The Texas Parks and Wildlife Commission (Commission) in a duly noticed meeting on June 20, 2016 adopted the repeal of §§65.90 - 65.94 and new §§65.90 - 65.99 concerning Chronic Wasting Disease - Movement of Deer. New §§65.90 - 65.92 and 65.94 - 65.98 are adopted with changes to the proposed text as published in the April 22, 2016, issue of the Texas Register (41 TexReg 2853). The repeals, new §65.93, and new §65.99 are adopted without changes and will not be republished.

Change to Definitions

The change to §65.90, concerning Definitions, adds a definition for "Interim Breeder Rules." The rules as adopted, include provisions predicated upon compliance with previous rules. Therefore, a definition of "Interim Breeder Rules" was added to provide a shorthand reference for those rules.

Changes to General Provisions

The change to §65.91, concerning General Provisions, alters subsection (a). As proposed, the subsection provided that to the extent any provision of the proposed new rules conflicted with any other provision of Chapter 65, the new rules would control; however, Chapter 65, Subchapter B, Division 1 contains provisions regarding Chronic Wasting Disease (CWD) management zones that are intended to function on their own terms. Therefore, it is necessary to clarify that fact.

The change to §65.91 also adds new subsection (d) to clarify that a deer breeding facility is prohibited from moving deer out of the breeding facility if such movement is prohibited under a hold order or quarantine imposed on the breeding facility by the Texas Animal Health Commission (TAHC). Under the rules as proposed, and as adopted, the lawful movement of breeder deer is predicated on a facility's designation as Movement Qualified (MQ). Although the provisions of §65.99 as adopted, concerning Violations and Penalties, provide that a person who possesses or receives white-tailed deer or mule deer pursuant to a Triple T permit, DMP or a deer breeder permit is subject to the provisions of TAHC regulations regarding Chronic Wasting Disease, subsection (d) was clarified to state that if a facility is prohibited from moving deer under a hold order or quarantine issued by TAHC, movement of deer under those circumstances is prohibited.

In addition, a change was made to §65.91(e) (which was §65.91(d) as proposed) to modify the cross-reference to the subsection regarding receipt of deer by a release site. The rules as adopted adjust the time period for release site testing. As a result, it is more appropriate to reference the entirety of §65.95(c) regarding release sites, rather than the more specific §65.95(c)(1)(D).

Changes to CWD Testing

The change to §65.92, concerning CWD Testing, clarifies who may collect the tissue upon which ante-mortem tests are to be conducted and provides additional detail to ensure that a valid sample is collected. As proposed, §65.92(b) required ante-mortem test samples be collected "by or under the supervision of a qualified licensed veterinarian." However, to ensure compliance with statutory requirements regarding the practice of veterinary medicine, as well as regulatory requirements of TAHC and the Texas Board of Veterinary Medical Examiners regarding the collection of ante-mortem samples, the change to §65.92(b) provides that ante-mortem samples must be collected by a "licensed veterinarian authorized pursuant to statutes and regulations governing the practice of veterinary medicine in Texas and regulations of the TAHC." In addition, to ensure that samples are sufficient to accommodate ante-mortem testing, §95.92(b) was modified to require that at least six lymphoid follicles be collected.

The change to §65.92(b) also eliminates the 16-month residency requirement for ante-mortem testing of breeder deer imposed by proposed subsection (b)(2). The intent of proposed subsection (b)(2) was to ensure that animals subjected to ante-mortem testing had been in a facility long enough to have contracted CWD if it were present. However, while a deer with a residency in a facility of less than 16 months may not have had sufficient incubation time to detect CWD if it was contracted in that facility, a test of that deer would provide information about any previous facility in which the deer was held. Therefore, the residency requirement was eliminated.

Another change to §65.92 reduces the interval of ante-mortem testing eligibility established in subsection (b)(3) from 36 months to 24 months. The intent of proposed subsection (b)(3) was to ensure that the epidemiological value of ante-mortem testing is not compromised. Repeated testing of a single animal for which "not detected" test results have been obtained would compromise the value of ante-mortem testing within a deer herd. In addition, ante-mortem testing is an invasive procedure that removes tissues and those tissues do not immediately regenerate; therefore, after several biopsies, sample quality may diminish. However, because most breeding facilities contain fewer than 50 deer, the rule as proposed would have made compliance with the 36-month interval between testing difficult for small herds. In addition, veterinarians have indicated that testing a deer every 24 months can be accomplished without significantly compromising sample quality. Therefore, the department reduced the testing frequency interval.

The change to proposed §65.92 also removes proposed subsection (c)(3), which imposed a five-month "window" for ante-mortem test results to be submitted to the department for purposes of increasing status. The rules as proposed included a mechanism to enable a deer breeding facility to achieve Transfer Category (TC) 1 by annually submitting "not detected" ante-mortem CWD 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. As a result, the proposal included a testing "window" to preserve administrative efficiency by restricting testing for the purpose of "upgrading" from a lower status to the time of year when deer breeders are typically handling deer for other purposes. However, because this option for "upgrading" has been eliminated as described in the discussion of changes to §65.95, the department has determined that year-round submission of ante-mortem test results can be sustained.

The change to §65.92 also clarifies who may collect tissue samples for post-mortem CWD testing. As proposed, §65.92(c) (proposed §65.92(d)) stipulated that to be valid for testing, an obex had to be collected by a qualified licensed veterinarian or other person certified by TAHC, and that a medial retropharyngeal lymph node collected by a qualified licensed veterinarian or other person approved by the department could be submitted in addition to or in lieu of an obex. In the interests of simplification, the provision has been altered to state that a sample is not valid unless it was collected by a qualified licensed veterinarian, TAHC-certified CWD sample collector, or other person approved by the department.

Finally, the change to §65.92 alters the ratio of ante-mortem test results that may be substituted for post-mortem test results in subsection (d) (proposed subsection (e)). As proposed, the ratio was two ante-mortem test results for every required post-mortem test result, provided at least two eligible mortalities had occurred in the facility during the corresponding reporting year and post-mortem test results equivalent to 50 percent of the total required results had been submitted. In other words, ante-mortem test results could be substituted for no more than 50 percent of the required post-mortem test results. As adopted, that ratio is three ante-mortem test results for every required post-mortem test result (i.e., a 3:1 ratio), but there is no limit on the number of post-mortem tests for which ante-mortem tests can be substituted. An ante-mortem to post-mortem ratio that is higher than 1:1 is necessary to compensate for the fact that deer that have died from natural causes are far more epidemiologically valuable than live and apparently healthy deer selected for ante-mortem testing. A deer that has died naturally, by definition, died as a result of some causal agent. As a result, it is more likely that a deer that has died naturally would test positive for CWD than an apparently healthy deer. During the public comment period, there was discussion of eliminating the maximum use of ante-mortem substitution. However, if no mortalities are tested, a higher number of ante-mortem tests would be required to achieve the same epidemiological benefits as post-mortem tests, perhaps as much as 6:1. There was stakeholder input suggesting a 4:1 substitution if less than 50 percent of mortalities were tested, and retaining the 2:1 ratio if the number of post-mortem tests submitted was equal to at least 50 percent of eligible mortalities. The department also received public comment and discussion suggesting the simplification of the regulations wherever possible. Therefore, in an effort to simplify this requirement, an ante-mortem substitution ratio of 3:1 was selected. From an epidemiological perspective, while more testing is preferred, a substitution ratio of 3:1 was determined to be adequate.

Changes to Breeding Facility Minimum Movement Qualifications (§65.94) and Movement of Breeder Deer (§65.95) - Generally

With regard to the changes to §65.94, concerning Breeding Facility Minimum Movement Qualification, and §65.95 concerning Movement of Breeder Deer, several changes were made in response to comments, stakeholder input, and public testimony.

The rules as proposed and as adopted (as well as the Emergency and Interim Breeder Rules) establish three categories of breeding facilities based on level of epidemiological risk, with Transfer Category 1 (TC 1) representing the lowest risk of harboring or transmitting CWD and TC 3 representing the highest risk. Similarly, three levels of release sites (sites onto which breeder deer had been liberated) are established, also based on the level of epidemiological risk, with Class I release sites representing the lowest risk of harboring or transmitting CWD and Class III release sites representing the highest risk.

The Emergency Rules and the Interim Breeder Rules required testing of hunter-harvested deer from sites on which breeder deer had been released, except for release sites that received deer only from Transfer Category 1 (TC 1) facilities. Under the Emergency and Interim Breeder Rules, only breeding facilities that had achieved "fifth year" or "certified status" in the TAHC CWD Herd Certification Program were TC 1 facilities.

As the department worked with stakeholders to develop the proposed rules, deer breeders continued to state that the elimination or reduction of testing at release sites was important to them. Out of the facilitated process, described elsewhere herein, came additional options for achieving TC 1 status that also incorporated ante-mortem testing. More specifically, three additional options were developed to enable breeding facilities that were not "fifth year" or "certified status" facilities to obtain TC 1 status and to provide for the use of ante-mortem tests to achieve TC 1 status more quickly.

As with previous rules, the proposed rules also established minimum testing requirements that a deer breeder must meet to transfer deer to another facility, including a release site. A breeding facility that met the minimum requirements for the transfer of deer (i.e., a breeding facility that was "movement qualified" or "MQ") but did not meet the requirements for being a TC 1 facility (and was not a TC 3 facility) would be classified as TC 2 facility. Because TC 2 represented a higher risk of harboring or transmitting CWD than a TC 1 breeding facility, under the proposed rules, a release site (which was not a Class III release site) onto which a deer from a TC 2 facility was liberated (classified as a Class II release site) would be required to submit CWD tests for hunter-harvested deer as provided in the rules.

During the public comment period and in testimony before the Commission, concerns continued to be raised about the continuation of required testing at release sites that received deer from TC 2 facilities (Class II release sites). As a result of those comments and additional discussions among stakeholders, the rules, as adopted, provide for the elimination of release site testing at Class II release sites after the 2018-2019 hunting year. To accomplish the elimination of Class II release site testing, it was necessary to adjust the provisions for classifying a facility as MQ or NMQ so that the probability of detection of CWD in all breeding facilities would increase to an acceptable level by the time no release site testing (except for Class III release sites) was required. As a result, changes were made in the rules as adopted to §65.94 concerning Breeding Facility Minimum Movement Qualifications and to §65.95 concerning Movement of Breeder Deer. In the rules as proposed and as adopted, the classification of TC 3 for breeding facilities and Class III for release sites is reserved for those breeding facilities and release sites that have been 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 have not been released from a TAHC hold order).

Changes to Breeding Facility Minimum Movement Qualifications (§65.94)

Changes were made to §65.94 concerning Breeding Facility Minimum Movement Qualifications to clarify the MQ requirements applicable upon the rules' effective date, to incorporate the modified MQ requirements that will go into effect April 1, 2017, and to make minor clarifying changes.

With regard to §65.94(a)(1)(A), under the proposed rules as well as the adopted rules, upon the rule's effective date, a breeding facility will be MQ if it has complied with the historic CWD testing requirement which required submission of CWD "not detected" test results for at least 20 percent of the total number of eligible mortalities that occurred in the facility since May 23, 2006. However, to accommodate facilities (mostly newer facilities) that had experienced a low number of mortalities, a provision was added that incorporated §65.604(d)(2) of the previous MQ requirements to provide that no testing was required if a breeding facility has had less than five eligible mortalities from May 23, 2006 through March 31, 2016.

The change to §65.94(a)(1)(B) sets out the MQ testing standard that will be effective with the reporting year beginning April 1, 2017. Under the rules as proposed, a deer breeder seeking to be MQ would be required to submit a number of "not-detected" post-mortem test results equal to least 50 percent of the total number of eligible mortalities in the facility each year, and beginning April 1, 2021, a minimum number of post-mortem "not detected" results for each of the previous five years of 2.25 percent of the eligible-aged population in the breeding facility. This standard is replaced with a requirement that to be MQ, a deer breeder must submit "not detected" test results for at least 80 percent of the eligible mortalities that occurred in the facility during the previous reporting year (i.e., the report year that ended March 31), with a minimum annual number of post-mortem "not detected" results for facilities that have been permitted for six months or more that is equal to at least 3.6 percent of the eligible aged population in the breeding facility. As explained below, 3.6 percent is 80 percent of the average expected annual mortality in a breeding facility. In addition, a provision was added to clarify that a breeding facility that had achieved "fifth-year" or "certified" status in the TAHC CWD Herd Certification Program meets the testing requirements to be considered MQ.

The change to §65.94 also inserts the word "or" after subsection (a)(3) because the list of criteria in subsection (a) is intended to be a list of criteria that are individually grounds for being designated NMQ.

The change to §65.94 also alters subsection (a)(4) to clarify that in addition to the recordkeeping and reporting provisions of 31 TAC §65.608, a permittee must be compliant with the recordkeeping and reporting provisions of the rules as adopted.

Finally, the change to §65.94 alters subsections (b) and (c) to clarify that "facility" as used in those subsections means deer breeding facility, and alters subsection (d) by replacing the word "received" with the phrase "have been in possession of," which is intended to clarify that the provision applies to deer that were ever in a facility as well as to deer that are within the facility at the current time.

Changes to Movement of Breeder Deer

The changes to §65.95, concerning Movement of Breeder Deer, consists of several alterations. As noted in the general discussion of the changes to §65.94 and §65.95, as a result of public comment and extensive outreach to the regulated community and stakeholders, the rule as adopted provides a testing program that eventually eliminates release site testing for all release sites (except for Class III release sites), and offers an ante-mortem testing component as a pathway for TC 2 breeding facilities to achieve TC 1 status (which would eliminate release-site testing obligations immediately).

Proposed §65.95(b)(1) would have assigned TC 1 status to a breeding facility if it satisfied one of three testing regimes: (1) submission of "not detected" post-mortem test results for at least 80 percent of eligible mortalities in each of the preceding five report years and then 80 percent of eligible mortalities annually thereafter, provided the "not detected" post-mortem test results for the five-year period were equal to or greater than the annual sum of the eligible-aged population and the eligible mortalities during the five-year period, multiplied by 3.6 percent; (2) a one-time ante-mortem "not detected" test result for 80 percent of the population of eligible-aged deer in the facility, followed by annual "not detected" post-mortem testing of 80 percent of eligible mortalities, provided that after April 1, 2021, "not detected" post-mortem test results for the preceding five-year period are equal to or greater than the sum of the eligible-aged population in the facility at the end of each report year and the eligible mortalities during the five-year period, multiplied by 3.6 percent; or (3) the annual submission of "not detected" ante-mortem test results for 25 percent of the facility's eligible-aged population and 50 percent of eligible mortalities.