As noted earlier in this preamble, the proposed amendments would remove references to the term "transfer category," "release category," and various provisions associated with those terms throughout the division. The proposed amendments to Division 2 would implement an improved methodology for determining the risk of deer breeding facilities with respect to the spread of CWD by conditioning movement restrictions solely on MQ status, which makes the concepts of transfer category and release site class unnecessary. The proposed amendment also references the provisions of proposed §65.99, concerning Breeding Facilities Epidemiologically Connected to Deer Infected with CWD, where necessary, to preserve current limitations on deer movement to and from deer breeding facilities determined to present the highest risk of spreading CWD (currently referred to as "TC 3" facilities). The proposed amendments also make nonsubstantive housekeeping-type changes in the interest of clarity and organization.

The proposed amendments and new section within Division 2 would incorporate the provisions of the current emergency rule in effect and comport the existing provisions of the division accordingly, with exceptions as noted.

The proposed amendments to §65.90, concerning Definitions, would eliminate definitions for "eligible-aged deer" "eligible mortality," "Interim Breeder Rules," "NUES tag," "originating facility," "status," "TAHC Herd Certification Program," and "TAHC Herd Plan," add definitions for "exposure," "herd plan," "inconclusive," "insufficient follicles," "last known exposure," "release," "test-eligible," "Tier 1 facility," "trace deer," and "trace-out breeding facility," and modify the definitions for "confirmed," "CWD-positive facility," "exposed deer," and "reconciled herd."

The definition of "eligible-aged deer" is being eliminated because the proposed amendment would replace it with a new definition for "test-eligible."

The definition of "eligible mortality" is being eliminated because the term is no longer used in the rules.

The definition of "Interim Breeder Rules" is being eliminated because it existed only to provide a point of reference for the transition from a previous set of rules intended to contain and manage CWD in breeding facilities to the current rules implementing a comprehensive CWD management plan.

The definition of "NUES tag" is being eliminated because the retention and visibility of NUES tags is suboptimal.

The definition of "originating facility" is being eliminated because the proposed rules would eliminate the current structure based on transfer and release status assigned to individual breeding and release facilities based on their comparative risk of spreading CWD; thus, the term is no longer used and is therefore unnecessary.

The definition of "status" is being eliminated because the term no longer has a specific meaning in the context of transfer and release facility designations.

The definitions of "TAHC CWD Herd Certification Program" and "TAHC herd plan" are being eliminated because the proposed rules acknowledge the cooperative nature of interagency planning and resource management activities between the department and the TAHC and the reality that the repeated emergence of CWD in deer breeding facilities has created operational stressors necessitating a shared burden in the development of plans for individual breeding facilities.

The proposed amendment would define "exposure" as "the period of time that has elapsed following the introduction of an exposed deer to a breeding facility." Because individual deer that have been exposed to CWD can incubate the disease at different rates, it is epidemiologically critical to establish a timeline to determine the highest likelihood of early detection of the disease if it is present.

The proposed amendment would define "inconclusive" as "a test result that is neither "positive" nor "not detected" on the basis of clinical deficiency." Current rules allow for the restoration of MQ status in certain situations on the basis of ante-mortem testing of an entire captive herd. Due to a number of factors, not all test samples yield definitive results as to the presence or absence of CWD. The department acknowledges that fact; therefore, the proposed rules would allow a certain percentage of test results to be inconclusive without jeopardizing the adequacy of surveillance. The most common cause of inconclusive test results is due to the lack of enough specific tissue in a sample to contain enough lymphoid follicles to produce a reliable test result, referred to as a result of "insufficient follicles." Therefore, the proposed amendment would include a definition of "insufficient follicles" for clarity's sake. The term would be defined as "a test result indicating that a tonsil or rectal biopsy sample contained an insufficient number of lymphoid follicles to produce a valid test result."

The proposed amendment would define "last known exposure" as "the last date a deer in a trace-out breeding facility was exposed to a trace deer prior to the death or transfer of that trace deer." The definition is necessary because the CWD testing requirements imposed by proposed new §65.99 are predicated upon the length of time since an exposed deer was in a facility.

The proposed amendment would define "release" as "the act of liberating a deer from captivity. For the purposes of this division the terms "release" and "liberate" are synonymous." The definition is necessary because Parks and Wildlife Code, Chapter 43, Subchapter L uses the terms "release" and "liberation" interchangeably and the department intends to provide a definitive affirmation that the two terms are indeed synonymous.

The proposed amendment would define "test-eligible" as "a deer at least 16 months of age prior to the effective date of the rules and following the effective date of the rules, a deer at least 12 months of age." The proposed rules lower the minimum age at which deer may be tested; however, that change will take place during the reporting year. The definition is necessary to make that clear.

The proposed amendment would define "Tier 1 facility" as "a breeding facility that has received an exposed deer that was in a trace-out breeding facility." The definition is necessary to acknowledge the epidemiological importance of exposed deer that were received indirectly via a Category A or Category B trace-out breeding facility.

The proposed amendment would define "trace deer" as "a deer that the department has determined had been in a CWD-positive deer breeding facility on or after the date the facility was first exposed to CWD, if known; otherwise, within the previous five years from the reported mortality date of the CWD-positive deer, or the date of the ante-mortem test result." The definition is necessary because proposed new §65.99 would create testing requirements for breeding facilities that have received deer epidemiologically connected to a positive facility.

The proposed amendment would define "trace-out breeding facility" as "a breeding facility that has received an exposed deer that was in a CWD-positive deer breeding facility."

The definition is necessary because new §65.99 would create testing requirements for breeding facilities that have received deer directly from a positive facility.

The proposed amendment would alter the definition of "confirmed" to include the Texas A&M Veterinary Medical Diagnostic Laboratory as a testing authority.

The proposed amendment would alter the definition of "CWD-positive facility" to include the term "positive facility" in order to reduce the repetition of an unwieldy term throughout the rules.

The proposed amendment would replace the definition of "exposed deer" with a more nuanced definition that reflects the emergency rule currently in effect and proposed for incorporation into Division 2 by this rulemaking. The proposed new definition is based on the importance of determining the extent to which any given deer breeding facility is epidemiologically connected to facilities where CWD is known to exist, which in turn determines the CWD testing requirements necessary to both determine the epidemiological status of the facility and the nature and extent of CWD testing necessary to allow the resumption of transfers by the facility. The current definition states that an exposed deer is a deer that is in a CWD-positive facility or was in a CWD-positive facility within five years prior to the discovery of CWD in that facility. The proposed new definition would define an exposed deer as a deer meeting any of three criteria: the deer is or was in a breeding facility after the date that the facility held a CWD-positive deer, the deer is or was in a facility within five years preceding the discovery of a CWD-positive deer that was in the same facility, or the deer is in a facility as of a determination that either of the first two conditions exists with respect to a given facility. The definition is based on the epidemiological need to characterize the potential of any given breeder deer to have been in any facility where the possibility of contracting CWD could have existed.

The proposed amendment to §65.91, concerning General Provisions, would eliminate current subsections (e) and (f) because they relate to the transfer categories and release site classes of the current rule as discussed earlier in this preamble. The proposed amendment would also conform language regarding herd plans as discussed previously, and make nonsubstantive housekeeping-type changes to standardize terminology (i.e., replacing phrases such as "introduce into or remove from" with "transfer," which means the same thing.

The proposed amendment to §65.91 would alter current subsection (g) to include exceptions for scientific research.

The proposed amendment to §65.91 would alter current subsection (h) to include "reports" in the list of various communications with the department that are required to be made via the department's online system for deer breeder permit administration, which is necessary for the sake of thoroughness in describing the types of documentation affected by the rules.

The proposed amendment to §65.91 would add new subsection (f), which is being relocated from current §65.94(e) because it is generally applicable to all breeding facilities, to provide upon the determination that a facility has received a CWD "suspect" test result, that all trace facilities that have been in possession of deer that was present within the CWD suspect facility within the previous five years shall be NMQ until it is determined that the facility is not epidemiologically linked to the CWD suspect deer or the CWD "suspect" test result is not confirmed positive. The intent of the proposed new subsection is to prohibit the transfer of breeder deer from trace facilities to another facility from the time when the initial CWD "suspect" test result is received and the result is confirmed.

The proposed amendment to §65.92, concerning CWD Testing, would consist of several substantive and nonsubstantive changes. Current rules require tissue samples for ante-mortem testing to be collected within six months of submission from deer at least 16 months of age that have not been the source of a "not detected" test within the previous 24 months. The proposed amendment to subsection (b) would change that standard by requiring samples to be collected within eight months of submission from a deer at least 12 months of age that has not been the source of a "not detected" test result within the previous 12 months. Both the current rules and the rules as proposed reflect the agency's strategy to establish some sort of general surveillance of captive deer populations. Because other provisions of this rulemaking would increase the minimum level of ante-mortem testing and require the testing of all mortalities occurring within breeding facilities, as well as the ante-mortem testing of all breeder deer prior to release, the department has determined that it is possible to allow test results from younger deer, increase the frequency with which deer may be tested, and increase the interval between sample collection and sample submission. In addition, the proposed change to subsection (b) includes references to other provisions that create exceptions allowing for the testing of deer that had been the source of a "not detected" test result with the previous 12 months.

Current subsection (c) provides that a post-mortem test is not valid unless performed on the obex or medial retropharyngeal lymph node (RLN). The proposed amendment would require the submission of the obex and the RLN. CWD in white-tailed deer and mule deer is typically detected in the RLN sooner than in the obex andthe department therefore reasons that requiring the submission of the RLN in addition to the obex will result in earlier detection of CWD positive deer and increase the efficacy of post-mortem CWD testing. In addition, by requiring the submission of both tissues, the possibility of wasted test effort is reduced. For example, if an obex from a deer yields inconclusive post-mortem testing results, an RLN from the same animal may not.

The proposed amendment to subsection (d) and proposed new subsection (e) would establish new standards regarding the use of ante-mortem tests to substitute for inadequate post-mortem testing and provide for a transition from the current rules to the amended rules (if adopted). As described earlier in this preamble, the department determines any given breeding facility's MQ status on the basis of a series of calculations intended to provide assurance that the level of post-mortem CWD-testing in a breeding facility is sufficient to monitor for the presence of CWD in the facility. If a facility is unable to provide sufficient post-mortem test results to be designated MQ on that basis alone, the current rules allow ante-mortem testing to be utilized to make up for the inadequate post-mortem surveillance; however, because post-mortem tests are of extremely high epidemiological value, a higher number of ante-mortem substitution tests are required in order to provide the same level of confidence that CWD can be detected. The proposed amendments would replace the testing rate in the current rules with a testing rate developed by the Center for Epidemiology and Animal Health (CEAH), which is an organization within the Animal Plant Health Inspection Service operated under the United States Department of Agriculture. Because ante-mortem substitution testing is a method of compensating for the lack of sufficient and more-desirable post-mortem testing and is calculated for each reporting year, the regulations must stipulate specific timeframes for the collection and submission of the samples in order to make substitution testing meaningful. In other words, MQ status in such situations, because it is dependent upon the herd collectively (rather than individual post-mortem samples) must be reflective of the herd over time within each reporting year. Therefore, the proposed subsection would stipulate that all provisions other than paragraphs (3) and (4), if adopted, would take effect April 1, 2022, which is the beginning of the next reporting year. Paragraphs (3) and (4) would take effect 20 days after the notice of adoption is filed with the Secretary of State. Proposed subsection (d)(1) would require ante-mortem test samples to be collected within eight months of the end of the reporting year to match the eight-month submission window created in the proposed amendment to subsection (b). Additionally, and for the same reasons, proposed new subsection (e) would accommodate the transition from the current rate at which ante-mortem test results may be substituted for post-mortem test results (3:1) to the proposed new ratio (5:1) by allowing the 3:1 substitution ratio to remain until the end of the current permit year.

Proposed subsection (d)(2) would provide that the number of ante-mortem results could not exceed 30 percent of the total number of required post-mortem results (multiplied by five, to reflect the new ratio of substitution imposed by the proposed amendment) in more than two reporting years. A post-mortem test conducted quickly after the death of a deer is the gold standard for CWD testing efficacy. Also (and described in the discussion of the proposed amendment to §65.94), the proposed rules would require deer breeders to test all mortalities instead of the current minimum of 80 percent. Because the department acknowledges the reality that it may not always be possible to locate a mortality and extract a sample that will be valid, both the current and proposed rules allow ante-mortem tests to be substituted for a portion of the required post-mortem test results. Because ante-mortem tests are less reliable, however, the department believes that it would not be prudent to allow them to be substituted for post-mortem test results at either a high percentage or on a repeated basis. Therefore, the proposed rules provide for what the department has determined, based on what is known about the incubation period and transmissibility of CWD, as well as the efficacy of ante-mortem testing compared to post-mortem testing, is a reasonable substitution standard and a limit on how frequently that standard may be exceeded. Similarly, the department considers that there will be circumstances in which a deer breeder may possess enough deer to make it possible to achieve MQ status, but is unable to meet the requirements of the rules because not enough time has elapsed since previous testing efforts on specific deer. Therefore, proposed subsection (d)(3) would allow test results from deer that were tested within the previous 12 months to be submitted, provided all test-eligible deer within the facility have been tested prior to the testing of deer that were tested within the previous 12 months. As explained above, because other provisions of this rulemaking would increase the minimum level of ante-mortem testing and require the testing of all mortalities occurring within breeding facilities, as well as the ante-mortem testing of all breeder deer prior to release, proposed subsection (d)(3) would allow test results from deer six months of age or older provided all test-eligible deer in the facility have been tested prior to the testing prior to the testing of any deer that is six months of age or older but younger than 12 months. Proposed subsection (d)(4) would establish a limit of 10 percent on the number of "inconclusive" test results that could be submitted to satisfy the provisions of §65.94(d), excluding facilities that test fewer than ten deer. The provision in question pertains to a small subpopulation of NMQ breeding facilities that although unable to meet the testing requirements of §65.94(a), are in compliance with inventory and inspection requirements, haven't received exposed deer, and don't contain enough deer to meet ante-mortem substitution requirements. Current rules allow such facilities to be designated MQ following two "whole herd" rounds of ante-mortem tests 12 months apart, provided the tests are begun within 12 months of being designated NMQ. It is not uncommon for test results to be inconclusive, which can happen for a variety of reasons; Cont'd...