New §65.91(f) provides 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 new subsection is necessary for the same reasons addressed in the discussion of new §65.91(e).

New §65.91(g) provides that the designation of status by the department in and of itself does not authorize the transfer or movement of deer. New §65.91(g) also prohibits any person from removing or causing the removal of deer from a facility that has been designated NMQ by the department. The provision is necessary because a breeding facility of any status can be designated NMQ.

New §65.91(h) requires 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. To provide greater regulatory efficiency, it is necessary to require the use of an automated system.

New §65.91(i) provides 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.

New §65.92, concerning CWD Testing, establishes the general provisions regarding the collection and submission of CWD test samples.

New §65.92(a) requires 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 provides for Texas Veterinary Medical Diagnostic Laboratory (TVMDL), an accredited laboratory that performs CWD testing, to notify the department of test results electronically. By 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 upload of test results by the permitted deer breeder and manual data entry by the department after the test results have been received.

New §65.92(b) sets forth the requirements for valid ante-mortem testing, including the identification of the specific tissues that may be used. New §65.92(b) also requires that tissue samples be collected by a licensed veterinarian, that the testing be done by an accredited laboratory, that at least six lymphoid follicles be collected, and that samples be submitted within six months of submission from a live deer that is at least 16 months of age and that has not been the source of a "not detected" ante-mortem test result submitted within the previous 24 months. To ensure consistency with the Texas Veterinary Practices Act (Occupations Code, Chapter 801), regulations applicable to the practice of veterinary medicine in Texas, and regulations of the TAHC, this subsection requires that ante-mortem samples be collected by a licensed veterinarian authorized to do so by the referenced statutes and regulations. Additionally, in order to be epidemiologically valuable, tissue samples must be extracted from deer older than 16 months of age. 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 24-month interval to increase the likelihood that sufficient host tissues are available for testing and to prevent the continued use of a single deer to provide tests. 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 may cause the subject animal to be euthanized and subjected to post-mortem testing for confirmation.

New §65.92(c) sets 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 or the medial retropharyngeal lymph node of an eligible mortality and may be collected only by a qualified licensed veterinarian, TAHC-certified CWD sample collector, or other person approved by the department. 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 deer 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 new rules require all CWD tests to be performed by a laboratory approved by USDA. Additionally, the new subsection specifies 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. To ensure that valid samples are collected, the new subsection also stipulates that the sample may only be collected by a qualified licensed veterinarian, TAHC-certified CWD sample collector, or other person approved by the department.

New §65.92(d) allows ante-mortem tests to be substituted for required post-mortem tests at a ratio of 3:1. The department acknowledges that natural mortality is unpredictable and that there will be time periods when test results for a sufficient number of mortalities cannot be submitted; therefore, the new rule allows substitution of ante-mortem tests for post-mortem tests. For reasons noted earlier in this preamble, test results from natural mortalities have a higher epidemiological value than ante-mortem tests; therefore, if ante-mortem tests are being conducted in lieu of post-mortem tests, the new rules provide that three "not detected" ante-mortem test results are required for each "not detected" post-mortem test result required.

New §65.92(e) prohibits the use of a single ante-mortem 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 in disease mitigation because the different ante-mortem testing requirements were developed to be used in combination, and to submit one test to meet two independent criteria does not provide the probability of detection anticipated by the department and on which the rules were based.

New §65.92(f) stipulates 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 new rules should not be able to avoid compliance simply by selling, donating, or trading property to another person related to the seller for the purpose of avoiding the requirements of the rules.

New §65.92(g) provides 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 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 new rule establishes a date certain for reporting test results to the department.

New §65.93, concerning Harvest Log, sets forth the elements and requirements for on-site harvest documentation. The new rules require a harvest log to be maintained on Class II and Class III release sites. For each deer harvested from a Class II or Class III release site for which a harvest log is required, the new rules 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 new provision will 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 new paragraph also requires 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 also provides for the format and retention of the harvest log.

New §65.94, concerning Breeding Facility Minimum Movement Qualification, sets forth the testing requirements necessary for a breeding facility to be able to transfer deer to other deer breeders or for purposes of liberation.

New §65.94(a) provides that a breeding facility will be NMQ (Not Movement Qualified--prohibited from transferring breeder deer anywhere for any purpose) if it has not met the testing, inventory, reporting, and recordkeeping, and TAHC Herd Plan requirements set forth in that subsection.

New §65.94(a)(1) sets forth the CWD testing requirements that must be met to avoid being NMQ. Pursuant to new §65.94(a)(1)(A), from the effective date of the rules through March 31, 2017, a breeding facility must have either had less than five eligible mortalities from May 23, 2006 through March 31, 2016, or obtained "not detected" test results for at least 20 percent of the eligible mortalities that occurred in the facility since May 23, 2006. The provisions of §65.94(a)(1)(A) are essentially the same as that provided in the deer breeder movement rules that existed prior to the June 2015 discovery of CWD in a deer breeding facility. Although this standard provides a very low statistical confidence of detecting CWD if it exists in a facility, this standard is the standard contained in previous rules, as well as the Interim Rules. In addition, the department reasons that any breeding facility not in compliance with this standard should not be allowed to move breeder deer until it has "tested out," or submitted sufficient test samples of "not detected" to provide a higher level of confidence that CWD will not be transmitted from the facility.

New §65.94(a)(1)(B)(i) provides that beginning April 1, 2017, and each April 1 thereafter, a breeding facility that has achieved "fifth-year" or "certified" status in the TAHC CWD Herd Certification Program will be considered to have met the testing requirements necessary to be considered MQ. In order to achieve and maintain "fifth-year" or "certified" status, a deer breeder must comply with certain disease monitoring protocols, including the testing of 100% of eligible mortalities and not receiving deer from facilities that have not obtained that "fifth year" or "certified" status. See, 4 TAC §40.3. For breeding facilities that have not achieved "fifth-year" or "certified status," beginning April 1, 2017 and each April 1 thereafter, annual CWD "not detected" test results for at least 80% of eligible mortalities occurring in the facility during the previous reporting year must be submitted. However, the department recognizes that if a breeding facility has an unusually low number of eligible mortalities, this provision could result in the submission of few test results. Therefore a provision is included to require that for breeding facilities that have been permitted at least six months, the number of "not detected" post-mortem test results submitted during each reporting year must be equal to or greater than the eligible-aged population in the breeding facility at the end of the reporting year, plus the eligible mortalities that occurred within the breeding facility in the reporting year, multiplied by 3.6 percent. This provision is intended to provide a minimum number of tests that must be submitted each year to achieve the epidemiological goals of the rules. To develop this number, the department considered that the average natural mortality in a deer breeding facility is approximately 4.5 percent of the eligible-aged deer population in the breeding facility each year. Therefore, if a deer breeding facility that has an average natural mortality rate among eligible-aged deer 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. As explained elsewhere in this preamble, the rules provide for ante-mortem substitution for these test results at ratio of three "not detected" ante-mortem test results for each required "not detected" post-mortem test result.

New §65.94 also provides additional criteria for designating NMQ status. Section 65.94(a)(2) - (3) provides that a breeding facility may be NMQ if it is not authorized to transfer deer pursuant to a TAHC Herd Plan associated with a TAHC hold order or quarantine, does not have a reconciled herd inventory, or is not in compliance with reporting and recordkeeping requirements. Department rules at §65.608 of this title (relating to Annual Reports and Records) require deer breeders to submit an annual report. The annual report must include a herd reconciliation that accounts for every breeder deer held, acquired, or transferred by a breeding facility, as well as births and mortalities. A breeding facility that is not in compliance with the reporting requirements or has submitted incomplete or inaccurate records frustrates efforts to determine the source and/or disposition of every deer in the facility, as a reconciled herd inventory is a necessary component of disease management. Also, as noted elsewhere in this preamble, a TAHC Herd Plan may contain provisions that impose movement restrictions in which case the TAHC Herd Plan will control. In addition, to ensure compliance with applicable regulatory provisions, it is imperative that the facility have an accurate herd inventory that accounts for the movement of breeder deer into and out of the breeding facility, as well as deaths and births within the facility.

New §65.94(b) provides that a breeding facility that has been designated NMQ for failure to comply with testing requirements will 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 status should be restored, so long as all other requirements for MQ status are met. The "not detected" test results can be provided through ante-mortem substitution as provided in §65.92(d) or by the submission of additional post-mortem test results. It should be noted, however, that if post-mortem test results are being submitted to satisfy the requirement to submit "not detected" post-mortem test results for 80% of the annual mortalities, the creation of additional mortalities will alter the calculation (i.e., the total number of mortalities will change, which will, in turn, alter the number of post-mortem tests required to achieve 80%).

New §65.94(c) requires a breeding 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 new rule requires facilities that are not in compliance with movement qualification requirements to report all mortalities immediately, rather than at the end of the reporting year.

New §65.94(d) provides that immediately upon the notification that a facility has received a "suspect" test result, all facilities that have been in possession of deer that were held in the suspect facility within the previous five years will be designated NMQ until a determination is made 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 new rules are intended to detect CWD if it is present and prevent the spread of CWD once it is detected; therefore, once a "suspect" test result has been returned, all movement to and from all connected facilities should be stopped until the "suspect" test is either confirmed or determined to be non-positive.

New §65.95, concerning Movement of Deer, establishes the various status levels and attendant testing requirements for breeding facilities and release sites.

New §65.95(a) allows a TC 1 or TC 2 breeding facility designated MQ and in compliance with the applicable provisions of the division 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. This subsection is necessary to set out the types of transfers that may be authorized by the rules.

New §65.95(b) establishes three categories of breeding facilities based on level of epidemiological risk: Transfer Category (TC) 1, TC 2, and TC 3. As noted in the discussion of the definition of "status" earlier in this preamble, the highest level/status (i.e., the level with the least risk for CWD) for a breeding facility is TC 1 and the lowest level is TC 3.