TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 1. TEXAS BOARD OF HEALTH

Subchapter A. PROCEDURES AND POLICIES

25 TAC §1.6

The Texas Department of Health (department) adopts an amendment to §1.6 concerning procedures and policies of the Board of Health (board) without changes to the proposed text as published in the December 1, 2000, issue of the Texas Register (25 TexReg 11860), and therefore the section will not be republished.

Specifically, the section addresses actions requiring board approval. The amendment requires that certain employee appointments made by the Commissioner of Health (commissioner) be subject to the approval of the Texas Board of Health (board). The amendment will ensure the board's oversight of the hiring of executive management positions.

No comments were received during the comment period.

The amendment is adopted under the Health and Safety Code, §12.001 which provides the board with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101180

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: December 1, 2000

For further information, please call: (512) 458-7236


Chapter 103. INJURY PREVENTION AND CONTROL

25 TAC §§103.1, 103.10-103.24

The Texas Department of Health (department) adopts an amendment to §103.1 and new §§103.10-103.24 concerning the injury reporting system. Section 103.11 and §103.23 are adopted with changes to the proposed text as published in the September 22, 2000, issue of the Texas Register (25 TexReg 9361). Sections 103.1, 103.10, 103.12-103.22, and 103.24 are adopted without changes and therefore the sections will not be republished.

Government Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a), 76th Legislature (1999), requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 103.1-103.9 have been reviewed and the department has determined that reasons for adopting the sections continue to exist. Section 103.1 is amended and §§103.10-103.24 are adopted as new rules.

The amendment and new sections implement Health and Safety Code, §92.002 which requires the Board of Health to adopt rules necessary to implement a system of injury reporting and Health and Safety Code, Chapter 773, Subchapter E, concerning the establishment of a trauma reporting and analysis system, implemented by Title 25, Texas Administrative Code §157.129. The trauma reporting and analysis system has been maintained by the Trauma Registry program which moved from the Bureau of Emergency Medical Services to the Bureau of Epidemiology in 1993.

Specifically, the amendment to §103.1 clarifies the effective date of §§103.1-103.9.

New §103.10 adds language regarding the establishment of a trauma reporting and analysis system and clarifies the effective date of §§103.10-103.24. New §103.11 defines words and terms to clarify the intent of the rules. New §§103.12-103.24 clarify injury reporting requirements effective January 1, 2002, describe reporting requirements, and clarify the Technical Advisory Committee on Injury Reporting. These sections specify who is to report, type of data to be reported, procedure for reporting, frequency of reporting, general control measures for reportable injuries, powers and duties of the department, confidential nature of case reporting, investigations, and clarify the operations of the Technical Advisory Committee on Injury Reporting. New §103.12 adds trauma patients and pre-hospital provider calls as reportable conditions.

New §103.21 updates the chapter number of the Injury Prevention and Control Act of the Health and Safety Code from Chapter 87 to Chapter 92, to be consistent with the renumbering of this statute by the legislature; adds language relating to the authority of the department to contact entities attending a person with a case or suspected case of a reportable injury; and adds language regarding the department's authority to provide summary data to local and regional health departments. New §103.22 includes the new name Texas Trauma Registry instead of State Trauma Registry and adds language concerning the provision of data to reporting health care entities and other department bureaus. New §103.23 correctly identifies the Texas Workers' Compensation Commission instead of the Texas Workforce Commission.

New §103.24 revises provisions relating to the operation of the Technical Advisory Committee on Injury Reporting. Specifically, language is revised to refer to the Government Code; to continue the committee until November 1, 2003; to clarify that members hold over until their replacement is appointed; to state that the presiding and assistant presiding officers shall be appointed by the chairman of the board for a term of two years; to allow a temporary vacancy in the office of assistant presiding officer to be filled by vote of the committee until appointment by the chairman of the board occurs; to clarify that the committee is prohibited from holding an executive session (closed meeting) for any reason; to clarify that the committee and its members may not participate in legislative activity in the name of the board, the department, or the committee except with certain approval; and to require the committee's annual report in November. These changes will clarify procedures for the committee and emphasize the advisory nature of the committee.

The department published a Notice of Intention to Review the sections as required by Government Code §2001.039 in the Texas Register on December 17, 1999, (24 TexReg 11541). There were no comments received due to the publication of the Notice.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §103.11(23), one commenter recommended adding "concussion and including" after the word "including" so that it would read: "An acquired injury to the brain, including concussions and including brain injuries caused by anoxia."

Response: The department agrees, and has added the suggested language.

Comment: Concerning §103.12(c), one commenter recommended adding "including concussions" so that it would read: "Traumatic brain injuries, including concussions."

Response: The department disagrees, and considers the proposed language to accurately include concussions in the definition. The diagnostic codes for concussions (850.0-850.9) are included in the definition of traumatic brain injury. No change was made as a result of this comment.

Comment: Concerning §103.14(c), one commenter requested adding "not included in paragraph (a) or (b) above" so that it would read: "For information on trauma patients, not included in paragraph (a) or (b) above."

Response: The department disagrees with the commenter. The definition of "trauma patient" is clearly stated in §103.11(21). No change was made as a result of this comment.

Comment: Concerning §103.19(c), one commenter requested adding "which shall in all cases conform with rules of the department."

Response: The department disagrees with proposed language since this is redundant with the wording of the rules. No change was made as a result of this comment.

Comment: Concerning §102.23(d), one commenter suggested correctly identifying the appropriate state agency (Texas Workers' Compensation Commission) and deleting reference to the Texas Workforce Commission.

Response: The department agrees and has added the suggested language.

Comment: Concerning the rules in general, two commenters suggested that the rules consistently require, from all reporting entities, documentation on name, address, social security number, address of injury, and results alcohol and drug testing. This should not be limited to just one type of injury.

Response: The department disagrees with the commenters. The department can specify who is to report, type of data to be reported, and frequency and procedure of reporting and it is recognized that there may be various levels of reporting. The department has received feedback from some hospitals who have raised concerns about the confidentiality, logistics, availability and usefulness of these data elements, and the burden to report those data elements to the state. The proposed rules specify the type of data required to be reported, but reporting entities are not limited to those data elements. For instance, name and social security number reporting are optional data which may be reported by hospitals. No change was made as a result of this comment.

The commenters were the Texas Brain Injury Advisory Council of Texas, Brain Injury Association of Texas, and the Texas Workers' Compensation Commission. The commenters were neither for nor against the rules in their entirety; however, they raised questions, offered comments for clarification purposes, and suggested clarifying language concerning specific provisions in the rules.

The amendment and new sections are adopted under Health and Safety Code, §92.002, which requires the board to adopt rules necessary to implement the reporting of injuries; Health and Safety Code, §§773.112(c) and 773.113(a)(3), which require the department to adopt rules necessary to implement a trauma reporting and analysis system; and Health and Safety Code, §12.001, which allows the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§103.11.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Board--The Texas Board of Health.

(2)

Case--A person in whom an injury is diagnosed by a physician, medical examiner, or justice of the peace, based upon clinical evaluation, interpretation of laboratory and/or roentgenographic findings, and an appropriate exposure history.

(3)

Commissioner--The commissioner of the Texas Department of Health.

(4)

Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3180.

(5)

Director--The director of the Texas Department of Health, who is the commissioner.

(6)

Health authority--A physician designated to administer state and local laws relating to public health under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121. The health authority, for purposes of these sections, may be the chief administrative officer of a public health district or a local health department, or the physician who is to administer state and local laws relating to public health.

(7)

Health care entity--A health care entity that is capable of treating an injured person. Health care entities include, but are not limited to, emergency medical service providers, hospitals, and rehabilitation facilities.

(8)

Hospital Reporting Guidelines--The Texas Trauma Registry's manual for hospitals which documents reporting procedures and format. A copy of the current guidelines can be obtained from the Trauma Registry, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(9)

Injury--Damage to the body that results from intentional or unintentional acute exposure to thermal, mechanical, electrical, or chemical energy, or from the absence of essentials such as heat or oxygen.

(10)

Pre-hospital Provider--A licensed Emergency Medical Services (EMS) provider which is a person who uses, operates, or maintains EMS vehicles and EMS personnel to provide EMS.

(11)

Pre-hospital Reporting Guidelines--The Texas Trauma Registry's manual for pre-hospital providers which documents reporting procedures and format. A copy of the current guidelines can be obtained from the Trauma Registry, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(12)

Program--The Injury Epidemiology and Surveillance Program.

(13)

Regional Trauma Registry--The organization which receives and collects trauma data for a designated area of the state and maintains the system by which the collected information is reported to the department.

(14)

Reportable injury--Any injury or condition required to be reported under this chapter.

(15)

Report of an injury--The notification to the appropriate health authority of the occurrence of a specific injury in a human, including all information required by the rules and forms promulgated by the Board of Health.

(16)

Spinal cord--That portion of the central nervous system which extends from the foramen magnum to the cauda equina. All nerve roots within the spinal canal are included.

(17)

Submersion injury--A drowning (a death resulting from suffocation within 24 hours of submersion in water) or near-drowning (survival for at least 24 hours after suffocation from submersion in water).

(18)

Suspected case--A case in which an injury is suspected, but the final diagnosis is not yet made.

(19)

Texas Trauma Registry--A statewide database administered by the Injury and Epidemiology and Surveillance Program which documents and integrates medical and system information related to the provision of trauma care by health care entities.

(20)

Trauma--An injury or wound to a living body caused by the application of an external force or violence, including burn injuries. Poisonings, near-drownings and suffocations, other than those due to external forces, are to be excluded from this definition.

(21)

Trauma patient--A patient that meets the following criteria: Has sustained at least one injury International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes between 800.0 and 959.9, excluding 905-909, 910-924, and 930-939, and admitted to a hospital inpatient setting (for more than 48 hours), or died after receiving any evaluation or treatment or was dead on arrival, or transferred into or out of the hospital. For subsequent editions of the International Classification of Diseases, equivalent codes should be used.

(22)

Trauma service area--A multi-county area in which an emergency medical services and trauma care system has been developed by a Regional Advisory Council and has been recognized by the department.

(23)

Traumatic brain injury--An acquired injury to the brain, including concussions and including brain injuries caused by anoxia due to near drowning. The term does not include brain dysfunction caused by congenital or degenerative disorders or birth trauma. The following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes are to be used to identify cases of traumatic brain injury: 800.0-801.9, 803.0-804.9 and 850.0-854.1. The ICD-9-CM diagnostic code to be used to identify traumatic brain injury caused by anoxia due to near drowning is 348.1 or 994.1. For subsequent editions of the International Classification of Diseases, equivalent codes should be used.

(24)

Traumatic spinal cord injury--An acute, traumatic lesion of the neural elements in the spinal canal, resulting in any degree of sensory deficit, motor deficits, or bladder/bowel dysfunction. The neurologic deficit or dysfunction can be temporary or permanent. The following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes are to be used to identify cases of traumatic spinal cord injury: 806.0-806.9 and 952.0-952.9. For subsequent editions of the International Classification of Diseases, equivalent codes should be used.

§103.23.Investigations.

(a)

The Texas Department of Health (department) shall investigate the causes of injuries and methods of prevention.

(b)

The commissioner or the commissioner's designee may enter at reasonable times and inspect within reasonable limits a public place or building, including a public conveyance, in the commissioner's duty to prevent an injury.

(c)

The commissioner or the commissioner's designee may not enter a private residence to conduct an investigation about the causes of injuries without first receiving permission from a lawful adult occupant of the residence.

(d)

When the department investigates work-related injuries, the Texas Workers' Compensation Commission shall be informed at the earliest opportunity.

(e)

When the department investigates traumatic spinal cord injuries and traumatic brain injuries, the Texas Rehabilitation Commission shall be informed at the earliest opportunity.

(f)

When the department investigates traumatic brain injuries, the Texas Traumatic Brain Injury Advisory Board shall be informed at the earliest opportunity.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101177

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Chapter 141. MASSAGE THERAPISTS

The Texas Department of Health (department) adopts the repeal of §§141.1 and 141.3-141.23 and new §§141.1-141.3, 141.5-141.7, 141.10-141.17, 141.20-141.47, 141.50-141.55, and 141.60-141.66 concerning the regulation and registration of massage therapists, massage therapy instructors, massage schools, and massage establishments. Sections 141.1-141.3, 141.5, 141.7, 141.11-141.12, 141.15, 141.21, 141.29, 141.32-141.34, 141.40, 141.42, 141.43, and 141.54 are adopted with changes to the proposed text as published in the September 22, 2000 issue of the Texas Register (25 TexReg 9377). The repeals and new §§141.6, 141.10, 141.13-141.14, 141.16-141.17, 141.20, 141.22-141.28, 141.30- 141.31, 141.35-141.39, 141.41, 141.44-141.47, 141.50-141.53, 141.55, and 141.60-141.66 are adopted without changes, and therefore the sections will not be republished.

The Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department reviewed Chapter 141 in its entirety and determined that all sections of the chapter should be repealed and new sections proposed. The review revealed that the sections needed reorganization and renumbering, had obsolete rules, had rules that did not reflect current board procedures, and had rules that did not reflect current legal and policy considerations.

Additionally, new rules are required by House Bill (HB) 2085 (relating to the continuation and functions of the Texas Department of Health, including the operation of certain boards and councils administratively attached to the department) and HB 3155 (relating to a nonsubstantive revision of provisions of the existing statutes applicable to the licensing and regulation of certain professions and business practices) passed by the 76th Legislature. The new rules have been edited and restructured to correct grammatical errors; eliminate subsection titles; update legal citations in accordance with HB 3155; delete repetitive, ambiguous, obsolete, unenforceable, and unnecessary language; and to include new provisions required by HB 2085. Each section has been edited in an effort to improve draftsmanship and make the rules more accessible, understandable, and usable.

New Subchapter A, §141.1 (relating to Definitions), numbers each definition, includes clarifying introductory language, and removes unnecessary definitions.

New Subchapter A, §141.2 (relating to Fees), establishes fees for the registration and renewal of massage therapists, massage therapy instructors, massage schools, massage establishments and providers of continuing education. Fees relating to time periods for late renewals are calculated based on the renewal fee and the length of time between registration expiration and late renewal, in accordance with HB 2085. Persons renewing within 90 days of the expiration date will pay a fee that is equal to one and one-half times the annual renewal fee. Persons renewing after 90 days but within one year of the expiration date will pay a fee that is two times the annual renewal fee. Previously, renewal fees for massage schools have been calculated based on the income generated by the school. Also, independent massage therapy instructors have paid less for the annual renewal. The renewal process, including an inspection of documents and physical locations, is the same for all registered massage schools and independent massage therapy instructors. Therefore, one fee is established which more accurately reflects the actual costs involved for the renewal process. HB 2085 requires the department to recognize, prepare, or administer continuing education programs for its registrants. A fee is established to cover costs associated with the annual approval of continuing education providers. The fees are necessary to cover the costs of operating the massage therapy registration program.

New Subchapter A, §141.3 (relating to Processing Applications), establishes procedural responsibilities relating to reimbursement and appeal.

New Subchapter B, §§141.5-141.7 (relating to Code of Ethics), identifies related categories of ethical conduct and includes language regarding initial consultations, billing practices, changes of name and address, and advertising practices by massage schools.

New Subchapter C, §§141.10 - 141.17, organizes and clarifies requirements pertaining to massage therapists including qualifications for registration, application procedures and documentation, temporary registration, examination, massage therapy certificates, and active military duty. Additionally, new language incorporates requirements for provisional registration and registration renewal.

New Subchapter D, §§141.20-141.25 (relating to Continuing Education Requirements), establishes continuing education approval and reporting requirements in accordance with HB 2085.

New Subchapter E, §§141.26-141.47 (relating to Massage Schools and Massage Therapy Instructors), reorganizes, renumbers and clarifies requirements pertaining to massage schools and instructors, including application procedures and documentation, personnel, massage therapy instructors, financial stability, change of ownership, locations, curriculum and internship for the basic course of instruction, admission requirements, enrollment procedures, tuition and fees, conduct policy, cancellation and refund policy, minimum progress standards, attendance standards, equipment and facility requirements, transcripts and records, student grievances, fire safety, sanitation and registration renewal.

New Subchapter F, §§141.50-141.55 (relating to Massage Establishments), reorganizes, renumbers and clarifies requirements pertaining to massage establishments including application procedures and registration, general requirements, sanitation, annual renewal, exemptions and change of ownership.

New Subchapter G, §§141.60-141.66 (relating to Violations, Complaints, and Disciplinary Actions), reorganizes, renumbers and clarifies requirements pertaining to the filing and investigation of complaints, grounds for registration denial or disciplinary action, formal hearings, suspension of registration for failure to pay child support, and registration of persons with criminal backgrounds. Additionally, new language adds reprimands and probated suspensions to the types of disciplinary actions the department may take against persons who violate the law, Texas Occupations Act, Chapter 455 (the Act), or the department's administrative rules, 25 TAC, Chapter 141 in accordance with HB 2085.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning the definition of "Act", language has been changed from "Texas Civil Statutes" to "Texas Revised Civil Statutes" to reflect the correct citation.

Change: Concerning the definition of "massage therapy", language in the first sentence has been reorganized to more correctly reflect the language in the Act. The modification does not alter the definition.

Change: Concerning §141.3(a)(4), language has been added to reflect the current procedures for processing applications. The department issues a letter of acceptance or a letter of deficiency within 30 working days of the receipt of an application for massage school, massage therapy instructor, or massage establishment registration.

Change: Concerning §141.11(d)(6), language has been deleted requiring applications to be notarized because the department plans to allow applicants to submit applications on-line in the future.

Change: Concerning §141.12(a), language has been added to cross-reference subsection (e) of that section.

Change: Concerning §141.15(f), the department has replaced the language "been lost in the mail" to "not been received by a registrant". The new language is a more accurate reflection of the situation under which a registrant may request a duplicate certificate or card at no charge.

Change: Concerning §141.21(a) and (b), language has been added to set out that acceptable continuing education will include advanced bodywork techniques acceptable to the department and that presenters of advanced bodywork techniques must be licensed, registered, or have education in the technique being presented. Addition of this language is necessary because of modifications made to the definition of "massage therapy" which deleted the list of advanced techniques from the definition.

Change: Concerning §141.32(g), "registration renewal card" was changed to "registration renewal certificate". Massage therapy educational programs will receive a new certificate each year. One of the sentences was deleted for further clarification.

Change: Concerning §141.33(b), a change was made to clarify that the course of instruction is the 300 hour supervised course of instruction required for massage therapy registration.

Change: Concerning §141.33(d), a change was made to clarify that the department will "approve" rather than "allow" a massage therapy educational program to begin operation at an additional location prior to inspection under specific circumstances.

Change: Concerning §141.40(b)(4), two changes have been made. The phrase "not more than 18 months in length" is removed to clarify that the requirement pertains to any massage therapy educational program. Language was added to clarify that the school is only required to calculate refunds based on the tuition made by the student.

Change: Concerning §141.40(f), language was modified to clarify that the department may pursue any disciplinary action authorized by the Act for violations of the rules.

Changes made to the proposed text resulted from comments received during the comment period. The details of the changes are described in the summary of comments that follow. Other minor editorial changes were made for clarification purposes.

The following comments were received concerning the proposed rules. Following each comment is the department's response and any resulting change(s).

Comment: Concerning the rules in general, one commenter expressed full support for the rules as proposed.

Response: The department agrees and no modifications were made as a result of this comment.

Comment: One commenter requested that the words "purpose" and "ethic" be defined in 141.1.

Response: The department responds that unless otherwise specified, all words have the meaning assigned in their normal usage. Any variance from normal usage would be specified and based on the appropriate source, such as Webster's Dictionary, Black's Legal Dictionary, or other recognized dictionaries. No change was made as a result of the comment.

Comment: Concerning the definition of "massage therapy", two commenters suggested creating two boards, one for Swedish massage and one for alternative techniques and modalities. Additionally, one commenter suggested the establishment of a board of complimentary and alternative therapies.

Response: The department responds that the creation of boards to regulate specific professions requires legislative enactment. No change was made as a result of the comment.

Comment: Concerning the definition of "massage therapy", 19 commenters stated opposition to the inclusion of reflexology in the definition of massage therapy; one commenter opposed the inclusion of shiatsu in the definition of massage therapy; three commenters opposed the inclusion of the Trager® approach; three commenters opposed the inclusion of Rolfing® in the definition of massage therapy and stated reflexology, shiatsu, Trager®, and Rolfing® are not the manipulation of soft tissue for the purpose of body massage; one commenter noted Rolfing® does involve the manipulation of soft tissue; one commenter proposes to exclude all forms of "bodywork" that are not for the purpose of body massage; and one commenter opposed including all modalities and techniques as massage therapy so individuals will have choices in seeking alternative methods of healing.

Response: The department agrees in part with the commenters. The definition of massage therapy was proposed to include reflexology, Rolfing®, Shiatsu, Tellington Touch on humans, and the Trager® approach. As a result of meetings with stakeholders and comments received during the comment period, the department determined that including specific modalities in the definition is not appropriate because some of the techniques and modalities may not involve the manipulation of soft tissue for the purpose of body massage and the types of advanced techniques and modalities are too numerous to provide an inclusive list. Additionally, the definition of "massage therapy" in the Act does not include a list of specific modalities. The department will continue to study alternate techniques and modalities on an individual basis to determine whether each constitutes the manipulation of soft tissue by hand or through a mechanical or electrical apparatus for the purpose of body massage. The definition of massage therapy has been modified to delete references to specific techniques or modalities.

Comment: Concerning the definition of "massage therapy", one commenter recommended excluding individuals practicing non-massage titled hands-on practices for which national standards exist and suggested the department require: (1) the regulation of only massage-title practices; (2) educational requirements that pertain only to massage-titled practices; (3) specific definition of each massage-titled practice; (4) only massage-titled diplomas be issued by registered massage therapy schools; and (5) full and fair disclosure of definitions and educational attainment be posted in the massage therapy workplace.

Response: The department disagrees. The Act mandates registration for anyone who engages in the practice of massage therapy and defines massage therapy as the manipulation of soft tissue for the purpose of body massage. The Act establishes regulations for the practice of massage therapy as defined in the Act and does not grant the department the authority to regulate only massage-titled practices. Massage therapy schools and instructors are not prohibited by the Act from offering courses in advanced or alternate techniques if those advanced or alternate techniques are not otherwise regulated; therefore, the department would not have the authority to require only massage-titled diplomas be issued by registered schools. No changes were made as a result of this comment.

Comment: Concerning the definition of "massage therapy", four commenters noted support for the language in the definition of massage therapy that excludes Reiki and Therapeutic Touch and one commenter suggested that any form of "energetic manipulation" or energy work be excluded from the definition of massage therapy.

Response: The department responds that as a result of stakeholder meetings and other comments on the proposed rules, the department has removed references to specific alternate techniques and modalities. Techniques, modalities, or practices which do not involve the manipulation of soft tissue for the purpose of body massage will not be considered as the practice of massage therapy.

Comment: Concerning the definition of "massage therapy", one commenter indicated that if techniques such as reflexology should be included in the definition of massage therapy, then those techniques should be regulated as reflexology. The commenter is concerned that the educational requirements for massage therapy are not sufficient to ensure that persons practicing reflexology are adequately trained. Additionally, the commenter stated that if reflexology is not regulated under massage therapy, then the practice needs to be regulated somehow to make sure standards are higher.

Response: The department agrees in part with the commenter. As a result of stakeholder meetings and other comments on the proposed rules, the department has removed references to specific alternate techniques and modalities. Techniques, modalities, or practices which do not involve the manipulation of soft tissue for the purpose of body massage will not be considered as the practice of massage therapy. The Act establishes educational requirements for registration under the Act and does not authorize the department to establish educational requirements for specific techniques or practices. No changes were made as a result of this comment.

Comment: Concerning the definition of "massage therapy", one commenter suggested adding "but not limited to" when listing techniques, modalities, or practices that are considered the practice of massage therapy.

Response: The department responds that the sentence the commenter suggested amending has been deleted as a result of other comments and no change was necessary as a result of the comment.

Comment: Concerning the definition of "massage therapy educational program", one commenter suggested changing the term to the "educational program for registration".

Response: The department responds that there is not a sufficiently significant difference in the two phrases to change the term throughout the sections. No change was made as a result of this comment.

Comment: Concerning the definition of "massage therapy instructor", one commenter suggested inserting the word "registered" before massage therapy instructor.

Response: The department responds that the term "massage therapy instructor" is defined in the Act and that the definition in the rules mirrors the definition in the Act. The department agrees the term refers to registered massage therapy instructors and no change was made as a result of the comment.

Comment: Concerning the definition of "owner", one commenter noted that school is referenced but not defined. The commenter also suggests including other legal entities and LLCs in the definition of owner.

Response: The department has modified the language to reference a massage therapy educational program rather than school and added language to include any other legal business entity.

Comment: Concerning the definition of "physiology", one commenter stated that there is no such thing as circulatory secretion.

Response: The department agrees and has added punctuation to clarify the definition of physiology.

Comment: Concerning the definition of "physiology", one commenter suggested removing the words "normal" and "vital" from the definition of physiology because schools need to teach enough about pathology to assist with recognizing contraindications to massage as a whole and to specific techniques.

Response: The department responds that the definition of "physiology" is not the only direction provided to massage therapy educational programs concerning the 25 hours of physiology required for registration. The department provides a curriculum to educational programs they are to follow and the programs are allowed to select the textbook to be used. Defining physiology does not limit an educational program from teaching pathology necessary to assist in recognizing contraindications to massage. No change was made as a result of this comment.

Comment: Concerning the definition of "state-approved educational institution", one commenter noted that the definition is not clear that it refers to a school, and the commenter suggested that massage school needs to be defined. The commenter also opposed any requirement that massage schools be regulated by the Texas Education Agency (TEA).

Response: The department responds that the definition of "state-approved educational institution" does not refer to massage schools, which are defined in the Act. The Act, §455.156(b) sets out that state-approved educational institutions are alternative methods for obtaining the 300 hour course of instruction. State-approved educational institution is not defined in the Act so defining it by rule is necessary. Additionally, the term is currently defined in existing rules using the same definition and the department confirms that massage schools and massage therapy educational programs are regulated by the department. No change was made as a result of this comment.

Comment: Concerning §141.2(d)(3), one commenter suggested the fee for a new certificate based on a name change has, in the past, and should now apply to all registrants, not just the 300 hour massage therapy educational programs.

Response: The department agrees and has moved §141.2(d)(3) to new subsection (i). The paragraphs under subsection (d) have been renumbered.

Comment: Concerning §141.5(a), one commenter suggested adding "under the auspices of" to the language in subsection (a).

Response: The department disagrees because it does not add to the ability to enforce the proposed language. No change was made as a result of this change.

Comment: Concerning §141.5(e), one commenter stated that requiring an initial consultation and documentation will create unnecessary paperwork that has no value, especially for massage therapists who specialize in relaxation massage.

Response: The department disagrees. The massage therapy registration program has noted a growing number of complaints that staff believes could have been avoided had the massage therapist communicated more completely with the client about the issues listed in §141.5(h) and if the client had been better informed about what he or she should expect from the massage therapy session. No change was made as a result of the comment.

Comment: Concerning §141.5(e), one commenter suggested that maintaining records for a minimum of three years on a potential one time client is excessive and recommended modifying the requirement to one year from the last visit.

Response: The department agrees in part. Three years may be longer than necessary to maintain the record of a client who becomes a one-time client. However, because there is no statute of limitations on filing a complaint against a registrant, it is in the interest of the massage therapist to maintain the records for more than one year. The language has been modified to reflect that the records should be maintained for a minimum of two years.

Comment: Concerning §141.5(d), (e), (g), (h), (i), (k), and (r), one commenter noted that while the requirements reflect good and ethical business practices, it is not appropriate or necessary to extend rules into the business and financial aspects at that level of detail.

Response: The department disagrees. The Act requires that rules relating to massage therapists must contain minimum standards for the practice of a massage therapist including the records kept by the massage therapist. The requirements in (k) and (r) are currently in effect for massage therapists and are not new requirements. Additionally, the requirement in (k) is set out in the Health Professions Council Act, Occupations Code, Chapter 101, and applies to all health professions regulated by any regulatory agency that is a member of the Health Professions Council, including the health licensing division of the Texas Department of Health (Professional Licensing and Certification Division). No change was made as a result of the comment.

Comment: Concerning §141.5(f), one commenter suggested that "minor" should be defined.

Response: The department agrees and has modified the language in subsections (f) and (g) to clarify that minor refers to persons under the age of 17.

Comment: Concerning §141.5(g), one commenter stated the requirement for documentation is excessive, burdensome, and unnecessary and noted that doctors, physical therapists, occupational therapists, nurses, and others are not required to maintain and provide the same documentation.

Response: The department disagrees and responds that the Health Professions Council Act, Occupations Code, §101.202, requires that health care professionals provide, in plain language, a written explanation of the charges for professional services previously made on a bill or statement for the patient. The Health Professions Council Act applies to all health professions regulated by any regulatory agency that is a member of the Health Professions Council, including the health licensing division of the Texas Department of Health (Professional Licensing and Certification Division), physicians, physical therapists, occupational therapists, nurses, and others. No change was made as a result of the comment.

Comment: Concerning §141.5(h)(1)-(6), two commenters stated opposition to all elements of a consultation form. One stated that the records identifying the techniques to be used during a massage session were meaningless to most clients; that listing the parts of the body to be massaged is pointless documentation and excessive paperwork; that breast massage is appropriate and indicated related to lymph flow, surgery, or implants; that therapists should be trusted to use professional judgement and clients should be informed users of services; that draping should not be legislated; that massage therapists are professionals not prostitutes; that the draping requirement is too vague; and the requirement creates too much paperwork without enhancing quality of work or ethical behavior. One of the commenters objected to the requirement of an initial consultation and documentation and considers the requirement to be "insulting", "demeaning", and "reactionary"; that it does not accomplish anything and is time consuming; that it may be useful in some settings, but is unnecessary in others; and that there is no need for professionals to be mistrusted by requiring written consent for breast massage.

Response: The department disagrees. The requirements for the initial consultation and consultation form were developed after a meeting with massage therapists who indicated that they do provide consultation to clients. The department's decision to require a written version that both the therapist and the client can sign resulted from consumer complaints received during the last two years that may have been avoided had there been better communication between the massage therapist and the client. No change was made as a result of the comments.

Comment: Concerning §141.5(h), one commenter asked for clarification concerning which clients the requirement applies to; whether all techniques could be listed for all clients because the therapist does not always know which techniques will be used; how specific does the therapist need to be when identifying the parts of the body to be massaged; and how detailed the consultation form should be when listing indications and contraindications to massage. The commenter is concerned about the amount of paperwork a massage therapist will be required to generate and maintain.

Response: The department disagrees. The requirements for the initial consultation and consultation form were developed after a meeting with massage therapists who indicated they do provide consultation to clients. The department's decision to require a written version that both the therapist and the client can sign resulted from consumer complaints received during the last two years that may have been avoided had there been better communication between the massage therapist and the client. No change was made as a result of the comment.

Comment: Concerning §141.5(h), one commenter stated that the requirement for an initial consultation and documentation form is too much paperwork for massage therapists whose practice is limited to general wellness massage. The commenter also opposed the additional paperwork for massage therapists whose practice is based on medical referrals because the chart notes would be required and used in that situation. An initial consultation and documentation form would be duplicative.

Response: The department disagrees. The requirements for the initial consultation and consultation form were developed after a meeting with massage therapists who indicated they do provide consultation to clients. The department's decision to require a written version that both the therapist and the client can sign resulted from consumer complaints received during the last two years that may have been avoided had there been better communication between the massage therapist and the client. Massage therapists who maintain chart notes for medical referrals would not necessarily be required to maintain two separate documents. The intent of the requirement is that registrants provide clients with information so the client knows what to expect. No change was made as a result of the comment.

Comment: Concerning §141.5(i), one commenter stated that the cross reference to subsection (h)(1)-(6) should be amended to (h)(1)-(4) since the information required in paragraphs (5) and (6) will not change from one session with a client to the next.

Response: The department agrees and has modified the language to cross reference subsection (h)(1)-(4).

Comment: Concerning §141.5(h)(1)-(4) and (i), one commenter suggested modifying the language to clarify that the initial consultation does not require a separate session or consultation and is opposed to requiring discussion and documentation of the techniques to be used and the body parts that may be massaged. The commenter believes the requirements are demeaning and requests the department to indicate other health care professionals who are required to follow these same practice requirements. The commenter is also opposed to discussing draping practices and preferences with the client. Concerning subsection (i), the commenter agrees it may be reasonable to require records kept in relation to changes in a client's needs, however, it is unreasonable to require written modifications to parts of the body being massaged. The commenter suggests changing the subsection to allow discussion with client regarding the techniques the therapist anticipates using rather than written documentation.

Response: The department disagrees. The massage therapy registration program has noted a growing number of consumer complaints that staff believes could have been avoided had the massage therapist communicated more completely with the client about the issues listed in §141.5(h) and if the client had been better informed about what he or she should expect. No change was made as a result of the comment.

Comment: Concerning §141.5(h) and (i), one commenter stated opposition to a consultation document that requires the therapist to discuss specific body parts, and stated that a discussion and consultation document may cause clients to have concerns they would not have otherwise had. The commenter is also concerned the requirement will create a bureaucratic paperwork nightmare for the conscientious, hard-working, ethical registrants who already follow the rules.

Response: The department disagrees. The massage therapy registration program has noted a growing number of consumer complaints that staff believes could have been avoided had the massage therapist communicated more completely with the client and if the client had been better informed about what he or she should expect. No change was made as a result of the comment.

Comment: Concerning §141.5(h) and (i), four commenters considered that an initial consultation may put chair massage therapists out of business because chair massages are based on convenience and affordability; chair massages are often conducted in public venues; clients are not required to remove clothing; the average chair massage takes only 15 to 20 minutes; and neither therapists nor clients will want to take the time for an interview before each chair massage session. One of the commenters stated that at sporting events, a person is out of a race or game temporarily and needs immediate attention. Requiring the consultation in that situation would be impossible. One of the commenters requested an exemption for chair massage.

Response: The department disagrees with the commenters. Massage therapists are trained in the indications of and contraindications to massage for clients, or the benefit of massage and specific conditions the client may have that would indicate the client is not a candidate for any type of massage. While chair massage is fairly routine, the fact that it is convenient, brief, conducted in public and provided to fully clothed clients does not alter the massage therapist's responsibility to ensure that any massage technique is appropriate for each prospective client. Massage therapists may create a document that provides the information required in §141.5(h) and allow the client a few minutes to read the information. The document could list specific contraindications to massage so the client can decide whether the chair massage will be beneficial or whether a condition exists that would indicate the client should not receive massage. Because the client's reason for seeking a chair massage would not change and because the nature of chair massage does not rely solely on repeat business, each consultation could be handled as an initial consultation and would not automatically require that §141.5(i) be applied. No change was made as a result of the comments.

Comment: Concerning §141.5(i), one commenter suggested that a client is much more likely to remember he or she wishes some different or additional massage therapy service after they are already on the massage table being treated by the therapist and that the need to modify a technique may only become apparent during the session. The commenter further suggests that most clients would consider it ludicrous to interrupt the session to fill out more paperwork.

Response: The department agrees; however, §141.5(i) does not prohibit modification of the consultation document after a subsequent massage therapy session. No change was made as a result of the comment.

Comment: Concerning §141.5(h)(1), one commenter suggested that requiring registrants to list the type of techniques he or she anticipates using could result in registrants simply creating a form that lists all of the modalities he or she knows. The commenter believes that providing the information after the first session would result in a more realistic assessment.

Response: The department disagrees. The intent of the requirement is to ensure first time clients understand what to expect during a massage session. No change was made as a result of the comment.

Comment: Concerning §141.5(h)(2), one commenter recommends that instead of listing the parts of the body that will be massaged that it would be easier and shorter to list the parts of the body the client wishes the therapist to avoid. The commenter also suggests that clients who simply wish to have a massage may consider it an invasion of their privacy to require them to give the therapist the necessary information to make the correct determination as to the true indications for massage.

Response: The department agrees in part and has modified the language to allow for either a list of the areas of the body to be massaged or the areas to be avoided to be included on the consultation document. The intent of the requirement is to ensure that the therapist and client discuss expectations, are in agreement about what the massage will involve, and document their agreement. Section 141.5(h)(2) does not require a client to provide information the client feels may violate his or her privacy. The intent of the requirement is that the registrant provide information to the client about indications and contraindications to massage and that the information and the client's responses, if any, be documented. If a client does not provide information to the registrant that would allow the registrant to identify indications or contraindications, then that would be reflected on the form signed by both the registrant and the client.

Comment: Concerning §141.5(h)(3), one commenter suggested having a potential client initial a release or request statement on the consultation form if they wish to have breast massage, rather than requiring a signature.

Response: The department disagrees. The intent of the consultation and documentation of the consultation is to ensure that the therapist and the client discuss expectations, that they are in agreement about what the massage will involve, and that they document their agreement. No change was made as a result of the comment.

Comment: Concerning 141.5(h)(3), one commenter suggested the need to clarify whether the requirement for written consent to breast massage applied to both women and men.

Response: The department agrees and has modified the language to be consistent with §141.6(a)(2). Written consent of female clients is required for breast massage.

Comment: Concerning §141.5(k), one commenter stated that the department has no jurisdiction over the pricing of massage services and assumes the prohibition of persistent or flagrant overcharging is aimed at discriminatory practices. The commenter suggests the department clarify the language. Additionally, the commenter indicated the portion of the subsection that prohibits over treating a client would be difficult to define because client needs and wishes vary.

Response: The department disagrees. The requirements in §141.5(k) exist in the current massage therapy rules and the language is clear that the prohibition for overcharging and over treating apply to unscrupulous practices. Additionally, this requirement is set out in the Health Professions Council Act, §101.203, which applies to all health professions regulated by any regulatory agency that is a member of the Health Professions Council, including the health licensing division of the Texas Department of Health (Professional Licensing and Certification Division). No change is made as a result of the comment.

Comment: Concerning §141.5(r)(1) and (2), one commenter suggested these paragraphs should end with the word "or".

Response: The department disagrees. The correct Texas Register format is used and the "or" appears between paragraphs (3) and (4). No change was made as a result of the comment.

Comment: Concerning §141.6, one commenter suggested that the phrase "during a session" is too ambiguous and needs to be better defined.

Response: The department disagrees and considers "during a session" to adequately reflect a session during which a client seeks out or receives massage therapy services from a registrant. No change was made as a result of the comment.

Comment: Concerning §141.6(a)(1)-(7), one commenter opposed defining sexual misconduct in explicit terms and suggested using the language that "a registrant shall not engage in unprofessional or inappropriate contact with a client."

Response: The department disagrees. The suggested language is too vague and ambiguous to be enforceable. The department must be able to identify a specific act if an investigation results in the pursuit of disciplinary action. No change was made as a result of the comment.

Comment: Concerning §141.6(a)(2), one commenter objects to the written consent for breast massage and asks what other health care professionals are required to do this.

Response: The department disagrees. The existing massage therapy rules currently prohibit a massage therapist from massaging the breasts of a female client without the client's consent. The department has resolved consumer complaints over the years through informal agreements and agreed orders requiring the therapist to obtain the written consent of a female client before providing breast massage. Requiring written consent will decrease the number of misunderstandings between massage therapists and clients that result in complaints being filed with the department. Other health care professionals are not specifically authorized to perform body massage and may have varying protocols for similar situations. No change is made as a result of the comment.

Comment: Concerning §141.6(a)(5), a commenter suggested that the word "deviate" should be changed to "deviant".

Response: The department responds that the language in paragraph (5) is taken from the Texas Penal Code and that deviate is the correct word in this context. No change is made as a result of the comment.

Comment: Concerning §141.7(a), one commenter suggested adding continuing education providers to the language prohibiting the use of the word "massage" by unregistered persons.

Response: The department responds that continuing education providers would be covered as a "person". No change was made as a result of the comment.

Comment: Concerning §141.7(b)(4), four commenters disagree and believe the use of testimonials from actual clients is appropriate, and two believe this requirement treats massage therapists different from other health care professionals.

Response: The department disagrees. The provisions in §141.7(b) concerning advertisements are required by the Health Professions Council Act, Occupations Code, §101.201, and apply to all health professions regulated by any regulatory agency that is a member of the Health Professions Council, including the health licensing division of the Texas Department of Health (Professional Licensing and Certification Division). Additionally, the advertising requirements set out in §141.7 are required in the existing massage therapy rules. No change was made as a result of the comments.

Comment: Concerning §141.7(b)(8), three commenters stated the language is unclear, arbitrary, not definable and is unenforceable. Two considered it odd to use the term patient rather than client.

Response: The department agrees in part. The language in §141.7(b)(8) was taken verbatim from the Health Professions Council Act, Occupations Code, §101.201, and applies to all health professions regulated by the regulatory agencies that are members of the Health Professions Council. The term patient is more commonly used among the professions; however, the department has defined and uses the term client in its proposed rules and has modified the language in this paragraph for consistency. The department does not agree that the language is unclear or arbitrary.

Comment: Concerning §141.7(d)-(h), a commenter asked if the advertising requirements apply to massage schools teaching programs for registration or continuing education providers.

Response: The department responds that §141.7(d)-(h) applies to the massage schools and massage therapy educational programs providing instruction in the 300 hour course of instruction for registration. The advertising requirements and prohibitions found in §141.7(b)(1)-(9) would apply to continuing education providers. No change was made as a result of this comment.

Comment: Concerning §141.7(i), two commenters disagree with prohibiting massage schools from the use of statements indicating the school has been accredited unless the accreditation is that of an accrediting agency listed by the United States Office of Education because the United States Office of Education does not include nationally recognized agencies that accredit massage therapy programs, such as the Commission on Massage Therapy Accreditation (COMTA).

Response: The department agrees in part and the language in §141.7(i) has been changed to delete the reference to the United States Office of Education. However, the department is concerned that advertisements and statements concerning accreditation be clear to prospective students and the general public. Therefore, the language in §141.7(i) has also been modified to require the name of the nationally recognized accrediting agency in any statement or advertisement related to accreditation.

Comment: Concerning §141.11(c), which sets out that registration applications not completed within 30 days after the date of notice of deficiency will be voided, one commenter suggested clarifying whether the 30 days applies to the postmark date or the date the department receives the additional documentation.

Response: The department responds that the postmark date will be used; however, the language in subsection (c) does not require modification. No change was made as a result of the comment.

Comments: Concerning §141.11(d)(4), which requires applicants to sign a statement that he or she understands fees are non-refundable, one commenter suggested adding the language "except as provided in section §141.3(c)" which allows for the refund of fees under certain circumstances.

Response: The department disagrees. Section 141.11(d) sets out information required on an application form and to include the suggested language would be nonsensical in that context. Additionally, §141.3(c) sets out procedures for an applicant to request a refund only in circumstances where the department has failed to process an application within stated time frames. The language in §141.3 clearly sets out procedures for requesting a refund and it is not necessary to reference that section in §141.11(d). No change was made as a result of the comment.

Comments: Concerning §141.14(i), one commenter stated that it should not take 30 days for the department to grade an examination and send the results to the examination candidates.

Response: The department disagrees. The Act, Texas Revised Civil Statutes, Article 4512k, §7E, establishes 30 days as the maximum time frame for grading examinations and notifying candidates of the results. No change was made as a result of the comment.

Comments: Concerning §141.14, one commenter suggested the department should establish more examination dates.

Response: The department neither agrees nor disagrees with the commenter. The proposed language in §141.14(h) allows the department to establish examination dates and locations; and currently, the department administers three examinations per year. Current resources prohibit holding more than three examinations per year. No changes are necessary as a result of the comment.

Comment: Concerning Subchapter D and the continuing education requirements in general, one commenter is concerned that massage therapists who specialize in Rolfing® will be forced to take continuing education that does not relate to their specialization. Additionally, the commenter is concerned that the requirements create a restriction of free trade and limits Rolfers from teaching rolfing techniques.

Response: The department disagrees. The continuing education requirements allow credit for advanced and alternate bodywork techniques and does not prohibit the instruction of advanced and alternate bodywork techniques. No changes were required as a result of this comment.

Comment: Concerning 141.20(a)(1), one commenter stated the six hours per year required for continuing education is a reasonable amount.

Response: The department agrees and no change was made as a result of the comment.

Comment: Concerning §141.20(a), one commenter does not think that massage therapists who have had extensive training in massage therapy will benefit from the continuing education requirements and should not be required to participate in the continuing education requirements.

Response: The department disagrees. The Act, Texas Revised Civil Statutes, Article 4512k, §7G, requires the department to recognize, prepare, or administer continuing education programs for its registrants. It is not possible or appropriate for the department to establish different requirements for specific categories of registrants. No change was made as a result of the comment.

Comment: Concerning §141.20(a), one commenter stated that six hours of continuing education is a burden on massage therapists; that continuing education requirements penalize persons who engage in the practice of massage therapy on a part time basis; and that the department should regulate the costs of continuing education.

Response: The department disagrees. The department established a six hour requirement so that compliance with continuing education requirements would not be unnecessarily burdensome for registrants. The department will accept attendance at a variety of activities that can be obtained locally at minimal costs to massage therapists such as local meetings of professional association affiliates, health related or business courses taught at or through community colleges or universities, and courses such as first aid and CPR. The department is authorized to establish continuing education requirements for its registrants, but is not authorized to regulate the cost of programs, seminars, workshops, activities, etc. No changes were made as a result of this comment.

Comment: Concerning §141.20, one commenter asked if massage therapy schools will need to develop a different form for documenting continuing education and asked how the schools would issue credit to a person who takes six hours of a 12 hour workshop.

Response: The department neither agrees nor disagrees and the comment does not require changes to the proposed language. The department will accept the same transcripts schools currently provide to students or will accept any documentation the school decides to use to verify attendance at programs, courses, workshops, seminars etc. A school is not required to provide a certificate of attendance to a person who attends a portion of a course nor is the school prohibited from doing so. No changes were made as a result of the comment.

Comment: Concerning §141.20, one commenter asked for clarification of the conversions set out in (b)(1)-(3), and suggested changing subsection (c) to read "one clock hour of classtime constitutes one hour of continuing education" rather than "a clock hour is equal to 50 minutes". The commenter also indicated confusion regarding continuing education units.

Response: The department responds that all of the criteria used in determining continuing education credit are standard conversion criteria. "Continuing education unit" is a specific educational term used by some organizations in describing and assigning credit. Organizations that use the continuing education unit or CEU formula assign credit as one (1) unit represents 10 clock hours, therefore, one clock hour would convert to 0.1 units or one-tenth of a unit. The department has used clock hours rather than units or the CEU formula for assigning credit. Defining one clock hour as 50 minutes is also a standard educational criteria. No changes were made as a result of the comment.

Comment: Concerning §141.20(b) and §141.22(4), one commenter stated that requiring attendance at continuing education events and activities and not allowing independent study as a means to meet the continuing education requirements, creates a hardship on massage therapists. A second commenter asked that independent study be accepted.

Response: The department disagrees. The department considered many factors in establishing the continuing education requirements to ensure that the requirements would not be unnecessarily burdensome for registrants. The number of hours was set at six so that in most cases, overnight travel and accommodations would not be required. The pre-approved provider category was established in part so that registrants would not be required to obtain the continuing education hours from a massage therapy school. Additionally, the department will accept many courses that can be obtained locally for the majority of massage therapists, such as local meetings of professional association affiliates, health related or business courses taught at or through community colleges or universities, and courses such as first aid and CPR. No changes were made as a result of the comments.

Comment: Concerning §141.20(a), one commenter stated that the only reason for requiring continuing education is to insure the safety of the client and that he believes there is a profound lack of incidents in which a client has been injured by massage therapists. Therefore, the commenter is concerned that the continuing education requirements will only benefit instructors who will charge whatever they want for the training and that massage therapists will have no option but to pay.

Response: The department disagrees because there are several avenues available to massage therapists for obtaining the continuing education, such as professional association meetings and courses offered by colleges and universities. Additionally, some prospective continuing education providers have indicated to department staff that they are interested in ensuring affordable programs will be provided. The requirements are intended to maintain and improve the quality of services provided to the public by massage therapists. No change was made as a result of this comment.

Comment: Concerning §141.20(a), two commenters support the continuing education requirements and one suggests a maximum number of hours be established.

Response: The department agrees with the commenters and responds that §141.20(a) does set a required number of hours at six per year. No change was made as a result of the comments.

Comment: Concerning §141.20(a), three commenters suggested limiting the years of continuing education by not requiring continuing education for massage therapists after 20 or 25 years.

Response: The department disagrees. The massage therapy registration requirements have been in effect since 1985 without continuing education requirements and the department was careful to establish a minimum requirement that would fairly and consistently meet the statutory requirements without imposing an undue burden on registrants. No change was made as a result of these comments.

Comment: Concerning §141.21, one commenter supports the rules relating to continuing education requirements and would not support rules that required continuing education be provided only by massage therapy schools. Additionally, the commenter believes schools will be able to sufficiently compete with individual presenters.

Response: The department agrees and no changes were made as a result of the comment.

Comment: Concerning §141.21(a), one commenter asked for clarification of the term "participation in or completion of" continuing education programs or activities and one commenter requested clarification regarding who determines an approved program.

Response: The department agrees and has modified the proposed language to read "attendance at and completion of" continuing education programs or activities. Additionally, the department confirms that the department is responsible for approving or recognizing continuing education programs approved by other organizations. No change was made as a result of these comments.

Comment: Concerning §141.21 and §141.24, two commenters are concerned that the requirements for continuing education presenters do not afford sufficient quality assurance of continuing education presentations. Additionally, the commenters suggest that since massage schools go through rigorous requirements to maintain quality, that at least the continuing education originating in-state be channeled through the massage therapy schools.

Response: The department disagrees. The department reviewed continuing education requirements for many other professions during its consideration and establishment of requirements for approximately 17,000 registered massage therapists. The majority of those reviewed allow a great deal of flexibility with regard to continuing education and allow the regulated persons the ability to seek out workshops, programs, and events of personal interest in areas related to the profession. To require that the hours be offered by and obtained through registered massage schools may create difficulties for massage therapists in rural areas to complete the requirements.

Comment: Concerning §141.21(b), one commenter asked the department to clarify whether the language referring to out-of-state presenters being licensed to practice nursing means RNs or LVNs.

Response: The department disagrees. The terms RN and LVN are terms used and regulated in Texas. The language in §141.21 refers to persons licensed, registered, or certified in other states and the more generic language is appropriate. No change was made as a result of this comment.

Comments: Concerning §141.21(b), one commenter suggested interchanging the order of paragraphs (2) and (3) and adding the word "or" between the two. The commenter suggested that otherwise, paragraph (1) makes paragraph (3) illegal.

Response: The department disagrees and responds that paragraph (3) pertains only to out-of- state presenters. No change was made as a result of the comment. Comment: Concerning §§141.21-141.22, one commenter recommends the department accept research and independent study to meet the continuing education requirements.

Response: The department disagrees. The proposed requirements afford a great deal of flexibility without imposing an undue burden on registrants. If the hour requirement were to be raised from the six hours proposed, then it might be more appropriate to consider allowing a portion from research or independent study. No change was made as a result of the comment.

Comment: Concerning §141.24, one commenter stated that the proposed "loosening" of the approval process for workshops is "too loose, too fast" and that approved massage schools should serve as gatekeepers for all continuing education offered other than that which is taught in TEA approved educational institutions or state or national conferences. The "gatekeeper" role would (1) examine and analyze all proposed continuing education from out-of-state presenters to ensure proper content, removing such burdens from the department; (2) ensure quality of continuing education by facilitating appropriate and effective curriculum, instruction, and environment; and (3) schools can be more accountable to the department than out-of-state presenters, ensuring better protection for the registrants in terms of monetary losses and unauthorized continuing education. The commenter also sets out the benefits to the department if the schools act as "gatekeepers" as (1) fewer providers to oversee; (2) registrants are protected by the schools from "fly-by-night" schemes; (3) schools will have more integrity, limiting the "selling" of certificates; (4) schools are responsible for offering only approved continuing education; and (5) the department can verify what schools are offering through random audit. Additionally, the commenter is concerned that registrants may register and pay for a certain workshop, seminar, or activity and attend believing he or she will receive credit for the workshop. The registrant may not learn until the time of audit that the activity will not be accepted by the department for credit.

Response: The department disagrees. The Act authorizes the department to recognize, prepare, or administer continuing education programs for its registrants. Many factors were considered in establishing the continuing education requirements. The department reviewed continuing education requirements for other professions during its consideration and establishment of requirements for approximately 17,000 registered massage therapists. The majority of those reviewed allow a great deal of flexibility with regard to continuing education and allow the regulated persons the ability to seek out workshops, programs, and events of personal interest in areas related to the profession. To require that the hours be offered by and obtained through registered massage schools may not afford the same flexibility for massage therapists in rural areas to complete the requirements. Additionally, the continuing education requirements proposed do not create a burden on the department for the recognition, preparation, or administration of the requirements. The flexibility of choosing programs of interest also creates a responsibility on the part of each registrant to ensure the activities he or she chooses will be accepted by the department. The department will maintain lists of pre-approved providers, massage schools, and approved programs, and make the lists available to registrants. No change was made as a result of the comment.

Comments: Concerning §141.25, a commenter supported the need to monitor continuing education through a random audit system, but is concerned that the process as proposed would allow registrants to wait until the last minute and if not selected for audit would be able to renew without complying with the continuing education requirements. If the notice of audit is sent with the renewal application, there is enough time for the registrant to take a quick workshop, complete the audit satisfactorily, and renew on time. The commenter suggests instead that each registrant sign a statement of assurance at the time of renewal and then the notice of audit be sent with the annual renewal card.

Response: The department disagrees. Each registrant will sign a document at the time of renewal indicating whether he or she has completed the hour requirements and listing the activity or activities attended. If a registrant receives notice that he or she has been selected for audit, the registrant will also include copies of certificates of attendance. The purpose of renewal is to ensure that a registrant has met all requirements of law to continue to hold a registration. If an audit after the renewal showed the registrant had failed to meet the continuing education requirements, the department would then be required to pursue disciplinary action against the registrant, instead of simply denying the renewal. No change was made as a result of the comment.

Comment: Concerning §141.28, one commenter is concerned that the language requiring each massage therapy educational program to designate a person as the director of the program is not consistent with the Act which allows the 300 hour course of instruction be taught by a single massage therapy instructor.

Response: The department disagrees. Section 141.28(a) clearly states that in the case of a massage therapy instructor operating the educational program independently, the director is the massage therapy instructor. No change is made as a result of this comment.

Comment: Concerning §141.29(a)(3), four commenters recommended increasing the training hours for massage therapy instructors; with one suggesting the department require two (2) years and 1,000 hours of hands-on practice and one suggesting 1,000 hours in a one (1) year period.

Response: The department disagrees. The new rules did increase the requirements for massage therapy instructors. Previously, instructors have been required to attend a course on or have experience in teaching adult learners, but no hour requirement was established. Massage therapists were also required to be registered as massage therapists for two years or one year if licensed or registered in another health care field, such as nursing, physical therapy, athletic training, etc, but did not require that the massage therapist engage in the practice of massage therapy. The new rules for massage therapy instructors require a registrant to be registered a minimum of one year, with at least 250 hours of hands-on experience, and to have completed a 30-hour course in teaching adult learners or document equivalent experience or training. Additionally, §141.29(a)(4) sets out that after January 1, 2002, applicants for massage therapy instructor will have to complete a 30-hour course in teaching adult learners. The department will not accept an equivalent experience or training after January 1, 2002. No changes were made as a result of this comment.

Comment: Concerning §141.29(a)(3), one commenter indicated concern that the proposed rules allow that hands-on practice accumulated during the time a person holds a temporary registration could be used to meet the requirements, although the temporary registration is issued prior to the time the person has satisfactorily sat for the massage therapy examination which is required for registration.

Response: The department agrees. A temporary registration is issued to individuals after completion of the 300 hour educational requirement and allows individuals to work until the next examination is offered. The temporary registration expires when the examination results are determined and persons who fail are not eligible for an extension or a second temporary registration. The proposed language has been modified to reflect that the 250 hours of hands-on massage required to be eligible for a massage therapy instructor must be obtained after the person has been issued a permanent registration.

Comment: Concerning §141.29(a)(4), one commenter stated that a 20 hour course in teaching adult learners is inadequate. The commenter also suggested a need for the department to clarify that demonstrated competency in teaching adult learners through experience in formal educational setting should include the preparation of lesson plans and other activities associated with formal education.

Response: The department agrees and has modified the proposed language to require the completion of a course in teaching adult learners that is at least 30 clock hours and to reflect that to demonstrate competency an applicant for massage therapy instructor must verify experience in the development of lesson plans and assessment methods.

Comment: Concerning §141.30(b), one commenter requested the department needs to tighten up the fiduciary responsibility of massage schools and require certified audits rather than compilations.

Response: The department agrees; however, the language in §141.30(a) and (b) does require audited financial documents for all business entities other than sole proprietorships and does not allow for compilations. No change was made as a result of the comment.

Comment: Concerning §141.30(e), one commenter suggested requiring financial statements at the time of renewal which are audited and certified by certified public accountants or public accountants are cost prohibitive for any but the largest massage schools and educational programs. The commenter also indicates that reviewed financial statements are only of value if the owner of the educational program is honest and truthful with regard to the information provided to the accountant. The commenter suggests financial reports do not protect the public from fraudulent business activities and that the requirement actually penalizes the public by increasing the cost of massage training programs.

Response: The department disagrees. Financial statements and records are required so the department can reasonably determine that a massage school or educational training program is solvent. The department understands that the submission of financial records does not always guarantee a massage school will not close without warning to the students; however, in most cases, it is a fair and reasonable gauge of a school's financial stability. No change was made as a result of the comment.

Comment: Concerning §141.31, one commenter suggested using the Texas Education Agency model for change of ownership requirements to ensure that the continuity of the training programs exists when a massage school is sold.

Response: The department disagrees. The department acknowledges that previous requirements created a cumbersome process for the sale of a massage school and that transitions from one owner to another created difficulties. However, the department believes the proposed language, modeled after the requirements for proprietary schools, does allow for a smoother transition at the time of sale and allows the department flexibility in processing changes of ownership. No change was made as a result of the comment.

Comment: Concerning §141.34, one commenter suggested that some direction should be provided to massage schools to ensure that students are able to complete the educational program in the time set out in the pre-enrollment information. The commenter also recommended restoring language which prohibited evening classes from extending beyond a reasonable time.

Response: The department agrees and has added subsection (i) to §141.34 to ensure that students can complete the educational program in the time stipulated and that evening classes do not extend beyond a reasonable time.

Comment: Concerning §141.34(h), one commenter indicated that massage schools with two or more locations in close proximity, such as in major metropolitan areas, often have students who enroll at one location for the classroom hours, but want to attend the internship portion of the educational program at another site because the hours work better for that student's schedule, because it is closer to the student's residence but the classroom hours were not scheduled at a time that met the student's schedule, or for a variety of other reasons. The commenter suggests that students should be allowed that flexibility, if possible. Another commenter suggests deleting the subsection because it could create a problem for students if a school had to close due to fire or insolvency causing the student to start over at another school.

Response: The department agrees that students should be allowed some flexibility when it is in their interest to do so and when it does not cause an undue burden on a school; however, the department is also concerned that a student be provided with the training at the location for which he or she enrolls if the student does not choose to do otherwise. The language in §141.34(h) has been modified to allow students to complete the internship portion of the 300 hour training program at a different location if both the student and the massage school agree.

Comment: Concerning §141.34(h), one commenter states that location leases can and are likely to be up for renewal at times that do not coincide with the completion of a class and that leases are not always renewable, in which case the students that are currently enrolled would not be able to complete the program at that location. The commenter asks for clarification as to whether this subsection requires an educational program to terminate that class and issue refunds of the unearned tuition.

Response: The department disagrees that the rule needs clarification. Section 141.33(e) prohibits massage schools, educational training programs, and instructors from providing instruction of the 300 hour course of instruction at any location that has not been approved by the department. It is the responsibility of the massage school or the educational program to negotiate a lease in a timely manner so that approval of a new location can be accomplished without discontinuing classes. No change was made as a result of the comment.

Comment: Concerning §141.35, one commenter suggests that a massage therapy instructor who instructs the 300 hour course of instruction independently should be allowed to hire additional instructors to teach advanced course work.

Response: The department agrees. No modification to the language in §141.35 is necessary because the rules does not prohibit independent instructors who are approved by the department to instruct the 300 hour course of instruction required for registration from having other instructors teach advanced courses at the location of the educational program.

Comment: Concerning §141.35(b), one commenter suggested the department clarify the word "diagnosis" to indicate that the practice of evaluation (assessment) and observation are fundamentally different skills and should not be prohibited in the training or practice of massage therapy.

Response: The department disagrees. The Act, §455.002(b), clearly states that therapy or therapeutic procedures related to massage do not include the diagnosis or treatment of illness or disease; or any service or procedure for which a license to practice medicine, chiropractic, physical therapy, or podiatry is required by law. It is appropriate to clarify this with regard to advanced training. No change was made as a result of the comment.

Comment: Concerning §141.37(a)(16)(A), one commenter asked that if a person who enrolls in the massage therapy educational program would be permanently barred from registration if at a young adult age, the person was convicted of public indecency even though rehabilitation and adequate time to mature has transpired.

Response: The department responds that public indecency and public lewdness are listed in the Penal Code as sexual offenses and the statutory language does indicate a permanent bar to registration. No change was made as a result of the comment.

Comment: Concerning §141.42(e), one commenter suggested the department clarify how the required termination of students after absences of 15% of the total clock hours in a program should be applied to students who enroll in portions of the 300 clock hour education program required for registration.

Response: The department agrees and has modified the language to clarify that students must be terminated if they accumulate absences of more than 15% of the total clock hours in a program or 15% of a portion of the program if the student enrolls in less than the total 300 hours.

Comment: Concerning §141.43(g)(2), one commenter suggested changing the maximum ratio of 35 pupils to 1 instructor to 36 pupils to 1 instructor to be consistent with Texas Education Agency requirements.

Response: The department agrees and has modified the language. The maximum ratios in §141.43(g)(1) and (2) are recommendations and the language in subsection (g) specifically allows each massage therapy educational program to vary the ratios to conform to specific conditions.

Comments: Concerning §141.54 which establishes exemptions to registrations for massage therapy establishments, a commenter suggests creating exemptions for chair massage being offered on-site in which the business has no fixed location.

Response: The department disagrees. The Act, §455.155(c) allows the department to establish exemptions to registration for massage establishments if the advertising or provision of massage therapy services is incidental to the primary enterprise of a person or business enterprise. Massage therapy services provided by massage therapists are not incidental to the primary enterprise of the therapist. No change was made as a result of the comment.

Comment: Concerning §141.54(9) and (10), a commenter noted that primary athletic and fund raising functions may reasonably last more than 24 hours, such as telethons or public television fund drives. The commenter also suggested changing the reference to registered massage therapy school in paragraph (10) to read massage therapy educational program.

Response: The department responds that athletic and fund-raising functions that anticipate lasting more than 24 hours in a calendar year are not prohibited from requesting exemptions, which will be considered at the time of request. No modification to the rule is necessary as a result of the comment. Concerning the exemption for registered massage therapy schools, the language in paragraph (10) has been modified to reference massage therapy educational program.

The commenters were the Texas Massage School Coalition, the Texas Association of Massage Therapists, and numerous individuals. All commenters were not against the rules in their entirety, however, they expressed concerns, asked questions and suggested recommendations for change as discussed in the summary of comments.

25 TAC §§141.1, 141.3 - 141.23

The repeals are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101169

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter A. THE DEPARTMENT

25 TAC §§141.1 - 141.3

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.1.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Words and terms defined in the Texas Occupations Code, Chapter 455 (the Act relating to the regulation of massage therapy) shall have the same meaning in this chapter as assigned in the Act.

(1)

Act--Texas Occupations Code, Chapter 455 and Texas Revised Civil Statutes, Article 4512k, relating to the regulation of massage therapists, massage therapy instructors, massage therapy schools and massage establishments.

(2)

Anatomy--The study of the structure of the human body including the following areas: bones, joints and muscles, the skin, blood and blood vessels, cells, tissues and membranes, the heart, the brain, spinal cord and nerves, the lymphatic system, the digestive system, the respiratory system, the urinary system, the reproductive system, glands and hormones.

(3)

Business practices and professional ethics standards--The study of standard bookkeeping and accounting practices, office practices, and advertising, and ethical guidelines for massage therapists established by law or the department.

(4)

Client--An individual or patron seeking or receiving massage therapy services.

(5)

Department--Texas Department of Health.

(6)

Health and hygiene--The study of recognized methods of sanitation and cleanliness including prophylaxis or disease prevention as applied to massage therapy services and current knowledge of elements of healthy life styles.

(7)

Hydrotherapy--The use of generally accepted methods of external application of water for its mechanical, thermal, or chemical effect.

(8)

Instructor--A person employed at a registered massage school who instructs one or more students in any section of the course of instruction, other than Swedish massage therapy techniques or the internship.

(9)

Massage therapy--The manipulation of soft tissue by hand or through a mechanical or electrical apparatus for the purpose of body massage. The term includes effleurage (stroking), petrissage (kneading), tapotement (percussion), compression, vibration, friction, nerve strokes, and Swedish gymnastics. Massage therapy may include the use of oil, salt glows, heat lamps, hot and cold packs, or tub, shower, or cabinet baths. Equivalent terms for massage therapy are massage, therapeutic massage, massage technology, myo-therapy, body massage, body rub, or any derivation of those terms. Massage therapy is a health care service when the massage is for therapeutic purposes. The terms "therapy" and "therapeutic" do not include diagnosis, the treatment of illness or disease, or any service or procedure for which a license to practice medicine, chiropractic, physical therapy, or podiatry is required by law. Massage therapy does not constitute the practice of chiropractic.

(10)

Massage therapy educational program--The supervised 300 hour course of instruction described in the Act, §455.156, required for registration provided by a registered massage school or massage therapy instructor.

(11)

Massage therapy instructor--A registered massage therapist who provides to one or more students instruction approved by the department in massage therapy.

(12)

Owner--An owner is, in the case of a massage therapy educational program or establishment, an individual, a partnership and any partners, a corporation, or any other legal business entity.

(13)

Physiology--The study of the normal vital processes of the human body including the processes of cells, tissues, and organs including the contractibility of muscle tissue; coordination through the nervous system; digestion; circulatory reproduction; and secretions.

(14)

Registrant--A person or entity registered under the Act as a massage therapist, massage school, massage therapy instructor or massage establishment.

(15)

State approved educational institution--An institution which is approved by the Texas Education Agency or which is an institution of higher education as defined in the Texas Codes Annotated, Texas Education Code, Chapter 61 or a higher education institution approved by a similar agency in another state.

(16)

Swedish gymnastics--Passive and active joint movements, nonspecific stretches, passive and active exercise, or any combination of these.

(17)

Swedish massage therapy techniques--The manipulation of soft tissue utilizing effleurage (stroking), petrissage (kneading), tapotement (percussion), compression, vibration, friction, nerve stroke, and Swedish gymnastics.

§141.2.Fees.

(a)

All fees are non-refundable and shall be submitted in the form of a personal check, certified check or money order made payable to the Texas Department of Health. Cash payments may be made in person only.

(b)

The fees related to the registration of massage therapists are as follows:

(1)

application fee (includes temporary & initial registration) - $53;

(2)

examination fee - to be determined by the agency approved by the department to administer the examination plus an administrative fee determined by the department at the time the applicant is scheduled for an examination;

(3)

re-examination fee - to be determined by the agency approved by the department to administer the examination plus an administrative fee determined by the department at the time the applicant is to be rescheduled for an examination;

(4)

written translation fee - the actual costs to the department of translating or having the examination translated into a foreign language, including salaries, travel expenses, and out of pocket expenses plus an administrative fee determined by the department;

(5)

examination review fee:

(A)

practical and written - $40;

(B)

practical only - $25;

(C)

written only - $15;

(6)

annual renewal fee - $40;

(7)

late renewal fees;

(A)

registration expired for 90 days or less - $60; and

(B)

registration expired more than 90 days but less than one year - $80.

(c)

The fees related to massage establishments are as follows:

(1)

massage establishment application and registration fee - $150;

(2)

annual renewal fee - $150;

(3)

late renewal fees;

(A)

registration expired 90 days or less - $225; and

(B)

registration expired more than 90 days but less than one year - $300.

(d)

The fees related to massage therapy educational programs (massage schools and massage therapy instructors offering the 300 hour course of instruction for registration) are as follows:

(1)

application and registration fee (includes inspection) - $1,400;

(2)

annual renewal fee (includes inspection) - $1,000; and

(3)

registration fee for a change of instructional address and additional locations separate from the main campus (includes inspection) - $375.

(e)

The fees related to massage therapy instructors are as follows:

(1)

registration fee - $100;

(2)

annual renewal fee - $100;

(3)

late renewal fees for massage therapy instructors;

(A)

registration expired for 90 days or less - $150; and

(B)

registration expired for more than 90 days but less than one year -$200;

(f)

Annual approval fee for pre-approved providers for continuing education - $100.

(g)

Registration certificate and identification card replacement fee - $20.

(h)

Returned check fee - $25.

(i)

Fee for name change - $20.

§141.3.Processing Applications.

(a)

The following periods of time shall apply from the date of receipt of an application until the date of issuance of a written notice that the application is complete and accepted for filing or that the application is deficient and additional specific information is required. A written notice stating that the application has been approved may be sent in lieu of the notice of acceptance of a complete application. The time periods are as follows:

(1)

letter of acceptance of application for massage therapist registration or temporary registration - 20 working days;

(2)

letter of application or renewal deficiency - 20 working days;

(3)

issuance of registration renewal after receipt of documentation of all renewal requirements - 10 working days; and

(4)

letter of acceptance or notice of deficiency of application for massage school, massage therapy instructor, or massage establishment registration - 30 working days.

(b)

The following periods of time shall apply from the receipt of the last item necessary to complete the application until the date of issuance of written notice approving or denying the application. The time periods for denial include notification of the proposed decision and of the opportunity, if required, to show compliance with the law and of the opportunity for a formal hearing. An application is not considered complete until the required examination has been successfully completed by the applicant. The time periods are as follows:

(1)

letter of approval for examination - 20 working days;

(2)

initial letter of approval for registration - 30 days;

(3)

letter of denial of registration - 30 days; and

(4)

issuance of registration renewal after receipt of documentation of all renewal requirements - 10 working days.

(c)

In the event an application is not processed in the time periods stated in subsection (a) of this section, the applicant has the right to request reimbursement of all fees paid in that particular application process. If the department does not agree that the time period has been violated or finds that good cause existed for exceeding the time period, the request will be denied. Good cause for exceeding the time period is considered to exist if the number of applications for registration and registration renewal exceeds by 15% or more the number of applications processed in the same calendar quarter the preceding year; another public or private entity relied upon by the department in the application process caused the delay; or any other condition exists giving the department good cause for exceeding the time period.

(d)

If a request for reimbursement under subsection (c) of this section is denied by the department, the applicant may appeal to the commissioner of the department for a timely resolution of any dispute arising from a violation of the time periods. The applicant shall give written notice to the commissioner at the address of the department that he or she requests full reimbursement of all fees paid because his or her application was not processed within the applicable time period. The administrator shall submit a written report of the facts related to the processing of the application and of any good cause for exceeding the applicable time period. The commissioner shall provide written notice of the commissioner's decision to the applicant and the administrator. An appeal shall be decided in the applicant's favor if the applicable time period was exceeded and good cause was not established. If the appeal is decided in favor of the applicant, full reimbursement of all fees paid in that particular application process shall be made.

(e)

The time periods for contested cases related to the denial of registration or registration renewals are not included within the time periods stated in subsection (a) of this section. The time period for conducting a contested case hearing runs from the date the department receives a written request for a hearing and ends when the decision of the department is final and appealable. A hearing may be completed within one to four months, but may extend for a longer period of time depending on the particular circumstances of the hearing.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101170

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter B. CODE OF ETHICS

25 TAC §§141.5 - 141.7

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.5.General Ethical Requirements.

(a)

A registrant shall not make deceptive, untrue, or fraudulent representations in the practice of massage or employ a trick or scheme in the practice of massage, including, but not limited to, warranty of results of such services and false claims of proficiency in any field.

(b)

A registrant shall not use a work area, equipment or clothing that is unclean or unsanitary.

(c)

A registrant shall not practice massage therapy fraudulently, with gross incompetence, with gross negligence on a particular occasion, or with negligence or incompetence on more than one occasion.

(d)

A registrant shall bill clients or third parties for only those services actually rendered or as agreed to by mutual understanding at the beginning of services or as later modified by mutual agreement.

(e)

For each client, a registrant shall keep accurate records of the dates of massage therapy services, types of massage therapy and billing information. Such records must be maintained for a minimum of two years.

(f)

A registrant must obtain the written consent of a parent or guardian to provide massage therapy services to a person under the age of 17.

(g)

On the written request of a client, a client's guardian, or a clients parent if the client is a under the age of 17, a registrant shall provide a written explanation of the charges for massage therapy services previously made on a bill or statement of the client. This requirement applies even if the charges are to be paid by a third party.

(h)

A registrant shall provide an initial consultation to each client(s) prior to the first massage session and obtain the signature of the client on the consultation document. The consultation document shall include:

(1)

the type of massage techniques the registrant anticipates using during the massage therapy session;

(2)

the parts of the client's body that will be massaged or the areas of the client's body that will be avoided during the session, including indications and contraindications;

(3)

a statement that the registrant shall not engage in breast massage of female clients without the written consent of the client;

(4)

a statement that draping will be used during the session, unless otherwise agreed to by both the client and the registrant;

(5)

a statement that if uncomfortable for any reason, the client may ask the registrant to cease the massage and the registrant will end the massage session; and

(6)

the signature of both the client and the registrant.

(i)

If the client's reason for seeking massage changes at any time and any of the information in subsection (h)(1)-(4) of this section is modified, the registrant must provide an updated consultation reflecting any changes and modifications to the techniques used or the parts of the client's body to be massaged.

(j)

A registrant shall not abuse alcohol or drugs in any manner which detrimentally affects the provision of massage therapy or massage therapy instruction.

(k)

A registrant may not persistently or flagrantly overcharge or over treat a client.

(l)

A registrant shall not practice in an unregistered massage establishment or massage school.

(m)

A registrant shall not allow an unregistered person to engage in activity for which registration is required.

(n)

A registrant shall not provide false information on material submitted to the department.

(o)

A registrant shall not interfere with a department investigation by the willful misrepresentation of facts to the department or its authorized representative, or by the use of threats or harassment against any person.

(p)

A registrant shall comply with any formal order issued by the department relating to the registrant.

(q)

A registrant shall be subject to disciplinary action by the department if the registrant is issued a public letter of reprimand, is assessed a civil penalty by a court, or has an administrative penalty imposed by the attorney general's office under the Texas Code of Criminal Procedure, §56.31.

(r)

A registrant shall notify each client of the name, mailing address, and telephone number of the department for the purpose of directing complaints to the department by providing notification:

(1)

on each written contract for services of a registrant;

(2)

on a sign prominently displayed in the primary place of business of each registrant;

(3)

on a bill for service provided by a registrant to a client or third party; or

(4)

by other written and documented method.

(s)

A registrant shall keep his or her registration file updated by notifying the department, in writing, of changes of names, address, telephone number and employment.

§141.7.Advertising.

(a)

A person, including a massage therapy instructor, a massage school, a massage therapist, or massage establishment that is not registered under the Act shall not use the word "massage" on any sign, display, or other form of advertising unless the person is expressly exempt from the registration requirements of the Act. Under no circumstances may a sexually oriented business use the word "massage" on any sign or other form of advertising.

(b)

A registrant shall not use advertising that is false, misleading, or deceptive or that is not readily subject to verification. False, misleading, or deceptive advertising or advertising that is not readily subject to verification includes advertising that:

(1)

makes a material misrepresentation of fact or omits a fact necessary to make the statement as a whole not materially misleading;

(2)

makes a representation likely to create an unjustified expectation about the results of a health care service or procedure;

(3)

compares a health care professional's services with another health care professional's services unless the comparison can be factually substantiated;

(4)

contains a testimonial;

(5)

causes confusion or misunderstanding as to the credentials, education, or registration of a health care professional;

(6)

advertises or represents that health care insurance deductibles or copayments may be waived or are not applicable to health care services to be provided if the deductibles or copayments are required;

(7)

advertises or represents that the benefits of a health benefit plan will be accepted as full payment when deductibles or copayments are required;

(8)

makes a representation that is designed to take advantage of the fears or emotions of a particularly susceptible type of client; or

(9)

advertises or represents in the use of a professional name, title or professional identification that is expressly or commonly reserved to or used by another profession or professional.

(c)

When an assumed name is used in a person's practice as a massage therapist or massage establishment, the legal name or registration number of the massage therapist must be listed in conjunction with the assumed name. An assumed name used by a massage therapist must not be false, misleading, or deceptive.

(d)

A massage therapy educational program shall not make false, misleading, or deceptive statements concerning the activities or programs of another massage therapy educational program.

(e)

A massage therapy educational program shall not maintain, advertise, solicit for or conduct any course of instruction intended to qualify a person for registration as a massage therapist without first obtaining registration from the department.

(f)

Advertisements by a massage therapy educational program seeking prospective students must clearly indicate that training is being offered, and shall not, either by actual statement, omission, or intimation, imply that prospective employees are being sought.

(g)

Advertisements seeking prospective students must include the full and correct name and registration number of the massage therapy educational program.

(h)

No statement or representation shall be made to prospective or enrolled students that employment will be guaranteed upon completion of any program or that falsely represents opportunities for employment.

(i)

No statement shall be made by a massage therapy educational program that it has been accredited unless the accreditation is granted from a nationally recognized accrediting agency or organization. The name of the accrediting agency or organization must be used in any accreditation statement.

(j)

No massage therapy educational program shall advertise as an employment agency under the same name or a confusingly similar name or at the same location as the educational program. No representative shall solicit students for a program through an employment agency.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101171

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter C. MASSAGE THERAPISTS

25 TAC §§141.10 - 141.17

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.11.Application Procedures and Documentation.

(a)

Unless otherwise indicated, an applicant for registration as a massage therapist must submit all required information and documentation of credentials on official department forms. Documents must be submitted on or before the examination deadline set by the department to be eligible for an examination. Applications which are received incomplete or late may cause the applicant to miss the examination deadline.

(b)

The application fee must accompany the application form. The department will not consider an application as officially submitted until the applicant pays the application fee.

(c)

If the application is incomplete, the department will send a notice listing any additional materials required to complete the application. An application not completed within 30 days after the date of the department's notice may be voided.

(d)

Applicants must provide the following information on official department forms, unless otherwise requested by the department:

(1)

specific information regarding personal data, social security number, birth date, place of employment, other state licenses and certifications held, misdemeanor and felony convictions, educational and training background, and work experience;

(2)

a statement that the applicant has read the Act and this chapter and agrees to abide by them;

(3)

a statement that the applicant, if issued a registration certificate, shall return the certificate and identification cards to the department upon the expiration, revocation or suspension of the registration;

(4)

a statement that the applicant understands that fees and materials submitted in the registration process are nonrefundable and nonreturnable;

(5)

a statement that the information in the application is truthful and that the applicant understands that providing false and misleading information on items which are material in determining the applicant's qualifications may result in the voiding of the application and failure to be granted any registration or the revocation of any registration issued; and

(6)

the applicant's signature.

(e)

Applicants must submit official transcript(s) of all relevant course work. A copy of an official transcript that has been notarized as a true and exact copy of an original may be submitted in lieu of the official transcript.

(f)

Applicants applying under §141.10(a)(3) of this title (relating to Qualifications for Registration as a Massage Therapist) must submit two or more of the following to the department on official department forms, if required:

(1)

an employer affidavit;

(2)

client affidavit(s) which shall include the client's name, address, phone number, and copies of receipt(s) for massage therapy services rendered. This information shall be used for no other purpose than to verify the five-year experience requirements;

(3)

W-2 form(s) or any other Internal Revenue Service form which reflects receipt of payment for massage therapy services;

(4)

an affidavit of referral for massage therapy from a licensed health care professional; or

(5)

any other documentation acceptable to the department.

§141.12.Temporary Registration.

(a)

A temporary registration shall be issued to an individual who meets the educational and experience requirements as defined in §141.10 of this title (relating to Qualifications for Registration as a Massage Therapist) and who has not previously been issued a temporary registration. A temporary registration may be issued to persons who qualify under subsection (e) of this section.

(b)

A person must file a complete application in accordance with §141.11 of this title (relating to Application Procedures and Documentation).

(c)

A temporary registration is valid for six months, until the applicant is issued a massage therapy registration after successful completion of the first examination for which the applicant is eligible, or until the applicant is notified by the department that he or she has failed the first examination for which the applicant was eligible, whichever is later, and is not subject to renewal or extension for any reason.

(d)

A person whose temporary registration has expired and who has never been registered as a massage therapist is not eligible to receive another temporary registration.

(e)

A person who has been registered as a massage therapist and allowed the registration to expire, may be eligible for a temporary registration upon submission and approval of a new application for registration. The expiration of a temporary registration issued under this subsection will be in accordance with subsection (c) of this section.

§141.15.Massage Therapist Registration Certificates.

(a)

The department will send each applicant whose application has been approved and who has passed the written and practical examination, a registration certificate and identification card containing a registration number. Registration certificates and identification cards remain the property of the department and must be surrendered to the department on demand.

(b)

A certificate must be displayed in an appropriate and public manner in the primary office or place of employment of the registrant. In the absence of a primary office or place of employment, the registrant shall carry a current identification card.

(c)

Neither the registrant nor anyone else shall display a photocopy of a certificate or carry a photocopy of an identification card in lieu of the original document.

(d)

Neither the registrant nor anyone else shall make any alteration on a certificate or identification card issued by the department.

(e)

The department will replace a lost, damaged, or destroyed certificate, temporary registration certificate, or identification card upon written request from a registrant and payment of the appropriate replacement fee. The request shall include a statement detailing the loss or destruction of the original certificate or identification card, or be accompanied by the damaged certificate or card.

(f)

Certificates and cards that may have not been received by a registrant may be replaced at no charge if the registrant notifies the department in writing and within 30 days of the date the certificate or card was issued.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101172

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter D. CONTINUING EDUCATION REQUIREMENTS AND DOCUMENTATION

25 TAC §§141.20 - 141.25

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.21.Acceptable Continuing Education.

(a)

Acceptable continuing education includes attendance at and completion of department approved or recognized programs (other than the 300 hour course of instruction required for registration), institutes, seminars, workshops, state or national conferences, advanced course work, or college and university academic courses that are:

(1)

directly related to the theory or clinical application of theory pertaining to the practice of massage therapy and the manipulation of soft tissue, business practices, professional ethics, anatomy, physiology, hydrotherapy, and health and hygiene;

(2)

advanced bodywork techniques acceptable to the department; and

(3)

designed to increase and enhance professional knowledge, skills, or competence in the practice of massage therapy.

(b)

Continuing education approved or recognized by the department must be developed and presented by qualified persons.

(1)

Massage therapy techniques and courses involving the manipulation of soft tissue must be taught or presented by a massage therapy instructor. Advanced bodywork techniques must be taught or presented by persons with licensure, registration, or education in the technique being presented.

(2)

Courses, other than techniques, may be taught or presented by persons with licensure, registration, education or practical experience in the subject being presented.

(3)

Out-of-state instructors or presenters offering continuing education in Texas on massage therapy techniques or involving the manipulation of soft tissue must be in compliance with any licensure, registration or certification requirements for massage therapists and massage therapy instructors in the instructor or presenter's home state or be licensed to practice medicine, chiropractic, athletic training, physical therapy, or nursing. If the instructor or presenter's home state does not have licensure, registration or certification requirements for massage therapists and massage therapy instructors, the instructor or presenter must provide documentation of education or practical experience specific to the continuing education being offered.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101173

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter E. MASSAGE SCHOOLS AND MASSAGE THERAPY INSTRUCTORS

25 TAC §§141.26 - 141.47

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.29.Massage Therapy Instructors.

(a)

A massage therapy instructor shall instruct the 125 hours of Swedish massage therapy and the internship portion of the required course of instruction. To qualify for registration as a massage therapy instructor, a person shall:

(1)

be a registered massage therapist (not a temporary registration);

(2)

have a high school diploma, a general equivalence diploma or a transcript from an accredited college or university showing successful completion of at least 12 semester hours;

(3)

submit a statement of assurance that the registrant has been engaged in the practice of massage therapy for at least one-year and has conducted 250 hours of hands-on experience (does not include internship hours). Hours accumulated while holding a provisional registration can be applied to the requirements of this paragraph; and

(4)

complete a 30-hour course on teaching adult learners or demonstrate competency in teaching adult learners. Courses attended may include an instructional certification program, a college level course in teaching adult learners, a continuing education course in teaching adult learners, or an advanced program approved by the department in teaching the course of instruction. Demonstrated competency means teaching adult learners varied subjects in a formal educational setting, including the development of lesson plans and assessment methods, which may be verified by a letter of reference. Effective January 1, 2002, applicants for registration as a massage therapy instructor must complete the 30-hour course on teaching adult learners.

(b)

Persons qualified to instruct courses other than massage therapy technique courses, must hold:

(1)

a baccalaureate or higher degree from an accredited college or university that includes:

(A)

satisfactory completion of nine semester hours or 12 quarter hours in subjects related to the subject area to be taught; or

(B)

have a minimum of one year of practical experience within the last ten years in the subject area to be taught;

(2)

an associate degree from an accredited college, university, or recognized post- secondary institution and must have:

(A)

a minimum of one year of practical experience within the last ten years in the subject area to be taught and the associate degree must include satisfactory completion of nine semester hours or 12 quarter credit hours in subjects related to the subject area to be taught; or

(B)

a minimum of two years of practical experience within the last 10 years in the subject area to be taught; or

(3)

a high school diploma, general equivalency degree (GED), or proof of satisfactory completion of relevant subject(s) from a recognized post-secondary institution and practical experience of a minimum of two years within the last ten years in the subject area to be taught.

(c)

Each massage therapy instructor and instructor employed by a registered massage school shall be evaluated by the school annually. A report of the evaluation shall be available for review by the department.

(d)

Registered massage schools shall ensure continuity of instruction through the reasonable retention of qualified instructors.

§141.32.Registration Renewal.

(a)

When issued, the registration of a massage therapy educational program is valid for one year beginning on the date of issuance of the initial registration. A registrant must renew the registration annually.

(b)

The renewal date of a registration shall be the last day of the month in which the registration was originally issued.

(c)

A complete application for renewal of a registration shall consist of:

(1)

the annual renewal fee;

(2)

the completed application for renewal;

(3)

the complete annual financial statements for the most recent fiscal year, demonstrating the massage therapy educational program is financially stable and capable of fulfilling its commitments for instruction; and

(4)

any other information deemed necessary by the department to determine compliance with the Act and this chapter.

(d)

At least 30 days prior to the registration expiration date, the department shall send a notice of the expiration date and the amount of the renewal fee due. The notice will be mailed to the address in the department's records. Each massage therapy educational program must complete and return the registration renewal form to the department with the required renewal fee.

(e)

The registration renewal forms for massage therapy educational programs shall require the address, the names of the owner/operator of the educational program, a statement of all misdemeanor and felony offenses for which the registrant or owner or operator have been convicted, entered a plea of nolo contendere or guilty, or received deferred adjudication.

(f)

A massage therapy educational program has renewed the registration when it has mailed the renewal form and the required renewal fee to the department prior to the expiration date of the registration. The postmark date shall be considered the date of mailing. Massage therapy educational programs should allow three to four weeks for the department to receive the registration renewal fees and documentation, and print the annual certificate.

(g)

The department shall issue a registration renewal certificate to a massage therapy educational program once all requirements for renewal are met.

(h)

A massage therapy educational program whose registration has expired for not more than one year may renew the registration by submitting to the department the renewal form and the fee. A massage therapy educational program that continues to operate with an expired registration may be subject to disciplinary action. Course hours taught during the time the registration is expired will not apply toward the 300 hour course of instruction. The postmark date shall be considered the date of mailing.

(i)

A massage therapy educational program whose registration has expired for more than one year from the expiration date may not renew the registration.

§141.33.Locations.

(a)

A certificate of registration shall be issued for each approved instructional location(s). Instruction shall not be provided at an additional location until the department has issued a certificate of registration for the additional location.

(b)

A massage therapy educational program shall obtain approval for any additional location(s) where the 300 hour supervised course of instruction will be offered. All policies and curriculum of the original location apply to an additional location(s).

(c)

A request for registration of an additional location shall include the appropriate fee and the following documents:

(1)

fire inspection report, if required by the city or county;

(2)

certificate of occupancy;

(3)

lease agreement; and

(4)

detailed floor plan.

(d)

The department may approve a massage therapy educational program to begin operation at an additional location prior to inspection if an inspection of the location has been conducted by the department within the preceding 90 days or if the instruction will be conducted at a public facility, such as a hotel, hospital, university, college, etc.

(e)

A request for a change of instructional location of a massage therapy educational program must be filed and approved by the department before the new location is used. Upon approval of a change of instructional location, no course work may be provided at the previous location.

(f)

Any refunds due under the cancellation and refund policy must be made before the department will approve an additional location or a change of location.

§141.34.Curriculum and Internship for the Basic Course of Instruction.

(a)

Each massage therapy educational program shall follow the curriculum prescribed by the department for the 300 hour supervised course of instruction.

(b)

A student must complete the first 250 hours of the supervised course of instruction before the student is eligible to enter the internship program.

(c)

A classroom hour shall include at least 50 clock minutes of actual classroom time and may include a maximum of 10 minutes of break time. Break time for hours which are taught consecutively in one sitting (i.e., in one evening) may be aggregated into a single break time during those consecutive hours, not to exceed 3 hour blocks of instruction, but not at the end of those hours. The 10 minutes of break time may not be accumulated and used in lieu of lunch or dinner breaks.

(d)

An instructor must be physically present with the student(s) during the classroom hours taught by that instructor.

(e)

An internship program must provide a student with a minimum of 40 hours of hands-on massage therapy experience at the location of the student's enrollment. A student enrolled at an additional location shall not be required to travel to another location to complete the internship.

(f)

During the hands-on experience, a massage therapy instructor must be available on the premises of the educational program and be immediately available to the student(s).

(g)

A massage therapy educational program shall not require a student to advertise for clients or to obtain clients as part of the internship program. At the student's option and with the educational program's permission, a student may obtain clients for the student's hands-on massage therapy experience.

(h)

A massage therapy educational program must provide all 300 hours of the basic course of instruction at the site where the student enrolled, unless otherwise agreed to by both the student and the massage therapy educational program.

(i)

A massage therapy educational program shall schedule classes so that the students will be able to complete the program during the length of time stipulated in the preenrollment information. No evening class may be scheduled to extend beyond a reasonable time.

§141.40.Cancellation and Refund Policy.

(a)

Each massage therapy educational program shall develop and implement a cancellation and refund policy which must provide a full refund of all monies paid by a student if:

(1)

the student cancels the enrollment agreement within 72 hours (until midnight of the third day excluding Saturdays, Sundays, and legal holidays) after the enrollment contract is signed by the prospective student;

(2)

the enrollment of the student was procured as the result of any misrepresentation in advertising, in promotional materials of the massage therapy educational program or by the owner, the massage school, or massage therapy instructor; or

(3)

the student was not provided ample opportunity to read the information provided in §141.37(a) of this title (relating to Enrollment Procedures).

(b)

The policy must provide for the refund of the unused portion of tuition, fees, and other charges in the event the student, after expiration of the 72-hour cancellation privilege, fails to enter, withdraws from, or is terminated from the program at any time prior to completion. The policy must provide that:

(1)

refunds for each program will be based on the program time expressed in clock hours;

(2)

refunds must be consummated within 30 days after the earliest of:

(A)

the effective date of termination if the student is terminated;

(B)

the date of receipt of written notice from the student of withdrawal; or

(C)

10 instructional days following the first day of the program if the student fails to enter;

(3)

if tuition is collected in advance of the first day of the program, and if, after expiration of the 72-hour cancellation privilege, the student does not enter the program, not more than $200 shall be retained by the massage therapy educational program;

(4)

if a student enters a massage therapy educational program and is terminated or withdraws, the minimum refund of the tuition will be:

(A)

during the first week or one-tenth of the program, whichever is less, 90% of the remaining tuition;

(B)

after the first week or one-tenth of the program, whichever is less, but within the first three weeks of the program, 80% of the remaining tuition;

(C)

after the first three weeks of the program, but within the first quarter of the program, 75% of the remaining tuition;

(D)

during the second quarter of the program, 50% of the remaining tuition;

(E)

during the third quarter of the program, 10% of the remaining tuition; and

(F)

during the last quarter of the program, the student may be considered obligated for the full tuition;

(5)

refunds of items of extra expense to the student, such as instructional supplies, books, student activities, laboratory fees, service charges, rentals, deposits, and all other such ancillary miscellaneous charges, where these items are separately stated and shown in the pre-enrollment information, will be made in a reasonable manner;

(6)

if a program is discontinued by the massage therapy educational program and this prevents the student from completing the program:

(A)

all tuition and fees paid shall be refunded if the student is not provided with a transcript of all successfully completed hours within 30 days of discontinuance of the program; or

(B)

in the event, an additional or changed location is 10 miles or more from the previously approved location of instruction and an enrolled student is unable to complete the program at the additional or changed location as determined by the department:

(i)

all tuition and fees paid shall be refunded if the student is not provided with a transcript of all successfully completed hours within 30 days of the change of location; or

(ii)

all unearned tuition and fees shall be refunded if a transcript of all successfully completed hours is provided within 30 days of the change of location.

(7)

If a student did not meet the admission requirements of a program and the student does not complete the program for any reason, all tuition and fees shall be refunded.

(c)

In all refund computations, leaves of absence, suspensions, school holidays, days when classes are not offered, and summer vacations shall not be counted as part of the elapsed time for purposes of calculating a student's refund.

(d)

A massage therapy educational program is considered to have made a good faith effort to consummate a refund if the student's file contains evidence of the following attempts:

(1)

certified mail to student's last known address;

(2)

certified mail to the student's permanent address; and

(3)

certified mail to the address of the student's parent, if different from the permanent address and if known.

(e)

If the department determines that the method used to calculate refunds is not in compliance with this section and if the massage therapy educational program does not provide the correct refund promptly, the educational program shall submit a report of an audit conducted by a certified public accountant or public accountant of the refunds due former students. The audit report shall be accompanied by a schedule of student refunds due which shall disclose the following information for the previous four years for each former student:

(1)

the name, address(es), and social security number;

(2)

the last date of attendance and date of termination;

(3)

the amount of refund with principal and interest separately stated, date and check number of payment if payment has been made, and any balance due; and

(4)

the reason for refund.

(f)

The department may take disciplinary action against the registration of a massage therapy educational program for a violation of this section; however, the department has no authority to recover a refund on behalf of a student.

§141.42.Attendance Standards.

(a)

Each massage therapy educational program shall develop and implement a written policy relating to attendance for students enrolled in the 300 hour course of instruction or any portion of the course of instruction.

(b)

The policy shall include requirements and fees for make-up work.

(c)

An absence shall be charged for a full day when a student attends none of the scheduled classes on that day. A partial day of absence shall be charged for any period of absence during the day.

(d)

School holidays shall not be considered as days of absence.

(e)

The attendance policy shall require the termination of students who accumulate absences of:

(1)

more than 10 consecutive school days; or

(2)

more than 15% of the total clock hours in a program, or 15% of a portion of the program if a student enrolls in less than the total 300 hours.

(f)

Refunds shall be made in accordance with §141.40 of this title (relating to Cancellation and Refund Policy). The effective date of termination for purposes of refunds shall be the last date of absence under subsection (e) of this section. A student whose enrollment is terminated for violation of the attendance policy may not reenter before the start of the next grading period.

(g)

A massage therapy educational program may not start students after 10% of the program has been taught except in those cases where appropriate credit for previous education has been given by the department.

(h)

Make-up work shall not be authorized for the purpose of removing an absence under subsection (e) of this section.

(i)

A leave of absence for reasonable purposes acceptable to the massage therapy educational program shall not exceed the lesser of 30 school days or 60 calendar days.

(1)

A student shall be granted only one leave of absence for each 12-month period.

(2)

Attendance records shall clearly show the dates for which the leave of absence was granted. A written statement as to why the leave of absence was granted, signed by both the student and the director of the massage therapy educational program indicating approval, shall be placed in the student's file.

(3)

If the student fails to return from leave, the student will be automatically terminated and a refund made in accordance with §141.40 of this title (relating to Cancellation and Refund Policy). The effective date of termination shall be the last day of the leave of absence.

(j)

Each massage therapy educational program must maintain a master record of attendance which clearly indicates the number of scheduled hours each day and the hours of absence for each student. Entries to the attendance log must indicate whether or not a student was in attendance and must be permanent.

§141.43.Equipment and Facility Requirements.

(a)

Each massage therapy educational training program shall provide adequate equipment in good working order. The equipment required for instruction shall be determined by the program objective(s). The equipment shall be comparable to that commonly found in the practice of massage therapy.

(b)

The equipment shall be of sufficient quality to meet the maximum use requirements of the current students, as demanded by the activity patterns of the program.

(c)

Equipment not in working order shall be removed from the instructional area, marked as out-of-order, or properly identified as awaiting repair.

(d)

The amount of classroom and laboratory space shall meet the use requirements of the maximum number of current students in class with appropriate seating facilities or work stations, as necessitated by the activity patterns of the program.

(e)

Enrollment shall not exceed the design characteristics of the student workstations.

(f)

The facilities shall meet any state and local ordinances or requirements governing building and safety for the designated use.

(g)

If adequate facilities and equipment are available, the following maximum ratios are recommended for the basic course of instruction, and may be varied at the discretion of the massage therapy educational program to conform to specific conditions:

(1)

laboratory - 12 tables to 1 instructor and 3 students to 1 table; and

(2)

classroom - 36 pupils to 1 instructor.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101174

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter F. MASSAGE ESTABLISHMENTS

25 TAC §§141.50 - 141.55

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§141.54.Exemptions.

(a)

The following establishments are specifically exempt from the provisions of the Texas Occupations Code, Chapter 455 (the Act), regulating massage establishments:

(1)

an establishment that holds a license, permit, certificate, or other credential issued by the state under another law, and that offers or performs massage therapy under the scope of that credential;

(2)

a registered massage therapist who practices as a solo practitioner in that therapist's legal name or uses an assumed name if the person's legal name or massage therapy registration number is used in any advertisement or presentation of the assumed name;

(3)

a nonprofit organization which is tax exempt under 26 United States Codes Annotated, §501(c) (Internal Revenue Code);

(4)

a hotel, motel, or similar commercial establishment which:

(A)

offers a sleeping room for rent for a period of time that is more than 10 hours; and

(B)

does not allow a tenant or occupant of a sleeping room to sublease the room for a period of time that is less than 10 hours;

(5)

a business whose primary business is devoted to the sale of food and food products;

(6)

a health spa in compliance with the Health Spa Act, Texas Occupations Code, Chapter 702;

(7)

the office of a physician, chiropractor, physical therapist, or member of another similarly licensed or regulated profession as determined by the department if the professional is practicing within the scope of his or her license. This exemption applies to a professional who uses a registered massage therapist to practice massage therapy in the professional's office or where the professional has authority to delegate tasks under the statutory authority for that professional;

(8)

an establishment owned or operated by the federal government, the state, a political subdivision of the state, or a municipality;

(9)

an establishment which is operational for a period of time of no more than 24 hours in a calendar year and in which the provision of massage therapy services is incidental to the primary athletic, fund raising, or other purpose of the event sponsored by the establishment:

(10)

a massage therapy educational program in compliance with the Act;

(11)

a beauty shop in compliance with the Texas Occupations Code, Chapter 1602; or

(12)

a barber shop in compliance with the Texas Occupations Code, Chapter 1601.

(b)

An establishment may request an exemption from the registration requirements of this section where it can show that the advertising or provision of massage therapy services is incidental to the person's primary enterprise.

(c)

Requests for exemptions must be in writing and must state the reasons why the exemption should be granted.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101175

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter G. COMPLAINTS, VIOLATIONS AND SUBSEQUENT DISCIPLINARY ACTIONS

25 TAC §§141.60 - 141.66

The new sections are adopted under the Occupations Code, §455.051, which provides the board with the authority to adopt rules necessary for the performance of its duties; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101176

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Chapter 229. FOOD AND DRUG

Subchapter G. MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE

The Texas Department of Health (department) adopts the repeal of existing §§229.111-229.120, and new §§229.111-229.115, concerning the manufacture, storage, and distribution of ice sold for human consumption, including ice produced at point of use. New §229.112 and §229.115 are adopted with changes to the proposed text as published in the December 1, 2000, issue of the Texas Register (25 TexReg 11869). The repealed sections and new §§229.111, 229.113-229.114 are adopted without changes, and therefore will not be republished.

New §§229.111-229.115 cover general provisions; definitions; source water; labeling of packaged ice; and ice equipment. Sections 229.111-229.120 are being proposed for repeal because the rules have not been updated since 1976 and many of the sections contain outdated references or are covered under more recent rules such as 25 Texas Administrative Code (TAC), Chapter 229, Food and Drug, Subchapter N, Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing or Holding Human Food. The new sections reorganize and rewrite the requirements resulting in content that reflects current practices in the industry.

Pursuant to the Government Code, §2001.039, each state agency is required to review and consider for readoption each rule adopted by that agency. The current rules have been reviewed and the department has determined that reasons for adopting these sections still exist. However, the language has been updated to better reflect current industry practice and allow for better assurances for the safety of source water used in the production of ice.

The department published a Notice of Intention to Review for §§229.111-229.120 as required by Government Code, §2001.039 in the Texas Register on April 7, 2000 (25 TexReg 3062). No comments were received as a result of the publication of the notice.

Change: Concerning §229.112(2), an editorial change was made in the first sentence to correctly show the possessive of "plant's" published in proposed text as "plants".

The following comments were received by the department concerning the proposed sections. Following each comment is the department's response and any resulting change.

Comment: Concerning §229.115(c), one commenter stated that the requirement for drains in ice storage vaults should be specified only for producers that store ice at 32 degrees Fahrenheit or above.

Response: The department disagrees with the commenter. The purpose of the drain is for proper cleaning of the ice vault. Ice vaults are required in the same section to be kept under sanitary conditions. However, this section applies to block ice plants. The department realizes that the way the section is structured, the application of this section only to block ice plants is not clear. The department has revised §229.115(b) with "facilities" and proposed §229.115(c) with new paragraph (1) and (2).

Comment: Concerning §§229.111-229.115, one commenter requested the rules contain a section requiring sampling of finished product ice.

Response: The department disagrees with the commenter. Prior to the proposal of these rules, the department conducted a limited survey of packaged ice in varying locations throughout the state. Analyses conducted by state approved laboratories found only two of eighty surveillance samples to be positive for total coliform. Follow up samples for the two positive analyses were negative. Therefore, since there is no standard for coliform in packaged ice at the federal level, the department does not feel that the additional burden placed on Texas industry is warranted. The department also has regulatory authority to collect during inspections. In addition, the department has no knowledge of any food-borne illness outbreaks associated with packaged ice. No change was made as a result of this comment.

The commenters were: SouthWest Foods Manufacturing and International Packaged Ice Association.

25 TAC §§229.111 - 229.120

The repeals are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101167

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: December 1, 2000

For further information, please call: (512) 458-7236


25 TAC §§229.111 - 229.115

The new rules are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, department, and the commissioner of health.

§229.112.Definitions.

The following words and terms, when used in these sections, shall pertain to ice production and shall have the following meanings unless the context clearly indicates otherwise.

(1)

Approved laboratory - An approved laboratory is one which is acceptable to the department, certified by the U.S. Environmental Protection Agency (EPA), or certified by the primacy enforcement authority in any state which has been granted primacy by EPA or certified by a third party organization acceptable to a primacy state.

(2)

Approved source (when used in reference to a plant's product water or operations water) - A source of water and the water there from, whether it be from a spring, artesian well, drilled well, municipal water supply, or any source, that has been inspected and the water sampled, analyzed, and found to be safe and sanitary quality according to applicable laws and regulations of State and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply.

(3)

Department - The Texas Department of Health.

§229.115.Ice Equipment.

(a)

Ice equipment. Equipment used in ice plants or as part of the facilities producing ice at point of use including, but not limited to, portable can fillers, core sucking devices, drop tubes, tank lids, ice cans, ice manufacturing, and ice dispensers shall be handled and maintained in such a manner as to prevent contamination. Equipment shall be located away from areas that could cause contamination such as toilets, vestibules, and openings to the outside. If at any time equipment is suspected as having been contaminated by improper handling, this equipment shall be sanitized.

(b)

Block ice facilities.

(1)

In order to minimize the possibility of contamination of ice during freezing, the operator employed on the tank floor shall use footwear which is limited to use only on the tank room floor. This footwear cannot be worn when leaving the tank room floor for any purpose. Only authorized persons are to be permitted on the tank room floor or within the ice storage rooms. Signs shall be posted stating that only authorized persons are allowed on the tank room floor and in ice storage vaults.

(2)

Ice storage vaults. Ice storage vaults must be kept under sanitary conditions and shall be maintained in such a condition as to prevent possible flooding of rooms with waste material. All vaults shall be provided with suitable drains. To prevent possible contamination of ice, all accumulations of rust, fungus growth, mold, or slime shall be controlled.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101168

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: December 1, 2000

For further information, please call: (512) 458-7236


Subchapter N. CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

25 TAC §§229.211, 229.217, 229.219

The Texas Department of Health (department) adopts amendments to §§229.211, 229.217, and 229.219, concerning the current good manufacturing practice and good warehousing practice in manufacturing, packing, or holding human food. Section 229.211 is adopted with changes to the proposed text as published in the December 1, 2000 issue of the Texas Register (25 TexReg 11871). Section 229.217 and §229.219 are adopted without changes and therefore will not be republished.

Specifically, the sections cover definitions; sanitary facilities and controls; and production and process controls. In §229.211, a definition for approved source of food was added and the definition for sanitization was clarified. Section 229.217 clarifies the requirements for water sources to include specific information on approved sources of water and sampling requirements. Language from the Sanitation in Pecan Shelling Plants, §229.134 of this title, which has been repealed, was added to §229.219.

The department received no public comments on the proposed amendments during the comment period.

Change: The department made an editorial change concerning §229.211(14)(B) to reflect a subscript "a w " for water activity which was incorrectly stated as "aw" in proposed rule.

The amendments are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, department, and the commissioner of health.

§229.211.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. Those definitions and interpretations of terms of the Federal Food, Drug, and Cosmetic Act (the Act), §201, are also applicable when used in this subchapter.

(1)

Acid foods or acidified foods--Foods that have an equilibrium pH of 4.6 or below.

(2)

Act--Federal Food, Drug, and Cosmetic Act.

(3)

Adequate--That which is needed to accomplish the intended purpose in keeping with good public health practice.

(4)

Approved source--A supplier of food that complies with applicable state and federal laws and is licensed, if required, and inspected by the regulatory authority having jurisdiction over the processing and distribution of food.

(5)

Batter--A semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

(6)

Blanching (except for tree nuts and peanuts)--A prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.

(7)

Control point--Any point, step, or procedure at which biological, physical, or chemical factors can be controlled.

(8)

Food--Articles used for food or drink for human consumption; chewing gum; and articles used for components of any such article.

(9)

Food-contact surfaces--Those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. "Food-contact surfaces" includes utensils and food-contact surfaces of equipment.

(10)

Lot--Food produced during a period of time indicated by a specific code.

(11)

Microorganisms--Yeasts, molds, bacteria, and viruses which include, but are not limited to, species having public health significance. The term "undesirable microorganisms" includes those microorganisms that are of public health significance; that subject food to decomposition; that indicate that food is contaminated with filth; or that otherwise may cause food to be adulterated within the meaning of the Act. Occasionally in these regulations, the adjective "microbial" is used instead of using an adjectival phrase containing the word microorganism.

(12)

Pests--Any objectionable animal or insect including, but not limited to, birds, rodents, flies, and larvae.

(13)

Plant--The building or facility, or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food.

(14)

Potentially hazardous food--A food that is natural or synthetic and requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms; the growth and toxin production of Clostridium botulinum ; or in raw shell eggs, the growth of Salmonella enteritidis .

(A)

The term includes a food of animal origin that is raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed sprouts; cut melons; and garlic and oil mixtures that are not acidified or otherwise modified at a food processing plant in a way that results in mixtures that do not support growth as specified in this definition.

(B)

The term does not include an air-cooled hard-boiled egg with shell intact; a food with a water activity (a w ) value of 0.85 or less; a food with a pH level of 4.6 or below when measured at 24 degrees Celsius (75 degrees Fahrenheit); and a food, in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution. The term also does not include a food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious or toxigenic microorganisms or the growth of S. enteritidis in eggs or C. botulinum cannot occur, such as a food that has an (a w ) and a pH that are above the levels specified above and that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms. The term also does not include a food that may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness, but that does not support the growth of microorganisms as specified in the definition of a potentially hazardous food.

(15)

Quality control operation--A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the Act.

(16)

Raw agricultural commodity--Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

(17)

Rework--Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.

(18)

Safe-moisture level--A level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity (a w ). An (a w ) will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given (a w ) will not support the growth of undesirable microorganisms.

(19)

Sanitization--The application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, yield a reduction of 5 logs, which is equal to a 99.999% reduction of representative disease microorganisms of public health importance.

(20)

Shall--Term to state mandatory requirements.

(21)

Should--Term to state recommended or advisory procedures or identify recommended equipment.

(22)

Water activity (a w )--A measure of the free moisture in a food. The quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101179

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: December 1, 2000

For further information, please call: (512) 458-7236


Subchapter X. LICENSURE OF DEVICE DISTRIBUTORS AND MANUFACTURERS

25 TAC §§229.432-229.436, 229.439, 229.441, 229.443

The Texas Department of Health (department) adopts amendments to §§229.432-229.436, 229.439, 229.441, and 229.443, concerning the licensure of device distributors and manufacturers. Section 229.433 is adopted with changes to the proposed text as published in the December 1, 2000 issue, of the Texas Register (25 TexReg 11876). Sections 229.432, 229.434-229.436, 229.439, 229.441, and 229.443 are adopted without changes, and therefore will not be republished.

The amendments clarify and update minimum standards for device distributors and manufacturers in order to conform with changes in federal requirements made pursuant to the U.S. Food and Drug Administration (FDA) Modernization Act of 1997. In addition, the amendments reflect changes necessitated as a result of a U.S. Supreme Court ruling that upheld a previous appellate court decision effectively negating FDA's attempts to regulate cigarette and smokeless tobacco products as devices. The rules contain new language related to combination products in order to reflect certain provisions of Senate Bill 1236, passed by the 76th Texas Legislature. The rules also contain new language related to the sale of contact lenses at flea markets in order to reflect certain provisions of House Bill 749, passed by the 76th Texas Legislature. The amendments clarify existing requirements for prescription devices as well as access to and retention of records required by these rules. Finally, the amendments update licensing procedures and contact references.

Due to staff comments an editorial change was made concerning §229.433(23) to delete the incorrect section symbols published in proposed preceding "adequate directions for use cannot be prepared."

No comments were received regarding the amended sections as proposed.

The amendments are adopted under Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§229.433.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Act--The Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.

(2)

Adulterated Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.111.

(3)

Advertising--All representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.

(4)

Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.

(5)

Board--The Texas Board of Health.

(6)

Commissioner--The Commissioner of Health.

(7)

Department--The Texas Department of Health.

(8)

Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:

(A)

recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;

(B)

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or

(C)

intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.

(9)

Distributor--A person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user. The term includes an importer or an own-label distributor. The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labeling of the finished device or the finished device package.

(10)

Electronic product radiation--Any ionizing or nonionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

(11)

Finished device--A device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.

(12)

Flea market--A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.

(13)

Health authority--A physician designated to administer state and local laws relating to public health.

(14)

Importer--Any person who initially distributes a device imported into the United States.

(15)

Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.

(16)

Labeling--All labels and other written, printed, or graphic matter:

(A)

upon any article or any of its containers or wrappers; or

(B)

accompanying such article.

(17)

Manufacture--The making by chemical, physical, biological, or other procedures of any article that meets the definition of device. The term includes the following activities:

(A)

repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; or

(B)

initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications.

(18)

Manufacturer--A person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device.

(19)

Misbranded Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.112.

(20)

Person--Includes individual, partnership, corporation, and association.

(21)

Place of business--Each location at which a device is manufactured or held for distribution.

(22)

Practitioner--Means a person licensed by the Texas State Board of Medical Examiners, State Board of Dental Examiners, Texas State Board of Podiatric Medical Examiners, Texas Optometry Board, or State Board of Veterinary Medical Examiners to prescribe and administer prescription devices.

(23)

Prescription device--A restricted device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.

(24)

Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

(25)

Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously.

(26)

Reconditioning--Any appropriate process or procedure by which distressed merchandise can be brought into compliance with departmental standards as specified in the Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter 432, §432.003, as interpreted in the rules of the board in §229.192 of this title (relating to Definitions).

(27)

Restricted device--A device subject to certain controls related to sale, distribution, or use as specified in the Federal Food, Drug, and Cosmetic Act, as amended, §520(e)(1).

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2001.

TRD-200101178

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2001

Proposal publication date: December 1, 2000

For further information, please call: (512) 458-7236


Part 16. TEXAS HEALTH CARE INFORMATION COUNCIL

Chapter 1301. HEALTH CARE INFORMATION

Subchapter E. TECHNICAL ADVISORY COMMITTEES

25 TAC §§1301.61-1301.69

The Texas Health Care Information Council (Council) adopts the repeal of §§1301.61-1301.69, relating to the Council's technical advisory committees (TACs), without changes to the proposed text as published in the December 15, 2000, issue of the Texas Register (25 TexReg 12317).

The Council adopts the repeal of §§1301.61-1301.69, in response to House Bill 1513, Acts 1999, 76th Legislature which, in part, amended Health and Safety Code §108.003 (g) to exclude the Council's technical advisory committees from the application of Chapter 2110 of the Government Code.

The Council did not hold a public hearing and none was requested on the proposed repeal of the rules. Additionally, the Council did not receive any written comments on the proposed repeal of rules.

The repeal of §§1301.61-1301.69 is adopted under the Health and Safety Code, §108.003 and §108.006. The Council interprets §108.003(g) as authorizing the Council to appoint technical advisory committees and those advisory committees shall include the technical advisory committees described in paragraphs one through five (1-5) of §108.003(g), Health and Safety Code and Government Code §2110 does not apply to these advisory committees. The Council interprets §108.006 as authorizing it to propose and adopt rules necessary to carry out Chapter 108, including proposing to repeal rules concerning the Council's advisory committees.

The Health and Safety Code, §108.003, is affected by the adopted repeal of these sections.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 5, 2001.

TRD-200101268

Jim Loyd

Executive Director

Texas Health Care Information Council

Effective date: March 25, 2001

Proposal publication date: December 15, 2000

For further information, please call: (512) 482-3312