Proposed Rules Title 4

TITLE 4. AGRICULTURE

PART 2. TEXAS ANIMAL HEALTH COMMISSION

The Texas Animal Health Commission (Commission) proposes amendments to Title 4, Texas Administrative Code, Chapter 40 titled "Chronic Wasting Disease." Specifically, amendments are proposed to §40.1, concerning Definitions, §40.2 concerning General Requirements, and §40.5 concerning Surveillance and Movement Requirements for Exotic CWD Susceptible Species.

BACKGROUND AND SUMMARY OF PROPOSED AMENDMENTS

The purpose of this chapter is to prevent and control the incidence of chronic wasting disease (CWD) in Texas by seeking to reduce the risk of interstate and intrastate transmission of CWD in susceptible cervid species. The Commission proposes amendments to §§40.1, 40.2, and 40.5 to clarify, correct, and update information regarding CWD management.

CWD is a degenerative and fatal neurological communicable disease recognized by the veterinary profession that affects susceptible cervid species. CWD can spread through natural movements of infected animals and transportation of live infected animals or carcass parts. Specifically, prions are shed from infected animals in saliva, urine, blood, soft-antler material, feces, or from animal decomposition, which ultimately contaminates the environment in which CWD susceptible species live. CWD has a long incubation period, so animals infected with CWD may not exhibit clinical signs of the disease for months or years after infection. The disease can be passed through contaminated environmental conditions, and may persist for a long period of time. Currently, no vaccine or treatment for CWD exists.

The purpose of the changes to §40.1 is to add, amend, and remove defined terms to provide clarity and align these rules with the federal standards regarding the management of CWD. The purpose of the changes to §40.2 is to provide clarity in the procedures for issuing hold orders and quarantines and reduce confusion for disease tracing and carcass disposal. The purpose of the changes to §40.5 is to change the testing requirements for exotic CWD susceptible species to align with federal standards and match state standards for testing native CWD susceptible species in order to increase surveillance of CWD in the state. Additionally, grammatical and editorial changes are proposed for consistency and improved readability.

SECTION-BY-SECTION DISCUSSION

Section 40.1 Definitions

The proposed amendments to §40.1, regarding definitions, add "APHIS," "Certified Herd," "CWD-Trace Herd," and "Postmortem tissue samples," to the list of definitions, amend the definitions of "Chronic Wasting Disease (CWD)," "Commingled, Commingling," "CWD-Exposed Animal," "CWD Susceptible Species," "Executive Director," "Farmed or Captive Cervids," "Herd," "Herd Plan," "Location Identification Number (LID)," "Official CWD Test," and remove the definitions for "Breeding Facility," "Farmed cervids," "Complete Physical Herd Inventory," "CWD Test Eligible," "Enrollment Date," "Enrolled Herd," "Herd Certification Program," "Herd Status," "Limited Contact," "Minimum Mortality Rate," "Release Facility," "Status Date," and "Trace Herd."

Section 40.2 General Requirements

The proposed amendments to §40.2(a)(1) improve readability and clarify that movement restriction shall remain in place until the Commission performs the epidemiologic investigation and approved laboratory testing is complete. The proposed amendments to §§40.2(a)(2), 40.2(a)(4), and 40.2(b) use the new definitions for CWD-trace herd and CWD-suspect herd found in §40.1.

In addition, the proposed amendments to §40.2(b)(1) through (3) clarify the agency or individual to whom CWD-suspect animals shall be presented and reported. The amendments to §40.2(b)(2)(C) clarify that all mortalities of all CWD susceptible species shall be immediately reported to a TAHC or USDA veterinarian to collect appropriate test samples. The amendments to §40.2(b)(2)(D) clarify what shall happen to CWD-exposed animals, how they shall be postmortem tested, or how long the CWD-exposed animals should be maintained. The amendments to §40.2(b)(3) clarify what happens to CWD-trace herds and mirror the amendments to §40.2(b)(2) for CWD-suspect animals and mortality reporting. The amendments to §40.2(c) clarify the disposal of CWD-suspect animal and CWD-exposed animal carcasses. The amendments to §40.2(d) improve readability.

Section 40.5 Surveillance and Movement Requirements for Exotic CWD Susceptible Species

The amendment to §40.5(a)(1) changes the definition of Eligible Mortality to lower the age of death that would qualify as an eligible mortality from 16 months to 12 months of age. The amendment to §40.5(a)(2) adds muntjac (Muntiacus) to the definition of Exotic CWD Susceptible Species.

The amendments to §40.5(b) specify that all eligible mortalities be tested for CWD within seven days using an official CWD test in accordance with the requirements in §40.5. The amendments also remove the limit to test only three animals a year. The amendments to §40.5(c) remove unnecessary additional language to explain the defined term "official animal identification" and to add information on where to report annual inventories. The amendments to §§40.5(d) and (e) clarify testing requirements and reporting and change the time to submit test results and reports from 30 days to 14 days. The amendments to §40.5(f) improve readability.

FISCAL NOTE

Ms. Myra Sines, Chief of Staff for the Texas Animal Health Commission, determined for each year of the first five years the rules are in effect, there are no estimated additional costs or reductions in costs to state or local governments as a result of enforcing or administering the proposed rules. Commission employees will administer and enforce these rules as part of their regular job duties and resources. Ms. Sines also determined for the same period that there is no estimated increase or loss in revenue to the state or local government as a result of enforcing or administering the proposed rules, and the proposed rules do not have foreseeable implications relating to costs or revenues of state governments.

PUBLIC BENEFIT

Ms. Sines determined that for each year of the first five years the proposed rules are in effect, the anticipated public benefits will be the protection of CWD susceptible species by increasing the surveillance of CWD susceptible species which will reduce the inadvertent spread of the disease from CWD susceptible species.

LOCAL EMPLOYMENT IMPACT STATEMENT

The Commission determined that the proposed rules will not impact local economies and, therefore, did not file a request for a local employment impact statement with the Texas Workforce Commission.

MAJOR ENVIRONMENTAL RULE

The Commission determined that Texas Government Code §2001.0225 does not apply to the proposed rules because the specific intent of these rules is not primarily to protect the environment or reduce risks to human health from environmental exposure, and therefore, is not a major environmental rule.

TAKINGS ASSESSMENT

The Commission determined that the proposal does not restrict, limit, or impose a burden on an owner’s rights to his or her private real property that would otherwise exist in the absence of government action. Therefore, the proposed rules are compliant with the Private Real Property Preservation Act in Texas Government Code §2007.043 and do not constitute a taking.

ECONOMIC IMPACT STATEMENT

The Commission determined that the proposed amendments to §§40.1, 40.2, and 40.5 may impact animal agricultural industries, which may meet the definition of a small business or microbusiness pursuant to Texas Government Code, Chapter 2006. Specifically, the Commission determined that the proposed rules may affect herd owners of CWD susceptible species or exotic CWD susceptible species.

The Commission determined that the proposed amendments would not adversely affect herd owners of CWD susceptible species because the amendments do not substantially change the movement, testing, and reporting requirements. The removal of the limit to test only three animal mortalities a year and the lowering of mortality test age for CWD may increase the cost to some herd owners, but the tradeoff in disease surveillance outweighs the potential cost to the herd owner. As such, these amendments to the movement, testing, and reporting requirements will allow the Commission to better monitor CWD in Texas. As a result, the application of the rule will help prevent adverse economic impacts associated with CWD.

Although the Commission does not predict adverse economic impacts to those directly regulated by the Commission, the Commission considered the businesses that may be impacted and regulatory alternatives as part of its rule proposal process. Texas has an unknown number of exotic cervid species that are free-ranging and also maintained on high-fenced premises. Many of those premises are hunting ranches, which are not subject to the seasonal and regulatory hunting restrictions of TPWD. The clarity provided by these amendments should reduce or eliminate any confusion those directly regulated by the Commission may have in reading and interpreting the rules.

REGULATORY FLEXIBILITY ANALYSIS

The Commission considered several alternative methods for achieving the proposed rules’ purpose while minimizing adverse economic impacts on small businesses, microbusinesses, and rural communities, as applicable, pursuant to Texas Government Code, Chapter 2006. The following sections analyze the substantive proposed changes that may have direct, adverse economic impacts on regulated parties in the order they are presented in Chapter 40.

The Commission considered an alternative method for achieving the proposed rules' purpose--by not changing the mortality testing requirements--but rejected the alternative because it would frustrate the Commission's ability to carry out Texas Agriculture Code §161.041 and eradicate or control any disease or agent of transmission, even if the agent of transmission is an animal species that is not subject to the jurisdiction of the Commission. This change also aligns the Commission’s regulations with other federal and state regulations over CWD susceptible species. The Commission determined these proposals are necessary to follow the legislative requirement that the Commission protect exotic livestock from certain diseases, specifically CWD.

GOVERNMENT GROWTH IMPACT STATEMENT

In compliance with the requirements of Texas Government Code §2001.0221, for each year of the first five years the proposed rules would be in effect, the Commission determined the following:

1. The proposed rules will not create or eliminate a government program;

2. Implementation of the proposed rules will not require the creation of new employee positions or the elimination of existing employee positions;

3. Implementation of the proposed rules will not require an increase or decrease in future legislative appropriations to the Commission;

4. The proposed rules will not require an increase or decrease in fees paid to the Commission;

5. The proposed rules will not create a new regulation;

6. The proposed rules will expand existing rules, but will not otherwise limit or repeal an existing regulation;

7. The proposed rules may increase the number of individuals subject to the regulation; and

8. The proposed rules will not adversely affect this state’s economy.

COST TO REGULATED PERSONS

The proposed amendments to §40.1 and §40.2 do not impose an additional cost to a regulated person. The proposed amendments to §40.5 may impose a cost on a regulated person by increasing the number of animals that may be required to be tested. The Commission determined these proposals are necessary to follow the legislative requirement that the Commission protect exotic livestock from certain diseases, specifically chronic wasting disease. The proposed rules do not otherwise impose a direct cost on a regulated person, state agency, a special district, or a local government within the state. Pursuant to Section 161.041 of the Texas Agriculture Code, Section 2001.0045 of the Texas Government Code does not apply to rules adopted under Section 161.041; therefore, it is unnecessary to amend or repeal any other existing rule.

REQUEST FOR COMMENT

Written comments regarding the proposed amendments may be submitted to Amanda Bernhard, Texas Animal Health Commission, 2105 Kramer Lane, Austin, Texas 78758, by fax at (512) 719-0719 or by e-mail to comments@tahc.texas.gov. To be considered, comments must be received no later than thirty (30) days from the date of publication of this proposal in the Texas Register. When faxing or emailing comments, please indicate "Comments on Chapter 40-CWD Rules" in the subject line.

STATUTORY AUTHORITY

The amendments to §§40.1, 40.2, and 40.5 within Chapter 40 of the Texas Administrative Code are proposed under the following statutory authority as found in Chapter 161 of the Texas Agriculture Code.

The Commission is vested by statute, §161.041(a), titled "Disease Control," to protect all livestock, exotic livestock, domestic fowl, and exotic fowl from disease. The Commission is authorized, through §161.041(b), to act to eradicate or control any disease or agent of transmission for any disease that affects livestock, exotic livestock, domestic fowl, or exotic fowl, even if the agent of transmission is an animal species that is not subject to the jurisdiction of the Commission.

Pursuant to §161.0415, titled "Disposal of Diseased or Exposed Livestock or Fowl," the Commission may require by order the slaughter of livestock, domestic fowl, or exotic fowl exposed to or infected with certain diseases.

Pursuant to §161.0417, titled "Authorized Personnel for Disease Control," the Commission must authorize a person, including a veterinarian, to engage in an activity that is part of a state or federal disease control or eradication program for animals.

Pursuant to §161.046, titled "Rules," the Commission may adopt rules as necessary for the administration and enforcement of this chapter.

Pursuant to §161.047, titled "Entry Power," Commission personnel are permitted to enter public or private property for the performance of an authorized duty.

Pursuant to §161.048, titled "Inspection of Shipment of Animals or Animal Products," the Commission may require testing, vaccination, or another epidemiologically sound procedure before or after animals are moved. An agent of the Commission is entitled to stop and inspect a shipment of animals or animal products being transported in this state to determine if the shipment originated from a quarantined area or herd; or determine if the shipment presents a danger to the public health or livestock industry through insect infestation or through a communicable or non-communicable disease.

Pursuant to §161.049, titled "Dealer Records," the Commission may require a livestock, exotic livestock, domestic fowl, or exotic fowl dealer to maintain records of all livestock, exotic livestock, domestic fowl, or exotic fowl bought and sold by the dealer. The Commission may also inspect and copy the records of a livestock, exotic livestock, domestic fowl, or exotic fowl dealer that relate to the buying and selling of those animals. The Commission, by rule, shall adopt the form and content of the records maintained by a dealer.

Pursuant to §161.054, titled "Regulation of Movement of Animals; Exception," the Commission, by rule, may regulate the movement of animals. The Commission may restrict the intrastate movement of animals even though the movement of the animals is unrestricted in interstate or international commerce. The Commission may require testing, vaccination, or another epidemiologically sound procedure before or after animals are moved. The Commission is authorized, through §161.054(b), to prohibit or regulate the movement of animals into a quarantined herd, premises, or area. The Executive Director of the Commission is authorized, through §161.054(d), to modify a restriction on animal movement, and may consider economic hardship.

Pursuant to §161.0541, titled "Elk Disease Surveillance Program," the Commission, by rule, may establish a disease surveillance program for elk. Such rules include the requirement for persons moving elk in interstate commerce to test the elk for chronic wasting disease. Additionally, provisions must include testing, identification, transportation, and inspection under the disease surveillance program.

Pursuant to §161.0545, titled "Movement of Animal Products," the Commission may adopt rules that require the certification of persons who transport or dispose of inedible animal products, including carcasses, body parts, and waste material. The Commission, by rule, may provide terms and conditions for the issuance, renewal, and revocation of a certification under this section.

Pursuant to §161.056(a), titled "Animal Identification Program," the Commission may develop and implement an animal identification program that is no more stringent than a federal animal disease traceability or other federal animal identification program to provide for disease control and enhance the ability to trace disease-infected animals or animals that have been exposed to disease. Section 161.056(d) authorizes the Commission to adopt rules to provide for an animal identification program more stringent than a federal program only for control of a specific animal disease or for animal emergency management.

Pursuant to §161.057, titled "Classification of Areas," the Commission may prescribe criteria for classifying areas in the state for disease control based on sound epidemiological principals and may prescribe control measures for classification areas.

Pursuant to §161.058, titled "Compensation of Livestock or Fowl Owner," the Commission may pay indemnity to the owner of livestock or fowl, if necessary, to eradicate the disease.

Pursuant to §161.060, titled "Authority to Set and Collect Fees," the Commission may charge a fee for an inspection made by the Commission as provided by Commission rule.

Pursuant to §161.061, titled "Establishment," if the Commission determines that a disease listed in §161.041 of this code or an agent of transmission of one of those diseases exists in a place in this state or among livestock, exotic livestock, domestic animals, domestic fowl, or exotic fowl, or a place in this state or livestock, exotic livestock, domestic animals, domestic fowl, or exotic fowl are exposed to one of those diseases or any agent of transmission of one of those diseases, the Commission shall establish a quarantine on the affected animals or on the affected place. The quarantine of an affected place may extend to any affected area, including a county, district, pasture, lot, ranch, farm, field, range, thoroughfare, building, stable, or stockyard pen. The Commission may, through §161.061(c), establish a quarantine to prohibit or regulate the movement of any article or animal the Commission designates to be a carrier of a disease listed in Section 161.041 or a potential carrier of one of those diseases, if movement is not otherwise regulated or prohibited for an animal into an affected area, including a county district, pasture, lot, ranch, field, range, thoroughfare, building, stable, or stockyard pen.

Pursuant to §161.0615, titled "Statewide or Widespread Quarantine," the Commission may quarantine livestock, exotic livestock, domestic fowl, or exotic fowl in all or any part of this state as a means of immediately restricting the movement of animals potentially infected with disease and shall clearly describe the territory included in a quarantine area.

Pursuant to §161.065, titled "Movement from Quarantined Area; Movement of Quarantined Animals," the Commission may provide a written certificate or written permit authorizing the movement of animals from quarantined places. If the Commission finds animals have been moved in violation of an established quarantine or in violation of any other livestock sanitary law, the Commission shall quarantine the animals until they have been properly treated, vaccinated, tested, dipped, or disposed of in accordance with the rules of the Commission.

Pursuant to §161.081, titled "Importation of Animals," the Commission may regulate the movement of livestock, exotic livestock, domestic animals, domestic fowl, or exotic fowl into this state from another state, territory, or country. The Commission, by rule, may provide the method for inspecting and testing animals before and after entry into this state, and for the issuance and form of health certificates and entry permits.

Pursuant to §161.101, titled "Duty to Report," a veterinarian, a veterinary diagnostic laboratory, or a person having care, custody, or control of an animal shall report the existence of the disease, if required by the Commission, among livestock, exotic livestock, bison, domestic fowl, or exotic fowl to the Commission within 24 hours after diagnosis of the disease.

Pursuant to §161.148, titled "Administrative Penalty," the Commission may impose an administrative penalty on a person who violates Chapter 161 or a rule or order adopted under Chapter 161. The penalty for a violation may be in an amount not to exceed $5,000.

The proposed rules in this chapter for adoption do not affect other statutes, sections, or codes.

§40.1.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

(1) APHIS--The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

(2) [~~(1)~~] Approved Laboratory--A diagnostic laboratory approved by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Administrator to conduct official tests for CWD in accordance with 9 CFR §55.8.

[(2) Breeding Facility--Privately owned, high-fenced pens where a cervid herd is managed for breeding purposes. The breeding facility must be registered with and assigned a facility identification number (FID) by the Texas Parks and Wildlife Department for white-tailed deer and mule deer.]

(3) Certified CWD Postmortem Sample Collector--An individual who has completed appropriate training recognized by the commission on the collection, preservation, laboratory submission, and proper recordkeeping of samples for postmortem CWD testing, and who has been certified by the commission to perform these activities.

(4) Certified Herd--A herd that has reached certified status in the CWD Herd Certification Program in §40.3 of this chapter (relating to CWD Herd Certification Program) or an equivalent state or federal program authorized under 9 CFR Part 55.

(5) [~~(4)~~] Chronic Wasting Disease (CWD)--A transmissible spongiform encephalopathy [~~(TSE)~~] of susceptible species. Clinical signs include, but are not limited to, loss of body condition, loss of appetite, incoordination, blank stares, tremors, listlessness, excessive salivation, difficulty swallowing, increased drinking and urination, depression, and other behavioral changes and eventual death.

(6) [~~(5)~~] Commingled, Commingling--Cervids [~~Farmed cervids~~] of any age are commingled when [if] they have [~~are housed or penned together having~~] direct physical contact with each other, have less than 10 feet of physical separation or share [~~except in cases of limited contact, or any activity where uninhibited contact occurs such as sharing an enclosure, a section of a transport vehicle, or sharing~~] equipment, pens or stalls, pasture, or water sources/watershed, including contact with bodily fluids or excrement from other farmed or captive cervids (i.e., indirect contact). [such as cervids housed in a pen that receives runoff or shares a natural or man-made body of water with another pen. Commingling includes contact with bodily fluids or excrement from other farmed or captive animals.] Animals are [~~also~~] considered to have commingled if they have had such direct or indirect contact with a CWD-positive animal [~~herd~~] or CWD contaminated premises within the last five [5] years. [~~Farmed cervids commingled with other farmed cervids assume the status of the lowest program status animal in the group.~~]

(7) [~~(6)~~] Commission--The Texas Animal Health Commission (TAHC).

~~[(7) Complete Physical Herd Inventory--A visual verification of all animals and identifications to reconcile records maintained by the owner.]~~

(8) CWD-Exposed Animal--A CWD susceptible species that is part of a CWD-positive herd, or that has been commingled with or been exposed to a CWD-positive animal or resided on a CWD contaminated premises within [~~the~~] five years of the discovery of CWD. [~~before diagnosis.~~]

~~[(9) CWD-Exposed Herd--A herd in which a CWD-positive animal has resided within 5 years prior to that animal's diagnosis as CWD-positive, as determined by a commission or USDA representative.]~~

(9) [~~(10)~~] CWD-Positive Animal--An animal that has had a diagnosis of CWD established through official confirmatory testing conducted by the National Veterinary Services Laboratories.

(10) [~~(11)~~] CWD-Positive Herd--A herd in which a CWD-positive animal resided at the time of CWD diagnosis.

(11) [~~(12)~~] CWD Susceptible Species--All species in the Cervidae family that have had a CWD diagnosis confirmed by an official test conducted by an approved laboratory. Including but not limited to [~~This includes~~] white-tailed deer (Odocoileus virginianus), mule deer (Odocoileus hemionus), black-tailed deer (Odocoileus hemionus columbianus), North American elk or wapiti (Cervus canadensis), red deer (Cervus elaphus), sika [~~Sika~~] deer (Cervus nippon), moose (Alces alces), reindeer and caribou (Rangifer tarandus), (Muntiacus) and any associated subspecies and hybrids.

(12) [~~(13)~~] CWD-Suspect Animal--A CWD susceptible species with unofficial CWD test results, laboratory evidence or clinical signs that suggest a diagnosis of CWD, as determined by a commission representative, but for which official laboratory results are inconclusive or not yet conducted.

(13) [~~(14)~~] CWD-Suspect Herd--A herd with unofficial CWD test results, laboratory evidence, or clinical signs that suggest a diagnosis of CWD, as determined by a commission representative, but for which official laboratory results are inconclusive or not yet conducted.

(14) CWD-Trace Herd--The term includes trace-back, trace-forward, and otherwise epidemiologically linked herds. A trace-back herd is any herd that contributed an animal to a CWD-positive herd within the five years prior to the diagnosis of CWD in the positive herd or is otherwise epidemiologically linked to a CWD-positive herd. A trace-forward herd is any herd which has received animals from a CWD-positive herd during a five-year period prior to the diagnosis of CWD in the positive herd or from the identified date of entry of CWD into the positive herd or is otherwise epidemiologically linked to a CWD-positive herd.

~~[(15) CWD Test Eligible--Unless otherwise specifically provided in these rules, all Cervidae 12 months of age and over.]~~

~~[(16) Enrollment Date--The day, month, and year when a herd that joins the CWD Herd Certification Program receives a satisfactory initial inspection.]~~

[(17) Enrolled Herd--A herd that has enrolled in the commission's Herd Certification Program and has met the minimum requirements defined in 9 CFR Part 55. Upon initial enrollment, all herds will be placed in First Year status unless the herd is assembled from other herds already participating in the program, and in such case will assume the status of the lowest herd.]

(15) [~~(18)~~] Executive Director--The Executive Director of the Texas Animal Health Commission[~~, or any individual authorized to act for the Executive Director~~].

(16) [~~(19)~~] Farmed or Captive Cervids --Privately or publicly maintained or held cervids for economic or other purposes within a perimeter fence or confined area, or captured from a free-ranging population for interstate or intrastate movement and release.

(17) [~~(20)~~] Herd--A group of cervids that is under common ownership, control, or supervision and is grouped on one or more parts of any single premises or on two or more geographically separated premises where cervids are commingled or have direct or indirect contact with one another. [~~An animal or group of animals that is:~~

~~[(A) Under common ownership, control, or supervision and are grouped on one or more parts of any single premises, including a lot, farm, or ranch where commingling of animals occurs; or]~~

~~[(B) All animals under common ownership, control, or supervision on two or more geographically-separated premises where animals are commingled or had direct contact with one another.]~~

~~[(21) Herd Certification Program--The program operated by the commission for the certification of CWD status cervid herds that meets the requirements of 9 CFR Part 55, subpart B.]~~

(18) [~~(22)~~] Herd Plan--A written herd or premises management agreement developed by the commission, the herd owner, and other affected parties. A herd plan sets forth the steps to take to control the spread of CWD from a CWD-positive herd, to control the risk of CWD in a CWD-exposed herd or CWD-suspect herd, or to prevent introduction of CWD into that herd or any other herd. [Requirements to prevent or control the possible spread of CWD, depending on the particular circumstances of the herd and its premises, including but not limited to depopulation of the herd, specifying the time when a premises must not contain cervids after CWD-positive, CWD-exposed, or CWD-suspect animals are removed from the premises, fencing requirements, selective culling of animals, restrictions on sharing and movement of possibly contaminated livestock equipment, premises cleaning and disinfection requirements, and other requirements may also be included in a herd plan. A herd plan requires the following: specified means of identification for each animal in the herd, regular examination of animals in the herd by a veterinarian for clinical signs of CWD, reporting to a commission representative any clinical signs of CWD, and recordkeeping.]

[(23) Herd Status--The status of a herd assigned under the commission CWD Herd Certification Program in compliance with Section 40.3 indicating a herd's relative risk for CWD. Herd status is the number of years of monitoring without evidence of the disease and any specific determinations that the herd has contained or has been exposed to a CWD-positive, CWD-exposed, or CWD-suspect animal. When a herd is first enrolled in the CWD Herd Certification Program, it will be placed in First Year status; except that, if the herd is composed solely of animals obtained from herds already enrolled in the program, the newly enrolled herd will have the same status as the lowest status of any herd that provided animals for the new herd. If the herd continues to meet the requirements of the program, each year, on the anniversary of the enrollment date the herd status will be upgraded by one year. One year from the date a herd is placed in Fifth Year status, the herd status will be changed to Certified, and the herd will remain in Certified Status as long as it is enrolled in the program, provided its status is not lowered, suspended, or revoked.]

(19) [~~(24)~~] High-risk area or county--An area or county that is epidemiologically determined to have a high probability for species susceptible for having, developing or being exposed to CWD.

(20) [~~(25)~~] Hold Order--A written commission order and action restricting movement of a herd, animal, or animal product pending the determination of CWD status.

[(26) Limited Contact--Any brief, incidental contact between cervids from different herds such as in sale or show rings and alleyways at fairs, livestock auctions, sales, shows, and exhibitions. Limited contact does not include penned animals having less than ten feet of physical separation or contact through a fence, or any activity where uninhibited contact occurs such as sharing an enclosure, a section of a transport vehicle, equipment, food, or water sources, or contact with bodily fluids or excrement. Pens at fairs, livestock auctions, sales, shows, and exhibitions must be thoroughly cleaned and all organic material removed after use and before holding another animal.]

(21) [~~(27)~~] Location Identification Number (LID)--A nationally unique number assigned by the commission to a premises starting with the state postal abbreviation (TX) followed by six random alphanumeric characters. Each LID is a geographically distinct location associated with a verifiable physical address, geospatial coordinates, or other location descriptors. [~~All herds in the CWD Herd Certification Program will be assigned a LID or PIN.~~]

[(28) Minimum Mortality Rate--Death loss from natural causes is expected to be five percent for white-tailed deer 12 months of age and older averaged over a three-year period, unless epidemiologically determined otherwise.]

(22) [~~(29)~~] Official Animal Identification--A device or means of animal identification approved by USDA to uniquely identify individual animals. The official animal identification must include a nationally unique animal identification number that adheres to one of the following numbering systems:

(A) - (D) (No change.)

(23) [~~(30)~~] Official CWD Test--A USDA-validated immunohistochemistry (IHC) test of appropriate tissue samples for the diagnosis of CWD conducted in an approved laboratory.

(24) Postmortem tissue samples--Means the obex, both medial retropharyngeal lymph nodes, and an official animal identification device attached to ear or skin tissue collected and prepared under USDA APHIS guidelines for CWD postmortem sample collection.

(25) [~~(31)~~] Premises Identification Number (PIN)--A nationally unique number assigned by the commission or USDA to a premises. Each PIN is a geographically distinct location associated with a verifiable physical address, geospatial coordinate, or other location descriptors.

(26) [~~(32)~~] Quarantine--A written commission order and [~~the~~] action of restricting animal or animal product movement from or onto a premises because of the existence of or exposure to CWD.

[(33) Release Facility--A privately owned, high-fenced premises where white-tailed deer or mule deer from a breeding facility are released for management as free-ranging animals. A release facility must be registered with and assigned a facility identification number (FID) by the Texas Parks and Wildlife Department.]

~~[(34) Status Date--The day, month, and year the commission approves a change in herd status.]~~

(27) [~~(35)~~] TAHC Authorized Veterinarian--A veterinarian who is licensed to practice medicine in Texas, Category II accredited by USDA APHIS VS, and has satisfactorily completed TAHC disease control or eradication program training pursuant to 4 TAC Chapter 47, concerning Authorized Personnel.

[(36) Trace Herd--The term includes both trace-back and trace-forward herds. A trace-back herd is any herd that contributed an animal to a CWD-positive herd within the 5 years prior to the diagnosis of CWD in the positive herd. A trace-forward herd is any herd which has received animals from a CWD-positive herd during a 5-year period prior to the diagnosis of CWD in the positive herd or from the identified date of entry of CWD into the positive herd.]

(28) USDA--The United States Department of Agriculture.

§40.2.General Requirements.

(a) Procedures for issuing hold orders and quarantines.

(1) Any CWD-suspect herd shall be immediately reported to a [~~representative of the~~] commission representative. The herd shall be restricted by hold order until the commission’s epidemiologic investigation and approved laboratory testing [~~diagnosis~~] are complete.

(2) A CWD-trace herd shall be restricted by hold order until an epidemiologic investigation by the commission is complete and the herd meets all herd plan requirements.

(3) A CWD-positive herd shall be restricted by quarantine until the herd meets all herd plan requirements.

(4) Any CWD-suspect herd, CWD-trace, and CWD-positive herd [~~CWD-positive herds~~] not complying with the epidemiologic investigation or herd plan requirements shall be restricted by quarantine.

(b) Requirements for CWD-suspect herds, CWD- trace herds, or CWD-positive herds.

(1) CWD-suspect animals shall be presented to a [~~representative of the~~] commission representative for the purpose of collection and submission of appropriate samples to an approved laboratory for diagnosis.

(2) Disposition of a CWD-positive herd as determined by a commission [~~TAHC~~] or USDA epidemiologist following completion of the investigation. A herd plan will be developed by a commission or USDA epidemiologist in consultation with the herd owner, and, if requested, their veterinarian. Unless otherwise determined by a commission epidemiologist and approved by the executive director [~~Executive Director~~], the herd plan shall include the following requirements for a period of five years:

(A) - (B) (No change.)

(C) All [~~Mandatory reporting of all~~] CWD-suspect animals and all mortalities of all CWD susceptible species [~~death losses. Mortality in animals of any age~~] shall be immediately reported to a commission or USDA veterinarian for the purpose of collection of appropriate samples for submission to an approved laboratory for CWD surveillance.

(D) CWD-exposed animals must be [~~removed from the herd and~~]:

(i) Humanely euthanized, tested for CWD by official CWD test, and disposed of as specified in subsection (c) of this section; or

(ii) Maintained under the terms of the herd plan until all requirements of the herd plan are met. [~~hold order for 5 years from the last exposure to a CWD-positive animal.~~]

(E) The herd shall remain under quarantine for five [5] years from the last exposure to a CWD-positive animal or a CWD-exposed animal and until such time that all herd plan requirements are met.

(3) Disposition of CWD-trace herds. A herd plan will be developed by a commission or USDA epidemiologist in consultation with the owner, and, if requested, their veterinarian. Unless otherwise determined by a commission epidemiologist and approved by the executive director [~~Executive Director~~], [~~the herd plan shall require the following for 5 years~~] the herd plan shall include the following requirements for a period of five years:

(A) - (B) (No change.)

(D) CWD-exposed animals must be [~~removed from the herd and~~]:

(i) Humanely euthanized, tested for CWD by official CWD test, and disposed of as specified in subsection (c) of this section; or

(ii) Maintained under the terms of the herd plan until all requirements of the herd plan are met. [~~hold order for 5 years from the last potential exposure.~~]

(c) Disposal of CWD-suspect animal and CWD-exposed animal carcasses. After all required postmortem tissue samples are collected, carcasses or remaining parts of CWD-suspect animals and CWD-exposed animals, including all animal products, by-products, and contaminated materials, shall be disposed of by deep burial or incineration on the premises where the animal was located or at a facility approved by the executive director. [CWD-exposed animals. Animals euthanized due to a presumptive positive of CWD, including CWD-exposed animals in CWD-positive and trace herds, shall be humanely euthanized and appropriate samples collected to confirm the diagnosis, and disposed of by deep burial or incineration, including all animal products, by-products, and contaminated materials:]

~~[(1) on the premises where a CWD diagnosis was disclosed; or]~~

~~[(2) at a facility approved by the Executive Director.]~~

(d) Payment of indemnity. The commission may participate in paying indemnity to purchase and dispose of CWD-positive animals, CWD-exposed animals, and CWD-suspect animals. Subject to available funding, the amount of the state payment for any such animals will be five percent of the appraised value established in accordance with 9 CFR §55.3. This payment is in participation with any federal [~~Federal~~] indemnity payments made in accordance with 9 CFR §55.2.

§40.5.Surveillance and Movement Requirements for Exotic CWD Susceptible Species.

(a) Definitions. In addition to the definitions in §40.1 of this chapter (relating to Definitions), the following words and terms, when used in this section, shall have the following meanings:

(1) Eligible Mortality--The death from any cause of an exotic CWD susceptible species that is 12 [16] months of age or older on any and all premises which raise and/or contain any exotic CWD susceptible species, whether a premises engages in live transport of these animals or not. This includes hunter harvest or herd culling on the premises, natural mortalities on the premises, and animals moved directly to slaughter.

(2) Exotic CWD Susceptible Species--A non-native cervid species determined to be susceptible to CWD, which means a species that has had a diagnosis of CWD confirmed by an official test conducted by an approved laboratory. This includes but is not limited to North American elk or wapiti (Cervus canadensis), red deer (Cervus elaphus), sika [~~Sika~~] deer (Cervus nippon), moose (Alces alces), reindeer and caribou (Rangifer tarandus), muntjac (Muntiacus), and any associated subspecies and hybrids. All mule deer, white-tailed deer, and other native species under the jurisdiction of the Texas Parks and Wildlife Department are excluded from this definition and application of this section.

(3) - (4) (No change.)

(b) Surveillance Requirements. The [~~Each calendar year, the~~] owner of a premises shall have all eligible mortalities tested for CWD within seven days using an official CWD test in accordance with subsection (d) of this section and shall report all results in accordance with subsection (e) of this section. [until such time that three animals are tested and valid test results are obtained. The owner of the premises shall ensure that the CWD samples are properly collected and submitted in compliance with the requirements for collection. The owner must report the test results to the commission within 30 days of receiving the test results.] This requirement applies to any premises where exotic CWD susceptible species are located and is not dependent on the live movement of any of these species or fence height.

(1) Live exotic CWD susceptible species moved or transported within the state shall be identified with an official animal identification [device, which may include an eartag that conforms to the USDA alphanumeric National Uniform Eartagging System (NUES), a visible and legible animal identification number (AIN) or other identification methods approved by the commission, including a RFID device].

(2) (No change.)

(3) An owner of a premises where exotic CWD susceptible species are located within a high fence shall keep herd records that include an annual inventory and mortality records for all exotic CWD susceptible species. The inventory shall be reconciled and submitted to the commission on or before April 1 of each year by mail to Texas Animal Health Commission, CWD Susceptible Species Reporting, P.O. Box 12966, Austin, Texas 78711-2966; by fax to (512) 719-0729; or by email to CWD_reports@tahc.texas.gov. Annual inventory records shall be retained for five years [~~one year~~] following submission to the commission.

(4) (No change.)

(d) Testing Requirements. All eligible mortalities shall be tested for CWD using an official CWD test. Unless the whole head is submitted for testing, postmortem tissue samples must be collected and prepared by a state or federal animal health official, an accredited veterinarian, or a certified CWD postmortem sample collector. [CWD test samples shall be collected and submitted to an approved laboratory for CWD diagnosis using an official CWD test for all eligible mortalities. Test reporting shall be directed to the appropriate TAHC Region Office. The samples may be collected by a state or federal animal health official, an accredited veterinarian, or a Certified CWD Postmortem Sample Collector. Tissue samples shall be the obex and one retropharyngeal lymph node from each test-eligible animal mortality.]

(e) Test Result Reporting. The owner shall submit [~~report~~] all test results and laboratory reports to the commission within 14 [30] days of receiving the test results by mail [~~writing~~] to Texas Animal Health Commission, CWD Susceptible Species Reporting, P.O. Box 12966, Austin, Texas 78711-2966; by fax to (512) 719-0729; or by email to CWD_reports@tahc.texas.gov.

(f) Mortality Recordkeeping.

(1) The owner of a premises where an exotic CWD susceptible species eligible mortality occurs shall maintain the following mortality records:

(A) - (B) (No change.)

(D) (No change.)

(2) The mortality records shall be made available upon request to any commission representative [~~acting in the performance of official duties~~].

(3) - (4) (No change.)

(g) Inspection. To ensure compliance with these rules, a premises where exotic CWD susceptible species are located may be inspected by the commission or authorized agents of the commission.

(h) (No change.)

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 27, 2023.

TRD-202301531

Jeanine Coggeshall

General Counsel

Texas Animal Health Commission

Earliest possible date of adoption: June 11, 2023

For further information, please call: (512) 719-0718

4 TAC §40.3

The Texas Animal Health Commission (Commission) proposes the repeal of existing §40.3, concerning Herd Certification Program for Cervidae in the Texas Administrative Code, Title 4, Part 2, Chapter 40. This repeal is proposed in conjunction with the proposal of a new §40.3, concerning CWD Herd Certification Program, which is also published simultaneously in this issue of the Texas Register.

BACKGROUND AND PURPOSE

The Commission has determined that due to the extensive reorganization of the new §40.3, concerning CWD Herd Certification Program, repeal of the entire section and replacement with a new section is more efficient than proposing multiple amendments to make the required changes.

The Commission's goals in proposing the new section are to align the Commission's CWD Herd Certification Program with federal standards, provide clear guidance to participants in the program, and improve the administration of the program.

SECTION-BY-SECTION SUMMARY

The proposed repeal will repeal the existing §40.3 in order to replace it with a new proposed §40.3.

FISCAL NOTE

Ms. Myra Sines, Chief of Staff for the Texas Animal Health Commission, has determined that for each of the first five years the proposed repeal is in effect, enforcing or administering the repeal will have no foreseeable implications relating to costs or revenues of state or local governments.

PUBLIC BENEFIT NOTE

Ms. Sines determined that for each year of the first five years the proposed repeal is in effect, the anticipated public benefit will be the adoption of new rules which improve administration and provide clarity and guidance for participants in the CWD Herd Certification Program.

TAKINGS IMPACT ASSESSMENT

The Commission determined that the proposed repeal does not restrict, limit, or impose a burden on an owner's rights to his or her private real property that would otherwise exist in the absence of government action. Therefore, the proposed rules are compliant with the Private Real Property Preservation Act in Texas Government Code §2007.043 and do not constitute a taking.

LOCAL EMPLOYMENT IMPACT STATEMENT

The Commission determined that the proposed repeal would not impact local economies and, therefore, did not file a request for a local employment impact statement with the Texas Workforce Commission pursuant to Texas Government Code §2001.022.

REGULATORY ANALYSIS OF MAJOR ENVIRONMENTAL RULES

The Commission determined that this proposed repeal is not a "major environmental rule" as defined by Government Code §2001.0225.

GOVERNMENT GROWTH IMPACT STATEMENT

The Commission has determined that during the first five years the repeal will be in effect:

1. the proposed repeal will not create or eliminate a government program;

2. implementation of the proposed repeal will not require the creation of new employee positions or the elimination of existing employee positions;

3. implementation of the proposed repeal will not require an increase or decrease in future legislative appropriations to the Commission;

4. the proposed repeal will not increase or decrease fees paid to the Commission;

5. the proposed repeal will not create a new regulation;

6. the proposed repeal will repeal an existing regulation, but the repealed regulations will be replaced with revised regulations;

7. the proposed repeal does not increase or decrease the number of individuals subject to the rule's applicability; and

8. the proposed repeal will not positively or adversely affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

The Commission determined there will be no adverse economic effect on small businesses, micro-businesses, or rural communities as a result of the proposed repeal. As such, the Commission is not required to prepare a regulatory flexibility analysis.

COSTS TO REGULATED PERSONS

The Commission determined there are no increase of costs to a regulated person by this proposed repeal. The proposed rules do not otherwise impose a direct cost on a regulated person, state agency, a special district, or a local government within the state. Pursuant to Section 2001.0045 of the Texas Government Code, therefore, it is unnecessary to amend or repeal any other existing rule.

REQUEST FOR COMMENT

Written comments regarding the proposed repeal may be submitted to Amanda Bernhard, Texas Animal Health Commission, 2105 Kramer Lane, Austin, Texas 78758, by fax at (512) 719-0719 or by e-mail to comments@tahc.texas.gov. To be considered, comments must be received no later than thirty (30) days from the date of publication of this proposal in the Texas Register. When faxing or emailing comments, please indicate "Comments on Chapter 40-CWD Rules" in the subject line.

STATUTORY AUTHORITY

The repeal is proposed under the following statutory authority as found in Chapter 161 of the Texas Agriculture Code.

Pursuant to §161.046, titled "Rules," the Commission may adopt rules as necessary for the administration and enforcement of this chapter.

Pursuant to §161.047, titled "Entry Power," Commission personnel are permitted to enter public or private property for the performance of an authorized duty.

Pursuant to §161.048, titled "Inspection of Shipment of Animals or Animal Product," the Commission may require testing, vaccination, or another epidemiologically sound procedure before or after animals are moved. An agent of the Commission is entitled to stop and inspect a shipment of animals or animal products being transported in this state to determine if the shipment originated from a quarantined area or herd; or determine if the shipment presents a danger to the public health or livestock industry through insect infestation or through a communicable or non-communicable disease.

Pursuant to §161.060, titled "Authority to Set and Collect Fees," the Commission may charge a fee for an inspection made by the Commission as provided by Commission rule.

The proposed repeal of the rules does not affect other statutes, sections, or codes.

§40.3.Herd Certification Program for Cervidae.

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 28, 2023.

TRD-202301532

Jeanine Coggeshall

General Counsel

Texas Animal Health Commission

Earliest possible date of adoption: June 11, 2023

For further information, please call: (512) 719-0718

4 TAC §40.3

The Texas Animal Health Commission ("Commission") proposes a new §40.3, concerning CWD Herd Certification Program to add to Title 4, Texas Administrative Code, Chapter 40 "Chronic Wasting Disease." The new section is proposed in conjunction with the repeal of existing §40.3 concerning Herd Certification Program for Cervidae.

BACKGROUND AND PURPOSE

The CWD Herd Certification Program is a voluntary, cooperative surveillance and certification program between the Commission, United States Department of Agriculture, herd owners, and other affected parties. The purpose of the program is to promote a consistent, national approach in controlling CWD in farmed and captive cervids and preventing the interstate spread of CWD. Participating herds that meet program requirements and have no evidence of CWD advance in status each year for five years, then are certified as low risk for CWD. Certified herd status permits interstate animal movement.

The United States Department of Agriculture publishes Chronic Wasting Disease Program Standards ("federal standards") to clarify and update acceptable methods for complying with the legal requirements in Title 9 of the Code of Federal Regulations Parts 55 and 81. The Commission's CWD Herd Certification Program is currently an approved program under the federal standards; to maintain its approved status, the Commission is required to follow the legal requirements of the federal regulations and continue to align the program with federal standards.

SECTION-BY-SECTION SUMMARY

Structurally, the new rule is divided into several subsections to provide clear guidance to participants. These new subsections include clear topics, including: definitions, program enrollment requirements, program requirements, herd status advancement and herd certification, effect of new animals on a herd, detection of CWD in an enrolled herd, and actions affecting enrollment.

Section 40.3(a) defines terms that are used within this section. Definitions for the terms "animal," "annual inspection window," "application and agreement," "eligible mortality," "enrolled herd," "enrollment date," "local TAHC region office," "program," "status," and "TWIMS" have been added to provide clarity to the program requirements.

Section 40.3(b) specifies the program enrollment process. This subsection lists all the prerequisites for enrollment into the program and includes all the steps a herd owner must take to have a herd enrolled in the program.

Section 40.3(c) specifies the program requirements. With the goal of clarity in mind, this section explicitly lists the requirements for participation in the program under a single subsection. While these program requirements existed in the previous rule, they were contained under multiple sections and required participants to navigate throughout the rule to determine requirements. In the new form, the requirements are enumerated with additional descriptions of the requirements for each component of the program.

This section also includes some substantive changes to eliminate ambiguity, improve the administration of the program, and align program requirements with federal standards.

Section 40.3(c)(3) modifies the former rule by specifying what reporting is required and the methods by which information is reported. This includes the requirement that immediate reporting be done by phone or email and that herds that have white-tailed deer or mule deer use the Texas Parks and Wildlife Department TWIMS system.

Section 40.3(c)(4) is amended to clarify that testing samples include postmortem tissue samples, as defined by §40.1(24) to mean the obex, both medial retropharyngeal lymph nodes, and an official animal identification device attached to ear or skin tissue collected and prepared under federal guidelines for CWD postmortem sample collection. The rule also specifies that the postmortem tissue samples must be prepared and collected by a state or federal health official, an accredited veterinarian or a CWD postmortem sample collector. The rule does not change the requirement that it be submitted within seven days or the requirement to report test results. The rule is amended to provide additional information regarding what will be considered missed or poor-quality samples and to provide guidelines for replacement testing.

Section 40.3(c)(5), regarding recordkeeping, maintains the same requirements as the previous rule but adds the requirement that herd owners with white-tailed deer and mule deer utilize TWIMS.

Section 40.3(c)(6) is amended to specify that annual inspections will take place during the annual inspection window, which is: "The period of time each year for an enrolled herd to complete an annual inspection. Unless a specific period is set by a commission representative in writing, the annual inspection window begins 30 days before the month and day of the enrollment date and ends 30 days after the month and day of the enrollment date." Previously, the inspection was to occur 11-13 months from the last inspection. That rule created confusion for participants and was difficult to administer. This proposed change would mandate that the annual inspection occur during the annual inspection window which will simplify this requirement for participants and for the Commission. This modification also allows for some flexibility for participants to request an adjustment to their inspection window to meet the needs of their herd. This should help eliminate and reduce missed or late annual inspections to keep participating herds in compliance with the regulations. This subsection also amends the visual verification requirement to require that every animal in the herd have one required identification visually verified. The prior rule required visual verification on 50 percent of the animals. This change is made to align with federal standards and ensure inventories are annually reconciled.

Section 40.3(c)(7), regarding a complete physical herd inventory, is amended to add additional flexibility for participants to complete physical herd inventory in accordance with federal standards. In order to visually verify both forms of identification, animals may need to be temporarily gathered in pens or by other means. During previous rule proposals, public comments indicated that it is safer to gather animals at certain times of the year, or complete a physical inventory on groups of animals while the animals are already penned. Participants indicated that performing a physical inventory at the three-year mark did not suit herd management. Based on public comments, observations of Commission staff, and consultation with the United States Department of Agriculture, this rule is modified to allow owners flexibility to complete the inventory at a time that best suits their herd.

Section 40.3(d) restructures the herd status advancement and herd certification standards. This portion of the rule is amended to mirror the federal regulations regarding herd status advancement and herd certification and follow the year-for-year advancement in the federal standards.

Section 40.3(e) relates to the effect of new animals on herd status. This amendment follows the previous rule in that, if new animals are acquired from a herd from a lower status, the herd will be lowered to match the status of the new animals. Where the amendment differs from the previous version, is that it specifies that the herd must be held in the lower status for at least 12 months, and can only advance status at the next anniversary of the enrollment date. This change is made to improve administration of the program. Because many of the requirements of the program follow a yearly cycle, it was administratively unwieldly to track and ensure all requirements for status advancement are met when the status date shifted due to the introduction of a new animal. This new rule will streamline that process and reduce confusion for participants regarding when their herds are eligible for status advancement.

Section 40.3(f) is a newly added section that explicitly addresses situations where CWD is detected or is suspected in an enrolled herd to comply with federal standards. This amendment is made to clarify the steps that the Commission will take once there is a CWD-positive animal or CWD-suspect animal and to align with federal standards.

The last subsection, §40.3(h) makes minor changes to clarify the actions affecting enrollment and the administrative appeal process. Because the program is voluntary and requires compliance with the program requirements and the rules contained in Chapter 40, the Commission is authorized to lower a herd status, suspend enrollment, or revoke program enrollment entirely. This rule specifies the process that a participant may challenge an action that affects herd enrollment.

FISCAL NOTE

Ms. Myra Sines, Chief of Staff for the Texas Animal Health Commission, determined that for each year of the first five years the rules are in effect, there are no estimated additional costs or reductions in costs to state or local governments as a result of enforcing or administering the proposed rules. Commission employees will administer and enforce these rules as part of their regular job duties and resources. Ms. Sines also determined for the same period that there is no estimated increase or loss in revenue to the state or local government as a result of enforcing or administering the proposed rules, and the proposed rules do not have foreseeable implications relating to costs or revenues of state governments.

PUBLIC BENEFIT

Ms. Sines determined that for each year of the first five years the proposed rules are in effect, the anticipated public benefits are to provide clarity and guidance for participants in the CWD Herd Certification Program and improve program administration. Ultimately, the program provides protection for herds with CWD susceptible species through biosecurity practices and surveillance measures.

LOCAL EMPLOYMENT IMPACT STATEMENT

The Commission determined that the proposed rules will not impact local economies and, therefore, did not file a request for a local employment impact statement with the Texas Workforce Commission.

MAJOR ENVIRONMENTAL RULE

TAKINGS ASSESSMENT

The Commission determined that the proposal does not restrict, limit, or impose a burden on an owner's rights to his or her private real property that would otherwise exist in the absence of government action. Therefore, the proposed rules are compliant with the Private Real Property Preservation Act in Texas Government Code §2007.043 and do not constitute a taking.

ECONOMIC IMPACT STATEMENT

The Commission determined that the proposed amendments to §40.3 do not impose any additional requirements that would impact a small business or microbusiness pursuant to Texas Government Code, Chapter 2006.

GOVERNMENT GROWTH IMPACT STATEMENT

In compliance with the requirements of Texas Government Code §2001.0221, the Commission prepared the following Government Growth Impact Statement (GGIS). For each year of the first five years the proposed rules would be in effect, the Commission determined the following:

1. The proposed rules will not create or eliminate a government program;

2. Implementation of the proposed rules will not require the creation of new employee positions or the elimination of existing employee positions;

3. Implementation of the proposed rules will not require an increase or decrease in future legislative appropriations to the Commission;

4. The proposed rules will not require an increase or decrease in fees paid to the Commission;

5. The proposed rules will not create a new regulation;

6. The proposed rules will expand existing rules, but will not otherwise limit or repeal an existing regulation;

7. The proposed rules may increase the number of individuals subject to the regulation; and

8. The proposed rules will not adversely affect this state's economy.

COST TO REGULATED PERSONS

The proposed amendments to §40.3 do not impose additional costs on regulated persons and are designed to provide flexibility to reduce the administrative burden of participants under the program. The proposed rules do not otherwise impose a direct cost on a regulated person, state agency, a special district, or a local government within the state. Section 2001.0045 of the Texas Government Code does not apply to rules adopted under Section 161.041.

REQUEST FOR COMMENT

Comments regarding the proposed amendments may be submitted to Amanda Bernhard, Texas Animal Health Commission, 2105 Kramer Lane, Austin, Texas 78758, by fax at (512) 719-0719 or by e-mail to comments@tahc.texas.gov. Comments must be received no later than thirty (30) days from the date of publication of this proposal in the Texas Register. When faxing or emailing comments, please indicate "Comments on Chapter 40-CWD Rules" in the subject line.

STATUTORY AUTHORITY

The new proposed §40.3 within Chapter 40 of the Texas Administrative Code is proposed under the following statutory authority as found in Chapter 161 of the Texas Agriculture Code.

Pursuant to §161.0415, titled "Disposal of Diseased or Exposed Livestock or Fowl," the Commission may require, by order, the slaughter of livestock, domestic fowl, or exotic fowl exposed to or infected with certain diseases.

Pursuant to §161.046, titled "Rules," the Commission may adopt rules as necessary for the administration and enforcement of this chapter.

Pursuant to §161.047, titled "Entry Power," Commission personnel are permitted to enter public or private property for the performance of an authorized duty.

Pursuant to §161.060, titled "Authority to Set and Collect Fees," the Commission may charge a fee for an inspection made by the Commission as provided by Commission rule.

The proposed rules in this chapter for adoption do not affect other statutes, sections or codes.

§40.3. CWD Herd Certification Program.

(a) Definitions. In addition to the definitions in Section 40.1, the following words and terms, when used in this section, shall have the following meanings:

(1) Animal--An animal in the Cervidae family.

(2) Annual inspection window--The period of time each year for an enrolled herd to complete an annual inspection. Unless a specific period is set by a commission representative in writing, the annual inspection window begins 30 days before the month and day of the enrollment date and ends 30 days after the month and day of the enrollment date.

(3) Application and Agreement--The CWD Herd Certification Application and Agreement, a form published by the commission that is available on the commission website and available at TAHC region offices.

(4) Eligible Mortality--The death from any cause of an animal 12 months of age or older, including hunter harvests and animals slaughtered at a slaughter facility or processing facility.

(5) Enrolled herd--A herd that has been approved for enrollment in the program.

(6) Enrollment Date--The day, month, and year in which an owner's herd is officially enrolled in the Program.

(7) Local TAHC Region Office--The TAHC Region Office that covers the county in which the herd's premises is located.

(8) Program--The CWD Herd Certification Program administered by the commission.

(9) Status--The status of a herd assigned under the program that follows the requirements in 9 CFR Part 55. Herd status is based on the number of years of compliance with the requirements of the program without evidence of the disease and without any specific determinations that the herd has contained or has been exposed to CWD.

(10) TWIMS--Texas Wildlife Information Management Services database operated by the Texas Parks and Wildlife Department's wildlife division

(b) Program Enrollment Process.

(1) Application and Agreement. For each herd, an owner shall submit a signed application and agreement to the local TAHC region office. An owner may enroll multiple herds but is required to submit an application and agreement for each herd and maintain each herd separately in accordance with this section.

(2) Enrollment Inspection. After application submission, a commission representative will schedule and conduct an enrollment inspection. For each herd, a commission representative will:

(A) visually observe each animal in the herd and the herd as a whole, for clinical signs of CWD;

(B) verify and record the two unique animal identification numbers for each individual animal, one of which is a nationally unique official animal identification, all required identification devices will be visually verified and reconciled with the herd owner's records;

(C) perform a herd inventory not more than 60 days prior to the herd's date of enrollment, unless an alternative timeframe is suggested by a commission representative and approved by the executive director; and

(D) identify the premises with a premise-based number system using a Premises Identification Number (PIN) or Location Identification Number (LID) and confirm perimeter fencing is adequate to prevent ingress and egress of cervids, structurally sound, in good repair, and meets any applicable height requirements.

(3) Fees. The commission will assess a fee of $100 per hour for the enrollment inspection performed by a commission representative. The herd owner is responsible for the fees assessed.

(4) Enrollment approval by a commission representative. After the enrollment inspection is complete, a commission representative will approve or deny the application. The date the application is approved is the enrollment date.

(1) Premises.

(A) Maintain the enrolled herd on the identified premises.

(B) Premises must have perimeter fencing adequate to prevent ingress and or egress of cervids. For herds established after October 15, 2021, the fence must be a minimum of eight feet high.

(i) separate herd inventories and records;

(ii) separate working facilities;

(iii) separate water sources;

(iv) separate equipment; and

(v) at least 30 feet between the perimeter fencing around separate herds, and no commingling of animals may occur.

(D) Movement of animals between separate herds by the same owner must be recorded as if they were separately owned herds.

(2) Animal Identification.

(A) Each animal is required to be identified by two forms of animal identification attached to the animal.

(i) One of the identifications must be a nationally unique official animal identification number linked to that animal in the CWD National Database or a commission approved database.

(ii) The second identification must be unique for the individual animal within the herd and linked to the CWD National Database or a commission approved database.

(B) Identify all animals born in the herd.

(i) Each animal born must be identified no later than March 31 of the year following the year the animal is born with the required identification.

(ii) Each animal born that changes ownership or is moved from the premises of origin before 12 months of age shall be identified with required identification prior to change of ownership or movement from the premises of origin.

(3) Reporting requirements.

(A) Required reporting. The herd owner shall:

(i) immediately report upon discovery all herd animals that escape or disappear;

(ii) immediately report upon discovery all free-ranging cervids that enter the facility;

(iii) immediately report a CWD-suspect animal;

(iv) report test results and provide laboratory reports within 14 days of receiving the results of an official CWD test;

(v) report all animals added to the herd within five business days of the acquisition, the report should include the official identification, species, age, and sex of the animal, date of acquisition, and name and identification of the herd of origin;

(vi) report all incidences of commingled animals within five business days, the report should include the official identification, species, age, and sex of the animal, when the commingling occurred, the length of time the commingling occurred, and name and identification of the herd of origin of the commingled animal; and

(vii) report all results from annual inspections and complete physical herd inventories performed by a TAHC authorized veterinarian within 14 days.

(B) Methods of reporting.

(i) Immediate reporting must be by phone or email to a local TAHC region office.

(ii) Enrolled herds with white-tailed deer and mule deer must use TWIMS to track births, deaths, CWD test results, and animal movement.

(iii) All other reporting must be made to the local TAHC region office in writing. Reporting may be submitted by email, fax, mail, or hand delivery during business hours. Reporting must be transmitted or postmarked by the reporting deadline.

(4) Testing.

(A) The herd owner must test all eligible mortalities for CWD via immunohistochemistry (IHC) testing with an official CWD test.

(B) Postmortem tissue samples must be collected and prepared by a state or federal animal health official, an accredited veterinarian, or a certified CWD postmortem sample collector and submitted to an approved laboratory within seven days.

(D) If samples are missed or poor-quality samples are submitted, a commission representative will review the circumstances and determine if replacement testing is needed and set the replacement testing requirements. Missing samples occur when any animal 12 months of age or older dies, is harvested, slaughtered, escapes, or is otherwise lost and samples are not submitted for an official CWD test. Poor quality samples include samples that are severely autolyzed, from the wrong portion of the brain, the wrong tissue, or not testable for other reasons.

(E) If the number of eligible mortalities is less than five percent of the herd when averaged over a three-year period, a commission representative will review the circumstances and determine if replacement testing is needed and set the replacement testing requirements.

(F) Approval for replacement testing must be obtained prior to performing the replacement testing. Animals eligible to be tested as replacements will be determined by a commission representative. If approved, replacement testing using postmortem samples will use a one to one replacement rate. If approved and antemortem testing is available for the species at an approved laboratory, replacement testing using antemortem testing will use a five to one replacement rate.

(5) Recordkeeping.

(A) The herd owner shall maintain herd records that include a complete inventory of animals with documents showing all births, deaths, acquisitions, dispositions, and escaped or disappeared animals.

(B) Herd owner inventory records, maintained outside of TWIMS, should indicate natural additions with "NA," purchased additions with "PA," and retagged animals with "RT."

(C) The herd owner shall maintain all test result records for those animals that died and be able to produce the full laboratory results upon request.

(D) For white-tailed deer and mule deer, all required animal information must be entered into TWIMS, including uploading full laboratory results.

(E) For animals that have left the herd or have died, the owner must maintain the following information for five years:

(i) All identifications (tags, tattoos, electronic implants, etc.);

(ii) Birth date;

(iii) Species;

(iv) Sex;

(v) Date of acquisition and source of each animal that was not born into the herd, including name and address;

(vi) Date of removal and destination of any animal removed from the herd, including name and address;

(vii) Date of death and cause, if known, for animals dying within the herd;

(viii) Date of CWD sample submission, submitter, owner, premises, animal information, and official CWD test results; and

(ix) Age.

(F) Records will be verified for completeness and accuracy at each annual inspection and complete physical inventory.

(G) Records must be made available to a commission or USDA representative upon request.

(6) Annual Inspection.

(A) Each year an annual inspection must be conducted by a commission representative or a TAHC Authorized Veterinarian.

(B) Unless authorized in writing by a commission representative, the annual inspection must occur during the herd's annual inspection window.

(i) inventory the herd by visually verifying one required identification on every animal;

(ii) reconcile the previous inventory and verify all dispositions and acquisitions are documented;

(iii) visually observe the herd for clinical signs of CWD;

(iv) verify records are complete and accurate;

(v) verify that CWD sampling requirements are met, test records are complete, and verify that all deficient, missed, or poor-quality samples were documented; and

(vi) inspect perimeter fencing for minimum standards and document needed repairs.

(D) A commission representative or TAHC Authorized Veterinarian will certify by signature that all annual inspection requirements are met and that the herd complies with the program.

(E) Results from the complete physical herd inventory must be reported to the commission within 14 days, unless the complete physical herd inventory is performed by a commission representative.

(F) The herd owner is responsible for assembling, handling, and restraining the animals and for all costs incurred to present the animals for inspection.

(G) If the herd owner requests the annual inspection be conducted by a commission employee, the commission will assess a fee of $100 per hour for the annual inspection performed by a commission representative. The herd owner is responsible for the fees assessed.

(H) If the annual inspection will be conducted by a TAHC Authorized Veterinarian, the herd owner must notify the local TAHC region office by phone or email at least 72 hours prior to any inspection performed by a TAHC Authorized Veterinarian.

(7) Complete Physical Herd Inventory.

(A) Every three years, a complete physical herd inventory must be conducted by a commission representative or a TAHC Authorized Veterinarian.

(B) Each complete physical herd inventory may occur any time before 36 months from the enrollment date or last complete physical herd inventory. Discrete groups of animals (e.g. does, bucks) may be physically inventoried at separate times as long as all animals are inventoried during the same status year. A complete physical herd inventory may be combined with an annual inspection or may occur at a separate time.

(i) conduct a physical inventory of the herd by visually verifying both forms of required identification on every animal and match the identifications to the herd's written or electronic records;

(ii) reconcile the previous inventory and verify all dispositions and acquisitions are documented;

(iii) visually observe the herd for clinical signs of CWD;

(iv) verify records are complete and accurate;

(v) verify that CWD sampling requirements are met, test records are complete, and verify that all deficient, missed, or poor-quality samples were documented; and

(vi) inspect perimeter fencing for minimum standards and document needed repairs.

(D) A commission representative or TAHC Authorized Veterinarian will certify by signature that all complete physical herd inventory requirements are met and the herd complies with the program.

(E) Results from the complete physical herd inventory must be reported to the commission within 14 days, unless the complete physical herd inventory is performed by a commission representative.

(F) The herd owner is responsible for assembling, handling, and restraining the animals and for all costs incurred to present the animals for the complete physical herd inventory.

(G) If the herd owner requests the complete physical herd inventory be conducted by a commission employee, the commission will assess a fee of $100 per hour for the complete physical herd inventory performed by a commission representative. The herd owner is responsible for the fees assessed.

(H) If the complete physical herd inventory will be conducted by a TAHC Authorized Veterinarian, the herd owner must notify the local TAHC region office by phone or email at least 72 hours prior to any complete physical herd inventory performed by a TAHC Authorized Veterinarian.

(8) Compliance Inspections. A herd owner must allow a commission representative to inspect premises where a herd is located or any animal at any time to determine compliance with the program and the requirements of this chapter. The herd owner is responsible for assembling, handling, and restraining the animals and for all costs incurred to present the animals for inspection.

(d) Herd Status Advancement and Herd Certification.

(1) Initial status.

(A) When a herd is first enrolled in the program, it will be placed in first year status.

(B) When a herd is first enrolled in the program and the herd is composed solely of animals obtained from herds already enrolled in the program, the newly enrolled herd may be assigned the same status as the lowest status of any herd that provided animals for the new herd.

(C) When a herd is first enrolled in the program and the herd is composed of animals obtained solely from other certified herds, the newly enrolled herd may be assigned the status of a certified herd.

(2) Status Advancement. If the herd continues to meet the requirements of the CWD Herd Certification Program, each year, no sooner than the anniversary of the enrollment date, the herd status will be upgraded by one year; i.e., second year status, third year status, fourth year status, and fifth year status.

(3) Certified herd status. If the herd continues to meet the requirements of the CWD Herd Certification Program, no sooner than one year from the date a herd is placed in fifth year status, the herd status will be changed to certified, and the herd will remain in certified status as long as it is enrolled in the program, continues to meet the requirements under the program, and its status is not suspended or revoked.

(e) Effect of new animals on herd status.

(1) A herd may add animals from herds with the same or a higher herd status in the program with no negative impact on the certification status of the receiving herd.

(2) If animals are acquired from a herd with a lower herd status, the receiving herd reverts to the program status of the source herd. Following the addition, the herd will be held at that lower status for at least 12 months. After 12 months have elapsed since the addition, the herd may advance status at the next anniversary of the enrollment date.

(3) If an enrolled herd adds animals from a nonparticipating herd, the receiving herd reverts to first year status. Following the addition, the herd will be held at first year status for at least 12 months. After 12 months have elapsed since the addition, the herd may advance status at the next anniversary of the enrollment date.

(4) If any animals in the herd are commingled with animals from native ingress or from a nonparticipating herd, the herd will revert to first year status. If any animals in the herd are commingled with an animal from a herd with a lower program status, the herd with the higher program status will be reduced to the status of the herd with which its animals commingled. After 12 months have elapsed since the addition, the herd may advance status at the next anniversary of the enrollment date.

(f) Detection of CWD in an enrolled herd.

(1) If a herd is designated as a CWD-positive herd or a CWD-exposed herd, its program enrollment will be revoked and the herd may only reenroll after entering into a herd plan and meeting the requirements of the herd plan.

(2) If a herd is designated a CWD-suspect herd or a CWD-trace herd, it will immediately be placed in suspended status pending an epidemiologic investigation by the commission.

(A) If the epidemiologic investigation determines that the herd was not commingled with a CWD-positive animal, the herd will be reinstated to its former program status, and the time spent in suspended status will count toward its promotion to the next herd status level.

(B) If the epidemiologic investigation determines that the herd was commingled with a CWD-positive animal, its program enrollment will be revoked and it will be designated a CWD-exposed herd.

(g) Actions affecting enrollment.

(1) If a herd owner does not comply with the requirements of this chapter, after notice is given, a commission representative may lower herd status, suspend enrollment, or revoke program enrollment.

(2) Protest of an action affecting enrollment.

(A) The herd owner may protest an action affecting enrollment by writing to the executive director within 15 days after receipt of notice of the action. The owner must include all of the facts and supportive evidence which the herd owner relies upon to show that the reasons for the action were incorrect.

(B) The herd owner may request a meeting with the executive director. The request for meeting must be in writing and accompany the protest. If needed, the meeting will be set by a commission representative no later than 21 days from the receipt of the request. The meeting will be held in Austin.

(C) The executive director shall render a written decision regarding the action within 30 days after receipt of the protest of the action or 30 days after the meeting with the herd owner, whichever is later. The executive director may affirm, rescind, or modify the action.

(3) Appeal of the executive director's decision.

(A) To appeal the decision of the executive director, the herd owner must file a notice of appeal within 15 days of the decision in writing with the executive director at the commission's office in Austin. The notice of appeal must specifically state the issues for consideration on appeal.

(B) A subsequent hearing on the specific issues appealed will be held in Austin, pursuant to the Administrative Procedure Act, Texas Government Code, Chapter 2001, the rules for the State Office of Administrative Hearings, and Chapter 32 of this title (relating to Hearing and Appeal Procedures).

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 28, 2023.

TRD-202301533

Jeanine Coggeshall

General Counsel

Texas Animal Health Commission

Earliest possible date of adoption: June 11, 2023

For further information, please call: (512) 719-0718