management@aphis.usda.gov

 

Subject: Secretary's Advisory Committee on Animal Health; Meeting [Docket No. APHIS-2016-0007] Singeltary Submission

 

Hello Mrs. R.J. Cabrera and USDA et al,

 

I would kindly like to submit and comment on the Secretary's Advisory Committee on Animal Health; Meeting [Docket No. APHIS-2016-0007] ;

 

http://animalhealthreportpriontse.blogspot.com/2016/02/secretarys-advisory-committee-on-animal.html

 

Saturday, April 16, 2016

 

APHIS [Docket No. APHIS-2016-0029] Secretary's Advisory Committee on Animal Health; Meeting May 2, 2016, and June 16, 2016 Singeltary Submission

 

http://animalhealthreportpriontse.blogspot.com/2016/04/aphis-docket-no-aphis-2016-0029.html

 

In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells

 

3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...

 

http://web.archive.org/web/20060307063531/http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

 

snip...see full text ;

 

*** SEE CWD HIGH INFECTION RATE MAPS FOR COLORADO ! ***

 

http://chronic-wasting-disease.blogspot.com/2016/04/colorado-chronic-wasting-disease-cwd.html

 

Thursday, March 31, 2016

 

*** Chronic Wasting Disease CWD TSE Prion Roundup USA 2016 ***

 

http://chronic-wasting-disease.blogspot.com/2016/03/chronic-wasting-disease-cwd-tse-prion.html

 

Sunday, May 1, 2016

 

Center for Biologics Evaluation and Research 25th Meeting of: The Transmissible Spongiform Encephalopathies Advisory Committee June 1, 2015 Transcript

 

AND DRUG ADMINISTRATION

 

http://tseac.blogspot.com/2016/05/center-for-biologics-evaluation-and.html

 

Saturday, April 23, 2016

 

v-CJD prion distribution in the tissues of patients at preclinical and clinical stage of the disease

 

http://vcjd.blogspot.com/2016/04/v-cjd-prion-distribution-in-tissues-of.html

 

*** 2001 FDA CJD TSE Prion Singeltary Submission ***

 

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

 

I remember Creekstone VS USDA et al and BSE Testing saga there ...see;

 

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

 

Argued May 9, 2008 Decided August 29, 2008

 

No. 07-5173

 

CREEKSTONE FARMS PREMIUM BEEF, L.L.C., APPELLEE/CROSS-APPELLANT

 

v.

 

DEPARTMENT OF AGRICULTURE AND EDWARD T. SCHAFER, SECRETARY OF AGRICULTURE, APPELLANTS/CROSS-APPELLEES

 

Consolidated with NO. 07-5199

 

Appeals from the United States District Court for the District of Columbia

 

(No. 06cv00544)

 

Eric Fleisig-Greene, Attorney, United States Department of Justice, argued the cause for the appellants/cross-appellees. Jeffrey S. Bucholtz, Acting Assistant Attorney General, Jeffrey A. Taylor, United States Attorney, and Mark B. Stern and Michael S. Raab, Attorneys, United States Department of Justice, were on brief. James J. Gilligan, Attorney, United States Department of Justice, and R. Craig Lawrence, Assistant United States Attorney, entered appearances.

 

2

 

Russell S. Frye argued the cause for the appellee/crossappellant.

 

Peter C. Choharis entered an appearance.

 

Before: SENTELLE, Chief Judge, HENDERSON and ROGERS, Circuit Judges.

 

Opinion for the court filed by Circuit Judge HENDERSON.

 

Concurring opinion filed by Circuit Judge ROGERS.

 

Dissenting opinion filed by Chief Judge SENTELLE.

 

KAREN LECRAFT HENDERSON, Circuit Judge: Creekstone Farms Premium Beef, LLC (Creekstone) raises and slaughters for sale Black Angus cattle. In December 2003, many countries began to ban or severely limit importation of U.S. beef because bovine spongiform encephalopathy (BSE)—“mad cow disease”—had been found in one cow in Washington State. See U.S. Dep’t of Agric., Publ’n No. LDP-M-143-01, An Economic Chronology of Bovine Spongiform Encephalopathy in North America 4 (2006) (Economic Chronology). To counter the fears of beef importers as well as domestic consumers, Creekstone developed a plan to test for BSE each of the approximately 300,000 cattle it slaughters each year. Declaration of John D. Stewart ¶ 6 (July 13, 2006) (Stewart Decl.). The United States Department of Agriculture (USDA), however, asserting authority under the Virus-Serum-Toxin Act, 21 U.S.C. §§ 151- 59 (VSTA or Act), denied Creekstone’s request to purchase or use a BSE test kit. Creekstone challenged the USDA’s action in the district court, alleging that two of USDA’s regulations are ultra vires under VSTA and that, even assuming the regulations are valid, they do not authorize USDA’s restriction on the sale/use of the BSE test kit. Creekstone also challenged USDA’s interpretation of another regulation. Both parties moved for summary judgment and the district court granted partial summary judgment to each party. 517 F. Supp. 2d 8, 13- 16 (D.D.C. 2007). For the reasons explained below, we affirm in part and reverse in part.

 

3

 

1Any violation of VSTA is a misdemeanor “punish[able] by a fine of not exceeding $1,000 or by imprisonment not

 

I.

 

A. Statutory/Regulatory Background

 

The Congress enacted VSTA in 1913 following reports that farmers were being sold ineffective anti-hog cholera serum. See Agriculture Appropriation Bill: Hearings Before the Senate Comm. on Agric., 62d Cong. 23-24 (1913) (testimony of A.M. Farrington, Asst. Chief, Bureau of Animal Indus., USDA). The Act makes it “unlawful . . . to prepare, sell, barter, or exchange . . . or to ship or deliver for shipment . . . any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals.” 21 U.S.C. § 151 (emphasis added). To this end, VSTA requires that “any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals . . . [be] prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding [a] license issued by the Secretary of Agriculture” (Secretary). Id. (emphasis added). In addition, VSTA makes it illegal to import “any virus, serum, toxin, or analogous product for use in the treatment of domestic animals” without a permit from the Secretary. Id. § 152. To implement the Act, the Secretary is authorized “to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment . . . of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out [VSTA].” Id. § 154 (emphasis added).1

 

4

 

exceeding one year, or by both such fine and imprisonment.” 21 U.S.C. § 158.

 

2The APHIS Administrator issues the relevant license, namely a U.S. veterinary biological product license. 9 C.F.R. § 102.5(a).

 

USDA has promulgated several regulations implementing VSTA. One regulation under review provides that “[w]here the Administrator [of USDA’s Animal and Plant Health Inspection Service (APHIS)] determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a [biological] product, the product shall be subject to . . . restrictions as . . . prescribed on the license.” 9 C.F.R. § 102.5(d).2 The second regulation under review provides that “[n]o biological product shall be brought into the United States unless a permit has been issued for such product” by the APHIS Administrator. 9 C.F.R. § 104.1(a). “Biological products” include “all viruses, serums, toxins, . . . or analogous products . . . which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response.” 9 C.F.R. § 101.2 (emphasis added). “Analogous products” are defined, in relevant part, as “[s]ubstances . . . which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity.” Id. § 101.2(2)(ii) (emphasis added). “Treatment” is defined as the “prevention, diagnosis, management, or cure of diseases of animals.” Id. § 101.2(3) (emphasis added).

 

https://pacer.cadc.uscourts.gov/internet/opinions.nsf/0B772DCBE1FDE3D68525780000551AD4/$file/07-5173-1135720.pdf

 

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

 

CREEKSTONE FARMS PREMIUM BEEF, L.L.C., Plaintiff,

 

v.

 

U.S. DEPARTMENT OF AGRICULTURE, et al., Defendants.

 

Civil Action No. 06-0544 (JR)

 

MEMORANDUM

 

Plaintiff Creekstone Farms Premium Beef, LLC wants to test every one of the approximately 300,000 head of cattle it slaughters each year to determine whether it was infected with bovine spongiform encephalopathy (BSE), commonly known as “mad cow disease.” The United States Department of Agriculture (USDA), however, has denied plaintiff's request to purchase BSE test kits, asserting its authority under the Virus-Serum-Toxin Act, 21 U.S.C. §§ 151-159, (VSTA). The parties have cross-moved for summary judgment on the first two counts of plaintiff's complaint, which assert that the agency has exceeded its authority under the VSTA, in violation of the Administrative Procedure Act, 5 U.S.C. § 706(2)(C), by (1) promulgating regulations that are inconsistent with the VSTA, and (2) denying Creekstone's request to perform BSE testing on its own cattle.

 

BACKGROUND

 

BSE is a fatal, irreversible disease that causes progressive degeneration of the brain and central nervous system in cattle. The disease is caused by prions, abnormal proteins that cause normal cellular protein to convert to an abnormal form. The existence of BSE in an animal is confirmed through postmortem microscopic examination of the animal’s brain tissue or by detection of the abnormal form of the prion protein in its brain tissue.

 

snip...

 

It is unnecessary to reach the question of whether BSE test kits are “worthless,” because their use may not be regulated under the VSTA unless they are both “intended for use in the treatment of animals” and “worthless.” The government may indeed be right that the tests are “ineffective, misleading, and essentially worthless...when used, as proposed by plaintiff, to diagnose the disease in all slaughter-aged normal-looking cattle.” Def.’s Mem. at 42. But, should a reviewing court determine that BSE could be detected in slaughter-age cattle, as is suggested by evidence put forward by plaintiff and the more extensive testing conducted by other countries, let it be noted that the government cannot have it both ways: the test kits cannot be both “used for treatment” and “worthless.” If USDA’s surveillance testing helps “manage” the disease by providing information about the prevalence of BSE and contributing to the knowledge of the disease, see Defs.’ Reply at 19-20, citing 9 C.F.R. § 101.2(3) (defining “treatment” to mean “the prevention, diagnosis, management, or cure of diseases of animals”)(emphasis in original), then so might the more extensive testing proposed by Creekstone.

 

The government’s additional argument, that private testing 14 somehow would interfere with USDA’s surveillance program, is unexplained and therefore rejected.

 

Of greater concern is the possibility that private testing 15 could produce a false positive result, which might trigger unnecessary public alarm. USDA has asserted this possibility as a reason to avoid private testing. Indeed, the Bio-Rad kits that Creekstone proposes using are used throughout the world, including as part of the USDA’s own surveillance testing.

 

- 18 -

 

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2006cv0544-22

 

http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html

 

kind regards, terry