TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 169. ZOONOSIS CONTROL

SUBCHAPTER G. CAGING REQUIREMENTS AND STANDARDS FOR DANGEROUS WILD ANIMALS

25 TAC §169.131, §169.132

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §169.131 and §169.132, concerning the caging requirements and standards for dangerous wild animals.

BACKGROUND AND PURPOSE

The amendments to §169.131 and §169.132 are necessary to comply with Health and Safety Code, Chapter 822, Subchapter E, "Dangerous Wild Animals," which requires an owner of a dangerous wild animal to keep and confine the animal in accordance with caging requirements and registration established by the Executive Commissioner.

The amendment to §169.131 will provide for safe, healthy, and humane environments for the animals; prevent escape by the animals; and clarify the requirements for caging requirements relating to the structures and facilities containing dangerous wild animals in compliance with Health and Safety Code, §822.111.

The amendment to §169.132 will provide clarification of the submission process of a certificate of registration copy to the department by the holder of a certificate of registration of a dangerous wild animal as required in Health and Safety Code, §822.106(b).

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Section 169.131 and §169.132 have been reviewed and the department has determined that reasons for adopting these sections continue to exist because rules on this subject are mandated.

SECTION-BY-SECTION SUMMARY

The amendment to §169.131(a)(2)(B) and (B)(i) - (ii) combines the definition of "shelter" with that of "nest box and den" to aid in clarity because there was notable overlap between the definitions.

The amendment to §169.131(b)(2) adds the phrase "or equal to" to clarify the inclusion of enclosures that are exactly 1,000 square feet.

The amendment to §169.131(c)(3)(A)(i), (B)(i), and (C)(i) adds shotcrete as a possible optional construction material for large cats and canids, non-human primates, and bears with the caveat that it be built with cognizance for not creating any holds for climbing if the enclosure is not covered. Shotcrete is an acceptable, durable construction material commonly used in zoo displays.

The amendment to §169.131(d)(1)(D) adds a requirement for primates to be kept in covered enclosures or, if they are kept in enclosures greater than 1,000 square feet that cannot feasibly be covered, they must implement measures to prevent escape. (The rule already requires that all enclosures that are 1,000 square feet or less must be covered.) This amendment is based on professional recommendations and supported by a survey of owners in Texas of registered baboons, chimpanzees, gorillas, or orangutans. All those surveyed already keep these animals in covered enclosures; hence, no fiscal impact is anticipated.

The amendment to §169.131(d)(1)(E)(i) - (iv) combines the minimum standards for chimpanzees, orangutans, and gorillas because the standards should be equivalent for the great apes. Based on ranging patterns, activity levels, and social structures, the area for the chimpanzees should be increased to at least that of the gorillas. Therefore, 400 square feet was chosen (halfway between Texas' current 300 square feet and the Association of Zoos and Aquariums' (AZA) 500 square feet and matching Ohio's 400 square feet for gorillas). The square footage per additional animal was set at 350 (midway between Texas' 200 and the AZA's 500). The wall heights, including those for baboons, have been amended from 8 feet to 10 feet (Ohio requires a minimum of 10 feet with at least 8 feet for useable climbing height). The department was more conservative on the area of primary enclosures than Florida or the Zoological Association of America (ZAA), both of which require/recommend 672 square feet, and the United States Zoological Association (USZA) that recommends 600 square feet for gorillas.

The amendment to §169.131(d)(2)(A) deletes the words "nest boxes" to be consistent with the amendments to the definitions in §169.131(a)(2)(B).

The amendment to §169.131(d)(2)(E)(i)(II) removes the word "outdoor" because these dimensions refer to any primary enclosure over 1,000 square feet (if uncovered). Additionally, the words "an attached" were added to clarify that the overhang is in addition to the height of the fence.

The amendment to §169.131(d)(2)(E)(i) and (ii) separates cheetahs from lions and tigers because they are generally not classed together with standards. Minimum enclosure heights for cheetahs did not change, so there is no anticipated fiscal impact pertaining to standards for this species.

The amendment to §169.131(d)(2)(E)(i)(II) increases the minimum enclosure heights for lions and tigers from 10 feet with a 2-foot-wide overhang to 12 feet with a 3-foot-wide overhang or from 12 feet to 16 feet without an overhang. This is partially to match the United States Department of Agriculture's (USDA) recommendations (not requirements); since the USDA has a higher height standard for these enclosures than Texas does, this amendment will prevent facilities from designing their enclosures to meet Texas' lower standards and then discover that they are not meeting the expectation of USDA inspectors. Additionally, these dimensions are conservative compared with the AZA recommendation for a height of at least 15 feet with an overhang and ZAA recommendations for 14 feet with an overhang. Six out of seven owners of registered lions and/or tigers in Texas that were surveyed already had either covered enclosures or walls at least 16 feet in height for these animals. One of the surveyed owners expressed that they would have a fiscal impact of $36,000 if they were required to meet the proposed standards.

The USDA stated that they dealt with two escapes of tigers in about a 6-month period, with one escape causing the death of a person; one escape was over a 12-foot solid concrete wall and the other one was over a 12-foot cyclone wire fence with an 18-inch kick in (overhang). The USDA indicated that if both fences had a 3-foot kick in, escape would have been much more difficult for these animals (they do not consider a straight 12-foot tall fence to be adequate containment for big cats, except for cheetahs).

The amendment to §169.131(d)(2)(E)(iii) increases the minimum square footage from 200 to 300 for one jaguar, leopard, or cougar (halfway between Texas' 200 and ZAA's 400). This is conservative compared with Ohio's 600 square feet. The minimum height of the enclosure was increased from 8 feet to 12 feet (which matches Ohio's requirement). One owner of registered cougars and a leopard suggested that the increase in height would give these species a better opportunity to assert their natural climbing tendencies and noted that none of these dimension increases would create a fiscal impact for that owner.

The amendment to §169.131(d)(2)(E)(iv)(I) modifies the minimum square footage from 80 to 100 for one animal (halfway between Texas' 80 and ZAA's 120 and conservative compared to Ohio's 200 square feet). The square footage per additional animal was modified from 40 to 50 square feet (conservative compared to Ohio's 100).

The amendment to §169.131(d)(2)(E)(iv)(II) adds a requirement for bobcats, lynxes, ocelots, caracals, and servals to be kept in covered enclosures or, if they are kept in enclosures greater than 1,000 square feet that cannot feasibly be covered, they must implement measures to prevent escape. (The rule already requires that all enclosures that are 1,000 square feet or less must be covered.) This amendment is based on professional recommendations and supported by a survey of owners in Texas of registered bobcats, lynxes, ocelots, caracals, and servals. All those surveyed already keep these animals in covered enclosures; hence, no fiscal impact is anticipated.

The amendment to §169.131(d)(3)(D) adds a recommendation to have bears in covered enclosures or in enclosures with an overhang. It appears that trends are going toward this type of precaution.

The amendment to §169.131(d)(3)(E)(i)(I) increases the minimum square feet for one sun bear from 200 to 300 (conservative compared with Ohio's 400) and for each additional animal from 100 to 150 (halfway between Texas' 100 and Ohio's 300). The height of an uncovered enclosure was raised from 8 feet to 12 feet (which is conservative compared with Ohio's requirements and ZAA's recommendations for 12 feet with an overhang and Kansas' requirements for 13 feet with an overhang). There are no owners of registered sun bears in Texas.

The amendment to §169.131(d)(3)(E)(ii)(I) increases the minimum square feet for one black bear or Asiatic sun bear from 300 to 400 (primarily to meet Texas state requirements already in rule under the Texas Parks and Wildlife Department (TPWD), but it also matches Ohio's, Florida's, and ZAA's 400 square feet) and for each additional animal from 150 to 175 (halfway between Texas' 150 and Ohio's 200). The height for an uncovered enclosure was raised from 8 to 12 feet (primarily to meet requirements of the TPWD already in rule, which is conservative compared with Ohio's requirements and ZAA's recommendations for 12 feet with an overhang and Kansas' requirements for 13 feet with an overhang).

The amendment to §169.131(d)(3)(E)(iii)(I) increases the minimum square feet for one brown bear or polar bear from 400 to 500 (which is conservative compared with Florida's requirements and AZA's recommendations for 768 square feet). The height of an uncovered enclosure was raised from 10 to 12 feet (which is conservative compared with Ohio's requirements and ZAA's recommendations for 12 feet with an overhang and Kansas' requirements for 13 feet with an overhang).

The amendment to §169.131(d)(4)(A) deletes the word "dens" to be consistent with the revisions to the definitions in §169.131(a)(2)(B).

The amendment to §169.131(d)(4)(E) deletes the wording "over 1,000 square feet" since any enclosure 1,000 square feet or less is required to be covered in §169.131(b)(2). It also deletes the word "outdoor" since the requirements would apply to any uncovered enclosures. Additionally, the wording "an attached" has been added to clarify that the overhang is in addition to the height of the fence.

The amendment to §169.132 adds pertinent information to be included on the certificate of registration from various animal registration agencies statewide, including the required $20 per animal filing fee to avoid confusion on the part of certificate owners as to the amount of the fee that needs to be submitted with their certificate copies. A procedure was established at the time of initial adoption of §169.131 in 2002 that an owner of a dangerous wild animal submitted an annual fee of $20 per animal to the department to cover the cost of filing a copy of a certificate of registration to the department, as mandated by Health and Safety Code, §822.106(b). In the past the certificate information has been recommended via sample templates from the department.

FISCAL NOTE

Ms. Imelda Garcia, Director, Infectious Disease Prevention Section, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS AND ECONOMIC COSTS TO PERONS AND IMPACT ON LOCAL EMPLOYMENT

Ms. Garcia has determined that there will be no adverse impact on small businesses or micro-businesses required to comply with §169.132 as proposed. This was determined by interpretation of the rule that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the section. There are no anticipated economic costs to persons who are required to comply with this section as proposed. There is no anticipated negative impact on local employment.

There will be an adverse impact on small businesses or micro-businesses or persons who are required to comply with §169.131 as proposed. There are currently eight registered owners of lions and tigers. Six out of seven owners of registered lions and/or tigers in Texas that were surveyed already had either covered enclosures or walls at least 16 feet in height for these animals. One surveyed owner of currently registered wild animals responded that the increase in the height standards for lion and tiger enclosures in §169.131(d)(2)(E)(i)(II) would cost that owner a one-time amount of approximately $36,000 to meet the amended requirements (9 habitats at approximately $4,000 per habitat). There is no anticipated negative impact on local employment.

PUBLIC BENEFIT

In addition, Ms. Garcia has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections will be that it enhances public health and safety by keeping dangerous wild animals contained in safe, healthy, and humane environments.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed amendments do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Tom Sidwa, DVM, MPH, Department of State Health Services, Infectious Disease Prevention Section, Zoonosis Control Branch, Mail Code 1956, P.O. Box 149347, Austin, Texas 78714-9347, or by email to Tom.Sidwa@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The amendments are authorized by Health and Safety Code, §822.111, which requires the Executive Commissioner to establish the caging requirements and standards for the keeping and confinement of dangerous wild animals; Health and Safety Code, §822.106(b), which requires the Executive Commissioner to charge a fee for filing a certificate of registration for a dangerous wild animal to be collected by the department; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. The review of §169.131 and §169.132 implements Government Code, §2001.039.

The amendments affect Health and Safety Code, Chapters 822 and 1001; and Government Code, Chapter 531.

§169.131.Caging Requirements and Standards for Dangerous Wild Animals.

(a) Definitions.

(1) (No change.)

(2) Where specified in this section, primary enclosures for dangerous wild animals shall be equipped to provide for a safe, healthy, and humane environment for the animals; prevent escape by the animals; and protect and enhance the public's health and safety. Such equipment includes, but is not limited to:

(A) (No change.)

(B) Shelter (including such structures as nest boxes or dens)[, nest box, or den]--An enclosed structure that provides protection from the elements and from extremes in temperature that are detrimental to the health and welfare of the animal(s). [A structure that protects the animal(s) from the elements (weather conditions).] Such a structure [structures] may vary in size depending on the security and biological needs of the species; it shall be large enough to accommodate all the animals in the enclosure simultaneously. Such a structure shall be within, attached to, or adjacent to the primary enclosure and be readily accessible to the animal(s). [The structures are particularly described as follows.]

[(i) Shelter--A structure that provides protection from the elements and from extremes in temperature that are detrimental to the health and welfare of the animal(s). When vegetation and landscaping is available to serve as protection from the elements, access to a shelter shall also be provided during inclement weather conditions. Such shelter shall be attached to or adjacent to the primary enclosure.]

[(ii) Nest box or den--An enclosed shelter that provides a retreat area within, attached to, or adjacent to a primary enclosure of specified size, which shall provide protection from the elements and from extremes in temperature that are detrimental to the health and welfare of the animal.]

(C) - (D) (No change.)

(b) General Requirements.

(1) (No change.)

(2) All primary enclosures less than or equal to 1,000 square feet shall be covered at the top to prevent escape.

(3) (No change.)

(c) Structural Requirements for Primary Enclosures. In addition to the size and equipment requirements for primary enclosures, dangerous wild animals shall be caged in accordance with the following requirements.

(1) - (2) (No change.)

(3) Additional minimum requirements for specific species and hybrids of those species shall be as follows.

(A) Chimpanzees, gorillas, and orangutans.

(i) Outdoor facilities--Construction material shall consist of steel bars, 2-inch galvanized pipe, masonry block, or their strength equivalent or greater. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.

(ii) (No change.)

(B) Baboons, jaguars, tigers, lions, leopards, cougars, cheetahs, bears, and hyenas.

(i) Outdoor facilities--Construction material shall consist of not less than 9-gauge chain link or equivalent. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.

(ii) (No change.)

(C) Ocelots, servals, lynxes, bobcats, caracals, coyotes, and jackals.

(i) Outdoor facilities--Construction material shall consist of not less than 12-gauge chain link or equivalent. Shotcrete walls can also be utilized; if used in uncovered enclosures, it must be applied appropriately to avoid formation of any holds that could be used for climbing.

(ii) (No change.)

(d) Primary Enclosure Size and Equipment Requirements. No dangerous wild animal shall be confined in any primary enclosure that contains more individual animals than specified in this section, is smaller in dimension than specified in this section, or is not equipped as specified in this section. The area occupied by pools, ponds, or lakes shall be in addition to the space requirements for the primary enclosure. Specifications in this section also pertain to hybrids of designated species.

(1) Primates.

(A) - (C) (No change.)

(D) Primates shall not be kept in uncovered enclosures. However, for enclosures over 1,000 square feet in which a cover is not feasible, humane alternative measures shall be taken to prevent escape; these measures shall not compromise the health and safety of the public or the health, safety, and overall welfare of the animal(s). Such measures may include, but are not limited to, increased fence heights; electrified wires on fences; fence placement distant from trees or other structures that an animal(s) can climb; and/or water moats surrounding the enclosure. The owner shall seek and provide proof of consultation with a zoological organization or association to confirm that the escape-prevention measure(s) implemented are appropriate and effective for the enclosed primate(s).

(E) [(D)] Requirements for specific primate species are as follows:

(i) Baboons. For one animal, the primary enclosure shall have a minimum floor area of 100 square feet with a wall or fence at least 10 [8] feet high. For each additional animal, primary enclosure size shall be increased by at least 100 square feet.

(ii) Chimpanzees, orangutans, and gorillas. For one animal, the primary enclosure shall have a minimum floor area of 400 [200] square feet with a wall or fence at least 10 [8] feet high. For each additional animal, primary enclosure size shall be increased by at least 350 [100] square feet.

[(iii) Orangutans. For one animal, the primary enclosure shall have a minimum floor area of 200 square feet with a wall or fence at least 10 feet high. For each additional animal, primary enclosure size shall be increased by at least 200 square feet.]

[(iv) Gorillas. For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 200 square feet.]

(2) Wild felines.

(A) In addition to requirements of this section, each primary enclosure shall be equipped with a shelter(s) [shelter(s)/nest box(es)] large enough to accommodate all the animals in the enclosure simultaneously.

(B) - (D) (No change.)

(E) Requirements for specific species of wild felines are as follows:

(i) Lions and[,] tigers[, and cheetahs].

(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 150 square feet.

(II) Primary [Outdoor primary] enclosures over 1,000 square feet (if uncovered) shall have vertical jump walls at least 12 [10] feet high with an attached [a] 45-degree inward-angle overhang at least 3 [2] feet wide or jump walls at least 16 [12] feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing.

(ii) Cheetahs.

(I) For one animal, the primary enclosure shall have a minimum floor area of 300 square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 150 square feet.

(II) Primary enclosures over 1,000 square feet (if uncovered) shall have vertical jump walls at least 10 feet high with an attached 45-degree inward-angle overhang at least 2 feet wide or 12 feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing.

(iii) [(ii)] Jaguars, leopards, and cougars.

(I) For one animal, the primary enclosure shall have a minimum floor area of 300 [200] square feet with a wall or fence at least 12 [8] feet high. For each additional animal, primary enclosure size shall be increased by at least 100 square feet.

(II) Jaguars, leopards, and cougars shall not be kept in uncovered enclosures.

(iv) [(iii)] Bobcats, lynxes, ocelots, caracals, and servals.

(I) For one animal, the primary enclosure shall have a minimum floor area of 100 [80] square feet with a wall or fence at least 8 feet high. For each additional animal, primary enclosure size shall be increased by at least 50 [40] square feet.

(II) Bobcats, lynxes, ocelots, caracals, and servals shall not be kept in uncovered enclosures. However, for enclosures over 1,000 square feet in which a cover is not feasible, humane alternative measures shall be taken to prevent escape; these measures shall not compromise the health and safety of the public or the health, safety, and overall welfare of the animal(s). Such measures may include, but are not limited to, increased fence heights; electrified wires on fences; overhangs on fences; predator guards on trees; and/or fence placement distant from trees or other structures that an animal(s) can climb. The owner shall seek and provide proof of consultation with a zoological organization or association to confirm that the escape-prevention measure(s) implemented are appropriate and effective for the enclosed feline(s).

(3) Bears.

(A) - (C) (No change.)

(D) Bears should be kept in covered enclosures or enclosures with an attached 45-degree inward-angle overhang at least 3 feet wide.

(E) [(D)] Requirements for specific types of bears are as follows:

(i) Sun bears.

(I) For one animal, the primary enclosure shall have a minimum floor area of 300 [200] square feet with a wall or fence at least 8 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 150 [100] square feet.

(II) Each primary enclosure shall have, as a minimum, a 3-foot by 4-foot pool of water, 2 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.

(ii) Black bears and Asiatic bears.

(I) For one animal, the primary enclosure shall have a minimum floor area of 400 [300] square feet with a wall or fence at least 8 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 175 [150] square feet.

(II) Each primary enclosure shall have, as a minimum, a 4-foot by 6-foot pool of water, 3 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.

(iii) Brown bears and polar bears.

(I) For one animal, the primary enclosure shall have a minimum floor area of 500 [400] square feet with a wall or fence at least 10 feet high if covered or at least 12 feet high if uncovered. For each additional animal, primary enclosure size shall be increased by at least 200 square feet.

(II) Each primary enclosure for brown bears shall have, as a minimum, a 6-foot by 10-foot pool of water, 4 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.

(III) Each primary enclosure for polar bears shall have, as a minimum, a 10-foot by 10-foot pool of water, 5 feet deep. The area occupied by the pool shall be in addition to the space requirements for the primary enclosure.

(4) Coyotes, jackals, and hyenas.

(A) In addition to the requirements of this section, each primary enclosure shall be equipped with a shelter(s) [shelter(s)/den(s)] that shall accommodate all the animals in the enclosure simultaneously.

(B) - (D) (No change.)

(E) Uncovered [outdoor] primary enclosures [over 1,000 square feet] shall have vertical jump walls at least 8 feet high with an attached [a] 45-degree inward-angle overhang at least 2 feet wide or jump walls at least 10 feet high without an overhang. The inward-angle fencing shall be made of the same material as the vertical fencing.

§169.132.Registration, Fee.

(a) Texas Health and Safety Code, §822.103, requires that a person must obtain a certificate of registration for a dangerous wild animal issued by an animal registration agency. The animal registration agency must include the following information on the certificate of registration:

(1) issuance date;

(2) certificate number;

(3) filing fee ($20 per animal) along with the department's mailing address as listed in subsection (b) of this section and a statement that the fee must be submitted to the department along with a copy of the certificate;

(4) name, address, and phone number of the owner of the dangerous wild animal;

(5) name and address of the animal registration agency;

(6) species, sex, age, color, distinguishing marks, and other features (for example, ear notch, tattoo, sterilization status) of the dangerous wild animal;

(7) the address of where the dangerous wild animal is kept;

(8) the expiration date (or a statement that the certificate expires one year from the issuance date) unless the certificate is revoked, that the certificate is non-transferable, and that the certificate must be displayed at the location where the dangerous wild animal is kept; and

(9) the signature of the authorized person at the animal registration agency.

(b) [To comply with] Texas Health and Safety Code, §822.106, requires that not later than the 10th day after the date a person receives the certificate of registration [required by Texas Health and Safety Code, Chapter 822], the person shall file a clear and legible copy of the certificate of registration with the Texas Department of State Health Services, Zoonosis Control, P.O. Box 149347, Mail Code 1956, Austin, Texas 78714-9347. The fee for filing the certificate is $20 per animal, submitted with the copy of the certificate.

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 March 22, 2017.

TRD-201701223

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: May 7, 2017

For further information, please call: (512) 776-6972


PART 7. TEXAS MEDICAL DISCLOSURE PANEL

CHAPTER 601. INFORMED CONSENT

25 TAC §601.2, §601.9

The Texas Medical Disclosure Panel (panel) proposes amendments to §601.2 and §601.9, concerning informed consent.

BACKGROUND AND PURPOSE

These amendments are proposed in accordance with the Texas Civil Practice and Remedies Code, §74.102, which requires the panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure.

Section 601.2 contains the List A procedures requiring full disclosure of specific risks and hazards to patients before being undertaken. Section 601.9 contains the disclosure and consent form for anesthesia and/or perioperative pain management (analgesia).

SECTION-BY-SECTION SUMMARY

Proposed amendments to §601.2(a) adds anesthesia risks and hazards related to potential long-term negative effects on memory, behavior, and learning with the use of prolonged (greater than 3 hours) or repeated exposure to anesthesia on the fetus of a woman in her 3rd trimester of pregnancy and on a child up to 3 years of age.

The proposed amendments to §601.9 revise the English and Spanish versions of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) to add risks and hazards related to potential long-term negative effects on memory, behavior, and learning with the use of prolonged (greater than 3 hours) or repeated exposure to anesthesia on the fetus of a woman in her 3rd trimester of pregnancy and on a child up to 3 years of age.

FISCAL NOTE

Jon Huss, Interim Associate Commissioner, Division for Regulatory Services, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal impact to state or local governments as a result of administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Mr. Huss also has determined that there are no anticipated economic costs to small businesses or micro-businesses that are required to comply with the amendments as proposed because regulated facilities already have an obligation to disclose risks and hazards related to medical care and surgical procedures. The amendments will not add additional costs.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There will be no economic costs to persons required to comply with the sections as proposed, and there will be no impact on local employment.

PUBLIC BENEFIT

In addition, Mr. Huss also has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing or administering these amended disclosure rules will be that patients are better informed about the risks and hazards related to dental surgical procedures they are considering in connection with deciding whether to consent to them.

REGULATORY ANALYSIS

The panel has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environment exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The panel has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Pamela Adams, Program Specialist, Facility Licensing Group, Regulatory Licensing Unit, Division of Regulatory Services, Department of State Health Services, Mail Code 2835, P.O. Box 149347, Austin, Texas 78714-9347, (512) 834-6600, extension 2607, by fax to (512) 834-4514, or by email to pamela.adams@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

STATUTORY AUTHORITY

The amendments are authorized under the Texas Civil Practice and Remedies Code, §74.102, which provides the Texas Medical Disclosure Panel with the authority to prepare lists of medical treatments and surgical procedures that do and do not require disclosure by physicians and health care providers of the possible risks and hazards, and to prepare the form(s) for the treatments and procedures which do require disclosure.

The amendments affect Texas Civil Practice and Remedies Code, Chapter 74.

§601.2.Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A.

(a) Anesthesia.

(1) (No change.)

(2) General.

(A) - (E) (No change.)

(F) Potential long-term negative effects on memory, behavior, and learning with prolonged (greater than 3 hours) or repeated exposure to anesthesia on the fetus of a woman in her 3rd trimester of pregnancy and on a child up to 3 years of age.

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

(5) Monitored Anesthesia Care (MAC) (conscious sedation).

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

(E) Potential long-term negative effects on memory, behavior, and learning with prolonged (greater than 3 hours) or repeated exposure to anesthesia on the fetus of a woman in her 3rd trimester of pregnancy and on a child up to 3 years of age.

(b) - (v) (No change.)

§601.9Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia).

The Texas Medical Disclosure Panel adopts the following form which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in anesthesia and/or perioperative pain management (analgesia). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Department of State Health Services.

(1) English form.

Figure: 25 TAC §601.9(1) (.pdf)

[Figure: 25 TAC §601.9(1)]

(2) Spanish form.

Figure: 25 TAC §601.9(2) (.pdf)

[Figure: 25 TAC §601.9(2)]

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 March 22, 2017.

TRD-201701229

Noah Appel, M.D.

Chairman

Texas Medical Disclosure Panel

Earliest possible date of adoption: May 7, 2017

For further information, please call: (512) 776-6972