ADOPTED RULES An agency may take final action on a section 30 days after a proposal has been published in the Texas Register. The section becomes effective 20 days after the agency files the correct document with the Texas Register, unless a later date is specified or unless a federal statute or regulation requires implementation of the action on shorter notice. If an agency adopts the section without any changes to the proposed text, only the preamble of the notice and statement of legal authority will be published. If an agency adopts the section with changes to the proposed text, the proposal will be republished with the changes. TITLE 1. ADMINISTRATION Part XIII. Texas Incentive and Productivity Commission Chapter 271. Procedural Rules 1 TAC sec.271.5 The Texas Incentive and Productivity Commission adopts new sec.271.5, concerning charges for copies of public records, with changes to the proposed text as published in the January 4, 1994, issue of the Texas Register (19 TexReg 13). The Commission adopts the rule to comply with actions taken by the 73rd Legislature in House Bill 1009 in relation to Texas Civil Statutes, Article 6252-17a (subsequently recodified at Government Code, Chapter 552), which requires agencies to adopt rules specifying charges for copies of open records. Changes to the proposed text were made in response to comments from the General Services Commission. In sec.271.5(a), the definition of the types of records for which copy costs may be recovered was broadened to include any public record. Non-substantive changes were made to sec.271.5(b). Section 271.5 provides a framework within which the Commission may recover the cost to provide copies of open records to persons requesting the copies. The Section also sets forth the Commission's option to waive these charges. The Commission received one comment suggesting that the language referring to open records should be broadened to include all open records, not just those that were readily available. Comments for adoption of the section with changes came from the General Services Commission. The Commission agreed with the comments and made changes to the text. The new Section is adopted in compliance with actions taken by the 73rd Legislature in House Bill 1009 in relation to Texas Civil Statutes, Article 6252-17a (subsequently recodified at Government Code, Chapter 552), which requires agencies to adopt rules specifying charges for copies of open records. sec.271.5. Charges for Copies of Public Records. (a) The charge to any person requesting copies of any public record of the Commission will be the charge established by the General Services Commission. (b) The Commission may reduce or waive these charges at the discretion of the executive director if there is a public benefit. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 7, 1994. TRD-9435846 M. Elaine Powell Executive Director Texas Incentive and Productivity Commission Effective date: March 1, 1994 Proposal publication date: January 4, 1994 For further information, please call: (512) 475-2393 TITLE 4. AGRICULTURE Part I. Texas Department of Agriculture Chapter 5. Quarantines Citrus Seed, Citrus Budwood, and Citrus Nursery Stock Quarantine 4 TAC sec.5.152, sec.5.153 The Texas Department of Agriculture (the department) adopts amendments to sec.5.152 and sec.5.153, concerning restricted shipments of citrus seed, citrus budwood, and citrus nursery stock, without changes to the proposed text as published in the December 24, 1993, issue of the Texas Register (18 TexReg 9881). The amendments are made to include the State of California as a source of disease-free citrus products. Currently, citrus seeds, citrus budded nursery stock or seedlings, citrus budwood or any part of any citrus tree or seedling can not be shipped, carried or in any way transported by an means into the State of Texas except from Florida under certain conditions. It is necessary to amend the restricted shipments section and the restrictions on citrus seed shipments section to include California as a state from which citrus products may be imported because California is a disease free source of certified citrus budwood and citrus seed for Texas producers and to accordingly provide for issuance of a certification statement from California. The amendments add the State of California to provisions regarding shipments of budwood and clarify that a certified statement is to come from the regulated states' department of agriculture deleting references to the Florida Plant Board. One comment was received from Texas Citrus Mutual in favor of the amendments. The amendments are adopted under the Texas Agriculture Code, sec.71.007, which gives the department the authority to make rules necessary for the protection of agricultural and horticultural interests. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 8, 1994. TRD-9435872 Dolores Alvarado Hibbs Chief Administrative Law Judge Texas Department of Agriculture Effective date: March 1, 1994 Proposal publication date: December 24, 1993 For further information, please call: (512) 463-7583 TITLE 13. CULTURAL RESOURCES Part IV. Texas Antiquities Committee Chapter 41. Practice and Procedure 13 TAC sec.41.24, sec.41.27 The Texas Antiquities Committee (committee) adopts amendments to sec.41.27, concerning Disposition of Archaeological Artifacts and Data, with changes to the proposed text as published in the November 12, 1993, issue of the Texas Register (18 TexReg 8300). Section 41.24, concerning Reports Relating to Archeological Permits, is adopted without changes and will not be republished. Section 41.27(c)(2) is changed by replacing the term 'certification' with the term 'accreditation'. The term accreditation more accurately reflects actions taken by the Council of Texas Archeologists Accreditation and Review Program. The program does not certify curatorial facilities, but recognizes facilities that maintain standards for archeological collections in accordance with the CTA Accreditation and Review Program guidelines. The amendment to sec.41.24 is justified to increase the number of antiquities reports to be dispersed to regional libraries, thereby providing for better communication with the public and researchers regarding the nature of archeological investigations on public lands in Texas. A second amendment is justified to require the submission of an Abstract From to be included with copies of the final antiquities permit reports. The amendments to sec.41.27 are justified to ensure that publicly-owned artifacts and other related materials are permanently preserved in research collections at a facility approved by the committee. The amendment to sec.41.24 increases the number of reports required by antiquities permit conditions from 12 to 20 in order to increase the number of regional libraries that receive the reports from 8 to 16. The amendment also requires permittees to submit a completed Department of Antiquities Protection Abstract Form with 20 copies of the final reports. The amendment to sec.41.27 ensures that publicly-owned specimens, artifacts, materials, and samples plus original field notes, maps, drawings, photographs, and standard state site forms are permanently preserved in research collections at a curatorial facility approved by the committee. Although an existing condition of antiquities permit requirements, the amendment provides a stronger enforcement mechanism. One comment supporting the adoption of the amendments was received from an individual representing the Council of Texas Archeologists (CTA). The commenter pointed out that there is a difference between the concepts of 'certification' and 'accreditation' as used by the CTA Accreditation and Review Committee. The commenter suggested the use of the term 'accreditation' rather than the use of the term 'certification' in sec.41.27(c)(2), regarding institutions housing antiquities recovered from archeological investigations conducted under antiquities permits. The Committee concurs with the suggestion and changed the proposed text. The amendments are proposed under the Natural Resources Code, Title 9, Chapter 191 (revised by Senate Bill 231, 68th Legislature, 1983, and by House Bill 2056, 70th Legislature, 1987), sec.191.02, which provides the Texas Antiquities Committee with authority to promulgate rules and require contract or permit conditions to reasonably effect the purposes of Chapter 191. sec.41.27. Disposition of Archeological Artifacts and Data. (a)-(b) (No change.) (c) Housing, conserving, and exhibiting antiquities from State Archeological Landmarks. (1) After investigation of a State Archeological Landmark has culminated in the reporting of results, the antiquities will be permanently preserved in research collections at the curatorial institution approved by the committee. Prior to the expiration of a permit, written proof that archeological collections and related field notes are housed in a curatorial facility is required. Failure to demonstrate proof before the permit's expiration date, will result in the permit being considered defaulted. (2) By January 1, 2000, institutions that curate artifacts recovered under antiquities permit(s) must be accredited through the Council of Texas Archeologists Accreditation and Review Committee accreditation program. Institutions housing antiquities from State Archeological Landmarks will be responsible for adequate security of the collections, continued conservation, periodic inventory, and for making the collections available to qualified institutions, individuals, or corporations for research purposes. (3) (No change.) (d) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 7, 1994. TRD-9435855 Mark H. Denton Certifying Official Texas Antiquities Committee Effective date: March 1, 1994 Proposal publication date: November 12, 1993 For further information, please call: (512) 463-6096 TITLE 16. ECONOMIC REGULATION Part IV. Texas Department of Licensing and Regulation Chapter 78. Talent Agencies 16 TAC sec.sec.78.1, 78.10, 78.20, 78.21, 78.30, 78.40, 78.60, 78. 70, 78.72- 78.74, 78.76, 78.80-78.82, 78.90-78.94 The Texas Department of Licensing and Regulation adopts the repeals of sec.sec.78.1, 78.10, 78.20, 78.21, 78.30, 78.40, 78.60, 78.70, 78.72-78.74, 78.76, 78.80-78.82, and 78.90-78.94, concerning talent agencies. The rules are repealed in order to adopt new sections covering the same subject matter in order to clarify, edit, renumber and reorganize the rules. The new rules will function by increasing understanding of the rules and making enforcement more efficient and by making the fees collected more nearly reflect costs of the program. No comments were received regarding adoption of the repeals. The sections are repealed under Texas Civil Statutes, Article 5221a-9, which provide the Texas Department of Licensing and Regulation with the authority to promulgate and enforce a code of rules and take all action necessary to assure compliance with the intent and purposes of the Texas Talent Agency Act. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 4, 1994. TRD-9435859 Jack W. Garison Executive Director Texas Department of Licensing and Regulation Effective date: March 1, 1994 Proposal publication date: August 20, 1993 For further information, please call: (512) 463-3127 16 TAC sec.sec.78.1, 78.10, 78.20-78.22, 78.30, 78.40, 78.70, 78. 72, 78.73, 78.74, 78.80-78.82, 78.90, 78.91, 78.100 The Texas Department of Licensing and Regulation adopts new sec.sec.78.1, 78. 10, 78.20-78.22, 78.30, 78.40, 78.70, 78.72-78.74, 78.80-78.82, 78.90, 78.91, and 78.100, concerning talent agencies. Sections 78.10, 78.20, 78.21, and 78. 30 are adopted with changes to the proposed text as published in the September 21, 1993, issue of the Texas Register (18 TexReg 6408). Sections 78.1, 78.22, 78.40, 78.70, 78.72-78.74, 78.80-78.82, 78.90, 78.91, and 78.100 are adopted without changes and will not be republished. The new sections are adopted to clarify, edit, renumber and reorganize existing rules. The sections increase the registration renewal fee and late renewal fee. The change in sec.78.10 changes the definition of Artist from wording taken from the Act to a reference to the definition in the Act. The changes in sec.78. 20(c) and sec.78.21(a) clarify who must sign applications for registration. The change in sec.78.30 adds the word "only" to clarify who is exempt in subparagraph (e). The new rules function by increasing understanding of the rules and making enforcement more efficient and by making the fees collected more nearly reflect costs of the program. Two comments were received sec.78.10, both of which opposed the definition of "Artist". Two comments were received on sec.78.30. One opposed the exemption of artists other than actors and models and the other suggested a change to exempt only those who represented no actors and models. One comment was received on sec.78.40 opposing the requirement of 30 days written notice of cancellation by bonding companies. One comment was received on sec.78.81 opposing increased renewal and late fees. All comments were from individuals. The agency agrees that the definition of artist should track the Act, and has changed the section. The agency stands by its position that the intention of the Act is not clear as to inclusion of artists other than actors and models, but the agency agrees with the comment that the language of sec.78.30 inadvertently exempted agencies who represented both actors and models and those exempted in the section. Section 78.30 is being adopted with that change. The agency disagrees with the comment opposing sec.78.40 because this provision was in the old rule which are being repealed and the agency is not award of problems caused by it. The agency believes that increased renewal and late fees are small enough to cause no hardship to talent agencies, and that the fees are justified by costs of administering the program. The new sections are adopted under Texas Civil Statutes, Article 5221a-9, which provide the Texas Department of Licensing and Regulation with the authority to promulgate and enforce a code of rules and take all action necessary to assure compliance with the intent and purposes of the Texas Talent Agency Act. sec.78.10. Definitions. The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Artist-An actor or a model, as they are defined in the Act. sec.78.20. Registration Requirements -General. (a) Unless exempted in sec.78.30 of this title (relating to Exemptions), all talent agencies that have a place of business in Texas, or advertise in Texas, and obtain or attempt to obtain employment for artists in Texas, or recruit artists from a temporary location in Texas, must obtain a certificate of registration in order to operate a talent agency. "Personal agents", or any persons under any name or title, who perform the services described in Texas Civil Statutes, Article 5221a-9, as any part of the services they provide, are talent agents under the Act. (b) A certificate of registration is not assignable or transferable. (c) All applications shall include a statement that all owners, partners, members of associations, trustees, or fiduciaries, have read and are familiar with the provisions of the Act. (d) Any talent agency using an assumed name(s) must comply with the Assumed Business or Professional Name Act, Texas Business and Commerce Code, Chapter 36. (e) Any incorporated talent agency must comply with the Texas Business Corporation Act, sec.2.05. (f) The talent agency must furnish a copy of all registrations filed with the clerk of the county in which the talent agency is located, or the registration filed with the Secretary of State. A copy of any changed or revised registrations must be furnished to the department within 30 days of filing. sec.78.21. Registration Requirements -New Certificates. (a) The application must be signed by the applicant. The application must be signed by each officer if a corporation, each partner if a partnership, each member if an association, or each trustee or fiduciary as applicable. (b) An initial application must contain: (1) the complete names, social security numbers, dates of birth, addresses, and phone numbers of all persons owning at least 10% of the talent agency. If the talent agency is a partnership, the names of all partners must be included. If the talent agency is a limited partnership, the names of all general and limited partners must be included, along with the name and address of the registered agent. If the talent agency is a corporation, the names of the corporate president, vice-president, secretary and treasurer must be included. The percent ownership interest must be stated in all cases; (2) the names of any talent agency owners who have a financial interest in any company involved in the casting, production or distribution of motion pictures or television motion pictures, independent video production companies, recording studios, photography studios, or any other companies or firms which would hire artists from time to time. This disclosure shall include the company or companies in which he has a financial interest, and the percent of ownership in each company listed. Such an interest shall not, in and of itself, be grounds for registration denial, suspension or revocation; (3) the names of any talent agency owners who have a financial interest in any school or course of instruction which is primarily intended for the professional study of acting or modeling. This disclosure shall include the school or course name and the percent of ownership held. Any person owning and/or operating a modeling or acting school must comply with the provisions of the Texas Proprietary School Act, Texas Education Code, Chapter 32, and the State Board of Education Rules for proprietary schools as they appear in 19 Texas Administrative Code, Chapter 69; and (4) a schedule of commissions and/or fees charged. sec. 78.30. Exemptions. (a) The term "talent agency" does not apply to: (1) a person who obtains or attempts to obtain employment for himself; (2) an organized labor union that represents artists and whose efforts to obtain or attempt to obtain employment for its members is incidental to representing its members; (3) a person who, without assessing a fee, operates a talent agency in conjunction with the person's own business, or as the authorized representative for a bona fide employer, for the exclusive purpose of employing artists for use in or for that business, or by that employer; or (4) attorneys licensed to practice who represent artists, strictly as legal advisors and not as managers. (b) The term "talent agency" applies only to persons who obtain or attempt to obtain employment for an actor who performs in a motion picture, theatrical, radio, television, or other entertainment production; and/or a model, as that term is defined herein. Based upon a review of the specific language throughout the entire statute, it is the department's interpretation that the legislation was intended to apply only to talent agencies dealing with those types of artists as described herein. While there is a reference to other types of artists in the statute, the department finds application of the statute to those other artists in conflict with the apparent legislative intent as it is expressed in specific provisions throughout the statute. In the alternative, and without waiving the position stated, there is insufficient legislative guidance to promulgate administrative rules regarding those other types of artists. Therefore, talent agencies representing only such artists are not required to comply with the requirements of the Act. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 4, 1994. TRD-9435858 Jack W. Garison Executive Director Texas Department of Licensing and Regulation Effective date: March 1, 1994 Proposal publication date: September 21, 1993 For further information, please call: (512) 463-3127 TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 103. Injury Prevention and Control General Provisions 25 TAC sec.sec.103.1-103.9 The Texas Department of Health (department) adopts new sec.sec.103.1-103.9, concerning injury prevention and control. Section 103.1 is adopted with changes to the proposed text as published in the November 9, 1993, issue of the Texas Register (18 TexReg 8103). Sections 103.2-103.9 are adopted without changes and will not be republished. The new sections implement the Health and Safety Code, Chapter 87, Injury Prevention and Control, sec.sec.87.001-87.009, which require the department to establish methods by which certain injuries shall be reported to the department, and the conduct of epidemiologic investigations. The sections describe the requirements for reporting the two reportable injuries, spinal cord injuries and submersion injuries. Epidemiologic investigations or inspections of the causes of the injuries are authorized, and medical information collected under these rules is protected under confidentiality provisions. In the event that the department desires to expand the list of reportable injuries, a technical advisory committee will be established to review and advise on the matter. The following comment was received in reference to the proposed sections. COMMENT: One comment was received from the Houston Health and Human Services Department recommending additional language in several sections which would specifically give local health departments the same authority as described for the department. RESPONSE: The proposed rules describe the department's authority and responsibility in these matters, and in no way interfere with the authority of a health authority, local health department, public health district, municipality or county to conduct the same activities within its jurisdiction. Therefore, the suggested changes are not adopted. However, a sentence which clarifies this point has been added to sec.103.1. The new sections are adopted under the Health and Safety Code, Chapter 87, Injury Prevention and Control, Chapter 41, Acts of the 73rd Legislature (1993), which require reporting of spinal cord injuries and submersion injuries; and under Health and Safety Code, Chapter 12, which gives the board authority to adopt rules for the performance of each duty imposed by law. sec.103.1. Purpose. These sections implement the Texas Injury Prevention and Control Act, House Bill 343, 73rd Legislature, 1993, which authorizes the Texas Board of Health to adopt rules concerning the reporting and control of injuries. Nothing in the rules shall be construed to preempt or impede the authority of a health authority, a local health department, a public health district, a municipality, or a county to conduct the same activities within its jurisdiction. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 8, 1994. TRD-9435887 Susan K. Steeg General Counsel, Office of General Counsel Texas Department of Health Effective date: March 1, 1994 Proposal publication date: November 9, 1993 For further information, please call: (512) 458-7236 Chapter 133. Hospital Licensing Subchapter I. Cooperative Agreements 25 TAC sec.133.131 The Texas Department of Health (department) adopts new sec.133.131, with changes to the proposed text as published in the November 2, 1993, issue of the Texas Register (18 TexReg 8030). The new section is adopted to implement the statutory requirements of House Bill 1884, established during the 73rd Texas Legislature, Regular Session, 1993, which amended the Health and Safety Code to add Chapter 313 relating to cooperative agreements among hospitals. Under the Health and Safety Code, Chapter 313, hospitals may voluntarily enter into cooperative agreements to share services, facilities, personnel and equipment. The intent of cooperative agreements among hospitals is to promote decreased costs and increased accessibility in providing health care to communities served by the hospitals which are parties to the agreement. Certificates of public advantage are issued to hospitals which enter into a cooperative agreement. The following comments were received relating to the proposed new section. Comment: Relating to sec.133.131(b)(2)(I), a commenter suggested that the language be revised to make clear that applicant hospitals must include a statement that addresses one or more of the benefits of the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.133.131(b)(2)(J), a commenter suggested that the word "appropriate" be inserted after the word "each" when referring to the consideration of the factors listed in the Health and Safety Code, sec.313. 002(f), which a hospital must address in the statement of disadvantages attributable to a reduction in competition resulting from the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.133.131(b)(2)(M) and (R), a commenter suggested that the language be revised to require that an application only include a description of the geographic area and the present and projected market share of the health care equipment, facilities, personnel or services which are the subject of the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.133.131(b)(2)(W), a commenter asked how and on what basis the department determined that a $10,000 application fee was appropriate. Response: The department responds that the amount of the application fee is based upon the anticipated cost of processing the application and upon the language in the Health and Safety Code, sec.313.002(b) which allows the department to collect a fee not to exceed $10,000 per application. Comment: Relating to proposed sec.133.131(d), a commenter recommended that this subsection be deleted and that proposed sec.133.131(g)-(k) be revised to utilize the terms "termination" and "terminate" in lieu of the terms "revocation" and "revoke." Response: The department has no objection to the recommendation and has revised the subsections as suggested. Comment: Relating to proposed sec.133.131(f), a commenter recommended that this subsection be revised to more specifically describe the data or information hospitals must provide on an annual basis as part of the department's monitoring process. Response: The department agrees and has revised the subsection accordingly. Minor editorial changes were made for clarification purposes. The Texas Hospital Association provided the comments on the proposed rules. The Association basically supported the rules, but had concerns and questions as previously mentioned. The new section is adopted under the Health and Safety Code, Chapter 313, which provides the Texas Board of Health (board) with the authority to adopt rules to implement legislative mandates of the 73rd Texas Legislature, Regular session, 1993, specifically House Bill 1884; and sec.12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law upon the board, the department and commissioner of health. sec.133.131. Cooperative Agreements and Certificates of Public Advantage. (a) Purpose. The purpose of this section is to establish procedures to implement the Health and Safety Code, Chapter 313, as added by Chapter 638, 73rd Legislature, Regular Session, 1993 (House Bill 1884), by which hospitals may enter into cooperative agreements with other hospitals in the state. (b) Review of cooperative agreements. (1) Hospitals which are parties to a cooperative agreement may file an application with the department for a certificate of public advantage governing the cooperative agreement. (A) Only persons licensed as a hospital under the Health and Safety Code, Chapters 241 or 577, may be parties to the cooperative agreement. (B) The cooperative agreement must be filed at least 120 days prior to the effective date of the agreement. (C) The cooperative agreement must be executed by all parties. (D) The application shall be filed jointly by all parties to the cooperative agreement; however, the parties shall designate one person to be the contact person with the department. (2) The application must include: (A) a table of contents; (B) a written copy of the cooperative agreement; (C) the exact name of each party and the address of the principal business office of each party; (D) the name of the registered agent and address of the registered office for each party which is a corporation; (E) the name, address, and telephone number of one contact person authorized to receive notices and communications with respect to the application; (F) a notarized statement by a responsible officer or partner, as appropriate, of each party attesting to the accuracy and completeness of the enclosed information; (G) a brief summary of the nature and scope of the cooperative agreement; (H) a description of any consideration passing to any party; (I) a statement of the likely benefits resulting from the cooperative agreement addressing one or more of the benefits of the cooperative agreement listed in the Health and Safety Code, sec.313.002(e) and any other benefits; (J) a statement of the disadvantages attributable to a reduction in competition that might result from the cooperative agreement addressing each appropriate factor listed in the Health and Safety Code, sec.313.002(f) and any other factors which should be considered; (K) a statement of how and why the likely benefits resulting from the cooperative agreement outweigh the disadvantages attributable to a reduction in competition that might result from the cooperative agreement; (L) a description of the geographic territory to be served by the health care equipment, facilities, personnel, or services which are the subject of the cooperative agreement; (M) if the geographic territory described in subparagraph (L) of this paragraph is different from the territory in which the parties have provided similar health care equipment, facilities, personnel or services over the last five years, a description of how and why the geographic territory differs; (N) identification of whether and how any services, personnel, facilities, or health care equipment similar to those covered by the cooperative agreement are currently being offered to or utilized by other health care providers, facilities, or patients in the geographic territory described in subparagraph (L) of this paragraph; (O) identification of the steps necessary under current market and regulatory conditions, for other parties to enter the territory described in subparagraph (L) of this paragraph and compete with the parties to the cooperative agreement in the delivery of health care services which are the subject of the cooperative agreement; (P) a description of the previous history of business transactions involving the delivery of health care services which are the subject of the cooperative agreement between the parties to the cooperative agreement; (Q) a detailed explanation of the projected effects, including expected volume, change in price, and increased revenue, of the proposed cooperative agreement on each party; (R) the present share of the health care services which are the subject of the cooperative agreement of each party to the cooperative agreement and of other health care providers or facilities affected by the cooperative agreement, and projected shares of that health care market after implementation of the cooperative agreement; (S) a statement of why the projected levels of cost, access, or quality could not be achieved in the existing market without the cooperative agreement; (T) an explanation of how the cooperative agreement relates to any likely adverse impact or reduction in competition effecting negotiation of optimal payment and service arrangements or the furnishing of goods or services including quality, availability, and price; (U) an explanation of the availability of arrangements that are less restrictive to competition and achieve similar benefits; (V) a detailed explanation of how the cooperative agreement will affect cost, access, and quality of services provided by each party; (W) a nonrefundable application fee in the amount of $10,000; (X) the proposed effective date of the agreement; and (Y) if the parties to the application desire a public hearing, a written request for a public hearing. (3) A copy of the application and copies of all additional related materials must be submitted to the Office of the Attorney General, Antitrust Division, Austin, Texas and to the Texas Department of Health (department) at the same time. (4) The department shall determine whether the application is complete within 30 days of receipt of an application. If the department determines that an application is unclear, incomplete, or provides an insufficient basis on which to base a decision, the department may return the application and specify the additional information required. The applicant may complete or revise the application and resubmit it. (5) The application shall not be considered to be filed until a complete application is received by the department, including additional information requested under paragraph (4) of this subsection. (6) Any person may request a public hearing within 30 days of the filing of an application. (A) The department shall inform the applicants in writing and publish in the Texas Register the date, time and location of the public hearing. (B) The purpose of the hearing will be to receive public comments on the application. (C) The comments shall be considered by the department and the attorney general in its determination on the request for a certificate of public advantage. (7) Any person may request a copy of the application with the supporting documentation at the person's expense. (8) The department shall consult with the attorney general on every application. (9) The department shall grant or deny the application within 120 days of the date of filing of the application. (10) The department shall issue a certificate of public advantage for a cooperative agreement if it determines that the applicants have demonstrated by clear and convincing evidence that the likely benefits resulting from the agreement outweigh any disadvantages attributable to a reduction in competition that may result from the agreement. (A) The certificate of public advantage shall include the terms by which the application was approved and shall contain any conditions by which the department and the attorney general shall monitor the benefits and disadvantages resulting from the approved agreement. (B) The certificate of public advantage shall be signed by the commissioner of health. (c) Denial of an application. If the department determines that there is not clear and convincing evidence that the likely benefits resulting from the agreement outweigh any disadvantages attributable to a reduction in competition that may result from the cooperative agreement, the department shall deny the application. The department's informal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health) shall apply. (d) Periodic submission of measurable data. A decision approving an application must require the periodic submission of specific data relating to cost, access, and quality, and to the extent feasible, identify objective standards of cost, access, and quality by which the success of the arrangement will be measured. If the department determines that the scope of a particular proposed arrangement is such that the arrangement is certain to have neither a positive or negative impact on one or two of the criteria, the department's decision need not require the submission of data or establish an objective standard relating to those criteria. (e) Monitoring of cooperative agreements. The department shall appropriately supervise, monitor, and regulate approved arrangements. (1) The department shall require the parties to an approved cooperative agreement to submit information and supporting data on an annual basis regarding the current status of the agreement, including information relative to the continued benefits and any disadvantages of the agreement. (2) The information and supporting data that must be submitted to the department by hospitals under paragraph (1) of this subsection shall include: (A) any proposed change in the cooperative agreement; (B) any change in the name or address of the principal business office of each party; (C) any change in the address of the registered agent or the address of the registered office of each party which is a corporation; (D) a statement concerning how and why the benefits resulting from the cooperative agreement outweigh any disadvantages attributable to a reduction in competition resulting from the agreement; (E) any change in the geographic territory that is served by the health care equipment, facilities, personnel or services which are subject of the cooperative agreement; (F) a detailed explanation of the actual effects of the agreement on each party, including any change in volume, market share, prices and revenues; (G) an explanation of how the cooperative agreement has impacted the ability of health care payors to negotiate optimal payment and service arrangements with health care providers; and (H) a detailed explanation of how the cooperative agreement has affected the cost, access, and quality of services provided by each party. (3) If, at any time following the approval of a cooperative agreement, the department determines that there may have been a change in the facts or circumstances under which the agreement was approved the department may require the parties to the agreement to submit information required by paragraph (2) of this subsection and any other information needed by the department to determine whether the benefits of the approved agreement continue to outweigh any disadvantages attributable to a reduction in competition resulting from the agreement. If requested, the department shall hold a public hearing to solicit additional information concerning the effects of the cooperative agreement. (4) Following its review of any information submitted or received under paragraph (2) or (3) of this subsection, the department shall notify the parties to the cooperative agreement whether they are in compliance with the approved certificate of public advantage. If the parties are not in compliance with the requirements of the certificate, the department shall identify the manner in which the parties are out of compliance and shall provide an opportunity for the parties to bring the agreement within compliance. (5) Hospitals receiving notification that an arrangement is not in compliance with the certificate of public advantage have 30 days from receipt of the notice in which to respond with additional data or rationale concerning the validity of the cooperative agreement. This response may include a proposal and a time schedule by which the hospitals will bring the arrangement into compliance with a certificate of public advantage. If the arrangement is not in compliance and the department and the hospitals can not agree to the terms of bringing the arrangement into compliance, the matter shall be set for a contested case hearing. (6) If the department determines that as a result of changed circumstances, the benefits from an approved agreement no longer outweigh any disadvantages attributable to a reduction in competition resulting from the agreement, the department may initiate proceedings to terminate the certificate of public advantage. (f) Termination. The department may terminate a certificate of public advantage, in accordance with the Health and Safety Code, sec.313.004 and the department's informal hearing procedures in Chapter 1 of this title, if: (1) the arrangement is not in substantial compliance with the terms of the application; (2) the arrangement is not in substantial compliance with the conditions of approval; (3) the arrangement has not and is not likely to substantially achieve the improvements in cost, access, or quality identified in the approval order as the basis for the department's approval of the arrangement; or (4) the conditions in the marketplace have changed to such an extent that competition would promote reductions in cost and improvements in access and quality better than does the arrangement at issue. In order to terminate on the basis that conditions in the marketplace have changed, the department's order must identify specific changes in the marketplace and articulate why those changes warrant termination. (g) Notice. The department shall begin a proceeding to terminate approval by providing written notice to the applicant describing in detail the basis for the proposed termination. (h) Procedure. A proceeding to terminate an approval must be conducted as a contested case proceeding upon the written request of the applicant. Decisions of the department in a proceeding to terminate approval are subject to judicial review. (i) Alternatives to termination. In deciding whether to terminate an approval, the department shall take into account the hardship that the termination may impose on the applicant and any potential disruption of the market as a whole. The department shall not terminate an approval if the arrangement can be modified, restructured, or regulated so as to remedy the problem upon which the termination proceeding is based. The applicant may submit proposals for alternatives to termination. An approved modified or restructured arrangement is subject to appropriate supervision. (j) Impact of termination. The applicant cannot be held liable under state or federal antitrust law for acts that occurred while the approval was in effect, except to the extent that the applicant failed to substantially comply with the terms of its application or failed to substantially comply with the terms of the approval. The applicant is fully subject to state and federal antitrust law after the termination becomes effective and may be held liable for acts that occur after the termination. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 9, 1994. TRD-9435895 Susan K. Steeg General Counsel, Office of General Counsel Texas Department of Health Effective date: March 2, 1994 Proposal publication date: November 2, 1993 For further information, please call: (512) 458-7236 Chapter 134. Private Mental Hospitals and Mental Health Facilities Licensing Subchapter G. Cooperative Agreements 25 TAC sec.134.101 The Texas Department of Health (department) adopts new sec.134.101, with changes to the proposed text as published in the November 2, 1993, issue of the Texas Register (18 TexReg 8033). The new section is adopted to implement the statutory requirements of House Bill 1884, established during the 73rd Texas Legislature, Regular Session, 1993, which amended the Health and Safety Code to add Chapter 313 relating to cooperative agreements among hospitals. Under the Health and Safety Code, Chapter 313, hospitals may voluntarily enter into cooperative agreements to share services, facilities, personnel and equipment. The intent of cooperative agreements among hospitals is to promote decreased costs and increased accessibility in providing health care to communities served by the hospitals which are parties to the agreement. Certificates of public advantage are issued to hospitals which enter into a cooperative agreement. The following comments were received relating to the proposed section. Comment: Relating to sec.134.101(b)(2)(I), a commenter suggested that the language be revised to make clear that applicant hospitals must include a statement that addresses one or more of the benefits of the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.134.101(b)(2)(J), a commenter suggested that the word "appropriate" be inserted after the word "each" when referring to the consideration of the factors listed in the Health and Safety Code, sec.313. 002(f), which a hospital must address in the statement of disadvantages attributable to a reduction in competition resulting from the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.134.101(b)(2)(M) and (R), a commenter suggested that the language be revised to require that an application only include a description of the geographic area and the present and projected market share of the health care equipment, facilities, personnel or services which are the subject of the cooperative agreement. Response: The department agrees and has revised the language accordingly. Comment: Relating to sec.134.101(b)(2)(W), a commenter asked how and on what basis the department determined that a $10,000 application fee was appropriate. Response: The department responds that the amount of the application fee is based upon the anticipated cost of processing the application and upon the language in the Health and Safety Code, sec.313.002(b) which allows the department to collect a fee not to exceed $10,000 per application. Comment: Relating to proposed sec.134.101(d), a commenter recommended that subsection be deleted and that sec.134.101(g)-(k) be revised to utilize the terms "termination" and "terminate" in lieu of the terms "revocation" and "revoke." Response: The department deleted proposed subsection (d) and has revised the following subsections as suggested. Comment: Relating to proposed sec.134.101(f), a commenter recommended that this subsection be revised to more specifically describe the data or information hospitals must provide on an annual basis as part of the department's monitoring process. Response: The department agrees and has revised the subsection accordingly. Comment: Regarding subsection (b)(1), department staff recommended that the term "mental" hospital be changed to "psychiatric" hospital due to the fact that the reference to mental hospital is outdated and the change would be consistent with the Texas Department of Mental Health/Mental Retardation definition for psychiatric hospital. Response: The department concurs and made the change. Minor editorial changes for made for clarification purposes. The Texas Hospital Association provided the comments on the proposed rules. The Association basically supported the rules, but had concerns and questions as previously mentioned. The new section is adopted under the Health and Safety Code, Chapter 313, which provides the Texas Board of Health (board) with the authority to adopt rules to implement legislative mandates of the 73rd Texas Legislature, Regular Session, 1993, specifically House Bill 1884; and sec.12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law upon the board, the department and commissioner of health. sec.134.101. Cooperative Agreements and Certificates of Public Advantage. (a) Purpose. The purpose of this section is to establish procedures to implement the Health and Safety Code, Chapter 313, as added by Chapter 638, 73rd Legislature, Regular Session, 1993 (House Bill 1884), by which hospitals may enter into cooperative agreements with other hospitals in the state. (b) Review of cooperative agreements. (1) Private psychiatric hospitals which are parties to a cooperative agreement may file an application with the department for a certificate of public advantage governing the cooperative agreement. (A) Only persons licensed as a hospital under the Health and Safety Code, Chapter 241 or 577, may be parties to the cooperative agreement. (B) The cooperative agreement must be filed at least 120 days prior to the effective date of the agreement. (C) The cooperative agreement must be executed by all parties. (D) The application shall be filed jointly by all parties to the cooperative agreement; however, the parties shall designate one person to be the contact person with the department. (2) The application must include: (A) a table of contents; (B) a written copy of the cooperative agreement; (C) the exact name of each party and the address of the principal business office of each party; (D) the name of the registered agent and address of the registered office for each party which is a corporation; (E) the name, address, and telephone number of one contact person authorized to receive notices and communications with respect to the application; (F) a notarized statement by a responsible officer or partner, as appropriate, of each party attesting to the accuracy and completeness of the enclosed information; (G) a brief summary of the nature and scope of the cooperative agreement; (H) a description of any consideration passing to any party; (I) a statement of the likely benefits resulting from the cooperative agreement addressing one or more of the benefits of the cooperative agreement listed in the Health and Safety Code, sec.313.002(e) and any other benefits; (J) a statement of the disadvantages attributable to a reduction in competition that might result from the cooperative agreement addressing each appropriate factor listed in the Health and Safety Code, sec.313.002(f), and any other factors which should be considered; (K) a statement of how and why the likely benefits resulting from the cooperative agreement outweigh the disadvantages attributable to a reduction in competition that might result from the cooperative agreement; (L) a description of the geographic territory to be served by the health care equipment, facilities, personnel, or services which are the subject of the cooperative agreement; (M) if the geographic territory described in subparagraph (L) of this paragraph is different from the territory in which the parties have provided similar health care equipment, facilities, personnel or services over the last five years, a description of how and why the geographic territory differs; (N) identification of whether and how any services, personnel, facilities, or health care equipment similar to those covered by the cooperative agreement are currently being offered to or utilized by other health care providers, facilities, or patients in the geographic territory described in subparagraph (L) of this paragraph; (O) identification of the steps necessary under current market and regulatory conditions, for other parties to enter the territory described in subparagraph (L) of this paragraph and compete with the parties to the cooperative agreement in the delivery of health care services which are the subject of the cooperative agreement; (P) a description of the previous history of business transactions involving the delivery of health care services which are the subject of the cooperative agreement between the parties to the cooperative agreement; (Q) a detailed explanation of the projected effects, including expected volume, change in price, and increased revenue, of the proposed cooperative agreement on each party; (R) the present share of the health care services which are the subject of the cooperative agreement of each party to the cooperative agreement and of other health care providers or facilities affected by the cooperative agreement, and projected shares of that health care market after implementation of the cooperative agreement; (S) a statement of why the projected levels of cost, access, or quality could not be achieved in the existing market without the cooperative agreement; (T) an explanation of how the cooperative agreement relates to any likely adverse impact or reduction in competition effecting negotiation of optimal payment and service arrangements or the furnishing of goods or services including quality, availability, and price; (U) an explanation of the availability of arrangements that are less restrictive to competition and achieve similar benefits; (V) a detailed explanation of how the cooperative agreement will affect cost, access, and quality of services provided by each party; (W) a nonrefundable application fee in the amount of $10,000; (X) the proposed effective date of the agreement; and (Y) if the parties to the application desire a public hearing, a written request for a public hearing. (3) A copy of the application and copies of all additional related materials must be submitted to the Office of the Attorney General, Antitrust Division, Austin, Texas and to the Texas Department of Health (department) at the same time. (4) The department shall determine whether the application is complete within 30 days of receipt of an application. If the department determines that an application is unclear, incomplete, or provides an insufficient basis on which to base a decision, the department may return the application and specify the additional information required. The applicant may complete or revise the application and resubmit it. (5) The application shall not be considered to be filed until a complete application is received by the department, including additional information requested under paragraph (4) of this subsection. (6) Any person may request a public hearing within 30 days of the filing of an application. (A) The department shall inform the applicants in writing and publish in the Texas Register the date, time and location of the public hearing. (B) The purpose of the hearing will be to receive public comments on the application. (C) The comments shall be considered by the department and the attorney general in its determination on the request for a certificate of public advantage. (7) Any person may request a copy of the application with the supporting documentation at the person's expense. (8) The department shall consult with the attorney general on every application. (9) The department shall grant or deny the application within 120 days of the date of filing of the application. (10) The department shall issue a certificate of public advantage for a cooperative agreement if it determines that the applicants have demonstrated by clear and convincing evidence that the likely benefits resulting from the agreement outweigh any disadvantages attributable to a reduction in competition that may result from the agreement. (A) The certificate of public advantage shall include the terms by which the application was approved and shall contain any conditions by which the department and the attorney general shall monitor the benefits and disadvantages resulting from the approved agreement. (B) The certificate of public advantage shall be signed by the commissioner of health. (c) Denial of an application. If the department determines that there is not clear and convincing evidence that the likely benefits resulting from the agreement outweigh any disadvantages attributable to a reduction in competition that may result from the cooperative agreement, the department shall deny the application. The department's informal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health) shall apply. (d) Periodic submission of measurable data. A decision approving an application must require the periodic submission of specific data relating to cost, access, and quality, and to the extent feasible, identify objective standards of cost, access, and quality by which the success of the arrangement will be measured. If the department determines that the scope of a particular proposed arrangement is such that the arrangement is certain to have neither a positive or negative impact on one or two of the criteria, the department's decision need not require the submission of data or establish an objective standard relating to those criteria. (e) Monitoring of cooperative agreements. The department shall appropriately supervise, monitor, and regulate approved arrangements. (1) The department shall require the parties to an approved cooperative agreement to submit information and supporting data on an annual basis regarding the current status of the agreement, including information relative to the continued benefits and any disadvantages of the agreement. (2) The information and supporting data that must be submitted to the department by hospitals under paragraph (1) of this subsection shall include: (A) any proposed change in the cooperative agreement; (B) any change in the name or address of the principal business office of each party; (C) any change in the address of the registered agent or the address of the registered office of each party which is a corporation; (D) a statement concerning how and why the benefits resulting from the cooperative agreement outweigh any disadvantages attributable to a reduction in competition resulting from the agreement; (E) any change in the geographic territory that is served by the health care equipment, facilities, personnel or services which are subject of the cooperative agreement; (F) a detailed explanation of the actual effects of the agreement on each party, including any change in volume, market share, prices and revenues; (G) an explanation of how the cooperative agreement has impacted the ability of health care payors to negotiate optimal payment and service arrangements with health care providers; and (H) a detailed explanation of how the cooperative agreement has affected the cost, access, and quality of services provided by each party. (3) If, at any time following the approval of a cooperative agreement, the department determines that there may have been a change in the facts or circumstances under which the agreement was approved the department may require the parties to the agreement to submit information required by paragraph (2) of this subsection and any other information needed by the department to determine whether the benefits of the approved agreement continue to outweigh any disadvantages attributable to a reduction in competition resulting from the agreement. If requested, the department shall hold a public hearing to solicit additional information concerning the effects of the cooperative agreement. (4) Following its review of any information submitted or received under paragraph (2) or (3) of this subsection, the department shall notify the parties to the cooperative agreement whether they are in compliance with the approved certificate of public advantage. If the parties are not in compliance with the requirements of the certificate, the department shall identify the manner in which the parties are out of compliance and shall provide an opportunity for the parties to bring the agreement within compliance. (5) Hospitals receiving notification that an arrangement is not in compliance with the certificate of public advantage have 30 days from receipt of the notice in which to respond with additional data or rationale concerning the validity of the cooperative agreement. This response may include a proposal and a time schedule by which the hospitals will bring the arrangement into compliance with a certificate of public advantage. If the arrangement is not in compliance and the department and the hospitals cannot agree to the terms of bringing the arrangement into compliance, the matter shall be set for a contested case hearing. (6) If the department determines that as a result of changed circumstances, the benefits from an approved agreement no longer outweigh any disadvantages attributable to a reduction in competition resulting from the agreement, the department may initiate proceedings to terminate the certificate of public advantage. (f) Termination. The department may terminate a certificate of public advantage, in accordance with the Health and Safety Code, sec.313.004 and the department's informal hearing procedures in Chapter 1 of this title, if: (1) the arrangement is not in substantial compliance with the terms of the application; (2) the arrangement is not in substantial compliance with the conditions of approval; (3) the arrangement has not and is not likely to substantially achieve the improvements in cost, access, or quality identified in the approval order as the basis for the department's approval of the arrangement; or (4) the conditions in the marketplace have changed to such an extent that competition would promote reductions in cost and improvements in access and quality better than does the arrangement at issue. In order to terminate on the basis that conditions in the marketplace have changed, the department's order must identify specific changes in the marketplace and articulate why those changes warrant termination. (g) Notice. The department shall begin a proceeding to terminate approval by providing written notice to the applicant describing in detail the basis for the proposed termination. (h) Procedure. A proceeding to terminate an approval must be conducted as a contested case proceeding upon the written request of the applicant. Decisions of the department in a proceeding to terminate approval are subject to judicial review. (i) Alternatives to termination. In deciding whether to terminate an approval, the department shall take into account the hardship that the termination may impose on the applicant and any potential disruption of the market as a whole. The department shall not terminate an approval if the arrangement can be modified, restructured, or regulated so as to remedy the problem upon which the termination proceeding is based. The applicant may submit proposals for alternatives to termination. An approved modified or restructured arrangement is subject to appropriate supervision. (j) Impact of termination. The applicant cannot be held liable under state or federal antitrust law for acts that occurred while the approval was in effect, except to the extent that the applicant failed to substantially comply with the terms of its application or failed to substantially comply with the terms of the approval. The applicant is fully subject to state and federal antitrust law after the termination becomes effective and may be held liable for acts that occur after the termination. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 9, 1994. TRD-9435896 Susan K. Steeg General Counsel, Office of General Counsel Texas Department of Health Effective date: March 2, 1994 Proposal publication date: November 2, 1993 For further information, please call: (512) 834-6655 Chapter 229. Food and Drug Minimum Standards for Licensure of Tattoo Studios 25 TAC sec.sec.229.401-229.412 The Texas Department of Health (department) adopts sec. sec.229.401-229.412, with changes to the proposed text published in the November 2, 1993 issue of the Texas Register (18 TexReg 7885). The sections cover general provisions, definitions, licensing fee and procedures, physical facilities, personnel responsibilities, client qualifications, sterilization, care of the tattoo, tattooing equipment, report of infection or allergic reactions, disposal of infectious waste, enforcement provisions, refusal/revocation/suspension of license, and administrative provisions. The sections establish licensing requirements for tattoo studios pursuant to the requirements of the Texas Health and Safety Code (Code), Chapter 146, which establishes an annual licensing fee and mandates standards of sanitation and aseptic technique. The sections also establish requirements for sterilization of equipment, instruction in care of the tattoo, reporting of adverse reactions and record keeping that must be met for licensure of tattoo studios. A summary of comments received during the comment period is as follows. COMMENT: Several commenters stated that the regulations do not effectively regulate those who persist in tattooing at unlicensed locations. RESPONSE: The department disagrees, since House Bill 1217 prohibits anyone from performing tattooing at any location that is not licensed and violations of the law will be subject to the same administrative and criminal penalties as violations at licensed locations. In recognition that the commenters request vigorous enforcement against unlicensed tattoo studios the department has added sec.229.401(c). COMMENT: The department's Office of General Counsel (OGC) determined that provisions in the regulations for a temporary location, temporary license and temporary license fee are not statutorily mandated and shall be deleted. RESPONSE: Pursuant to that decision, the department has deleted the temporary location definition in sec.229.402 and clarified sec.229.403(a). The department believes that the final regulations do not prohibit tattooing at a single event or celebration if the tattooing is performed in a licensed, permanent, nondwelling building. COMMENT: Concerning sec.229.402, one commenter recommended that the definition for "client" state that a person is requesting the tattoo, rather than contracting for, the tattoo. RESPONSE: The department agrees and changed the definition for "client" in sec.229.401. COMMENT: Concerning sec.229.402, the OGC introduced a new definition for "license holder" to replace the definition for "operator" to more accurately describe who may be licensed. RESPONSE: The department agrees and has deleted the definition for "operator" and replaced the definition with "license holder". COMMENT: Concerning sec.229.401, a commenter stated that the Texas Food, Drug, and Cosmetic Act be referenced in the regulations. RESPONSE: The department agrees and has added reference to the Texas Food, Drug, and Cosmetic Act (Chapter 431, Health and Safety Code) in new sec.229.401 (d). COMMENT: Representative Maxey commented that the regulations should reference, and tattoo studios be required to abide by, provisions of the Americans With Disabilities Act. RESPONSE: The department agrees and has added a new paragraph in final sec.229.401(e). COMMENT: Concerning department regulatory procedures, a commenter stated that the department investigator's accountability, inspection procedures, applicable penalties, appeal and grievance policy, and complaint investigation procedure be detailed in the regulations. The same commenter stated that the department should form an advisory council to provide input into regulation of the industry. RESPONSE: The department disagrees with the first comment, since general rights, procedures and policies for all department activities are detailed in 25 TAC Chapter 1; Texas Government Code, sec.2001; and in Health and Safety Code (Code), Chapter 431. The department has added new subsection (c) to sec.229.412 to cite applicable enforcement provisions and administrative penalties provided in the Code, Chapter 146. The department disagrees with the last comment. Recent legislation has required the department to review all advisory committees for cost effectiveness. Pending the outcome of this audit and report to the legislature, the department may again revisit the possibility of forming an advisory committee concerning the Tattoo Parlor Act. COMMENT: A commenter stated that the State has an obligation and responsibility to notify each tattoo studio of proposed regulations and the public hearings. RESPONSE: The proposed regulations and official public notification of the public hearing were published in the Texas Register on November 2, 1993. Future regulations and hearings will be published in the Texas Register, as required. Separate notification of each individual affected by the regulations is not feasible or dictated by statutory authority. COMMENT: Several commenters stated that other procedures performed in tattoo studios such as body piercing and branding be regulated with the same training and standards as tattooing. RESPONSE: The department agrees since body piercing is within the definition of "cosmetic." Branding and scarification are within the definition of "tattooing". The department added new language to final sec.229.405(h) and sec.229.407(b) to include other cosmetic procedures such as body piercing. COMMENT: Numerous commenters stated that the person performing tattooing and intradermal cosmetics should be required to obtain a license from the department. Another commenter stated that tattooing should be taught through certified or licensed programs and that tattooists be required to pass a standard state board exam for licensure. RESPONSE: The department disagrees since House Bill 1217 provides for the licensure of the tattoo studio, not the tattooist. The department agrees that education and training in aseptic technique would be beneficial for all tattooists. The department believes it is the tattooists' responsibility to know and practice these techniques, but will evaluate the effectiveness of this approach in our first year of regulatory activities and amend the rules if necessary. COMMENT: Numerous commenters stated that each tattooist at a location should be required to license with the department, rather than only the tattoo studio owner. RESPONSE: The department agrees that if the owner is not willing to be responsible for other tattooists at the licensed location, each tattooist must maintain a license at the location and be individually responsible for adherence to the tattoo regulations. New language was added to the definition of "tattooist", a new definition for "license holder" in sec.229.402, and new descriptive requirements for address was added to sec.229.403(c)(2). The definition of "owner" was replaced by "license holder" in sec.229.403(f)(1) and a person who holds a license was replaced by "license holder" in sec.229.403(f) (2). COMMENT: Concerning sec.229.402, a department program suggested revisions in the definition for "aseptic technique". RESPONSE: The department agrees and made changes in sec.229.402. COMMENT: Concerning sec.229.402, under the definition of "tattooist" one commenter stated that the term "permanent cosmetics" be referred to as "intradermal cosmetics" due to advances in removal techniques and in the types pigments used. RESPONSE: The department agrees and has changed permanent cosmetic to intradermal cosmetic each place it appears in the rules. COMMENT: Concerning sec.229.403, several commenters stated that tattooing at health care entities such as medical offices and hospitals for medical procedures such as tumor markings, medical camouflage and dermal pigmentation should be exempt from the Tattoo Parlor Act and the regulations. RESPONSE: Even though an exemption is not specifically mentioned in the Tattoo Parlor Act, the department believes that it was not the legislative intent to license health care entities such as physician's offices and hospitals, since standards for sanitation, sterilization, aseptic technique and record keeping are already mandated by other State and Federal regulations. COMMENT: Concerning sec.229.403, one commenter stated that equipment used by persons tattooing in an unlicensed location should be confiscated. RESPONSE: The department disagrees since it does not have confiscatory authority. COMMENT: Concerning sec.229.403(a), one commenter stated that a statement of financial responsibility and a cash bond be required for licensure of tattoo studios, tattoo artists, and temporary locations. RESPONSE: The department disagrees since House Bill 1217 specifies a license application fee. COMMENT: Concerning sec.229.403(a), one commenter stated that the license fee be changed to $200 per tattoo artist. RESPONSE: The department disagrees at this time based on our predictions of expected revenue. The department will evaluate fee revenue during the first year to determine if license fees are adequate to fund regulatory activities. COMMENT: Concerning sec.229.403(a)(1), one commenter stated that the licensure fee should be changed from $130 per studio to $100 per tattoo studio with an additional $30 per year for each tattooist working at the studio. RESPONSE: The department disagrees since many owners commented they are not willing to take responsibility for all tattooists at the licensed location. COMMENT: Concerning sec.229.403(a)(2), several commenters stated that provisions should be made to allow mobile studios as long as the owner operates a licensed studio and obtains a temporary license for each location. RESPONSE: The department disagrees. The statute defines tattoo studio as a permanent, nondwelling building located in an area in which the location is permissible under local zoning codes, if any. COMMENT: Concerning sec.229.403(c)(5), one commenter stated that the requirement to list all tattooists working at the studio would involve excessive time and paper work due to high turnover rate. RESPONSE: The department disagrees since the requirement to list the studio's tattooists on new and annual renewal applications is necessary to track facility operations. COMMENT: Concerning sec.229.403(c)(6), several commenters objected to the requirement to include the hours of operation on the license statement since many tattoo studios are not open on a regular schedule. One commenter wanted assurance it would not be a violation to open beyond reported operating hours. RESPONSE: The department disagrees since hours of operation are necessary to schedule inspections and facilitate contact with the tattoo studio. However, the department acknowledges that some studios are not open the same schedule each day, and final sec.229.403(c)(6) is changed to require the listing of the usual hours of operation. COMMENT: Concerning sec.229.403(c)(8), the department's OGC requested that the terms "owner or manager" be replaced with "applicant". RESPONSE: The department agrees and changed sec.229.403(c)(8). COMMENT: Concerning sec.229.403(d), a department program requested the addition of "an agent of" the department to clarify who will inspect tattoo studios. RESPONSE: The department agrees and changed sec.229.403(d). COMMENT: Concerning sec.229.403(f)(2), one commenter objected to a $100 delinquency fee because owners of multiple locations might have difficulty keeping up with renewal times. RESPONSE: The department disagrees since owners of multiple locations can arrange with the department's Licensure Branch of the Division for the same renewal time for all their locations. COMMENT: Concerning sec.229.403(f)(3)(A), one commenter stated a lesser transfer fee be imposed for changes in location of a studio. RESPONSE: The department disagrees because of the expense to the department of a statutorily required pre-licensing inspection of the new location. COMMENT: Concerning sec.229.403(f)(3)(B), one commenter questioned the requirement for a 30-day notification period for change of studio location since a similar period was not required for other businesses such as beauty shops. RESPONSE: The department disagrees since due to requirements in the statute, the department must have sufficient time to inspect the new facility and check for prohibitive local zoning ordinances before a license may be issued. COMMENT: Concerning sec.229.404(a), several commenters questioned whether the nondwelling provision would prohibit licensure of studios that are attached to a dwelling. RESPONSE: The department believes that sec.229.404(a) is clear that dwellings may not be used. COMMENT: Concerning sec.229.404, a commenter stated that due to the risk of infection from airborne micro-organisms in areas where hair and fingernail services are performed, tattooing should only be allowed in an area separate or enclosed from those services. RESPONSE: The department agrees and has added the requirements in new subsection (j) of sec.229.404. COMMENT: Concerning sec.229.404(a), several commenters stated that locations for temporary licenses are not always permanent buildings. RESPONSE: The department agrees. However, the statute does not address temporary locations. Consequently, these rules cannot allow for a temporary license or locations in nonpermanent buildings. COMMENT: Concerning sec.229.404(b)(1), two commenters stated that acceptable disinfectants for work surfaces be more clearly defined and that disinfecting requirements for work surfaces be different from the cleaning and disinfecting requirements for building areas. RESPONSE: The department agrees and has modified final sec.229.404(b)(1) and added new sec.229.404(b)(2). COMMENT: Concerning sec.229.404(f), one commenter stated that it is frequently not possible to have running water at a tattooing facility and suggested that the provisions in sec.229.405(f) suffice as an alternative. RESPONSE: The department disagrees, since proper and frequent handwashing is a required procedure in the practice of aseptic technique. COMMENT: Concerning sec.229.404(f), a department program stated that single-use towels be required. RESPONSE: The department agrees and made appropriate changes to sec.229. 404(f). COMMENT: Concerning sec.229.404(g), two commenters stated that this restriction would prevent the practice of tattooing serial numbers on animals in tattoo studios. Other commenters stated that aquariums containing fish, spiders, or other animals should be allowed since they do not pose a risk of contamination to the tattoo area. RESPONSE: The department disagrees with the first comment, since animal tattooing can be performed in a separate enclosed area from human tattooing. The department agrees with the second other comment and has made appropriate changes in final sec.229.404(g). COMMENT: Concerning sec.229.404 (h), numerous commenters stated that smoking should be allowed at the owner's discretion in an area separate from the tattooing area or in a waiting room area, since smoking is allowed in other businesses. Several commenters stated that smoking should be allowed because it has a calming effect for persons receiving a tattoo. One commenter stated that smoking should be prohibited only by the tattooist while he/she is performing tattooing. Two commenters disagreed with provisions that would prohibit smokeless tobacco. RESPONSE: The department agrees with the first commenters that smoking tobacco in a separate area be allowed and has made the appropriate changes in the final sec.229.404(h). The department disagrees with the commenters who advocate allowing smoking in the tattooing area since the practice is not consistent with the practice of aseptic technique. The department agrees with the last commenters that use of smokeless tobacco be allowed and changes sec.229.404(h). COMMENT: Concerning sec.229.404, a commenter stated that tattoo studios be required to have a separate waiting area and a screen or curtain for client privacy. RESPONSE: The department agrees that a separate waiting area is preferred, but the financial burden on some studios make the requirement impractical at this time. The department agrees that privacy should be provided at the client's request and has added sec.229.404(k). COMMENT: Concerning sec.229.404(h), a commenter stated that alcoholic beverages and illegal substances in any form be prohibited from tattoo studios. RESPONSE: The department agrees that alcoholic beverages be prohibited and changes sec.229.404(h). The department believes that illegal substances are already prohibited by other statutes. COMMENT: Concerning sec.229.404(i), a department program recommended new language to require the studio to be kept free of rodents and vermin. RESPONSE: The department agrees and has changed sec.229.404(i) to reflect the recommendation. COMMENT: Concerning sec.229.405, a commenter stated that individuals performing tattooing or intradermal cosmetic procedures should possess a health certificate or health records. RESPONSE: The department disagrees at this time since the practice of aseptic technique and use of proper sterilization procedures effectively minimize the risk of disease transmission. COMMENT: Concerning sec.229.405(b), a commenter questioned the requirement for handwashing in hot water, since the temperature is not specified. RESPONSE: The department agrees that the temperature for hot water is not provided and has added the option of using tempered water to sec.229.405(b). COMMENT: Concerning sec.229.405(c), a commenter stated that a requirement be added to immediately remove and replace torn or perforated gloves. Another commenter questioned the requirement for approved gloves. RESPONSE: The department agrees with the first commenter and made changes to sec.229.405(d). The department agrees with the second commenter and has clarified the type of glove required in sec.229.405(c). COMMENT: Concerning sec.229.405(e), one commenter stated that tattooists should not be permitted to tattoo if sores or lesions are present on his/her hands. RESPONSE: The department agrees and changed final sec.229.405(e). COMMENT: Concerning sec.229.405(f), one commenter stated that 50% isopropyl alcohol is adequate for treating the skin. RESPONSE: The department disagrees since 70% isopropyl alcohol is the minimum concentration recommended for acceptable antiseptic activity. COMMENT: Concerning sec.229.405(g), several commenters objected to the requirement for tattooists to use single service razors, since the State Board of Cosmetology allows reusable razors after disinfection. RESPONSE: The department agrees and has made appropriate changes to sec.229. 405(g). COMMENT: Concerning sec.229.405(h), several commenters questioned the definition of a qualified individual. Several commenters questioned the content and length of required training. RESPONSE: The department agrees that this section lends itself to many interpretations, but the intention was to require individuals performing tattooing to know and practice aseptic technique at all times. The department clarified this intent in sec.229.405(h). COMMENT: Concerning sec.229.405(h), one commenter stated that an annual "check up" or annual appraisal would be sufficient to maintain expertise in the use of aseptic technique. RESPONSE: The department has clarified the final wording of sec.229.405(h) to require the tattooist to know and use aseptic technique, but the type or length of training is not specified, since no training regimens are currently available. The department will evaluate the effectiveness of this section in the first year of regulatory activities. COMMENT: Concerning sec.229.406, one commenter stated that the required client information should be gathered in a "face-to-face" interview rather than by filling out a form, since clients are more inclined to lie. RESPONSE: The department's response is that the regulations, as written, do not prevent the tattooist from personally interviewing the client during completion of required records. COMMENT: Concerning sec.229.406(a), a commenter stated that persons under the age of 18 be allowed to receive tattoos with parental permission. One commenter stated that underage tattooing be allowed only with orders from a court of law. Several commenters stated that medical procedures such as reconstructive procedures, scar revisions, or tattooing to alter or cover unwanted tattoos should be allowed with parental and physician consent for persons under the age of 18. RESPONSE: The department disagrees with the first two commenters, since the statute does not provide for exceptions to the age limit. While the department agrees with the last commenters, the statute does not exempt anyone thus exemptions will need to come from the legislature. The department does not believe that it is the intent of the statute is to prohibit medical procedures. COMMENT: Concerning sec.229.406(a), one commenter stated that a state driver's license, state identification or military identification card should be the only acceptable means to verify the age of potential clients. Two commenters stated that a picture identification be required. RESPONSE: The department agrees with the first commenter that these types of identification are preferred to ensure that persons under 18 do not receive tattoos and to protect the liability of the tattooist. However, the department disagrees at this time that these be the only allowable types of identification or that picture identification be required, since some clients may not be able to provide them. The department has modified sec.229.406(a) to require documentation of the client's age and the type of identification accepted. The department will evaluate the effectiveness of this requirement in our first year of regulatory activities. COMMENT: Concerning, sec.229.406(a), Representative Glen Maxey commented that if drivers license numbers are required to be recorded, a confidentiality clause be added to the rules to protect the privacy of individuals seeking tattoos. RESPONSE: The department agrees and has eliminated the requirement to record drivers license number in sec.229.406(a). COMMENT: Concerning sec.229.406(b), one commenter stated that the wording of this section would prohibit the use of anesthesia in surgery, since surgical procedures result in scar formation. RESPONSE: The department's response is that the intent or effect of House Bill 1217 does not override the provisions of the Medical Practice Act of Texas, which regulates the performance of medical procedures by licensed practitioners. A surgical procedure is not necessarily a tattoo. COMMENT: Concerning sec.229.406(d), one commenter stated that the department should specify what risks and dangers should be described to the client. RESPONSE: The department agrees and has made changes to sec.229.406(d). COMMENT: Concerning record keeping requirements in sec.229.406(e) and sec.229. 408(b), several commenters stated that the same time be required for retention of all patient records. One commenter stated that a one year period was sufficient. RESPONSE: The department agrees and has made appropriate changes to sec.229. 406(e) and sec.229.408(b). COMMENT: Concerning sec.229.406(d)(1), several commenters stated that requirements for tattoo studios to record the name, address and telephone number of the client was an invasion of privacy. RESPONSE: The department disagrees since client identification is necessary for both the department and tattooists to inform clients if a public health risk associated with specific tattooing is discovered. COMMENT: Concerning sec.229.406(d)(4), numerous commenters stated that requirements for tattoo studios to keep records of the specific location and description of the client's tattoo is an invasion of privacy, unconstitutional, may cause certain persons to obtain tattoos in unlicensed locations, and that the information may be used by enforcement agencies to identify individuals. RESPONSE: The department agrees at this time and has eliminated the requirement in sec.229.406(d)(4). The department will evaluate the necessity for this requirement in our first year of regulatory activities. COMMENT: Concerning sec.229.406(d)(4), numerous commenters objected to the requirement to keep records of each pigment used in applying a tattoo. Two commenters stated that a tattoo artist may use over 200 different colors and that the source for these pigments is a trade secret that many tattooists do not want revealed to clients or competitors. Other commenters stated that recording pigments would be difficult since many tattooists manufacturer their own pigments or combine pigments. Numerous commenters stated that if the intent of recording colors is to aid in laser removal at a later date, it should not be the tattooists' responsibility, since clients choose to receive an indelible tattoo. Two commenters stated that the client should be given a copy of the brand names, colors or ingredients of pigments in the event later tattoo removal is desired. RESPONSE: The department disagrees with the first four comments, since reporting and tracking of adverse reactions to pigments and dyes inserted under the skin surface has not been performed and the department believes this information is invaluable to determine the safety of pigments used in tattooing and to aid those who decide to have the tattoo removed. The department agrees with the last commenter at this time, since numerous other commenters stated that the sources of colors are a trade secret. The department will evaluate the necessity for this requirement in our first year of regulatory activities. COMMENT: Concerning sec.229.407(a), several commenters questioned what type of sterilization equipment would be allowed in tattoo studios. RESPONSE: The department agrees that the paragraph is not definitive and has clarified sec.229.407(a). COMMENT: Concerning sec.229.407, several commenters stated that reuse of needles be prohibited. RESPONSE: The department disagrees to the extent that proper sterilization of equipment and use of aseptic technique will effectively minimize the risk of disease transmission. COMMENT: Concerning sec.229.407(f), several commenters stated that sterilization records should be kept for the same length of time as other required records. RESPONSE: The department agrees and changed sec.229.407(f). COMMENT: Concerning sec.229.408, one commenter stated that a single record be required for large tattoos that require several sessions to complete. RESPONSE: The department disagrees, since the documentation of each tattooing session, including pigments applied and care instructions for each tattooing procedure, is necessary. The tattooist may maintain a client file that contains required information from the first session and only the additional new information to document subsequent tattoo sessions. COMMENT: Concerning sec.229.408(c), a commenter stated that a time period of at least two weeks be added to the sun exposure limit requirement. The same commenter stated that swimming in fresh, salt or chlorinated pool water be discouraged for at least two weeks. RESPONSE: The department agrees and has added the requirements to sec.229. 408(c). COMMENT: Concerning sec.229.408(c)(4), one commenter stated that sterile bandage application was not possible for certain facial tattoos. Other commenters stated that bandages were not recommended after 24 hours. RESPONSE: The department agrees and changed sec.229.408(c)(4). COMMENT: Concerning sec.229.408(c)(6), a department program recommended that new language be added for clarification purposes. RESPONSE: The department agrees and changed sec.229.408(c)(6). COMMENT: Concerning sec.229.408, two commenters stated that a requirement be added to report adverse reactions to the tattooist and to the Texas Department of Health. RESPONSE: The department agrees and added sec.229.408(c)(5), sec.229.408(c)(8) . COMMENT: Concerning sec.229.409, several commenters stated that the regulations should prohibit licensed tattoo studios from selling tattoo supplies to the general public. RESPONSE: The department disagrees since restricting the sale of tattooing equipment, which are classified as unrestricted medical devices, would constitute restraint of trade. COMMENT: Concerning sec.229.409(d), a commenter stated that this requirement should be eliminated. RESPONSE: The department disagrees since this requirement is one of the many procedures necessary for the practice of aseptic technique. COMMENT: Concerning sec.229.409(e), several commenters stated that all acetate tattoo stencils should be single-service. RESPONSE: The department agrees and has added changes to sec.229.409(e). COMMENT: Concerning sec.229.409(f), a department program recommended that a generic name be used to replace a trade name in an example of a germicidal solution. RESPONSE: The department agrees and changed sec.229.409(f). COMMENT: Concerning sec.229.409(g), one commenter recommended that cleaning of tattoo equipment be performed by gloved personnel. RESPONSE: The department agrees and changed sec.229.409(g). COMMENT: Concerning sec.229.409(i), several commenters stated that the record keeping requirements for cleaning of tattoo equipment prior to sterilization were not necessary since the procedure was outlined in detail. RESPONSE: The department agrees and eliminated sec.229.409(i). COMMENT: Concerning sec.229.410, a commenter asked whether the common occurrence of cold sores or fever blisters after application of intradermal lip lining was considered a reportable infection. RESPONSE: The department response is that only a licensed health care practitioner is qualified to diagnosis a herpes simplex I infection. COMMENT: Concerning sec.229.410, a commenter stated that only physicians, not tattooists, can diagnosis or test for causative organisms and that clients are sometimes allergic to soaps or creams that cause reactions not related to the application of the tattoo. RESPONSE: The department's response is that sec.229.410(a)(3) requires reporting of the causative organism only if known, and if known, it is assumed that the patient has received a diagnosis from a physician. To clarify this provision, the department has eliminated reference to causative organism, but retained the reporting of the name and address of health care provider in sec.229.410(a)(3). COMMENT: Concerning sec.229.410(a), one commenter stated that the requirement to report infection or allergic reaction resulting from the application of a tattoo was discriminatory against tattooists since doctors are not required to report infections from their procedures. The same commenter was concerned that tattooists may be blamed for infections from clients who do not follow care instructions. RESPONSE: Physicians are licensed and regulated by the Board of Medical Examiners. The department agrees that some infections or adverse reactions to tattooing are due to client negligence. The department believes that statewide reporting is needed to evaluate the extent and cause of adverse reactions to pigments, infections, or client negligence in care of the tattoo. The department has added new sec.229.410(b) to define how the department will utilize the reported information. COMMENT: Concerning sec.229.411(a), a department program recommended rewording this section to clarify its intent. RESPONSE: The department agrees and changed sec.229.411(a). COMMENT: Concerning sec.229.411(b), a department program recommended a general description of tattoo studio waste. RESPONSE: The department agrees and changed sec.229.411(b). COMMENT: Regarding sec.229.412, the Office of General Counsel recommended that the penalty provisions of the statute be noticed in the regulations. RESPONSE: The department agrees and new paragraph sec.229.412(c) has been added. Minor editorial changes were made for clarification purposes. The commenters were Representative Glen Maxey, University of Texas At Arlington School of Nursing, Classic Beauty Concepts, Texas Institute of Permanent and Corrective Cosmetics, Texas Department of Health, Division of Infectious Diseases, Epidemiology, and Surveillance, Happy Dragon Tattooing Studio, Imperial Tattoo, Rich Color Tattoos, Texas Abate Confederation, Inc., Custom 23 Tattoo, Custom Design Tattoo, Houston Tattoo Artists Association, Dragon Mike and Tiger John's, Tattoos Tri-Star Tattoo, Tattoo City, Texas Tattoo Association, Tigger's Body Art Gallery, Ragoo's Tattoos, Inkslingers Tattoos, Chuck's Custom Tattoos, Dallas Tattoo Association, Derma-Graph, The Tattoo Studio, Tattoos 4 U, Tattoos By Larry Shaw, Tattooing by Adrian, Taylor Hancock, Attorney at Law, Tattoos By Dr. Who, Touch of A Feather, American Institute of Intradermal Cosmetics, Inc., Singapore John's Tattoo Arcades. In addition, numerous individuals commented. All commenters were not against the rules in their entirety, however they expressed concerns, questions and recommendations. The new sections are adopted under the Texas Health and Safety Code, sec.146. 010(a) and sec.146.015(a), which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 146; and sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health and the Commission of Health. sec.229.401. General Provisions. (a) These sections provide for the licensing and regulation of tattoo studios. (b) The "Tattoo Parlor Act," House Bill 1217, 73rd Legislature, Regular Session, 1993, Health and Safety Code, Chapter 146, requires the Texas Board of Health to adopt rules regulating tattoo studios. (c) No person may cause, suffer or allow the operation, management or maintenance of a tattoo studio without a license issued in accordance with these sections. (d) All tattoo studios shall comply with the minimum standards specified in these sections in addition to the existing standards contained in the Tattoo Parlor Act and the Health and Safety Code, Chapter 431, the Texas Food, Drug, and Cosmetic Act, relating to drugs and cosmetics, including adulteration and misbranding. (e) All tattoo studios should comply with applicable provisions of the Americans With Disabilities Act. sec.229.402. Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Act-The Tattoo Parlor Act, House Bill 1217, 73rd Legislature, Regular Session, 1993, Health and Safety Code, Chapter 146. Aseptic technique -A hygienic practice which prevents and hinders the direct transfer of microorganisms, regardless of pathogenicity, from one person or place to another person or place. Authorized agent -An employee of the department designated by the Commissioner to enforce the Act. Client-A person requesting the application of a tattoo. Commissioner-Commissioner of the Texas Department of Health. Cosmetic-An article or substance intended to be rubbed, poured, sprinkled, or sprayed on or introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearances; or an article or substance for use as a component of such an article, except that the term does not include soap. Department-The Texas Department of Health. License holder -A person who conducts, operates or maintains a tattoo studio in compliance with these sections. Sanitize-To treat a clean surface and destroy pathogenic microorganisms. Single-service items -Articles intended for one-time, one-person use and which are to be discarded after such use. Tattoo/tattooing-The practice of producing an indelible mark or figure on the human body by scarring or inserting a pigment under the skin using needles, scalpels, or other related devices; intradermal cosmetics. Tattooist-A person who performs tattooing or applies intradermal cosmetics and who is responsible for adherence to the provisions of these sections. Tattoo parlor or tattoo studio-A permanent, nondwelling building or portion of a building, designated by a license holder and located in accordance with applicable local zoning codes where tattooing or intradermal cosmetic application is performed. Studios attached to a residence shall maintain a separate entrance which shall not open from a residential quarter. In these sections, tattoo parlors shall be referred to as tattoo studios. sec.229.403. Licensing Fee and Procedures. (a) License fee. All tattoo studios shall obtain a license annually with the Texas Department of Health (department) and shall pay a license fee of $130 per tattoo studio. (b) License forms. License forms may be obtained from the Texas Department of Health, Division of Food and Drugs, 1100 West 49th Street, Austin, Texas 78756- 3182. (c) License application. The tattoo studio license application shall be signed and verified on the license application furnished by the department, and shall contain the following information: (1) the full or legal name under which the tattoo studio is conducted; (2) the address of each tattoo studio that is to be licensed. Sufficient descriptive information must be included if the studio is located in a portion of the building with other license holders; (3) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, then the names of the principals of such association; (4) for each tattoo studio, the name(s) and residence address(es) of the individual(s) in charge thereof; (5) the name(s) of the tattoo studio's tattooist(s); (6) the usual days and hours of operation of each tattoo studio; (7) a description of all services to be provided at the tattoo studio; and (8) an application form which shall be verified and signed by the applicant. (d) Pre-licensing inspection. On receipt of the initial license application, an agent of the department shall inspect the proposed tattoo studio to determine compliance with these sections and to determine compliance with existing building and zoning codes applicable to the studio. (e) Issuance of license. The department may issue a license to the tattoo studio after determining that the studio is in compliance with applicable statutes, rules, and building and zoning codes. (1) The initial license shall be valid for one year from the date of issuance which becomes the anniversary date. (2) The renewal license shall be valid for one year from the anniversary date. (3) The license shall be displayed in a prominent place in the tattoo studio. (f) Renewal of license. (1) Each year, the license holder shall renew its license in accordance with the requirements of this section. (2) The license holder shall renew the license by filing an application for renewal on the form prescribed by the department accompanied by the appropriate licensure fee. A licensee must file for renewal before the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee. (3) Failure to submit the renewal annually shall subject the tattoo studio to the enforcement provisions of the Tattoo Parlor Act and also to the provisions of sec.229.412 of this title (relating to Refusal, Revocation or Suspension of License and Enforcement Provisions). (A) Amendment of license. A license must be amended when the name, ownership, or location of the licensed tattoo studio is changed. Such changes require submission of the fees as outlined in subsection (a) of this section. (B) Notification of change of location of tattoo studio. (i) Not fewer than 30 days in advance of the change, the licensee shall notify the commissioner or the commissioner's designee in writing of the licensee's intent to change the location of a licensed tattoo studio. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the tattoo studio at the new location. (ii) Notice will be deemed adequate if the licensee provides the intent and verification notices to the commissioner or the commissioner's designee within the established time frames of clause (i) of this subparagraph by certified mail, return receipt requested, mailed to the Texas Department of Health, Division of Food and Drugs, 1100 West 49th Street, Austin, Texas, 78756. (iii) Not later than the tenth day after the change of location is complete, the license holder shall notify the department in writing and shall verify the information submitted under clause (i) of this subparagraph. sec.229.404. Physical Facilities. (a) A tattoo studio must be in a permanent, nondwelling building located in an area in which the location is permissible under local zoning codes, if any. (b) The tattoo studio shall be maintained in a sanitary condition. (1) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning methods, equipment, and the use of hospital (grade) United States Environmental Protection Agency registered disinfectants or a 1:100 dilution of household bleach and water (1/4 cup bleach and 1 gallon of water) to be used in disinfecting all work surfaces. (2) Other environmental surfaces shall be cleaned with an all-purpose detergent-disinfectant. (c) The walls, ceilings and floors shall be kept in good repair. Tattooing areas and restrooms shall be constructed of smooth, hard surfaces that are easily cleaned. (d) Tattoo studios shall have adequate lighting of at least 50-foot candles of illumination in the tattooing area. (e) Adequate ventilation shall be provided. (f) Each tattoo studio shall be provided with adequate, conveniently located hand-washing facilities for its personnel, including a lavatory or lavatories equipped with hot and cold or tempered running water, germicidal soap, single- service towels or other approved hand-drying devices and refuse container. Such facilities shall be kept clean and in good repair. (g) Animals are not permitted in the tattoo studios, except for guide or service animals accompanying persons with disabilities, or non-mammalian animals in enclosed glass containers such as fish aquariums, which shall be outside the tattooing area. (h) Smoking shall be prohibited in the tattooing area. Consumption of alcoholic beverages shall be prohibited in tattoo studios. (i) The tattoo studio shall be kept free of rodents and vermin and protected from infestation by insects. (j) If tattooing is performed where cosmetology services are provided, it shall be performed in an area that is separate and enclosed. (k) The tattoo studio shall have available a closed area, screen, or curtain to accommodate those clients who request privacy during tattooing. sec.229.405. Personnel Responsibilities. (a) All tattooists while applying tattoos shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty. (b) All tattooists shall wash their hands thoroughly using hot or tempered water with a germicidal soap before and after applying a tattoo and as often as necessary to remove contaminants. (c) All tattooists must wear single-service examination gloves while applying tattoos and intradermal cosmetics. (d) When a tattoo session is interrupted or immediately after gloves are torn or perforated: (1) gloves shall be removed and discarded; and (2) hands shall be washed and a fresh pair of gloves used. (e) Tattooists shall be free of communicable disease, open sores or exudative lesions while applying tattoos. (f) The area of the client's skin to be tattooed shall be adequately cleaned with a germicidal skin preparation and the tattooist shall treat the skin with 70% isopropyl alcohol, iodophor, or other United States Food and Drug Administration approved antiseptic products. (g) If shaving is required, razors shall be single-service, or if reused, they shall be washed thoroughly in soap and water and disinfected with a hospital (grade) United States Environmental Protection Agency registered disinfectant solution before reuse. (h) Each tattooist, or any person performing any cosmetic procedure in the tattoo studio, shall have the education, training and experience, or any combination thereof, to practice aseptic technique. All tattoo procedures shall be performed using aseptic technique. sec.229.406. Client Qualifications, Disclosure and Records. (a) Clients must be a minimum of 18 years of age and have a positive identification card in their possession. Documentation of verification of age must be provided by recording the client's age and type of identification provided. (b) No person may be tattooed who appears to be under the influence of alcohol or drugs. (c) Tattooing shall not be performed on any skin surface which manifests any evidence of unhealthy conditions such as rashes, boils, infections, or abrasions. (d) Before receiving a tattoo, each client shall be informed in writing about the possible risk and dangers associated with the application of each tattoo. These shall include but are not limited to at least the following: the possibility of discomfort or pain, the permanence of the markings, the risk of infection, and the possibility of allergic reaction to the pigments or other materials used. (e) The tattoo studio shall maintain proper records of each client. The information shall be permanently recorded and made available for examination by the authorized agent in the tattoo studio for at least one year following the date of the last entry. These permanent records shall include: (1) the name, address, and telephone number of the client; (2) the date tattoo was applied; (3) the client's date of birth; (4) the specific color or colors of the tattoo applied to the client and when available, the manufacturer's catalogue or identification number of each color used; (5) the name of the tattooist; and (6) the signature of the client. sec.229.407. Sterilization. (a) A tattoo studio shall contain sterilization equipment that is approved by the United States Food and Drug Administration for the purpose of sterilization, and adequate in size to accommodate needles, tubes, tips, and other necessary utensils and equipment. (b) Each tattooist, or any person performing any cosmetic procedure in the tattoo studio, is responsible for always performing and being able to demonstrate correct sterilization procedures and the proper operation of autoclave and/or dry heat sterilization equipment. (c) After each use, the tattooing equipment shall be cleansed to remove blood and tissue residue before sterilization as described in sec.229.409(h) of this title (relating to Tattooing Equipment). (d) Each batch of equipment sterilized shall be monitored for sterilization by the use of chemical/heat sensitive indicators. (e) Sterilized equipment shall be stored, wrapped, or covered in a manner which will ensure that it will remain sterile until used. Each batch shall be labeled with the date of sterilization and the initials of the person sterilizing. (f) Each tattoo studio shall maintain sterilization records for at least one year from the date of the last entry, which shall include the following information: (1) date of sterilization; (2) quantity and type of equipment to be sterilized; and (3) name of individual sterilizing the equipment. (g) Sterilized equipment stored in an approved manner and not used within thirty days after sterilization shall no longer be considered sterile and shall be re-sterilized before use. (h) One of the following methods of sterilization shall be used. (1) Autoclave-steam under pressure: (A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of at least 15 pounds per square inch for not less than 30 minutes after the chamber of the autoclave has been evacuated of air and has reached temperature; and (B) as specified in the manufacturer's operator's manual. (2) Dry heat sterilization: (A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than two hours under atmospheric pressure after the sterilizer has reached the required temperature; and (B) as specified in the manufacturer's operator's manual. sec.229.408. Care of the Tattoo. (a) Each time a tattoo is applied the client shall receive oral and written instructions on the care of the newly applied tattoo. (b) The client shall sign a written statement acknowledging that the client has read and understood the recommended instructions for the care of the newly applied tattoo. A copy of the signed instruction statement must be kept by the operator at the tattoo studio for at least six months after the application of the tattoo. (c) The written statement shall contain at least the following items: (1) for at least two weeks, the need to minimize exposure to the sun, and to discourage swimming in fresh, salt or chlorinated pool water; (2) to properly cleanse the tattooed area; (3) to apply antibiotic ointment or cream; (4) to use sterile bandage(s) or other sterile dressing(s) when necessary; (5) the name of the tattooist, the name, address, and telephone number of the tattoo studio, and the instructions for the client to advise the tattooist of any infection, allergic or adverse reaction resulting from the application of the tattoo; (6) the instructions for the client to consult a health care provider at the first sign of infection or an allergic reaction; (7) the signature of the client; and (8) the instructions for the client to report to the Texas Department of Health's toll-free number any infection, adverse reaction, or allergic reaction resulting from the application of a tattoo. sec.229.409. Tattooing Equipment. (a) Needles, bars, and tubes shall be constructed in a manner that permits easy cleaning and sterilization. (b) All dyes or pigments used in tattooing shall be non-toxic, free from adulteration, and made from materials generally regarded as safe. (c) Only single-service pigment or dye containers shall be used for each client. Individual containers of dye or pigment shall be discarded after use. (d) In order to minimize transmission of body fluids and disease, single- service plastic covers shall be used to cover spray bottles or other reusable accessories for multiple client use that are handled by the tattooist during application of tattoos to multiple clients. (e) All acetate tattoo stencils shall be single-service. (f) Contaminated needles and tubes will be placed in a covered container of germicidal solution such as 2.0% alkaline glutaraldehyde (not to be construed as all-inclusive), until they can be cleaned and sterilized. (g) All containers holding contaminated needles and tubes and container lids will be cleaned and sanitized daily or as often as needed. (h) Needles and tubes (items) will be cleaned by gloved personnel prior to sterilization by one of the following methods: (1) mechanically pre-clean the items by using a clean cottonball or swab moistened with a solution of low-residue detergent and cool water, with care taken to ensure removal of any pigment inside tube/tubes not visible to the eye, thoroughly rinse with warm water and then drain, and clean by soaking in a protein dissolving detergent-enzyme cleaner used according to manufacturer's instructions; or (2) clean the items in an ultrasonic cleaning unit used according to manufacturer's instruction; and (3) rinse and dry the items prior to packaging for sterilization. sec.229.410. Report of infection or allergic reactions. A written report of any infection or allergic reaction resulting from the application of a tattoo shall be forwarded to the Texas Department of Health (department) within five working days of its occurrence or knowledge thereof. (1) The report shall include: (A) the name of the affected client; (B) the name and location of the tattoo studio; (C) the location of the infection; (D) the name and address of the health care provider, if any; (E) the name of the tattooist; and (F) any other information considered relevant to the situation. (2) The department shall utilize these reports in their efforts to identify the source of the adverse reaction(s) and to take action to prevent its recurrence. sec.229.411. Disposal of Infectious Waste. (a) Used tattoo needles and other sharps shall be subjected to the methods of treatment and disposal of sharps as described in sec.1.136 of this title (relating to Approved Methods of Treatment and Disposition) and Title 30, Texas Administrative Code, Chapter 330, Subchapter Y. (b) Other studio waste generated during the tattoo process, i.e., cotton balls, Q-tips, Kleenex, paper towels, gloves, pigment containers and soiled linens (not to be construed as all-inclusive) shall be disposed of in a sanitary landfill in accordance with Solid Waste Management rules (30 Texas Administrative Code, sec.330.136(b)(1)). sec.229.412 Refusal, Revocation, or Suspension of License and Enforcement Provisions. (a) Basis. The Texas Department of Health (department) may, after providing opportunity for hearing, refuse to license a tattoo studio, or may revoke or suspend the license for violations of the requirements in these sections or for any reasons described in the Tattoo Parlor Act, or in the Texas Health and Safety Code, Chapter 431. (b) Hearing. Any hearings for the refusal, revocation or suspension of a license are governed by the department's formal hearing procedures in Chapter 1 of this title (relating to the Board of Health) and the Administrative Procedure Act, Texas Civil Statutes, Chapter 2001. (c) Enforcement Provisions, Including Administrative Penalties. The enforcement provisions, including administrative procedures, is generally governed by the Tattoo Parlor Act, sec.sec.146.018-146.019, and the Health and Safety Code, Chapter 431. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 8, 1994. TRD-9435886 Susan K. Steeg General Counsel, Office of General Counsel Texas Department of Health Effective date: March 1, 1994 Proposal publication date: November 2, 1993 For further information, please call: (512) 458-7248 Chapter 313. Athletic Trainers General Requirements and Guidelines 25 TAC sec.sec.313.2, 313.7, 313.12, 313.14, 313.15 The Advisory Board of Athletic Trainers adopts amendments to sec.sec.313.2, 313.7, 313.12, 313.14, and 313.15, concerning licensed athletic trainers. Section 313.15 is adopted with changes to the proposed text as published in the September 21, 1993, issue of the Texas Register (18 TexReg 6421). Sections 313.2, 313.7, 313.12, and 313.14 are adopted without changes and will not be republished. The amendments add standing committees; add a limit to the number of times an applicant may retake the licensure examination; add requirements for additional coursework for an applicant who repeatedly fails the licensure examination; add consumer information provisions; define deceptive advertising; add criminal convictions related to the profession of athletic training; add various minor changes while clarifying meaning without substantial change, improve grammar and style; and implement legislation passed in 1993. The following comments were received concerning the proposed sections. COMMENT: Concerning sec.313.15(f)(2)(C), (E) and (H), a commenter felt the wording in the rules may be misleading to the public because the words "health care professional" do not appear in the law relating to athletic trainers. RESPONSE: Texas Civil Statutes, Article 4512p, sec.4 (Senate Bill 674) states that advertising that is false, misleading, or deceptive or that is not readily subject to verification is declared unlawful and is subject to action by the appropriate health licensing agency. The law lists nine types of advertising which the legislature declared to be unlawful. The Board has determined that it is a health licensing agency because athletic training is a health related field. The language in subparagraphs (C), (E) and (H) correctly reflects the statutory language. COMMENT: Concerning sec.313.15(f)(2)(F) and (G), a commenter stated that reimbursement issues belong in the insurance codes. RESPONSE: The language correctly reflects the statutory language in Senate Bill 674 stating that certain types of advertising is unlawful. The language does not determine or govern who will be covered by insurance benefits. COMMENT: Concerning sec.313.15(g), a commenter stated that reimbursement issues belong in the insurance code. RESPONSE: Section 313.15(g) correctly reflects statutory language in Texas Civil Statutes, Article 4512p, sec.5 and the Board's interpretation of that section in the second sentence of sec.313.15(g)(1). Minor editorial changes were made in sec.313.15(e) for clarity. A public hearing was held on December 6, 1993. The hearing was held at the request of the Texas Physical Therapy Association. Testimony was received from the Texas Physical Therapy Association. The comments were neither for or against the sections in their entirety; however they raised questions. 12> The amendments are adopted under Texas Civil Statutes, Article 4512d, sec.5, which provide the Advisory Board of Athletic Trainers with the authority to adopt rules concerning the regulation and licensure of athletic trainers. sec.313.15. Guidelines for Conduct. (a)-(c) (No change.) (d) Professional relationships with clients. (1)-(5) (No change.) (6) Under normal circumstances a licensee shall not offer professional services to a person concurrently receiving the same or similar professional services from another individual except with the knowledge of that individual. (e) Sanctions. A licensee shall be subject to disciplinary action by the board if the licensee: (1) is issued a public letter of reprimand; (2) is assessed a civil penalty by a court; or (3) has an administrative penalty imposed by the attorney general's office under the Crime Victims Compensation Act, Texas Civil Statutes, Article 8309-1. (f) Unlawful false, misleading, or deceptive advertising. (1) A licensee shall not use advertising that is false, misleading, or deceptive or that is not readily subject to verification. (2) False, misleading, or deceptive advertising or advertising that is not readily subject to verification includes advertising that: (A) makes a material misrepresentation of fact or omits a fact necessary to make the statement as a whole not materially misleading; (B) makes a representation likely to create an unjustified expectation about the results of a health care service or procedure; (C) compares a health care professional's service with another health care professional's services unless the comparison can be factually substantiated; (D) contains a testimonial; (E) causes confusion or misunderstanding as to the credentials, education, or licensure of a health care professional; (F) 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; (G) advertises or represents that the benefits of a health benefit plan will be accepted as full payment when deductibles or copayments are required; (H) makes a representation that is designed to take advantage of the fears or emotions of a particularly susceptible type of patient; or (I) advertises or represents in the use of a professional name a title or professional identification that is expressly or commonly reserved to or used by another profession or professional. (3) For purposes of this section a "health care professional" includes a licensed athletic trainer, temporary licensed athletic trainer, or any other person licensed, certified, or registered by the state in a health-related profession. (g) Billing information required: prohibited practices. (1) On the written request of a client, a client's guardian, or a client's parent, if the client is a minor, a licensee shall provide, in plain language, a written explanation of the charges for athletic training services previously made on a bill or a statement for the client. This requirement applies even if the charges are to be paid by a third-party. (2) A licensee may not persistently or flagrantly overcharge or overtreat a client. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 8, 1994. TRD-9435888 Michael Saly Chairman Advisory Board of the Athletic Trainers Effective date: March 1, 1994 Proposal publication date: September 21, 1993 For further information, please call: (512) 834-6615 TITLE 31. NATURAL RESOURCE AND CONSERVATION Part II. Texas Parks and Wildlife Department Chapter 57. Fisheries Commercially Protected Finfish 31 TAC sec.57.372 The Texas Parks and Wildlife Commission in a regularly scheduled public hearing held January 20, 1994 adopted sec.57.372, concerning the packaging requirements to commercially protected finfish, with no changes to the proposed text as published in the October 1, 1993, issue of the Texas Register (18 TexReg 6729). The rule will exempt retail markets and restaurants, who sell commercially protected finfish to the consumers only, from submitting receiver invoices to the Parks and Wildlife Department. The rule will eliminate the burden on retailers and restaurants of sending in copies of the commercially protected finfish invoice; however, they will need to retain a copy of the invoice for a period of one year. Six persons commented by phone on the proposed rule. All were in agreement with the proposed change. Austin Seafood; Texas Restaurant Association; Texas Aquaculture Association; Pace Fish Company; and Harvest Fresh Seafood, Inc., commented in favor of the rule. There were no comments opposed to adoption of the rule. The rule is adopted under the Parks and Wildlife Code, sec.66.020, which provides the Texas Parks and Wildlife Commission with the authority to regulate the importation of commercially protected finfish. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 7, 1994. TRD-9435819 Paul M. Shinkawa Director, Legal Services Texas Parks and Wildlife Department Effective date: February 28, 1994 Proposal publication date: October 1, 1993 For further information, please call: 1 (800) 792-1112, Ext. 4433 or (512) 389- 4433