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 7. BANKING AND SECURITIES PART VII. State Securities Board CHAPTER 109.Transactions Exempt From Registration 7 TAC sec.109.3 The State Securities Board adopts an amendment to sec.109.3, an exemption concerning transactions with financial institutions and certain institutional investors under sec.5.H of the Texas Securities Act. The rule was adopted without changes to the proposed text as published in the November 28, 1997, issue of the Texas Register (22 TexReg 11619). The amendment clarifies that dealers and investment advisers dealing solely with institutional investors named in sec.5.H of the Texas Securities Act and sec.109.3 of the Board's rules are not required to register. The amendment formalizes a longstanding agency policy that provides an exemption from registration for dealers, salesmen, investment advisers, and agents when such persons are engaging in the offer or sale of securities and/or the rendering of investment advisory services to certain financial institutions or other institutional investors. Two comment letters were received regarding adoption of the amendment. Both commenters, Sheinfeld, Maley & Kay, and the Investment Company Institute, supported adoption of the amendment. The Board agreed and adopted the amendment as published. The amendment is adopted under Texas Civil Statutes, Articles 581-28-1 and 581- 12.B. Section 28-1 provides the Board with the authority to adopt rules and regulations necessary to carry out and implement the provisions of the Texas Securities Act, including rules and regulations governing registration statements and applications; defining terms; classifying securities, persons, and matters within its jurisdiction; and prescribing different requirements for different classes. Section 12.B provides that the Board may prescribe dealer/agent registration exemptions by rule. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 16, 1998. TRD-9803802 Denise Voigt Crawford Securities Commissioner State Securities Board Effective date: April 5, 1998 Proposal publication date: November 28, 1997 For further information, please call: (512) 305-8300 CHAPTER 114.Federal Covered Securities 7 TAC sec.114.1, sec.114.3 The State Securities Board adopts amendments to sec.114.1 and sec.114.3, concerning federal covered securities. Section 114.3 is adopted with changes to the proposed text as published in the November 28, 1997, issue of the Texas Register (22 TexReg 11619). Non-substantive changes were made to delete an unnecessary phrase in subsection (b) and correct a cross reference in subsection (c). Section 114.1 is adopted without changes and will not be republished. The amendment to sec.114.1 formalizes the staff's position that offers and sales of federal covered securities may be exempt under the Texas Securities Act and Board rules. The amendment to sec.114.3 clarifies the staff's position that a consent to service is not required from a registered dealer in a firmly underwritten offering of federal covered securities since one is already on file for the dealer. The amendments apprise issuers of, and persons dealing in, federal covered securities of the filing requirements associated with the offer and sale of such securities in Texas. One comment letter was received regarding the amendment to sec.114.1. The Investment Company Institute supported adoption of this amendment. The Board agreed and adopted the amendment. No comment letters were received regarding the amendment to sec.114.3. The amendments are adopted under Texas Civil Statutes, Articles 581-28-1 and 581-5.T. Section 28-1 provides the Board with the authority to adopt rules and regulations necessary to carry out and implement the provisions of the Texas Securities Act, including rules and regulations governing registration statements and applications; defining terms; classifying securities, persons, and matters within its jurisdiction; and prescribing different requirements for different classes. Section 5.T provides that the Board may prescribe new exemptions by rule. sec.114.3.Consents to Service of Process. (a) Unless otherwise provided in this section, a consent to service of process is required from an issuer of federal covered securities that is organized under the laws of any other state, territory, or government, or domiciled in any state other than Texas. The written consent to service of process must be duly executed by an authorized agent of the issuer, under proper resolution or authority of the appropriate governing body, and irrevocably appoint the Securities Commissioner as the issuer's true and lawful attorney upon whom all process may be served in any action or proceeding against such issuer arising out of any transaction subject to the Texas Securities Act with the same effect as if such issuer were organized or created under the laws of Texas and had been lawfully served with process therein. (b) The consent to service of process is not required when the notice filing is made by a registered dealer acting as a principal in a firm commitment underwriting. (c) The consent to service of process filed through the Securities Registration Depository System will satisfy, in all respects, the requirements governing consents to service of process set out in this section and in the Texas Securities Act, sec.8. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 16, 1998. TRD-9803803 Denise Voigt Crawford Securities Commissioner State Securities Board Effective date: April 5, 1998 Proposal publication date: November 28, 1997 For further information, please call: (512) 305-8300 TITLE 16. ECONOMIC REGULATION PART I. Railroad Commission of Texas CHAPTER 3. Oil and Gas Division 16 TAC sec.3.46 The Railroad Commission of Texas (commission) adopt an amendment to sec.3.46, relating to fluid injection into productive reservoirs, to provide for issuance of area permits. These amendments are adopted with changes to the proposed text published in the October 10, 1997, issue of the Texas Register (22 TexReg 10093). The commission amends sec.3.46(d)(2) to delete a reference to disposal wells that was inadvertently included when amendments to sec.3.46 were adopted last year. The commission also adds a new subsection (o) to sec.3.46 that provides for issuance of area permits. Once an area permit is issued, individual injection wells within the area covered by the area permit would be permitted under streamlined requirements. Four commenters expressed support for the area permit concept. Staff appreciates these comments. No change was made in response to these comments. One commenter suggested that the commission explore the possibility of defining the maximum size of a "permit area" inside of the lease or unit boundaries as no closer than the setbacks applicable to producing wells in the same field and unit. Injection wells located closer to the lease or unit boundaries than allowed for producing wells in the same field could be approved for injection purposes individually. The commission disagrees with this recommendation. First, incorporating this recommendation into sec.3.46 (commonly referred to as "Rule 46") would impose distance limitations in sec.3.37 (commonly referred to as "Rule 37") on injection wells. Injection wells have never been subject to such distance limitations. Second, this commenter raised this possibility in meetings with staff as an alternative to having to specify the maximum volume of fluid to be injected into any particular well. The commission has determined that such information is not necessary unless an offset operator raises concerns about the volume of fluid to be injected into a well near his or her lease, in which case necessary volume limitations for injection within a certain distance of that lease can be included in the conditions for the area permit. The commission believes that the flexibility to cover the maximum area under an injection permit outweighs any benefits that might be gained through the Rule 37-type approach recommended by this commenter. Based on discussions with this commenter, the commission believes that deletion of the requirement for specifying the maximum injection volume on a per-well basis would address the concerns that prompted this comment. No change was made in response to this comment. Two commenters requested that the requirement of subsection (o)(1)(A) that the operator specify the maximum number of injection wells be deleted. The commission agrees because the authorized injection pressure is more pertinent than the number of injection wells. This requirement has been deleted. One commenter expressed its understanding that subsections (o)(1)(C) and (o)(1)(D) are intended to cover the same requirements. This commenter reads these provisions as requiring operators to provide wellbore diagrams of typical injection well conversions. One diagram would be for newly drilled wells and a second for conversions. Individual wells would not be identified on these diagrams. The commission believes that this commenter has misunderstood the requirements of subsections (o)(1)(C) and (o)(1)(D). Subsection (o)(1)(C) (now (o)(1)(B)) requires that a sample wellbore diagram for similarly completed wells that may be converted to injection be submitted with the application. The rule clearly states that the wells having such configuration be identified on the sample diagram. Identification of particular wells having the sample configurations is necessary so that the commission can verify that such wells are completed in the manner represented. As clearly stated in the proposed rule amendments, subsection (o)(1)(D) (now (o)(1)(C)) requires that the operator identify the manner in which newly drilled injection wells--not existing wells that may be converted to injection--will be completed. Therefore, the commission makes no change to these subsections. Three comments addressed the provisions of subsection (o)(1)(H) (now subsection (o)(1)(G)). One commenter recommended that subsection (o)(1)(H) be revised to require that injection volumes be specified on a cumulative basis based on anticipated project life, not on a daily per-well basis. Two commenters recommended that subsection (o)(1)(H) be revised to require volume information on a monthly rather than daily basis to be consistent with the Form H-10 reporting requirements. The commission agrees with the first comment and disagrees with the second two commenters. This commission has revised the subsection to require the applicant to specify the maximum cumulative injection volume for the project on a daily basis. This change addresses concerns expressed by one commenter in meetings with staff that operators frequently are unable to predict the maximum volume that will be injected into any individual well. As to the Form H-10 reporting requirements, the commission notes that the database for injection well reporting information is managed differently than the permit database. The Form H-10 tracks reporting information on a monthly basis. The permit database for all injection and disposal wells (over 53,000 wells) tracks volumes on a daily, rather than monthly, basis. One commenter expressed its belief that there is little value to providing the commission a map (proposed to be required in subsection (o)(1)(J) (now subsection (o)(1)(I)) showing typical well types that may or may not actually be included in the project at the time of the area permit as the operator may change its plans at a later date. The commission disagrees. The primary purpose of this requirement is to ensure that completions for each and every well that may be converted to injection have been evaluated. This provision requires that the operator identify on a map each and every existing well that may be converted to injection. The requirement for identifying the location of new drills has been deleted as the required completions for these wells will be addressed in the permit conditions. One commenter questioned whether the notice requirements of subsection (o)(2) would be amended if the notice requirements for individual well permits are changed in the future. The provisions of subsection (o)(2) parallel the notice requirements for individual wells, except that the notice requirements apply for the entire permit area. It is likely that any change to the notice requirements for individual well permits would precipitate parallel changes in notice requirements for area permits. The commission notes, however, that amendments to the notice requirements for individual well permits have not been proposed to date. No change was made in response to this comment. One commenter recommended that subsection (o)(3) be revised to read "... by the area permit as filed." The commission disagrees. Under the area permit process, individual wells must be authorized independently after the area permit is issued. Therefore, this provision was properly worded as proposed. One commenter objected to the provisions of subsection (o)(4)(B) that a supplemental area-of- review evaluation be conducted prior to commencement of injection in a converted or newly drilled well. The commission agrees that this additional area-of-review is unnecessary and has deleted this requirement. Two commenters suggested deleting subsection (o)(4)(C) which requires that, for an individual well, the operator provide completion information at least 20 days before injection commences in that well as such information would have been provided with the area permit application. The commission disagrees. With the application, the operator provides completion information for groups or categories of wells, not individual wells. The original construction and remedial workover of individual wells varies considerably. Before any particular well is utilized for injection, the commission must have the opportunity to ensure that the completion of that specific well conforms to the more generic information submitted at the time of application. The commission makes no change to subsection (o)(4)(C). One commenter recommended that subsection (o)(4)(E) be deleted because the commission has the authority to request additional information if warranted. This commenter felt that this provision could encourage arbitrary requests. The commission disagrees with this commenter. Paragraph (4) identifies the information that must be submitted to obtain an individual permit authorization. Subparagraph (E) has been included in anticipation of specific requirements that may be included in an area permit. For example, if an area permit is conditioned such that certain wells must be squeeze cemented before they can be used for injection, this provision might require that documentation of such cementing be provided with the request for individual permit authorization. No change has been made in response to this comment. Two comments were received regarding the provisions of subsection (o)(5). One commenter indicated that it interprets subsection (o)(5) as meaning that if an operator does not hear from the commission within 20 days of submitting required information on a converted or newly drilled well, the operator can assume the permit has been agreed to and injection into the well can commence. Staff concurs with this commenter's interpretation of subsection (o)(5). The other commenter indicated that the 20-day period for reviewing information on an individual well provided for under subsection (o)(5) should be capable of being shortened by "walking through" information on an individual well. The commission disagrees with this comment. It is not unreasonable to expect an operator to be able to plan his or her operations at least 20 days in advance. The suggested procedure for "walk throughs" would disrupt other permit processing activities, causing delays for other permit applications. This provision remains unchanged. One commenter noted that the proposed amendments did not explicitly address the requirements of 40 Code of Federal Regulations sec.144.33(b)(2) that area permits specify the requirements for construction, monitoring, reporting, operation, and abandonment for all wells authorized by the permit. In response to this comment, a clarifying provision has been inserted in subsection (o) which provides: "Area permits will specify requirements for injection well construction, operation, monitoring, and reporting." One commenter indicated that subsection (o)(J)(5), which provides for automatic permit issuance in certain circumstances, does not provide any safeguards from the possibility of an inadequately constructed injection well receiving authorization. The commission disagrees. This provision is more protective of the environment than at least some area permits issued by the United States Environmental Protection Agency (EPA) that provide for automatic permit issuance but do not provide for a pre-review of individual wells by EPA, as do the amendments to Rule 46. In addition, all permits issued under Rule 46, both area permits and individual well permits, require a demonstration of mechanical integrity prior to commencement of injection. Finally, any operator who uses an injection well in violation of applicable rules or permit requirements is subject to enforcement. No change was made in response to this comment. The following groups or associations filed comments which expressed general support for the amendments to sec.3.46: Texas Oil and Gas Association, Texas Independent Producers and Royalty Owners Association, and North Texas Oil & Gas Association. The amendments to sec.3.46 are adopted under Texas Water Code, Chapter 27, which authorizes the commission to adopt and enforce rules relating to injection wells and Texas Natural Resources Code: sec.81.052, which authorizes the commission to adopt all necessary rules for governing persons and their operations under the jurisdiction of the commission under sec.81.051; sec.85.042(b), which authorizes the commission to adopt and enforce rules for the prevention of actual waste of oil or operations in the field dangerous to life or property; sec.85.201, which authorizes the commission to make and enforce rules for the conservation of oil and gas and prevention of waste of oil and gas; sec.85.202, which authorizes the commission to adopt rules to prevent waste of oil and gas in producing operations and to require wells to be operated in a manner that will prevent injury to adjoining property; and sec.91.101, which authorizes the commission to adopt rules relating to the production of oil and gas wells and the handling of any material associated with any operation or activity regulated by the commission. The Texas Water Code, Chapter 27; Texas Natural Resources Code, sec.sec.81.052, 85.042(b), 85.201, 85.202, and 91.101 are affected by the proposed amendments to sec.3.46. sec.3.46. Fluid Injection into Productive Reservoirs. (a)-(c) (No change). (d) Subsequent commission action. (1) (No change). (2) An injection well permit may be transferred from one operator to another operator provided that the commission's delegate does not notify the present permit holder of an objection to the transfer prior to the date the lease is transferred on commission records. (e)-(n) (No change). (o) Area Permits. A person may apply for an area permit that authorizes injection into new or converted wells located within the area specified in the area permit. For purposes of this subsection, the term "permit area" shall mean the area covered or proposed to be covered by an area permit. Except as specifically provided in this subsection, the provisions of subsections (a) - (n) of this section shall apply in the case of an area permit and all injection wells converted, completed, operated, or maintained in accordance with that permit. Area permits will specify requirements for injection well construction, operation, monitoring, and reporting. Except as otherwise specified in the area permit, once an area permit has been issued, the operator may apply to operate individual wells within the permit area as injection wells as specified in paragraph (3) of this subsection. (1) An application for an area permit must be accompanied by an application for at least one injection well. The applicant must: (A) identify the depth(s) of usable-quality water within the permit area, as determined by the Texas Natural Resource Conservation Commission; (B) for each existing well in the permit area that may be converted to injection under the area permit, provide a wellbore diagram that specifies the casing and liner sizes and depths, packer setting depth, types and volumes of cement, and the cement tops for the well. A single wellbore diagram may be submitted for multiple wells that have the same configuration, provided that each well with that type of configuration is identified on the wellbore diagram and the diagram identifies the deepest cement top for each string of casing among all the wells covered by that diagram; (C) provide a wellbore diagram(s) showing the type(s) of completion(s) that will be used for injection wells drilled after the date the application for the area permit is filed, including casing and liner sizes and depths and a statement indicating that such wells will be cemented in accordance with the cementing requirements of sec.13 of this chapter (sec.3.13 of this title (relating to Casing, Cementing, Drilling, and Completion Requirements)); (D) identify the type or types of fluids that are proposed to be injected into any well within the permit area; (E) identify the depths from top to bottom of the injection interval throughout the permit area; (F) specify the maximum surface injection pressure for any well in the permit area covered by the area permit; (G) specify the maximum amount of fluid that will be injected daily in the permit area; (H) in lieu of the area-of-review required under subsection (e) of this section and subject to the area-of-review variance provisions of subsection (e) of this section, review the data of public record for wells that penetrate the proposed injection interval within the permit area and the area 1/4 mile beyond the outer boundary of the permit area to determine if all abandoned wells have been plugged in a manner that will prevent the movement of fluids from the injection interval into freshwater strata. The applicant shall identify in the application the wells which appear from the review of such public records to be unplugged or improperly plugged and any other unplugged or improperly plugged wells of which the applicant has knowledge. The applicant shall also identify in the application the date of plugging of each abandoned well within the permit area and the area 1/4 mile beyond the outer boundary of the permit area; and (I) furnish a map showing the location of each existing well that may be converted to injection under the area permit. The map shall be keyed to identify the configuration of all such wells as described in subparagraph (B) of this paragraph. (2) In lieu of the notice required under subsection (c)(1) of this section, notice of an area permit shall be given by providing a copy of the area permit application to each surface owner within the permit area; each adjoining offset operator; the county clerk of each county in which all or part of the permit area is located; and the city clerk or other appropriate city official of any incorporated city which is located wholly or partially within the permit area, on or before the date the application is mailed to or filed with the commission. Notice of an application for an area permit shall also be given in accordance with the requirements of subsection (c)(2). If, in connection with a particular application, the commission or its delegate determines that another class of persons, such as adjacent surface owners or an appropriate underground water conservation district, should receive notice of the application, the commission or its delegate may require the applicant to mail or deliver a copy of the application to members of that class. (3) Once an area permit has been issued and except as otherwise provided in the permit, no notice shall be required when an application for an individual injection well permit for any well covered by the area permit is filed. (4) Prior to commencement of injection operations in any well within the permit area, the operator shall file an application for an individual well permit with the commission in Austin. The individual well permit application shall include the following: (A) the well identification and, for a new well, a location plat; (B) a description of the well configuration, including casing and liner sizes and setting depths, the type and amount of cement used to cement each casing string, depth of cement tops, and tubing and packer setting depths; (C) an application fee in the amount of $100 per well; and (D) any other information required by the area permit. (5) An individual well permit may be issued by the commission or its delegate in writing or, if no objection to the application is made by the commission or its delegate within 20 days of receipt of the application, the individual well permit shall be deemed issued. (6) All individual injection wells covered by an area permit must be permitted in accordance with the requirements of this subsection and converted or completed, operated, maintained, and plugged in accordance with the requirements of this section and the area permit. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803887 Issued in Austin, Texas on March 17, 1998 Mary Ross McDonald Deputy General Counsel, Office of the General Counsel Railroad Commission of Texas Effective date: April 7, 1998 Proposal publication date: October 10, 1997 For further information, please call: (512) 463-7008 16 TAC sec.3.50 The Railroad Commission of Texas adopt an amendment to sec.3.50, relating to Enhanced Oil Recovery Projects - Approval and Certification for Tax Incentive, with changes to the proposed text as published in the January 23, 1998, issue of the Texas Register (23 TexReg 488). The amendments were proposed to conform the section to Texas Tax Code, sec.202.054, as amended by Senate Bill 582, 75th Legislature, Regular Session, which extends the deadline for applying for certification for a tax incentive for new and expanded enhanced oil recovery (EOR) projects from January 1, 1998, until January 1, 2008, and to clarify existing provisions regarding approval and certification of enhanced oil recovery projects for tax incentives. The proposed amendments to sec.3.50 amend subsection (c)(5) by adding a provision to the definition of EOR project to clearly indicate that pressure maintenance and water disposal projects are excluded from coverage by this section. The proposed amendments to subsection (c)(6) delete the unnecessary references to past active operation commencement deadlines. The proposed amendments to subsection (c)(13) add a descriptive provision to the definition of pressure maintenance which states, "wherein fluid injection volumes are approximately equal to fluid withdrawals and no attempt is made to refill pre-existing reservoir voidage or to displace in situ hydrocarbons." Proposed new subsection (c)(20) defines water disposal project as that term is excluded from coverage in amended subsection (c)(5). The exclusion from coverage for pressure maintenance operations was previously contained in sec.3.50 (commonly referred to as Statewide Rule 50), but was inadvertently deleted during revisions made in 1991; however, the exclusion of pressure maintenance operations has always been enforced by the Commission. Likewise, the exclusion of water disposal projects has always been enforced by the Commission and is being included in revised subsection (c)(5) for clarification. The proposed amendments to subsection (d)(1) delete the unnecessary references to past active operation commencement deadlines and add the qualification of "EOR project and area designation" to indicate the appropriate application. Additionally, the application deadline, extended from January 1, 1998, to January 1, 2008, by Senate Bill 582, is corrected in subsections (d)(1) and (i)(1). The proposed amendments add "injection history" to subsection (d)(2) as an example of relevant information to be included with the application. The proposed amendments to subsection (e) remove unnecessary language regarding separate filings and clarify the procedure for filing concurrent applications. The proposed amendments to subsection (g)(1)(A) delete unnecessary references to the past active operation commencement deadlines. Subsection (g)(2) is amended by adding "injection graphs" and "supporting tabular" data as information required to be submitted with the positive production response certificate application. The proposed amendments to subsection (i) require that an application for reduced or enlarged project area certification be filed prior to the filing of an application for positive production response certification to ensure that only one application for positive production response certification per project will be filed. Comments were received from two associations - the Texas Independent Producers and Royalty Owners Association ("TIPRO") and the Texas Oil and Gas Association ("TxOGA"). In its correspondence, TIPRO stated that it does not, at this time, take issue with the recommended changes. TxOGA indicated that it generally supports the amendments, but recommended several specific changes to the rule as published. In sec.3.50(c)(6), TxOGA suggested that the Commission insert the term "or expanded" after the word "new", because the Commission approves both new EOR and expanded EOR projects, and the reference needs to be made to both, as it is in other parts of the rule. The Commission declines to make the suggested change because the specific phrase "as a new EOR project" was not modified by the Commission's proposed amendments. Moreover, an existing project may have experienced several changes to injection patterns or the addition of injection and producing wells prior to approval of the tax certification/project designation application (i.e., Form H-12). Such changes are irrelevant. A project as defined at the time of approval of the Form H-12 EOR application is an "existing" project since no prior EOR application had been approved. The term "expansion" is reserved to show proposed changes to an "existing project" that will permit the existing project to be approved if the proposed changes are made. Finally, while an existing project can be expanded, a new project cannot be expanded, as prohibited by sec.3.50(b)(2), hence the need for the distinction between "existing" and "new" EOR projects. TxOGA further recommended that the definition of "expanded enhanced recovery project or expansion" in sec.3.50(c)(7) be amended to recognize that the extension of a completed tertiary recovery project would be included in the definition such that it would state, "the addition of injection and producing wells, the change of injection pattern, the extension of a completed tertiary recovery project, or other Commission approved operating changes to an existing enhanced oil recovery project that will result in the recovery of oil that would not otherwise be recovered." Again, the Commission did not propose any amendment to subsection (c)(7), which was indicated as having no change. A subdivision proposed as "no change" may not be changed upon adoption. In any case, the Commission would not propose the suggested change because the suggested language unnecessarily narrows the coverage of the definition contained in sec.3.50(c)(7). An extension of a completed tertiary recovery project is already included by the phrase, "or other Commission approved operating changes to an existing enhanced oil recovery project that will result in the recovery of oil that would not otherwise be recovered," along with several other operating changes too numerous to list therein. Additionally, TxOGA suggested that in sec.3.50(c)(13) and sec.3.50(c)(20), the language "refill existing reservoir voidage" could be interpreted to apply to the entire reservoir, while many projects only apply to a portion of the reservoir. Therefore, TxOGA recommends that the words "in approved project area" be added after the word "voidage" to clarify the intent. The Commission agrees and has amended sec.sec.3.50(c)(13) and (c)(20) to add the clarifying language. TxOGA stated that it agrees with the amendments proposed to sec.sec.3.50(d)(1) and (2), sec.sec.3.50(e)(1) and (2), and sec.sec.3.50(g)(1)(A) and (g)(2)(B)(i). TxOGA did not address the amendments proposed to sec.3.50(c)(5). TxOGA considers the proposed language in sec.3.50(h)(1) to be a problem for the reasons that the response certification date is often more than a year old when Commission approval is received, therefore making it impossible to file an annual report within thirty days of the first anniversary of the certification date in such instances. TxOGA suggests that making the due date thirty days after the first anniversary of the Form H-13 action date would eliminate this potential problem. The Commission agrees because the Form H-13 action date (the date of approval or rejection of the Form H-13) is, in fact, the anniversary date referenced in sec.3.50(h)(1), not the response certification date shown on the Form H-13. Moreover, the language complained of was not changed by the Commission's proposed amendments. However, in an effort to further clarify the requirements of sec.3.50(h)(1), the Commission has further amended sec.3.50(h)(1) to read, "...This form must be filed within thirty days of the first anniversary of the date that the Commission acted on the EOR positive production response certification application and annually thereafter." TxOGA further suggested that a more practical approach would be to require all annual reports (Form H-14) to be filed at the same time, instead of having the due dates staggered throughout the year. TxOGA argued that this would be consistent with the Comptroller's requirements for annual tax reports. The Commission declines to adopt these additional suggestions for the reasons that such changes to sec.3.50(h)(1) would result in the Commission staff receiving a year's worth of annual reports all at once, thus exceeding the staff's capacity. Additionally, TxOGA's suggestion would require that first-time annual reports would be filed without a year's worth of data attached in support thereof. Finally, TxOGA recommended that sec.3.50(i)(1) and (2) be deleted such that subsection (i) would read, "Reduced or enlarged areas. The operator may apply for reduced or enlarged project area certification." TxOGA suggests that there is no need to restate the deadline for approval and that an operator should be able to enlarge an approved EOR project even if response has already been approved because any response trend will constitute a new production base for the expanded project. Therefore, the operator would forfeit tax benefits on production associated with the original project, and expanded project would have to show additional positive oil production response. TxOGA pointed out that usually the operator would just call the enlarged area a new project, but there may be some operators who would rather include the original and the enlarged areas as one project to simplify production allocation and reporting. The Commission declines to adopt TxOGA's suggested changes because to do so could potentially extend the statutorily mandated ten-year period in which to receive tax benefits by the period of time from the original positive oil production response certification to the subsequent or enlarged project's positive oil production response certification. Such an unauthorized expansion of the statutorily mandated ten-year period would be invalid. Additionally, the underlying statute, Texas Tax Code, sec.202.054, does not provide for enforcing or accounting for any forfeiture of tax benefits from production associated with the original project as suggested by TxOGA. The Commission, however, agrees with TxOGA in that, if the operator chooses not to apply for enlargement of the project area prior to the filing of an application for positive production response certification of the original EOR, then the operator is free to apply for new project designation for the enlarged area pursuant to sec.3.50(b)(1)(A). The Commission finds that the changes to the adopted text are not substantive, are clarifying in nature, and the changed rules are fairly within the notice given by the originally published proposal. The Commission adopts the amendments pursuant to Texas Natural Resources Code, sec.sec.81.051, 81.052, 85.201, 85.202, 86.041 and 86.042, which authorize the Commission to prevent waste of oil and gas and to protect correlative rights. The Texas Natural Resources Code, sec.sec.81.051, 81.052, 85.201, 85.202, 86.041, and 86.042, and the Texas Tax Code, sec.sec.202.052 and 202.054, are affected by the adopted amendments. sec.3.50. Enhanced Oil Recovery Projects--Approval and Certification for Tax Incentive. (a)-(b) (No change.) (c) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1)-(4) (No change.) (5) Enhanced oil recovery project (EOR)--The use of any process for the displacement of oil from the reservoir other than primary recovery and includes the use of an immiscible, miscible, chemical, thermal, or biological process. This term does not include pressure maintenance or water disposal projects. (6) Existing enhanced recovery project--An EOR project that has begun active operation but was not approved by the Commission as a new EOR project. (7)-(12) (No change.) (13) Pressure maintenance--The injection of fluid into the reservoir for the purpose of maintaining the reservoir pressure at or near the bubble point or other critical pressure wherein fluid injection volumes are not sufficient to refill existing reservoir voidage in the approved project area and displace oil that would not be displaced by primary recovery operations. (14)-(18) (No change.) (19) Tertiary recovery project--An EOR project using a tertiary recovery method (as defined in the federal June 1979 energy regulations referred to in the Internal Revenue Code of 1986, sec.4993, or approved by the United States secretary of the treasury for purposes of administering the Internal Revenue Code of 1986, sec.4993, without regard to whether that section remains in effect) including those listed as follows: (A)-(I) (No change.) (20) Water disposal project--The injection of produced water into the reservoir for the purpose of disposing of the produced water wherein the water injection volumes are not sufficient to refill existing reservoir voidage in the approved project area and displace oil that would not be displaced by primary recovery operations. (d) Application requirements. To qualify for the recovered oil tax rate the operator must: (1) submit an application for approval on the appropriate form before January 1, 2008. All applications must be filed at the Commission's Austin office. The form shall be executed and certified by a person having knowledge of the facts entered on the form. If an application is already on file under the Natural Resources Code, Chapter 101, Subchapter B, or for approval as a tertiary recovery project for purposes of the Internal Revenue Code of 1986, sec.4993, the operator may file a new EOR project and area designation application if the active operation of the project does not begin before the application under this section is approved by the Commission; (2) submit all necessary forms to the Oil and Gas Division and provide the Commission with any relevant information required to administer this section such as: area plats showing the proposed project area and all injection and producing wells within the area, production and injection history, planned enhanced oil recovery procedures, and any other pertinent data; (3)-(4) (No change.) (e) Concurrent applications. The operator may file concurrently: (1) an application for approval of a new or expanded EOR project under this section, together with; (2) an application for approval of a unitization agreement for purposes of carrying out the enhanced oil recovery project under the Natural Resources Code, sec.sec.101.001 et seq.; or (3) an application for approval for certification of the project as a tertiary recovery project. (f) (No change.) (g) Approval and certification. (1) Project approval. In order to be eligible for the recovered oil tax rate as provided in the Tax Code, sec.202.052(b), the operator must apply for and be granted Commission approval of a new EOR project or an expansion of an existing EOR project, prior to commencing active operation of the new project or expanded project. For a project to be approved the operator must: (A) prove that it qualifies as an EOR project; (B) designate the area to be affected by the project and obtain Commission approval of the designation; and (C) if production from the wells within the project area is reported with production from wells not in the project area, designate the method to account for and report production from the project area. (2) Positive production response certificate. (A) (No change.) (B) The application for positive response certification shall include: (i) production and injection graphs with supporting tabular data illustrating a positive production response and volumes of water or other substances that have been injected on the designated area since the initiation of the new or the expanded EOR project; (ii)-(iii) (No change.) (C) (No change.) (h) Annual reporting. (1) The operator must file an annual report on the appropriate form with the Oil and Gas Division each year the project remains eligible for the reduced severance tax rate. This form must be filed within 30 days of the first anniversary of the date that the Commission acted on the EOR positive production response certification application and annually thereafter. (2) (No change.) (i) Reduced or enlarged areas. The operator may apply for reduced or enlarged project area certification if: (1) the application for reduction or enlargement of the project is received before January 1, 2008; and (2) the application for reduction or enlargement is received prior to the filing of an application for positive production response certification of the original enhanced oil recovery project. (j) (No change.) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 17, 1998. TRD-9803875 Issued in Austin, Texas on March 17, 1998 Mary Ross McDonald Deputy General Counsel, Office of the General Counsel Railroad Commission of Texas Effective date: April 6, 1998 Proposal publication date: January 23, 1998 For further information, please call: (512) 463-7008 PART II. Public Utility Commission of Texas CHAPTER 23.Substantive Rules Telephone 16 TAC sec.23.104, sec.23.108 The Public Utility Commission (commission) of Texas adopts amendments to sec.23.104 (relating to Telecommunications Pricing) and new sec.23.108 (relating to Reclassification of Telecommunications Services for Electing Incumbent Local Exchange Carriers (ILECs)). The amendments to sec.23.104 and new sec.23.108 are adopted with changes to the proposed text as published in the December 5, 1997, issue of the Texas Register (22 TexReg 11903). The commission established this rulemaking to establish standards for the reclassification of telecommunications services as directed by the Public Utility Regulatory Act, Texas Utilities Code Annotated sec.58.024 (Vernon 1998) (PURA). Commission staff filed a list of questions in the May 2, 1997 Texas Register (22 TexReg 3957) seeking comments to assist in the development of proper standards to determine whether a service should be reclassified. Written comments to those questions were filed by interested persons on May 9, 1997, and a staff workshop was held on May 14, 1997 to consider those comments. A staff report was presented to the commission at the June 26, 1997 open meeting where approval was granted to develop a proposed rule. An additional workshop was held on August 22, 1997 to obtain further feedback on staff proposals. The rule was proposed in the December 5, 1997 Texas Register. Written comments to the proposal were filed on January 5, 1998. A public hearing on the proposed rule was held on January 12, 1998. Reply comments were filed on January 20, 1998. Under the new rule, incumbent local exchange carriers (ILECs) electing incentive regulation under PURA Chapter 58 may make an application for reclassification of a service. See PURA sec.58.021. Upon election, the services provided by an electing ILEC are classified into three categories: (1) basic network services; (2) discretionary; and (3) competitive services. The commission is specifically authorized to reclassify (1) a basic network service as a discretionary or competitive service or; (2) a discretionary service as a competitive service. See PURA sec.58.024. The new rule establishes criteria for the reclassification of services, procedures for the filing of applications as required by the rule, and procedures for commission processing of the applications. The amendments to sec.23.104 of this title make this rule consistent with new sec.23.108 of this title, and correct citations to the Public Utility Regulatory Act since it was codified into the Texas Utilities Code. The commission received timely written comments on the proposed rule from AT&T Communications of the Southwest, Inc. (AT&T), MCI Telecommunications Corp. (MCI), Southwestern Bell Telephone Company (SWB), and GTE Southwest, Inc. (GTE). In addition, the Office of Public Utility Counsel (OPC) filed comments. MCI generally supported the rule and made no specific comments on the rule in its written comments. The other commenters all support the establishment of standards to effect the reclassification of telecommunications services and submitted specific written comments. Reply comments were received from MCI and SWB. General Comments: OPC suggested that this rulemaking be abated until the consequences of the decision in SBC Communications, Inc. v. FCC, 981 F.Supp. 996 (N.D. Tex. 1997), is known. In that case, the court ruled that the special provisions concerning Bell operating companies in the Federal Telecommunications Act of 1996 (FTA), FTA sec.sec.271-277, are unconstitutional. OPC stated that SWB will no longer have any incentive to see that local markets are open or remain open to competition if the court's ruling is upheld and, thus, the commission should wait before granting SWB and other ILECs additional flexibility. SWB disagreed that this rulemaking should be deferred pointing out that the reclassification scheme in PURA is not dependent on the FTA. The commission disagrees with the comments that this rulemaking should be abated. The commission is not granting, by this rulemaking, any ILEC flexibility, rather the commission is establishing standards to judge whether a service should be reclassified. The standards established by the commission are not dependent on the outcome of this lawsuit but only on the nature of the service and the level of competition for these services in the marketplace. Moreover, the concerns expressed by OPC are not applicable to exchanges served by an electing ILEC other than SWB, since the restrictions in FTA sec.sec.271- 275 apply only to SWB in Texas. Therefore, there is no need to delay establishing these standards. sec.23.108 Downward reclassification standards AT&T suggested that additional standards should be provided in the rule to reclassify a service "downward," to allow a competitive service to be reclassified as either a discretionary or basic network service, or to allow a discretionary service to be reclassified as a basic network service. OPC noted the lack of standards to reclassify services downward and advised caution. SWB disagreed that the rule should cover reverse reclassifications and argued that sec.58.024 of PURA does not allow a service to be reclassified into a more regulated class. The commission stated in the adoption of sec.23.104 that PURA does not prohibit reverse reclassifications; however, the commission continues to believe that such reclassifications are not likely, and need not be addressed by this rule. See 22 TexReg 3405, 3412 (April 11, 1997). In addition, procedures in a reverse reclassification case, such as who would initiate the docket and the contents of the initial application, would differ from those in a typical reclassification docket and lead to undue complexity in this rule. If an application for a reverse reclassification were filed, the commission will address the procedures in that case. In addition, the commission would, where appropriate, evaluate criteria similar to those enumerated in this rule in making its decision on an application for a reverse reclassification. Number of Competitors OPC stated that the rule does not provide for a specific number of competitors before a service can be reclassified. OPC also stated that oligopolistic pricing or price collusion among a few firms is just as detrimental to consumers as monopoly pricing. The commission believes it more appropriate to analyze the market when a reclassification application is filed than to specify the required "number of competitors" at this time. The commission is not aware of any viable method to calculate a specific number of competitors and OPC did not suggest any methodology or criteria to establish such a number. The commission, therefore, declines to add such a provision to the rule. The commission, however, agrees with OPC that oligopolistic pricing, or price collusion among a few firms is detrimental to consumers. The commission believes that the removal of barriers to entry, allowing new firms to supply the market and undercut the price offerings of any price-setting firm or group of firms, will help to protect consumers against such practices. Facilities-based competition SWB and GTE disagreed with a basic concept underlying the proposed rule: Facilities-based competition is the only source of alternative service that can support an application to reclassify a service from a more regulated category to a less regulated category. SWB argued that resold service should also be recognized as a service capable of providing viable competition, as recognized in both PURA and FTA. MCI requested that the commission retain the "facilities- based" requirement. The commission disagrees with SWB and GTE that a provider of resold services is as capable as a provider of facilities-based services in creating a vibrant competitive market for local exchange service. The commission believes that facilities-based competition has important potential benefits over total service resale. In a competitive market, firms distinguish themselves by price and quality. Providing service through resale limits a competitor's ability to distinguish itself in both of these areas. The cost of providing total service resale is based on the retail rate charged by the incumbent for the service provided. Therefore, resellers cannot discipline the price charged by an incumbent because the reseller's costs increase in proportion to the incumbent's retail rate increase. In addition, the quality of service offered by a total service reseller is determined by the owner of the facilities. A reseller cannot, except in rare circumstances, innovate or improve upon the quality of service that is offered to their customers. Based upon the comments, the commission modifies the definition of "facilities-based provider" to clarify its intentions on this point. sec.23.108(d) This subsection contains the general standards that must be met to reclassify a service. SWB objected to the competitive safeguard prerequisites found in subsection (d)(1) of the rule. Specifically, SWB objected to the reference to PURA Subchapter H. SWB argued that this additional subchapter is not included in PURA sec.58.024(c), and that the proposed rule illegally deviates from the statute by adding this additional requirement. SWB argued that this rule must "mirror exactly the requirements in 58.024 (c)." AT&T pointed out that the recodification of the Public Utility Regulatory Act of 1995 (PURA95) into the Texas Utilities Code incorrectly omitted subchapter H from the list of prerequisite competitive safeguards and notes that the non- substantive recodification cannot effect a substantive change in the law. MCI requests that the competitive criteria in the proposed rule be retained. The recodification of PURA in the Texas Utilities Code was a non-substantive recodification. See Act of May 8, 1997, 75th Leg., R.S., ch. 166, sec.10, 1997 Tex. Gen. Laws 713, 1018. The commission agrees with AT&T that the non- substantive recodification of PURA in the Utilities Code could not effect a substantive change in the law. See Minton v. Perez, 803 S.W.2d 803, 805 (Tex. App.--San Antonio 1990, no writ). Thus, the substantive requirements, as reflected in former PURA95 sec.3.357(b), continue in force, and subchapter H is a legal prerequisite to a service reclassification. See Johnson v. City of Forth Worth, 774 S.W.2d 653, 654-55 (Tex. 1989). Moreover, the commission disagrees with SWB that this rule must mirror exactly the requirements in PURA sec.58.024(b) and (c). The commission is explicitly directed to establish criteria for determining whether a service should be reclassified. See PURA sec.58.024(a). That is the purpose of this rule: To publish the standards for reclassification established by the commission. The only limit imposed on the commission by PURA sec.58.024 is that the commission's criteria must include consideration of the four items enumerated in PURA sec.58.024(b). In addition, regardless of the criteria established by the commission, the commission may not reclassify a service until the requirements in PURA sec.58.024(c) are also met. Thus, the commission is not bound to establish criteria that "mirror" sec.58.024, rather the commission is directed to use its knowledge and experience to determine what criteria are necessary to determine whether a service should be reclassified. AT&T stated that the "geographic area" restriction in subsection (d)(2) is too limited. AT&T suggested a "two-pronged test," where both the geographic area and the service being reclassified must be reviewed. AT&T also asserted that the appropriate scope of the geographic market may be driven in part by the service at issue. AT&T also argued that a statewide market will be the appropriate geographic scope so long as the electing ILEC's wholesale rates are not de- averaged, and that allowing the electing ILEC to regionally de-average its retail rates could, therefore, result in anticompetitive practices by the ILEC. SWB disagreed and argued that pricing flexibility should not be limited to a statewide basis. As written, the reclassification standards in the rule are written on a service- by-service basis. The commission finds that an application requesting reclassification of multiple services would require review of each service. Thus, the "two-pronged test" suggested by AT&T is intrinsic to the rule. The commission disagrees with AT&T's concerns regarding the rule's provisions that allow ILECs to reclassify services on an exchange-by-exchange basis. The pricing flexibility granted for both discretionary services, see PURA sec.58.103(b), and competitive services, see PURA sec.58.152(b), provides electing ILECs the ability to respond to consumer demand elasticity and competitive pressures once it has been determined that the electing ILEC's monopoly power over a particular service has been sufficiently eroded. It is unlikely that competition will develop on a state-wide basis. Instead, competitors focus on services and geographic areas where market entry is most lucrative. If competition in a particular exchange is intense, new competitors will have an unfair competitive advantage if the incumbent is not allowed to compete on a level playing field. The commission recognizes that disparate treatment in neighboring exchanges can cause some customer confusion; however, the commission finds that such confusion can not be avoided when the level of competition varies from exchange to exchange. SWB stated at the public hearing that there should be no geographic limitations in the rule. SWB suggested that it should be able to seek pricing flexibility for an area as small as one customer. The commission disagrees with SWB's recommendation. As previously discussed, areas less than state-wide can be used to allow electing ILECs the ability to fairly respond to competition; however, reclassification areas that are too small can cause customer confusion, arbitrary price differentials, and provide electing ILECs the ability to price their services in a predatory manner. For example, next door neighbors located in the same exchange could be charged different rates because of an artificial distinction created in a reclassification application. The commission believes that establishing the market on an exchange area basis will appropriately balance these concerns. Further, the commission notes that allowing reclassifications for a single customer would create one-buyer markets, which is not consistent with the competitive goals of the statute. The commission modifies subsection (d)(2) to make clear that a reclassification area must contain the entire exchange area of each exchange area included in the reclassification area to address these concerns. By working on an exchange basis, the commission minimizes the possibility that discrimination among NXX codes could occur. sec.23.108(e) This subsection contains specific standards for reclassifying a basic network service to a discretionary service. GTE objected to the requirement in subsection (e)(1), that to qualify for reclassification, a basic network service "cannot be necessary for completion of a telephone call." GTE argued that this requirement "ignores the fact that basic network services are currently subject to competition in Texas" and that those services should be afforded the same flexibility as other discretionary services with similar competition. SWB argued that "service" and "necessary to complete a telephone call" are dangerously vague and would allow opponents to argue that all services are "necessary" so that no services could be reclassified. SWB also argued that this rule must "mirror exactly" the provisions in PURA sec.58.024. In particular, SWB is concerned that an opponent to a service reclassification could argue that the phrase "necessary to complete a call" would prevent a second line from being reclassified to the "discretionary" category. The commission disagrees with GTE and SWB that all services could be claimed as "necessary" so that no services could be reclassified. Although some of the services in the basic network service classification will likely remain necessary for the public welfare of consumers, once meaningful competition develops for these services, they may be reclassified as competitive services. It is not necessary for a basic network service to be reclassified as a discretionary service before it may be reclassified as a competitive service. In other words, if a service continues to be "necessary", it cannot be reclassified as discretionary. However, the same service could be reclassified as competitive if sufficient competition exists. With regard to SWB's concern regarding multiple lines, the commission does not intend to create a blanket rejection of the reclassification of such a transfer by using the "necessary" language. The party requesting such a reclassification would have to demonstrate that multiple lines are not "necessary to complete a call" and that such a reclassification is in the public interest, and that all other requirements of the rule are met. Such an application would need to address, among other things, whether there are any operational difficulties that would prohibit the reclassification of multiple lines and whether such a reclassification is consistent with the policies underlying the universal service fund. AT&T stated that the two criteria listed in subsection (e) are ambiguous and that they are too limited. AT&T suggested that the special nature of basic network services requires additional detailed criteria and proposes a new paragraph (3) containing additional criteria. OPC suggested that a new paragraph (3) should be added to address consumer demand elasticity. OPC argued that elasticity is essential to determine the nature of the service. OPC asserted that a clearly defined standard will result in greater certainty and more effective reclassification with less litigation. SWB argued that these proposals are an attempt to create a complex set of criteria that would allow opponents of reclassification to "game the proceeding" and impede the reclassification process. SWB argued that the only question is whether the consumer has a choice in telecommunications service and that this can be determined from the four issues listed in PURA sec.58.024. The commission does not adopt the proposed additional criteria suggested by AT&T. The added criteria may be appropriate when evaluating whether to reclassify a service to the competitive service category, but they are not appropriate when making a determination of whether to reclassify a basic network service to the discretionary service category. To be reclassified as a discretionary service, the relevant inquiry is whether the service is an optional service that is offered in addition to the basic network services that are necessary for a customer to place a telephone call. The commission does not agree with SWB's characterization of AT&T's proposed additional criteria, but as just discussed does not adopt AT&T's suggestion. The commission also does not agrees with SWB that the primary focus when reclassifying services to the discretionary service category is the competitiveness of the market as discussed in response to AT&T's comments above. The commission disagrees with OPC that the inclusion of customer demand elasticity is essential to determine the nature of the service. The rule includes proxies for this difficult estimate; for example, the existence of adequate substitutes could affect whether the service is necessary to complete a telephone call. Based upon the comments to this subsection, the commission modifies subsection (e) to clarify the requirements to reclassify a basic network service to a discretionary service. sec.23.108(f) This subsection contains specific standards for reclassifying a basic network service or a discretionary service to a competitive service. AT&T stated that reclassification of a service to the competitive service category should meet all of the requirements for transfer of a basic network service to discretionary service (as modified by its comments). AT&T asserted that this will ensure that true competition exists before a service is reclassified into the least restrictive category. As previously discussed, the requirements of subsection (e) do not have to be met in addition to the requirements of subsection (f) before a service may be reclassified as competitive. The movement of a service from a basic network service classification to a competitive service classification is not incumbent upon the service being able to be classified as a discretionary service. The criteria listed in subsection (e) and subsection (f) are independent from one another and distinct for this reason. The commission modifies subsection (f) to clarify the requirements to reclassify a service to the competitive service category. GTE and SWB opposed the "facilities-based" requirement in subsection (f)(1). GTE stated that the language is over-broad and that such considerations should be made on a case-by-case basis. GTE identified long distance, public pay phone, and 800 services as competitive services that are not totally facility-based. SWB argued that the provisions in PURA sec.58.024(b)(1) only requires services from other providers, which includes resale providers, and the rule improperly excludes resale providers. OPC asserted that the term "effective alternative facilities- based provider" is ambiguous and asked what makes a provider "effective." As stated previously, the commission disagrees with the position that a provider of resold service is as capable as facilities-based service provider in creating a vibrant competitive market for local exchange service because the reseller's underlying ILEC controls both the cost and quality of the reseller's offerings. The commission also previously discussed the requirements in PURA sec.58.024(b) and disagrees with SWB that the commission must simply "mirror" those requirements. In this rule, the commission properly implements the language of the statute by determining the level and type of competitors that must exist before a service is reclassified as a competitive service. The commission believes that facilities-based competitors are necessary for meaningful competition. The commission agrees with OPC that the term "effective" is ambiguous and also finds that the term is unneeded. To simplify the rule, the commission deletes the term from subsection (f)(1). AT&T suggested that the criteria in subsection (f)(2) be changed from "existing competitors," to "alternative, facilities-based competitors" to make this requirement consistent with other portions of the rule and to ensure true competition prior to any service reclassification. The commission agrees with AT&T that consistency in the rule is needed and changes the language of subsection (f)(2) to read "alternative, facilities-based providers" in place of "existing competitors." OPC objected that even though an area may meet the 60% requirement in subsection (f)(2), there may be pockets within the area that do not meet this criteria. OPC argued that such pockets should be excluded from reclassification or special rules should apply to such pockets. SWB argued that OPC's proposal was unreasonable and unworkable and contrary to how ILECs currently price their services and would hinder ILECs from flexibly pricing their services. The commission disagrees with OPC that areas within a reclassification area should be excluded or have special rules. Such an arrangement would overly complicate the reclassification of services and transform a review of the competitive status of an area into a review of each individual customer in the area. As previously noted, competition will not develop on a state-wide basis. Likewise, it is probable that less than 100% of the customers in an exchange will have access to all competitive services offered in that exchange. This fact would not, however, mitigate against finding that an electing ILEC's monopoly power over a particular service has been sufficiently eroded where it has been demonstrated that the standards set out in the rule have been met for the exchange area. Also, the commission notes that ILECs price their services on an exchange basis (with the exception of customer-specific pricing), and that customers in pockets of an exchange without an alternative provider would still receive the benefits of lower, competitive prices reflecting competition in the rest of the exchange. However, to allow the commission to properly evaluate the competitiveness of a reclassification area, subsection (g)(2) of the rule has been modified to require that information be provided in the application to allow the commission to evaluate the standards in the rule for each exchange within the reclassification area. In addition, the commission modifies subsection (f)(2) of the rule to clarify that the 60% requirement applies to the type of line, residential, business, or both, for which the service is provided. OPC asserted that the term "substantial barrier to entry" in subsection (f)(3) is ambiguous, asked what makes a barrier to entry substantial, and suggested that it is important to identify what is an acceptable barrier. SWB disagreed that this term needs further definition or that this requirement should be present in the rule. The commission believes the term "substantial barrier to entry" is appropriate. The term "substantial" signifies the commission's position that minor market imperfections may be inevitable while allowing parties to present arguments concerning the ability of a market imperfection to actually impair competitive entry. OPC stated that the term "easily" in the phrases "easily obtain additional capacity" and "easily enter the market in response to an increase in price" in subsection (f)(4) is ambiguous and asked that this standard be defined. SWB disagreed that this term needs further definition or that this requirement should be present in the rule. The commission believes the term "easily" as used in this subsection is appropriate. The term "easily" signifies the commission's position that minor market imperfections may be inevitable while allowing parties to present arguments concerning the ability of a market imperfection to actually impair competitive entry. Consequently, the term "easily" is more appropriate than a term such as "costlessly." GTE opposed the market power test in subsection (f)(5) as contrary to PURA and as being anticompetitive. GTE argued that PURA sec.58.024 established only four criteria that have to be met for the reclassification of services and that PURA does not require a market power test. It also argued that the requirements in subsection (f)(1)-(4) are adequate to address such concerns. Finally, GTE warned that use of the market power test provides disparate pricing flexibility between companies which have equivalent access to consumers. The commission believes that the market power test is properly applied when analyzing a proposed service reclassification. The market power standard in the rule is not a direct test of market share percentages. The legislature, by classifying this service category as "competitive", demonstrates that it intends that a service be truly competitive before it can be so classified. The commission properly exercises its judgment when it determines that an electing ILEC's market power for that service must be sufficiently ameliorated before the market for that service can be "competitive." As previously discussed, the commission may establish the reclassification standards of this rule beyond the exact criteria listed in PURA sec.58.024. OPC stated that the term "sufficient market power" in subsection (f)(5) is ambiguous and needs clarification. OPC asserted that the proposed rule would allow an ILEC with some degree of market power to reclassify a service. OPC objected to such a standard. MCI requested that the commission retain the market power test. In adopting this rule, the commission strikes a balance between providing benchmarks for electing ILECs to meet when seeking a service reclassification and avoiding overly complex criteria that could not be reasonably demonstrated in a contested case. It is not reasonable to expect an electing ILEC to be able to show that it has no market power. Instead, an electing ILEC must show that competitive pressures are such that it has "insufficient" market power to control the market in a manner inconsistent with the public interest. For these reasons, the commission recognizes that the market share of the electing ILEC may remain high, even after the presence of an alternative facilities-based provider. The appropriate inquiry is whether the electing ILEC could use its market share and cost advantages, to artificially restrict entry and inflate prices. OPC suggested a new paragraph that would require a service to be priced at forward looking economic costs to competitors if the service is required as an input for other services provided by competitors. OPC asserted that such language is necessary to give new entrants access and an ability to compete since the electing ILEC was previously a monopoly provider. SWB argued that such a requirement is unnecessary because electing ILECs must file cost studies pursuant to sec.23.91, and this rule should not address the setting of prices. The commission finds that the creation of a pricing restriction is not within the scope of this rule. Any service of an electing ILEC which is an input for services required by facility-based competitors will be reclassified as competitive only if adequate alternatives to this input are available. Moreover, where effective competition exists, price regulation should be minimized. OPC's concerns are more appropriately directed to the provisions found in sec.23.104, which outlines the pricing requirements of each service classification. sec.23.108(g) This subsection contains the requirements for notice and the contents of the application. GTE objected to the requirement in subsection (g) requiring information in the application on the alternative facilities-based providers in the reclassification area. The commission addressed the "facilities-based" requirement of this rule in response to SWB's and GTE's comments regarding subsection (f)(1). The requirement that this information be provided in the application is consistent with the substantive requirements of the rule. To clarify this point, proposed subparagraphs (I)-(K) are renumbered as clauses (i)-(iii) and moved to subparagraph (G) of subsection (g)(2). SWB stated that the application process in subsection (g) is too burdensome and should be simplified and made consistent with its proposed revisions to the rule. GTE suggested that the market penetration reporting in clauses (i)-(iii) of subsection (g)(2)(G) should be designated as "Highly Confidential and Proprietary" and should only be submitted to commission staff and their assigns. GTE argued that this information is highly sensitive and could be used by competitors to target areas of competitive vulnerability. The commission disagrees with SWB that the proposed application process is too burdensome. As previously discussed, the commission is not limited to "mirroring" the provisions in PURA sec.58.024(b). The application process will provide the commission with data necessary to evaluate whether the criteria to reclassify telecommunication services as established by this rule are met. Removing these requirements would make such an evaluation difficult, if not impossible. The commission disagrees with GTE's position that information concerning market penetration should be designated as "Highly Confidential and Proprietary." As the commission determined in Complaint of MCI Telecommunications Corporation Regarding the Unreasonableness and Anticompetitive Effect of the Access Charges of GTE Southwest, Inc., Docket No. 17930, and in the commission's new dispute resolution rules, with greater competition comes competitor-versus-competitor disputes that require an efficient resolution that does not unduly increase litigation costs. The "Highly Confidential and Proprietary" designation and the burdensome procedures they encompass increase litigation costs and slow down the administrative process. Therefore, the commission does not adopt GTE's request. GTE opposed the market-share reporting requirement in paragraph (2)(I) of this subsection. GTE stated that the deletion of this language is consistent with their objection to the market power test as discussed in its comments to subsection (f)(5). For the reasons stated in response to GTE's comments regarding the market share test in subsection (f)(5), the commission denies GTE's request to delete the market share reporting requirement. Market share data will often be important when determining whether an electing ILEC's market power has been sufficiently diminished to classify the market for a particular service as "competitive." sec.23.104 sec.23.104(g) This subsection specifies criteria that must be met to exercise pricing flexibility for a competitive service. SWB noted that proposed subsection (g)(3) (existing subsection (g)(4)) does not require a facility-based provider but simply references "another provider" as should be done in new sec.23.108 of this title (relating to Reclassification of Telecommunications Services for Electing ILECs). The commission disagrees with SWB and notes that the cited provision relates to pricing flexibility for a competitive service, not service reclassification. In addition, the cited provision does not reference "another provider." sec.23.104 (h) This subsection specified criteria to reclassify telecommunications services. SWB objected to the inclusion of PURA sec.60.141 as a competitive safeguard prerequisite to reclassification of services as discussed more fully under comments to sec.23.108. The commission disagrees with SWB that inclusion of PURA sec.60.141 is improper as discussed above, but SWB's comments highlights the confusion that could be caused by subsection (h) and deviation of the requirements from those in new sec.23.108. Therefore, the commission finds it is unnecessary to maintain these inconsistent and duplicative requirements and deletes subsection (h). This new rule and amendment are adopted under PURA sec.sec.14.002, which provides the Public Utility Commission with the authority to make and enforce rules reasonably required in the exercise of its powers and jurisdiction and specifically, PURA sec.58.024, relating to service reclassification. Cross Index to Statutes: Public Utilities Regulatory Act sec.sec.14.002 and 58.024. sec.23.104.Telecommunications Pricing. (a) (No change.) (b) Application. Except as otherwise provided herein, the provisions of this section shall apply to dominant certified telecommunications utilities (DCTUs). Unless the DCTU has elected to be regulated under the terms of the Public Utility Regulatory Act (PURA) Chapter 58, the provisions of this section may be applied to a DCTU serving 31,000 or more but fewer than one million access lines only on a bona fide request by a holder of a Certificate of Operating Authority or Service Provider Certificate of Operating Authority. (c) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Electing LEC — A DCTU electing to be regulated under the terms of PURA Chapter 58. (2) - (4) (No change.) (d) (No change.) (e) Basic network services. Except as provided by paragraph (2) of this subsection, a DCTU may not exercise pricing flexibility for a basic network service. (1) The following services are initially classified as basic network services: (A) - (C) (No change.) (D) service connection for basic services; (E) - (O) (No change.) (2) - (3) (No change.) (f) Discretionary services. Except as provided by paragraph (5) of this subsection, a DCTU may not exercise pricing flexibility for a discretionary service. (1) - (3) (No change.) (4) The price ceiling for a discretionary service provided by an electing LEC may not be set below or above the rate in effect on September 1, 1995, without regard to proceedings pending under PURA sec.sec.12.004, 15.001, 15.002, 53.151 and 53.152 or under Government Code, Chapter 2001, Subchapter G. The ceiling may be raised only after the proceedings required under PURA, Chapter 60. Thereafter, on application by the DCTU or on the commission's own motion, the commission may change the price ceiling but may not increase the ceiling more than 10% annually. (5) - (6) (No change.) (g) Competitive services. Except as provided by paragraphs (2) and (4) of this subsection, a DCTU may not exercise pricing flexibility for a competitive service. (1) (No change.) (2) The price for a competitive service shall not be set below LRIC or the price floor prescribed by sec.23.102 of this title, whichever is higher. An electing LEC may request the establishment of a price floor for a competitive service that is above the floor prescribed by this paragraph. (3) An electing LEC may set the price for a competitive service at any level above the floor prescribed in this subsection. Permissible pricing flexibility includes volume and term discounts, zone density pricing, packaging of services, customer specific contracts, and other promotional pricing flexibility, subject to the requirements of PURA sec.60.001 and sec.60.002. However, an electing LEC may not increase the price of a service in a geographic area in which that service or a functionally equivalent service is not readily available from another provider. The pricing flexibility allowed by this subsection permits the packaging of a competitive service with one or more discretionary services only if the DCTU demonstrates that the rate for the package of services is greater than the sum of the LRIC of the competitive service and the tariffed rates of the discretionary services included in the package. (4) Prices for competitive services may not be unreasonably preferential, prejudicial, or discriminatory. sec.23.108.Reclassification of Telecommunications Services for Electing Incumbent Local Exchange Carriers (ILECs). (a) Purpose. The provisions of this section: (1) establish the minimum criteria and standards for reclassifying a basic network service as a discretionary service or competitive service; or a discretionary service as a competitive service, pursuant to the Public Utility Regulatory Act (PURA) sec.58.024; and (2) to establish the procedures to be followed in petitioning for reclassification. (b) Definitions. The following words and terms when used in this section shall have the following meaning unless the context clearly indicates otherwise: (1) Basic network services (BNS) — Those services as defined in PURA sec.58.051, and any other service the commission subsequently categorizes as a basic network service. (2) Competitive services (CS) — Those services as defined in PURA sec.58.151, and any other service the commission subsequently categorizes as a competitive service. (3) Discretionary services (DS) — Those services as defined in PURA sec.58.101, and any other service the commission subsequently categorizes as a discretionary service. (4) Electing ILEC — An electing ILEC is an incumbent local exchange company that has filed the notification of election referenced in PURA sec.58.021. (5) Exchange area — That definition given in sec.23.3 of this title (relating to Definitions). (6) Facilities-based provider — A telecommunications provider that provides telecommunications services using facilities that it owns or leases or a combination of facilities that it owns and leases, including unbundled network elements. (7) Incumbent local exchange company (ILEC) — That definition given in sec.23.3 of this title. (8) Reclassification area — The geographic area within the electing ILEC's territory, consisting of one or more exchange areas, for which it seeks reclassification of a service. (c) Application. This section applies to electing ILECs. (d) General standards for reclassification of a service. The following conditions must be satisfied in order to reclassify a service. (1) Prerequisite for reclassification of a service. The commission may not reclassify a service until each competitive safeguard prescribed by PURA Chapter 60, Subchapters (B) through (H), is fully implemented. (2) Designation of reclassification area. An electing ILEC must designate the exchange areas for which it is seeking to reclassify each service. A reclassification area must contain the entire territory of each exchange area designated. (3) Identification of services to be reclassified. An electing ILEC must identify each service which it is seeking to reclassify and specify, for each service, whether the service is for residential lines, business lines, or both. (4) Public interest standard. The reclassification of the service is just and reasonable, is not unreasonably preferential, prejudicial, or discriminatory, or predatory or anti-competitive, and is in the public interest. (5) Rate changes. Rate changes shall be contemplated by the commission, in a separate proceeding, after reclassification has occurred. (e) Standards for reclassification of a basic network service as a discretionary service. In addition to meeting the requirements in subsection (d), the following conditions must be satisfied in order to reclassify a basic network service as a discretionary service: (1) The service is not necessary to complete a telephone call; and (2) Public policy determines that the service does need not to remain in a basic network service classification. (f) Standards for reclassification of a basic network service or discretionary service as a competitive service. In addition to meeting the requirements in subsection (d), the following conditions must be satisfied in order to reclassify a basic network service as a competitive service or to reclassify a discretionary service as a competitive service: (1) There is an alternative facilities-based provider offering the same, equivalent, or substitutable service at comparable rates, terms, and conditions in the reclassification area; (2) At least 60% of access lines of the type, either residential, business, or both, for which the service is provided that are located in the reclassification area have access to alternative, facilities-based providers; (3) Substantial barriers to entry do not exist for the relevant market; (4) The existing competitors have or can easily obtain additional capacity, or new competitors may easily enter the market in response to an increase in price of the electing ILEC's rates; and (5) The electing ILEC does not have market power sufficient to control, in a manner that is adverse to the public interest, the price of the service in the reclassification area. (g) Requirements for notice and contents of the application in compliance with this section. (1) Notice of Application. The electing ILEC shall provide direct notice to all Certificate of Convenience and Necessity, Service Provider Certificate of Operating Authority and Certificate of Operating Authority holders offering service in the reclassification area and direct notice to all the ILEC's customers in the reclassification area. The notice shall include a description of the requested reclassification, the service, the proposed rates, the reclassification area, other terms of the service, the types of customers likely to be affected if the application is approved, the proposed effective date for the application, the following language: "Persons who wish to comment on this application should notify the commission by (specified date, 10 days before the proposed effective date), and any other item required by the presiding officer. Requests for further information should be mailed to the Public Utility Commission of Texas, P. O. Box 13326, Austin, Texas 78711-3326, or you may call the Public Utility Commission's Office of Customer Protection at (512) 936-7120. Hearing- and speech-impaired individuals with text telephones (TTY) may contact the commission at (512) 936- 7136." (2) Contents of application for each electing ILEC seeking a service reclassification. In addition to the commission's filing requirements, one copy of the application shall be delivered to the Office of Regulatory Affairs and one copy shall be delivered to the Office of Public Utility Counsel. The application shall contain the following: (A) A showing by the electing ILEC that the competitive safeguards in PURA, Chapter 60, Subchapters (B) through (H) have been met; (B) For each exchange in the reclassification area, a description of the reclassification sought, the service(s) and the rates, terms, and conditions under which the service(s) is currently provided and how the proposed reclassification of the service(s) is just and reasonable and is not unreasonably preferential, prejudicial, or discriminatory, or predatory or anti- competitive; (C) A description of the reclassification area, specifying the exchange area or areas, for which the reclassification is requested; (D) The proposed effective date of the reclassification; (E) A statement detailing the method and content of the notice, if any, the utility has provided or intends to provide to the public regarding the application and a brief statement explaining why the electing ILEC's notice proposal is reasonable and that the electing ILEC's notice proposal complies with applicable law; (F) A copy of the text of the notice, if any; (G) A showing that the relevant standards required under subsection (e) or (f) of this section, whichever is applicable, have been satisfied for each exchange in the reclassification area; (i) An estimate of the number and size of alternative facilities-based providers offering the service to be reclassified for each exchange in the reclassification area; (ii) The total number and percentage of the electing ILEC's subscribers of the service in the reclassification area, for each exchange, measured by number of customers and access lines; (iii) An estimate of the electing ILEC's market share for the service, for each exchange, measured by number of customers and access lines; and (H) An explanation of how the reclassification of the service advances the public interest for each exchange in the reclassification area. (h) Commission processing of application. (1) Administrative review. An application considered under this section may be reviewed administratively unless the electing ILEC requests the application be docketed or the presiding officer, for good cause, determines at any point during the review that the application should be docketed. (A) The operation of the proposed rate schedule may be suspended for 35 days after the effective date of the application. The effective date shall be no earlier than 30 days after the filing date of the application or 30 days after public notice is completed, whichever is later. (B) The application shall be examined for sufficiency. If the presiding officer concludes that material deficiencies exist in the application, the applicant shall be notified within 10 working days of the filing date of the specific deficiency in its application, and the earliest possible effective date of the application shall be no less than 30 days after the filing of a sufficient application with substantially complete information as required by the presiding officer. Thereafter, any time deadlines shall be determined from the 30th day after the filing of the sufficient application and information or from the effective date if the presiding officer extends that date. (C) While the application is being administratively reviewed, the commission staff and the staff of the Office of Public Utility Counsel may submit requests for information to the electing ILEC. Six copies of all answers to such requests for information shall be filed with central records and one copy shall be provided the Office of Public Utility Counsel within 10 days after receipt of the request by the electing ILEC. (D) No later than 20 days after the filing date of the sufficient application, interested persons may provide to the commission staff written comments or recommendations concerning the application. The commission staff shall and the Office of Public Utility Counsel may file with the presiding officer written comments or recommendations concerning the application. (E) No later than 35 days after the effective date of the application, the presiding officer shall issue an order approving, denying, or docketing the electing ILEC's application. (2) Approval or denial of application. The application shall be approved by the presiding officer if the proposed reclassification complies with each requirement of this section. If, based on the administrative review, the presiding officer determines that one or more of the requirements not waived have not been met, the presiding officer shall docket the application. (3) Standards for docketing. The application may be docketed pursuant to the commission's Procedural Rules sec.22.33(b) of this title (relating to Tariff Filings). (4) Review of the application after docketing. If the application is docketed, the deadline is automatically suspended to a date 120 days after the applicant has filed all of its direct testimony and exhibits, or 155 days after the effective date, whichever is later. Affected persons may move to intervene in the docket, and the presiding officer may schedule a hearing on the merits. The application shall be processed in accordance with the commission's rules applicable to docketed cases. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803917 Rhonda Dempsey Rules Coordinator Public Utility Commission of Texas Effective date: April 7, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 936-7308 TITLE 22. EXAMINING BOARDS PART XVII. Texas State Board of Plumbing Examiners CHAPTER 361.Definitions 22 TAC sec.361.1 The Texas State Board of Plumbing Examiners adopts an amendment to sec.361.1, defining the meanings of words and terms used in the Plumbing License Law and Board Rules without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 705). The purpose of the amendment is to clarify that a plumbing inspector may be an agent of a political subdivision and is not required to be a full time employee of a political subdivision in order to be licensed by the Board. The Board interprets "employee" found in Section (2)(5) of the Plumbing License Law broadly to include not only traditional employer/employee relationships, but also to include plumbing inspector services provided on a contract basis. Political subdivisions, especially smaller ones that do not have a need to perform frequent plumbing inspections, benefit from this rule by being able to use a licensed plumbing inspector on a temporary or contract basis. This rule also allows for a licensed plumbing inspector to perform plumbing inspections as an agent for more than one political subdivision. No comments were received regarding the adoption of the amendment to the rule. This new section is adopted under the authority of Texas Revised Civil Statutes Annotated Article 6243-101, sec.2(5) and sec.5(a) and sec.14(a) and sec.15(a), (Vernon's Supp. 1998) which the Board interprets as giving it authorization to determine the qualifications for plumbing inspectors. Chapter 361 Administration. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9804073 Robert L. Maxwell Chief of Field Services/Investigations Texas State Board of Plumbing Examiners Effective date: April 9, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 458-2145, Ext. 233 CHAPTER 363.Examination 22 TAC sec.363.1 The Texas State Board of Plumbing Examiners adopts an amendment to sec.363.1, regarding the eligibility requirements for taking the examinations offered by the Board without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 705). The purpose of the amendment is to allow more individuals that do not meet the requirements to be licensed plumbers, to become licensed plumbing inspectors. The rule amendment will give these unlicensed individuals additional means to qualify to take the plumbing inspector examination. This will be accomplished by the Board accepting an applicant's certification from the International Conference of Building Officials (ICBO), in lieu of a plumbing license, as a qualification to take the plumbing inspector examination. The following interested groups or associations presented comments: Municipal building officials and municipal code enforcement officials. All comments received were favorable for the adoption of the amendment. The amendment is adopted under the authority of Texas Revised Civil Statutes Annotated Article 6243-101, sec.2(5) and sec.5(a), (Vernon's Supp. 1998). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9804070 Robert L. Maxwell Chief of Field Services/Investigations Texas State Board of Plumbing Examiners Effective date: April 9, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 458-2145, Ext. 233 22 TAC sec.363.11 The Texas State Board of Plumbing Examiners adopts an amendment to sec.363.11, defining the requirements for providers of endorsement training programs without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 706). The purpose of the amendment is to ensure that the Water Supply Protection Specialist Training Programs will always be provided equitably across the state, as the Medical Gas Endorsement Training Programs are. The public benefit is to those licensed plumbers that wish to receive a Water Supply Protection Specialist endorsement on their license will receive equal access to the required training classes. No comments were received regarding the adoption of the amendment. This new amendment is adopted under the authority of Texas Civil Statutes Annotated Article 6243-101, sec. 11(A) and sec.5(a), (Vernon's Supp. 1998). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9804069 Robert L. Maxwell Chief of Field Services/Investigations Texas State Board of Plumbing Examiners Effective date: April 9, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 458-2145, Ext. 233 CHAPTER 365.Licensing 22 TAC sec.365.5 The Texas State Board of Plumbing Examiners adopts an amendment to sec.365.5, regarding renewal of licenses and endorsements without changes to the proposed text as published in the February 6, 1998, issue of the Texas Register (23 TexReg 889). The purpose of the rule amendment is to make it easier for a plumber to renew a medical gas endorsement on a plumbing license by allowing that individual to meet the continuing education requirements for renewal any time within the three year period of the endorsement. The former requirement was for the licensee to meet the continuing education requirements only within the third year of the endorsement period. The public benefit will be a higher quality of plumbers performing medical gas work by requiring that holders of a medical gas endorsement take a medical gas continuing education course within the three year period of the endorsement in order to renew the endorsement. The amendment further requires that the same medical gas continuing education class may not count twice towards meeting the requirements to renew the endorsement in order to help ensure that the licensee receives the most up to date continuing education. No comments were received regarding the adoption of the amendment. The amendment is adopted under the authority of Texas Revised Civil Statutes Annotated Article 6243-101, sec.5(a) and sec.12B, (Vernon's Supp. 1998). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9804068 Robert L. Maxwell Chief of Field Services/Investigations Texas State Board of Plumbing Examiners Effective date: April 9, 1997 Proposal publication date: February 6, 1998 For further information, please call: (512) 458-2145, Ext. 233 CHAPTER 367.Enforcement 22 TAC sec.367.3 The Texas State Board of Plumbing Examiners adopts an amendment to sec.367.3, which defines the requirements for plumbing companies to meet when offering to perform plumbing work and defines the requirements for a master plumber when he or she is acting as Responsible Master Plumber for a plumbing company without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 706). The purpose of the rule amendment is a response to master plumbers and plumbing inspectors complaining that some master plumbers are claiming to be Responsible Master Plumbers for multiple plumbing companies without actually assuming the responsibilities of the work performed under his or her master license. The Board Rules require that a Responsible Master Plumber be knowledgeable of and responsible for all permits, contracts, and agreements to perform plumbing work secured and plumbing work performed under his or her master plumber's license. The Rules also require that a Responsible Master Plumber provide for proper supervision of individuals performing plumbing work under his license. The purpose of the rule amendment is to ensure that the master plumber will not be allowed to dilute his supervisory and knowledge capabilities by attempting to act as a Responsible Master Plumber for multiple companies solely for the purpose of receiving compensation from multiple companies. The public benefit will be greater protection of health, safety and welfare by clearly defining that each plumbing company must be under the supervision of a Responsible Master Plumber that is supervising only one plumbing company. A master plumber will be required to properly supervise and be knowledgeable of and responsible for all plumbing work performed under his license while acting as a Responsible Master Plumber. No comments were received regarding the adoption of the amendment. This amendment is adopted under the authority of Texas Revised Civil Statutes Annotated Article 6243-101, sec.2(2) and sec.5(a), (Vernon's Supp. 1998). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9804067 Robert L. Maxwell Chief of Field Services/Investigations Texas State Board of Plumbing Examiners Effective date: April 9, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 458-2145, Ext. 233 PART XXII. Texas State Board of Public Accountancy CHAPTER 501.Professional Conduct 22 TAC sec.501.47 The Texas State Board of Public Accountancy adopts an amendment to sec.501.47 with changes to the proposed text published in the February 6, 1998, issue of the Texas Register, (23 TexReg 890). The Board adopted these changes to a proposed amended rule to clarify that this subsection of the rule does not prohibit an accurate geogrphic representation per se. Subsection (b)(3)(A) was changed to replace "contains" with "indicates"; "area of service which is not based on verifiable facts; or" was added following the word "geographic"; and "and" was deleted at the end of this sentence. The changes to subsection (b)(3)(A) are not substantive. The changes were made because the Board considered "indicates" to be the correct word for this subsection, and because "area of service not based on verifiable facts" was the narrow area that this part of the rule is aimed at correcting or improving rather than the earlier broad sweep of geographic area. In paragraph (b)(7), "unless the entity was organized prior to September 1993" was added following the word "name." This change is not substantive. The change was made because prior to September 1, 1993 there was no "professional" in the limited liability company and limited partnership Acts. Companies organized under these Acts may continue to use their earlier recognized names. The amendment should allow consumers to have commercial information that is increased in amount and accuracy. The amendment will function by requiring increased and accurate disclosure in a firm name. No comments were received concerning adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 41a-1, sec.6, which provides the Texas State Board of Public Accountancy with the authority to make such rules as may be necessary or advisable to effectuate the purposes of the law. sec.501.47.Firm Names. (a) No certificate or registration holder shall engage in the practice of public accountancy using a firm name that includes descriptive words relating to the quality of services offered or that is misleading about the legal form of the firm, or about the persons who are partners, officers, or shareholders of the firm, or about any other matter, provided, however, that names of one or more former partners or shareholders may be included in the name of a firm or its successor. (b) A firm name will be considered to be misleading if: (1) the name contains a misrepresentation of facts; (2) the name indicates character or grade of service which is not based upon verifiable facts; (3) the name is likely to mislead or deceive because it fails to make full disclosure of relevant facts; the following are examples, but are not inclusive: (A) the name indicates a geographic area of service which is not based on verifiable facts; or (B) the firm name includes a non-owner firm employee. (4) the name is intended or likely to create false or unjustified expectations of favorable results; (5) the name implies special expertise; (6) the name implies educational or professional attainment or licensing recognition of the firm and/or of its owners, partners, or shareholders which are not supported in fact; (7) the name of the firm that is incorporated does not include the words "corporation," "incorporated," "professional corporation," or "company," or in each case, an abbreviation thereof, as a part of the firm name; the words "professional corporation," or "PC" are not included with the firm name each time it is used; and the name of a firm organized under the limited liability partnership rules does not include the words "professional limited liability company" or "professional limited liability partnership" as appropriate, or an abbreviation thereof as part of the firm name unless the entity was organized prior to September 1, 1993; (8) the name includes the designation "and company," "company," "group," "associates" or "and associates" or abbreviations thereof or similar names implying more than one employed member of the firm unless there are at least two licensees involved full time in the practice; (9) the name of a firm that is a partnership or professional corporation fails to contain the personal name or names of one or more individuals presently or previously a partner, officer, or shareholder thereof; (10) the name of a firm that is a sole proprietorship fails to contain the name of the sole proprietor; or (11) the name contains other representations or implications that in reasonable probability will cause a person of ordinary prudence to misunderstand or be deceived. (c) A partner surviving the death or withdrawal of all other partners may continue to practice under a partnership name for up to two years after becoming a sole practitioner. (d) The name of any former partner or former shareholder may not be used in a registered firm name during the period of sanction when the former partner or former shareholder has been prohibited from practicing public accountancy or prohibited from using the title "CPA" or "PA". This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 17, 1998. TRD-9803882 William Treacy Executive Director Texas State Board of Public Accountancy Effective date: April 6, 1998 Proposal publication date: February 6, 1998 For further information, please call: (512) 305-7800 CHAPTER 511.Certification of CPA 22 TAC sec.511.57 The Texas State Board of Public Accountancy adopts an amendment to sec.511.57 without changes to the proposed text published in the February 6, 1998, issue of the Texas Register, (23 TexReg 891). The amendment allows applicants to receive credit towards the total semester hours required for licensure by successfully completing these courses. The amendment will function by giving credit towards the total semester hours required for licensure to applicants for successfully completing these courses. One comment was received in support of adoption of this rule as published. No changes were suggested. A response from the board is unnecessary. The amendment is adopted under Texas Civil Statutes, Article 41a-1, sec.6, which provides the Texas State Board of Public Accountancy with the authority to make such rules as may be necessary or advisable to effectuate the purposes of the law and sec.12 which authorizes the Board to promulgate rules regarding educational requirements. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 17, 1998. TRD-9803883 William Treacy Executive Director Texas State Board of Public Accountancy Effective date: April 6, 1998 Proposal publication date: February 6, 1998 For further information, please call: (512) 305-7800 PART XXIV. Texas Board of Veterinary Medical Examiners CHAPTER 571.Licensing The Texas Board of Veterinary Medical Examiners adopts the repeal of licensing and examination requirements currently contained in 22 TAC, Part XXIV, Chapter 571, rules sec.sec.571.1, 571.2, 571.3, 571.5, 571.8, 571.11, 571.12, 571.13, 571.15 and 571.36 with changes to the proposed repeal published in the November 14, 1997, issue of the Texas Register (22 TexReg 11045). Section(c)(2) was amended to allow for a successor to the Interstate Reporting Service. The Board adopts new section 22 TAC sec.571.3, concerning Eligibility for Examination and Licensure with changes to the proposed text published in the December 12, 1997, issue of the Texas Register (22 TexReg 12210). Section (c)(2) of the rule is changed to state "The Board will accept certified scores issues by the Interstate Reporting Division of the Professional Examination Service, or its successor, for NBE and CCT examinations conducted concurrently with the Texas State board Licensing Examination." The agency is adopting this new section and repealing the above numbered rules so that all the requirements for licensure are contained in one rule. The new section clarifies that only schools approved by the Board and accredited by the American Veterinary Medical Association provide a sufficient veterinary medical education for the practice of veterinary medicine. A graduate of another veterinary school may demonstrate that he or she received a sufficient veterinary medical education by obtaining an Educational Commission for Foreign Veterinary Graduates Certificate issued by the American Veterinary Medical Association. No comments were received regarding the adoption of the repeals. Examinations 22 TAC sec.sec.57.11, 571.3, 571.5, 571.8, 571.11, 571.13, 571.15 The repeals are adopted under the authority of the Veterinary Licensing Act, Texas Civil Statutes, Article 8890, sec.7(a) which provides that the Board may enact or amend rules which are necessary to carry into effect the provisions of the Veterinary Licensing Act and therefore the provisions of sec.10 of the Act which sets out the requirements for licensure. The repeals affect the Veterinary Licensing Act, Article 8890, sec.10. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 12, 1998. TRD-9803596 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: April 1, 1998 Proposal publication date: November 14, 1997 For further information, please call: (512) 305-7555 22 TAC sec.571.3 The new section is adopted under the authority of the Veterinary Licensing Act, Texas Civil Statutes, Article 8890, sec.7(a) which provides that the Board may enact or amend rules which are necessary to carry into effect the provisions of the Veterinary Licensing Act and therefore the provisions of sec.10 of the Act which sets out the requirements for licensure. The amendments affect the Veterinary Licensing Act, Article 8890, sec.10. sec.571.3.Eligibility for Examination and Licensure. (a) QUALIFICATIONS OF LICENSEES. To be eligible for licensure, an applicant must present satisfactory proof to the Board that the applicant: (1) is at least 18 years of age; (2) obtained a minimum passing score of 75 % on: (A) the NBE and the CCT examinations; and (B) the Texas State Board Licensing Examination; and (3) is a graduate of a school or college of veterinary medicine that is approved by the Board and accredited by the American Veterinary Medical Association (AVMA). Applicants who are not graduates of a school or college accredited by the AVMA are eligible provided the applicant presents satisfactory proof to the Board that he/she is a graduate of a school or college of veterinary medicine and possesses an Educational Commission for Foreign Veterinary Graduates Certificate issued by the AVMA. The Board may refuse to issue a license to an applicant who meets the qualification criteria but is otherwise disqualified as provided in Section 14 of the Veterinary Licensing Act. (b) APPLICATION FOR REGULAR LICENSE AND EXAMINATION (1) The applicant for a regular veterinary license and examination(s) shall make application on the form furnished by the Board. (2) The completed application for regular veterinary license and examination(s), including payment of examination fees, must be received at the Board Offices no later than 45 days prior to the date of the examination for which the applicant desires to sit. (c) LICENSING EXAMINATION (1) Eligibility Prior to Graduation. An applicant who has not graduated from veterinary medical school, may sit for examinations provided the following conditions have been complied with: (A) To sit for the Texas State Board Licensing Examination, applicants must be enrolled in an approved and accredited veterinary medical school or college as defined in subsection (a) and must obtain a document from the Dean of the school or college from which he/she expects to graduate certifying that the applicant is within 60 days of completion of a veterinary college program and is expected to graduate. (B) To sit for the National Board Examination (NBE) or the Clinical Competency Test (CCT), an applicant must be enrolled in an approved and accredited veterinary medical school or college as defined in subsection (a) and must obtain a document from the Dean of the school or college from which he/she expects to graduate certifying that the applicant is a graduating senior in good academic standing and is expected to graduate. (C) An applicant enrolled in a joint or combined degree program who has completed his/her veterinary medical education but who has not received a diploma or transcript certifying award of his/her DVM degree, must obtain a letter from the Dean of the school or college of veterinary medicine stating the applicant did in fact graduate before the applicant is eligible to sit for examination(s). (2) Results of NBE and CCT Examination. An applicant must obtain a minimum passing score of 75% on the NBE and CCT to be eligible to qualify for licensure in Texas. The Board will accept certified scores issued by the Interstate Reporting Division of the Professional Examination Service, or its successor, for the NBE and CCT examinations conducted concurrently with the Texas State Board Licensing Examination. Results of the Texas State Board Licensing Examination will not be released to applicants who fail to pass concurrently administered NBE or CCT examinations. The Board will accept certified scores issued by the Interstate Reporting Division of the Professional Examination Service for the NBE and CCT examinations conducted in another jurisdiction provided the examinations were conducted within five years prior to the date the applicant sits for the Texas State Board Licensing Examination. (3) Score Information. All requests for information on examination scores shall be processed as follows: (A) All requests from other state licensing boards for an applicant's raw scores on the NBE or CCT will be referred to the Interstate Reporting Division of the Professional Examination Service. (B) All requests from other state licensing boards for an applicant's converted scores on the NBE and CCT will be based upon national data submitted by the Professional Examination Service. (C) Upon written request of an applicant, the Board will certify the score of the Texas State Board Licensing Examination to another state licensing board. Upon written request of an applicant, the Board will make NBE or CCT scores available for informational purposes only to another state licensing board but will not certify the NBE or CCT scores. (4) Release of Examination Grades. The Board will provide examination grades only to an applicant or another state licensing board upon the written request of an applicant. (5) Request For Analysis Of Failed Examination. Any applicant who has failed the Texas State Board Licensing Examination may submit a written request, within 30 days of the release of the examination results, for an analysis of his/her examination. The Board will not provide an analysis to an applicant who has not submitted to the Board proof of graduation from an approved and accredited school or college of veterinary medicine. An applicant who submits proof of graduation from an approved and accredited school or college of veterinary medicine after release of the examination results may request an analysis of his/her examination within 30 days of the date the Board receives proof of graduation. An analysis provided by the Board under this provision will be in writing. The Board will not disclose any actual examination documents or materials. (6) Reapplication. An applicant for examination who (A) does not appear for examination within one year of the date of his/her application; or (B) does not attend either of the two regularly scheduled examinations following the date of his/her application, shall be required to reapply. Reapplication requirements include submission of an application form and payment of the current examination fee prior to admission for examination. An applicant who has previously failed an examination or has been refused a license is required to submit an application form and payment of the current examination fee prior to admission for examination. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 12, 1998. TRD-9803597 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: April 1, 1998 Proposal publication date: November 14, 1997 For further information, please call: (512) 305-7555 Reciprocals 22 TAC sec.571.36 The repeal is adopted under the authority of the Veterinary Licensing Act, Texas Civil Statutes, Article 8890, sec.7(a) which provides that the Board may enact or amend rules which are necessary to carry into effect the provisions of the Veterinary Licensing Act and therefore the provisions of sec.10 of the Act which sets out the requirements for licensure. The amendments affect the Veterinary Licensing Act, Article 8890, sec.10. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 12, 1998. TRD-9804448 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: April 1, 1998 Proposal publication date: November 14, 1997 For further information, please call: (512) 305-7555 TITLE 25. HEALTH SERVICES PART I. Texas Department of Health CHAPTER 14.County Indigent Health Care Program The Texas Department of Health by majority vote of the Texas Board of Health on March 20, 1998, enters this order finally adopting amendments to sec.14.1, sec.14.101, sec.sec.14.103-14.106 and sec.14.204 concerning the County Indigent Health Care Program (CIHCP) without changes to the proposed text as published in the December 5, 1997, issue of the Texas Register (22 Tex Reg 11929), and therefore the sections will not be republished. Two proposed changes to sec.14.1 concern public hospitals and are a result of new legislation. House Bill 2556, 75th Legislature, 1997, allows state assistance funds to be received by a county that provides indigent health care services to its eligible residents through a hospital established by a board of managers jointly appointed by a county and a municipality. House Bill 2397, 75th Legislature, 1997, allows a county to amend or revoke an indigent health care agree- ment made between a county and a city with a population of less than 15,000 that owns, operates or leases a public hospital if a hospital district with boundaries that cover all or part of the county is created after the effective date of the agreement. Health and Safety Code, Chapter 61 mandates that rules for the County Indigent Health Care Program (CIHCP) be no more restrictive than the Aid to Families with Dependent Children (AFDC) program which is now called Temporary Assistance to Needy Families (TANF). A definition of Temporary Assistance to Needy Families (TANF) is added to sec.14.101. All references to AFDC are changed to TANF in sec.14.101, sec.14.103, and sec.14.104. Two changes to the TANF program regarding the limit on available resources and the countable value of vehicles resulted in changes to sec.14.105 and sec.14.106. All references to the Texas Medicaid or Vendor Drug program in sec.14.1 and sec.14.204 are changed for consistency. No comments were received on the proposal during the comment period. SUBCHAPTER A.County Program Administration 25 TAC sec.14.1 The amendment is adopted under Health and Safety Code, Chapter 61; and Human Resources Code, Chapter 32. The department has rule making authority for CIHCP under Chapter 15, sec.1.07, Acts of the 72nd Legislature, First Called Session (1991). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804121 Susan K. Steeg General Counsel Texas Department of Health Effective date: April 12, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 SUBCHAPTER B.Determining Eligibility 25 TAC sec.sec.14.101, 14.103-14.106 The amendments are adopted under Health and Safety Code, Chapter 61; and Human Resources Code, Chapter 32. The department has rule making authority for CIHCP under Chapter 15, sec.1.07, Acts of the 72nd Legislature, First Called Session (1991). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804120 Susan K. Steeg General Counsel Texas Department of Health Effective date: April 12, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 SUBCHAPTER C.Providing Services 25 TAC sec.14.204 The amendment is adopted under Health and Safety Code, Chapter 61; and Human Resources Code, Chapter 32. The department has rule making authority for CIHCP under Chapter 15, sec.1.07, Acts of the 72nd Legislature, First Called Session (1991). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804119 Susan K. Steeg General Counsel Texas Department of Health Effective date: April 12, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 CHAPTER 143.Medical Radiologic Technologists 25 TAC sec.143.3 The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on March 20, 1998, enters this order finally adopting an amendment to sec.143.3 concerning the composition of the Medical Radiologic Technologist Advisory Committee (committee), with changes to the proposed text as published in the December 12, 1997, issue of the Texas Register (22 TexReg 12212), as a result of comments received during the 30-day comment period. The rule reduces the number of certified medical radiologic technologists (MRTs) serving on the committee from five to three, and replaces the positions with one licensed physician who practices in a rural or underserved community in Texas and one registered nurse (RN) or certified physician assistant (PA) who practices in a rural or underserved community in Texas. This change is necessary to insure (i) that matters of interest to both the urban and rural health care providers and recipients are fully considered by the committee, and (ii) that clear, reliable, and efficient regulations continue to be promulgated that will protect Texans from the harmful effects of excessive radiation used for medical purposes. The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting changes. Comment: Concerning the phrase "underserved community in Texas" one commenter suggested substituting the phrase "a rural community or at a site serving a medically underserved population as defined in the Medical Practice Act." Response: The department agrees that this addition would better define the phrase "underserved community" and has added appropriate wording in sec.143.3(f)(5) and (6). Comment: One commenter believed that if there is a need for rural representation on the committee then an MRT representative should be appointed from a rural community. Response: The department disagrees. The health care needs of rural Texas (or those needing care while traveling in a rural area) are being met by a variety of health care providers. Those providers serve the public under conditions that need consideration best provided by the proposed changes to the committee. No change was made as a result of the comment. Comment: One commenter recommended a majority representation of MRTs on the committee. The radiologic technology fields (mammography, special procedures, nuclear medicine, radiation therapy and general radiologic technology) should be represented. Response: The advice of committees is most frequently needed in development of policy reflecting principles basic to the science in question, to which all members contribute from their education, experience and background. The department believes that the MRT representation of the proposed committee will provide sufficient expertise. No change was made as a result of the comment. Comment: Several commenters were in opposition to reducing the number of MRTs on the committee and recommended that consumer member positions be used to include a physician and an RN or PA who practice in a rural or underserved community. Response: By law, committees must appoint two public members not licensed or employed in the field of health care. No change was made as a result of the comments. Comment: Several commenters were in opposition to reducing the number of MRTs on the committee and if rural representation is necessary suggested adding additional positions for a rural physician, a rural RN, a rural PA, and a rural MRT. Response: The department disagrees with the addition of another position to the committee. The Texas Legislature has repeatedly directed its operational groups to limit their size and scope (e.g., the Texas Board of Health was reduced from 18 to six members in 1993). Advisory committee membership should continue at current levels. No change was made as a result of the comments. Comment: Several commenters suggest the reduction of the number of MRTs on the committee eliminates experience in the field of radiography, and experts in radiological sciences. The reduction would adversely affect the care of the patients and the quality of diagnostic procedures and could undo many things that MRT certification has done for the profession. Response: The department disagrees. It is important that individuals with varying clinical and practical experiences contribute in advising the board, to ensure broad consideration in policy development, and the proposed committee membership will best accomplish these goals. No change was made as a result of the comments. The Texas Academy of Family Physicians, Texas Academy of Physician Assistants, Texas Association of Rural Health Clinics, Texas Hospital Association, Texas Organization of Rural and Community Hospitals, Texas Medical Association and Texas Nurses Association presented a written comment of support to the board when the rule was proposed. An additional comment of support was received from the Texas Academy of Family Physicians. The commenters were from the Advanced Health Education Center, Cook Children's Medical Center, Fort Worth Society of Radiologic Technologists, Methodist Medical Center, North Texas Society of Radiation Therapists, Texas Academy of Family Practice, Texas Nurses Association, and Texas Society of Radiologic Technologist, Inc., and six individuals. The amendment is adopted under the Medical Radiologic Technologist Certification Act (Act), Texas Civil Statutes, Article 4512m, sec.2.05(e) which provides the board with the authority to adopt rules necessary to implement the Act; the Texas Health and Safety Code sec.11.016, which provides the board with the authority to appoint advisory committees to assist the board in performing its duties; and the Texas Health and Safety Code sec.12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.143.3.Medical Radiologic Technologist Advisory Committee. (a) - (e) (No change.) (f) Composition. The committee shall be composed of nine members appointed by the board. The composition of the committee shall include: (1) - (4) (No change.) (5) one licensed physician who has experience in radiologic procedures and who practices in a rural community or at a site serving a medically underserved population in Texas as defined in the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5)(E)(iv); and (6) one registered nurse or certified physician assistant who has experience in radiologic procedures and who practices in a rural community or at a site serving a medically underserved population in Texas as defined in the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5)(E)(iv). (g) Terms of office. The term of office of each member shall be six years. (1) Members shall be appointed for staggered terms so that the terms of three members will expire on January 1 of each odd-numbered year. (2) (No change.) (h) - (o) (No change.) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 20, 1998. TRD-9804095 Susan K. Steeg General Counsel Texas Department of Health Effective date: April 9, 1998 Proposal publication date: December 12, 1997 For further information, please call: (512) 458-7236 CHAPTER 157.Emergency Medical Services SUBCHAPTER G.Emergency Medical Services Trauma Systems 25 TAC sec.157.130 The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on March 20, 1998, enters this order finally adopting new sec.157.130 concerning distribution of monies from the Emergency Medical Services (EMS) and Trauma Care System Fund (fund) with changes to the proposed text as published in the December 12, 1997 issue of the Texas Register (22 TexReg 12213). Senate Bill 102, 75th Legislature, 1997, amended Health and Safety Code, Chapter 773 and, as a result, the law created an EMS and Trauma Care System Fund. Monies in the amount of $1,500,000 for fiscal year 1998 and $2,500,000 for fiscal year 1999 were allocated to the fund. The purpose of these monies is to support the continued development and implementation of a statewide EMS/Trauma System. This section delineates the allocations of the fund to EMS, Regional Advisory Councils (RACs), and uncompensated care; specify eligibility requirements for EMS providers, RACs, trauma facilities, and counties; and describe the process for disbursement of the monies through the counties. The department is making the following minor changes due to staff comment to clarify the intent and improve accuracy of the section. Change: Concerning subsection (d)(1), the reference to publishing a request for proposals was deleted because the legislation states that the RAC chairs will petition for the uncompensated care allotment. The language regarding payments to be made to designated trauma facilities for uncompensated care provided in the current or immediately previous fiscal year was added to clarify the time period for which the department will reimburse these costs. Change: Concerning subsection (d)(2)(A), the amount of uncompensated care was added as one of the issues that will be considered when the department makes the awards. The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s). Comment: Concerning subsection (a), one commenter questioned why a new federal definition of "emergency" which had been in an early draft was removed and asked that it be re-inserted. Response: The department disagrees because the new federal definition does not relate to this section. No change was made as a result of this comment. Comment: Concerning subsection (a)(3), two commenters asked that the population levels to determine a rural county be raised. Response: The department disagrees because the definition of rural as proposed is a standard national definition. No change was made as a result of these comments. Comment: Concerning subsection (c)(2), one commenter requested that the rules specify exactly how the counties will disburse the funds received from the department. Response: The department disagrees because the legislation directs the department to distribute the funds to counties on behalf of eligible recipients, which will be done by contract; it is the counties' decision how to distribute those funds to the eligible EMS providers and RACs. No change was made as a result of this comment. Comment: Concerning subsection (c)(3), two commenters requested that the RAC allocation be distributed directly to each RAC, rather than through the county of residence of the RAC chair. Response: The department disagrees because the legislation directs the department to distribute the funds to counties on behalf of eligible recipients. No change was made as a result of these comments. Comment: Concerning subsection (c)(5), two commenters opposed the language that does not allow counties to retain administrative costs. Response: The department disagrees because there is no provision in the legislation for county administration costs. No change was made as a result of these comments. Comment: Concerning subsection (c)(6), two commenters opposed and one commenter supported the language that requires the monies to be used for new purposes, not to offset monies already being spent by a county to support emergency medical services. Response: The department disagrees because this is the first funding provided by the legislature for comprehensive EMS/trauma system development and it is very important to develop the infrastructure of this system in the many areas of the state where it is not available. No change was made as a result of these comments. Comment: Concerning subsection (e), one commenter stated that EMS providers should be required to participate in their RAC activities in order to be eligible for funds every year, that those agencies that only provide transfer services should not be eligible for these funds, and that EMS providers be required to submit data to the RAC regional registry in all TSAs in which they operate. Another commenter stated that there were quite a few eligibility requirements for a small amount of money. Response: The department agrees with the first comment, but feels that this issue is already addressed in the rules as proposed. The department disagrees with the second comment because the law states that the funding is for eligible local EMS providers, which may include some transfer agencies. The department disagrees with the third comment because participation on a RAC regional registry is voluntary; EMS providers may submit data directly to the department if they choose. The department disagrees with the final comment in that the initial eligibility requirements are relatively easy to meet; in fact, most potential recipients should already be meeting the requirements for the first two years. The eligibility requirements in the succeeding years are gradually increased for the purpose of continuing development of the EMS/trauma system. No changes were made as a result of these comments. Comment: Concerning subsection (e)(C)(iii), one commenter felt the wording regarding the requirement that EMS providers demonstrate utilization of RAC protocols in all TSAs in which they operate could result in a situation where there are differing interpretations. Response: The department disagrees because the pertinent RACs will be reporting compliance with this requirement to the department. No change was made as a result of this comment. Comment: Concerning subsection (f)(1), eleven commenters opposed the funding formula which weights the distribution of the EMS allocation towards rural and frontier areas. Response: The department worked with the Texas Conference of Urban Counties and other interested individuals and has reached a compromise which will allow the funding formula to remain as proposed for the first two years which will help to establish the infrastructure of the state EMS/trauma system in the many areas of the state where it is not currently in place. The compromise resulted in the new language under subsection (f)(1), deletion of subsections (f)(1)(E) and (f)(1)(F), new subsection (f)(2) which specifies a new formula to be based on relative county population, size, and number of emergency health care runs without any weighting factor should the legislature provide funding for the next biennium, and the renumbering of old subsection (f)(2) as (f)(3). The following associations and individuals commented on each section as follows. Commenters in favor of the rule as proposed were Representative David Swinford, the Emergency Health Care Advisory Committee, the Texas Trauma Coordinators Forum, the North Central Texas Regional Advisory Council, the South Plains Emergency Medical Services Regional Advisory Council, the Far West Texas and Southern New Mexico Regional Advisory Council, the Texas "J" Regional Advisory Council, the Southwest Texas Regional Advisory Council for Trauma, the Trauma Service Area - P Trauma Coordinators, the Houston Area Trauma Coordinators, Borden County, Burnet County, Hill County, Hopkins County, Kent County, Llano County, Mills County, Rusk County, Terrell County, Blackwell Volunteer Fire Department, Deer Park Fire Department, Harker Heights Fire Department, Jim Hogg County EMS, Kinney County EMS, Lifenet EMS, Lubbock County EMS, Midland Memorial Hospital and Medical Center, San Jacinto College Central, Scott and White/Rockdale EMS, Texas EMS, Thomason Hospital, Val Verde Medical Center, Zapata County Fire Department, and other individuals. Some of these commenters also asked questions and suggested recommendations for changes as discussed in the summary of comments. Commenters in opposition to the proposed funding formula for distribution of the EMS allotment were Senator Mario Gallegos Jr, Senator Mike Moncrief, Representative Ted Kamel, Representative Robert R. Puente, the Texas Conference of Urban Counties, Texas Orthopedic Association, Bexar County, Dallas County, Tarrant County, Galena Park Fire Department, and Jacinto City. Some of these commenters also asked questions and suggested recommendations for changes as discussed in the summary of comments. The new section is adopted under the Health and Safety Code, sec.773.115, which provides the board with the authority to adopt rules for the development of an EMS/trauma care system; and Health and Safety Code sec.12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.157.130.Emergency Medical Services and Trauma Care System Fund. (a) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Extraordinary emergency - An event or situation which may disrupt the services of a regional ems/trauma system. (2) Frontier county - A county with a population that averages less than six people per square mile. (3) Rural county - A county with a population of less than 50,000 and that averages more than six people per square mile. (4) Trauma support area - Trauma service area. (5) Urban county - A county with a population of 50,000 or more. (b) Reserve. On September 1 of each year, there shall be a reserve of $250,000 in the emergency medical services (EMS) and trauma care system fund (fund) for extraordinary emergencies. During the fiscal year, distributions may be made from the reserve by the commissioner of health based on requests which demonstrate need and impact on the EMS and trauma care system (system). (c) Allotments. The EMS and trauma service area (TSA) allotments shall be 70% and 25%, respectively, of the funds remaining in the fund after any amount necessary to maintain the extraordinary emergency reserve of $250,000 has been deducted. (1) By August 31 of each year, the bureau of emergency management (bureau) shall determine: (A) eligibility of all EMS providers, regional advisory councils (RACs), trauma facilities, and counties; (B) the TSA and EMS allotments; (C) each county's share of the EMS allotment; and (D) each RAC share of the TSA allotment. (2) The bureau shall contract with each county in which eligible EMS providers are based to distribute the EMS allotment. In counties with a population of 291,000 or more, joint authorization of the chief executive of the county and the mayor of the principal municipality in the county is required for disbursement of the county allocation. (3) The bureau shall contract with each county in which a RAC chairperson resides to distribute the TSA allotment. For any RAC whose chairperson resides in a county outside of Texas, the chairperson must appoint another officer of the RAC who resides in a Texas county as his or her representative in order to determine to which county the RAC's share of the TSA allotment shall be distributed. (4) Contracts with the counties shall include at a minimum: (A) a list of eligible participants; (B) a list of eligible expenditures; (C) requirements for reporting; and (D) requirements for returning undisbursed monies to the fund. (5) The county allocations shall be distributed directly to eligible recipients without any reduction in the total amount allocated by the Texas Department of Health (department). (6) The county allocations shall be used as an addition to current county EMS funding of eligible recipients, not as a replacement. (7) The bureau shall investigate all complaints regarding distribution of the EMS and TSA allotments. (d) Uncompensated care allotment. The uncompensated care allotment shall be 2.0% of the funds remaining in the fund after any amount necessary to maintain the extraordinary emergency reserve of $250,000 has been deducted plus any monies not otherwise expended by counties and/or eligible recipients in a given fiscal year. (1) Each fiscal year, the bureau shall request proposals to distribute funds from the uncompensated care allotment for uncompensated trauma care provided by designated trauma facilities in either the current or immediately previous fiscal year or innovative projects to enhance the delivery of patient care in the overall system. (2) Contract awards from the uncompensated care allotment shall be made based on, but not limited to: (A) demonstration of need and the amount of uncompensated trauma care provided; (B) innovation of proposal; (C) broad system impact; (D) enhancement of system development; and (E) availability of funds. (e) Eligibility requirements. To be eligible for funding from the fund, all potential recipients must maintain active involvement in regional system development within all of the TSAs in which they operate. By August 31, 1998, to be eligible for funding from the fund all potential recipients must meet requirements for reports of expenditures from the previous year and planning for use of the funding in the upcoming year. (1) To be eligible for funding, an EMS provider must: (A) by December 31, 1997, maintain provider licensure as described in sec.157.11 of this title (relating to Requirements for an EMS Provider License) and provide emergency medical services and/or emergency transfers; and (B) by August 31, 1998; (i) maintain provider licensure as described in sec.157.11 of this title and provide emergency medical services and/or emergency transfers; and (ii) submit a plan for electronically submitting patient care report data to the RAC regional registry or the department as described in sec.157.129 of this title (relating to State Trauma Registry). (C) by August 31, 1999; (i) maintain provider licensure as described in sec.157.11 of this title and provide emergency medical services and/or emergency transfers; (ii) electronically submit at least the essential data set to the RAC regional registry or the department as described in sec.157.129 of this title; and (iii) demonstrate utilization of the RAC regional protocols regarding patient destination and transport in all TSAs in which they operate. (D) by August 31, 2000, and in subsequent years; (i) maintain provider licensure as described in sec.157.11 of this title and provide emergency medical services and/or emergency transfers; (ii) electronically submit at least the essential data set to the RAC regional registry or the department as described in sec.157.129 of this title; (iii) demonstrate utilization of the RAC regional protocols regarding patient destination and transport in all TSAs in which they operate; and (iv) demonstrate active participation in the regional system quality improvement (QI) program in all TSAs in which they operate. (2) To be eligible for funding, a RAC must: (A) by December 31, 1997; (i) be officially recognized by the department as described in sec.157.123 of this title (relating to Regional Advisory Councils); and (ii) submit documentation of ongoing system development activity and future planning. (B) by August 31, 1998; (i) be officially recognized by the department as described in sec.157.123 of this title; (ii) submit documentation of ongoing system development activity and future planning; and (iii) have received approval from the department on at least three of its system plan components as described in sec.157.124 of this title (relating to Regional EMS/Trauma Systems) to include at least prehospital triage criteria and bypass protocols. (C) by August 31, 1999; (i) be officially recognized by the department as described in sec.157.123 of this title; (ii) submit documentation of ongoing system development activity and future planning; (iii) have implemented a regional registry or submitted to the department documentation that at least 10% of the total number of EMS providers and hospitals in the TSA are electronically submitting the pertinent essential data set to the department as described in sec.157.129 of this title; and (iv) have received approval of its regional system plan from the department. (D) by August 31, 2000; (i) be officially recognized by the department as described in sec.157.123 of this title; (ii) submit documentation of ongoing system development activity and future planning; (iii) have implemented a regional registry or submitted to the department documentation that at least 40% of the total number of EMS providers and hospitals in the TSA are electronically submitting the pertinent essential data set to the department as described in sec.157.129 of this title; and (iv) have demonstrated that a regional system QI process is ongoing. (3) To be eligible for funding, a trauma facility must maintain its designation status. (f) Calculation of county shares. (1) EMS allotment for FY 1998 and FY 1999. (A) Counties will be classified as urban, rural, or frontier based on the latest official federal census population figures. (B) The EMS allotment will be divided into allocations for urban, rural, and frontier counties based on the percentage of each type of county in the state. (C) An individual county's share of the EMS allotment shall be based on its relative geographic size and population as compared to all other counties of its classification. (D) The formula shall be: (((the county's percentage of the classification group's population) plus (the county's percentage of the classification group's geographic size) divided by 2)) times (the total classification group's allocation). (2) EMS allotment after August 31, 1999. Should the legislature allocate funds, they will be distributed as follows: (A) The counties will not be divided into classifications. (B) Each individual county's share shall be based on its relative geographic size, population and number of emergency runs as compared to all other counties. (C) The formula shall be: (((the county's percentage of state population) plus (the county's percentage of the state's geographic size) plus (the county's percentage of total state emergency health care runs)) divided by 3) times the total EMS allotment. Total emergency health care runs shall be the number of emergency runs electronically transmitted to the department in a given year by EMS providers. (3) TSA allotment. (A) A RAC's share of the TSA allotment shall be based on its relative geographic size and population as compared to all other TSAs. (B) The formula shall be: (((the TSA's percentage of the state's population) plus (the TSA's percentage of the state's geographic size)) divided by 2) times (the total TSA allotment). (C) After August 31, 2000, a RAC's share of the TSA allotment shall be based on its relative geographic size, population, and trauma care provided as compared to all other TSAs. (D) The formula shall be: ((the TSA's percentage of the state's population) plus (the TSA's percentage of the state's geographic size) plus (the TSA's percentage of the state's total trauma care) divided by 3)) times (the total TSA allotment). Total trauma care shall be the number of major and severe trauma patient records electronically transmitted to the department in a given year by EMS providers and hospitals. (g) Loss of funding eligibility. If the department finds that a county, EMS provider, RAC, or trauma facility has violated the Health and Safety Code, sec.773.122 or fails to comply with this section, the department may withhold fund monies for a period of one to three years depending upon the seriousness of the infraction. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804124 Susan K. Steeg General Counsel Texas Department of Health Effective date: April 12, 1998 Proposal publication date: December 12, 1997 For further information, please call: (512) 458-7236 CHAPTER 289.Radiation Control The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on March 20, 1998, enters this order finally adopting the repeal of existing sec.289.116 and new sec.289.227, concerning the use of radiation machines in the healing arts and veterinary medicine, with changes to the proposed text as published in the December 5, 1997, issue of the Texas Register (22 TexReg 11957), as a result of comments received during the 45-day comment period. The repeal of sec.289.116 is adopted without changes and therefore will not be republished. The section adopted for repeal adopts by reference Part 32, titled "Use of Radiation Machines in the Healing Arts and Veterinary Medicine" of the Texas Regulations for Control of Radiation (TRCR). The new section incorporates language from Part 32 that has been rewritten in Texas Register format and includes addition and revision of several subsections of the section. The repeal and new section are part of the renumbering phase in the process of rewriting the department's radiation rules in the Texas Register format. The new section reflects the renumbering. The revision is part of the department's ongoing review of the radiation rules to update them in accordance with current practices and technologies. The revision adds and revises numerous definitions and deletes several definitions no longer used in the section. Language is included to indicate that required surveys may constitute the practice of medical physics and therefore may require a license from the Texas Board of Licensure for Professional Medical Physicists. Clarifying language and revised duties for licensed medical physicists with regard to therapy are included. Clarifying language is added to ensure that while the Dental Practice Act, Texas Civil Statutes, Annotated, Title 71, Health-Public, Chapter 9, Article 4551o exempts dental facilities from the Texas Medical Physics Practice Act, Texas Civil Statutes, Article 4512n, these facilities must continue to have certain tests performed. Other minor grammatical changes were made to the section. Requirements are added for educational and research facilities. Record keeping requirements and items for operating and safety procedures are added for authorized use locations and mobile services. The revision incorporates requirements for bone densitometry and the revised United States Food and Drug Administration (FDA) entrance exposure rate limits for fluoroscopy. Requirements for technique charts, protective devices, entrance exposure limits for radiographic units, automatic and manual film processing, kilovolt peak, and the intervals for performing equipment performance evaluations are revised. Calibration requirements for radiation detection instruments used for these evaluations are deleted since they are addressed elsewhere in this chapter. Requirements are added to exempt registrants from posting "Caution Radiation Area" signs if the operator has continuous surveillance of the area. Certain exemptions for hand held portable fluoroscopy units are added as well as an exemption from the aural communication requirements for computerized tomography for veterinary facilities. Also, exemptions from the radiation protection program, posting of notices, and operating and safety procedures for individuals who are sole practitioners/sole operators of an x-ray machine are included. Mammography requirements are deleted as mammography is now under a separate section. The measurement protocol for radiation entrance exposure limits is deleted as there are several methods of measuring entrance exposure. Requirements for radiation therapy simulators and protocol for calibrating therapy machines are added as well as criteria for therapy misadministrations and the reporting of these incidents. The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section. Change: Concerning sec.289.227, due to the deletion of sec.289.227(x), the department renumbered subsequent subsections; therefore, all references to the renumbered subsections were changed accordingly throughout the section. Change is reflected in sec.289.227(c)(3); (d)(39) and (76); (e)(2) and (4), (4)(B), and (5)(A); (f)(1); (n)(3)(M), (N), and (O); (p); (q)(1) and (2)(B); (u)(8); (v)(3)(C) and (4)(B); (x), (4)(A)(ii) and (C)(vi); (y), (1)(A) and (3)(C)(vi); (z); (aa); (bb); (cc), (3)(D), (F), and (H); and Figure 10: 25 TAC sec.289.227(cc)(2). Change: Concerning sec.289.227, due to the deletion of Figure 6: 25 TAC sec.289.227(s)(2)(D) referenced in sec.289.227(s)(2)(D), the department renumbered subsequent Figures accordingly throughout the section. Change is reflected in sec.289.227(s)(5), (x)(1)(A), (y)(1)(D)(i), (y)(1)(D)(iii), and (cc)(4). Change: Concerning sec.289.227(c)(4)(A), the department deleted this exemption and added an exemption to include all healing arts and veterinary medicine registrants and subsequently, sec.289.227(c)(4)(B) and (C) were renumbered. Change is reflected in sec.289.227(c)(7). Change: Concerning sec.289.227(c)(5), the department added the word "Physics" and deleted the word "Physicists" to indicate the correct name of this act. The department also added the word "performed" following "tests" for clarification. Change: Concerning sec.289.227(d), the department added a definition for beam quality for diagnostic x-ray to differentiate from a definition added by commenters on beam quality for therapy. Change is reflected in sec.289.227(d)(10). Change: Concerning sec.289.227(d)(15), the department inserted the word "comparative" before the word "response" to clarify the definition. Change is reflected in sec.289.227(d)(17). Change: Concerning sec.289.227(d), the department added a definition for Institutional review boards to clarify subsection (f)(2). Change is reflected in sec.289.227(d)(56). Change: Concerning sec.289.227(d)(32), the department added the words "or any animal" following "body" for clarification. Change is reflected in sec.289.227(d)(33). Change: Concerning sec.289.227(d)(38), the department deleted the definition because it was unnecessary and provided no clarification. Change: Concerning sec.289.227(d)(53), the department deleted the definition because it was unnecessary and provided no clarification. Change: Concerning sec.289.227(d)(86), the department added the words "as a physician" following "Texas State Board of Medical Examiners" to differentiate from physician's assistants who are not practitioners. Change is reflected in sec.289.227(d)(87). Change: Concerning sec.289.227(d)(107), the department deleted the definition because it was unnecessary and provided no clarification. Change: Concerning sec.289.227(d)(110), the department added the acronym (SID) following the name of the definition for clarification. Change is reflected in sec.289.227(d)(111). Change: Concerning sec.289.227(d)(117), the department deleted the definition because it was unnecessary and provided no clarification. Change: Concerning sec.289.227(d)(137)(B), the department inserted the word "or" following "hand-carried" for clarification. Change is reflected in sec.289.227(d)(139)(B). Change: Concerning sec.289.227(d), the department added a definition for "record mode for fluoroscopy" for clarification. Change is reflected in sec.289.227(d)(98). Change: Concerning sec.289.227(d), the department added a definition for "therapy system" at the request of the Office of General Counsel. Change is reflected in sec.289.227(d)(127). Change: Concerning sec.289.227(d), due to the addition and/or deletion of definitions, the department renumbered a majority of the definitions and corrected the references accordingly in the Figures for this subsection. Change is reflected in sec.289.227(d)(10)-(38), (53)-(55), and (85)-(144). Change: Concerning sec.289.227(e)(2), the department deleted the words "and may be included in a radiation protection program required by sec.289.202(e) of this title" as registrants are exempt from the requirement to have a radiation protection program in accordance with subsection (c)(7) of this section. Change: Concerning sec.289.227(e)(6), the department added the word "credentialing" following "appropriate" for clarification. Change: Concerning sec.289.227(i)(2), the department deleted the original paragraph and replaced it with language to clarify the operator's position during the examination. Change: Concerning sec.289.227(i)(3)(A), the department deleted the phrase "as low as reasonably achievable (ALARA)" and replaced it with the acronym "ALARA" for simplification of the term and also added the words "a minimum of" following "having" for clarification. Change: Concerning sec.289.227(i)(3)(B), the department added the words "a minimum of" following "protective barriers of" for clarification. Change: Concerning sec.289.227(k)(3), the department deleted the original paragraph and replaced it with language to clarify the operator's position during the examination. Change: Concerning sec.289.227(n)(1)(E), the department corrected the reference due to the renumbering of sec.289.227(l) and (m). Change: Concerning sec.289.227(n)(1)(G), the department deleted the words "certification of inspection or" as this is only applicable to mammography. The department added the words "if applicable" following "inspection" for clarification. Change: Concerning sec.289.227(n)(2)(A), the department added referencing of specific sections of the chapter instead of the designation of categories of manuals to coincide with the manner in which the department will begin the new distribution process for the regulations. Change: Concerning sec.289.227(n)(2)(C), the department deleted the subparagraph as it was no longer necessary in this subsection because the exemption is being addressed in sec.289.227(c)(7). The department also renumbered the subsequent subparagraphs due to the deletion of this subparagraph. Change is reflected in sec.289.227(n)(2)(C)-(J). Change: Concerning sec.289.227(n)(2)(H), the department corrected the reference due to the renumbering of sec.289.227(l) and (m). Change is reflected in sec.289.227(n)(2)(G). Change: Concerning sec.289.227(n)(3)(A), the department added referencing of specific sections of the chapter instead of the designation of categories of manuals to coincide with the manner in which the department will begin the new distribution process for the regulations. Change: Concerning sec.289.227(n)(3)(C), the department deleted the subparagraph as it was no longer necessary in this subsection because the exemption is being addressed in sec.289.227(c)(7). The department also renumbered the subsequent subparagraphs due to the deletion of this subparagraph. Change is reflected in sec.289.227(n)(3)(C)-(P). Change: Concerning sec.289.227(n)(3)(J), the department corrected the reference due to the renumbering of sec.289.227(l) and (m). Change is reflected in sec.289.227(n)(3)(I). Change: Concerning sec.289.227(n)(3)(Q), the department deleted the words "certification of inspection or" as this is only applicable to mammography. The department added the words "if applicable" following "inspection" for clarification. Change is reflected in sec.289.227(n)(3)(P). Change: Concerning sec.289.227(r)(1)(C)(i) and (ii), the department deleted these clauses and replaced it with language comparable to language requirements of the FDA. Change: Concerning sec.289.227(r)(3)(D)(ii), the department added the requirement for measurement of entrance exposure rates to be posted since this language had been deleted from an early draft. Change: Concerning sec.289.227(r)(3)(D)(ii), the department corrected the reference in this clause. Change: Concerning sec.289.227(r)(3)(D)(iii)(IV), the department combined subclause (II) and (IV) for clarification. Change is reflected in sec.289.227(r)(3)(D)(iii)(II). Change: Concerning sec.289.227(r)(3)(D)(iii)(III), the department added the word "clinical" following "kVp typical of the" for clarification. Change: Concerning sec.289.227(s)(1)(A)(i), the department added the word "shall" in place of "may" for emphasis that the x-ray field shall not exceed the parameters. Change: Concerning sec.289.227(s)(1)(A)(iii), the department added language to require a source-to-image distance (SID) indicator for general purpose and mobile x-ray systems to be consistent with the requirement for stationary general purpose x-ray systems. Change: Concerning sec.289.227(s)(2)(D), the department changed the title from "Reproducibility" to "Exposure interval reproducibility" and incorporated the revised formula within text. Figure 6: 25 TAC sec.289.227(s)(2)(D) that contained the original formula was deleted. The revised language corrects the equation and better defines this subparagraph. Change: Concerning sec.289.227(s)(5), the department incorporated language that describes factors contained in the last sentence in Figure 7: 25 TAC sec.289.227(s)(5) to be consistent with other equations in the chapter. The last sentence in Figure 7: 25 TAC sec.289.227(s)(5) was deleted and the equation was corrected. Change is reflected in Figure 6: 25 TAC sec.289.227(s)(5). Change: Concerning sec.289.227(t)(1)(B), the department changed the title from "Reproducibility" to "Exposure interval reproducibility" and incorporated the revised formula within text. Figure 8: 25 TAC sec.289.227(t)(1)(B) that contained the original formula was deleted. The revised language corrects the equation and better defines this subparagraph. Change: Concerning sec.289.227(v)(4), the department added the words "United States" following "manufacturer's" for clarification. Change: Concerning sec.289.227(x), the department deleted this subsection on requirements for post-mortem facilities as this section addresses medical human and veterinary use. Post-mortem facilities will be addressed in another section of this chapter. Change: Concerning sec.289.227(y)(4)(D)(ii), the department added the words "or port film" and "immobilized" in place of "held" to better define the intent of this clause. Change is reflected in sec.289.227(x)(4)(D)(ii). Change: Concerning sec.289.227(z)(3)(E)(ii), the department added the words "or port film" to better define the intent of this clause. Change is reflected in sec.289.227(y)(3)(E)(ii). Change: Concerning sec.289.227(z)(1)(C), the department added the word "requirements" following "filters" for clarification. Change is reflected in sec.289.227(y)(1)(C). Change: Concerning sec.289.227(z)(1)(E)(iii)(V)(-d-), the department added the word "retained" in place of "required" for clarification. Change is reflected in sec.289.227(y)(1)(E)(iii)(V)(-d-). Change: Concerning sec.289.227(z)(1)(F), the department replaced the word "is" following "irradiation" with "shall be" for clarification. Change is reflected in sec.289.227(y)(1)(F). Change: Concerning sec.289.227(z)(1)(L), the department added the word "requirements" after "following" for clarification. Change is reflected in sec.289.227(y)(1)(L). Change: Concerning sec.289.227(aa)(2)(C)(i), the department added the word "collimator" in parenthesis after "beam-limiting device" for clarification. Change is reflected in sec.289.227(z)(2)(C)(i). Change: Concerning sec.289.227(aa)(2)(C)(iii), the department added the word "collimator" in parenthesis after "beam-limiting device" for clarification. The department also moved the word "numerically" to follow "shall" for clarification. Change is reflected in sec.289.227(z)(2)(C)(iii). Change: Concerning sec.289.227(cc)(1)(C), the department deleted the original subparagraph and replaced it with the reformatted subparagraph for clarification. Change is reflected in sec.289.227(bb)(1)(C). Change: Concerning sec.289.227(cc)(2), the department deleted this paragraph and replaced it with the reformatted subparagraph for clarification. Change is reflected in sec.289.227(bb)(2). Change: Concerning sec.289.227(dd)(1)(B), the department added the words "for all x-ray systems (except bone densitometers)" following "procedures" for clarification. Change is reflected in sec.289.227(cc)(1)(B). Change: Concerning sec.289.227(dd)(1)(C), the department added this subparagraph for clarification and renumbered subsequent subparagraphs accordingly. Change is reflected in sec.289.227(cc)(1)(C)-(E). Change: Concerning sec.289.227(dd)(2), the department deleted this paragraph because this requirement is no longer applicable to registrants. The department also renumbered subsequent paragraphs accordingly due to the deletion of this paragraph. Change is reflected in sec.289.227(cc)(2)-(4). Change: Concerning sec.289.227(dd)(3)(R), the department deleted this subparagraph as there is an exemption for registrants from the requirement of having a radiation protection program in accordance with sec.289.227(c)(7). The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s). Other minor editorial changes were made for clarification purposes. Comment: Concerning the section in general, one commenter stated that sec.289.227 referenced other sections of the chapter but the commenter did not have access to them and these could not be reviewed. Response: The department acknowledges the commenter's concern, however no change was made as a result of the comment. Comment: Concerning the section in general, one commenter stated that the section is difficult to review since the grouping of items was not clearly visible. The commenter proposed that the header for each group indicated by an alpha letter in parentheses be duplicated on top or on the bottom and/or be highlighted. Response: The department agrees with the commenter and will have headers at the top of each page of the section when it is distributed, as was the practice with the previous format. Comment: Concerning the section in general, one commenter suggested it would be practical to issue such rules in a concise small booklet applicable to the sections it addressed like users of diagnostic x-ray units for clinics, hospitals, and specialty groups such as podiatrist, dentists, and so on. Response: The department agrees in part with the commenter and has plans to separate the dental requirements into one section in the future. No change was made as a result of the comment. Comment: Concerning the section in general, one commenter suggested that it would be practical to indicate at the front of the rule or in the appendices where to find periodic or reoccurring tasks such as "dose check on an annual basis" or "protective devices tests." Response: The department disagrees with the commenter. There will be a table of contents accompanying the section when it is distributed to delineate individual subsections but there are no plans to identify specific tasks. No change was made as a result of the comment. Comment: Concerning the section in general, one commenter stated that very few quality statements, if any, were added in the revision. The commenter expressed that it would still be possible for a user of an old or incorrectly calibrated radiographic and fluoroscopic system to apply the same maximum dose to a patient of any size as long as 10 R/min was not exceeded or used television monitors that presented distorted images. For image intensified imaging systems, input dose to produce an image should be around <0.6 µGy/sec and maximum <1.2 µGy/sec measured at 80 kVp. No minimal resolution is given for typical radiography. Response: The department acknowledges the commenter's concerns, however no change was made as a result of the comment. Comment: Concerning the section in general, one commenter suggested some values that might be incorporated into the rules. The commenter suggested to eliminate x-ray systems with super large focal spots, defective buckys or 6:1 ratio buckys for adult spine work and provide an image quality statement for image intensified exposures. Response: The department acknowledges the commenter's concerns. Some of the suggestions involve manufacturing of x-ray equipment which is regulated by the FDA. The use of other equipment may fall under a physician's preference and would be considered the practice of medicine. No change was made as a result of the comment. Comment: Concerning the section in general, one commenter suggested that there is no plan to move forward and use the international measuring system and expressed that the metric system should be used. Response: The department agrees with the commenter and has added the metric system in parenthesis throughout the section. Comment: Concerning the section in general, one commenter was concerned with the philosophical approach the department has taken regarding these regulations which the commenter expresses are confusing or even internally conflicting. The commenter indicated that when the last revision of TRCR Part 32 was published, many tasks were added in order to comply with the federal Mammography Quality Standards Act (MQSA). The commenter further stated now that mammography had its own section, sec.289.230, the department did not seem to have a clear vision. The commenter expressed that there was a fundamental conflict on whether the regulations would address radiological image quality issues for the rest of radiology, the way MQSA did, or whether the new regulations would stick to the department's traditional concern of radiation protection. The commenter stated that while stricter dose limitations are proposed in sec.289.227(h), no requirements for maintaining image quality in the face of these exposure reductions are required or even proposed. The commenter indicated that film processor image quality was mandated in sec.289.227(l) and (m) but no other aspect of quality control in the image chain was mentioned. The commenter expressed that patient exposures and radiological image quality are inextricably linked and a reduction of the former can not be rationally considered without looking at the consequences on the later. The commenter indicated that if the department wished to lower doses to patients, a complete quality assurance program, such as the one put in place by the MQSA, must be implemented. The commenter further indicated that such a program would include measurements of image contrast, limiting resolution, focal spot size, and standard phantoms for measuring dose. The commenter stated that this was what MQSA mandated for mammography and this was what diagnostic radiological physicists try to implement in their practices. As a professional diagnostic radiological physicist, the commenter was concerned that the department, with all good intentions, was putting forth an incomplete and confusing message. The commenter indicated that it was the current standard of practice that x-ray imaging equipment be surveyed annually, both for entrance radiation exposures and image quality by a licensed diagnostic medical physicist to ensure that the equipment was working safely and effectively. The commenter expressed that the regulations, as proposed, sent the message that safety was more important than effectiveness and thus indicated why stay within the proposed radiation limits if the resulting film was useless. Response: The department acknowledges the commenter's concerns. MQSA was a specific federal law that addressed mammography. In accordance with Health and Safety Code, Chapter 401, sec.401.001, the department's responsibility is to protect occupational and public health and safety and the environment by maintaining a regulatory program for sources of radiation that provides for compatibility with federal standards and regulatory programs and a regulatory system that is to the degree possible, compatible with other states' systems. The acceptance of a film for diagnosis lies with a practitioner of the healing arts and is not the authority of the department to regulate. No change was made as a result of the comments. Comment: Concerning sec.289.227(a)(1), one commenter stated that there appears to be some conflicting authorizations allowed under the "supervision of a practitioner" clause. The definition of supervision in sec.289.227(d)(121) allows the practitioner to delegate authorized tasks to anyone he/she desires. This appears to conflict with the responsibilities placed upon the registrant by sec.289.227(a)(2) and sec.289.227(e)(6). The commenter wanted responsibilities clarified and also questioned who would be cited if the practitioner in an outpatient clinic (HMO registrant) through the supervision clause designated the receptionist to take x-rays. Response: The department disagrees with the commenter. Section 289.227(d)(121) delegates the task of applying radiation in accordance with this section. Section 289.227(e)(6) states that individuals who operate radiation machines shall meet the appropriate credentialing requirements of the Medical Radiologic Technologist (MRT) Act. If the receptionist was not credentialed under the MRT act, the registrant would be cited by the department and the receptionist would be cited under the MRT act. If the practitioner was also the registrant, he/she would be cited. No change was made as a result of the comments. Comment: Concerning sec.289.227(c)(4), one commenter stated that this exempts sole practitioners/operators from submitting radiation protection programs and operating and safety procedures. The commenter questioned how the department would confirm procedures that are adequate to "minimize danger to public health" as required in sec.289.226(d)(4) if there were no procedures. The commenter asked if the sole practitioner was also exempt from documenting dose to the general public resulting from the operation of his/her equipment. The commenter also stated that exemptions are a double standard and should not be granted without serious consideration of future ramifications. Response: The department acknowledges the commenter's concerns. These exemptions cover sole practitioners who are the only occupationally exposed individual in his/her practice. With the current rule, he/she has to write procedures and a radiation protection program to cover him/herself, oversee procedures on him/herself, and document any problems with him/herself. The practitioner, except for dentists, must document dose to the general public. No change was made as a result of the comment. Comment: Concerning sec.289.227(c)(5), the commenter stated that there was no problem with exempting dental practices from the Medical Physics Practice Act, but questioned what the requirements were for registration by the department. The commenter asked if a dentist could hire anyone he or she chose since registration carries no precise training and education requirements to become a "qualified person." Response: The department acknowledges the commenter's concerns. Individuals must be registered by the department and meet the training requirements of sec.289.226(e) and (s)(3). No change was made as a result of the comment. Comment: Concerning sec.289.227(d), several commenters suggested adding a definition for beam quality for therapy. Response: The department agrees with the commenters and added the definition reflected in sec.289.227(d)(11). Comment: Concerning Figure 1: 25 TAC sec.289.227(d)(19), one commenter indicated that "n=1" should be "n-1". Change is reflected in Figure 1: 25 TAC sec.289.227(d)(21). Response: The department agrees with the commenter and has corrected the equation accordingly. Comment: Concerning sec.289.227(d)(25), one commenter suggested deleting the word "manually" from this definition because the selection of some of the push buttons (AEC, auto brightness control, etc) lead to automatic selection of technique factors while the system is operating. Response: The department disagrees with the commenter. While the selection of some of the push buttons lead to automatic selection of technique factors, an individual must manually push the buttons. No change was made as a result of the comment. Comment: Concerning sec.289.227(d)(31), one commenter did not believe that "mr" was the appropriate abbreviation for millirem and that it should be "mrem." Response: The department agrees with the commenter; however, the definition has been deleted because it is no longer used in the section. No change was made as a result of the comment. Comment: Concerning sec.289.227(d)(45), one commenter suggested that the definition should read "the area projected from the anode and not on the anode." Response: The department disagrees with the commenter as this is the area projected "on the anode." No change was made as a result of the comment. Comment: Concerning sec.289.227(d)(52), one commenter suggested that the definition would be clearer if the 10 R/min were identified as an entrance exposure rate. Response: The department agrees with the commenter and made the suggested language change to the definition. Comment: Concerning sec.289.227(d)(66)(A), one commenter stated that 10 mAs is 10 milliampere - second not milliampere per second. Response: The department agrees with the commenter and made the correction to the definition. Comment: Concerning sec.289.227(d)(68), one commenter suggested that "experience" should be "experiences." Response: The department agrees with the commenter and made the change to the definition. Comment: Concerning sec.289.227(d), several commenters suggested adding a definition for performance evaluation meaning those tests and analyses performed by a licensed medical physicist for purposes of establishing that the equipment is suitable for use on humans both in terms of radiation safety and its ability to produce a diagnostic quality image. Response: The department disagrees with the commenters. The equipment performance evaluation is a list of items that are self explanatory. References to use of licensed medical physicists are made in sec.289.227(e)(7). No change was made as a result of the comments. Comment: Concerning sec.289.227(d), several commenters suggested adding a definition for port film as an x-ray exposure of limited absorbed dose made with a therapy system to visualize a patient's treatment area using film or other imaging devices. Response: The department agrees with the commenters and added the definition reflected in sec.289.227(d)(85). Comment: Concerning sec.289.227(d)(103), one commenter stated that the definition of "primary scattered radiation" could not be found as indicated in parenthesis. Response: The department agrees with the commenter. The department deleted the definition of "primary scattered radiation" and has deleted the reference to this definition reflected in sec.289.227(d)(105). Comment: Concerning sec.289.227(d), several commenters suggested adding a definition for spacer. Response: The department agrees with the commenters and added the definition reflected in sec.289.227(d)(113). Comment: Concerning sec.289.227(d)(114), several commenters suggested revising the existing definition for spot check be changed to include those tests and analyses performed by or under the direct supervision of a licensed medical physicist for the purpose of determining the constancy of operation of imaging or radiation therapy equipment. Response. The department partially agrees with the commenters and included all suggested language in the revised definition with the exception of the reference to a licensed medical physicist. Change is reflected in sec.289.227(d)(116). Comment: Concerning sec.289.227(d)(121), one commenter suggested to either replace the word "by" with "to" or delete the word "not". Response: The department agrees with the commenter and changed the word "by" to "to." Change is reflected in sec.289.227(d)(122). Comment: Concerning sec.289.227(d), several commenters suggested adding a definition of survey to include those tests and analyses performed by a licensed medical physicist to determine the presence and extent of radiological hazard. Response: The department disagrees with the commenters as this is delineated in sec.289.227(e)(7). No change was made as a result of the comments. Comment: Concerning sec.289.227(d)(124)(D), one commenter questioned whether the words "and the scan time" after "mAs" should be deleted. Response: The department agrees with the commenter and deleted the wording from the definition. Change is reflected in sec.289.227(d)(125)(D). Comment: Concerning sec.289.227(d)(138) and (d)(42), one commenter expressed that the two definitions define very similar concepts but use a different quantitative criterion for defining the boundary. The commenter suggested consideration of using the same fraction for defining the edge in each case or perhaps state that one was primarily applied in diagnostic imaging and the other primarily in therapy. Response: The department disagrees with the commenter and expresses that the definitions indicate two separate items, field size and x-ray field. No change was made as a result of the comment. Comment: Concerning sec.289.227(e)(1), one commenter indicated that this paragraph requires relevancy of a technique chart to a particular x-ray unit without further relating it to the image recording system, film distance, or to the procedures done on that particular machine. The commenter suggested that terminology that was removed should be reinstated as the sensitivity of the image recorded is critically relevant to the technique chart and a particular machine is not often used for all procedures. Response: The department disagrees with the commenter as the definition in sec.289.227(d)(124) addresses these items. No change was made as a result of the comment. Comment: Concerning sec.289.227(e)(7), several commenters suggested that since the section stated that certain surveys must be performed by licensed medical physicists, they recommended that all registrants, including service companies be advised of this in a manner other than simply placing the requirement in the regulations. The commenters suggested placing a special notice in the registrant's annual bill and including a notice in the Radiation Newsletter. Response: The department acknowledges the comments. A general summary of the requirements will appear in the Radiation Report; however, it is the responsibility of registrants to familiarize themselves with the contents of the section. No change was made as a result of the comments. Comment: Concerning sec.289.227(e)(7), one commenter stated that the title of this paragraph should read "Medical physicist credentials" and the words "survey" that had no definition in sec.289.227(d) and "may" should be deleted and replaced with the following text: "Performance tests relating to image quality, radiation dose/exposure measurements and the evaluation of radiation safety procedures required by this part are the practice of medical physics and require a license from the Texas Board of Licensure for Professional." Response: The department agrees in part with the commenter. The department changed the title to "Practice of Medical Physics" and added the words "tests, or evaluations" after the word "surveys" in the first sentence. The paragraph is a notification to registrants that the Medical Physics Practice Act exists and keeps the department from adding specific exemptions to the requirements. Comment: Concerning sec.289.227(e)(7), several commenters suggested changing this paragraph to read: "Surveys and Performance Evaluations. Surveys and Performance Evaluations required by this section constitute the Practice of Medical Physics in accordance with the Medical Physics Practice Act unless specifically exempted under sec.24 of the Act or 601.21(b) of the Rules Relating to the Regulation of Medical Physicists." Response: The department agrees in part with the commenters. The department changed the title to "Practice of Medical Physics" and added the words "tests, or evaluations" after the word "surveys" in the first sentence. The paragraph is a notification to registrants that the Medical Physics Practice Act exists and keeps the department from adding specific exemptions to the requirements. Comment: Concerning sec.289.227(f)(2) and (dd)(2), many commenters indicated that these subsections conflicted with federal law 45 Code of Federal Regulations (CFR) 46 that grants Institutional Review Boards (IRBs) the authority to review medical research protocols including those using sources of radiation and urged the department to delete this paragraph and appendix. Response: The department agrees with the commenters and has eliminated the paragraphs and replaced these with a new paragraph to indicate that all research involving humans must be approved by an IRB as required by 45 CFR 46 and 21 CFR 56. The department also added a definition of IRB reflected in sec.289.227(d)(56). Comment: Concerning sec.289.227(g), several commenters stated that this paragraph should be eliminated as exceptions to credentialing and other quality control requirements were not justified and encouraged poor and potentially dangerous practice. Response: The department disagrees with the commenters. This paragraph is for educational facilities utilizing phantoms. Operators of x-ray equipment are credentialed under the Medical Radiologic Technologist Act and this applies only to operators performing exams on humans. The department agrees that quality control requirements are important but does not agree that these can be mandated for facilities utilizing non-humans for examinations. No change was made as a result of the comments. Comment: Concerning sec.289.227(h), several commenters suggested moving this paragraph to subsection (q), Equipment performance evaluation, and relabel it as sec.289.227(q)(7). One commenter expressed that the inclusion of a determination of entrance skin exposures (ESE) for equipment specific performed diagnostic examinations was an essential component of the performance evaluation. Such inclusion would be consistent with the American College of Radiology (ACR) Standard of Practice (Res 17, effective 1/1/98, paragraph IV. D.) that identifies the ESE determination as part of the equipment performance evaluation. The FDA in MQSA also requires a machine specific typical patient dose to be monitored. Several other commenters also suggested that the words "be performed by a licensed medical physicist" be included. Response: The department disagrees with the commenter. The intent of subsection (q) is to require minimum items to be checked in lieu of requirements suggested by the manufacturer. MQSA is specific to mammography. Reference to the Medical Physics Practice Act was included in proposed sec.289.227(e)(7). No change was made as a result of the comments. Comment: Concerning sec.289.227(h), two commenters questioned the use of the proposed entrance exposure limits (EELs). The first commenter stated that the old limits were based on empirical data obtained through the Conference of Radiation Control Program Directors NEXT program (National Evaluation of X-Ray Trends) and that the new limits were not linked to any clear data source. Additionally, this commenter indicated that the department has eliminated the specific measurement protocol for determining these limits and that this regulation fails to take into account how an arbitrary reduction of entrance exposure will negatively impact image quality and the diagnostic utility of the x ray exam. The commenter expressed that the regulations, as proposed, would have negligible positive benefits to the public health, and may hinder medical diagnosis. The second commenter suggested that instead of trying to legislate medical practice, the department should retain the previously required entrance exposure limits and that the new regulations in this section also should have stated that entrance exposure measurements should be performed annually by a licensed medical physicist. Response: The department disagrees with the commenters. The proposed EELs were derived from several years of data compiled from facilities during actual measurements of EELs during inspections. Reference to the Medical Physics Practice Act was included in proposed sec.289.227(e)(7). No change was made as a result of the comments. Comment: Concerning sec.289.227(i)(2)(C), one commenter did not agree with the required six-foot extension from a portable radiographic unit but understood that it was included because it was a long-standing recommendation of the National Council on Radiation Protection (NCRP). The commenter questioned the restriction of 2 mR in one hour and asked if this was to the protective apron or to the unprotected head and neck. The commenter further asked if this exposure was to a radiation monitor or if this was effective dose (E). The commenter also stated that since technologists operating portable equipment are monitored for occupational radiation exposure, the additional requirement of less than 2 mR in anyone hour was confusing, conflicting, and unnecessary. Response: The department agrees with the commenter and has deleted these subparagraphs and replaced them with one statement addressing the operator's position during exposure. Comment: Concerning sec.289.227(l) and (m), several commenters suggested that this entire section be eliminated as there are no specific safety benefits that insure from these requirements. The commenters expressed that these requirements essentially stated that equipment must be operated according to manufacturer's recommendations and made no reference as to what would constitute noncompliance. Several other commenters indicated that the ACR and themselves supported and encouraged the use of film processor quality control programs in radiological practice. The commenters indicated that their efforts to promote such programs are documented in the ACR Standards for Radiology and the ACR Accreditation programs. The commenters expressed however, that there was no clear mandate for the department to regulate such a quality control program since film processing equipment did not produce ionizing radiation. Additionally, these commenters expressed that the department's effort was incomplete and would be ineffective because there was no regard for quality assurance programs aimed at maintaining the accuracy of the x-ray system's resolution, detectability and contrast nor were quality assurance programs mandated for image display media, other than film. These commenters further indicated that currently, private market forces were independently requiring improved performance and documentation for a whole range of quality assurance activities in radiology and that the benefits to be gained by additional oversight from the department were not supported by documentation and the department's additional costs in trying to implement such a program were not directly considered in the proposed regulations. One commenter suggested eliminating the requirements for manual processing as they should meet the same criteria as automatic processors. Response: Overall, the department disagrees with the commenters. However, the department agrees in part with the commenter who suggested that the department combine the requirements for manual and automatic film processing. Some commenters indicated in the general section that these subsections should be expanded, yet others suggested these subsections should be deleted. The department regulates a wide range of facilities across Texas and the majority of the department's registrants are not familiar with the ACR or their standards of practice. Frequently the department finds that registrants develop films at the wrong temperature, fail to change chemicals, and that fog from light leaks are a problem resulting in repeat films and poor film quality. The requirements included are minimal and elementary yet will go a long way to improve film quality for a number of facilities. In the future, the department plans to have regulatory guides that will further delineate darkroom quality assurance. The department deleted sec.289.227(l) and (m) and replaced these subsections with language that combined the requirements for automatic and manual film processing reflected in sec.289.227(l). The department also moved requirements for alternative processing systems from sec.289.227(l)(4) to sec.289.227(m). Comment: Concerning sec.289.227(n)(l), several commenters expressed that only the certificate of registration should be on-board a mobile service since all other records were available at the records location. One commenter stated that the document duplication was unnecessary. Response: The department disagrees with the commenters. Some of the mobile services registered with the department travel throughout Texas and rarely go to the home office where records are maintained. The department usually inspects the mobile van and the home office at different times. The records required on board are minimal. No change was made as a result of the comments. Comment: Concerning (n)(2)(J), several commenters expressed that requiring this record was redundant and should be eliminated since it was part of the fluoroscopy requirements. Response: The department disagrees with the commenters. The fluoroscopy section requires that the annual survey be performed while this section requires that a record of the survey be maintained. No change was made as a result of the comments. Comment: Concerning (n)(2)(K), several commenters expressed that requiring this record was redundant and should be eliminated since it was part of the CT requirements. Response: The department disagrees with the commenters. The CT section requires that the dose measurements and quality control films or images are performed while this section requires that a record of the dose measurements and films or images be maintained. No change was made as a result of the comments. Comment: Concerning sec.289.227(n)(3), several commenters expressed that all of this, except the requirement for a copy of the certificate of registration, should be eliminated since all records are maintained at the records location. Response: The department disagrees with the commenters. The department is eliminating the use of records locations since many registrants have multiple sites because of corporate ownership of many medical facilities. The department is requiring that records pertaining to that authorized use location be maintained at that location and not duplicated at a records location. The department is making this change since it is common to have records at a corporate office that may be out of state. No change was made as a result of the comments. Comment: Concerning sec.289.227(q)(1), several commenters suggested that the last sentence of this section be changed to read as follows: "Such tests shall be performed at the frequency listed in subsection (cc)(4) of this section and shall be performed by a licensed diagnostic medical physicist. Response: The department disagrees with the commenters. Reference to the Medical Physics Practice Act is in sec.289.227(e)(7). No change was made as a result of the comments. Comment: Concerning sec.289.227(q)(1), one commenter indicated that the frequency of equipment performance evaluation monitoring listed in sec.289.227(cc)(4) was at variance with accepted national standards. The commenter questioned if the department was proposing new standards and if so, the commenter suggested that the proper approach was through the national standards setting organizations, such as NCRP, ACR, and ACMP. The commenter further stated that essentially, all of these organizations, including the FDA, recommend annual performance monitoring, not at two or three year intervals. The commenter indicated that if the department held to this schedule, that is a variance with national standards, health care facilities would be further confused and questioned if compliance should be with published standards of care or with the lesser standards of the department. Response: The department disagrees with the commenter. The intent of subsection (q) is to require minimum items to be checked in lieu of requiring maintenance suggested by the manufacturer. The one national standard that is voluntarily followed is that of the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) and this only applies to hospitals, day surgeries, or facilities that are part of a network. The department registers a wide range of facilities across Texas. JCAHO facilities constitute less than 10% of all registrants. No change was made as a result of the comment. Comment: Concerning sec.289.227(q)(3)(A), one commenter questioned the use of 0.5 seconds since faster film-screen combinations are now in use and the average exposure time is now significantly shorter. The commenter suggested 0.2 seconds. Response: The department agrees partially with the commenter that there are faster film-screen combinations available for use; however, these may not be used by all department registrants and the department has no authority to require them to do so. No change was made as a result of the comment. Comment: Concerning (r)(1)(A)(iii), several commenters questioned why this requirement was in the regulations as it applies to the manufacturer. Another commenter questioned where this requirement came from and another indicated that it was confusing. The commenters suggested that this paragraph be eliminated. Response: The department partially agrees with the commenters that the requirement applies to the manufacturer, however the department disagrees that this should be eliminated since the exposure rate due to transmission through the barrier must be checked after an image intensifier is replaced. The requirement is from 21 CFR 1020.32(a)(1). No change was made as a result of the comments. Comment: Concerning sec.289.227(r)(1)(B), several commenters indicated that if their suggestion of eliminating sec.289.227(r)(1)(A) was followed then this paragraph on measuring compliance of barrier transmission should be deleted. Response: The department disagrees with the commenters and did not eliminate sec.289.227(r)(1)(A); therefore, the department did not eliminate this paragraph on measuring compliance of barrier transmission. No change was made as a result of the comments. Comment: Concerning sec.289.227(r)(3)(A)(i), several commenters suggested replacing 2.58 x 10-3 coulomb per kilogram per minute (C/kg/min) with the appropriate air kerma rate throughout the section. Response: The department disagrees with the commenters as this unit of measure is used by FDA. No change was made as a result of the comments. Comment: Concerning sec.289.227(r)(3)(A)(iv), several commenters suggested that this requirement be performed by a licensed medical physicist. Response: The department agrees with the commenters and added this language in sec.289.227(r)(3)(D). Comment: Concerning sec.289.227(r)(3)(A)(iv)(III), several commenters stated that in a C-arm type fluoroscope the exposure rate should be measured at 30 cm from the phosphor with the shortest SID and not 30 cm from the input phosphor with source positioned at any SID. Response: The department agrees with the commenters and revised the language in the requirement. Comment: Concerning sec.289.227(r)(3)(A)(iv)(IV), several commenters wanted an explanation for the use of the language "lateral type of fluoroscope." Response: The department agrees with the commenters and added the word "horizontal" in parenthesis to add clarification. This language is from 21 CFR 1020.32(d)(4)(iv) and 1020.32(e)(3)(iv). Comment: Concerning sec.289.227(r)(3)(B)(iii), several commenters suggested that this requirement be performed by a licensed medical physicist. Response: The department agrees with the commenters and added the suggested language in sec.289.227(r)(3)(D). Comment: Concerning sec.289.227(r)(3)(B)(iii)(III), several commenters stated that in a C-arm type fluoroscope the exposure rate should be measured at 30 cm from the phosphor with the shortest SID and not 30 cm from the input phosphor with source positioned at any SID. Response: The department agrees with the commenters and revised the language in the requirement. Comment: Concerning sec.289.227(r)(3)(B)(iii)(IV), several commenters wanted an explanation for the use of the language "lateral type of fluoroscope." Response: The department agrees with the commenters and added the word "horizontal" in parenthesis to add clarification. This language is from 21 CFR 1020.32(d)(4)(iv) and 1020.32(e)(3)(iv). Comment: Concerning sec.289.227(r)(3)(D), several commenters suggested that periodic measurement of entrance exposure rate be performed by a licensed medical physicist. Response: The department agrees with the commenters and added the appropriate language. Comment: Concerning sec.289.227(r)(3)(D)(i), several commenters suggested that the words "before use" be deleted. Another commenter suggested that the words "before installation" be replaced by "within 30 days." Response: The department agrees with the commenters and deleted the word "at installation before use" and replaced it with language to indicate the measurements shall be made within 30 days of installation. Comment: Concerning sec.289.227(r)(3)(D)(iii)(II), (III), and (IV), one commenter suggested that each occurrence of "AEC" be replaced with "AERC." Response: The department agrees with the commenter and made the suggested language changes in sec.289.227(r)(3)(D)(iii)(II) and (III). Comment: Concerning sec.289.227(r)(6) and (7), one commenter did not understand the basis for these requirements and questioned if this was dictating a manufacturing policy. The commenter expressed that this would keep some x-ray equipment out of Texas because this was not always accommodated at the point of manufacture. The commenter suggested these sections be deleted. Response: The department disagrees with the commenter. These are manufacturer's requirements from 21 CFR 1020.32(g); however, the department inspectors frequently find the fluoroscopic timer to be nonfunctional. No change was made as a result of the comment. Comment: Concerning sec.289.227(s)(l)(A)(i)(I), several commenters suggested adding the word "or" at the end of this sentence to comply with sec.289.227(s)(1)(A)(i). Response: The department disagrees with the commenters. The addition of the word "or" would not clarify the requirement. No change was made as a result of the comments. Comment: Concerning sec.289.227(v)(1)(E)(iii), one commenter suggested that the words "to within" could possibly be deleted. Response: The department agrees with the commenter and deleted the language. Comment: Concerning sec.289.227(v)(3), several commenters suggested that dose measurements be performed by a licensed medical physicist. Response: The department agrees with the commenters and added the suggested language. Comment: Concerning sec.289.227(v)(3)(A), one commenter indicated that this requirement was very confusing as the department required performance measurements to be made annually, yet in appendix sec.289.227(cc)(4), other performance measurements were required only every two or three years. Response: The department acknowledges the commenter's concerns. The intent of the equipment performance evaluations in sec.289.227(q) is to require minimum items to be checked in lieu of requiring maintenance suggested by the manufacturer. The dose measurements required for a CT unit are to be considered as a separate item. No change was made as a result of the comment. Comment: Concerning sec.289.227(v)(3)(A)(ii), several commenters suggested that CT dose measurements should be made within 60 days of the x-ray tube replacement. Response: The department acknowledges the commenters concerns. While there are newer tubes on the market, CT tubes traditionally are replaced at a rapid frequency. There are situations where a tube would have to be replaced before the 60 days period ends. No change was made as a result of the comments. Comment: Concerning sec.289.227(v)(3)(B), several commenters indicated that there is no national standard that a CT dosimetry system can be traced to. Another commenter suggested that a CT dosimetry system be traced to NIST, the national standards laboratory. This commenter also suggested that this frequency was the same as for radiation oncology dosimetry equipment and this was too frequent and suggested a three year interval with intercomparison. Response: The department partially agrees with the commenters and has deleted the language "or intercompared with a calibrated chamber." Comment: Concerning sec.289.227(v)(4), several commenters suggested that the maintenance schedule be developed by a licensed diagnostic or medical health physicist in accordance with the manufacturer's Department of Health and Human Services maintenance schedule. Response: The department disagrees with the commenters. The regulations do not prohibit a facility from seeking the services of a physicist, however. No change was made as a result of the comments. Comment: Concerning sec.289.227(v)(4), one commenter suggested that this section be deleted. The commenter was concerned that the term "maintenance schedule" in accordance with the manufacture's Department of Health and Human Services maintenance schedule was used and stated that he had never heard of such a thing. The commenter asked if the department has a reference. Response: The department acknowledges the commenter's concerns. This is referenced in 21 CFR 1020.30(h)(1)(ii) and applies to radiographic, fluoroscopic, and CT equipment. No change was made as a result of the comment. Comment: Concerning sec.289.227(y)(1)(J)(iii), several commenters suggested that this requirement be deleted as it was not an FDA requirement on manufacturers. Change is reflected in sec.289.227(x)(1)(J)(iii). Response: The department agrees with the commenters and has deleted this clause. Comment: Concerning sec.289.227(y)(4)(B)(iv), several commenters suggested that the language "traceable to a national standard" be replaced with "by a calibration laboratory accredited as performing calibrations traceable to the National Institute of Standards and Technology(NIST)." Response: The department agrees with the commenters and has modified the definition of "traceable to a national standard" in sec.289.227(d)(131) to include NIST. Comment: Concerning sec.289.227(y)(4)(B)(vi), several commenters suggested replacing this clause with "A copy of the latest calibrated absorbed dose rate measured on a particular therapy system shall be available at a designated area within the building housing that therapy system." Response: The department agrees with the commenters and has added the suggested, slightly modified, language. Change is reflected in sec.289.227(x)(4)(B)(vi). Comment: Concerning sec.289.227(y)(4)(C)(vi), several commenters suggested replacing this clause with "A copy of the most recent spot check shall be available at a designated area within the building housing that therapy system." Response: The department agrees with the commenters and has added the suggested, slightly modified, language. Change is reflected in sec.289.227(x)(4)(C)(vi). Comment: Concerning sec.289.227(z), several comments suggested the words "be calibrated" in the second sentence be replaced with "be functionally tested." Response: The department agrees with the commenters and made the suggested language change. Change is reflected in sec.289.227(y). Comment: Concerning sec.289.227(z)(1)(B), several commenters suggested changing "2.0%" to "4.0%." Response: The department agrees with the commenters and made the suggested language change. Change is reflected in sec.289.227(y)(1)(B). Comment: Concerning sec.289.227(z)(l)(C)(iii)(III), several commenters suggested replacing the word "filters" with "beam quality." Response: The department agrees with the commenters and made the suggested language change. Change is reflected in sec.289.227(y)(1)(C)(iii)(III). Comment: Concerning sec.289.227(z)(l)(M), several commenters suggested adding the words "producing more than one beam quality" in place of the words " both x- ray therapy and electron therapy." Response: The department agrees with the commenters and made the suggested language change. Change is reflected in sec.289.227(y)(1)(M). Comment: Concerning sec.289.227(z)(l)(N)(iv), several commenters suggested deleting this clause since measurements necessary to conform to this requirement were difficult to make and were not yet available. Response: The department agrees with the commenters and deleted the clause. Change is reflected in sec.289.227(y)(1)(N)(iv). Comment: Concerning sec.289.227(z)(2)(E), several commenters suggested this subparagraph be rewritten as follows for clarification: "Treatment room entrances shall be provided with a warning light in a readily observable position near the outside of all access doors to indicate when the useful beam is "on". Response: The department agrees with the commenters and rewrote the subparagraph. Change is reflected in sec.289.227(y)(2)(E). Comment: Concerning sec.289.227(z)(3)(A)(i), several commenters suggested that "review of absorbed doses delivered to patients" be added to the responsibilities of the physicist. Response: The department agrees with the commenters and added the suggested language. Change is reflected in sec.289.227(y)(3)(A)(i). Comment: Concerning sec.289.227(z)(3)(A)(ii), one commenter suggested deleting the current language and replacing with the following: "The radiation oncology physicist shall be available, when necessary, for consultation with the radiation oncologist and to provide advice or direction to technical staff when patients are being planned or treated. When a physicist is not immediately available on site, clinical needs shall be supplemented by documented procedures. Practices without full time physics support must have regular on- site physics support during hours of clinical activity, at least weekly." Response: The department disagrees with the commenter and expresses that the current language adequately describes the availability of the physicist. No change was made as a result of the comment. Comment: Concerning 289.227(z)(3)(C)(iii)(I), several commenters suggested replacing the words "having a calibration factor for cobalt-60 gamma rays traceable to a national standard" with "having a calibration factor for cobalt- 60 gamma rays traceable to the NIST." Response: The department agrees with the commenters and has modified the definition of "traceable to a national standard" in sec.289.227(d)(131) to include NIST. Comment: Concerning sec.289.227(z)(3)(C)(vii), several commenters suggested replacing this clause with "A copy of the most recent calibrated absorbed dose rate measured in accordance with clause (i) of this subparagraph shall be available at a designated area within the building housing that therapy system." Response: The department agrees with the commenters and has added the suggested language with modifications. Change is reflected in sec.289.227(y)(3)(C)(vii). Comment: Concerning sec.289.227(z)(3)(D)(ii), one commenter endorsed AAPM's Task Group 40 as an acceptable protocol to do spot checks of linac dose calibration and agreed with this. The commenter further stated however that the frequency of spot checks proposed by this section was five treatment days maximum and the tolerance allowed was 5% from the expected value before a medical physicist must be notified. The commenter indicated that this was not consistent with Task Group 40 which recommends daily output checks for electrons and x-rays with 3% tolerance (per Table II on p.589 of the TG-40 protocol). Response: The department agrees with the commenter and changed the tolerance to 3.0%. Change is reflected in sec.289.227(y)(3)(D)(ii). Comment: Concerning sec.289.227(z)(3)(D)(iv), several commenters suggested that this clause be eliminated as making beam spot checks at or near the calibration depth was not always the best representation of the condition of the beam. Response: The department agrees with the commenters and deleted the language and renumbered the subsequent clauses. Comment: Concerning sec.289.227(z)(3)(E)(ii), several commenters suggested that the word "immobilized" be used in place of "held." Response: The department agrees with the commenters and modified the language accordingly. Change is reflected in sec.289.227(y)(3)(E)(ii). Comment: Concerning sec.289.227(aa)(3)(E), several commenters suggested that this requirement be eliminated since simulators do not deliver therapeutic doses of radiation, and spot checks required on these systems would, at most, be regulated to the same degree as diagnostic x-ray and fluoroscopic systems. To require spot checks as for therapy systems would significantly increase the cost of maintenance that would, of necessity, be passed on to the public. The commenters expressed that such testing would not decrease risks to the public and therefore were not justified. One commenter questioned that sec.289.227(z)(3)(E) required weekly intervals but Task Group 40 recommended daily and monthly. The commenter expressed that the regulation as written, misses the daily spot checks, but over tests for the monthly. Response: The department agrees with the commenters and changed the wording to read that "simulators must duplicate the geometric conditions of the radiation therapy equipment plan and therefore spot checks regarding geometric conditions shall be performed in accordance with subsection (y)(3)(D)(i) of this section." Change is reflected in sec.289.227(z)(3)(E). Comment: Concerning sec.289.227(dd)(4), several commenters suggested that the change in the frequency of equipment performance evaluations and inspection intervals in sec.289.201 be conveyed to all registrants, including service companies, in a manner other than simply placing the requirement in the regulations. The commenters suggested placing a special notice in the registrant's annual bill and including a notice in the Radiation Newsletter. Response: The department acknowledges the comments. A general summary of the requirements will appear in the Radiation Report; however, it is the responsibility of registrants to familiarize themselves with the contents of the section. No change was made as a result of the comments. Commenters included Medical & Radiation Physics, Inc., Mario Wedenmeier, U.S. FDA Center for Devices and Radiological Health, The University of Texas Southwestern Medical Center at Dallas, General Electric Medical Systems, The University of Texas Health Science Center at San Antonio, American Association of Physicists in Medicine (Southwest Regional Chapter), Texas Radiological Society, Geoffrey D. Clarke, and Baylor College of Medicine. The commenters were generally in favor of the proposal; however, they presented comments and suggestions for changes to the proposal as previously discussed. SUBCHAPTER C.Texas Regulations for Control of Radiation 25 TAC sec.289.116 The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the board with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804130 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 SUBCHAPTER E.Registration Regulations 25 TAC sec.289.227 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the board with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.289.227.Use of Radiation Machines in the Healing Arts and Veterinary Medicine. (a) Purpose and scope. (1) This section establishes requirements for the use of radiation machines in the healing arts and in the practice of veterinary medicine. All usage of such machines under this section shall be made by or under the supervision of a practitioner of the healing arts or licensed veterinarian. The usage of mammography radiation machines is exempt from this section and is covered in sec.289.230 of this title (relating to Certification of Mammography Systems), with the exceptions listed in sec.289.230(c)(1) and (2) of this title. (2) The registrant shall be responsible for directing the operation of the radiation machines under the administrative control of the registrant. The registrant shall assure that the requirements of this section are met in the operation of such radiation machines. (3) In addition to the requirements of this section, all registrants, unless otherwise specified, are subject to the requirements of sec.289.112 of this title (relating to Hearing and Enforcement Procedures), sec.289.114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), sec.289.201 of this title (relating to General Provisions), sec.289.202 of this title (relating to Standards for Protection Against Radiation), sec.289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), and sec.289.226 of this title (relating to Registration of Radiation Machine Use and Services). (b) Prohibitions. (1) The agency may prohibit use of machines that pose significant threat or endanger public health and safety, in accordance with sec.289.112 of this title and sec.289.201 of this title. (2) Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes: (A) exposure of an individual for training, demonstration, or other non-healing arts purposes; (B) exposure of an individual for the purpose of healing arts screening except as authorized by subsection (f)(1) of this section; and (C) exposure of an individual for the purpose of research except as authorized by subsection (f)(2) of this section. (3) Non-image-intensified fluoroscopic equipment shall not be used. (c) Exemptions. (1) Individuals who operate only dental radiographic systems for diagnostic purposes are exempt from the personnel monitoring requirements of sec.289.202(q) of this title. (2) Portable units designed to be hand-held are exempt from the requirements of subsection (o)(2) of this section. The portable unit must be held by the tube housing support or handle. (3) Veterinary facilities are exempt from the aural communication requirements of computed tomography (CT) in subsection (v)(2)(A) of this section and therapy systems in subsections (x)(2)(A) and (y)(2)(D) of this section. (4) Individuals who are sole practitioners and sole operators and the only occupationally exposed individual are exempt from the following requirements: (A) 22.11 of Texas Regulations for Control of Radiation (TRCR) Part 22 as adopted by reference in sec.289.114 of this title; and (B) subsection (e)(2) of this section. (5) In accordance with the Dental Practice Act, Texas Civil Statutes, Article 4551o, dental practices are exempt from the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n. Dentists required to have tests performed in accordance with subsection (q)(5) of this section may select any qualified person authorized by registration through the Bureau of Radiation Control. (6) Registrants are exempt from the posting of the radiation area requirements in sec.289.202(aa)(1) of this title provided that the operator has continuous surveillance and access control of the radiation area. (7) All healing arts and veterinary medicine registrants are exempt from the radiation protection program requirements of sec.289.202(e). (d) Definitions. The following words and terms when used in this section shall have the following meaning unless the context clearly indicates otherwise. (1) Accessible surface - The external surface of the enclosure or housing provided by the manufacturer. (2) Aluminum equivalent - The thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper. (3) Applicator - A structure that determines the extent of the treatment field at a given distance from the virtual source. (4) Attenuation block - A block or stack, having dimensions 20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper. (5) Automatic exposure control (AEC) - A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer). (6) Automatic exposure rate control (AERC) - A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation per unit time at preselected locations. (7) Barrier (See definition for protective barrier). (8) Beam axis - A line from the source through the centers of the x-ray fields. (9) Beam indicating device - A device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device. (10) Beam quality (diagnostic x-ray) - A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kVp and filtration. (11) Beam quality (therapy) - A term that describes the type and quality of ionizing radiation produced by a therapy system for certain machine settings. (12) Beam-limiting device - A device that provides a means to restrict the dimensions of the x-ray field. (13) Beam monitoring system - A system designed to detect and measure the radiation present in the useful beam. (14) Beam scattering foil - A foil used in order to scatter a beam of electrons. (15) Block tray - A device attached to the radiation head to support auxiliary beam blocking material. (16) Bone densitometer - A device intended for medical purposes to measure bone density and mineral content by x-ray transmission measurements through the bone and adjacent tissues. (17) Calibration of instruments - The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument. (18) Calibration of machines - The measurement and specification of absorbed dose to a medium, or exposure in air, at a defined point in a radiation beam. (19) Central axis of the beam - A line passing through the virtual source and the center of the plane figure formed by the edge of the first beam-limiting device. (20) Certified equipment - Equipment that has been certified in accordance with 21 Code of Federal Regulations (CFR). (21) Coefficient of variation or C - The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation: Figure 1: 25 TAC sec.289.227(d)(21) (22) Collimator - A device or mechanism by which the x-ray beam is restricted in size. (23) Computed tomography (CT) - The production of a tomogram by the acquisition and computer processing of x-ray transmission data. (24) Contact therapy system - An x-ray system used for therapy with the x-ray tube port placed in contact with or within 5 cm of the surface being treated. (25) Continuous pressure type switch - A switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator. (26) Contrast scale (CS) - The change in the linear attenuation coefficient per CT number (CTN) relative to water; that is: Figure 2: 25 TAC sec.289.227(d)(26) (27) Control panel - The part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors. (28) CT conditions of operation - All selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection. (29) CT gantry - The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components. (30) CT number (CTN) - The number used to represent the x-ray attenuation associated with each elemental area of the CT image, that is: Figure 3: 25 TAC sec.289.227(d)(30) (31) Detector (See definition for radiation detector). (32) Diagnostic source assembly - The tube housing assembly with a beam-limiting device attached. (33) Diagnostic x-ray system - An x-ray system designed for irradiation of any part of the human body or any animal for the purpose of diagnosis or visualization. (34) Diaphragm - A device or mechanism by which the x-ray beam is restricted in size. (35) Dose monitoring system - A system of devices for the detection, measurement, and display of quantities of radiation. (36) Dose monitor unit - A unit response from the dose monitoring system from which the absorbed dose can be calculated. (37) Entrance exposure - The exposure expressed in roentgens (R), measured in air with the specified technique, calculated or adjusted to represent the exposure at the point where the center of the useful beam enters the patient. (38) Entrance exposure rate - The exposure per unit time at the point where the center of the useful beam enters the patient. (39) Existing equipment - Therapy systems subject to subsections (x) and (y) of this section that were manufactured on or before March 1, 1989. (40) Field emission equipment - Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field. (41) Field-flattening filter - A filter used to provide dose uniformity over the area of a useful beam of x-rays at a specified depth. (42) Field size - The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source to image distance and defined by the intersection of the major axes and the 50% isodose line. (43) Filter - Material placed in the useful beam to preferentially absorb selected radiations. (44) Fluoroscopic imaging assembly - A subsystem in which x-ray photons produce a fluoroscopic image. It includes the image receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly. (45) Focal spot - The area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates. (46) Gantry - That part of the system supporting and allowing possible movement of the radiation source. (47) General purpose x-ray system - Any radiographic x-ray system that is not limited by design to radiographic examinations of specific anatomical regions. (48) Gonadal shield - A protective barrier for the testes or ovaries. (49) Half-value layer (HVL) - The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. (50) Healing art - Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition. (51) Healing arts screening - The testing of asymptomatic human beings using x- ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment. (52) High level control for fluoroscopy - Any selected mode having an entrance exposure rate above 10 roentgens per minute (R/min). This mode must meet the high level requirements in subsection (r)(3)(A)(i)(II), (ii)(II), or (iii)(II) of this section. (53) Image intensifier - A device, installed in its housing, that instantaneously converts an x-ray pattern into a corresponding light image of higher energy density. (54) Image receptor - Any device, such as a fluorescent screen or radiographic film, that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. (55) Inherent filtration - The filtration of the useful beam provided by the permanently installed components of the x-ray tube housing assembly. (56) Institutional Review Board (IRB) - Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects. (57) Interlock - A device for precluding access to an area of high radiation by automatically reducing the exposure rate. (58) Interruption of irradiation - The stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel. (59) Irradiation - The exposure of matter to ionizing radiation. (60) Isocenter - A fixed point in space located at the center of the smallest sphere through which the central axis of the beam passes in all conditions. (61) kV - Kilovolt. (62) kVp - Kilovolt peak (See definition for peak tube potential). (63) kWs - Kilowatt-second. It is equivalent to 10 E 3 watt-second, where 1 watt-second =1 kV x 1 mA x 1 second. (64) Lead equivalent - The thickness of lead affording the same attenuation, under specified conditions, as the material in question. (65) Leakage radiation - Radiation emanating from the diagnostic or therapeutic source assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated. (66) Leakage technique factors - The technique factors associated with the diagnostic or therapeutic source assembly that are used in measuring leakage radiation. They are defined as follows: (A) for diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (i.e., 10 milliampere-second (mAs)) or the minimum obtainable from the unit, whichever is larger; (B) for diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum- rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; or (C) for all other diagnostic or therapeutic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential. (67) Licensed medical physicist - An individual holding a current Texas license under the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n. (68) Linear attenuation coefficient (u) - The quotient of dN/N by dl when dN/N is the fraction of uncharged ionizing radiation that experiences interactions in traversing a distance dl in a specified material. (69) mA - Milliampere. (70) mAs - Milliampere-second. (71) Medical research - The investigation of various health risks and diseases using radiation machines as part of the evaluation process. (72) Mobile services - The utilization of radiation machines in temporary locations for limited time periods. The radiation machines may be fixed inside a mobile van or transported to temporary locations. (73) Mobile x-ray equipment - (See definition for x-ray equipment). (74) Moving beam therapy - Radiation therapy with relative displacement of the useful beam and/or the patient during irradiation. It includes arc therapy, skip therapy, and rotational therapy. (75) Multiple tomogram system - A computed tomography x-ray system that obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram. (76) New equipment - Systems subject to subsections (x) and (y) of this section that were manufactured after March 1, 1989. (77) Nominal tomographic section thickness - The full-width at half-maximum of the sensitivity profile taken at the center of the cross sectional volume over which x-ray transmission data are collected. (78) Non-certified equipment - Equipment manufactured and assembled prior to certification requirements of 21 CFR. (79) Normal treatment distance - The following treatment distances shall apply. (A) For electron irradiation, the distance from the scattering foil or exit window of the electron beam to the surface along the central axis of the useful beam, or from the virtual source to the surface along the central axis of the useful beam as specified by the manufacturer. (B) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer. (80) Patient - An individual subjected to healing arts examination, diagnosis, or treatment. (81) Peak tube potential - The maximum value of the potential difference across the x-ray tube during an exposure. (82) Phantom - A volume of material behaving in a manner that can be related to tissue with respect to the attenuation and scattering of radiation. (83) Phototimer - A method for controlling radiation exposures to image receptors by the amount of radiation that reaches a radiation monitoring device. The radiation monitoring device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control). (84) Portable x-ray equipment (See definition for x-ray equipment). (85) Port film - An x-ray exposure of limited absorbed dose made with a therapy system to visualize a patient's treatment area using film or other imaging devices. (86) Practical range of electrons - This corresponds to the classical electron range where the only contribution to dose is from bremsstrahlung x rays. Precise definition may be found in Task Group-21 protocol (Medical Physics 10(6): 741- 771, Nov/Dec 1983) and International Commission on Radiation Units and Measurements (ICRU) Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV," ICRU, September 15, 1984. (87) Practitioner of the healing arts (practitioner) - A person licensed to practice healing arts by either the Texas State Board of Medical Examiners as a physician, the Texas State Board of Dental Examiners, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatry Examiners. (88) Primary dose monitoring system - A system that will monitor the useful beam during irradiation and that will terminate irradiation when a preselected number of dose monitor units have been acquired. (89) Primary protective barrier - (See definition for protective barrier). 90) Protective apron - An apron made of radiation absorbing materials used to reduce radiation exposure. (91) Protective barrier - A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows: (A) primary protective barrier - The material, excluding filters, placed in the useful beam, for protection purposes, to reduce the radiation exposure. (B) secondary protective barrier - A barrier sufficient to attenuate the stray radiation to the required degree. (92) Protective glove - A glove made of radiation absorbing materials used to reduce radiation exposure. (93) Radiation detector - A device, which in the presence of radiation, provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation. (94) Radiation head - The structure from which the useful beam emerges. (95) Radiation oncologist - A practitioner with a specialty in radiation therapy. (96) Radiation therapy simulation system - An x-ray system intended for localizing and confirming the volume to be irradiated during radiation treatment and confirming the position and size of the therapeutic irradiation field. (97) Radiograph - An image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record. (98) Record mode for fluoroscopy - The mode that is activated, records dynamic fluoroscopic images for a time sequence, and is then deactivated. Last image hold is not considered a fluoroscopic record mode. (99) Recording - Producing a permanent form of an image resulting from x-ray photons. (100) Reference plane - A plane that is displaced from and parallel to the tomographic plane. (101) Scan - The complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms. (102) Scan increment - The amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement. (103) Scan sequence - A preselected set of two or more scans performed consecutively under preselected CT conditions of operation. (104) Scan time - The period of time between the beginning and end of x-ray transmission data accumulation for a single scan. (105) Scattered radiation - radiation that has been deviated in direction during passage through matter. (106) Secondary dose monitoring system - A system that will terminate irradiation in the event of failure of the primary system. (107) Secondary protective barrier (See definition for protective barrier). (108) Shutter - A device attached to the tube housing assembly that can totally intercept the useful beam and that has a lead equivalency not less than that of the tube housing assembly. (109) Single tomogram system - A CT x-ray system that obtains x-ray transmission data during a scan to produce a single tomogram. (110) Source - The focal spot of the x-ray tube. (111) Source-to-image receptor distance (SID) - The distance from the source to the center of the input surface of the image receptor. (112) Source-to-skin distance (SSD) - The distance between the source and the skin of the patient. (113) Spacer - A device designed to limit the target to skin distance. (114) Special purpose x-ray system - Any radiographic x-ray system that is limited by design to radiographic examinations of specific anatomical regions. Special purpose x-ray systems include, but are not limited to, dedicated chest units, cystography units, and head and skull units. (115) Special procedures - The application of special x-ray equipment and specialized techniques to obtain required diagnostic information. This usually provides enhanced detail of a given anatomical structure but with reduced visualization of others. Special procedures include, but are not limited to, angiography, cardiac catheterization, myelogram, and surgery. (116) Spot check - Those tests and analyses performed for the purpose of determining the constancy of operation of imaging or radiation therapy equipment. (117) Spot film - A radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure. (118) Spot film device - A device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph. (119) Stationary beam therapy - Radiation therapy without relative displacement of the useful beam and the patient during irradiation. (120) Stationary x-ray equipment - (See definition for x-ray equipment). (121) Stray radiation - The sum of leakage and scattered radiation. (122) Supervision - The delegating of the task of applying radiation in accordance with this section to persons not licensed in the healing arts or veterinary medicine, who provide services under the practitioner's control. The licensed practitioner assumes full responsibility for these tasks and must assure that the tasks will be administered correctly. (123) Target - The part of a radiation head that by design intercepts a beam of accelerated particles with subsequent emission of other radiation. (124) Technique chart - A chart that provides all necessary generator control settings and geometry needed to make clinical radiographs when the radiography system is in manual mode. (125) Technique factors - The conditions of operation that are specified as follows: (A) for capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs; (B) for field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses; (C) for CT equipment designed for pulsed operations, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs; (D) for CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds or the product of tube current and exposure time in mAs when the scan time and exposure time are equivalent; and (E) for all other equipment, peak tube potential in kV and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs. (126) Termination of irradiation - The stopping of irradiation in a fashion that will not permit continuance of irradiation without the resetting of operating conditions at the control panel. (127) Therapy system - An x-ray system that utilizes prescribed doses of ionizing radiation for treatment. (128) Tomogram - The depiction of the x-ray attenuation properties of a section through the body. (129) Tomographic plane - The geometric plane that is identified as corresponding to the output tomogram. (130) Tomographic section - The volume of an object whose x-ray attenuation properties are imaged in a tomogram. (131) Traceable to a national standard - This indicates that a quantity or a measurement has been compared to a national standard (e.g., National Institute of Standards and Technology) directly or indirectly through one or more intermediate steps and that all comparisons have been documented. (132) Tube - An x-ray tube, unless otherwise specified. (133) Tube housing assembly - The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing. (134) Useful beam - The radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam-limiting device when the exposure controls are in a mode to cause the system to produce radiation. (135) Veterinarian - An individual licensed by the Texas Board of Veterinary Medical Examiners, with license in good standing. (136) Virtual source - A point from which radiation appears to originate. (137) Wedge filter - An added filter effecting continuous progressive attenuation on all or part of the useful beam. (138) X-ray control - A device that controls input power to the x-ray high- voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices that control the technique factors of an x-ray exposure. (139) X-ray equipment - An x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows: (A) mobile x-ray equipment - x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled; (B) portable x-ray equipment - x-ray equipment designed to be hand-carried; or (C) stationary x-ray equipment - x-ray equipment that is installed in a fixed location. (140) X-ray field - That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection. (141) X-ray high-voltage generator - A device that transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high- voltage switches, electrical protective devices, and other appropriate elements. (142) X-ray system - An assemblage of components for the controlled production of x rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system. (143) X-ray subsystem - Any combination of two or more components of an x-ray system. (144) X-ray tube - Any electron tube that is designed to be used primarily for the production of x rays. (e) General requirements for chiropractic, dental, medical, podiatric, and veterinary facilities. (1) Technique chart. A technique chart relevant to the particular x-ray unit shall be provided or electronically displayed in the vicinity of the control panel and used by all operators. (2) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures. These procedures shall be made available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. These procedures shall include, but are not limited to, the items in subsection (cc)(3) of this section. (3) Occupational dose limitation and personnel monitoring. Except as otherwise exempted, all individuals who are associated with the operation of a radiation machine are subject to the radiation dose limits of sec.289.202(f), (j), and (l)-(m) of this title regarding dose limits to individuals, and the personnel monitoring requirements of sec.289.202(q) of this title. (4) Protective devices. Protective devices shall be utilized when required, as in subsection (i)(3) of this section, subsections (j)(2), (k)(5)(B), (r)(7), and (x)(4)(D)(iii) of this section. (A) Protective devices shall be made of no less than 0.25 millimeter (mm) lead equivalent material. (B) Protective devices, including aprons, gloves, and shields shall be checked annually for defects, such as holes, cracks, and tears. These checks may be performed by the registrant by visual, tactile, or x-ray imaging. If such defect is found, equipment shall be replaced or removed from service until repaired. A record of this test shall be made and maintained by the registrant in accordance with subsection (cc)(2)of this section for inspection by the agency. (5) Records. (A) The registrant shall maintain the following records for each radiation machine in accordance with subsection (cc)(3) of this section for inspection by the agency: (i) records of receipt; (ii) transfer; (iii) disposal; (iv) surveys; (v) calibrations; (vi) maintenance; (vii) equipment performance evaluation tests; and (viii) modifications performed on the radiation machine after April 1, 1989. (B) Records required in subparagraph (A) of this paragraph may be maintained in electronic format and shall include the following: (i) manufacturer name, model number, and serial number from the control panel or console of the radiation machine; (ii) dates of receipt, transfer, and disposal; and (iii) name of the individual recording the information. (6) Operator credentialing. Individuals who operate radiation machines shall meet the appropriate credentialing requirements of rules issued in accordance with the Medical Radiologic Technologist Act, Texas Civil Statutes, Article 4512m. Copies of the credentialing document shall be maintained at the locations(s) where the individual is working. (7) Practice of Medical Physics. Surveys, tests, or evaluations required by this section may constitute the practice of medical physics and, therefore, require a license from the Texas Board of Licensure for Professional Medical Physicists in accordance with the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n. (f) Healing arts screening and medical research. (1) Any person proposing to conduct a healing arts screening program for humans shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the information outlined in subsection (cc)(1)of this section. If any information submitted to the agency becomes invalid or outdated, the agency shall be notified within 15 days. (2) Any research using radiation producing devices on humans must be approved by an IRB as required by 45 CFR 46 and 21 CFR 56. The IRB must include at least one practitioner of the healing arts to direct any use of radiation in accordance with sec.289.201(a) of this title. (g) Educational facilities. Facilities conducting training using non-humans are held to all the requirements of this section except for subsection (e)(6) of this section concerning operator credentialing, subsection (h) of this section concerning radiographic entrance exposure limits, subsections (l)-(m) of this section concerning film processing, and subsection (q) of this section concerning equipment performance evaluation. (h) Radiographic entrance exposure limits for chiropractic, dental, medical, and podiatric facilities. This does not apply to veterinary facilities. The in-air exposure determined for the technique used for the specified average human adult patient thickness for routine medical radiography shall not exceed the entrance exposure limits in the following Table I: Figure 4: 25 TAC sec.289.227(h) (i) Additional operational requirements for medical, podiatric, and chiropractic facilities. (1) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system shall be provided to permit the operator to continuously observe the patient during irradiation. The operator shall be able to maintain verbal, visual, and aural contact with the patient. (2) Operator position. The operator's position during the exposure shall be such that the operator exposure is as low as reasonably achievable (ALARA) and/or protected by an apron, gloves, or other shielding having a minimum of 0.25 mm lead equivalent material. (3) Exposure of individuals other than the patient. Except for patients who cannot be moved out of the room (e.g., critical care areas, emergency rooms, or trauma units), only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiation exposure. (A) All individuals, other than the patient being examined, shall be positioned so that exposure is ALARA and/or protected by an apron, gloves, or other shielding having a minimum of 0.25 millimeter (mm) lead equivalent material. (B) Notwithstanding the provisions of subparagraph (A) of this paragraph, other patients who are in line with the primary beam and who cannot be removed from the room, shall be protected by whole body protective barriers of a minimum of 0.25 mm lead equivalent material or so positioned that the nearest portion of their body is at least six feet from both the tube head and the nearest edge of the image receptor. (4) Gonadal shielding. Gonadal shielding shall be used on patients when the gonads are in or within 5 cm of the useful beam. This requirement does not apply if the shielding will interfere with the diagnostic procedure. Gonadal shielding shall be of at least 0.5 mm lead equivalent material. (5) Holding of patient or film. When a patient or film must be provided with auxiliary support during a radiation exposure the following shall apply. (A) Mechanical holding devices shall be used when the technique permits. The written operating and safety procedures required by subsection (e)(2) of this section shall list circumstances in which mechanical holding devices cannot be routinely utilized. (B) The requirements for selecting an individual who holds or supports the patient, and the procedure that the holder shall follow, shall be included in the written safety procedures as required by subsection (e)(2) of this section. (C) The human holder shall be protected, as required by subparagraph (A) of this paragraph. (D) In no case shall an individual hold the x-ray tube housing during any radiographic exposure. (E) In those cases where the patient must hold the film, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.25 mm lead equivalent material. (j) Additional operational controls for dental radiographic systems. (1) Film holding devices shall be used except in individual cases in which the practitioner has determined that such holding devices are contraindicated. Written operating and safety procedures required by subsection (e)(2) of this section shall state the criteria under which the exception may apply. (2) The operator shall stand at least six feet from the useful beam or behind a protective barrier. The operator shall maintain verbal, aural, and visual contact with the patient. (3) The tube housing support shall be constructed and adjusted so that the tube housing shall not drift from its set position during an exposure. Neither the tube housing nor support housing shall be hand-held during an exposure. (k) Additional operational controls for veterinary x-ray systems. (1) All exams and retakes shall be ordered by the veterinarian. (2) In no case shall an individual hold the x-ray tube during any radiographic exposure. (3) The operator's position during the exposure shall be such that the operator exposure shall be as low as reasonably achievable (ALARA) and/or protected by an apron, gloves, or other shielding having a minimum of 0.25 mm lead equivalent material. (4) No individual, other than the operator, shall be in the x-ray room or area while exposures are being made unless such individual's assistance is required. (5) When an animal must be held in position during radiography, mechanical supporting or restraining devices shall be used when technique permits. (A) A pregnant member of the public shall not hold or restrain an animal. (B) If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron, in accordance with subsection (e)(4) of this section and the person shall be so positioned that no part of his/her body except hands and arms will be struck by the useful beam. (l) Automatic and manual film processing for chiropractic, dental, medical, podiatric, and veterinary facilities and mobile services. (1) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. The specified developer temperature for automatic processing and the time-temperature chart for manual processing shall be posted in the darkroom. (2) Chemicals shall be replaced according to the chemical manufacturer's or supplier's recommendations or at an interval not to exceed three months. (3) Darkroom light leak tests shall be performed and any light leaks corrected at intervals not to exceed six months. (4) Lighting in the film processing/loading area shall be maintained with the filter, bulb wattage, and distances recommended by the film manufacturer for that film emulsion or with products that provide an equivalent level of protection against fogging. (5) Corrections or repairs of the light leaks or related deficiencies in paragraphs (3) and (4) of this subsection shall be initiated within 72 hours of discovery and completed no longer than 15 days from detection of the deficiency unless a longer time is authorized by the agency. Records of the correction or repairs shall include the date and initials of the individual performing these functions and shall be maintained in accordance with subsection (cc)(2) of this section for inspection by the agency. (6) Documentation of the items in paragraphs (2), (3), and (5) of this subsection shall be maintained at the site where performed and shall include the date and initials of the individual completing these items. These records shall be kept in accordance with subsection (cc)(2) of this section for inspection by the agency. (m) Alternative processing systems. Users of daylight processing systems, laser processors, self-processing film units, or other alternative processing systems shall follow manufacturer's recommendations for image processing. (n) Record requirements for mobile services and authorized use locations for chiropractic, dental, medical, podiatric, and veterinary facilities. (1) Copies of the following records shall be kept with units authorized for mobile service: (A) operating and safety procedures in accordance with subsection (e)(2) of this section; (B) credentials of operators of radiation machines operating at that location in accordance with subsection (e)(6) of this section; (C) current sec.289.112 of this title, sec.289.114 of this title, sec.289.201 of this title, sec.289.202 of this title, sec.289.226 of this title, and sec.289.227 of this title; (D) certificate of registration; (E) current film processing records for at least 90 days for on-board processors in accordance with subsection (l)(2), (3), and (5)of this section, as applicable; (F) documentation of completion of equipment performance evaluation and corrective actions in accordance with subsection (q) of this section; and (G) notice of violation from last inspection, if applicable, and documentation of corrections of any violations. (2) Copies of the following records for mobile services shall be maintained at the authorized records location: (A) current sec.289.112 of this title, sec.289.114 of this title, sec.289.201 of this title, sec.289.202 of this title, sec.289.204 of this title, sec.289.226 of this title, and sec.289.227 of this title; (B) certificate of registration; (C) surveys of radiation levels in unrestricted areas in accordance with sec.289.202(n) of this title; (D) personnel monitoring records of occupationally exposed individuals in accordance with sec.289.202(f), (j), or (m) of this title, as applicable; (E) documentation of annual check of protective devices in accordance with subsection (e)(4)(B) of this section; (F) records of receipt, transfer, and disposal and surveys, calibrations, maintenance, equipment performance evaluations, and modifications of radiation machines in accordance with subsection (e)(5) of this section; (G) film processing records for that location and all on-board processors in accordance with subsection (l)(2), (3), and (5) of this section, as applicable (excluding the records that are maintained on-board with the mobile service); (H) United States Food and Drug Administration (FDA) variances in accordance with subsection (p) of this section; (I) current annual survey of fluoroscopic x-ray machines being operated on-board in accordance with subsection (r)(3)(D) of this section; and (J) CT dose measurements and CT quality control films or images in accordance with subsection (v)(3)(A) and (v)(4)(B) of this section. (3) Copies of the following records shall be maintained at authorized use locations: (A) current sec.289.112 of this title, sec.289.114 of this title, sec.289.201 of this title, sec.289.202 of this title, sec.289.204 of this title, sec.289.226 of this title, and sec.289.227 of this title; (B) certificate of registration; (C) surveys of radiation levels in unrestricted areas in accordance with sec.289.202(n) of this title; (D) personnel monitoring records of occupationally exposed individuals in accordance with sec.289.202(f), (j), or (m) of this title, as applicable; (E) operating and safety procedures in accordance with subsection (e)(2) of this section; (F) documentation of annual check of protective devices at that location in accordance with subsection (e)(4)(B) of this section; (G) records of receipt, transfer, and disposal and surveys, calibrations, maintenance, equipment performance evaluation, and modification of radiation machines at that location in accordance with subsection (e)(5) of this section; (H) credentials of operators of radiation machines operating at that location in accordance with subsection (e)(6) of this section; (I) film processing records for that location in accordance with subsection (l)(2), (3), and (5 ) of this section, as applicable; (J) FDA variances of machines at that location in accordance with subsection (p) of this section; (K) current annual survey of fluoroscopic x-ray machines being operated at that location in accordance with subsection (r)(3)(D) of this section; (L) CT dose measurements and CT quality control films or images at that location in accordance with subsection (v)(3)(A) and (v)(4)(B) of this section; (M) therapy (under 500 kV) surveys and calibrations of equipment at that location in accordance with subsection (x)(4)(A)(i) and (ii) and (B)(v) of this section; (N) therapy (above 500 kV) surveys and calibrations of equipment at that location in accordance with subsection (y)(3)(C)(vi) and (D)(vii) of this section; (O) records, notices, and reports of therapy misadministrations in accordance with subsection (bb)(2) of this section; and (P) notice of violation from last inspection, if applicable, and documentation of corrections of any violations. (o) General requirements for all diagnostic x-ray systems for chiropractic, dental, medical, podiatric, and veterinary facilities. (1) Warning label. The warning label will meet the requirements of sec.289.202(cc)(3) of this title. (2) Mechanical support of tube head. The tube housing assembly shall be adjusted to remain stable during an exposure unless tube housing movement is a designed function of the x-ray system. The tube housing assembly supports shall not be hand-held. (3) Battery charge indicator. On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation. (4) Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 mR in one hour at 5 cm from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Measurement is averaged over an area of 100 square centimeter (cm2) with no linear dimension greater than 20 cm. (5) Beam quality. The following requirements apply to beam quality. (A) Half-value layer. (i) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following Table II. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table II, linear interpolation may be made. Figure 5: 25 TAC sec.289.227(o)(5)(A)(i) (ii) For capacitor energy storage equipment, compliance with the requirements of paragraph (5) of this subsection shall be determined with the maximum quantity of charge per exposure. (B) Filtration controls. For x-ray systems that have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filters and shall prevent an exposure unless the minimum amount of filtration required by subparagraph (A) of this paragraph is in the useful beam for the given kVp that has been selected. Any other system having removable filters shall be required to have the minimum amount of filtration as required by subparagraph (A)(i) of this paragraph permanently located in the useful beam during each exposure. (6) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly that has been selected. (7) Technique and exposure indicators. (A) The technique factors to be used during an exposure shall be indicated before the exposure begins except when automatic exposure controls are used, in which case the technique factors that are set prior to the exposure shall be indicated. (B) On equipment having fixed technique factors, the requirement of subparagraph (A) of this paragraph may be met by permanent markings. (C) The x-ray control shall provide visual indication of the production of x rays. (D) The indicated technique factors shall be accurate to within manufacturer's specifications. If these specifications are not available from the manufacturer, the factors shall be accurate to within ñ10% of the indicated setting. (p) Certified equipment for chiropractic, medical, dental, and podiatric facilities. This subsection does not apply to veterinary facilities. In addition to the requirements of this chapter, the registrant shall not make, nor cause to be made, any modification of components or installations of components certified in accordance with the United States Food and Drug Administration (FDA) 21 CFR 1020, "Performance Standards for Ionizing Radiation Emitting Products," as amended in any manner that could cause the installations or the components to fail to meet the requirements of the applicable parts of the standards specified in 21 CFR 1020, except where a variance has been granted by the Director, Center for Devices and Radiological Health, FDA. A copy of the variance shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (q) Equipment performance evaluation for chiropractic, medical, dental, and podiatric facilities. This subsection does not apply to veterinary facilities. (1) For all x-ray systems listed in paragraphs (3)-(6) of this subsection, the registrant shall perform, or cause to be performed, tests necessary to assure proper function of equipment with the indicated standard for each item specified. Such tests shall be performed at the frequency listed in subsection (cc)(4) of this section. (2) Any items not meeting the specifications of the tests shall be corrected or repaired. (A) Correction or repair shall begin within 30 days following the check and shall be performed according to a plan designated by the registrant. Correction or repair shall be completed no longer than 90 days from discovery unless authorized by the agency. (B) Records of the test results, including any numerical readings, and any corrections or repairs shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (3) Radiographic x-ray equipment performance evaluation. (A) Timer. The accuracy of the timer shall meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy shall be ñ10% of the indicated time with testing performed at 0.5 second. (B) Exposure reproducibility. Exposure reproducibility shall meet the requirements of subsection (s)(4) of this section. (C) Linearity. mR/mAs stations shall meet the requirements of subsection (s)(5) of this section.. (D) kVp. If the registrant possesses documentation of the appropriate manufacturer's kVp specifications, the unit shall meet those specifications. If the registrant does not possess documentation of the appropriate manufacturer's kVp specifications, the indicated kVp shall be accurate to within ñ10% of the indicated setting at no less than three points over the usual operating range of the machine. (E) Tube stability. The x-ray tube shall remain physically stable during exposures. In cases where tubes are designed to move during exposure, the registrant shall assure proper and free movement of the unit. (F) Collimation. The following items shall meet the requirements of subsection (s)(1) of this section: (i) numerical indicators of x-ray field size; (ii) light field versus x-ray field congruence; (iii) automatic and semi-automatic collimators unless disabled; and (iv) center of x-ray field alignment with center of image receptor. (4) Fluoroscopic x-ray systems and spot film devices equipment performance evaluation. Fluoroscopic equipment shall meet the requirements of subsection (r) of this section. (5) Dental x-ray systems equipment performance evaluation. (A) Timer. The accuracy of the timer shall meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy shall be ñ10% of the indicated time with testing performed at 0.5 second. (B) Exposure reproducibility. Exposure reproducibility shall meet the requirements of subsection (t)(1)(D) of this section. (C) kVp. If the registrant possesses documentation of the appropriate manufacturer's kVp specifications, the unit shall meet those specifications. If the registrant does not possess documentation of the appropriate manufacturer's kVp specifications, the indicated kVp shall be accurate to within ñ10% of the indicated setting at no less than three points over the usual operable range of the machine. For units with fewer than three fixed kVp settings, the unit shall be checked at those settings. (D) Tube stability. The x-ray tube shall remain physically stable during exposures. In cases where tubes are designed to move during exposure, the registrant shall assure proper and free movement of the unit. (E) Collimation. Field limitation shall meet the requirements of subsection (t)(3) of this section. (6) CT x-ray systems equipment performance evaluation. CT x-ray systems shall meet the requirements of subsection (v) of this section. (r) Fluoroscopic x-ray systems and spot-film devices for all facilities. (1) Limitation of the useful beam shall be as follows. (A) Primary barrier. (i) The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. (ii) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the useful beam and the imaging device is in place and operable. (iii) The exposure rate due to transmission through the barrier with the attenuation block in the useful beam, combined with radiation through the image intensifier if provided, shall not exceed 3.34 x 10-3 % of the entrance exposure rate at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. (B) Measuring compliance of barrier transmission. (i) The exposure rate due to transmission through the primary protective barrier combined with radiation through the image intensifier shall be determined by measurements averaged over an area of 100 cm2 with no linear dimension greater than 20 cm. (ii) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. (iii) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. (iv) Movable grids and compression devices shall be removed from the useful beam during the measurement. (v) The attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly. (vi) The collimator shall be fully open when the measurement is made. (C) X-ray field. (i) Equipment with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either stepless adjustment of the x-ray field or a means to further limit the x-ray field at the image receptor to 125 cm2 or less. If the equipment is provided with stepless adjustment, the minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor. (ii) Equipment with a variable SID or a fixed SID with the capability of a visible area of greater than 300 cm2 shall be provided with stepless adjustment of the field size. The minimum x-ray field size at the maximum SID shall be less than or equal to 5 cm by 5 cm at the image receptor. (iii) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID. (iv) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x- ray field that pass through the center of the visible area of the image receptor. (v) For fluoroscopic equipment with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor. (vi) Spot-film devices shall meet the following additional requirements. (I) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film that has been selected on the spot-film selector. (-a-) Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. (-b-) The total misalignment of the edges of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor shall not exceed 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. (-c-) The sum, without regard to sign of the misalignment along any two orthogonal dimensions, shall not exceed 4.0% of the SID. (II) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2.0% of the SID. (vii) Compliance with subparagraph (B) of this paragraph shall be determined with the beam axis perpendicular to the plane of the image receptor. (2) Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the fluoroscopist for the entire time of the exposure (continuous pressure type switch). When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposures at any time, but means may be provided to permit completion of any single exposure of the series in process. (3) Entrance exposure rate allowable limits. (A) The following requirements apply to fluoroscopic equipment manufactured prior to May 19, 1995. (i) Equipment with automatic exposure rate control (AERC). Fluoroscopic equipment that is provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 x 10-3 coulomb per kilogram per minute (C/kg/min) (10 roentgens per minute (10 R/min)) at the point where the center of the useful beam enters the patient, except: (I) during recording of fluoroscopic images, or (II) when an optional high-level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 x 10-3C/kg/min (5 R/min) at the point where the center of the useful beam enters the patient, unless the high-level control is activated. Special means of activation of high- level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (ii) Equipment without AERC (manual mode). Fluoroscopic equipment that is not provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 x 10-3 C/kg/min (5 R/min) at the point where the center of the useful beam enters the patient, except: (I) during recording of fluoroscopic images, or (II) when an optional high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (iii) Equipment with both an AERC mode and a manual mode. Fluoroscopic equipment that is provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 x 10-3 C/kg/min (10 R/min) in either mode at the point where the center of the useful beam enters the patient except: (I) during recording of fluoroscopic images, or (II) when the mode or modes have an optional high-level control, in which case that mode or modes shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 x 10- 3C/kg/min (5 R/min) at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activation of high-level control shall be required. The high level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high- level is being employed. (iv) Measuring compliance. Compliance with subparagraph (A) of this paragraph shall be determined as follows. (I) If the source is below the x-ray table, the exposure rate shall be measured at 1 cm above the tabletop or cradle. (II) If the source is above the x-ray table, the exposure rate shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (III) In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly. The applicable limit shall not be exceeded at any available SID. (IV) In a lateral (horizontal) type of fluoroscope, the exposure rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table. (B) Entrance exposure rate limits. The following requirements apply to fluoroscopic equipment manufactured on and after May 19, 1995. (i) Fluoroscopic equipment operable at any combination of tube potential and current that will result in an exposure rate greater than 1.29 x 10-3 C/kg/min (5 R/min) at the point where the center of the useful beam enters the patient shall be equipped with AERC. Provision for manual selection of technique factors may be provided. (ii) Fluoroscopic equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 x 10-3C/kg/min (10 R/min) at the point where the center of the useful beam enters the patient except: (I) During the recording of images from an x-ray image-intensifier tube using photographic film or a video camera when the x-ray source is operated in a pulsed mode. (II) When the high-level control is activated, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 5.16 x 10 -3C/kg/min (20 R/min) at the point where the center of the useful beam enters the patient. Special means of activation of high-level controls shall be required. The high-level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed. (iii) Measuring compliance. Compliance with subparagraph (B) of this paragraph shall be determined as follows. (I) If the source is below the x-ray table, the exposure rate shall be measured at 1 cm above the tabletop or cradle. (II) If the source is above the x-ray table, the exposure rate shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (III) In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly. The applicable limit shall not be exceeded at any available SID. (IV) In a lateral (horizontal) type of fluoroscope, the exposure rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table. (C) Hand-held fluoroscopes. For hand-held fluoroscopes, the exposure rate shall be measured at the point closest to the source. (D) Periodic measurement of entrance exposure rate. Periodic measurement of entrance exposure rate shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics as follows. (i) Such measurements shall be made within 30 days of installation, annually, and within 30 days after any maintenance of the system that might affect the exposure rate. (ii) Results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscope and retained as required in subsections (e)(5) and (cc)(2) of this section. The measurement results shall be stated in R/min and include the technique factors used in determining such results. The name of the person performing the measurements and the date the measurements were performed shall be included in the results. (iii) Conditions of periodic measurement of entrance exposure rate are as follows. (I) The measurement shall be made in accordance with subparagraph (A)(iv) or (B)(iii) of this paragraph, as applicable. (II) X-ray systems that do not incorporate an AERC shall utilize a milliamperage and kVp typical of the clinical use of the x-ray system. Materials should be placed in the useful beam between the detection and imaging systems when conducting these periodic measurements to protect the imaging system. (III) X-ray systems that do incorporate an AERC shall have sufficient material placed in the useful beam to produce a milliamperage and kVp typical of the clinical use of the x-ray system. (4) Indication of potential and current. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated at the control panel and/or the fluoroscopist's position. (5) SSD. The SSD shall not be less than the following: (A) 38 cm on stationary fluoroscopes installed after March 1, 1989; (B) 35.5 cm on stationary fluoroscopes that were in operation prior to March 1, 1989; (C) 30 cm on all mobile and portable fluoroscopes; (D) 20 cm for image-intensified fluoroscopes used for examinations as specified in the registrant's operating and safety procedures. The written operating and safety procedures shall provide precautionary measures to be adhered to during the use of this device. The procedures must provide information on the means to restore the unit to a 30 cm SSD when the unit is returned to general service; and (E) the FDA approved variance for a specific manufacturer of a hand-held fluoroscope. (6) Fluoroscopic timer. (A) Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. (B) A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. In lieu of such signal, the timer shall terminate the beam after the preset cumulative on-time is completed. (7) Control of scattered radiation. (A) Fluoroscopic configuration, including fluoroscopic table designs, shall not permit any portion of any individual's body, except the head, neck, and extremities, to be exposed to scattered radiation emanating from above or below the tabletop unless the radiation has passed through not less than a total of 0.25 mm lead equivalent material. The material may be, but is not limited to, drapes, self-supporting curtains, or viewing shields, in addition to any lead equivalency provided by a protective apron. (B) Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met. (i) All persons, except the patient, in the room where fluoroscopy is performed, shall wear protective aprons that provide a shielding equivalent of 0.5 mm of lead. (ii) The fluoroscopic field size shall be reduced to the absolute minimum required for the procedure being performed (area of clinical interest). (iii) Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or nonuse of the protective drapes. (C) For image-intensified fluoroscopic equipment with only a manual mode of collimation, the x-ray field produced shall be limited to the area of the spot- film cassette at 16 inches above tabletop. Additionally, during fluoroscopy, the beam shall be restricted to the area of the input phosphor. (s) Additional technical standards for chiropractic, medical, and podiatric facilities. This subsection does not apply to fluoroscopic, dental, veterinary, or computed tomography systems. (1) Beam limitation shall be as follows. (A) Stationary general purpose and mobile x-ray systems. (i) Beam limiting devices shall restrict the useful beam to the area of clinical interest. The x-ray field shall not exceed any one of the following: (I) 2.0% of the SID for the length or width of the image receptor for manual rectangular collimation; (II) 2.0% of the SID for the diagonal of the image receptor for circular or polygon collimation; or (III) 3.0% of the SID for the length or width or if the sum of the length and width difference, without regard to sign, exceed 4.0% of the SID for automatic or semi-automatic collimation. (ii) A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam. (iii) An SID indicator shall be present and shall be accurate to within 2.0% of the SID. (B) Additional requirements for stationary general purpose x-ray systems are as follows. (i) A method shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x- ray field with respect to the center of the image receptor to within 2.0% of the SID and to indicate the SID to within 2.0%. (ii) The beam-limiting device shall indicate numerically the field size in the plane of the image receptor, to which it is adjusted. (iii) Indication of field size dimensions and SID's shall be specified in inches and/or centimeters, and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor that correspond to those indicated by the beam-limiting device by no more than 2.0% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor. (iv) An SID indicator shall be present and shall be accurate to within 2.0% of the actual SID. (C) X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within 2.0% of the SID, or shall be provided with means to both size and align the x-ray field such that the x- ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. (D) Special purpose x-ray systems. (i) Means shall be provided to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2.0% of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor. (ii) Means shall be provided to align the center of the x-ray field with the center of the image receptor to within 2.0% of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. (iii) Clause (i) and (ii) of this subparagraph may be met with a system that meets the requirements for a general purpose x-ray system as specified in subparagraphs (A) or (B)(i) of this paragraph or, when alignment means are also provided, may be met with either of the following: (I) an assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or (II) a beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use. (2) Radiation exposure control devices shall include the following: (A) X-ray control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for an exposure of 0.5 second or less or during serial radiography when means shall be provided to permit completion of any single exposure of the series in process. The exposure switch shall be of the continuous pressure type. (B) Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. (C) AEC. When an AEC is provided, the following shall occur: (i) indication shall be made on the control panel when this mode of operation is selected; (ii) if the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two pulses; (iii) the minimum exposure time for all equipment other than that specified in clause (ii) of this subparagraph shall be equal to or less than 0.0167 second or a time interval required to deliver 5 mAs, whichever is greater; (iv) either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kWs per exposure, or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except that, when the x-ray tube potential is less than 50 kVp, the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and (v) a visible and/or audible signal shall indicate when an exposure has been terminated at the limits required by clause (iv) of this subparagraph, and manual resetting shall be required before further automatically timed exposures can be made. (D) Exposure interval reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure interval for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (3) SSD. All mobile or portable radiographic systems shall be provided with means to limit the SSD to equal to or greater than 30 cm. (4) Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (5) Linearity. Figure 6: 25 TAC sec.289.227(s)(5) (6) Radiation from capacitor energy storage equipment in standby status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of two milliroentgens per hour (mR/hr) at 5 cm from any accessible surface of the diagnostic source assembly, with the beam- limiting device fully open. (t) Additional technical standards for dental facilities. (1) General requirements are as follows. (A) Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. (B) Exposure interval reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure interval for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (C) X-ray control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time, except for exposures of 0.5 second or less. Each x-ray control shall be located in such a way as to permit the operator to remain in an area of less than 2 mR in any one hour during the entire exposure.] The exposure switch shall be of the continuous pressure type. (D) Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (2) Additional requirements for dental intraoral systems are as follows. (A) SSD. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit SSD to not less than: (i) 18 cm if operable above 50 kVp; or (ii) 10 cm if not operable above 50 kVp. (B) Field limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that: (i) if the minimum SSD is 18 cm or more, the x-ray field at the minimum SSD shall be restricted to a dimension of no more than 7 cm; and (ii) if the minimum SSD is less than 18 cm, the x-ray field at the minimum SSD shall be restricted to a dimension of no more than 6 cm. (3) Additional requirements for dental extraoral systems are as follows. (A) Field limitation. Dental rotational panoramic systems shall be provided with means to restrict the x-ray beam to the imaging slit in the transverse axis and shall not exceed a total of 0.5 inches larger than the imaging slit in the vertical axis. (B) All other dental extraoral radiographic systems (e.g., cephalometric) shall be provided with means to restrict the x-ray field to the area of clinical interest. The restriction may not exceed the following: (i) 2.0% of the SID for the length or width of the image receptor for rectangular collimation; or (ii) 2.0% of the SID for the diagonal of the image receptor for circular or polygon collimation. (u) Additional technical standards for veterinary x-ray facilities. (1) The x-ray control shall provide visual or audible indication of the production of x-rays observable at or from the operator's protected position whenever x-rays are produced. (2) Beam limiting devices shall provide the same degree of protection as is required of the housing and shall restrict the useful beam to the area of clinical interest. A method shall be provided so that the primary beam shall be centered with the film or image receptor. The restriction may not exceed the following: (A) 2.0% of the SID for the length or width of the image receptor for rectangular collimation; or (B) 2.0% of the SID for the diagonal of the image receptor for circular collimation. (3) Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. (4) A continuous pressure type exposure switch shall be provided, together with an exposure control cord of sufficient length, so that the operator can stand out of the useful beam and at least six feet from the animal during all x-ray exposures. (5) When all technique factors are held constant, including control panel selections associated with AEC systems, the coefficient of variation of exposure for both manual and AEC systems shall not exceed 0.05. This requirement applies to clinically used techniques. (6) The technique factors to be used during an exposure shall be indicated before the exposure begins. If AECs are used, the technique factors that are set prior to the exposure shall be indicated. (7) For machines having fixed technique factors, the requirements of paragraph (6) of this subsection may be met by permanent markings on the equipment. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist. (8) Fluoroscopic, CT, and therapy systems used in veterinary facilities shall meet the requirements of subsections (r), (v), (x), and (y) of this section, except the aural communications requirements of subsections (v)(2)(A), (x)(2)(A), and (y)(2)(D) of this section. (9) Portable machines shall be used in a manner that complies with this section. (v) CT x-ray systems. (1) Equipment requirements shall be as follows. (A) Tomographic plane indication and alignment. (i) For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. (ii) For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. The reference plane can be offset from the location of the tomographic planes. (iii) If a device using a light source is used to satisfy the requirements of clause (i) or (ii) of this subparagraph, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux. (B) Indication of CT conditions of operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible. (C) Initiation of operation shall be as follows. (i) The x-ray control and gantry shall provide visual indication whenever x rays are produced and, if applicable, whether the shutter is open or closed. (ii) Means shall be provided to require operator initiation of each individual scan or series of scans. (iii) All emergency buttons/switches shall be clearly labeled as to their functions. (D) Termination of exposure shall be as follows. (i) Means shall be provided to terminate the x-ray exposure automatically by either deenergizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function. (ii) A signal visible to the operator shall indicate when the x-ray exposure has been terminated through the means required by clause (i) of this subparagraph. (iii) The operator shall be able to terminate the x-ray exposure at any time during a scan or series of scans under CT x-ray system control, of greater than 0.5 second duration. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of operation prior to initiation of another scan. (E) Additional requirements applicable to CT x-ray systems containing a gantry manufactured after September 3, 1985 are as follows. (i) The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 mm. (ii) If the x-ray production period is less than 0.5 second, the indication of x-ray production shall be actuated for at least 0.5 second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible. (iii) The deviation of indicated scan increment versus actual increment shall not exceed ñ1 mm with any mass from 0 to 100 kilograms (kg) resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment can be taken anywhere along this travel. (2) Facility design requirements shall include the following. (A) Provision shall be made for two-way aural communication between the patient and the operator at the control panel. (B) Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel. When the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system. (3) Dose measurements of the radiation output of the CT x-ray system shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics as follows. (A) Performance of the measurements shall be: (i) at intervals not to exceed 12 months; (ii) when major maintenance, except x-ray tube replacement, that could affect radiation output is performed; and (iii) when a major change in equipment operation (e.g. introduction of a new software package) is accomplished. (B) Measurements of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The dosimetry system shall have been calibrated within the preceding 24 months and shall be traceable to a national standard. During the calendar year in which the dosimetry system is not calibrated, an intercomparison to a system calibrated within the previous 12 months shall be performed. (C) Records of dose measurements shall be maintained by the registrant in accordance with subsection (cc)(2) of this section. (4) A maintenance schedule shall be developed in accordance with the manufacturer's United States Department of Health and Human Services maintenance schedule. The schedule shall include but may not be limited to the following: (A) dose measurements required by paragraph (3)(A) of this subsection; and (B) acquisition of images obtained with phantoms using the same processing mode and CT conditions of operation as are used to perform dose measurements required by paragraph (3)(A) of this subsection. The registrant shall retain either of the following in accordance with subsection (cc)(2) of this section for inspection by the agency: (i) photographic copies of the images obtained from the image display device; or (ii) images stored in digital form. (w) Requirements for bone densitometers. Bone densitometers shall be exempt from this chapter except for the following: (1) sec.289.112 of this title, sec.289.114 of this title, sec.289.201 of this title, sec.289.202 of this title, sec.289.204 of this title, and sec.289.226 of this title; (2) purpose and scope in accordance with subsection (a)(1) and (2) of this section; (3) prohibitions in accordance with subsection (b)(1) and (2) of this section; (4) exemptions in accordance with subsection (c) of this section; (5) definitions in accordance with subsection (d) of this section, as applicable; (6) operating and safety procedures in accordance with subsection (e)(2) of this section; (7) records in accordance with subsection (e)(5) and of this section; (8) operator credentialing in accordance with subsection (e)(6) of this section; (9) healing arts screening and medical research in accordance with subsection (f) of this section; (10) gonadal shielding in accordance with subsection (i)(4) of this section; (11) record requirements for mobile services in accordance with subsection (n)(1)(A)-(D) and (G) of this section and subsection (n)(2)(A)-(G) of this section; (12) record requirements for authorized use locations in accordance with subsection (n)(3)(A)-(I) and (Q) of this section; and (13) warning labels in accordance with subsection (o). (x) X-ray therapy equipment operating below 500 kV for all facilities. (1) Equipment requirements are as follows. (A) When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the values specified at the distance stated for the classification of that x-ray system shown in the following Table III. Figure 7: 25 TAC sec.289.227(x)(1)(A) (B) Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or a higher degree of protection as required for the tube housing assembly. (C) Removable and adjustable beam-limiting devices shall be as follows. (i) Removable beam-limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than 1.0% of the useful beam at the maximum kV and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient. (ii) Adjustable beam-limiting devices installed before March 1, 1989, shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than 5.0% of the useful beam at the maximum kV and maximum treatment filter. (iii) Adjustable beam-limiting devices installed after March 1, 1989, shall meet the requirements of clause (i) of this subparagraph. (D) The filter system shall be so designed that: (i) the filters cannot be accidentally displaced at any possible tube orientation; (ii) for equipment installed after March 1, 1989, an interlock system prevents irradiation if the proper filter is not in place; (iii) the radiation at 5 cm from the filter insertion slot opening does not exceed 30 (R/hr) under any operating conditions; and (iv) each filter is marked as to its material of construction and its thickness. For wedge filters, the wedge angle shall appear on the wedge or wedge tray. (E) The tube housing assembly shall be capable of being immobilized for stationary treatments. (F) The tube housing assembly shall be so marked that it is possible to determine the location of the focal spot to within 5 mm, and such marking shall be readily accessible for use during calibration procedures. (G) Contact therapy tube housing assemblies shall have a removable shield of at least 0.5 mm lead equivalency at 100 kVp that can be positioned over the entire useful beam exit port during periods when the beam is not in use. (H) The timer shall: (i) have a display provided at the treatment control panel and a pre-set time selector; (ii) activate with the production of radiation and retain its reading after irradiation is interrupted. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to zero; (iii) terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation; (iv) permit selection of exposure times as short as one second; (v) not permit an exposure if set at zero; (vi) not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer factor to compensate for mechanical lag; and (vii) be accurate to within 1.0% of the selected value or one second, whichever is greater. (I) The control panel, in addition to the displays required in other provisions of this subsection, shall have the following: (i) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible; (ii) an indication of whether x rays are being produced; (iii) means for indicating x-ray tube potential and current; (iv) means for terminating an exposure at any time; (v) a locking device that will prevent unauthorized use of the x-ray system (a computerized pass-word system would also constitute a locking device); (vi) for x-ray systems manufactured after March 1, 1989, a positive display of specific filters in the beam; and (vii) all emergency buttons/switches shall be clearly labeled as to their functions. (J) When a control panel may energize more than one x-ray tube, the following shall apply: (i) it shall be possible to activate only one x-ray tube at any time; and (ii) there shall be an indication at the control panel identifying which x-ray tube is activated. (K) There shall be means of determining initially the SSD to within 1 cm and of reproducing this measurement to within 2 mm thereafter. (L) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. After the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel. An indication of shutter position shall appear at the control panel. (M) Each x-ray system equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and at the control panel. (2) Facility design requirements for x-ray systems capable of operating above 50 kVp. (A) Provision shall be made for two-way aural communication between the patient and the operator at the control panel. However, where excessive noise levels or treatment requirements make aural communication impractical, other methods of communication shall be used. (B) Windows, mirrors, closed-circuit television, or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel. (i) When the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system. (ii) Should both systems described in clause (i) of this subparagraph fail or be inoperative, treatment shall not be performed with the unit until one of the systems is restored. (3) Additional requirements for x-ray systems capable of operation above 150 kVp. (A) All protective barriers shall be fixed except for entrance doors or beam interceptors. (B) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room. (C) Interlocks shall be provided such that all entrance doors must be closed, including doors to any interior booths, before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel. When any door is opened while the x-ray tube is activated, the exposure at a distance of 1 m from the source shall be reduced to less than 100 mR/hr. (4) Surveys, calibrations, spot checks, and operating procedures. (A) Surveys shall be performed as follows. (i) All new facilities, and existing facilities not previously surveyed, shall have a survey made by a licensed medical physicist with a specialty in therapeutic radiological physics or medical health physics. Additional surveys shall be done after any change in the facility, facility design, or equipment that might cause a significant increase in radiation hazard. (ii) The registrant shall obtain a written report of the survey from the licensed medical physicist. A copy of the initial report and all subsequent reports shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (iii) The survey and report shall indicate all instances where the installation is in violation of applicable rules or regulations. (B) Calibrations shall be performed as follows. (i) The calibration of a therapy system shall be performed at intervals not to exceed one year and after any change or replacement of components that could cause a change in the radiation output. The calibrations shall be such that the dose at a reference point in a water or plastic phantom can be calculated to within an uncertainty of 5.0%. (ii) The calibration of the radiation output of the therapy system shall be performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during such calibration. (iii) The calibration of the therapy system shall include, but not be limited to, the following determinations: (I) verification that the therapy system is operating in compliance with the design specifications; (II) HVL for each kV setting and filter combination used; (III) the exposure rates as a function of field size, technique factors, filter, and treatment distance used; and (IV) the degree of congruence between the radiation field and the field indicated by the localizing device if such device is present that shall be within 5 mm for any field edge. (iv) Calibration of the radiation output of a therapy system shall be performed with a calibrated dosimetry system. The dosimetry system shall be calibrated within the previous 24 months and shall be traceable to a national standard. During the calendar year in which the dosimetry system is not calibrated, an intercomparison to a system calibrated within the previous 12 months shall be performed. (v) Records of calibration measurements under subparagraph (B) of this paragraph shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (vi) A copy of the latest calibrated absorbed dose rate measured on a particular therapy system shall be available at a designated area within the therapy facility housing that therapy system. (C) Spot checks shall be performed on therapy systems capable of operation at greater than 150 kVp. Such measurements shall meet the following requirements. (i) The spot check procedures shall be in writing and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics. (ii) If a licensed medical physicist does not perform the spot check measurements, the results of the spot check measurements shall be reviewed by a licensed medical physicist with a specialty in therapeutic radiological physics within five treatment days and a record made of the review. If the output varies by more than 5.0% from the expected value, a licensed medical physicist shall be notified immediately. (iii) The spot check procedures shall specify the frequency that tests or measurements are to be performed and that the spot check shall be performed during the calibration specified in subparagraph (B) of this paragraph. The acceptable tolerance for each parameter measured when compared to the value for that parameter determined in the calibration specified in subparagraph (B) of this paragraph shall be stated. (iv) The written spot check procedures shall include special operating instructions that shall be carried out whenever a parameter in clause (iii) of this subparagraph exceeds an acceptable tolerance. (v) Whenever a spot check indicates a significant change in the operating characteristics of a system, as specified in the procedures, the system shall be recalibrated, as required in subparagraph (B) of this paragraph. (vi) Records of spot check and any necessary corrective actions shall be maintained by the registrant in accordance with subsection (cc)(2) of this section. A copy of the most recent spot check shall be available at a designated area within the therapy facility housing that therapy system. (vii) When a spot check involves a radiation measurement, such measurement shall be obtained using a system satisfying the requirements of subparagraph (B)(iv) of this paragraph or that has been intercompared with a system meeting those requirements within the previous year. (D) Operating procedures shall include the following. (i) Therapy systems shall not be left unattended unless the system is secured against unauthorized use. (ii) When a patient or port film must be immobilized in position for radiation therapy, mechanical supporting or restraining devices shall be used. (iii) The tube housing assembly shall not be held by hand during operation unless the system is designed to require such holding and the peak tube potential of the system does not exceed 50 kVp. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 mm lead equivalency at 100 kVp. (iv) No individual other than the patient shall be in the treatment room unless such individual is protected by a barrier sufficient to meet the requirements of sec.289.202(n) of this title. No individual other than the patient shall be in the treatment room during exposures from therapy systems operating above 150 kVp. (v) The therapy system shall not be used in the administration of radiation therapy unless the requirements of subparagraphs (B) and (C)(v) of this paragraph have been met. (vi) In addition to the operating procedures in clauses (i)-(v) of this subparagraph, the general operational control requirements of subsection (e)(2)- (6) of this section shall apply. (y) X-ray and electron beam therapy equipment operating at 500 kV and above for all facilities. Section 289.119 of this title (relating to Radiation Safety Requirements for Particle Accelerators) shall apply to medical facilities using therapy systems with energies 500 kV and above, except that area monitors required by 35.11(c) of TRCR Part 35 as adopted by reference in sec.289.119 of this title shall be functionally tested at intervals not to exceed one year. (1) Equipment requirements are as follows. (A) For operating conditions producing maximum leakage radiation, the absorbed dose in rads due to leakage radiation, including x rays, electrons, and neutrons, at any point in a circular plane of 2 m radius centered on and perpendicular to the central axis of the beam at the isocenter or normal treatment distance and outside the maximum useful beam size shall not exceed 0.1% of the maximum absorbed dose in rads of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface. Measurements excluding those for neutrons shall be averaged over an area up to, but not exceeding, 100 cm2 at the positions specified. Measurements of the portion of the leakage radiation dose contributed by neutrons shall be averaged over an area up to, but not exceeding, 200 cm2. For each system, the registrant shall determine or obtain from the manufacturer the leakage radiation existing at the positions specified for the specified operating conditions. Records on leakage radiation measurements shall be maintained in accordance with subsection (cc)(2) of this section for inspection by the agency. (B) Adjustable or interchangeable beam-limiting devices shall be provided and such devices shall transmit no more than 4.0% of the useful photon beam at the normal treatment distance for the portion of the useful beam that is to be attenuated by the beam-limiting device. The neutron component of the useful beam shall not be included in this requirement. (C) Filter requirements shall be as follows. (i) Each filter that is removable from the system shall be clearly marked with an identification number. Documentation available at the control panel shall contain a description of the filter. For wedge filters, the wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge tray is damaged, the wedge transmission factor shall be redetermined. (ii) If the absorbed dose rate data required by subparagraph (P) of this paragraph relates exclusively to operation with a field-flattening filter or beam scattering foil in place, such filter shall be removable only by the use of tools. (iii) For new equipment that utilizes a system of wedge filters, interchangeable field-flattening filters, or interchangeable beam scattering foils, the following shall apply: (I) irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically; (II) an interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position; (III) a display shall be provided at the treatment control panel showing the beam quality in use; and (IV) an interlock shall be provided to prevent irradiation if any filter selection operation carried out in the treatment room does not agree with the filter selection operation carried out at the treatment control panel. (D) Beam quality. The registrant shall determine data sufficient to assure that the following beam quality requirements in tissue equivalent material are met. (i) The absorbed dose resulting from x rays in a useful electron beam at a point on the central axis of the beam 10 cm greater than the practical range of the electrons shall not exceed the values stated in the following Table IV. Linear interpolation shall be used for values not stated. Figure 8: 25 TAC sec.289.227(y)(1)(D)(i) (ii) Compliance with clause (i) of this subparagraph shall be determined using: (I) a measurement within a tissue equivalent phantom with the incident surface of the phantom at the normal treatment distance and normal to the central axis of the beam; (II) a field size of 10 cm by 10 cm; and (III) a phantom whose cross-sectional dimensions exceed the measurement radiation field by at least 5 cm and whose depth is sufficient to perform the required measurement. (iii) The absorbed dose at a surface located at the normal treatment distance, at the point of intersection of that surface with the central axis of the useful beam during x-ray irradiation, shall not exceed the limits stated in the following Table V. Linear interpolation shall be used for values not stated. Figure 9: 25 TAC sec.289.227(y)(1)(D)(iii) (iv) Compliance with clause (iii) of this subparagraph shall be determined by measurements made: (I) within a tissue equivalent phantom using an instrument that will allow extrapolation to the surface absorbed dose; (II) using a phantom whose size and placement meet the requirements of clause (ii) of this subparagraph; (III) after removal of all beam modifying devices that can be removed without the use of tools, except for beam scattering or beam-flattening filters; and (IV) using the largest field size available that does not exceed 15 cm by 15 cm. (E) All therapy systems shall be provided with radiation detectors in the radiation head. These shall include the following as appropriate. (i) New equipment shall be provided with at least two independent radiation detectors. The detectors shall be incorporated into two independent dose monitoring systems. (ii) Existing equipment shall be provided with at least one radiation detector. This detector shall be incorporated into a primary dose monitoring system. (iii) The detector and the system into which that detector is incorporated shall meet the following requirements. (I) Each detector shall be removable only with tools and shall be interlocked to prevent incorrect positioning. (II) Each detector shall form part of a dose monitoring system from whose readings in dose monitor units the absorbed dose at a reference point in the treatment volume can be calculated. (III) Each dose monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation. (IV) For new equipment, the design of the dose monitoring systems shall assure that the malfunctioning of one system shall not affect the correct functioning of the secondary system; and failure of any element common to both systems that could affect the correct function of both systems shall terminate irradiation. (V) Each dose monitoring system shall have a legible display at the treatment control panel. For new equipment, each display shall: (-a-) maintain a reading until intentionally reset to zero; (-b-) have only one scale and no scale multiplying factors; (-c-) utilize a design such that increasing dose is displayed by increasing numbers and shall be so designed that, in the event of an overdosage of radiation, the absorbed dose may be accurately determined; and (-d-) in the event of power failure, the dose monitoring information shall be retained by at least one system for a 20-minute period of time. (F) In new equipment inherently capable of producing useful beams with unintentional asymmetry exceeding 5.0%, the asymmetry of the radiation beam in two orthogonal directions shall be monitored before the beam passes through the beam-limiting device. If the difference in dose rate between one region and another region symmetrically displaced from the central axis of the beam exceeds 5.0% of the central axis dose rate, indication of this condition shall be at the control panel; and if this difference exceeds 10% of the central axis dose rate, the irradiation shall be terminated. (G) Selection and display of dose monitor units shall be as follows. (i) Irradiation shall not be possible until a selection of a number of dose monitor units has been made at the treatment control panel. (ii) The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation. (iii) After termination of irradiation, it shall be necessary to reset the dosimeter display to zero before subsequent treatment can be initiated. (iv) For new equipment, after termination of irradiation, it shall be necessary to manually reset the pre-selected dose monitor units before irradiation can be initiated. (H) Termination of irradiation by the dose monitoring system or systems during stationary beam therapy shall be as follows. (i) Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system. (ii) If original design of the equipment includes a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15% or 40 dose monitor units, whichever is smaller, above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system. (iii) For new equipment, a secondary dose monitoring system shall be present. That system shall be capable of terminating irradiation when not more than 10% or 25 dose monitoring units, whichever is smaller, above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system. (iv) For new equipment, an indicator on the control panel shall show which dose monitoring system has terminated irradiation. (I) A locking device shall be provided in the system to prevent unauthorized use of the x-ray system. A computerized pass-word system would also constitute a locking device. (J) It shall be possible to interrupt irradiation and equipment movements at any time from the operator's position at the treatment control panel. Following an interruption, it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre- selected value during an interruption, irradiation and equipment movements shall be automatically terminated. (K) It shall be possible to terminate irradiation and equipment movements or go from an interruption condition to termination conditions at any time from the operator's position at the treatment control panel. (L) The following requirements shall apply to timers. (i) A timer that has a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator. (ii) The timer shall be a cumulative timer that activates with the production of radiation and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to zero. (iii) For new equipment, after termination of irradiation and before irradiation can be reinitiated, it shall be necessary to manually reset the pre-set time selector. (iv) The timer shall terminate irradiation when a preselected time has elapsed if the dose monitoring systems have not previously terminated irradiation. (M) Equipment capable of producing more than one beam quality shall meet the following additional requirements. (i) Irradiation shall not be possible until a selection of radiation type has been made at the treatment control panel. (ii) An interlock system shall be provided to: (I) ensure that the equipment can emit only the radiation type that has been selected; (II) prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel; (III) prevent irradiation with x-rays except to obtain a port film when electron applicators are fitted; and (IV) prevent irradiation with electrons when accessories specific for x-ray therapy are fitted. (iii) The radiation type selected shall be displayed at the treatment control panel before and during irradiation. (N) Equipment capable of generating radiation beams of different energies shall meet the following requirements. (i) Irradiation shall not be possible until a selection of energy has been made at the treatment control panel. (ii) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel. (iii) The nominal energy value selected shall be displayed at the treatment control panel before and during irradiation. (O) Equipment capable of both stationary beam therapy and moving beam therapy shall meet the following requirements. (i) Irradiation shall not be possible until a selection of stationary beam therapy or moving beam therapy has been made at the treatment control panel. (ii) An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected. (iii) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel. (iv) The mode of operation shall be displayed at the treatment control panel. (v) For new equipment, an interlock system shall be provided to terminate irradiation if movement of the gantry occurs during stationary beam therapy or stops during moving beam therapy unless such stoppage is a preplanned function. (vi) Moving beam therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement. (I) For new equipment, an interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of arc differs by more than 20% from the selected value. (II) For new equipment, where gantry angle terminates the irradiation in arc therapy, the dose monitor units shall differ by less than 5.0% from the value calculated from the absorbed dose per unit angle relationship. (vii) Where the dose monitor system terminates the irradiation in moving beam therapy, the termination of irradiation shall be as required by subparagraph (H) of this paragraph. (P) For new equipment, a system shall be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated. The radiation detectors specified in subparagraph (E) of the paragraph may form part of this system. In addition, the dose monitor unit rate shall be displayed at the treatment control panel. If the equipment can deliver under any conditions an absorbed dose rate at the normal treatment distance more than twice the maximum value specified by the manufacturer for any machine parameters utilized, a device shall be provided that terminates irradiation when the absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be in a record maintained by the registrant. (Q) The registrant shall determine, or obtain from the manufacturer, the location with reference to an accessible point on the radiation head of the x- ray target or the virtual source of x-rays and the electron window or the virtual source of electrons if the system has electron beam capabilities. (R) Capabilities shall be provided so that all radiation safety interlocks can be checked for correct operation. (2) Facility and shielding requirements. The following design requirements shall apply. (A) All protective barriers shall be fixed except for entrance doors or beam interceptors. (B) The control panel shall be located outside the treatment room and all emergency buttons/switches shall be clearly labeled as to their functions. (C) Windows, mirrors, closed-circuit television, or an equivalent system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the control panel. When the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system. (D) Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel independent of the particle accelerator. However, where excessive noise levels or treatment requirements make aural communication impractical, other methods of communication shall be used. When this is the case, a description of the alternate method shall be submitted to and approved by the agency. (E) Treatment room entrances shall be provided with a warning light in a readily observable position near the outside of all access doors to indicate when the useful beam is "on". (F) Interlocks shall be provided such that all entrance doors must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel. (3) Operational requirements shall include the following. (A) The services of a licensed medical physicist with a specialty in therapeutic radiological physics shall be utilized in facilities having therapy systems with energies of 500 kV and above. (i) The physicist shall be responsible for: (I) calibration of radiation machines; (II) supervision and review of beam and clinical dosimetry; (III) measurement, analysis, and tabulation of beam data; (IV) establishment of quality assurance procedures and performance of spot check review; and (V) review of absorbed doses delivered to patients. (ii) The licensed medical physicist described in clause (i) of this subparagraph shall also be available and responsive to immediate problems or emergencies. (B) Surveys shall include the following. (i) All new facilities and existing facilities not previously surveyed shall have a survey made by a licensed medical physicist with a specialty in therapeutic radiological physics or medical health physics. In addition, such surveys shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard. (ii) The registrant shall obtain a written report of the survey and a copy of the report shall be maintained for inspection by the agency. (iii) The survey and report shall indicate all instances where the installation, in the opinion of the licensed medical physicist, is in violation of applicable regulations. (C) Calibrations shall include the following. (i) The calibration of systems subject to this subsection shall be performed in accordance with an established calibration protocol before the system is first used for irradiation of a patient and thereafter at time intervals that do not exceed 12 months and after any change that might significantly alter the calibration, spatial distribution, or other characteristics of the therapy beam. The calibration procedures shall be performed in accordance with established protocol, shall be in writing, and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics. The calibration protocol entitled, "A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams," Task Group 21, Radiation Therapy Committee, American Association of Physicists in Medicine, Medical Physics 10(6): 741-771, Nov/Dec 1983, is accepted as an established protocol. (ii) The calibration shall be performed by a licensed medical physicist with a specialty in therapeutic radiological physics who is physically present at the facility during the calibration. (iii) Calibration radiation measurements required by clause (i) of this subparagraph shall be performed using a dosimetry system: (I) having a calibration factor for cobalt-60 gamma rays traceable to a national standard; (II) that has been calibrated within the previous 24 months and after any servicing that may have affected its calibration. During the calendar years in which the dosimetry system is not calibrated, an intercomparison to a system calibrated within the previous 12 months shall be performed; (III) that has been calibrated in such a fashion that an uncertainty can be stated for the radiation quantities monitored by the system; and (IV) that has had constancy checks performed on the system as specified by the licensed medical physicist with a specialty in therapeutic radiological physics. (iv) Calibrations shall be in sufficient detail that the dose at a reference point in a tissue equivalent phantom can be calculated to within an uncertainty of 5.0%. (v) The calibration of the therapy unit shall include, but not be limited to, the following determinations. (I) Verification that the equipment is operating in compliance with the design specifications concerning the light field, patient positioning lasers, and back- pointer lights with the isocenter when applicable, variation in the axis of rotation for the table, gantry, and collimator system, and beam flatness and symmetry at the specified depth. (II) The absorbed dose rate at various depths in a tissue equivalent phantom for the range of field sizes used, for each effective energy, that will verify the accuracy of the dosimetry of all therapy procedures utilized with that therapy beam. (III) The uniformity of the radiation field to include symmetry, flatness, and dependence on gantry angle. (IV) Verification that existing isodose charts applicable to the specific machine continue to be valid or are updated to existing machine conditions. (V) Verification of transmission factors for all accessories such as wedges, block trays, and/or universal and custom made beam modifying devices. (vi) Records of calibration measurements under clause (i) of this subparagraph and dosimetry system calibrations under clause (iii) of this subparagraph shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (vii) A copy of the latest calibrated absorbed dose rate measured in accordance with clause (i) of this subparagraph shall be available at a designated area within the therapy facility housing that therapy system. (D) Spot checks shall be performed on systems subject to this subsection during calibrations and thereafter at weekly intervals with the period between spot checks not to exceed five treatment days. Such radiation output measurements shall meet the following requirements. (i) The spot check procedures shall be performed in accordance with established protocol, shall be in writing, and shall have been developed by a licensed medical physicist with a specialty in therapeutic radiological physics. The spot check protocol entitled, "Comprehensive QA for Radiation Oncology," Task Group 40, Radiation Therapy Committee, American Association of Physicists in Medicine, Medical Physics 21(4), April, 1994, is accepted as an established protocol. (ii) If a licensed medical physicist does not perform the spot check measurements, the results of the spot checks measurements shall be reviewed by a licensed medical physicist within three treatment days and a record kept of the review. If the output varies by more than 3.0% from the expected value, a licensed medical physicist shall be notified immediately. (iii) The spot check procedures shall specify the frequency at which tests or measurements are to be performed and the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration. (iv) Where a system has built-in devices that provide a measurement of any parameter during irradiation, such measurement shall not be utilized as a spot check measurement. (v) A parameter exceeding a tolerance set by a licensed medical physicist shall be corrected before the system is used for patient irradiation. (vi) Whenever a spot check indicates a significant change in the operating characteristics of a system, as specified in a licensed medical physicist's written procedures, the system shall be recalibrated, as required in subparagraph (C) of this paragraph. (vii) Records of spot check measurements and any necessary corrective actions shall be maintained by the registrant in accordance with subsection (cc)(2) of this section for inspection by the agency. (viii) When a spot check involves a radiation measurement, such measurement shall be obtained using a system satisfying the requirements of subparagraph (C)(iii) of this paragraph or that has been intercompared with a system meeting those requirements within the previous year. (E) Operating procedures shall include the following. (i) No individual other than the patient shall be in the treatment room during treatment of a patient. (ii) If a patient or port film must be immobilized in position during treatment, mechanical supporting or restraining devices shall be used. (iii) The system shall not be used in the administration of radiation therapy unless the requirements of subparagraphs (A)-(D) of this paragraph have been met. (iv) In addition to the operating procedures listed above, the general requirements of subsection (e)(2)-(6) of this section shall apply. (z) Radiation therapy simulators. (1) Radiation therapy simulators are exempt from this chapter except for the following: (A) sec.289.112 of this title, sec.289.114 of this title, sec.289.201 of this title, sec.289.202 of this title, sec.289.204 of this title, and sec.289.226 of this title; (B) purpose and scope in accordance with subsection (a)(1) and (2) of this section; (C) prohibitions in accordance with subsection (b) of this section; (D) exemptions in accordance with subsection (c) of this section; (E) definitions in accordance with subsection (d) of this section, as applicable; (F) technique charts in accordance with subsection (e)(1) of this section; (G) operating and safety procedures in accordance with subsection (e)(2) of this section; (H) protective devices in accordance with subsection (e)(4) of this section; (I) records in accordance with subsection (e)(5) of this section; (J) operator credentialing in accordance with subsection (e)(6) of this section; (K) viewing systems in accordance with subsection (i)(1) of this section; (L) x-ray control in accordance with subsection (i)(2) of this section; (M) record requirements for authorized use locations as applicable in accordance with subsection (n)(3) of this section; and (N) warning labels in accordance with subsection (o) of this section. (2) Additional requirements for radiation therapy simulators used in the general radiographic mode of operation. (A) Beam quality (HVL) shall be in accordance with subsection (o)(5)(A)(i) of this section. (B) Technique and exposure indicators shall be in accordance with subsection (o)(7)(A), (C), and (D) of this section. (C) Beam limitation shall be as follows. (i) The beam limiting device (collimator) shall restrict the useful beam to the area of clinical interest. (ii) A method shall be provided to visually define the center (cross-hair centering) of the x-ray field to within a 2 mm diameter. (iii) The beam limiting device (collimator) shall numerically indicate the field size. (iv) When an optical distance indicator (ODI) is present, it shall be accurate to within 2 mm. (v) When field delineator wires are present, the coincidence with the x-ray field shall be within 2 mm. (D) X-ray control shall be in accordance with subsection (s)(2)(A) of this section. (E) Timers shall be in accordance with subsection (s)(2)(B) of this section. In addition, a visual and/or audible signal shall indicate when an exposure has been terminated. (F) AEC shall be in accordance with subsection (s)(2)(C)(i) of this section. (G) Timer reproducibility shall be in accordance with subsection (s)(2)(D) of this section. (H) Exposure reproducibility shall be in accordance with subsection (s)(4) of this section. (I) Linearity shall be in accordance with subsection (s)(5) of this section. (3) Additional requirements for radiation therapy simulators utilizing fluoroscopic capabilities are as follows. (A) Activation of the fluoroscopic tube shall be in accordance with subsection (r)(2) of this section. (B) Indication of potential and current shall be in accordance with subsection (r)(4) of this section. (C) The SSD shall be in accordance with subsection (r)(5)(D) of this section. (D) Fluoroscopic timers shall be in accordance with subsection (r)(6) of this section. (E) Simulators must duplicate the geometric conditions of the radiation therapy equipment plan and therefore spot checks regarding geometric conditions shall be performed in accordance with subsection (y)(3)(D)(i) of this section. (aa) Therapy misadministrations. (1) Misadministrations involving equipment operating at 500 kV and below shall be reported when: (A) it involves the wrong individual, wrong mode of treatment, or wrong treatment site; (B) the treatment consists of three or fewer fractions and the calculated total administered dose differs form the total prescribed dose by more than 10% of the total prescribed dose; (C) the calculated weekly administered dose exceeds the weekly prescribed dose by 30% or more; or (D) the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose. (2) Misadministrations involving equipment operating above 500 kV shall be reported when: (A) it involves the wrong individual, wrong mode of treatment, or wrong treatment site; (B) the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose; (C) the calculated weekly administered dose exceeds the weekly prescribed dose by 30% or more; or (D) the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose. (bb) Records, notices, and reports of misadministrations. (1) For a misadministration, a registrant shall: (A) notify the agency by telephone no later than 24 hours after discovery of the misadministration; (B) notify the referring physician and also notify the patient of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the patient or that, based on medical judgement, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant shall notify the patient as soon as possible thereafter. The registrant may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification; (C) submit a written report to the agency within 15 days after the discovery of the misadministration. The report must not include the patient's name or other information that could lead to identification of the patient. The written report must include the following: (i) registrant's name; (ii) prescribing physician's name; (iii) a brief description of the event; (iv) why the event occurred; (v) the effect on the patient; (vi) what improvements are needed to prevent recurrence; (vii) actions taken to prevent recurrence; (viii) whether the registrant notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as "the patient"; and if not, why not; and (ix) if the patient was notified, what information was provided to the patient; and (D) furnish the following to the patient within 15 days after discovery of the misadministration if the patient was notified: (i) a copy of the report that was submitted to the agency; or (ii) a brief description of both the event and the consequences, as they may affect the patient, provided a statement is included that the report submitted to the agency can be obtained from the registrant. (2) Each registrant shall retain a record of each misadministration in accordance with subsection (cc)(2) of this section. The record shall contain the following: (A) the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician; (B) the patient's social security number or identification number if one has been assigned; (C) a brief description of the misadministration; (D) why it occurred; (E) the effect on the patient; (F) what improvements are needed to prevent recurrence; and (G) the actions taken to prevent recurrence. (3) Aside from the notification requirement, nothing in subsection (aa) of this section and paragraphs (1) and (2) of this subsection shall affect any rights or duties of registrants, and physicians in relation to each other, patients, or the patient's responsible relatives or guardians. (cc) Appendices. (1) Information to be submitted by persons proposing to conduct healing arts screening. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation. (A) Administrative controls shall include the following: (i) the name and address of the applicant and, where applicable, the names and addresses of agents within Texas; (ii) the diseases or conditions for which the x-ray examinations are to be used in diagnoses; (iii) a detailed description of the x-ray examinations proposed in the screening program; (iv) a description of the population to be examined in the screening program (i.e., age, sex, physical condition, and other appropriate information); and (v) an evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x-ray examination. (B) Operating procedures for all x-ray systems (except bone densitometers) shall include the following: (i) an evaluation of the x-ray systems to be used in the screening program. The evaluation shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics. The evaluation shall show that such systems do satisfy all requirements of this section; (ii) a description of the diagnostic film quality control program; and (iii) a copy of the technique chart for the x-ray examination procedures to be used. (C) Operating procedures for bone densitometers shall include the manufacturer's evaluation of the system to be used in the screening program. The evaluation shall show that such systems do satisfy all requirements of this section. (D) Training data shall include the following: (i) the qualifications of each individual who will be operating the x-ray systems; (ii) the qualifications of the individual who will be supervising the operators of the x-ray systems. The extent of supervision and the method of work performance evaluation shall be specified; and (iii) the name and address of the practitioner who will interpret the radiographs. (E) Records shall include the following: (i) a description of the procedures to be used in advising the individuals screened, and their private practitioners of the healing arts, of the results of the screening procedure and any further medical needs indicated; and (ii) a description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations. (2) Retention requirements for record keeping. Figure 10: 25 TAC sec.289.227(cc)(2) (3) Operating and safety procedures. The registrant's operating and safety procedures shall include, but are not limited to, the following procedures as applicable: (A) use of a technique chart in accordance with subsection (e)(1) of this section; (B) radiation dose requirements in accordance with sec.289.202(f), (j), and (l)- (n) of this title; (C) personnel monitoring requirements in accordance with sec.289.202(p)-(r) of this title; (D) use of protective devices in accordance with subsections (e)(4), (i)(3), (j)(2), (k)(5)(B), (r)(7), and (x)(4)(D)(iii) of this section; (E) credentialing requirements for individuals operating radiation machines in accordance with subsection (e)(6) of this section; (F) exposure of individuals other than the patient in accordance with subsections (i)(3), (k)(5), (x)(4)(D)(iv), and (E)(i) of this section; (G) gonadal shielding in accordance with subsection (i)(4) of this section; (H) holding of patients, film, or animals in accordance with subsections (i)(5), (j)(1) and (3), (k)(5), (x)(4)(D)(ii), and (y)(3)(E)(ii) of this section; (I) film processing program in accordance with subsections (l)-(m) of this section; (J) control of scattered radiation in accordance with subsection (r)(7) of this section; (K) use of 20 cm SSD (spacers) in accordance with subsection (r)(5)(D) of this section; (L) procedures for restriction and alignment of beam in accordance with subsections (r)(1), (s)(1), (t)(2)(B) and (C), and (u)(2) of this section; (M) posting notices to workers in accordance with 22.11 of TRCR Part 22 as adopted by reference in sec.289.114 of this title; (N) instructions to workers in accordance with TRCR Part 22.12 as adopted by reference in sec.289.114 of this title; (O) notifications and reports to individuals in accordance with 22.13 of TRCR Part 22 as adopted by reference in sec.289.114 of this title; (P) ordering x-ray exams in accordance with sec.289.201(a) of this title; and (Q) posting of a radiation area in accordance with sec.289.202(g) of this title. (4) Intervals for equipment performance evaluation. Intervals for equipment performance evaluation shall be in accordance with the following chart: Figure 11: 25 TAC sec.289.227(cc)(4) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804129 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 SUBCHAPTER C.Texas Regulations for Control of Radiation 25 TAC 289.122 The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on March 20, 1998, enters this order finally adopting the repeal of existing sec.289.122 and new sec.289.226, concerning the registration of radiation machine use and services, with changes to the proposed text as published in the December 5, 1997, issue of the Texas Register (22 TexReg 11982), as a result of comments received during the 45-day comment period. The repeal of sec.289.122 is adopted without changes and therefore will not be republished. The section adopted for repeal adopts by reference Part 42, titled "Registration of Radiation Machine Use and Services" of the Texas Regulations for Control of Radiation. The new section incorporates language from Part 42 that has been rewritten in Texas Register format and includes addition and revision of several subsections of the section. The repeal and new section are part of the renumbering phase in the process of rewriting the department's radiation rules in the Texas Register format. The new section reflects the renumbering. The revision is part of the department's ongoing review of the radiation rules to update them in accordance with current practices and technologies. The new section requires that a person who has made application for registration comply with applicable radiation control requirements prior to receiving the certificate of registration. Clarifying language prohibiting exposure of an individual for training, demonstration, or other non-healing arts purposes is added. Language on appropriate authorized signatures for an application is included. The new section will clarify that a certificate of registration must be received before accelerators are activated, including acceptance testing. The requirement to notify the department prior to certain changes in a certificate of registration is deleted and replaced with language allowing notification within 30 days of the change. Requirements for registration of x-ray machines used in clinical trial evaluations and loaner x-ray units are added. Requirements for termination and expiration of certificates of registration are separated to eliminate confusion. Language is added to allow nurse practitioners and physician assistants with appropriate experience to be Radiation Safety Officers (RSO). The requirement for a quarterly audit by an RSO is deleted. Language is also added to indicate that certain services may constitute the practice of medical physics and therefore may require a license from the Texas Board of Licensure for Professional Medical Physicists. The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section. Change: Concerning sec.289.226(a)(2), the department added the following language as the last sentence "Services listed in subsection (a)(3) of this section may constitute the practice of medical physics and, therefore, require a license from the Texas Board of Licensure for Professional Medical Physicists in accordance with the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n" to indicate that certain services may constitute the practice of medical physics and therefore may require a license from the Texas Board of Licensure for Professional Medical Physicists. Change: Concerning sec.289.226(a)(3), the department deleted the word "may" and replaced it with "shall" to indicate that the listed services are considered radiation services and also deleted the word "shall" and replaced it with "may" to indicate that the list of services may not be all-inclusive because of emerging technologies and possible related services. Change: Concerning sec.289.226(a)(3)(E), the department deleted this subparagraph and combined it with sec.289.226(a)(3)(G) for clarification. The department renumbered the subsequent subparagraphs due to the deletion. Change is reflected in sec.289.226(a)(3)(F). Change: Concerning sec.289.226(a)(3)(G), the department added the following words in parenthesis, "i.e., installation, repair, or maintenance" and deleted the words "or repair of radiation machines" for clarification. Change is reflected in sec.289.226(a)(3)(F). Change: Concerning sec.289.226(a)(3)(J), the department deleted the words "(i.e., mobile services)" because the provision of radiation machines on a routine basis to a facility for limited time periods is not considered a mobile service and also added the words "shall be" in place of "is" in the last sentence to emphasize that this requirement must be directed by a licensed practitioner. Change is reflected in sec.289.226(a)(3)(I). Change: Concerning sec.289.226(a)(4), the department added the words "as a physician" following the words "Texas State Board of Medical Examiners" to differentiate from physician's assistants who are also licensed by the Texas State Board of Medical Examiners. Change: Concerning sec.289.226(b)(6), the department added the words "institutions" following the word "academic" and "facilities" following the word "development" for clarification. Change: Concerning sec.289.226(d)(1), the department added language to clarify that mobile services, clinical trial evaluations, and healing arts screening are addressed in other subsections of this section and chapter. Change: Concerning sec.289.226(d)(4), the department added the words "shall be" in place of "are" following the words "operating and safety procedures" to provide emphasis that the procedures must be adequate to minimize danger to public health and safety. Change: Concerning sec.289.226(e), the department added language on consultants, providers of equipment, and radiation services and deleted language referring to "maintenance" and "radiation protection and health physics surveys" to clarify the meaning of radiation services. Change: Concerning sec.289.226(e)(3), the department deleted the existing language and replaced it with language that better defines the requirements for different types of radiation services. Change: Concerning sec.289.226(e)(7), the department added language that better defines the requirements for providers of equipment. Change: Concerning sec.289.226(h)(2), (3), and (6), the department deleted the language pertaining to "providers of equipment" and moved this language to sec.289.226(e)(7) to better clarify radiation services. Change: Concerning sec.289.226(h)(1), the department added the word "institution" following the word "academic" for clarification. Change: Concerning sec.289.226(h)(3), the department added the word "institutions" following the word "academic" for clarification. Change: Concerning sec.289.226(k)(2), the department deleted the word "receipt" to be consistent with the language in sec.289.226(a)(1). Change: Concerning sec.289.226(m)(1)(A), the department added the following language, "This does not relieve the registrant of the responsibility to assure that proper notification has been made," to further delineate the responsibilities of the registrant. Change: Concerning sec.289.226(m)(2), the department added language clarifying the requirements for the registration of loaner x-ray units and units used for clinical trial evaluation. The department renumbered the subsequent paragraphs because of the addition. Change: Concerning sec.289.226(m)(8)(C), the department moved the word "form" to follow "(FDA)" for clarification. Change: Concerning sec.289.226(n)(3), the department deleted language addressing certificates of registration with no expiration date as the department will have dates on all certificates. Change: Concerning sec.289.226(p)(1), the department revised the reference clarifying the items that need to be submitted for a renewal of a certificate of registration. Change: Concerning sec.289.226(q)(1), the department added the words "in this chapter" following "rules" to be consistent with Texas Register language. Change: Concerning sec.289.226(q)(2), the department reformatted this paragraph and deleted the original paragraph for easier readability. Change: Concerning sec.289.226(s)(1)(A)(ii), the department changed the word equipment "registered" to equipment "used" for clarification. Change: Concerning sec.289.226(s)(1)(B), the department added the word "requirements" in place of "categories" for clarification. Change: Concerning sec.289.226(s)(1)(B)(i)(I), the department added the word "with" in place of "that require" for clarification. Change: Concerning sec.289.226(s)(1)(B)(i)(II), the department added the words "with the following" in place of "that require" for clarification. Change: Concerning sec.289.226(s)(1)(B)(i)(II)(-a-) through (-g-)(-2-), (-g-)(- 5-), and (-h-), the department deleted the word "or" following each item or subitem as it was unnecessary. Change: Concerning sec.289.226(s)(1)(B)(ii)(I) and ( II), the department added the word "with" in place of "that require" for clarification. Change: Concerning sec.289.226(s)(1)(B)(iii), the department added the word "institutions" in place of "facilities" for consistency with language in other subsections. Change: Concerning sec.289.226(s)(2)(A), the department reworded the subparagraph for clarification. Change: Concerning sec.289.226(s)(2)(C), the department added the words "determining" and "taking" in place of "to determine" and "to take" for consistency with language throughout the subparagraphs of this paragraph. Change: Concerning sec.289.226(s)(2)(D), the department added the word "keeping" in place of "to keep" for consistency with language throughout the subparagraphs of this paragraph. Change: Concerning sec.289.226(s)(3)(C), the department added the words "registrant" in place of "company" and "valid" before "certificate" for clarification. The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s). Other minor editorial changes were made for clarification purposes. Comment: Concerning the section in general, one commenter stated that sec.289.226 referenced other sections of the chapter but the commenter did not have access to them and these could not be reviewed. Response: The department acknowledges the commenter's concern, however no change was made as a result of the comment. Comment: Concerning the section in general, one commenter stated that the section is difficult to review since the grouping of items was not clearly visible. The commenter proposed that the header for each group indicated by an alpha letter in parentheses be duplicated on top or on the bottom and/or be highlighted. Response: The department agrees with the commenter and will have headers at the top of each page of the section when it is distributed, as was the practice with the previous format. Comment: Concerning the section in general, one commenter suggested it would be practical to issue such rules in a concise small booklet applicable to the sections it addressed like users of diagnostic x-ray units for clinics, hospitals, and specialty groups such as podiatrist, dentists, and so on. Response: The department agrees in part with the commenter and has plans to separate the dental requirements into one section in the future. No change was made as a result of the comment. Comment: Concerning the section in general, one commenter suggested that it would be practical to indicate at the front of the rule or in the appendices where to find periodic or reoccurring tasks such as "dose check on an annual basis" or "protective devices tests." Response: The department disagrees with the commenter. There will be a table of contents accompanying the section when it is distributed to delineate individual subsections but there are no plans to identify specific tasks. No change was made as a result of the comment. Comment: Concerning sec.289.226(a)(3)(A) and (e), one commenter indicated that his professional society had previously corresponded with the bureau chief on their recommendation that licensure of medical physicists by the department of health should satisfy the requirement for registration as required by current Part 42 of the Texas Regulations for Control of Radiation (TRCR). The commenter stated that medical physicists do not service x-ray equipment and are regulated through a separate, professional state board. Response: The department disagrees with the commenter. The Health and Safety Code, sec.401.101 requires that a person using a source of radiation must have a registration from the department. Practitioners of the healing arts and veterinarians are also licensed by separate, professional state boards and are likewise required to register with the agency. No change was made as a result of the comment. Comment: Concerning sec.289.226(b)(6), several commenters expressed that this appears to be a "double standard" exemption for certain facilities to ignore all requirements in sec.289.226(e) and (i) pertaining to expected minimum qualifications of the registrant's service staff. The commenters were concerned that the service company employees must meet certain requirements to service x- ray equipment while "in-house" bio-med employees do not have to meet the same requirements. The commenter stated that the hospital or clinic employee should not have to be registered with the department but indicated that they should be as well trained as the "outside" service company employee. Response: The department agrees in part with the commenters. The intent of sec.289.226(b)(6) was to keep a registered facility with resident physicists or in-house service personnel from having to obtain a separate certificate of registration for their personnel performing service. The department's authority by statute on this issue is limited. The department added language to the radiation safety officer's (RSO) responsibilities in sec.289.226(s)(2)(G) that requires the RSO to ensure that personnel, including those that may service the machines, are "adequately trained." No change other than the change made to sec.289.226(s)(2)(g) was made as a result of the comment. Comment: Concerning sec.289.226(c)(2), one commenter indicated that this requirement requires the RSO to be designated on the application form but does not require his acceptance of those responsibilities as delineated in sec.289.226(s)(2) unless that individual is also the registrant. The commenter urged that the documentation submitted required the acknowledgment of the RSO's responsibility by requiring his/her signature on the application as done in sec.289.226(d)(5). Response: The department disagrees with the commenter. Section 289.226(c) applies to any facility or individual applying for a certificate of registration. In addition to sec.289.226(c), a facility or individual must also comply with subsections sec.289.226(d) through (i) as applicable. These sections require the RSO signature for all applications unless the RSO is also the licensed practitioner or licensed veterinarian. No change was made as a result of the comment. Comment: Concerning sec.289.226(d), one commenter suggested that the department should require submission of the operating and safety procedures (OSP) with the application as required for particle accelerator applicants in sec.289.226(d)(6). The commenter indicated that the OSPs should be reviewed and signed by a licensed medical health physicist. Response: The department disagrees with the commenter. The OSPs are maintained by the registrant and reviewed at inspection. Registrant's are responsible for their OSPs and they may have them reviewed by a licensed medical health physicist should they choose to do so. No change was made as a result of the comment. Comment: Concerning sec.289.226(e)(6), one commenter indicated that this paragraph appeared to be vague in asking for calibration procedures for test equipment. The commenter indicated that this equipment is usually "calibrated" against appropriate standards by an independent calibration facility. The commenter suggested that the "procedures" needed would pertain to installing or repairing the radiation machine and should be provided by the manufacturer. Response: The department agrees with the commenter and has rewritten this paragraph to clarify the meaning of calibration procedures. Comment: Concerning sec.289.226(s)(1)(B)(i)(II)(-e-), (-f-), and (-g-), one commenter was concerned that this requirement would authorize individuals with no formal training in radiation protection and safety to be RSOs. The commenter stated that formal training with examination(s) allowed evaluation of the individual's understanding of the fundamentals of radiation hazards, protection requirements, and safety procedures. The commenter further indicated that without this as a minimum, there is no judgment or evaluation of these individual's knowledge base. The commenter urged the removal of these individuals whose only credentialing for this was experience under someone not specifically trained in radiation safety. The commenter suggested that if satisfactory completion of a formal training program acceptable to the agency was required for these individuals, his opposition would be lessened. Response: The department acknowledges the commenter's concerns. Section 289.226(s)(1)(A) requires that all RSOs meet general requirements including educational courses related to ionizing radiation safety or a radiation safety officer course, experience in the use and familiarity of the type of equipment used, knowledge of potential radiation hazards or emergency precautions, and varying degrees of supervised use of radiation machines depending on the type machine and background of the individual. No change was made as a result of the comments. Commenters included Medical & Radiation Physics, Inc., Mario Wedenmeier, The University of Texas Health Science Center at San Antonio, and the Texas Radiological Society. The commenters were generally in favor of the proposal; however, they presented comments and suggestions for changes to the proposal as previously discussed. The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the board with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804125 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 SUBCHAPTER E.Registration Regulations 25 TAC sec.289.226 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the board with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.289.226 Registration of Radiation Machine Use and Services. (a) Scope and purpose. (1) This section provides for the registration of persons using radiation machines and persons who are in the business of providing radiation machine installation or radiation services. No person shall use radiation machines or perform radiation services except as authorized in a certificate of registration issued by the agency in accordance with the requirements of this section. A person who has made application for registration in accordance with this section and is using a radiation machine prior to receiving a certificate of registration is subject to the requirements of this chapter. (2) In addition to the requirements of this section, all registrants are subject to the requirements of sec.289.112 of this title (relating to Hearing and Enforcement Procedures), sec.289.114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), sec.289.201 of this title (relating to General Provisions), sec.289.202 of this title (relating to Standards for Protection Against Radiation), and sec.289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services). Registrants using radiation machines in industrial radiographic operations are subject to the requirements of sec.289.115 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography); registrants using machines in the healing arts and veterinary medicine are subject to the requirements of sec.289.227 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine); registrants using mammography x-ray equipment are subject to the requirements of sec.289.230 of this title (relating to Certification of Mammography Systems); registrants using analytical x-ray equipment are subject to the requirements of sec.289.118 of this title (relating to Radiation Safety Requirements for Analytical X-Ray Equipment); and registrants using particle accelerators are subject to the requirements of sec.289.119 of this title (relating to Radiation Safety Requirements for Particle Accelerators). If an accelerator is used to produce radioactive materials, a license issued in accordance with sec.289.252 of this title (relating to Licensing of Radioactive Material) is required. Services listed in subsection (a)(3) of this section may constitute the practice of medical physics and, therefore, require a license from the Texas Board of Licensure for Professional Medical Physicists in accordance with the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n. (3) For the purposes of this section, radiation services shall include, but may not be limited to the following: (A) provision of radiation protection or health physics consultations or surveys that require the consultant to operate or cause a radiation machine to be operated in order to make measurements or gather data; (B) presentation of agency-accepted training courses; (C) calibration of radiation machine output; (D) calibration of survey and measurement instruments; (E) demonstration and sales of radiation machines that require the individual to operate or cause a radiation machine to be operated in order to demonstrate or sell; (F) assembly (i.e., installation, repair, or maintenance); (G) provision of personnel monitoring services; (H) performance of equipment performance evaluations on radiation machines; or (I) provision of radiation machines on a routine basis to a facility for limited time periods. For purposes of this section, a person providing the services described in this subparagraph is a provider of equipment. For healing arts facilities, the use of radiation machines shall be directed by a licensed practitioner employed by the contracting facility. (4) For purposes of this section, a practitioner of the healing arts is a person licensed to practice healing arts by either the Texas State Board of Medical Examiners as a physician, the Texas State Board of Dental Examiners, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatry Examiners. (5) Exposure of an individual for training, demonstration, or other non-healing arts purposes is prohibited. (b) Exemptions. (1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this section, provided that the dose equivalent rate averaged over an area of 10 square centimeters (cm2) does not exceed 0.5 millirem per hour (mrem/hr) at 5 centimeters (cm) from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt. (2) Radiation machines in transit or in storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of radiation machines for mobile services. Facilities that have placed all radiation machines in storage, including storage in place, and have notified the agency in writing, are exempt from the requirements of this section. This exemption is void if any radiation machine is energized resulting in the production of radiation. (3) Domestic television receivers and video display terminals, including the servicing of such devices, are exempt from the requirements of this section. (4) Inoperable radiation machines are exempt from the requirements of this section. For the purposes of this section, an inoperable radiation machine means a radiation machine that cannot be energized when connected to a power supply without repair or modification. (5) Financial institutions that take possession of radiation machines as the result of foreclosure, bankruptcy, or other default of payment are exempt from the requirements in this section to the extent that they demonstrate that the unit is operable for the sole purpose of selling, leasing, or transferring. (6) Facilities, including academic institutions and research and/or development facilities, registered for the use of radiation machines are exempt from the registration requirements of subsection (e) of this section and subsection (i) of this section to the extent that their personnel perform radiation services only for the facility by whom they are employed. (c) Application for registration. (1) Application for registration shall be completed on forms prescribed by the agency and shall contain all the information required by the form and accompanying instructions. (2) A radiation safety officer (RSO) shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The RSO shall meet the applicable requirements of subsection (s)(1) of this section and carry out the responsibilities of subsection (s)(2) of this section. (3) The agency may at any time after the filing of the original application require further statements in order to enable the agency to determine whether the certificate of registration should be issued, denied, modified, or revoked. (4) An application for a certificate of registration may include a request for a certificate of registration authorizing one or more activities. Applications for certification of mammography systems must be made separately. (5) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with sec.289.201(n) of this title. (6) Each application for a certificate of registration shall be accompanied by the fee prescribed in sec.289.204 of this title. (7) BRC Form 226-1 shall be submitted with the application to confirm that no tax owed the state under Tax Code, Chapter 171, is delinquent. (d) Application for registration for human or veterinary use of radiation machines. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person having a radiation machine used in healing arts or veterinary medicine shall apply for registration with the agency within 30 days following the commencement of the operation of the radiation machine, except for mobile services that shall be registered in accordance with subsection (g) of this section, clinical trial evaluations that shall be registered in accordance with subsection (m)(2)(B) of this section, and healing arts screening programs that shall be approved in accordance with subsection (f)(1) of sec.289.227 of this title. (2) Each person having an accelerator for human use shall apply for and receive a certificate of registration from the agency before activation, including acceptance testing, of the accelerator. (3) The applicant shall be qualified by reason of training and experience to use the radiation machine(s) for the purpose requested in accordance with this section in such a manner as to minimize danger to public health and safety. (4) The applicant's proposed equipment, facilities, and operating and safety procedures shall be adequate to minimize danger to public health and safety. (5) An application for healing arts must be signed by a licensed practitioner and an application for veterinary medicine must be signed by a licensed veterinarian. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility is a licensed hospital or a medical facility with more than ten radiation machines. The application shall also be signed by the RSO if the RSO is someone other than the licensed practitioner or licensed veterinarian. (6) An application for accelerators for human use must be signed by a practitioner licensed by the Texas State Board of Medical Examiners. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility is a licensed hospital or a medical facility with more than ten radiation machines. The application shall also be signed by the RSO if the RSO is someone other than the licensed practitioner. Each applicant shall submit operating and safety procedures as described in 35.3 and 35.10 of Texas Regulations for Control of Radiation (TRCR) Part 35 as adopted by reference in sec.289.119 of this title, and a description of the proposed facilities in accordance with 35.7-35.9 and 35.12 of TRCR Part 35 as adopted by reference in sec.289.119 of this title. (e) Application for registration of radiation machine assembly, calibration, or repair, consultants, providers of equipment, and radiation services other than providers of personnel monitoring service, agency-accepted training courses, and calibration of survey and measurement instruments. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person who intends to engage in the business of providing radiation services described in subsection (a)(3) of this section shall apply for and receive a certificate of registration from the agency before providing such service. (2) An application for radiation services shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO if the RSO is someone other than the applicant or registrant. (3) The applicant shall submit to the agency written documentation of the specific training and experience that qualifies each individual to discharge the duties of this service. Documentation of each individual's training shall be maintained for inspection by the agency. As a minimum, each applicant shall submit the following: (A) for assembler and/or calibration of x-ray equipment, the qualifications listed in subsection (s)(3) of this section; (B) for all other services, the qualifications listed in subsection (s)(1) (A) of this section. (4) No person shall perform services specified in this subsection that are not specifically authorized by the agency. (5) No person shall perform these machine services, other than initial installation of the first machine on the premises, for an individual who cannot produce evidence of registration with the agency authorizing the possession and use of the machines in question. (6) The applicant shall submit the interval to be followed to calibrate electronic equipment used in radiation machine servicing (e.g., kVp meters, voltmeters). (7) Each applicant for providers of equipment shall submit the following: (A) an established main location where the machine, records, etc. will be maintained for inspection. This must be a street address, not a post office box number; (B) evidence that the healing arts facility responsible for administering or supervising the administering of radiation is registered in accordance with the rules in this section; (C) current copy of the applicant's operating and safety procedures; and (D) a list of facilities where equipment will be provided. (f) Application for registration for provider of personnel monitoring services. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person who intends to provide personnel monitoring services shall apply for and receive a certificate of registration from the agency before providing such services. (2) An application for personnel monitoring services shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO if the RSO is someone other than the applicant or registrant. (3) The applicant shall submit documentation that the facility has been accredited by the National Voluntary Laboratory Accreditation for Personnel Dosimetry Processors of the National Institute of Science and Technology in accordance with accreditation criteria established in 15 Code of Federal Regulations (CFR) Part 7b, as amended. (4) The maximum allowable time delay between the end date of the monitoring period and the date at which processing will not be performed shall be stated. (5) The maximum time between processing and reporting results shall be stated. (g) Application for registration of mobile services used in the healing arts and veterinary medicine. In addition to the requirements of subsections (c) and (d) of this section or sec.289.230(f) of this title, as applicable, each applicant shall apply for and receive authorization for mobile services before beginning mobile service operation. The following shall be submitted. (1) An established main location where the machine, records, etc. will be maintained for inspection. This must be a street address, not a post office box number. (2) A sketch or description of the normal configuration of each x-ray unit's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location. (3) For mobile services used in the healing arts, current copy of the applicant's operating and safety procedures regarding radiological practices for protection of patients, operators, employees, and the general public. (h) Application for registration for use of radiation machines in industrial radiography, analytical equipment, accelerators for non-human use, and academic and/or research and development facilities. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person having analytical equipment or radiation machines in an academic institution and/or research and development facility, shall apply for registration with the agency within 30 days following the commencement of the operation of the radiation machines. (2) Each person having an accelerator for non-human use or a radiation machine used in industrial radiographic operations shall apply for and receive a certificate of registration from the agency before beginning use of the accelerator or radiation machine. (3) An application for industrial radiographic operations, analytical x-ray, accelerators for non-human use and radiation machines in academic institutions and/or research and development facilities shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO if the RSO is someone other than the applicant or registrant. (4) Each applicant for industrial radiographic operations shall submit the information required in 31.46 of TRCR Part 31 as adopted by reference in sec.289.115 of this title. (5) Each applicant for accelerators for non-human use shall submit the following: (A) operating and safety procedures as described in 35.3 and 35.10 of TRCR Part 35 as adopted by reference in sec.289.119 of this title; and (B) a description of the applicant's proposed facilities in accordance with 35.7-35.9, and 35.12 of TRCR Part 35 as adopted by reference in sec.289.119 of this title. (i) Application for registration of calibration of survey and measurement instruments. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person who intends to engage in the business of providing calibration of survey and measurement instruments shall apply for and receive a certificate of registration from the agency before providing services. (2) An application for calibration of survey and measurement instruments shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO if the RSO is someone other than the applicant or registrant. (3) Each applicant shall submit the following: (A) procedures for calibration; (B) qualifications of personnel performing the calibration; (C) a copy of the calibration certificate to be used; and (D) a copy of the expiration sticker to be used. (j) Application for registration of agency-accepted training courses. In addition to the requirements of subsection (c) of this section, each applicant shall comply with the following. (1) Each person who intends to engage in the business of providing agency- accepted training courses shall apply for and receive a certificate of registration from the agency before providing training. (2) An application for agency-accepted training courses shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO if the RSO is someone other than the applicant or registrant. (3) Each applicant shall submit the following: (A) a course syllabus; (B) the number of instructional hours for each subject; (C) a list of training resources (e.g., reference books, texts, workbooks, physical facilities, etc.); (D) all test questions and corresponding answers; and (E) resumes containing the radiation safety training, education, and experience of each instructor. (k) Issuance of certificate of registration. (1) Upon a determination that an application meets the requirements of the type- name="italic">Texas Radiation Control Act (Act) and the requirements of the agency, the agency may issue a certificate of registration authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. (2) The agency may incorporate in the certificate of registration at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the registrant's possession, use, and transfer of radiation machines subject to this part as it deems appropriate or necessary in order to: (A) minimize danger to public health and safety; (B) require such reports and the keeping of such records, and to provide for such inspections of activities under the registration as may be appropriate or necessary; and (C) prevent loss or theft of radiation machines subject to this section. (l) Specific terms and conditions of certificates of registration. (1) Each certificate of registration issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements and orders of the agency. (2) No certificate of registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the agency authorizes the transfer in writing. (3) Each person registered by the agency for radiation machine use in accordance with this section shall confine use and possession of the radiation machine registered to the locations and purposes authorized in the certificate of registration. (m) Responsibilities of registrant. (1) The registrant shall notify the agency in writing of any changes that would render the information contained in the application for registration and/or the certificate of registration inaccurate. (A) Notification is required within 30 days of any change of radiation machine inventory. This includes installation or removal and the disposition of any machine disposed of or transferred. The assembler's notification of installation may be accepted in lieu of notification by the registrant with the exception of mammographic x-ray units. This does not relieve the registrant of the responsibility to assure that proper notification has been made. (B) Notification is required within 30 days of the following changes: (i) name and mailing address; (ii) street address where machine(s) will be used; (iii) radiation safety officer; (iv) type of servicing and/or services provided; or (v) name of facility contracted for "provider of equipment." (C) Notification is required prior to any changes that would render the information contained in the application or the certification of mammography systems inaccurate. (2) The following criteria applies to loaner units and units used for clinical trial evaluations. (A) Radiation machines used for clinical trial evaluations and loaner units may be used for up to 60 days without adding the unit to an existing certificate of registration. The facility is required to notify the agency in writing of the period of use. If the use period will exceed 60 days, the facility will be required to add the unit to their certificate of registration and a fee will be assessed. (B) Facilities who do not have existing certificates of registration may not evaluate radiation machines unless an application for a certificate of registration has been submitted to the agency along with the appropriate fees prior to beginning use of the unit. (C) No fees will be assessed for the operation of loaner units or evaluation periods of 60 days or less unless the loaner units or evaluation periods are in a facility described in subparagraph (B) of this paragraph. (3) No registrant shall engage any person for services described in subsection (e) of this section until such person provides evidence of registration with the agency. (4) Records of training and experience required by this section shall be maintained for review until disposal is authorized by the agency. (5) The following applies to voluntary or involuntary petitions for bankruptcy. (A) Each registrant shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapters of Title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against: (i) a registrant; (ii) an entity (as that term is defined in 11 U.S.C. 101(14)) controlling a registrant or listing the certificate of registration or registrant as property of the estate; or (iii) an affiliate (as that term is defined in 11 U.S.C. 101(2)) of the registrant. (B) This notification must include: (i) the bankruptcy court in which the petition for bankruptcy was filed; and (ii) the date of the filing of the petition. (C) A copy of the "petition for bankruptcy" shall be submitted to the agency along with the written notification. (6) The registrant is responsible for complying with this chapter and the conditions of the certificate of registration. (7) No person shall use machines or perform services that are not authorized in the certificate of registration issued by the agency. (8) Assembler and/or transferor obligations are as follows. (A) No person shall transfer a radiation machine to or install for, other than initial installation of the first machine on the premises, any person who does not possess a current certificate of registration issued by the agency in accordance with this section. (B) Any person who sells, leases, lends, disposes, assembles, installs, or otherwise transfers radiation machines in the state shall notify the agency of the following information within 15 days of such action: (i) the name, address, and certificate of registration number, except in the case of initial machine installation, of persons who have received such machines; (ii) the type of radiation machine, the manufacturer, model, and control panel serial number of each radiation machine; and (iii) the date of transfer or disposal of each radiation machine. (C) In the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report on United States Food and Drug Administration (FDA) form 2579, prepared in compliance with requirements of the federal diagnostic x-ray standards (21 CFR 1020.30(d)), shall be submitted to the agency within 15 days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler to the agency. (D) No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the components of such machines unless such machines and equipment, when properly placed in operation and used, meet the applicable requirements of this chapter. (n) Expiration of certificates of registration. (1) Except as provided by subsection (p) of this section, each certificate of registration that specifies an expiration date expires at the end of the day on that date. Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter. (2) If a registrant does not submit an application for renewal of the certificate of registration under subsection (p) of this section, as applicable, the registrant shall on or before the expiration date specified in the certificate of registration: (A) terminate use of all radiation machines and/or terminate radiation machine servicing or radiation services; (B) submit a record of the disposition of the x-ray units; and (C) pay any outstanding fees in accordance with sec.289.204 of this title. (o) Termination of certificates of registration. When a registrant decides to terminate all activities involving radiation machines or services authorized under the certificate of registration, the registrant shall notify the agency immediately and: (1) request termination of the certificate of registration in writing; (2) submit a record of the disposition of the x-ray units; and (3) pay any outstanding fees in accordance with sec.289.204 of this title. (p) Renewal of certificate of registration. (1) Application for renewal of registration shall be filed in accordance with subsection (c)(1)-(5) of this section, and applicable paragraphs of subsections (d)-(f) of this section and subsections (h)-(j) of this section, and sec.289.230(f) of this title as applicable. (2) If a registrant files an application in proper form before the existing certificate of registration expires, such existing certificate of registration shall not expire until the application status has been determined by the agency. (q) Modification and revocation of certificates of registration. (1) The terms and conditions of all certificates of registration shall be subject to amendment, revision, or modification. A certificate of registration may be suspended or revoked by reason of amendments to the Act, or by reason of rules in this chapter and orders issued by the agency. (2) Any certificate of registration may be revoked, suspended, or modified, in whole or in part, for any of the following: (A) any material false statement in the application or any statement of fact required under provisions of the Act; (B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a certificate of registration on an original application; or (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the certificate of registration, or order of the agency. (3) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no certificate of registration shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate or achieve compliance with all lawful requirements. (r) Reciprocal recognition of out-of-state certificates of registration. (1) Whenever any radiation machine is to be brought into the state for any temporary use, the person proposing to bring such machine into the state shall file written notice with the agency at least three working days before such machine is to be used in the state. The notice shall include: (A) the number(s) and type(s) of radiation machine(s); (B) the nature, start date, duration, and scope of use; (C) the exact location(s) where the radiation machine(s) is(are) to be used; (D) the name(s) of the Texas licensed practitioner(s) if the machines are used to irradiate human beings; (E) a copy of the person's operating and safety procedures; and (F) the name(s) and address(es) where the machine user(s) can be reached while in the state. (2) If, for a specific case, the three-day period would impose an undue hardship on the person, he/she may, at the determination of the agency, obtain permission to proceed sooner. (3) The out-of-state person shall provide a copy of their certificate of registration or equivalent document. If the state from which the machines are proposed to be brought does not issue certificates of registration or equivalent documents, a certificate of registration must be obtained from the agency in accordance with the provisions of this section. (4) In addition, the out-of-state person shall: (A) submit an annual fee as specified in sec.289.204(e)(7) of this title; (B) comply with all applicable requirements of the agency; and (C) supply the agency with such other information as the agency may reasonably request. (5) The agency may withdraw, limit, or qualify its acceptance of any certificate of registration or equivalent document issued by another agency upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property. (6) Whenever radiation services are to be provided by a person from out-of-state for any temporary use, that person shall apply for and receive a certificate of registration from the agency before providing services. The application shall be filed in accordance with subsection (c) of this section and subsections (e)-(f) of this section and subsections (i)-(j) of this section as applicable. (s) Appendices. (1) Requirements for RSOs for registrants. (A) All RSOs shall meet the following general requirements in addition to requirements in specific categories except for industrial radiography RSOs: (i) educational courses related to ionizing radiation safety or a radiation safety officer course; (ii) experience in the use and familiarity of the type of equipment used; and (iii) knowledge of potential radiation hazards or emergency precautions. (B) Specific requirements for RSOs by facility are as follows: (i) healing arts facilities shall have: (I) licensed practitioner RSOs with documentation of licensing board number; or (II) non-practitioner RSOs with the following: (-a-) evidence of a valid general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Civil Statutes, Article 4512m, and at least two years of supervised use of radiation machines; (-b-) evidence of a valid limited general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Civil Statutes, Article 4512m, and at least four years of supervised use of radiation machines; (-c-) evidence of registry by the American Registry of Radiologic Technologists (ARRT) or the American Registry of Clinical Radiologic Technologists (ARCRT) and at least two years of supervised use of radiation machines; (-d-) evidence of associate degree in radiologic technology, health physics, or nuclear technology, and at least two years of supervised use of radiation machines; (-e-) evidence of registration with the Board of Nurse Examiners as a Registered Nurse or a Registered Nurse with an extended scope of practice (Nurse Practitioner) performing radiologic procedures, and at least two years of supervised use of radiation machines in the respective practitioners' specialty; (-f-) evidence of registration with the Texas State Board of Physician Assistant Examiners, and at least two years of supervised use of radiation machines in the respective practitioners' specialty; (-g-) evidence of: (-1-) registration with the Texas State Board of Medical Examiners performing radiologic procedures under a physician's instruction and direction; (-2-) registration with the Texas State Board of Dental Examiners performing radiologic procedures under a dentist's instruction and direction or evidence of a valid certificate as a registered dental hygienist; (-3-) registration with the Texas State Board of Chiropractic Examiners performing radiologic procedures under a chiropractor's instruction and direction; or (-4-) registration with the Texas State Board of Podiatry Examiners performing radiologic procedures under a podiatrist's instruction and direction; and (-5-) at least four years of supervised use of radiation machines in the respective practitioners' specialty; (-h-) for radiotherapy facilities, evidence of registry by the ARRT or ARCRT and at least four years of supervised experience in radiotherapy; (-i-) evidence of bachelor's (or higher) degree in a natural or physical science, health physics, radiological science, nuclear medicine, or nuclear engineering; or (-j-) evidence of a current Texas license under the Medical Physics Practice Act, Texas Civil Statutes, Article 4512n, in one or more of the following appropriate specialties: (-1-) medical health physics, diagnostic radiological physics, or medical nuclear physics for diagnostic x-ray facilities; or (-2-) medical health physics or therapeutic radiological physics for radiotherapy facilities. (ii) Veterinary facilities shall have: (I) veterinarian RSOs with documentation of veterinary license board number; or (II) non-veterinarian RSOs with two years minimum experience in the use of radiation machines in veterinary medicine under the supervision of a licensed veterinarian. (iii) Academic institutions and/or research and development facilities shall have RSOs who are faculty or staff members in radiation protection, radiation engineering, or related disciplines. (This individual may also serve as the RSO over the healing arts section of the facility). (iv) Industrial radiography operations shall have RSOs who meet the requirements of 31.23 of TRCR Part 31 as adopted by reference in sec.289.115 of this title. (C) Exemptions. The RSO identified on a certificate of registration issued before September 1, 1993, need not comply with the training requirements in this subsection. (2) Responsibilities of radiation safety officers for certificates of registration. Specific duties of the RSO include, but are not limited to, the following: (A) establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and to review them regularly to ensure that the procedures are current and conform with this chapter; (B) ensuring that personnel monitoring devices are properly used by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by sec.289.114 of this title; (C) investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this chapter and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence; (D) having a thorough knowledge of management policies and administrative procedures of the registrant and keeping management informed on a periodic basis of the performance of the registrant's radiation protection program; (E) assuming control and having the authority to institute corrective actions including shut-down of operations when necessary in emergency situations or unsafe conditions; (F) maintaining records as required by this chapter; (G) ensuring that personnel are adequately trained and complying with this chapter, the conditions of the certificate of registration, and the operating and safety procedures of the registrant. (3) Minimum education and training for persons performing radiation machine assembly, maintenance, and repair. All persons performing radiation machine assembly, maintenance, and repair shall meet the general requirements in subparagraph (A) of this paragraph and one or more of the specialized requirements in subparagraph (B) of this paragraph. (A) General requirements include: (i) experience or education providing familiarity with the type(s) of equipment to be serviced to include radiation safety; (ii) knowledge of protective measures to reduce potentially hazardous conditions; and (iii) six months of supervised assembly and repair of the type(s) of equipment to be serviced. (B) Specialized requirements include: (i) one year of formal training (may be satisfied by factory school, military technical training school, or other courses in radiation machine assembly, maintenance, and repair techniques) or an associate's degree in biomedical equipment repair; (ii) bachelor's degree in electrical engineering with specialized training in radiation producing devices; or (iii) combination of training and experience equal to clause (i) of this subparagraph. (C) Exemptions. A registrant holding a valid certificate of registration who has hired individuals to perform services before September 1, 1993, need not comply with the education and training requirements in this paragraph. Individuals hired after September 1, 1993, must comply with the education and training requirements in this paragraph. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804126 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1998 Proposal publication date: December 5, 1997 For further information, please call: (512) 458-7236 PART VIII. Interagency Council on Early Childhood Intervention Services CHAPTER 621.Early Childhood Intervention Early Childhood Intervention Service Delivery 25 TAC sec.621.23 The Interagency Council on Early Childhood Intervention adopts an amendment to sec.621.23, concerning Service Delivery Requirements for Comprehensive Services without changes to the proposed text as published in the September 26, 1997, issue of the Texas Register (22 TexReg 9626). The proposed amendment is being adopted because the deleted provision is no longer relevant. Chapter 1 funds are no longer available. No comments were received regarding adoption of the amendment. The amendment is being adopted under Human Resources Code, Chapter 73 which authorizes the Interagency Council on Early Childhood Intervention to establish rules regarding services provided for children with developmental delays. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 19, 1998. TRD-9804031 Donna Samuelson Deputy Executive Director Interagency Council on Early Childhood Intervention Services Effective date: April 8, 1998 Proposal publication date: September 26, 1997 For further information, please call: (512) 424-6754 Early Childhood Intervention Service Delivery for Milestones Services 25 TAC sec.sec.621.82-621.84 The Interagency Council on Early Childhood Intervention adopts amendments to sec.621.82-621.84, which relates to Early Childhood Intervention Service Delivery for Milestones without changes to the proposed text as published in the September 19, 1997, issue of the Texas Register (22 TexReg 9425). Sections 621.82-621.84 are being adopted to allow local service area boards to utilize existing community boards or task forces following initial implementation of the Milestones program and to more clearly define Service Area Board in the definitions section. No comments were received regarding adoption of the amendments. The amendments are being adopted under Human Resources Code, Chapter 73 which authorizes the Interagency Council on Early Childhood Intervention Services to establish rules regarding services provided for children with developmental delays. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 19, 1998. TRD-9804032 Donna Samuelson Deputy Executive Director Interagency Council on Early Childhood Intervention Services Effective date: April 8, 1998 Proposal publication date: September 19, 1997 For further information, please call: (512) 424-6754 Case Management Services for Infants and Toddlers with Developmental Disabilities 25 TAC sec.621.126 The Interagency Council on Early Childhood Intervention adopts an amendment to sec.621.126 (Case Management Services for Infants and Toddlers with Developmental Disabilities) without changes to the proposed text as published in the September 19, 1997, issue of the Texas Register (22 TexReg 9427). The proposed amendment is being adopted to correct an internal inconsistency in the rule as originally published. No comments were received regarding the adoption of the amendment. The amendment is being adopted under Human Resources Code, Chapter 73 which authorizes the Interagency Council on Early Childhood Intervention Services to establish rules regarding services provided for children with developmental delays. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 19, 1998. TRD-9804033 Donna Samuelson Deputy Executive Director Interagency Council on Early Childhood Intervention Services Effective date: April 8, 1998 Proposal publication date: September 19, 1997 For further information, please call: (512) 424-6754 TITLE 30. ENVIRONMENTAL QUALITY PART I. Texas Natural Resource Conservation Commission CHAPTER 106. Exemptions From Permitting SUBCHAPTER A. General Requirements 30 TAC sec.106.4 The Texas Natural Resource Conservation Commission (TNRCC or commission) adopts an amendment to sec.106.4, concerning Requirements for Exemption from Permitting. The amendment is adopted without changes to the proposed text as published in the December 19, 1997, issue of the Texas Register (22 TexReg 12399) and will not be republished. EXPLANATION OF THE ADOPTED RULE. The Federal Clean Air Act (FCAA), sec.182(f), specifies that required measures for major sources of volatile organic compounds must also be applied to major sources of nitrogen oxides (NO x[sub]x reductions would not contribute to attainment of the ozone standard. The United States Environmental Protection Agency's (EPA) interpretation of sec.182(f) allows the following federally required NO x[sub] x reductions do not contribute to ozone attainment: reasonably available control technology (RACT), nonattainment new source review (NNSR), vehicle inspection/maintenance, and general and transportation conformity. On April 12, 1995, the EPA approved a temporary sec.182(f) exemption from these NOx measures in the Houston/Galveston (HGA) and Beaumont/Port Arthur (BPA) ozone nonattainment areas. The EPA's approval was based on the state's preliminary demonstration, using Urban Airshed Model (UAM) modeling, that NOx reductions in HGA and BPA would not lower ozone levels, and in fact could make them worse ("NOx disbenefit"). The temporary exemption allowed more time to conduct UAM modeling, using data from the Coastal Oxidant Assessment for Southeast Texas (COAST), an intensive 1993 field study. These UAM results were judged critical in determining whether, and to what extent, NOx reductions are needed to attain the ozone standard. The EPA specified that the temporary exemption would expire on December 31, 1996. On May 23, 1997, the EPA approved a one-year extension of the sec.182(f) temporary exemption, which since expired on December 31, 1997. This additional year allowed the commission to accommodate improvements in the UAM, using COAST data, and to better substantiate an emission reduction strategy. As a result of the original exemption and extension, the agency revised certain rules, including sec.106.4, to be consistent with the sec.182(f) waiver. In the fall of 1997, commission staff completed the UAM modeling analysis of the airshed of the upper Texas Gulf Coast. This study indicated that NOx reductions are a necessary step toward the area's attaining the federal air quality standard for ozone. Because of the modeling and the need to continue steady reductions of the pollutants that contribute to ozone smog, on November 24, 1997, the commission determined not to seek further federal sec.182(f) waivers from the NOx reduction requirements of the 1990 FCAA for the HGA and BPA areas. This amendment to Chapter 106, regarding Exemptions from Permitting, requires a source seeking a standard exemption to instead undergo full NNSR if the project constitutes a new major source or major modification for NOx. REGULATORY IMPACT ANALYSIS. The commission has reviewed this rulemaking in light of the regulatory analysis requirements of Texas Government Code (the Code), sec.2001.0225, and has determined that the rulemaking is not subject to sec.2001.0225 because it does not meet the definition of a "major environmental rule" as defined in the Code. The amendment, which implements the requirements of FCAA, sec.sec.172(c)(5), 173, and 182(f), does not meet the definition of "major environmental rule" because the obligations have already been established by federal law and thus are not new requirements. The full federal NNSR requirements became effective by operation of federal law upon expiration of the temporary sec.182(f) exemption. No comments on the regulatory impact analysis were received. TAKINGS IMPACT ASSESSMENT. The commission has prepared a takings impact assessment for this amended section under Texas Government Code, sec.2007.043. The following is a summary of that assessment. The specific purpose of this amendment is to remove an existing waiver for NOx NNSR. As adopted, some new or modified sources located in the HGA and BPA ozone nonattainment areas will no longer qualify for an exemption and instead will be subject to a review of their NOx emissions and possibly new control measures. However, there is no restriction or taking of private real property associated with the adoption of this amendment. COASTAL MANAGEMENT PLAN. The commission has determined that this rulemaking action relates to an action or actions subject to the Texas Coastal Management Program (CMP) in accordance with the Coastal Coordination Act of 1991, as amended (Texas Natural Resources Code, sec.sec.33.201 et. seq.), and the commission's rules in 30 TAC Chapter 281, Subchapter B, concerning Consistency with the Texas Coastal Management Program. As required by 31 TAC sec.505.11(b)(2) and 30 TAC sec.281.45(a)(3) relating to actions and rules subject to the CMP, commission rules governing air pollutant emissions must be consistent with the applicable goals and policies of the CMP. The commission has reviewed this rulemaking action for consistency with the CMP goals and policies in accordance with the rules of the Coastal Coordination Council, and has determined that this rulemaking action is consistent with the applicable CMP goals and policies. The primary CMP policy applicable to this rulemaking action is the policy that commission rules comply with regulations at Code of Federal Regulations, Title 40, to protect and enhance air quality in the coastal area. Adoption of the proposed amendment should result in reductions of ambient NOx and ozone concentrations. Therefore, in compliance with 31 TAC sec.505.22(e), the commission affirms that this rulemaking is consistent with CMP goals and policies. HEARING AND COMMENTERS. A public hearing was held on January 20, 1998. No testimony was provided at the hearing. The public comment period also closed on January 20, 1998. Three commenters, the Galveston-Houston Association for Smog Prevention, an individual, and an attorney representing the Texas Industry Project, expressed general support for the amendment. These commenters referenced the proposed rulemaking in their comments on the concurrent proposed amendments to Chapter 116, without specific comments in regard to the Chapter 106 amendment. There was no general opposition to the amendment. STATUTORY AUTHORITY. The amendment is adopted under the Texas Health and Safety Code, the Texas Clean Air Act (TCAA), sec.sec.382.012, 382.017, 382.051, and 382.057. Section 382.012 requires the commission to prepare and develop a general, comprehensive plan for the proper control of the state's air. Section 382.017 authorizes the commission to adopt rules consistent with the policy and purposes of the TCAA, while sec.382.051 authorizes the commission to adopt rules as necessary to comply with changes in federal law or regulations applicable to permits issued under the Health and Safety Code, Chapter 382. Section 382.057 authorizes the commission by rule to exempt certain facilities or changes to facilities from the requirements of sec.382.0518 if such facilities or changes will not make a significant contribution of air contaminants to the atmosphere. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803968 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 7, 1998 Proposal publication date: December 19, 1997 For further information, please call: (512) 239-1966 CHAPTER 115. Control of Air Pollution From Volatile Organic Compounds The commission adopts amendments to sec.115.10, concerning Definitions; new sec.115.420 and amendments to sec.sec.115.421-115.423, 115.426, 115.427, and 115.429, concerning Surface Coating Processes. Adopted with changes to the proposed text as published in the December 19, 1997, issue of the Texas Register (22 TexReg 12401) are sec.sec.115.420, 115.421, 115.423, 115.426, 115.427, and 115.429. Sections 115.10 and 115.422 are adopted without changes and will not be republished. EXPLANATION OF ADOPTED RULES. The commission adopts these revisions to Chapter 115, concerning Control of Air Pollution from Volatile Organic Compounds (VOC) and to the State Implementation Plan (SIP) in order to add wood furniture coating rules and shipbuilding/ship repair coating rules which are based upon two Control Techniques Guideline (CTG) guidance documents issued by the United States Environmental Protection Agency (EPA). Under sec.183 of the 1990 Amendments to the Federal Clean Air Act (FCAA), the EPA is required to issue CTGs for the purpose of assisting states in developing reasonably available control technology (RACT) controls for sources of VOC emissions. In turn, each state is required to submit a revision to its SIP which implements RACT for VOC sources in moderate or above ozone nonattainment areas. Specifically, FCAA sec.182(b)(2) requires states to submit RACT regulations for VOC sources that are covered by a CTG issued after November 15, 1990 (the enactment date of the 1990 FCAA), but prior to the time of attainment. FCAA sec.183(b)(4) requires the EPA to issue a CTG concerning emissions of VOC and particulate matter from coatings and solvents used in shipbuilding and ship repair. However, unlike the more general CTG requirements which mandate that the EPA establish a RACT level of control, sec.183(b)(4) instead requires the EPA to develop the shipbuilding and ship repair CTG based on best available control measures (BACM). BACM is a broadly defined term referring to "best" technologies and other "best" available measures that can be used to control pollution. Limits in state rules must be at least as stringent as the CTG limits or otherwise must be determined to meet RACT (and in the case of shipbuilding/ship repair, BACM). The EPA issued a final wood furniture manufacturing CTG (61 Federal Register (FR) 25223, May 20, 1996), although this CTG did not establish adoption and implementation dates. Later, the EPA published a schedule for states to adopt and implement RACT rules based on the CTG (61 FR 50823, September 27, 1996). Consequently, adoption of RACT rules for this CTG source category is now required for VOC sources in ozone nonattainment areas. The wood furniture manufacturing CTG states (on page 5-3) that "RACT requirements apply to all sources located in nonattainment areas (other than extreme areas) that emit or have the potential to emit 25 tons per year (TPY) or more of VOCs." Similarly, the EPA issued a final shipbuilding and ship repair CTG (61 FR 44050, August 27, 1996), and adoption of RACT rules for this CTG source category is now required for major VOC sources in ozone nonattainment areas. Under FCAA sec.182(b)(2)(C), (c), and (d), the state must also implement RACT for all major stationary VOC sources located in moderate, serious, and severe ozone nonattainment areas that are not covered by any EPA CTG document. The EPA did not include offshore oil or gas drilling platforms in the shipbuilding/ship repair CTG, despite the fact that marine vessels and offshore oil or gas drilling platforms are subject to the same corrosive sea water environment. Therefore, offshore oil or gas drilling platforms which are coated at shipbuilding/ship repair facilities will be subject to the surface coating requirements for shipbuilding/ship repair operations to ensure that this federal requirement for major source RACT is satisfied. Offshore oil or gas drilling platforms which are coated elsewhere will not be subject to the surface coating requirements for shipbuilding/ship repair operations. It should be noted that the EPA's recommendations in the wood furniture and shipbuilding/ship repair CTGs are the result of a cooperative effort involving major stakeholders. Participants throughout the CTG development included representatives from industry (including small businesses), the Navy, the coatings industry, environmental groups, states, and local agencies. Also, the CTGs were developed concurrently with the maximum achievable control technology (MACT) air toxics standards for wood furniture manufacturing operations (60 FR 62930, December 7, 1995) and for shipbuilding and ship repair surface coating (60 FR 64330, December 15, 1995). Finally, the exemption levels for the wood furniture and shipbuilding/ship repair coating rules may need to be lowered in the future in order to generate additional VOC emission reductions needed to maintain progress toward attaining the national ambient air quality standard for ozone. The revisions to sec.115.10, concerning Definitions, delete the definitions of architectural coating, automotive basecoat/clearcoat system, automotive precoat, automotive pretreatment, automotive primer or primer surfacers, automotive sealers, automotive specialty coatings, automotive three- stage system, automotive wipe-down solutions, clear coat, clear sealers, coating, coating application system, coating line, drum, extreme performance coating, final repair coat, high-bake coatings, high-volume low-pressure spray guns, low-bake coatings, non-flat architectural coating, opaque ground coats and enamels, pail, pounds of VOC per gallon of coating (minus water and exempt solvents), pounds of VOC per gallon of solids, semitransparent spray stains and toners, semitransparent wiping and glazing stains, shellacs, surface coating processes (which includes definitions for large appliance coating, metal furniture coating, coil coating, paper coating, fabric coating, vinyl coating, can coating, automobile coating, light-duty truck coating, miscellaneous metal parts and products coating, factory surface coating of flat wood paneling, mirror backing coating, and wood parts and products coating), topcoat, transfer efficiency, varnishes, vehicle refinishing (body shops), and wash coat. These definitions were relocated to the new sec.115.420, concerning Surface Coating Definitions, without changes, except that the semantics in the second sentence in the definition of coating application system have been clarified; the definition of automotive pretreatment has been revised to clarify that adhesion refers to adhesion of subsequent coatings; and the references to other paragraphs in the definition of miscellaneous metal parts and products coating have been updated due to the relocation to sec.115.420. In addition, the revisions to sec.115.10 delete the definition of VOC because this term is already defined in sec.101.1, concerning Definitions. This deletion facilitates future revisions to the corresponding definition of VOC in sec.101.1, concerning Definitions. The new sec.115.420 includes all definitions used exclusively within the Chapter 115 surface coating rules and organizes them according to the type of surface coating process. The new sec.115.420 also adds definitions of adhesive, aerospace vehicle or component, air flask specialty coating, antenna specialty coating, antifoulant specialty coating, basecoat, batch, bitumens, bituminous resin coating, cleaning operations, clear coat (as used in miscellaneous metal parts and products coating), coating solids (or solids), continuous coater, conventional air spray, epoxy, finishing application station, finishing material, finishing operation, general use coating, heat resistant specialty coating, high-gloss specialty coating, high-temperature specialty coating, inorganic zinc (high-build) specialty coating, maximum allowable thinning ratio, military exterior specialty coating, mist specialty coating, navigational aids specialty coating, nonskid specialty coating, nonvolatiles (or volume solids), normally closed container, nuclear specialty coating, organic solvent, organic zinc specialty coating, pleasure craft, pretreatment wash primer specialty coating, repair and maintenance of thermoplastic coating of commercial vessels (specialty coating), rubber camouflage specialty coating, sealant for thermal spray aluminum, sealer, ship, shipbuilding and ship repair operations, special marking specialty coating, specialty interior coating, stain, strippable booth coating, tack coat specialty coating, topcoat, touch-up and repair, undersea weapons systems specialty coating, washcoat, washoff operations, weld-through preconstruction primer (specialty coating), wood furniture, wood furniture component, and wood furniture manufacturing operations. The definition of aerospace vehicle or component is simply a placeholder for the definitions included in the forthcoming aerospace CTG, such that when the EPA finalizes this CTG, no renumbering of other definitions in sec.115.420 will be necessary. Clear coat, as this term is used in miscellaneous metal parts and products coating, has not been previously defined. The new definition of clearcoat is consistent with a June 1, 1995, regulation interpretation concerning this term. The remaining new definitions are used in the new rules which are based upon CTGs for wood furniture manufacturing and shipbuilding/ship repair. The changes to sec.115.421, concerning Emission Specifications, establish emission limits for various coatings used in wood furniture manufacturing operations and shipbuilding/ship repair operations (including offshore oil or gas platforms); establish optional emission limit averaging equations for wood furniture manufacturing operations; establish equations for determining the maximum allowable amount of thinner which may be added to marine coatings; delete references to sec.115.10 for terms which are being relocated to sec.115.420; and change the term "applied" to "delivered to the application system" for consistency with the various emission limits in sec.115.421. The changes to sec.115.422, concerning Control Requirements, establish emission limitations and procedures for cleaning operations at wood furniture manufacturing operations and shipbuilding/ship repair operations; and restrict the use of conventional air atomization spray guns at wood furniture manufacturing operations to specific circumstances. The changes to sec.115.423, concerning Alternate Control Requirements, correct several references from "this section" to "this division." The changes to sec.115.426, concerning Recordkeeping Requirements, update a reference to a rule which has been renumbered; establish an alternate recordkeeping procedure for wood parts/products coating operations which have VOC emissions less than 25 TPY; and clarify that temperature monitoring of direct-flame incinerators is to be done immediately downstream of the firebox, such that the firebox temperature is measured rather than the somewhat cooler stack temperature. The changes to sec.115.427, concerning Exemptions, update the terminology in the existing miscellaneous metal parts/products exemption from "fully assembled marine vessels and fixed offshore structures" to "ships and offshore oil or gas drilling platforms" for consistency with the new requirements for surface coating of ships and offshore oil or gas drilling platforms. The changes to sec.115.427 also exempt shipbuilding/ship repair operations in the Beaumont/Port Arthur and Houston/Galveston ozone nonattainment areas with VOC emissions from ship and offshore oil or gas drilling platform surface coating operations of less than 100 TPY and 25 TPY, respectively. In addition, the changes to sec.115.427 exempt wood furniture manufacturing facilities in the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston ozone nonattainment areas with VOC emissions less than 25 TPY from the new wood furniture emission specifications and control requirements. Because wood furniture manufacturing facilities in the Dallas/Fort Worth, El Paso, and Houston/Galveston ozone nonattainment areas with VOC emissions of at least 25 TPY are already subject to the wood parts/products emission limits of sec.115.421(a)(13), the revisions to sec.115.427 also exempt these facilities from sec.115.421(a)(13) once they begin complying with the new requirements of sec.115.421(a)(14) and sec.115.422(3). This will ensure that these wood furniture manufacturing facilities only have to comply with one set of requirements at a time. Wood parts/products coating operations in the Beaumont/Port ozone nonattainment area with VOC emissions less than 25 TPY continue to be exempt from the requirements of sec.115.421(a)(13). Finally, the changes to sec.115.427 add an exemption for hand-held, nonrefillable, aerosol containers ("spray paint"). This exemption is being added because surface coating operations which include use of spray paint typically will limit its use due to cost considerations and switch to more conventional spray guns and coatings if more than a deminimis amount of spray paint is used. In addition, the EPA has published notice of its intent to regulate spray paint under a national consumer and commercial products rule (60 FR 15264, March 23, 1995) as required by FCAA sec.183(e). The changes to sec.115.429, concerning Counties and Compliance Schedules, specify the compliance schedules for the new requirements. REGULATORY IMPACT ANALYSIS The commission has reviewed this rulemaking in light of the regulatory analysis requirements of Texas Government Code, sec.2001.0225 and has determined that the rulemaking is not subject to sec.2001.0225 because although it meets the definition of a "major environmental rule" as defined in the act, it does not meet any of the four applicability requirements listed in sec.2001.0225(a). No comments on the proposal were received. TAKINGS IMPACT ASSESSMENT. The commission has prepared a Takings Impact Assessment for these rules pursuant to Texas Government Code Annotated, sec.2007.043. The following is a summary of that assessment. The specific purpose of the rulemaking is to add wood furniture coating rules and shipbuilding/ship repair coating rules which are based upon two CTG guidance documents issued by the EPA, as required by sec.182(b)(2) of the FCAA. Promulgation and enforcement of the rule amendments will not affect private real property which is the subject of the rules because this rulemaking action does not restrict or limit the owner's right to the property that would otherwise exist in the absence of the rulemaking. Further, this rulemaking is not the producing cause of a reduction in the market value of private real property. Therefore, this action does not create a burden on private real property. COASTAL MANAGEMENT PROGRAM CONSISTENCY REVIEW. The commission has determined that this rulemaking action is subject to the Texas Coastal Management Program (CMP) in accordance with the Coastal Coordination Act of 1991, as amended (Texas Natural Resources Code, sec.sec.33.201 et. seq.), the rules of the Coastal Coordination Council (31 TAC Chapters 501-506), and the commission's rules in 30 TAC Chapter 281, Subchapter B, concerning Consistency with the Texas Coastal Management Program. As required by 31 TAC sec.505.11(b)(2) and 30 TAC sec.281.45(a)(3) relating to actions and rules subject to the CMP, agency rules governing air pollutant emissions must be consistent with the applicable goals and policies of the CMP. The commission has reviewed this action for consistency, and has determined that this rulemaking is consistent with the applicable CMP goals and policies. The primary CMP policy applicable to this rulemaking action is the policy that commission rules comply with regulations at Code of Federal Regulations, Title 40, to protect and enhance air quality in the coastal area. No new sources of air contaminants will be authorized by the rule revisions, and the revisions are expected to result in a reduction in VOC emissions. Therefore, in compliance with 31 TAC sec.505.22(e), the commission affirms that this rulemaking is consistent with CMP goals and policies. HEARING AND COMMENTERS. A public hearing on this proposal was held in Austin on January 13, 1998. No commenters submitted oral testimony on the proposal. Five commenters submitted written comments on sec.115.10, concerning Definitions, and sec.sec.115.420-115.423, 115.426, 115.427, and 115.429, concerning Surface Coating Processes. The City of Dallas (Dallas), the EPA, Galveston County Health District (Galveston), and an individual generally supported the proposed revisions but suggested changes or clarifications. The Galveston-Houston Association for Smog Prevention (GHASP) supported the individual's comments. An individual suggested that appropriate training on the new wood furniture manufacturing and shipbuilding/ship repair rules be provided for field personnel. On September 18, 1996, the EPA conducted training course ET00296SB, Wood Furniture Surface Coating, with the author of the wood furniture CTG and MACT available to answer questions. Additional training regarding wood furniture coatings and shipbuilding/ship repair coatings may be available in the future as needed. Dallas supported the relocation of surface coating definitions from sec.115.10 to sec.115.420, noting that the new arrangement is more user-friendly than the previous one. The commission appreciates the commenter's support of its regulatory reform efforts. An individual commented that there are too many coating categories for wood furniture manufacturing and shipbuilding/ship repair, and suggested that the definitions be simplified. It should be noted that the EPA developed the coating categories for the wood furniture and shipbuilding/ship repair CTGs in conjunction with the wood furniture and shipbuilding/ship repair MACTs. While the commission agrees that the wood furniture and shipbuilding/ship repair definitions in sec.115.420(b)(12) and sec.115.420(b)(15)(B) include numerous coating categories, elimination of specific coating categories would cause these definitions to become inconsistent with the associated MACTs. Therefore, the commission has made no changes in response to the comment. Galveston commented on sec.115.420(b)(12)(U) and sec.115.420(b)(12)(Z), concerning the definitions of pleasure craft and ship, respectively. Galveston noted that a yacht that is at least 20 meters in length does not appear to meet the definition of either pleasure craft or ship. Galveston questioned whether a yacht that is at least 20 meters in length is covered by the shipbuilding/ship repair rules. Vessels which are at least 20 meters in length are intended to be regulated by the shipbuilding/ship repair rules, regardless of the vessel's usage, while vessels less than 20 meters in length are intended to be regulated by the shipbuilding/ship repair rules only if used for commercial or military purposes. In order to clarify the rule applicability to all nonmilitary, noncommercial vessels which are at least 20 meters in length, the commission deleted the phrase "used for military or commercial operations" from the definition of ship. An individual commented on sec.115.420(b)(13)(B)(ix), concerning the definition of vehicle refinishing (body shops). This definition specifically excludes the repair and recoating of trailers and construction equipment. The individual suggested that the definition state that trailers and construction equipment fall under the miscellaneous metal parts and products (MMPP) coating category. Also, the individual questioned whether surface coating of semi-tractor trailers falls under vehicle refinishing or MMPP. The recoating of trailers (including trailers pulled by heavy-duty trucks) and construction equipment falls under the MMPP coating category, rather than the vehicle refinishing (body shops) category. Because the definition of MMPP found in sec.115.420(b)(10)(F) specifically includes transportation equipment, no additional clarification appears necessary. Therefore, the commission has made no changes in response to the comment. The commission revised the term "undesignated head" to "division" in sec.115.420(a) and (b) in response to recently revised Texas Register rules (23 TexReg 1289, February 13, 1998). An individual stated that surface coating of plastic and fiberglass should be regulated under sec.115.421. The individual's suggestion is beyond the scope of this rulemaking, and therefore the commission has made no changes in response to this comment. However, the commission may reevaluate this suggestion in the future if additional VOC reductions are needed to maintain progress toward attaining the national ambient air quality standard for ozone. Dallas and Galveston commented on sec.115.421(a)(14) and stated that the wood furniture manufacturing coating limits should be in units of pounds of VOC per gallon of solids rather than pounds of VOC per pound of solids. Dallas also suggested that the limits in English units be listed before the limits in metric units. The coating limits in sec.115.421(a)(14) are given in metric units for consistency with the wood furniture CTG, which in turn is consistent with the wood furniture MACT. The English units are given in parentheses for the convenience of the reader. The commission has made no changes in response to the comments. Dallas and an individual commented on the exclusion of adhesives from sec.115.421(a)(14) and stated that VOC emissions from adhesives can be considerable in the wood furniture manufacturing industry. The individual likewise commented on the definition of adhesive in sec.115.420(b)(15)(B)(i), and objected to the exclusion of adhesives from sec.115.421(a)(14) in this definition. The commission excluded adhesives from the wood furniture manufacturing requirements of sec.115.421(a)(14) for consistency with the wood furniture CTG, which in turn is consistent with the wood furniture MACT. The commission has made no changes in response to the comments but may reevaluate this exclusion in the future if additional VOC reductions are needed to maintain progress toward attaining the national ambient air quality standard for ozone. An individual commented on sec.115.421(a)(14)(A)(iv) and stated that the emissions averaging equation is too complicated, and that a simple, easy-to-use formula is needed. While the commission agrees that simple equations are preferable whenever possible, it should be noted that the EPA developed this particular equation for the wood furniture CTG in conjunction with the wood furniture MACT. Substitution of a different equation would cause sec.115.421(a)(14)(A)(iv) to become inconsistent with the wood furniture MACT. Also, this averaging equation is optional. Therefore, the commission has made no changes in response to the comment. The EPA commented on sec.115.421(a)(14)(A)(iv) and stated that the emissions averaging equation should specify a daily averaging period. The commission agrees and has revised sec.115.421(a)(14)(A)(iv) and the lead-in paragraph of sec.115.421(a) to clarify that the averaging period for sec.115.421(a)(14)(A)(iv) is daily. It has come to the commission's attention that in sec.115.421(a)(14)(A)(iv) and sec.115.421(a)(14)(B), "pounds of VOC per pound of solids" was inadvertently written as "pounds of VOC per gallon of solids" in the proposal. The commission has corrected these phrases. In addition, the commission revised the term "undesignated head" to "division" in the lead-in paragraphs of sec.115.421(a) and (b) in response to recently revised Texas Register rules (23 TexReg 1289, February 13, 1998). An individual commented on sec.115.421(a)(15)(B) and stated that the equation for determining emission limits for thinned coatings is too complicated, and that a simple, easy-to-use formula is needed. While the commission agrees that simple equations are preferable whenever possible, it should be noted that the equation in sec.115.421(a)(15)(B) is optional because this equation is used only if thinner is added to the coatings. Also, the EPA developed this particular equation for the shipbuilding/ship repair CTG in conjunction with the shipbuilding/ship repair MACT. Substitution of a different equation would cause sec.115.421(a)(15)(B) to become inconsistent with the shipbuilding/ship repair MACT. Therefore, the commission has made no changes in response to the comment. Dallas commented on sec.115.422(3) and (4) and expressed support for limitations on the use of conventional spray guns in wood furniture manufacturing and on cleanup operations in wood furniture manufacturing and shipbuilding/ship repair operations. The commission appreciates the support. The EPA stated that all work practice standards outlined in the wood furniture manufacturing CTG should be included in sec.115.422(3). Specifically, the EPA referred to a leak inspection and maintenance program; work practice standards for general cleaning, washoff tanks, and spray gun/line cleaning; and work standards implementation plans. The commission disagrees with the commenter. The commission has evaluated the work practice standards suggested in the wood furniture manufacturing CTG, and selected for inclusion in the proposed sec.115.422(3) those work practices which it determined to be reasonable. Requirements which the commission determined to be unreasonable (for example, a leak inspection and maintenance program) were not included in the proposed sec.115.422(3). The commission has made no changes in response to the comment. An individual suggested that sec.115.422 be revised to require high-volume low- pressure (HVLP) spray guns for most coating applications, including miscellaneous metal parts and products. Coatings usage, and therefore emissions, can be reduced through the use of coating application systems with a higher transfer efficiency than that of conventional air atomization spray guns. The individual's suggestion is beyond the scope of this rulemaking, and therefore the commission has made no changes in response to this comment. However, the commission may reevaluate this suggestion in the future if additional VOC reductions are needed to maintain progress toward attaining the national ambient air quality standard for ozone. No comments were received on sec.115.423. However, the commission revised the term "undesignated head" to "division" in sec.115.423(a)(1)-(2) and (b)(1)-(2) in response to recently revised Texas Register rules (23 TexReg 1289, February 13, 1998). Dallas commented on sec.115.426(a)(1)(B)(ii) and expressed support for this alternative recordkeeping procedure for wood parts and products coating operations. The commission appreciates the support. The EPA commented on sec.115.426(a) and emphasized the need for a variety of records for wood furniture manufacturing and shipbuilding/ship repair subject to sec.115.421(a)(14) and sec.115.421(a)(15), respectively. Specifically, the EPA recommended inclusion of the following records: identification of the control method to meet the RACT requirement; accounting of the volume of each coating and solvent in storage and in use, and for what purposes; the results of any performance testing; certified product data sheets, including the maximum VOC content data calculated using Test Method 24 or an equivalent alternative; and calculations of the daily usage of the as-applied solvents or coatings. Section 115.426(a)(1)(A) requires maintenance of records documenting the VOC content of coatings and solvents available for use in surface coating processes sufficient to determine continuous compliance. Section 115.426(a)(1)(B) requires maintenance of coating and solvent usage records sufficient to calculate the applicable weighted average of VOC for all coatings, and sec.115.426(a)(1)(C) requires maintenance of testing records. The records required by these rules should be sufficient to document continuous compliance. The commission has made no changes in response to the comment. The EPA commented on sec.115.426(a) and stated that wood furniture manufacturing operations using the emissions averaging equation of sec.115.421(a)(14)(A)(iv) should be required to maintain and submit records including the results of Inequalities (1) or (2), daily coating usage, and VOC content of coatings. The commission agrees that maintenance of these records is necessary and appropriate for demonstrating compliance with the requirements of sec.115.421(a)(14)(A)(iv), but notes that the actual submission of reports containing these records is unnecessary. Because sec.115.426(a)(1) already requires maintenance of these records, with the records to be made available upon request, the commission has made no changes in response to the comment. However, it has come to the commission's attention that sec.115.426(a)(1)(B) and sec.115.426(b)(1)(B) require recordkeeping beyond what is necessary to demonstrate compliance with the emission limitations of sec.115.421. Specifically, the records required by these subparagraphs do not appear to be necessary if all of an operation's coatings, as delivered to the coating application system, are below the applicable control limits. In order to streamline the recordkeeping requirements, the commission has revised sec.115.426(a)(1)(B) and sec.115.426(b)(1)(B) accordingly. The EPA and an individual commented on sec.115.427(a)(3)(E), (G), and (H), concerning the exemptions for wood furniture manufacturing (25 TPY) and shipbuilding/ship repair (25 TPY in Houston/Galveston, and 100 TPY in Beaumont/Port Arthur). The individual objected to these exemptions and stated that emission reductions from these sources are necessary if the ozone nonattainment areas are to have a chance of meeting the attainment deadlines. The EPA recommended basing these exemptions on "potential to emit" rather than on actual uncontrolled emissions. Most sources in these surface coating categories are below the exemption level, regardless of whether the exemption is based upon the "potential to emit" or actual uncontrolled emissions. As noted in the Explanation of Adopted Rules section, the exemption levels for the wood furniture and shipbuilding/ship repair coating rules may need to be lowered in the future in order to generate additional VOC emission reductions needed to maintain progress toward attaining the national ambient air quality standard for ozone. The commission has made no changes in response to the comments. Dallas and an individual commented on sec.115.427(a)(3)(I), which established an exemption for aerosol coatings ("spray paint"). Dallas supported the addition of this exemption, while the individual opposed this exemption. The individual stated that emission reductions from spray painting are necessary if the ozone nonattainment areas are to have a chance of meeting the attainment deadlines. As noted in the Explanation of Adopted Rules section, this exemption is being added because surface coating operations which include use of spray paint typically will limit its use due to cost considerations and switch to more conventional spray guns and coatings if more than a deminimis amount of spray paint is used. In addition, the EPA has published notice of its intent to regulate spray paint under a national consumer and commercial products rule (60 FR 15264, March 23, 1995) as required by FCAA sec.183(e). Therefore, emissions from spray paint will be regulated in the future at the national level. The commission has made no changes in response to the comments. However, it has come to the commission's attention that a spray paint exemption should also be added to 115.427(b) for Gregg, Nueces, and Victoria Counties for consistency. Consequently, the commission has added an exemption for spray paint in these counties as new sec.115.427(b)(4). Finally, the commission revised the term "undesignated head" to "division" in sec.115.427(a)(3)(I) in response to recently revised Texas Register rules (23 TexReg 1289, February 13, 1998). No comments were received on sec.115.429. However, the commission has changed the phrase "affected by" to "subject to" in the first sentence of sec.115.429(a) for consistency with sec.115.429(b) and the second sentence of sec.115.429(a). In addition, the commission revised the term "undesignated head" to "division" in sec.115.429(b) in response to recently revised Texas Register rules (23 TexReg 1289, February 13, 1998). SUBCHAPTER A. Definitions 30 TAC sec.115.10 STATUTORY AUTHORITY. The amendment is adopted under the Texas Health and Safety Code (Vernon 1992), the Texas Clean Air Act (TCAA), sec.382.017, which provides the commission with the authority to adopt rules consistent with the policy and purposes of the TCAA; and TCAA sec.382.012, which requires the commission to develop plans for protection of the state's air. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803987 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 7, 1998 Proposal publication date: December 19, 1997 For further information, please call: (512) 239-1970 SUBCHAPTER E. Solvent-Using Processes Division 2. Surface Coating Processes 30 TAC sec.sec.115.420-115.423, 115.426, 115.427, 115.429 The amendments and new section are adopted under the Texas Health and Safety Code (Vernon 1992), the Texas Clean Air Act (TCAA), sec.382.017, which provides the commission with the authority to adopt rules consistent with the policy and purposes of the TCAA; and TCAA sec.382.012, which requires the commission to develop plans for protection of the state's air. sec.115.420. Surface Coating Definitions. (a) General surface coating definitions. The following terms, when used in this division (relating to Surface Coating Processes), shall have the following meanings, unless the context clearly indicates otherwise. Additional definitions for terms used in this division are found in sec.115.10 of this title (relating to Definitions), sec.101.1 of this title (relating to Definitions), and sec.3.2 of this title (relating to Definitions). (1) Coating - A material applied onto or impregnated into a substrate for protective, decorative, or functional purposes. Such materials include, but are not limited to, paints, varnishes, sealants, adhesives, thinners, diluents, inks, maskants, and temporary protective coatings. (2) Coating application system - Devices or equipment designed for the purpose of applying a coating material to a surface. The devices may include, but are not be limited to, brushes, sprayers, flow coaters, dip tanks, rollers, knife coaters, and extrusion coaters. (3) Coating line - An operation consisting of a series of one or more coating application systems and including associated flashoff area(s), drying area(s), and oven(s) wherein a surface coating is applied, dried, or cured. (4) Coating solids (or solids) - The part of a coating that remains after the coating is dried or cured. (5) High-volume low-pressure (HVLP) spray guns - Equipment used to apply coatings by means of a spray gun which operates between 0.1 and 10.0 pounds per square inch gauge air pressure. (6) Normally closed container - A container that is closed unless an operator is actively engaged in activities such as adding or removing material. (7) Pounds of volatile organic compounds (VOC) per gallon of coating (minus water and exempt solvents) - Basis for emission limits for surface coating processes. Can be calculated by the following equation: Figure: 30 TAC sec.115.420(a)(7) (8) Pounds of VOC per gallon of solids - Basis for emission limits for surface coating process. Can be calculated by the following equation: Figure: 30 TAC sec.115.420(a)(8) (9) Surface coating processes - Operations which utilize a coating application system. (10) Transfer efficiency - The amount of coating solids deposited onto the surface of a part or product divided by the total amount of coating solids delivered to the coating application system. (b) Specific surface coating definitions. The following terms, when used in this division (relating to Surface Coating Processes), shall have the following meanings, unless the context clearly indicates otherwise. (1) Aerospace vehicle or component - Any fabricated part, processed part, assembly of parts, or completed unit, with the exception of electronic components, of any aircraft including but not limited to airplanes, helicopters, missiles, rockets, and space vehicles. (2) Architectural coating. (A) Architectural coating - Any protective or decorative coating applied to the interior or exterior of a building or structure, including latex paint, alkyd paints, stains, lacquers, varnishes, and urethanes. (B) Non-flat architectural coating - Any coating which registers a gloss of 15 or greater on an 85 degree gloss meter or 5 or greater on a 60 degree gloss meter, and which is identified on the label as gloss, semigloss, or eggshell enamel coating. (3) Can coating - The coating of cans for beverages (including beer), edible products (including meats, fruit, vegetables, and others), tennis balls, motor oil, paints, and other mass-produced cans. (4) Coil coating - The coating of any flat metal sheet or strip supplied in rolls or coils. (5) Fabric coating - The application of coatings to fabric, which includes rubber application (rainwear, tents, and industrial products such as gaskets and diaphragms). (6) Factory surface coating of flat wood paneling - Coating of flat wood paneling products, including hardboard, hardwood plywood, particle board, printed interior paneling, and tile board. (7) Large appliance coating - The coating of doors, cases, lids, panels, and interior support parts of residential and commercial washers, dryers, ranges, refrigerators, freezers, water heaters, dishwashers, trash compactors, air conditioners, and other large appliances. (8) Metal furniture coating - The coating of metal furniture (tables, chairs, wastebaskets, beds, desks, lockers, benches, shelves, file cabinets, lamps, and other metal furniture products) or the coating of any metal part which will be a part of a nonmetal furniture product. (9) Mirror backing coating - The application of coatings to the silvered surface of a mirror. (10) Miscellaneous metal parts and products coating. (A) Clear coat - A coating which lacks opacity or which is transparent and which may or may not have an undercoat that is used as a reflectant base or undertone color. (B) Drum (metal) - Any cylindrical metal shipping container with a nominal capacity equal to or greater than 12 gallons (45.4 liters) but equal to or less than 110 gallons (416 liters). (C) Extreme performance coating - A coating intended for exposure to extreme environmental conditions, such as continuous outdoor exposure; temperatures frequently above 95 degrees Celsius (203 degrees Fahrenheit); detergents; abrasive and scouring agents; solvents; and corrosive solutions, chemicals, or atmospheres. (D) High-bake coatings - Coatings designed to cure at temperatures above 194 degrees Fahrenheit. (E) Low-bake coatings - Coatings designed to cure at temperatures of 194 degrees Fahrenheit or less. (F) Miscellaneous metal parts and products coating - The coating of miscellaneous metal parts and products in the following categories: (i) large farm machinery (harvesting, fertilizing, and planting machines, tractors, combines, etc.); (ii) small farm machinery (lawn and garden tractors, lawn mowers, rototillers, etc.); (iii) small appliances (fans, mixers, blenders, crock pots, dehumidifiers, vacuum cleaners, etc.); (iv) commercial machinery (computers and auxiliary equipment, typewriters, calculators, vending machines, etc.); (v) industrial machinery (pumps, compressors, conveyor components, fans, blowers, transformers, etc.); (vi) fabricated metal products (metal-covered doors, frames, etc.); and (vii) any other category of coated metal products, except those surface coating processes specified in paragraphs (2) - (9) and (11)-(15) of this subsection, including, but not limited to, those which are included in the Standard Industrial Classification Code major group 33 (primary metal industries), major group 34 (fabricated metal products), major group 35 (nonelectrical machinery), major group 36 (electrical machinery), major group 37 (transportation equipment), major group 38 (miscellaneous instruments), and major group 39 (miscellaneous manufacturing industries). (G) Pail (metal) - Any cylindrical metal shipping container with a nominal capacity equal to or greater than 1 gallon (3.8 liters) but less than 12 gallons (45.4 liters) and constructed of 29 gauge or heavier material. (11) Paper coating - The coating of paper and pressure-sensitive tapes (regardless of substrate and including paper, fabric, and plastic film) and related web coating processes on plastic film (including typewriter ribbons, photographic film, and magnetic tape) and metal foil (including decorative, gift wrap, and packaging). (12) Marine coatings. (A) Air flask specialty coating - Any special composition coating applied to interior surfaces of high pressure breathing air flasks to provide corrosion resistance and that is certified safe for use with breathing air supplies. (B) Antenna specialty coating - Any coating applied to equipment through which electromagnetic signals must pass for reception or transmission. (C) Antifoulant specialty coating - any coating that is applied to the underwater portion of a vessel to prevent or reduce the attachment of biological organisms and that is registered with the United States Environmental Protection Agency as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act. (D) Batch - The product of an individual production run of a coating manufacturer's process. (A batch may vary in composition from other batches of the same product.) (E) Bitumens - Black or brown materials that are soluble in carbon disulfide, which consist mainly of hydrocarbons. (F) Bituminous resin coating - Any coating that incorporates bitumens as a principal component and is formulated primarily to be applied to a substrate or surface to resist ultraviolet radiation and/or water. (G) Epoxy - Any thermoset coating formed by reaction of an epoxy resin (i.e., a resin containing a reactive epoxide with a curing agent). (H) General use coating - Any coating that is not a specialty coating. (I) Heat resistant specialty coating - Any coating that during normal use must withstand a temperature of at least 204 degrees Celsius (400 degrees Fahrenheit). (J) High-gloss specialty coating - Any coating that achieves at least 85% reflectance on a 60 degree meter when tested by the American Society for Testing and Materials (ASTM) Method D-523. (K) High-temperature specialty coating - Any coating that during normal use must withstand a temperature of at least 426 degrees Celsius (800 degrees Fahrenheit). (L) Inorganic zinc (high-build) specialty coating - A coating that contains 960 grams per liter (eight pounds per gallon) or more elemental zinc incorporated into an inorganic silicate binder that is applied to steel to provide galvanic corrosion resistance. (These coatings are typically applied at more than two mil dry film thickness.) (M) Maximum allowable thinning ratio - The maximum volume of thinner that can be added per volume of coating without exceeding the applicable VOC limit of sec.115.421(a)(15)(A) of this title (relating to Emission Specifications). (N) Military exterior specialty coating - Any exterior topcoat applied to military or U.S. Coast Guard vessels that are subject to specific chemical, biological, and radiological washdown requirements. (O) Mist specialty coating - Any low viscosity, thin film, epoxy coating applied to an inorganic zinc primer that penetrates the porous zinc primer and allows the occluded air to escape through the paint film prior to curing. (P) Navigational aids specialty coating - Any coating applied to Coast Guard buoys or other Coast Guard waterway markers when they are recoated aboard ship at their usage site and immediately returned to the water. (Q) Nonskid specialty coating - Any coating applied to the horizontal surfaces of a marine vessel for the specific purpose of providing slip resistance for personnel, vehicles, or aircraft. (R) Nonvolatiles (or volume solids) - Substances that do not evaporate readily. This term refers to the film-forming material of a coating. (S) Nuclear specialty coating - Any protective coating used to seal porous surfaces such as steel (or concrete) that otherwise would be subject to intrusion by radioactive materials. These coatings must be resistant to long- term (service life) cumulative radiation exposure (ASTM D4082-83), relatively easy to decontaminate (ASTM D4256-83), and resistant to various chemicals to which the coatings are likely to be exposed (ASTM 3912-80). (For nuclear coatings, see the general protective requirements outlined by the U.S. Atomic Energy Commission in a report entitled "U.S. Atomic Energy Commission Regulatory Guide 1.54" dated June 1973, available through the Government Printing Office at (202) 512-2249 as document number A74062-00001.) (T) Organic zinc specialty coating - Any coating derived from zinc dust incorporated into an organic binder that contains more than 960 grams of elemental zinc per liter (eight pounds per gallon) of coating, as applied, and that is used for the expressed purpose of corrosion protection. (U) Pleasure craft - Any marine or fresh-water vessel used by individuals for noncommercial, nonmilitary, and recreational purposes that is less than 20 meters (65.6 feet) in length. A vessel rented exclusively to, or chartered for, individuals for such purposes shall be considered a pleasure craft. (V) Pretreatment wash primer specialty coating - Any coating that contains a minimum of 0.5% acid by weight that is applied only to bare metal surfaces to etch the metal surface for corrosion resistance and adhesion of subsequent coatings. (W) Repair and maintenance of thermoplastic coating of commercial vessels (specialty coating) - Any vinyl, chlorinated rubber, or bituminous resin coating that is applied over the same type of existing coating to perform the partial recoating of any in-use commercial vessel. (This definition does not include coal tar epoxy coatings, which are considered "general use" coatings.) (X) Rubber camouflage specialty coating - Any specially formulated epoxy coating used as a camouflage topcoat for exterior submarine hulls and sonar domes. (Y) Sealant for thermal spray aluminum - Any epoxy coating applied to thermal spray aluminum surfaces at a maximum thickness of one dry mil. (Z) Ship - Any marine or fresh-water vessel, including self-propelled vessels, those propelled by other craft (barges), and navigational aids (buoys). This definition includes, but is not limited to, all military and Coast Guard vessels, commercial cargo and passenger (cruise) ships, ferries, barges, tankers, container ships, patrol and pilot boats, and dredges. Pleasure craft and offshore oil or gas drilling platforms are not considered ships. (AA) Shipbuilding and ship repair operations - Any building, repair, repainting, converting, or alteration of ships or offshore oil or gas drilling platforms. (BB) Special marking specialty coating - Any coating that is used for safety or identification applications, such as ship numbers and markings on flight decks. (CC) Specialty interior coating - Any coating used on interior surfaces aboard U.S. military vessels pursuant to a coating specification that requires the coating to meet specified fire retardant and low toxicity requirements, in addition to the other applicable military physical and performance requirements. (DD) Tack coat specialty coating - Any thin film epoxy coating applied at a maximum thickness of two dry mils to prepare an epoxy coating that has dried beyond the time limit specified by the manufacturer for the application of the next coat. (EE) Undersea weapons systems specialty coating - Any coating applied to any component of a weapons system intended to be launched or fired from under the sea. (FF) Weld-through preconstruction primer (specialty coating) - A coating that provides corrosion protection for steel during inventory, is typically applied at less than one mil dry film thickness, does not require removal prior to welding, is temperature resistant (burn back from a weld is less than 1.25 centimeters (0.5 inches)), and does not normally require removal before applying film-building coatings, including inorganic zinc high-build coatings. When constructing new vessels, there may be a need to remove areas of weld-through preconstruction primer due to surface damage or contamination prior to application of film-building coatings. (13) Vehicle coating. (A) Automobile and light-duty truck manufacturing. (i) Automobile coating - The assembly-line coating of passenger cars, or passenger car derivatives, capable of seating 12 or fewer passengers. (ii) Light-duty truck coating - The assembly-line coating of motor vehicles rated at 8,500 pounds (3,855.5 kg) gross vehicle weight or less and designed primarily for the transportation of property, or derivatives such as pickups, vans, and window vans. (B) Vehicle refinishing (body shops). (i) Basecoat/clearcoat system - A topcoat system composed of a pigmented basecoat portion and a transparent clearcoat portion. The VOC content of a basecoat (bc)/clearcoat (cc) system shall be calculated according to the following formula: Figure: 30 TAC sec.115.420(b)(13)(B)(i) (ii) Precoat - Any coating that is applied to bare metal to deactivate the metal surface for corrosion resistance to a subsequent water-based primer. This coating is applied to bare metal solely for the prevention of flash rusting. (iii) Pretreatment - Any coating which contains a minimum of 0.5% acid by weight that is applied directly to bare metal surfaces to etch the metal surface for corrosion resistance and adhesion of subsequent coatings. (iv) Primer or primer surfacers - Any base coat, sealer, or intermediate coat which is applied prior to colorant or aesthetic coats. (v) Sealers - Coatings that are formulated with resins which, when dried, are not readily soluble in typical solvents. These coatings act as a shield for surfaces over which they are sprayed by resisting the penetration of solvents which are in the final topcoat. (vi) Specialty coatings - Coatings or additives which are necessary due to unusual job performance requirements. These coatings or additives prevent the occurrence of surface defects and impart or improve desirable coating properties. These products include, but are not limited to, uniform finish blenders, elastomeric materials for coating of flexible plastic parts, coatings for non-metallic parts, jambing clear coatings, gloss flatteners, and anti- glare/safety coatings. (vii) Three-stage system - A topcoat system composed of a pigmented basecoat portion, a semitransparent midcoat portion, and a transparent clearcoat portion. The VOC content of a three-stage system shall be calculated according to the following formula: Figure: 30 TAC sec.115.420(b)(13)(B)(vii) (viii) Wipe-down solutions - Any solution used for cleaning and surface preparation. (ix) Vehicle refinishing (body shops) - The repair and recoating of vehicles, including, but not limited to, motorcycles, passenger cars, vans, light-duty trucks, medium-duty trucks, heavy-duty trucks, buses, and other vehicle body parts, bodies, and cabs by a commercial operation other than the original manufacturer. The repair and recoating of trailers and construction equipment are not included. (14) Vinyl coating - The use of printing or any decorative or protective topcoat applied over vinyl sheets or vinyl-coated fabric. (15) Wood parts and products coating. (A) The following terms apply to wood parts and products coating facilities subject to sec.115.421(a)(13) of this title. (i) Clear coat - A coating which lacks opacity or which is transparent and uses the undercoat as a reflectant base or undertone color. (ii) Clear sealers - Liquids applied over stains, toners, and other coatings to protect these coatings from marring during handling and to limit absorption of succeeding coatings. (iii) Final repair coat - Liquids applied to correct imperfections or damage to the topcoat. (iv) Opaque ground coats and enamels - Colored, opaque liquids applied to wood or wood composition substrates which completely hide the color of the substrate in a single coat. (v) Semitransparent spray stains and toners - Colored liquids applied to wood to change or enhance the surface without concealing the surface, including but not limited to, toners and nongrain-raising stains. (vi) Semitransparent wiping and glazing stains - Colored liquids applied to wood that require multiple wiping steps to enhance the grain character and to partially fill the porous surface of the wood. (vii) Shellacs - Coatings formulated solely with the resinous secretions of the lac beetle (laccifer lacca), thinned with alcohol, and formulated to dry by evaporation without a chemical reaction. (viii) Topcoat - A coating which provides the final protective and aesthetic properties to wood finishes. (ix) Varnishes - Clear wood finishes formulated with various resins to dry by chemical reaction on exposure to air. (x) Wash coat - A low-solids clear liquid applied over semitransparent stains and toners to protect the color coats and to set the fibers for subsequent sanding or to separate spray stains from wiping stains to enhance color depth. (xi) Wood parts and products coating - The coating of wood parts and products, excluding factory surface coating of flat wood paneling. (B) The following terms apply to wood furniture manufacturing facilities subject to sec.115.421(a)(14) of this title. (i) Adhesive - Any chemical substance that is applied for the purpose of bonding two surfaces together other than by mechanical means. Adhesives are not considered to be coatings or finishing materials for wood furniture manufacturing facilities subject to sec.115.421(a)(14) of this title. (ii) Basecoat - A coat of colored material, usually opaque, that is applied before graining inks, glazing coats, or other opaque finishing materials and is usually topcoated for protection. (iii) Cleaning operations - Operations in which organic solvent is used to remove coating materials from equipment used in wood furniture manufacturing operations. (iv) Continuous coater - A finishing system that continuously applies finishing materials onto furniture parts moving along a conveyor system. Finishing materials that are not transferred to the part are recycled to the finishing material reservoir. Several types of application methods can be used with a continuous coater, including spraying, curtain coating, roll coating, dip coating, and flow coating. (v) Conventional air spray - A spray coating method in which the coating is atomized by mixing it with compressed air at an air pressure greater than 10 pounds per square inch gauge (psig) at the point of atomization. Airless and air-assisted airless spray technologies are not conventional air spray because the coating is not atomized by mixing it with compressed air. Electrostatic spray technology is also not conventional air spray because an electrostatic charge is employed to attract the coating to the workpiece. In addition, high- volume low-pressure (HVLP) spray technology is not conventional air spray because its pressure is less than 10 psig. (vi) Finishing application station - The part of a finishing operation where the finishing material is applied (for example, a spray booth). (vii) Finishing material - A coating used in the wood furniture industry. For the wood furniture manufacturing industry, such materials include, but are not limited to, basecoats, stains, washcoats, sealers, and topcoats. (viii) Finishing operation - Those activities in which a finishing material is applied to a substrate and is subsequently air-dried, cured in an oven, or cured by radiation. (ix) Organic solvent - A liquid containing VOCs that is used for dissolving or dispersing constituents in a coating; adjusting the viscosity of a coating; cleaning; or washoff. When used in a coating, the organic solvent evaporates during drying and does not become a part of the dried film. (x) Sealer - A finishing material used to seal the pores of a wood substrate before additional coats of finishing material are applied. Washcoats, which are used in some finishing systems to optimize aesthetics, are not sealers. (xi) Stain - Any color coat having a solids content of no more than 8.0% by weight that is applied in single or multiple coats directly to the substrate. Includes, but is not limited to, nongrain raising stains, equalizer stains, sap stains, body stains, no-wipe stains, penetrating stains, and toners. (xii) Strippable booth coating - A coating that is applied to a booth wall to provide a protective film to receive overspray during finishing operations; is subsequently peeled off and disposed; and reduces or eliminates the need to use organic solvents to clean booth walls. (xiii) Topcoat - The last film-building finishing material applied in a finishing system. A material such as a wax, polish, nonoxidizing oil, or similar substance that must be periodically reapplied to a surface over its lifetime to maintain or restore the reapplied material's intended effect is not considered to be a topcoat. (xiv) Touch-up and repair - The application of finishing materials to cover minor finishing imperfections. (xv) Washcoat - A transparent special purpose coating having a solids content of 12% by weight or less. Washcoats are applied over initial stains to protect and control color and to stiffen the wood fibers in order to aid sanding. (xvi) Washoff operations - Those operations in which organic solvent is used to remove coating from a substrate. (xvii) Wood furniture - Any product made of wood, a wood product such as rattan or wicker, or an engineered wood product such as particleboard that is manufactured under any of the following standard industrial classification codes: 2434 (wood kitchen cabinets), 2511 (wood household furniture, except upholstered), 2512 (wood household furniture, upholstered), 2517 (wood television, radios, phonograph and sewing machine cabinets), 2519 (household furniture not elsewhere classified), 2521 (wood office furniture), 2531 (public building and related furniture), 2541 (wood office and store fixtures, partitions, shelving and lockers), 2599 (furniture and fixtures not elsewhere classified), or 5712 (custom kitchen cabinets). (xviii) Wood furniture component - Any part that is used in the manufacture of wood furniture. Examples include, but are not limited to, drawer sides, cabinet doors, seat cushions, and laminated tops. However, foam seat cushions manufactured and fabricated at a facility that does not engage in any other wood furniture or wood furniture component manufacturing operation are excluded from this definition. (xix) Wood furniture manufacturing operations - The finishing, cleaning, and washoff operations associated with the production of wood furniture or wood furniture components. sec.115.421. Emission Specifications. (a) No person in the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas as defined in sec.115.10 of this title (relating to Definitions) may cause, suffer, allow, or permit volatile organic compound (VOC) emissions from the surface coating processes affected by paragraphs (1)-(15) of this subsection to exceed the specified emission limits. These limitations are based on the daily weighted average of all coatings delivered to each coating line, except for those in paragraph (10) of this subsection which are based on paneling surface area, those in paragraph (11) of this subsection which are based on the VOC content of architectural coatings sold or offered for sale, and those in paragraph (14) of this subsection which, if using an averaging approach, must use one of the daily averaging equations within that paragraph. For the purposes of this division (relating to Surface Coating Processes), daily weighted average means the total weight of VOC emissions from all coatings, divided by the total volume of all coatings (minus water and exempt solvent) delivered to the application system each day. (1)-(7) (No change.) (8) Vehicle coating. (A) (No change.) (B) VOC emissions from the coatings or solvents used in vehicle refinishing (body shops) shall not exceed the following limits, as delivered to the application system: (i) 5.0 pounds per gallon (0.60 kg/liter) of coating (minus water and exempt solvent) for primers or primer surfacers; (ii) 5.5 pounds per gallon (0.66 kg/liter) of coating (minus water and exempt solvent) for precoat; (iii) 6.5 pounds per gallon (0.78 kg/liter) of coating (minus water and exempt solvent) for pretreatment; (iv) 5.0 pounds per gallon (0.60 kg/liter) of coating (minus water and exempt solvent) for single-stage topcoats; (v) 5.0 pounds per gallon (0.60 kg/liter) of coating (minus water and exempt solvent) for basecoat/clearcoat systems; (vi) 5.2 pounds per gallon (0.62 kg/liter) of coating (minus water and exempt solvent) for three-stage systems; (vii) 7.0 pounds per gallon (0.84 kg/liter) of coating (minus water and exempt solvent) for specialty coatings; (viii) 6.0 pounds per gallon (0.72 kg/liter) of coating (minus water and exempt solvent) for sealers; and (ix) 1.4 pounds per gallon (0.17 kg/liter) of wipe-down solutions. (C) (No change.) (9)-(12) (No change.) (13) Surface coating of wood parts and products. (A) In the Dallas/Fort Worth, El Paso, and Houston/Galveston areas, VOC emissions from the coating of wood parts and products shall not exceed the following limits, as delivered to the application system, for each surface coating type: (i) 5.9 pounds per gallon (0.71 kg/liter) of coating (minus water and exempt solvent) for clear topcoats; (ii) 6.5 pounds per gallon (0.78 kg/liter) of coating (minus water and exempt solvent) for wash coats; (iii) 6.0 pounds per gallon (0.72 kg/liter) of coating (minus water and exempt solvent) for final repair coats; (iv) 6.6 pounds per gallon (0.79 kg/liter) of coating (minus water and exempt solvent) for semitransparent wiping and glazing stains; (v) 6.9 pounds per gallon (0.83 kg/liter) of coating (minus water and exempt solvent) for semitransparent spray stains and toners; (vi) 5.5 pounds per gallon (0.66 kg/liter) of coating (minus water and exempt solvent) for opaque ground coats and enamels; (vii) 6.2 pounds per gallon (0.74 kg/liter) of coating (minus water and exempt solvent) for clear sealers; (viii) for shellac: (I)-(II) (No change.) (ix) 5.0 pounds per gallon (0.60 kg/liter) of coating (minus water and exempt solvent) for varnish; and (x) (No change.) (B)-(C) (No change.) (14) Surface coating at wood furniture manufacturing facilities. After December 31, 1999, the following requirements apply to wood furniture manufacturing facilities in the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas. For facilities which are subject to this paragraph, adhesives are not considered to be coatings or finishing materials. (A) VOC emissions from finishing operations shall be limited by: (i) Using topcoats with a VOC content no greater than 0.8 kilograms of VOC per kilogram of solids (0.8 pounds of VOC per pound of solids), as delivered to the application system; or (ii) Using a finishing system of sealers with a VOC content no greater than 1.9 kilograms of VOC per kilogram of solids (1.9 pounds of VOC per pound of solids), as applied, and topcoats with a VOC content no greater than 1.8 kilograms of VOC per kilogram of solids (1.8 pounds of VOC per pound of solids), as delivered to the application system; or (iii) For wood furniture manufacturing facilities using acid-cured alkyd amino vinyl sealers or acid-cured alkyd amino conversion varnish topcoats, using sealers and topcoats which meet the following criteria. (I) If the wood furniture manufacturing facility uses acid-cured alkyd amino vinyl sealers and acid-cured alkyd amino conversion varnish topcoats, the sealer shall contain no more than 2.3 kilograms of VOC per kilogram of solids (2.3 pounds of VOC per pound of solids), as applied, and the topcoat shall contain no more than 2.0 kilograms of VOC per kilogram of solids (2.0 pounds of VOC per pound of solids), as delivered to the application system; or (II) If the wood furniture manufacturing facility uses a sealer other than an acid-cured alkyd amino vinyl sealer and acid-cured alkyd amino conversion varnish topcoats, the sealer shall contain no more than 1.9 kilograms of VOC per kilogram of solids (1.9 pounds of VOC per pound of solids), as applied, and the topcoat shall contain no more than 2.0 kilograms of VOC per kilogram of solids (2.0 pounds of VOC per pound of solids), as delivered to the application system; or (III) If the wood furniture manufacturing facility uses an acid-cured alkyd amino vinyl sealer and a topcoat other than an acid-cured alkyd amino conversion varnish topcoat, the sealer shall contain no more than 2.3 kilograms of VOC per kilogram of solids (2.3 pounds of VOC per pound of solids), as applied, and the topcoat shall contain no more than 1.8 kilograms of VOC per kilogram of solids (1.8 pounds of VOC per pound of solids), as delivered to the application system; or (iv) Using an averaging approach and demonstrating that actual daily emissions from the wood furniture manufacturing facility are less than or equal to the lower of the actual versus allowable emissions using one of the following inequalities: Figure: 30 TAC sec.115.421(a)(14)(A)(iv) (v) Using a vapor recovery system that will achieve an equivalent reduction in emissions as the requirements of clauses (i) or (ii) of this subparagraph. If this option is used, the requirements of sec.115.423(a)(3) of this title (relating to Alternate Control Requirements) do not apply; or (vi) Using a combination of the methods presented in clauses (i), (ii), (iii), (iv), and (v) of this subparagraph. (B) Strippable booth coatings used in cleaning operations shall contain no more than 0.8 kilograms of VOC per kilogram of solids (0.8 pounds of VOC per pound of solids), as delivered to the application system. (15) Marine coatings. After December 31, 1999, the following requirements apply to shipbuilding and ship repair operations in the Beaumont/Port Arthur and Houston/Galveston areas. (A) The following VOC emission limits apply to the surface coating of ships and offshore oil or gas drilling platforms at shipbuilding and ship repair operations, and are based upon the VOC content of the coatings as delivered to the application system: Figure: 30 TAC sec.115.421(a)(15)(A) (B) For a coating to which thinning solvent is routinely or sometimes added, the owner or operator shall determine the VOC content as follows. (i) Prior to the first application of each batch, designate a single thinner for the coating and calculate the maximum allowable thinning ratio (or ratios, if the shipbuilding and ship repair operation complies with the cold-weather limits in addition to the other limits specified in subparagraph (A) of this paragraph) for each batch as follows: Figure: 30 TAC sec.115.421(a)(15)(B)(i) [sub]s is not supplied directly by the coating manufacturer, the owner or operator shall determine Vs as follows: Figure: 30 TAC sec.115.421(a)(15)(B)(ii) (b) No person in Gregg, Nueces, and Victoria Counties may cause, suffer, allow, or permit VOC emissions from the surface coating processes affected by paragraphs (1)-(9) of this subsection to exceed the specified emission limits. These limitations are based on the daily weighted average of all coatings delivered to each coating line, except for those in paragraph (9) of this subsection which are based on paneling surface area. For the purposes of this division (relating to Surface Coating Processes), daily weighted average means the total weight of VOC emissions from all coatings, divided by the total volume of all coatings (minus water and exempt solvent) delivered to the application system each day. (1)-(9) (No change.) sec.115.423. Alternate Control Requirements. (a) For all affected persons in the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas, the following alternate control requirements may apply. (1) Emission calculations for surface coating operations performed to satisfy the conditions of sec.101.23 of this title (relating to Alternate Emission Reduction "Bubble" Policy), sec.115.910 of this title (relating to Availability of Alternate Means of Control), or other demonstrations of equivalency with the specified emission limits in this division (relating to Surface Coating Processes) shall be based on the pounds of volatile organic compounds (VOC) per gallon of solids for all affected coatings. The following equation shall be used to convert emission limits from pounds of VOC per gallon of coating to pounds of VOC per gallon of solids: Figure: 30 TAC sec.115.423(a)(1) (2) Any alternate methods of demonstrating and documenting continuous compliance with the applicable control requirements or exemption criteria in this division, such as use of improved transfer efficiency, may be approved by the executive director in accordance with sec.115.910 of this title if emission reductions are demonstrated to be substantially equivalent. (3)-(4) (No change.) (b) For all affected persons in Gregg, Nueces, and Victoria Counties, the following alternate control requirements may apply: (1) Emission calculations for surface coating operations performed to satisfy the conditions of sec.101.23 of this title, sec.115.910 of this title, or other demonstrations of equivalency with the specified emission limits in this division (relating to Surface Coating Processes) shall be based on the pounds of VOC per gallon of solids for all affected coatings. The following equation shall be used to convert emission limits from pounds of VOC per gallon of coating to pounds of VOC per gallon of solids: Figure: 30 TAC sec.115.423(b)(1) (2) Any alternate methods of demonstrating and documenting continuous compliance with the applicable control requirements or exemption criteria in this division, such as use of improved transfer efficiency, may be approved by the executive director in accordance with sec.115.910 of this title if emission reductions are demonstrated to be substantially equivalent. (3)-(4) (No change.) sec.115.426. Monitoring and Recordkeeping Requirements. (a) For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas, the following recordkeeping requirements shall apply: (1) Any person affected by sec.115.421(a) of this title (relating to Emission Specifications) shall satisfy the following recordkeeping requirements. (A) (No change.) (B) Records shall be maintained of the quantity and type of each coating and solvent consumed during the specified averaging period if any of the coatings, as delivered to the coating application system, exceed the applicable control limits. Such records shall be sufficient to calculate the applicable weighted average of VOC for all coatings. (i) As an alternative to the recordkeeping requirements of this subparagraph, any vehicle refinishing (body shop) operation subject to sec.115.421(a)(8)(B) of this title may substitute the recordkeeping requirements specified in sec.106.436 of this title (relating to Auto Body Refinishing Facility (Previously Standard Exemption 124)) provided that all coatings and solvents meet the emission limits of sec.115.421(a)(8)(B) of this title. If a vehicle refinishing (body shop) operation uses any coating(s) or solvent(s) which exceeds the limits of sec.115.421(a)(8)(B) of this title, then that vehicle refinishing (body shop) operation shall maintain daily records of the quantity and type of each coating and solvent consumed in sufficient detail to calculate the daily weighted average of VOC for all coatings and solvents. (ii) As an alternative to the recordkeeping requirements of this subparagraph, any wood parts and products coating operation subject to sec.115.421(a)(13) of this title may substitute the recordkeeping requirements specified in sec.106.231 of this title (relating to Manufacturing, Refinishing, and Restoring Wood Products) provided that all coatings and solvents meet the emission limits of sec.115.421(a)(13) of this title. If a wood parts and products coating operation uses any coating(s) or solvent(s) which exceeds the limits of sec.115.421(a)(13) of this title, then that wood parts and products coating operation shall maintain daily records of the quantity and type of each coating and solvent consumed in sufficient detail to calculate the daily weighted average of VOC for all coatings and solvents. (C)-(D) (No change.) (2) The owner or operator of any surface coating facility which utilizes a vapor recovery system approved by the executive director in accordance with sec.115.423(a)(3) of this title (relating to Alternate Control Requirements) shall: (A) install and maintain monitors to accurately measure and record operational parameters of all required control devices, as necessary, to ensure the proper functioning of those devices in accordance with design specifications, including: (i) continuous monitoring of the exhaust gas temperature immediately downstream of direct-flame incinerators and/or the gas temperature immediately upstream and downstream of any catalyst bed; (ii)-(iv) (No change.) (B)-(C) (No change.) (3)-(4) (No change.) (b) For Gregg, Nueces, and Victoria Counties, the following recordkeeping requirements shall apply: (1) Any person affected by sec.115.421(b) of this title shall satisfy the following recordkeeping requirements. (A) (No change.) (B) Records shall be maintained of the quantity and type of each coating and solvent consumed during the specified averaging period if any of the coatings, as delivered to the coating application system, exceed the applicable control limits. Such records shall be sufficient to calculate the applicable weighted average of VOC for all coatings. (C)-(D) (No change.) (2) The owner or operator of any surface coating facility which utilizes a vapor recovery system approved by the executive director in accordance with sec.115.423(b)(3) of this title shall: (A) install and maintain monitors to accurately measure and record operational parameters of all required control devices as necessary to ensure the proper functioning of those devices in accordance with design specifications; including (i) continuous monitoring of the exhaust gas temperature immediately downstream of direct-flame incinerators and/or the gas temperature immediately upstream and downstream of any catalyst bed; (ii)-(iv) (No change.) (B)-(C) (No change.) (3) (No change.) sec.115.427. Exemptions. (a) For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas, the following exemptions shall apply: (1) The following coating operations are exempt from the application of sec.115.421(a)(9) of this title (relating to Emission Specifications): (A) (No change.) (B) vehicle refinishing (body shops), except as required by sec.115.421(a)(8)(B) and (C) of this title; and (C) ships and offshore oil or gas drilling platforms, except as required by sec.115.421(a)(15) of this title. (2) (No change.) (3) The following exemptions shall apply to surface coating operations, except for aircraft prime coating controlled by sec.115.421(a)(9)(A)(v) of this title and vehicle refinishing (body shops) controlled by sec.115.421(a)(8)(B) and (C) of this title. (A) Surface coating operations on a property which, when uncontrolled, will emit a combined weight of VOC of less than 3 pounds per hour and 15 pounds in any consecutive 24-hour period shall be exempt from the provisions of sec.115.421(a) of this title and sec.115.423(a) of this title (relating to Alternate Control Requirements). (B) Surface coating operations on a property which, when uncontrolled, will emit a combined weight of VOC of less than 100 pounds in any consecutive 24-hour period shall be exempt from the provisions of sec.115.421(a) and sec.115.423(a) of this title if documentation is provided to and approved by both the executive director and the EPA to demonstrate that necessary coating performance criteria cannot be achieved with coatings which satisfy applicable emission specifications and that control equipment is not technically or economically feasible. (C) (No change.) (D) Wood furniture manufacturing facilities which are subject to and are complying with the requirements of sec.115.421(a)(14) of this title and sec.115.422(3) of this title (relating to Control Requirements) are exempt from the requirements of sec.115.421(a)(13) of this title. These wood furniture manufacturing facilities shall continue to comply with the requirements of sec.115.421(a)(13) of this title until these facilities are in compliance with the requirements of sec.115.421(a)(14) and sec.115.422(3) of this title. (E) Wood furniture manufacturing facilities which, when uncontrolled, emit a combined weight of VOC from wood furniture manufacturing operations less than 25 tons per year are exempt from the requirements of sec.115.421(a)(14) and sec.115.422(3) of this title. (F) Wood parts and products coating facilities in Hardin, Jefferson, and Orange Counties are exempt from the requirements of sec.115.421(a)(13) of this title. (G) Shipbuilding and ship repair operations in Hardin, Jefferson, and Orange Counties which, when uncontrolled, emit a combined weight of VOC from ship and offshore oil or gas drilling platform surface coating operations less than 100 tons per year are exempt from the requirements of sec.115.421(a)(15) and sec.115.422(4) of this title. (H) Shipbuilding and ship repair operations in Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller Counties which, when uncontrolled, emit a combined weight of VOC from ship and offshore oil or gas drilling platform surface coating operations less than 25 tons per year are exempt from the requirements of sec.115.421(a)(15) and sec.115.422(4) of this title. (I) Coatings applied with hand-held, nonrefillable, aerosol containers ("spray paint") are exempt from the requirements of this division (relating to Surface Coating Processes). (4)-(6) (No change.) (b) For Gregg, Nueces, and Victoria Counties, the following exemptions shall apply: (1)-(3) (No change.) (4) Coatings applied with hand-held, nonrefillable, aerosol containers ("spray paint") are exempt from the requirements of this division (relating to Surface Coating Processes). sec.115.429. Counties and Compliance Schedules. (a) All wood furniture manufacturing facilities subject to sec.115.421(a)(14) of this title (relating to Emission Specifications) in Brazoria, Chambers, Collin, Dallas, Denton, El Paso, Fort Bend, Galveston, Hardin, Harris, Jefferson, Liberty, Montgomery, Orange, Tarrant, and Waller Counties shall be in compliance with sec.115.421(a)(14) of this title and sec.115.422(3) of this title (relating to Control Requirements) as soon as practicable, but no later than December 31, 1999. All wood furniture manufacturing facilities subject to sec.115.421(a)(14) of this title in Brazoria, Chambers, Collin, Dallas, Denton, El Paso, Fort Bend, Galveston, Harris, Liberty, Montgomery, Tarrant, and Waller Counties shall continue to comply with the requirements of sec.115.421(a)(13) of this title until these coating operations are in compliance with the requirements of sec.115.421(a)(14) and sec.115.422(3) of this title. (b) All shipbuilding and ship repair surface coating facilities subject to sec.115.421(a)(15) of this title in Brazoria, Chambers, Fort Bend, Galveston, Hardin, Harris, Jefferson, Liberty, Montgomery, Orange, and Waller Counties shall be in compliance with this division (relating to Surface Coating Processes) as soon as practicable, but no later than December 31, 1999. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803986 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 7, 1998 Proposal publication date: December 19, 1997 For further information, please call: (512) 239-1970 CHAPTER 116. Control of Air Pollution by Permits for New Construction or Modification The Texas Natural Resource Conservation Commission (commission) adopts amendments to sec.116.12, concerning Nonattainment Review Definitions, sec.116.150, concerning New Major Source or Major Modification in Ozone Nonattainment Area, and sec.116.151, concerning New Major Source or Major Modification in Nonattainment Area Other than Ozone. The sections are adopted with changes to the proposed text as published in the December 19, 1997, issue of the Texas Register (22 TexReg 12415). EXPLANATION OF ADOPTED RULES. The Federal Clean Air Act (FCAA), sec.182(f) specifies that required measures for major sources of volatile organic compounds must also be applied to major sources of nitrogen oxides (NO x[sub]x reductions would not contribute to attainment of the ozone standard. The United States Environmental Protection Agency's (EPA) interpretation of sec.182(f) allows the following federally required NOx measures to be waived if the state demonstrates that NOx reductions do not contribute to ozone attainment: reasonably available control technology (RACT), nonattainment new source review (NNSR), vehicle inspection/maintenance, and general and transportation conformity. On April 12, 1995, the EPA approved a temporary sec.182(f) exemption from these NOx measures in the Houston/Galveston (HGA) and Beaumont/Port Arthur (BPA) ozone nonattainment areas. The EPA's approval was based on the state's preliminary demonstration, using Urban Airshed Model (UAM) modeling, that NOx reductions in HGA and BPA would not lower ozone levels, and in fact could make them worse ("NOx disbenefit"). The temporary exemption allowed more time to conduct UAM modeling, using data from the Coastal Oxidant Assessment for Southeast Texas (COAST), an intensive 1993 field study. These UAM results were judged critical in determining whether, and to what extent, NOx reductions are needed to attain the ozone standard. The EPA specified that the temporary exemption would expire on December 31, 1996. On May 23, 1997, the EPA approved a one-year extension of the sec.182(f) temporary exemption, which since expired on December 31, 1997. This additional year allowed the commission to accommodate improvements in the UAM, using COAST data, and to better substantiate an emission reduction strategy. As a result of the original exemption and extension, the agency revised certain rules, including sec.116.150, to be consistent with the sec.182(f) waiver. In the fall of 1997, commission staff completed the UAM modeling analysis of the airshed of the upper Texas Gulf Coast. This study indicated that NOx reductions are a necessary step toward the area's attaining the federal air quality standard for ozone. Because of the modeling and the need to continue steady reductions of the pollutants that contribute to ozone smog, on November 24, 1997, the commission determined not to seek further federal sec.182(f) waivers from the NOx reduction requirements of the 1990 FCAA for the HGA and BPA areas. [sub] x in HGA and BPA, consisting of application of lowest achievable emission rate (LAER), compliance certification, offsets, and alternative site analysis. These NOx requirements apply to permit applications determined to be administratively complete after December 31, 1997. Adopted sec.116.150(a) and (c)(2) contain these reinstated provisions. In addition, the rulemaking implements certain revisions to NNSR which are specified in the 1990 FCAA amendments. The EPA's New Source Review (NSR) reform package, published in the Federal Register on July 23, 1996, clarifies the implementation of these federal statutes. The EPA proposal and the FCAA, sec.182(c)(7) and (8) allow creditable internal offsets at a ratio of 1.3 to 1 to be used in certain nonattainment areas to either: avoid NNSR at existing major sources that emit, or have the potential to emit, less than 100 tons per year (tpy) of an ozone precursor; or substitute Best Available Control Technology (BACT) for LAER at existing major sources that emit, or have the potential to emit, 100 tpy or more of an ozone precursor. Also, if NNSR is required, the EPA proposal and the FCAA, sec.182(c)(7), allow the substitution of BACT for LAER at existing major sources with less than 100 tpy of an ozone precursor. The adopted revisions to sec.116.150(a)(1) and (3) incorporate language to allow these substitutions. The adopted rule also implements the FCAA, sec.182(c)(6), in accordance with the EPA's proposal. The EPA proposed a preliminary step of determining whether there is an "increase in the net emissions" from the proposed modification for which NSR applicability is in question. Where there is a "project net" increase in emissions, the next step is to combine those "project net" increases with the contemporaneous increases and decreases to determine if NNSR is required. Adopted sec.116.12 includes a new definition of "project net" consistent with the EPA's proposed definition. Adopted sec.116.150(a) requires an applicant to submit contemporaneous netting calculations (de minimis threshold test) where the project has an increase in emissions of greater than five tpy and there is a "project net" emissions increase. In addition, the adopted rule updates and makes minor corrections to the sec.116.12 definitions of "contemporaneous period," "de minimis threshold test," and "offset ratio." Also, the adopted amendments to sec.116.151 reword the NNSR provisions for nonattainment areas other than ozone consistent with the adopted amendments to the sec.116.150 provisions for ozone nonattainment areas. REGULATORY IMPACT ANALYSIS. The commission has reviewed this rulemaking in light of the regulatory analysis requirements of Texas Government Code (the Code), sec.2001.0225, and has determined that the rulemaking is not subject to sec.2001.0225 because it does not meet the definition of a "major environmental rule" as defined in the Code. The amendments, which implement the requirements of FCAA, sec.sec.172(c)(5), 173, and 182(f), do not meet the definition of "major environmental rule" because the obligations have already been established by federal law and thus are not new requirements. The full federal NNSR requirements became effective by operation of federal law upon expiration of the temporary sec.182(f) exemption. No comments on the regulatory impact analysis were received. TAKINGS IMPACT ASSESSMENT. The commission has prepared a takings impact assessment for these sections under Texas Government Code, sec.2007.043. The following is a summary of that assessment. The specific purpose of these amendments is to remove an existing waiver for NOx NNSR. New or modified major sources of NOx located in the HGA or BPA ozone nonattainment areas of the state will be subject to a review of their NOx emissions and possibly additional control measures. However, there is no restriction or taking of private real property associated with the adoption of these amendments. COASTAL MANAGEMENT PLAN. The commission has determined that this rulemaking action relates to an action or actions subject to the Texas Coastal Management Program (CMP) in accordance with the Coastal Coordination Act of 1991, as amended (Texas Natural Resources Code, sec.sec.33.201 et. seq.), and the commission's rules in 30 TAC Chapter 281, Subchapter B, concerning Consistency with the Texas Coastal Management Program. As required by 31 TAC sec.505.11(b)(2) and 30 TAC sec.281.45(a)(3) relating to actions and rules subject to the CMP, commission rules governing air pollutant emissions must be consistent with the applicable goals and policies of the CMP. The commission has reviewed this rulemaking action for consistency with the CMP goals and policies in accordance with the rules of the Coastal Coordination Council, and has determined that this rulemaking action is consistent with the applicable CMP goals and policies. The primary CMP policy applicable to this rulemaking action is the policy that commission rules comply with regulations at Code of Federal Regulations, Title 40, to protect and enhance air quality in the coastal area. Adoption of these amendments should result in reductions of ambient NOx and ozone concentrations. Therefore, in compliance with 31 TAC sec.505.22(e), the commission affirms that this rulemaking is consistent with CMP goals and policies. HEARING AND COMMENTERS. A public hearing was held in Austin on January 20, 1998. No testimony was provided at the hearing. The public comment period also closed on January 20, 1998. The following commenters submitted written comments in general support of the proposal, but with suggested changes: Galveston-Houston Association for Smog Prevention (GHASP), an individual, and an attorney representing the Texas Industry Project (TIP). The EPA submitted comments without stating any general support or opposition to the amendments, but suggested changes. No commenter generally opposed the proposed amendments. [sub]x NNSR, but opposed the proposed changes to the NNSR rules resulting from the EPA's NNSR proposal. They also commented that allowing creditable internal offsets to be used to avoid NNSR for sources with a potential to emit of 100 tpy or less is not consistent with reaching attainment in Houston by the year 2007. Further, the individual found this proposal particularly objectionable given that a major source in Houston for NOx is 25 tpy yet the rule would allow a 100 tpy source to use a loophole such that RACT, BACT, and LAER would not be fully implemented. The commission appreciates the support for the reinstatement of NOx NNSR. In response to the opposition to the NNSR reform changes, the commission emphasizes that these changes implement statutory requirements specified in the 1990 amendments to the FCAA and the EPA's clarification of the implementation of those requirements. The purpose of NNSR is to prevent point source growth from interfering with the attainment demonstration strategy contained in the state implementation plan. Each of the adopted amendments maintains the requirement to provide emission reductions which fully offset, or net out, the new point source emissions. The adopted rules allow for sources with a potential to emit of less than 100 tpy to use internal offsets to avoid NNSR. These offsets provide the assurance that the modification will not interfere with Houston reaching attainment by the year 2007. In addition, although the amendments allow the less-than-100 tpy source to avoid NNSR requirements by applying internal offsets at the ratio prescribed in the federal rule, the source is not exempted from RACT or BACT. [sub]x waiver was illegal and suggested that NNSR be applied retroactively to the sources that avoided NNSR during the exemption period. [sub]x requirements to be waived if the reductions would not cause ozone benefits. The preliminary modeling available in 1994 showed this to be the case. Above and beyond the legal minimum requirements, the commission maintained the offset requirements during this period. Sources were required to hold offsetting emission reductions in abeyance, to be provided if further modeling showed the NOx reductions to be beneficial. The amendments to sec.116.150(c)(2) remove the conditionality of this requirement and these sources will have to provide the offsets or internal reductions by January 1, 2000. The EPA and TIP commented that the proposed revision to the definition of "offset ratio" in sec.116.12 needed more specific criteria for creditability than the proposed reference to "the credibility criteria established in sec.101.29." The TIP suggested alternative language for the definition. The EPA expressed confusion on which version of sec.101.29 was being referenced. The commission is agreeable to modifying the definition of offset ratio substantively as recommended by TIP. However, instead of relying on a cross- reference to sec.101.29(c)(1)(B) as recommended by TIP, for readability the commission has included its relevant substance in the adopted definition. In response to the EPA's confusion, the intent was that the cross-reference reflect the current version, effective December 23, 1997. Directly specifying the relevant sec.101.29 requirements in the offset ratio definition eliminates any confusion about which version was intended to be cross-referenced. The EPA recommended that the commission not revise sec.116.151(2), by changing the applicability from "owner or operator" to "owner and operator." The EPA commented that changing the applicability in this way would exempt a facility that is not both owned and operated by the same person. The commission agrees with the EPA. Adopted sec.116.152(2) says "owned or operated." In addition, the commission has corrected a similar drafting error in the second sentence of sec.116.150(a), which as proposed, inadvertently omitted the reference to the existing exception in subsection (c) of that section. To correct this error, adopted sec.116.150(a) says, "...except as provided in subsections (b) and (c) of this section." SUBCHAPTER A. Definitions 30 TAC sec.116.12 STATUTORY AUTHORITY. The amendment is adopted under the Texas Health and Safety Code, the Texas Clean Air Act (TCAA), sec.sec.382.012, 382.017, and 382.051. Section 382.012 requires the commission to prepare and develop a general, comprehensive plan for the proper control of the state's air. Section 382.017 authorizes the commission to adopt rules consistent with the policy and purposes of the TCAA, while sec.382.051 authorizes the commission to adopt rules as necessary to comply with changes in federal law or regulations applicable to permits issued under the Health and Safety Code, Chapter 382. sec.116.12. Nonattainment Review Definitions. Unless specifically defined in the Texas Clean Air Act (TCAA) or in the rules of the commission, the terms used by the commission have the meanings commonly ascribed to them in the field of air pollution control. The terms in this section are applicable to permit review for major source construction and major source modification in nonattainment areas. In addition to the terms which are defined by the TCAA, and in sec.101.1 of this title (relating to Definitions), the following words and terms, when used in sec.116.150 and sec.116.151 of this title (relating to Nonattainment Review), shall have the following meanings, unless the context clearly indicates otherwise. (1)-(6) (No change.) (7) Contemporaneous period-As follows. (A) For major sources with the potential to emit 250 tpy or more of a nonattainment pollutant, the period between: (i) November 15, 1992; and (ii) (No change.) (B)-(C) (No change.) (8) De minimis threshold test (netting)-A method of determining if a proposed emission increase will trigger nonattainment review. The summation of the proposed increase with all other creditable source emission increases and decreases during the contemporaneous period is compared to the MAJOR MODIFICATION column of Table I (in tpy) for that specific nonattainment area. If the major modification level is exceeded, then nonattainment review is required. (9)-(10) (No change.) (11) Major modification-Any physical change in, or change in the method of operation of a facility/stationary source that causes a significant net emissions increase for any air contaminant for which an NAAQS has been issued. At a facility/stationary source that is not major prior to the increase, the increase by itself must equal or exceed that specified in the MAJOR SOURCE column of Table I of this section. At an existing major facility/stationary source, the increase must equal or exceed that specified in the MAJOR MODIFICATION column of Table I. A physical change or change in the method of operation shall not include: (A)-(F) (No change.) (G) any change in ownership at a stationary source. Figure: 30 TAC sec.116.12(11)(G) (12)-(13) (No change.) (14) Offset ratio-For the purpose of satisfying the emissions offset reduction requirements of the FCAA, sec.173(a)(1)(A), the emissions offset ratio is the ratio of total actual reductions of emissions to total allowable emissions increases of such pollutants. The minimum offset ratios are included in Table I of this section under the definition of major modification. In order to be considered creditable, offsets must be enforceable, permanent, quantifiable through a replicable methodology, real, and surplus. The reduction must be surplus at the time it was created as well as when it is used. The reduction must have occurred after January 1, 1990, and have been reported or represented in the 1990 or a subsequent emissions inventory. The reduction must not have been relied on in the issuance of a previous nonattainment or prevention of significant deterioration permit. (15) (No change.) (16) Project net-The sum of the following: the total proposed increase in emissions resulting from a physical change or change in the method of operation at a stationary source, minus any sourcewide creditable actual emission decreases proposed at the source between the date of application for the modification and the date the resultant modification begins emitting. Increases and decreases must meet the creditability criteria listed under paragraph (13) of this section. (17)-(18) (No change.) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803969 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 7, 1998 Proposal publication date: December 19, 1997 For further information, please call: (512) 239-1966 SUBCHAPTER B. New Source Review Permits Division 5. Nonattainment Review 30 TAC sec.116.150, sec.116.151 STATUTORY AUTHORITY. The amendments are adopted under the Texas Health and Safety Code, the Texas Clean Air Act (TCAA), sec.sec.382.012, 382.017, and 382.051. Section 382.012 requires the commission to prepare and develop a general, comprehensive plan for the proper control of the state's air. Section 382.017 authorizes the commission to adopt rules consistent with the policy and purposes of the TCAA, while sec.382.051 authorizes the commission to adopt rules as necessary to comply with changes in federal law or regulations applicable to permits issued under the Health and Safety Code, Chapter 382. sec.116.150. New Major Source or Major Modification in Ozone Nonattainment Areas. (a) This section applies to administratively complete applications submitted on or after November 15, 1992, for new construction or modification of facilities located in any area designated as nonattainment for ozone in accordance with the FCAA, sec.107. The owner or operator of a proposed new or modified facility which will be a new major stationary source of volatile organic compound (VOC) emissions or nitrogen oxides (NOx) emissions, or the owner or operator of an existing major stationary source of VOC or NOx emissions that will undergo a major modification with respect to VOC or NOx, shall meet the requirements of paragraphs (1)-(4) of this subsection, except as provided in subsections (b) and (c) of this section. Table I of sec.116.12 of this title (relating to Nonattainment Review Definitions) specifies the various classifications of nonattainment along with the associated emission levels which designate a major stationary source or major modification for those classifications. Except as noted in subsection (b) of this section regarding NOx , the de minimis threshold test (netting) shall be required for all modifications to existing major sources of VOC or NOx, unless at least one of the following conditions are met: the proposed emissions increases associated with a project, without regard to decreases, is less than five tons per year of the individual nonattainment pollutant or, the project emissions increases coupled with project actual emissions decreases for the same pollutant, summed as the project net, are less than or equal to zero tons per year. In applying the de minimis threshold test, if the net emissions increases, aggregated over the contemporaneous period, are greater than the major modification levels stated in Table I, then the following requirements apply. (1) The proposed facility shall comply with the lowest achievable emission rate (LAER) as defined in sec.116.12 of this title for the nonattainment pollutants for which the facility is a new major source or major modification except as provided in paragraph (3)(B) of this subsection and except for existing major stationary sources that have a potential to emit (PTE) of less than 100 tons per year of the applicable nonattainment pollutant. For these sources, Best Available Control Technology (BACT) can be substituted for LAER. LAER shall otherwise be applied to each new emission unit and to each existing emission unit at which the net emissions increase will occur as a result of a physical change or change in method of operation of the unit. (2) (No change.) (3) At the time the new or modified facility or facilities commence operation, the emissions increases from the new or modified facility or facilities shall be offset. The proposed facility shall use the offset ratio for the appropriate nonattainment classification as defined in sec.116.12 of this title and shown in Table I of sec.116.12 of this title. Internal offsets which are generated at the source and which otherwise meet all creditability criteria can be applied as follows. (A) Major stationary sources with a PTE of less than 100 tons per year of an applicable nonattainment pollutant are not required to undergo Nonattainment New Source Review under this section, if the project increases are offset with internal offsets at a ratio of at least 1.3 to 1. (B) Major stationary sources with a PTE of greater than or equal to 100 tons per year of an applicable nonattainment pollutant can substitute BACT for LAER, if the project increases are offset with internal offsets at a ratio of at least 1.3 to 1. Internal offsets used in this manner can also be applied to satisfy the offset requirement. (4) (No change.) (b) For sources located in the Dallas/Fort Worth ozone nonattainment area (Collin, Dallas, Denton, and Tarrant counties) or in the El Paso ozone nonattainment area (El Paso County), the requirements of this section do not apply to NOx emissions. (c) For sources located in the Houston/Galveston (HGA) ozone nonattainment area (Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller counties) or the Beaumont/Port Arthur (BPA) ozone nonattainment area (Hardin, Jefferson, and Orange counties), the following shall apply to NOx emissions. (1) (No change.) (2) The commission has reviewed the results of the Urban Airshed Model for the HGA and BPA ozone nonattainment areas, using data from the Coastal Oxidant Assessment for Southeast Texas study, in accordance with the United States Environmental Protection Agency document "Guideline for Determining the Applicability of Nitrogen Oxides Requirements under Section 182(f)" (December 1993). The commission has determined that additional NOx reductions in the HGA and BPA nonattainment areas will contribute to attainment of the National Ambient Air Quality Standards for ozone. The commission will notify sources which have permit requirements in abeyance pursuant to paragraph (1)(B) of this subsection, that the period of abeyance has ended. The source shall obtain the NO x offsets as specified in subsection (a)(3) of this section no later than January 1, 2000. sec.116.151. New Major Source or Major Modification in Nonattainment Areas Other Than Ozone. This section applies to administratively complete applications submitted on or after November 15, 1992, for new construction or modification of facilities located in a designated nonattainment area for an air contaminant other than ozone. The owner or operator of a proposed new or modified facility which will be a new major stationary source for that nonattainment air contaminant, or the owner or operator of an existing major stationary source that will undergo a major modification with respect to that nonattainment air contaminant, shall meet the additional requirements of paragraphs (1)-(4) of this section. Table I of sec.116.12 of this title (relating to Nonattainment Review Definitions) specifies the various classifications of nonattainment along with the associated emission levels which designate a major stationary source or major modification for those classifications. (1) The proposed facility shall comply with the lowest achievable emission rate (LAER) as defined in sec.116.12 of this title for the nonattainment pollutants for which the facility is a new major source or major modification. LAER shall be applied to each new emission unit and to each existing emission unit at which the net emissions increase will occur as a result of a physical change or change in method of operation of the unit. (2) All major stationary sources owned or operated by the applicant (or by any person controlling, controlled by, or under common control with the applicant) in the state shall be in compliance or on a schedule for compliance with all applicable state and federal emission limits and standards. (3) At the time the new or modified facility or facilities commence operation, the emission increases from the new or modified facility or facilities shall be offset. The proposed facility shall use the offset ratio for the appropriate nonattainment classification as defined in sec.116.12 of this title and shown in Table I of sec.116.12 of this title. (4) (No change.) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803971 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 7, 1998 Proposal publication date: December 19, 1997 For further information, please call: (512) 239-1966 CHAPTER 122. Federal Operating Permits SUBCHAPTER F. General Operating Permits 30 TAC sec.122.516 The Texas Natural Resource Conservation Commission (TNRCC or commission) adopts new sec.122.516, concerning the requirements for a Site-wide General Operating Permit (site-wide GOP or GOP), with changes to the proposed text as published in the November 21, 1997, issue of the Texas Register (22 TexReg 11232). EXPLANATION OF THE ADOPTED RULE. The adopted sec.122.516, concerning site-wide GOP, provides an alternate permitting mechanism to owners or operators of major sources subject to the Texas Title V Operating Permit Full Program (Full Program) which have only site-wide requirements. The Texas Title V Operating Permit Program is implemented through the provisions of 30 TAC Chapter 122, concerning Federal Operating Permits. A site-wide requirement is a fairly simple requirement that applies uniformly to all of the emission units at the site as opposed to operational characteristics and requirements for individual emission units. As an example, the Operating Permits Division (OPD) has designated certain requirements of 30 TAC Chapter 111, concerning Control of Air Pollution from Visible Emissions and Particulate Matter, such as the opacity limits for stationary vents, as site-wide requirements. These requirements were designated to have site-wide applicability, since many sites have numerous stationary vents and each must comply with the appropriate opacity limit. The qualification criteria in sec.122.516(a) states the criteria that owners or operators of sites must meet for authorization to operate under this GOP. The qualification criteria consists of the conditions consistent with the limitations of a permit by rule and the intended use of this GOP. Since this adopted GOP is intended for use by sites that are subject to only site-wide requirements, a criterion in this section states that sites requiring another federal operating permit to codify any other applicable requirements will not qualify for this GOP. This criterion is also necessary because this GOP could be obtained for only the site-wide requirements that apply to a site and another federal operating permit from being acquired for all other applicable requirements at the site. Since federal operating permits, other than this GOP, issued for a site will also contain site-wide requirements, this criterion prevents the duplication of site-wide requirements in multiple federal operating permits issued for the site. Additionally, since a permit by rule cannot contain compliance provisions or a schedule for a specific site, a criterion is included in this section stating that owners or operators must apply for a site operating permit that contains a compliance schedule if the site or units at the site are out of compliance at the time of application submittal. The qualification criteria also states that the site and the units located at a site may be authorized to operate under this GOP provided that they are not subject to any federal prevention of significant deterioration (PSD) or federal nonattainment (NA) permits. This criterion was necessary, since federal PSD or federal NA permits are applicable requirements under Chapter 122; however, these permits are specific to each site and the requirements contained within each permit cannot be codified in a permit by rule. Once the owner or operator has determined that the site and the units at the site qualify for this GOP, a permit application should be submitted to the commission for review at the time specified in sec.122.130, concerning initial application due dates. If the commission grants authority to operate under this GOP, after reviewing the permit application, the owner or operator must comply with sec.122.516(b)-(f), concerning site-wide requirements; general terms and conditions; recordkeeping terms and conditions; reporting terms and conditions; and compliance certification terms and conditions. Provisions contained in sec.122.516(b) codify site-wide requirements from sec.111.111, concerning visible emissions; sec.sec.111.133, 111.135, and 111.137, concerning Abrasive Blasting of Water Storage Tanks Performed by Portable Operations; sec.sec.111.141, 111.143, 111.145, 111.147, and 111.149, concerning Materials Handling, Construction, Roads, Streets, Alleys, and Parking Lots; sec.111.151, concerning Emission Limits on Nonagricultural Processes; and sec.sec.111.201, 111.205, 111.209, 111.213, 111.219, and 111.221, concerning Outdoor Burning. Since the rule proposal, periodic monitoring requirements have been added to the site-wide requirements for sec.111.111. These additions are based on comments received during the site-wide GOP comment period. Periodic monitoring is required whenever a monitoring method or frequency is insufficient to ensure annual compliance with the emission limitation. To ensure annual compliance with the opacity requirement in sec.122.516, an annual observation has been added for periodic monitoring requirements. If nothing is observed, the source is considered in compliance. Also, should the facility operate continuously for over 24 hours on liquid fuel, a similar observation is required. If nothing is observed, the facility is in compliance. However, if visible emissions are observed, the facility must either perform a certified opacity test to determine compliance or record and, if required, report an opacity deviation. This periodic monitoring requirement is also consistent with TNRCC Rule Interpretation Number 60D.001, which is available through OPD. Additionally, provisions in sec.112.516(b) codify requirements from 30 TAC sec.sec.115.221, 115.222, and 115.224-115.226, concerning Filling of Gasoline Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities; sec.sec.115.234-115.236, concerning Control of Volatile Organic Compound Leaks From Transport Vessels; sec.sec.115.241, 115.242, 115.244, 115.245, and 115.246, concerning Control of Vehicle Refueling Emissions (Stage II) at Motor Vehicle Fuel Dispensing Facilities; sec.sec.115.252, 115.255, and 115.256, concerning Control of Reid Vapor Pressure of Gasoline; and sec.sec.115.541, 115.542, and 115.544-115.546, concerning Degassing or Cleaning of Stationary, Marine, and Transport Vessels. Since the rule proposal, a provision has been added relating to the control of Reid Vapor Pressure of gasoline for a tank, reservoir, storage vessel, or other stationary container with a nominal capacity of 500 gallons or less. This addition was necessary due to an erroneous omission of the provision in the proposed rule. A provision for Title 40 Code of Federal Regulations, Part 82 (40 CFR 82), concerning Protection of Stratospheric Ozone, is included in sec.122.516(b). Also included is a provision for Title 40 Code of Federal Regulations, Part 68 (40 CFR 68) relating to Chemical Accident Prevention Provisions (Risk Management Plans). The adopted rule provides general terms and conditions, in sec.122.516(c), that owners or operators must meet following the initial granting of the authorization to operate under this GOP. These general terms and conditions are consistent with Chapter 122 requirements that must be codified in a federal operating permit. The general terms and conditions provide requirements relating to jurisdiction of the commission or local air pollution program representatives, provisional terms and conditions of the permit, property rights, state-only requirements, and emissions fees. The general terms and conditions also provide requirements relating to permit term length, records, and information requested or required by the executive director. Since the rule proposal, sec.122.516(c)(5) and (6) were revised to be consistent with the general terms and conditions in the November 1997 revision to Chapter 122. Recordkeeping terms and conditions required following the initial granting of the GOP are in sec.122.516(d). These recordkeeping terms and conditions are consistent with Chapter 122. The recordkeeping terms and conditions provide requirements relating to maintenance of records, information contained in the records, and confidentiality of records. Section 122.516(e) of the adopted rule contains the reporting terms and conditions for this GOP. These reporting terms and conditions are consistent with Chapter 122 requirements that must be codified in a federal operating permit. The reporting terms and conditions provide requirements relating to monitoring, deviation, unauthorized emission, upset or maintenance, start-up, and shutdown reports. Provisions in sec.122.516(f), relating to compliance certification terms and conditions, provide requirements for owners or operators following the initial granting of the authorization to operate under this GOP. These certification terms and conditions are consistent with Chapter 122 requirements that must be codified in a federal operating permit and specify information and due dates required for annual compliance certification. GOPs are subject to the requirements of sec.122.360, concerning Public Petition. The public petition for this GOP will begin on the date the adopted rule is published in the Texas Register. This date is expected to be April 3, 1998. REGULATORY IMPACT ANALYSIS. The commission has reviewed the adopted section in light of the regulatory analysis requirements of Texas Government Code (the Code), sec.2001.0225, and has determined that the rulemaking is not subject to sec.2001.0225 because it does not meet the definition of a "major environmental rule" as defined in the Code, and it does not meet any of the four applicability requirements listed in sec.2001.0225(a). While the rule should have wide application throughout the state, it will provide a simplified permitting mechanism for owners or operators having only site-wide requirements. This will reduce the amount of time and money a regulated operator must spend to secure a permit. TAKINGS IMPACT ASSESSMENT. The commission has prepared a Takings Impact Assessment for this adopted new section under Texas Government Code, sec.2007.043. The following is a summary of that assessment. The specific purpose of this rulemaking is to provide a simplified alternate permitting mechanism to owners or operators of major sources subject to the Full Program, having only site-wide requirements. The adopted new section will substantially advance this purpose, since it contains a GOP that is a permit by rule. It contains conditions and limitations with which owners or operators of the sources must comply. Adoption is achieved through the rulemaking process consistent with the requirements of the Government Code, Administrative Procedure Act, Chapter 2001 or 2002. The GOP is also subject to the public participation requirements of 40 CFR 70. Each general operating permit, during the rulemaking process, will be subject to review by the United States Environmental Protection Agency (EPA), public petition, and affected state review. Since a review of the adopted general operating permit occurred during rulemaking, individual permit applications are not required to undergo public notice or EPA approval prior to sources being authorized to operate under the general operating permit. This gives the regulated community and the commission a simplified permit application and review process. Staff resources of the regulated community and the commission are used more efficiently and a considerable time savings is provided to both parties. Interested members of the public are able to participate in the GOP development during the public comment period and by using the public participation options available under 40 CFR 70. Promulgation and enforcement of the new section will not be a burden on private real property which will be subject of the section because it only codifies applicable requirements that may be used by owners or operators of sources subject to the Full Program in order to comply with Chapter 122 and 40 CFR 70. The new section will not make existing regulations less stringent. This rulemaking proposal is also exempt under Texas Government Code, sec.2007.003(b), since the commission is fulfilling its requirement to implement a federally mandated program, Title V of the 1990 Federal Clean Air Act Amendments. COASTAL MANAGEMENT PLAN. The commission has determined that this rulemaking action relates to an action or actions subject to the Texas Coastal Management Program (CMP) in accordance with the Coastal Coordination Act of 1991, as amended (Texas Natural Resources Code, sec.sec.33.201 et. seq.), the rules of the Coastal Coordination Council (31 TAC Chapters 501-506), and the commission's rules in 30 TAC Chapter 281, Subchapter B, concerning Consistency with the Texas Coastal Management Program. As required by 31 TAC sec.505.11(b)(2), sec.505.22(a), and 30 TAC sec.281.45(a)(3) relating to actions and rules subject to the CMP, commission rules governing air pollutant emissions must be consistent with the applicable goals and policies of the CMP. The commission has reviewed this rulemaking action and has determined that this rulemaking action is consistent with the applicable CMP goals and policies. The permits issued under Chapter 122 do not authorize an increase in air emissions. Therefore, in compliance with 31 TAC sec.505.22(e), the commission affirms that this rule is consistent with CMP goals and policies. HEARING AND COMMENTERS. A public hearing was held in Austin on December 18, 1997. No oral testimony was received at the hearing. The public comment period closed January 9, 1998. Two commenters submitted written comments on the proposal. The EPA and Radian International (Radian) suggested changes without directly stating their overall position on the proposal. The EPA commented that sec.122.516(b)(3) states the limits for opacity and the test methods for compliance. However, the EPA added that the rule must also include an appropriate monitoring frequency, either daily or weekly, to assure compliance. The commission has added appropriate periodic monitoring requirements into sec.122.516(b)(3)(A), (B), (D), and (E). Monitoring methods are specified in the sections of Chapter 111 referenced in the GOP. The commission has added the additional monitoring methods and frequencies where the requirements of Chapter 111 are insufficient for the GOP. The EPA commented that the rule must specify monitoring methods for permit holders and testing frequency for volatile organic compounds (VOC) to assure compliance. Monitoring methods and frequency for VOC are contained in the cited sections of Chapter 115, and these sections are referenced within the new sec.122.516. The EPA commented that sec.122.516(c)(6) contains a conflict between two sentences. It states "If the permit holder fails to comply with any provisional terms and conditions, the original terms and conditions of this general operating permit shall be enforceable. In every case, the applicable requirements and state-only requirements are always enforceable." The EPA suggested that the first sentence "If the permit ... shall be enforceable" should be deleted. Also, the same sentence in sec.122.516(c)(5) "In every case, the applicable requirements and state-only requirements are always enforceable" should be also deleted. To remain consistent with sec.122.143(c)(6), the first sentence "If the permit holder fails to comply with any provisional terms and conditions, the original terms and conditions of this general operating permit shall be enforceable" has been removed from sec.122.516(c)(6). However, to remain consistent with sec.122.143(c)(6), the second sentence, "In every case, the applicable requirements and only requirements are always enforceable," in sec.122.516(c)(6) must be retained. The EPA commented that sec.122.516(e)(2)(B) allows for the permit holder to submit deviation reports to the TNRCC every six months. The EPA does not consider six-month reporting of deviations to be adequate. EPA believes that an operator or owner must notify the permitting authority within 24 - 48 hours after the emission limitation was exceeded and follow by a written report within ten days. The EPA stated that the TNRCC must modify the site-wide GOP to require a shorter time for deviation reporting. To maintain consistency with the deviation reporting requirements of sec.122.145(2)(B), the requirement in sec.122.516(e)(2)(B) must remain as written. In addition, 40 CFR sec.70.6(a)(3)(iii)(B) requires the permitting authority to define "prompt" in relation to the degree and type of deviation likely to occur and the applicable requirements. The commission requires the most significant deviations to be reported within 24 hours under the unauthorized emissions, upset or maintenance, start-up, and shutdown requirements of 30 TAC Chapter 101. Deviations must also be reported as required by any underlying applicable requirement. The commission then requires those deviations of least significant concern to be reported at least every six months. These are only those deviations that do not require reporting within 24 hours and do not require more frequent reporting by any underlying applicable requirement. This approach involves three levels of deviation reporting based on the degree and type of deviation likely to occur and the applicable requirements. If the commission were to require every deviation, regardless of significance, to be reported within 24 hours, it would be extremely difficult for staff to quickly identify serious instances requiring immediate action. In addition, through post-1990 new source performance standards, EPA itself has set a precedent for allowing some deviations to be reported within six months. Because the six-month deviation report will include not only a description of all deviations reported on the six-month schedule but also a reference to any deviations submitted under Chapter 101, this report will be a comprehensive record of all deviations that occurred over the previous six months. Receiving the information in this consolidated manner will allow staff to easily identify trends that require attention. This comprehensive list provides more relevant information regarding the compliance of a source than individual reports of each minor deviation. For these reasons, the commission will continue to require the most serious deviations to be reported within 24 hours and allow other deviations to be reported at a frequency consistent with the reporting requirements in the permit. In every case, deviations would be reported on at least a six-month, if not more frequent, schedule. The rule language in sec.122.516(e)(3), which is consistent with sec.122.145(3), also clarifies that even if a deviation is exempt from reporting under Chapter 101, the six-month deviation reporting requirements in sec.122.516(e)(2) still apply. The EPA commented that the site-wide GOP must include a statement that the source will continue to comply with applicable requirements of the permit and a statement that the source will meet, in a timely manner, applicable requirements that become effective during the life of the permit. The GOP includes a provision in sec.122.516(c)(4) stating that the source will comply with the applicable requirements of the permit and the source will meet applicable requirements that become effective during the life of the permit. This provision is consistent with sec.122.143(4). The EPA commented that it does not consider the state's permit revision process to be substantially equivalent to 40 CFR 70, the Operating Permit Rules. EPA is concerned with the state implementing "provisional term and conditions" as part of the revision process for general operating permits. The EPA will address this issue in the state's Title V program approval process. The commission considers provisional terms and conditions as part of the revision process for this general operating permit, especially when newly promulgated applicable requirements have not been incorporated into the permit. Provisional terms and conditions are also necessary when rule citations change in existing applicable requirements. The provisional terms and conditions must codify the new requirements to the same level of detail as required in the permit. Provisional terms and conditions must be consistent with and accurately incorporate the applicable requirements, state-only requirements, and cannot authorize the violation of any applicable or state-only requirement. The provisional terms and conditions must be maintained with the permit and become enforceable terms and conditions of the permit. In every case, the applicable requirements and state- only requirements are always enforceable. The permit holder may also be subject to enforcement action if the permit holder makes a change using one of the revision tracks and the change is later determined not to qualify for that type of permit revision. As specified in Chapter 122, both applicable requirements and state-only requirements must be codified in provisional terms and conditions by the compliance dates of the new requirements. For the purposes of this discussion, applicable and state-only requirements refer to those requirements that can only be applied site-wide. The provisional terms and conditions will be maintained with the permit in order to provide an accurate compliance and enforcement tool for both the permit holder and inspectors. Although the commission does not agree with the EPA concerning the equivalency of the revision process in Chapter 122 as compared to that in 40 CFR part 70, the commission agrees that this issue should be addressed during the process for full program approval. Radian commented that sec.122.516(a)(1)(A) states that a site does not qualify for a GOP if it is subject to a federal PSD or NA permit. Radian gave the example of a Title V permit applicant whose site includes units subject to a PSD permit and the only other applicable requirements are those in sec.122.516(b). If the applicant must obtain a Site Operating Permit (SOP), the application would only consist of Form OP-REQ1, Form OP-CRO1, and Form OP-SUM (merely to specify units included in the PSD permit). Unit attribute forms and a Form OP- REQ3 would not be included. Radian noted that the commission intends merely to incorporate by reference PSD permits into operating permits. Since PSD permit conditions will not be specifically addressed in the operating permit, Radian requested that the proposed site-wide GOP include a provision requiring compliance with any PSD permit issued for units at the site. In this way, the PSD permit is addressed, but sites with no specific requirements to be specified on Form OP-REQ3 can take advantage of the GOP. Federal PSD and NA permit terms and conditions are applicable requirements under Chapter 122. By federal law, a federal operating permit must contain a list of individual units subject to the PSD or NA permit and operating conditions for those units. The commission has elected to codify these terms and conditions by referencing the PSD or NA permit number through a provision in each federal operating permit. Since a GOP is a permit by rule, referencing a PSD or NA permit number in the GOP is not possible. Because of the inability to reference these permit numbers, one of the qualification criteria in the GOP must be that emission units located at the site are not subject to any federal PSD or NA permits. Otherwise, an applicant may submit a GOP permit application for a site containing units having a PSD or NA permit and the commission would not have a mechanism to codify the respective permit numbers as applicable requirements. It should also be noted that all GOP applications must contain Form OP-ACPS (Application Compliance Plan and Schedule), in addition to all relevant application forms, to certify compliance with the applicable requirements contained in the GOP. STATUTORY AUTHORITY. The new section is adopted under the Texas Health and Safety Code, the Texas Clean Air Act, sec.382.012, which gives the commission the authority to develop a comprehensive plan for control of the state's air, and sec.382.017, which gives the commission authority to adopt rules. This section is also adopted under the sec.382.051, which establishes the permitting authority of the commission, including the authority to issue a general permit for numerous similar sources, and sec.382.054, which prohibits operation of a federal source without a federal operating permit. sec.122.516. Site-wide General Operating Permit. (a) Qualification criteria. A site and the individual emission units located at a site may be authorized to operate under this general operating permit provided that: (1) no emission unit located at the site is subject to any federal prevention of significant deterioration permits or federal nonattainment permits; (2) the site and each emission unit located at the site are subject to only the applicable requirements codified in subsection (b) of this section; (3) at the time of application submittal, the site and each emission unit located at the site are in compliance with the applicable requirements codified in subsection (b) of this section; and (4) the site and each emission unit located at the site are not subject to any other permit or general operating permit issued under this chapter. (b) Site-wide requirements. (1) The permit holder shall comply with the requirements relating to general operating permits which are contained in this subchapter. (2) The requirements of preconstruction authorizations referenced in the general operating permit application are not eligible for the permit shield provisions in sec.122.148 of this title (relating to Permit Shield). (3) The permit holder shall comply with the following requirements of Chapter 111 of this title (relating to Control of Air Pollution From Visible Emissions and Particulate Matter). (A) Visible emissions from stationary vents constructed on or before January 31, 1972, shall not exceed 30% opacity averaged over a six-minute period as required in sec.111.111(a)(1)(A) of this title (relating to Requirements for Specified Sources). Compliance with the visible emission standard of sec.111.111(a)(1)(A) of this title shall be determined as required in sec.111.111(a)(1)(F)(ii) of this title by Test Method 9 (40 Code of Federal Regulations (CFR) Part 60, Appendix A), or as required in sec.111.111(a)(1)(F)(iii) of this title by Alternate Method 1 to Method 9, Light Detection and Ranging (40 CFR Part 60, Appendix A), or other equivalent test method approved in accordance with sec.111.111(a)(1)(F)(iv) of this title. The permit holder shall also comply with the following periodic monitoring requirements. (i) For purposes of the annual compliance certification under subsection (f) of this section, the permit holder is required to conduct an observation of stationary vents once during each 12-month certification period. If liquid fuel is fired for 24 consecutive hours, the permit holder shall conduct an observation of the stationary vent to determine if visible emissions are observed. (ii) If visible emissions are not observed during an observation required by clause (i) of this subparagraph, the responsible official may certify that the source is in compliance with the applicable opacity requirement in sec.111.111(a)(1) and (a)(1)(A) of this title. Documentation is not required for observations where no visible emissions are present. (iii) If visible emissions are observed during the observation required by clause (i) of this subparagraph, the permit holder shall either list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section or conduct an appropriate opacity test specified in sec.111.111(a)(1)(F)(i)-(iii) of this title to determine if the source is in compliance with the opacity requirements. (I) If an opacity test is performed and the source is determined to be in compliance, the responsible official may certify that the source is in compliance with the applicable opacity requirement. (II) If an opacity test is performed and the source is determined to be out of compliance, the permit holder shall list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section. (iv) Visible emissions shall be determined with all sources in clear view of the observer. The observer shall be at least 15 feet, but not more than 0.25 miles, away from the emission source during the observation. For outdoor locations, the observer shall select a position where the sun is not directly in the observer's eyes. Documentation is not required for observations where no visible emissions are present. (B) Visible emissions from stationary vents constructed after January 31, 1972, shall not exceed 20% opacity averaged over a six-minute period as required in sec.111.111(a)(1)(B) of this title. Compliance with the visible emission standard of sec.111.111(a)(1)(B) of this title shall be determined as required in sec.111.111(a)(1)(F)(ii) of this title by Test Method 9 (40 CFR Part 60, Appendix A), or as required in sec.111.111(a)(1)(F)(iii) of this title by Alternate Method 1 to Method 9, Light Detection and Ranging (40 CFR Part 60, Appendix A), or other equivalent test method approved in accordance with sec.111.111(a)(1)(F)(iv) of this title. The permit holder shall also comply with the following periodic monitoring requirements. (i) For purposes of the annual compliance certification under subsection (f) of this section, the permit holder is required to conduct an observation of stationary vents once during each 12-month certification period. If liquid fuel is fired for 24 consecutive hours, the permit holder shall conduct an observation of the stationary vent to determine if visible emissions are observed. (ii) If visible emissions are not observed during an observation required by clause (i) of this subparagraph, the responsible official may certify that the source is in compliance with the applicable opacity requirement in sec.111.111(a)(1) and (a)(1)(B) of this title. Documentation is not required for observations where no visible emissions are present. (iii) If visible emissions are observed during the observation required by clause (i) of this subparagraph, the permit holder shall either list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section or conduct an appropriate opacity test specified in sec.111.111(a)(1)(F)(i)-(iii) of this title to determine if the source is in compliance with the opacity requirements. (I) If an opacity test is performed and the source is determined to be in compliance, the responsible official may certify that the source is in compliance with the applicable opacity requirement. (II) If an opacity test is performed and the source is determined to be out of compliance, the permit holder shall list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section. (iv) Visible emissions shall be determined with all sources in clear view of the observer. The observer shall be at least 15 feet, but not more than 0.25 miles, away from the emission source during the observation. For outdoor locations, the observer shall select a position where the sun is not directly in the observer's eyes. Documentation is not required for observations where no visible emissions are present. (C) Visible emissions during the cleaning of a firebox or the building of a new fire, soot blowing, equipment changes, ash removal, and rapping of precipitators may exceed the limits set forth in sec.111.111 of this title for a period aggregating not more than six minutes in any 60 consecutive minutes, nor more than six hours in any ten-day period as required in sec.111.111(a)(1)(E) of this title. This exemption shall not apply to the emissions mass rate standard, as outlined in sec.111.151(a) of this title (relating to Allowable Emissions Limits). (D) Visible emissions from structures shall not exceed 30% opacity for any six- minute period from any building, enclosed facility, or other structure as required in sec.111.111(a)(7)(A) of this title. Compliance with the visible emission standard of sec.111.111(a)(7)(A) of this title shall be determined as required in sec.111.111(a)(7)(B)(i) of this title by Test Method 9 (40 CFR Part 60, Appendix A), or other equivalent test method approved in accordance with sec.111.111(a)(7)(B)(ii) of this title. The permit holder shall also comply with the following Periodic Monitoring requirements. (i) For purposes of the annual compliance certification under subsection (f) of this section, the permit holder is required to conduct an observation of stationary vents once during each 12-month certification period. (ii) If visible emissions are not observed during the observation of the stationary vents for the annual compliance certification, the responsible official may certify that the source is in compliance with the applicable opacity requirement in sec.111.111(a)(7) and sec.111.111(a)(7)(A) of this title. Documentation is not required for observations where no visible emissions are present. (iii) If visible emissions are observed during the observation of the stationary vents for the annual compliance certification, the permit holder shall either list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section or conduct the appropriate opacity test specified in sec.111.111(a)(7)(B)(i) of this title to determine if the source is in compliance with the opacity requirements. (I) If an opacity test is performed and the source is determined to be in compliance, the responsible official may certify that the source is in compliance with the applicable opacity requirement. (II) If an opacity test is performed and the source is determined to be out of compliance, the permit holder shall list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section. (iv) Visible emissions shall be determined with all sources in clear view of the observer. The observer shall be at least 15 feet, but not more than 0.25 miles, away from the emission source during the observation. For outdoor locations, the observer shall select a position where the sun is not directly in the observer's eyes. Documentation is not required for observations where no visible emissions are present. (E) Visible emissions from all other sources not specified in sec.111.111(a)(1), (4), or (7) of this title shall not exceed 30% opacity for any six-minute period from any building, enclosed facility, or other structure as required in sec.111.111(a)(8)(A) of this title. Compliance with the visible emission standard of sec.111.111(a)(8)(A) of this title shall be determined by applying Test Method 9 (40 CFR Part 60, Appendix A) as required in sec.111.111(a)(8)(B)(i) of this title, or other equivalent test method approved in accordance with sec.111.111(a)(8)(B)(ii) of this title. The permit holder shall also comply with the following periodic monitoring requirements. (i) For purposes of the annual compliance certification under subsection (f) of this section, the permit holder is required to conduct an observation of stationary vents once during each 12-month certification period. (ii) If visible emissions are not observed during the observation of the stationary vents for the annual compliance certification, the responsible official may certify that the source is in compliance with the applicable opacity requirement in sec.111.111(a)(8) and sec.111.111(a)(8)(A) of this title. Documentation is not required for observations where no visible emissions are present. (iii) If visible emissions are observed during the observation of the stationary vents for the annual compliance certification, the permit holder shall either list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section or conduct the appropriate opacity test specified in sec.111.111(a)(8)(B)(i) of this title to determine if the source is in compliance with the opacity requirements. (I) If an opacity test is performed and the source is determined to be in compliance, the responsible official may certify that the source is in compliance with the applicable opacity requirement. (II) If an opacity test is performed and the source is determined to be out of compliance, the permit holder shall list this occurrence as a deviation on the next deviation report as required under subsection (e)(2) of this section. (iv) Visible emissions shall be determined with all sources in clear view of the observer. The observer shall be at least 15 feet, but not more than 0.25 miles, away from the emission source during the observation. For outdoor locations, the observer shall select a position where the sun is not directly in the observer's eyes. Documentation is not required for observations where no visible emissions are present. (F) Certification of opacity readers determining opacities under Method 9 (as outlined in 40 CFR 60, Appendix A) to comply with sec.111.111(a)(1)(G) of this title shall be accomplished by completing the Texas Natural Resource Conservation Commission Visible Emissions Evaluators Course, or approved agency equivalent, no more than 180 days before the opacity reading. (G) Contributions from uncombined water shall not be included in determining compliance with sec.111.111 of this title as required in sec.111.111(b) of this title. (H) Emission limits on nonagricultural processes are as follows. (i) Emissions of particulate matter from any source may not exceed the allowable rates specified in Table 1 as required in sec.111.151(a) of this title (relating to Allowable Emissions Limits). Figure 1: 30 TAC sec.122.516(b)(3)(H)(i)[sub]e[sub]e), as determined from Table 2, must reduce the allowable emission level by multiplying it by [he[sub] e[sup]2 as required in sec.111.151(b) of this title. Figure: 30 TAC sec.122.516(b)(3)(H)(ii) (iii) Effective stack height shall be calculated by the following equation as required in sec.111.151(c) of this title. Figure: 30 TAC sec.122.516(b)(3)(H)(iii) (I) Open burning, as stated in sec.111.201 of this title (relating to General Prohibition), shall not be authorized unless the following requirements are satisfied: (i) sec.111.205 of this title (relating to Exception for Fire Training); (ii) sec.111.209(3) of this title (relating to Exception for Disposal Fires); (iii) sec.111.213 of this title (relating to Exception for Hydrocarbon Burning); (iv) sec.111.219 of this title (relating to General Requirements for Allowable Outdoor Burning); and (v) sec.111.221 of this title (relating to Responsibility for Consequences of Outdoor Burning). (J) The permit holder for a site subject to the provisions of this chapter in which the site has materials handling, construction, roads, streets, alleys, and parking lots shall comply with the requirements of sec.sec.111.143, 111.145, 111.147, and 111.149 of this title (relating to Materials Handling; Construction and Demolition; Roads, Streets, and Alleys; and Parking Lots) if they are located in the following areas: (i) the City of El Paso, including the Fort Bliss Military Reservation, except for training areas as referenced in sec.111.141 of this title (relating to Geographic Areas of Application and Date of Compliance); (ii) the area of Harris County located inside Beltway 8 (Sam Houston Tollway); or (iii) the area of Nueces County outlined in the Group II state implementation plan for inhalable particulate matter. (K) Abrasive blasting of water storage tanks performed by portable operations shall not be authorized unless the following state-only requirements are satisfied: (i) sec.111.133(a)(1) and (2), (b), and (c) of this title (relating to Testing Requirements); (ii) sec.111.135(a), (b), and (c)(1) - (4) of this title (relating to Control Requirements for Surfaces with Coatings Containing Lead); and (iii) sec.111.137(a), (b)(1) - (4), and (c) of this title (relating to Control Requirements for Surfaces with Coatings Containing Less than 1.0% Lead). (4) The permit holder for a site in the Houston/Galveston, Beaumont/Port Arthur, Dallas/Fort Worth, or El Paso ozone nonattainment area that is subject to the provisions of this chapter and affected by the requirements of Chapter 115, Subchapter C of this title (relating to Volatile Organic Compound Transfer Operations) shall comply with the following. (A) The requirements in the undesignated head Filling of Gasoline Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities in Chapter 115, Subchapter C of this title, are as follows: (i) sec.115.221 of this title (relating to Emission Specifications); (ii) sec.115.222 of this title (relating to Control Requirements); (iii) sec.115.224 of this title (relating to Inspection Requirements); (iv) sec.115.225(1)-(5) of this title (relating to Testing Requirements); and (v) sec.115.226 of this title (relating to Recordkeeping Requirements). (B) The requirements in the undesignated head Filling of Gasoline Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities in Chapter 115, Subchapter C of this title, at motor vehicle fuel dispensing facilities, constructed prior to November 15, 1992, with stationary gasoline storage containers with a nominal capacity less than or equal to 1,000 gallons are as follows: (i) sec.115.224 of this title; (ii) sec.115.226(1) and (2)(B) of this title; and (iii) sec.115.227(1) of this title (relating to Exemptions). (C) The requirements in the undesignated head Filling of Gasoline Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities in Chapter 115, Subchapter C of this title, at motor vehicle fuel dispensing facilities, constructed prior to November 15, 1992, with transfers to stationary storage tanks located at a facility which has dispensed no more than 10,000 gallons of gasoline in any calendar month after January 1, 1991, are as follows: (i) sec.115.224 of this title; (ii) sec.115.226 of this title; and (iii) sec.115.227(2) of this title. (D) The requirements in the undesignated head Control of Volatile Organic Compound Leaks From Transport Vessels in Chapter 115, Subchapter C of this title, are as follows: (i) sec.115.234 of this title (relating to Inspection Requirements); (ii) sec.115.235(1), (2), (3)(A), and (4) of this title (relating to Approved Test Methods); and (iii) sec.115.236 of this title (relating to Recordkeeping Requirements). (E) The requirements in the undesignated head Control of Vehicle Refueling Emissions (Stage II) at Motor Vehicle Fuel Dispensing Facilities in Chapter 115, Subchapter C of this title, are as follows: (i) sec.115.241 of this title (relating to Emission Specifications); (ii) sec.115.242 of this title (relating to Control Requirements); (iii) sec.115.244 of this title (relating to Inspection Requirements); (iv) sec.115.245(1), (2), (3), (5), and (6) of this title (relating to Testing Requirements); and (v) sec.115.246 of this title (relating to Recordkeeping Requirements). (5) The permit holder for a site in the El Paso ozone nonattainment area that is subject to the provisions of this chapter and affected by the requirements of Chapter 115, Subchapter C of this title shall comply with the following. (A) The requirements in the undesignated head Control of Reid Vapor Pressure of Gasoline in Chapter 115, Subchapter C of this title, are as follows: (i) sec.115.252 of this title (relating to Control Requirements); (ii) sec.115.255 of this title (relating to Approved Test Methods); and (iii) sec.115.256 of this title (relating to Recordkeeping Requirements). (B) The requirements in the undesignated head Control of Reid Vapor Pressure of Gasoline in Chapter 115, Subchapter C of this title, at any stationary tank, reservoir, or other container used exclusively for the fueling of implements of agriculture are as follows: (i) sec.115.255 of this title; and (ii) sec.115.257(1) of this title (relating to Exemptions). (C) The requirements in the undesignated head Control of Reid Vapor Pressure of Gasoline in Chapter 115, Subchapter C of this title, at a motor vehicle fuel dispensing facility are as follows: (i) sec.115.252 of this title; (ii) sec.115.255 of this title; and (iii) sec.115.257(2) of this title. (D) The requirements in the undesignated head Control of Reid Vapor Pressure of Gasoline in Chapter 115, Subchapter C of this title, at any tank, reservoir, storage vessel, or other stationary container with a nominal capacity of 500 gallons or less are as follows: (i) sec.115.255 of this title; and (ii) sec.115.257(3) of this title. (6) The permit holder for a site which degasses or cleans any transport vessel with a nominal storage capacity of 8,000 gallons or more in the Houston/Galveston, Beaumont/Port Arthur, Dallas/Fort Worth, or El Paso ozone nonattainment area that is subject to the provisions of this chapter shall comply with the following requirements in the undesignated head Degassing or Cleaning of Stationary, Marine, and Transport Vessels in Chapter 115, Subchapter F of this title (relating to Miscellaneous Industrial Sources): (A) sec.115.541(a)(2) of this title (relating to Emission Specifications); (B) sec.115.542(a) of this title (relating to Control Requirements); (C) sec.115.544 of this title (relating to Inspection Requirements); (D) sec.115.545(1) - (9) of this title (relating to Approved Test Methods); and (E) sec.115.546 of this title (relating to Monitoring and Recordkeeping Requirements). (7) For covered processes subject to 40 CFR and specified in 40 CFR, sec.68.10, the permit holder shall comply with the requirements of the Accidental Release Prevention Provisions in 40 CFR 68. The permit holder shall submit to the appropriate agency, either a compliance schedule for meeting the requirements of 40 CFR 68 by the date provided in 40 CFR, sec.68.10(a), or as part of the compliance certification submitted under sec.122.143(4) of this title (relating to General Terms and Conditions), a certification statement that the source is in compliance with all requirements of 40 CFR 68, including the registration and submission of a risk management plan. This general provision is enforceable only by the EPA. (8) The permit holder for a site subject to Title VI of the FCAA shall meet the following requirements for protection of stratospheric ozone which are enforceable only by the EPA. (A) Operation, servicing, maintenance, and repair on refrigeration and non-motor vehicle air conditioning appliances using ozone-depleting refrigerants on-site shall be conducted in accordance with 40 CFR 82, Subpart F. The permit holder shall ensure that repairs or refrigerant removal are performed only by properly certified technicians using approved equipment. Records shall be maintained as required by Subpart F. (B) Servicing, maintenance, and repair of fleet vehicle air conditioning using ozone-depleting refrigerants shall be conducted in accordance with 40 CFR 82, Subpart B. The permit holder shall ensure that repairs or refrigerant removal are performed only by properly certified technicians using approved equipment. Records shall be maintained as required by Subpart B. (c) General terms and conditions. (1) Compliance with the permit does not relieve the permit holder of the obligation to comply with any other applicable rules, regulations, or orders of the commission, or of the EPA. (2) The authorization to operate under this general operating permit shall not exceed five years from the date the authorization was granted or renewed. (3) Consistent with the authority in Texas Health and Safety Code, Chapter 382, Subchapter B (relating to Powers and Duties of Commission), the permit holder shall allow representatives from the commission or the local air pollution control program having jurisdiction to do the following: (A) enter upon the permit holder's premises where an emission unit is located or emissions-related activity is conducted, or where records must be kept under the conditions of this general operating permit; (B) access and copy any records that must be kept under the conditions of this general operating permit; (C) inspect any emission unit, equipment, practices, or operations regulated or required under this general operating permit; and (D) sample or monitor substances or parameters for the purpose of assuring compliance with this general operating permit at any time. (4) The permit holder shall comply with all terms and conditions codified in this general operating permit and any provisional terms and conditions required to be included with this general operating permit. Any noncompliance with either the permit terms and conditions or the provisional terms and conditions, if any, constitutes a violation of the FCAA and the TCAA and may be grounds for enforcement action. It shall not be a defense in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to comply with the permit terms and conditions of this general operating permit. (5) The permit holder need not comply with terms and conditions codified in this general operating permit that have been replaced by provisional terms and conditions before the granting of a new authorization to operate under this general operating permit. (6) In every case, the applicable requirements and state-only requirements are always enforceable. (7) The executive director may request any information necessary to determine compliance with this general operating permit. The permit holder shall submit the information no later than 60 days after the request, unless the deadline is extended by the executive director. (8) The permit holder shall pay fees to the commission consistent with the fee schedule in sec.101.27 of this title (relating to Emissions Fees). (9) This general operating permit does not convey any property rights of any sort, or any exclusive privilege. (10) A copy of this general operating permit, the permit application, and the authorization to operate shall be maintained at the location specified in the authorization to operate. (11) Any report or annual compliance certification required by a permit to be submitted to the executive director shall contain a certification in accordance with sec.122.165 of this title (relating to Certification by a Responsible Official). (12) State-only requirements will not be subject to any of the following requirements of this chapter: public notice, affected state review, notice and comment hearings, EPA review, public petition, recordkeeping, six-month monitoring reporting, six-month deviation reporting, compliance certification, or periodic monitoring. (d) Recordkeeping terms and conditions. (1) The permit holder shall maintain records of all required monitoring data and support information for a period of at least five years from the date of the monitoring sample, measurement, report, or application. If an applicable requirement or state-only requirement specifies a longer data retention period, the records shall be maintained for at least the period of time specified in the applicable requirement or state-only requirement. The monitoring records shall include, but are not limited to, the following: (A) the date, place as defined in this general operating permit, and time of sampling or measurements; (B) the date(s) analyses were performed; (C) the company or entity that performed the analyses; (D) the analytical techniques or methods used; (E) the results of such analyses; (F) the relevant operating conditions which are deemed necessary to characterize emission rates at the time of sampling or measurement; (G) the data from all calibration and maintenance records; (H) all strip-chart recordings for continuous monitoring instrumentation; and (I) copies of all reports required by this general operating permit. (2) Records may be stored electronically. (3) All records required to be maintained by this chapter shall be maintained at the location specified in the authorization to operate under this general operating permit. (4) Records required by this general operating permit, including confidential information, shall be provided, upon request, in a legible form, to representatives from the commission or the local air pollution control program having jurisdiction within a reasonable period of time. (5) The EPA may require that the records be sent directly to the EPA along with any claim of confidentiality. Any confidentiality claim should be made in accordance with federal law, including 40 CFR 2. (6) Permit holders shall maintain records of the duration of the stay at a site of any temporary source. (e) Reporting terms and conditions. (1) Monitoring reports. (A) Reports of monitoring data required to be submitted by an applicable requirement shall be submitted to the executive director. (B) Reports shall be submitted for at least each six-month period following the initial granting of the authorization to operate under this general operating permit or at the frequency required by an applicable requirement which requires more frequent reporting. (C) The monitoring reports shall be submitted no later than 30 days after the end of each reporting period. (D) The reporting of monitoring data does not change the data collection requirements specified in an applicable requirement. (2) Deviation reports. (A) The permit holder shall report, in writing, to the executive director all instances of deviations, the probable cause of the deviations, and any corrective actions or preventative measures taken for each emission unit addressed by the general operating permit application. (B) A deviation report shall be submitted for at least each six-month period following the initial granting of the authorization to operate under this general operating permit or at the frequency required by an applicable requirement which requires more frequent reporting. However, no report is required if no deviations occurred over the six-month reporting period. (C) The deviation reports shall be submitted no later than 30 days after the end of each reporting period. (D) If a deviation is reported, in writing, under paragraph (3) of this subsection, the deviation report need only include a reference to the unauthorized emissions, upset or maintenance, and start-up and shutdown report containing details related to the deviation. (3) Unauthorized emissions, upset or maintenance, and start-up and shutdown reports. (A) Reports of deviations resulting from any unauthorized emissions, upset or maintenance, and start-up and shutdown shall be submitted in accordance with sec.sec.101.6, 101.7, and 101.11 of this title (relating to Upset Reporting and Recordkeeping Requirements; Maintenance, Start-up and Shutdown Reporting, Recordkeeping, and Operational Requirements; and Exemptions from Rules and Regulations). (B) Nothing in this paragraph shall relieve the permit holder from submitting any deviation report in accordance with the requirements of paragraph (2) of this subsection. (f) Compliance certification terms and conditions. (1) The permit holder shall certify compliance with the terms and conditions of this general operating permit for at least each 12-month period following the initial granting of authority to operate under this general operating permit. (2) The certification shall be submitted no later than 30 days after the end of the certification period. (3) The executive director shall make a copy of the compliance certification accessible to the EPA. (4) The certification shall be based on at a minimum, the monitoring method (or recordkeeping method, if appropriate) required by this general operating permit to be used to assess compliance. (5) The annual compliance certification shall include or reference the following information: (A) the identification of each term, or condition, of this general operating permit for which the permit holder is certifying compliance and the method used for determining the compliance status of each emission unit; (B) for emission units addressed by the general operating permit application for which no deviations have occurred over the certification period, a statement that the emission units were in continuous compliance over the certification period; and (C) for any emission unit addressed by the general operating permit application for which one or more deviations occurred over the certification period, the following information indicating the potentially intermittent compliance status of the emission unit: (i) the identification of the emission unit; (ii) the applicable requirement for which a deviation occurred; (iii) the monitoring method (or recordkeeping method, if appropriate) used to assess compliance; (iv) the frequency with which sampling, monitoring, or recordkeeping was required to be conducted by the monitoring or recordkeeping requirement of this general operating permit; and (v) the total number of times that the assessment required by the monitoring or recordkeeping method specified in this general operating permit indicated that a deviation had occurred; (D) the identification of all other terms and conditions of this general operating permit for which compliance was not achieved. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 19, 1998. TRD-9804012 Kevin McCalla Director, Legal Division Texas Natural Resource Conservation Commission Effective date: April 8, 1998 Proposal publication date: November 21, 1997 For further information, please call: (512) 239-1966 TITLE 31. NATURAL RESOURCES AND CONSERVATION PART I. General Land Office CHAPTER 13.Land Resources Application to Purchase or Lease Vacant and Unsurveyed Public School Land 31 TAC sec.sec.13.71-13.86 The General Land Office (GLO) adopts new sec.sec.13.71-13.86 relating to applications to purchase or lease vacant and unsurveyed public school land under Texas Natural Resources Code, Subchapter E, with editorial changes to the proposed text as published in the February 20, 1998 issue of the Texas Register (23TexReg 1512). The new rules set forth policies and procedures relating to applications to purchase or lease vacant and unsurveyed public school land under Texas Natural Resources Code, Chapter 51, Subchapter E. Adoption of the new rules is necessary to provide the GLO and affected parties with policies and procedures to comply with Texas Natural Resources Code, Chapter 51, Subchapter E. Certain editorial changes were made to the proposed text for accuracy and clarity. In sec.13.73(b), a comma was added after the word hearing for clarity. In sec.13.77(a), several minor editorial changes were made for clarity. In sec.13.79(c), an incorrect statutory reference was corrected. In sec.13.80(c), a phrase was added to the end of the first sentence to clarify which rules of civil procedure will be applicable to the notice required under that subsection. In sec.13.80(e), a reference to this subsection was changed to this section. In sec.13.83(b), the first word of the second sentence was changed from A to That to clarify the reference. No comments were received on the proposed new rules. The new rules are proposed under Texas Natural Resources Code Annotated, sec.51.201, which authorizes the commissioner to promulgate rules relating to the purchase or lease of vacant and unsurveyed public school land and the existence of vacancies under Texas Natural Resources Code, Chapter 51, Subchapter E. sec.13.73. General Provisions/Exclusions. (a) Delegation of powers and duties. The commissioner may delegate to one or more employees of the agency the authority to perform any action of the commissioner or the agency required or permitted by this subchapter, provided however, only the commissioner may sign final orders in contested cases (as that term is defined in the Texas Government Code, Administrative Procedures Act, Chapter 2001). In the event of the death, disability, or absence of the commissioner, the official designated by law to act in such events may sign such orders. (b) Exceptions to this subchapter. The commissioner may, upon written motion from an interested person or the agency, and upon notice and opportunity for hearing, grant exceptions to the procedural provisions of this subchapter if the commissioner determines that such exceptions are in the interest of justice or the efficient administration of this subchapter. sec.13.76.Establishing Good-Faith Status (a) An applicant may assert good-faith status as to all or a portion of the land claimed to be unsurveyed public school land in the application. (b) An applicant or interested person may assert status as a good-faith claimant by filing a claim no later than the 20th day preceding the first date on which the hearing on the merits begins. (1) a claim of good-faith status shall state the grounds for the claim and describe the land subject to the applicant's or interested person's good-faith claim. (2) a person asserting good-faith status shall serve a copy of the notice of the claim filed with the commissioner on all interested persons by certified mail, return receipt requested. A person responsible for service shall return the original US Postal Service receipts and shall become their custodian. (c) An applicant or interested persons seeking good-faith status shall submit evidence of good-faith status by affidavit accompanied by certified copies of documents evidencing title. A good-faith claimant may amend an affidavit of good-faith status or file additional documents in support thereof upon the request of the commissioner or otherwise no less than 10 days preceding the date the hearing on the merits begins. Evidence of good-faith claims may include: (1) a certified copy of one or more recorded instruments, such as deeds, judgments, or other muniments of title; (2) a sworn affidavit by two disinterested third parties containing facts supporting the occupancy and use of the land claimed to be vacant by the good- faith claimant or the claimant's predecessors in interest; and (3) such other evidence deemed reliable by the commissioner. sec.13.77Priority Among Good-Faith Claimants (a) If more than one interested person files a claim of good-faith status on land claimed to be vacant or on some portion thereof, and the commissioner enters a finding that more than one claimant is a good-faith claimant under Texas Natural Resources Code sec.51.172(3), then a claimant qualifying as a good-faith claimant under sec.51.172(3)(B) shall have priority over an applicant or good-faith claimant qualifying as a good-faith claimant under sec.51.172(3)(A), and a good-faith claimant under sec.51.172(3)(C) and a good- faith claimant under sec.51.172(3)(D) shall have the lowest priority among good- faith claimants. (b) In the event the commissioner determines there are multiple good-faith claimants who desire to purchase all or a portion of property found to be vacant, unsurveyed public land, the commissioner shall apply the priority rules set forth in (a) of this section and allocate the preference right to purchase under Texas Natural Resources Code, sec.51.197 among the various good-faith claimants. The preference right to purchase may be exercised as provided in Texas Natural Resources Code, sec.51.197. sec.13.79. Appointment of Surveyor (a) No later than the 60th day after the date on which the required deposit is received by the agency, the commissioner shall appoint an eligible surveyor to survey the area claimed to be vacant. The commissioner shall select among the eligible surveyors based on the following factors: (1) the prior experience and knowledge of an eligible surveyor with the land titles in the area of the alleged vacancy; and (2) the location of an eligible surveyor in relation to the location of the alleged vacancy, with preference given to those within 100 miles of the alleged vacancy. (b) All fees and expenses, including notices and copies, shall be paid by the applicant from the initial deposit or any supplementary deposits made by the applicant in accordance with sec.13.78 of this title (relating to Deposit for Cost of Proceeding on the Application). (c) The commissioner shall provide a statement of the disposition of deposited funds at the time and in the manner provided by Texas Natural Resources Code , sec.51.177). sec.13.80. Notice of Intent to Survey (a) No later than the 10th day after the date on which the commissioner appoints the surveyor, the commissioner shall give notice of intent to survey by certified mail, return receipt requested, to all interested persons at the addresses set out in the application, along with a true and legible copy of the application. (b) The notice shall contain: (1) the date of the notice; (2) a statement that a vacancy application has been made; (3) the name, address and telephone number of the surveyor appointed to make the survey; (4) a statement that the survey may begin any time after the 20th day after the date of the notice but may be delayed by law; and (5) a statement that an interested person is entitled to: (A) observe the conduct of the survey; (B) receive a copy of the final survey report and other documents filed by the surveyor; and (C) participate in any proceedings related to the vacancy determination. (c) If the location of an interested person is unknown or if notice is returned as unclaimed or undeliverable, the commissioner shall publish notice as prescribed by the Texas Rules of Civil Procedure for persons notice to whom is returned as unclaimed or undeliverable. The foregoing does not apply if the notice is returned marked refused. (d) If notice by publication is made, the survey may not begin and further proceedings may not be held until the 30th day after publication is completed, provided however, upon receipt of a written request to proceed with the survey along with a statement by an interested person or the surveyor that the delay required by publication may materially affect the accuracy of the survey because of the possibility of the destruction, alteration, or removal of natural features, monuments, or witness objects, or for other good cause, the commissioner may enter a written order that the survey proceed prior to the 30th day after the date of the last publication of the notice. Notice of the request to proceed with the survey and of any order issued in response to the request shall be sent by the commissioner by first class mail to all interested persons. (e) The cost of providing the notices required by this section shall be paid by the applicant out of the initial deposit or any supplementary deposits made by the applicant in accordance with sec.13.78 of this title (relating to Deposit for Cost of Proceeding on the Application). (f) A person may waive service of notice as provided in Texas Natural Resources Code, sec.51.180. A waiver of notice shall be in the form prescribed by the commissioner. sec.13.83.Exceptions to Survey (a) An interested person or the agency may file exceptions or other responses to the survey report, field notes, and plat not later than the 30th day after the date the survey is accepted by the commissioner. Any interested person, or the agency, may file a reply to exceptions no later than the 20th day after the date the exceptions are filed. (b) A person filing exceptions or a reply to exceptions shall include a statement that a copy has been served by US mail, return receipt requested on each interested person, the surveyor and the agency. That person shall retain the original US Postal Service receipts and become their custodian. (c) Neither failing to file exceptions and/or replies nor filing exceptions and/or replies to original or additional survey reports, field notes, plats, or other documents prepared by the surveyor shall in any way affect or impair the right of an applicant or interested person to make exceptions to the survey at a hearing on the merits. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804139 Garry Mauro Commissioner General Land Office Effective date: April 12, 1998 Proposal publication date: February 20, 1998 For further information, please call: (512) 305-9129 TITLE 34. PUBLIC FINANCE PART V. Texas County and District Retirement System CHAPTER 107.Miscellaneous Rules 34 TAC sec.107.4 The Texas County and District Retirement System adopts new sec.107.4, concerning the establishment of rules for determining the amortization period for the funding of prior service credit, with changes to the proposed text as published in the February 6, 1998 issue of the Texas Register (23 TexReg 918). The rule is adopted for purposes of determining the amortization period upon which the prior service contribution rate must be based in accordance with the Government Code, Chapter 844, Subchapter H, sec.844.703(f). The rule will assist in providing a funding mechanism that is appropriate for the current benefit plan design and budgetary considerations of subdivisions participating in the Texas County and District Retirement System. The length of the open amortization period of 30 years as set forth in paragraph 1 of the proposed rule has been changed to 20 years. This change will allow for greater flexibility in future funding arrangements. The effect of the rule will be to provide a more orderly and consistent funding of pension benefits which in turn will produce a more stable and predictable annual pension liability. No comments were received from the public regarding adoption of the rule. This new section is adopted under the Government Code, Chapter 845, Subchapter B, sec.845.102 which provides the board of trustees with the authority to adopt rules necessary or desirable for the effective administration of the System. sec.107.4.Amortization Period. In accordance with Government Code, Chapter 844, Subchapter H, sec.844.703(f), for purposes of determining the amortization period for annually determined contribution rate (ADCR) plans, the following rules are effective for plan years beginning after December 31, 1998 based on actuarial valuations on and after December 31, 1997. 1. The prior service contribution rate prescribed by sec.844.703(b) shall be based on an open amortization period of 20 years. 2. If a subdivision has an overfunded obligation instead of an unfunded obligation in its plan, the negative prior service contribution rate prescribed by sec.844.703(b) shall be based on an open amortization period of 30 years. 3. If the governing body of a subdivision has adopted an ADCR plan and has also elected to contribute at a higher integer contribution rate as allowed by sec.844.703(d), the amortization period for the actuarially determined contribution rate shall be determined from one of the two rules stated above. The amortization period for the higher integer contribution rate shall be calculated in each annual actuarial valuation as the number of years required to amortize the unfunded obligation in that actuarial valuation, assuming that the employer contribution rate available to amortize the unfunded obligation shall be equal each year in the future, beginning one year after the actuarial valuation date, to the excess of the higher integer contribution rate over the normal cost contribution rate determined in that actuarial valuation. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 17, 1998. TRD-9803823 Terry Horton Director Texas County and District Retirement System Effective date: April 6, 1998 Proposal publication date: February 6, 1998 For further information, please call: (512) 328-8889 TITLE 40. SOCIAL SERVICES AND ASSISTANCE PART I. Texas Department of Human Services CHAPTER 48.Community Care for Aged and Disabled Medicaid Home and Community-based Waiver Services for Aged and Disables Adults Who Meet Criteria for Alternatives to Nursing Facility Care 40 TAC sec.sec.48.6092, 48.6094, 48.6096 The Texas Department of Human Services (DHS) adopts new sec.sec.48.6092, 48.6094, and 48.6096 in its Community Care for Aged and Disabled chapter. New sec.48.6094 is adopted with a change to the proposed text published in the January 23, 1998, issue of the Texas Register (23 TexReg 534). New sec.sec.48.6092 and 48.6096 are adopted without changes to the proposed text and will not be republished. The justification for the new sections is to establish provider standards and performance outcomes for service delivery. The new sections will function by establishing the performance outcomes of timely initiation of service, the use of trained providers, and services delivered in accordance with the individual plan of care. No comments were received regarding adoption of the new sections. DHS, however, is adopting sec.48.6094(a) with a change. DHS has changed the word "verbally" to "orally." The new sections are adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Government Code sec.531.021, which provides the Health and Human Services Commission with the authority to administer federal medical assistance funds. The new sections implement sec.sec.22.001-22.030 and 32.001-32.042 of the Human Resources Code. sec.48.6094.Delay of Community Based Alternatives (CBA) Home and Community Support Services (HCSS) Initiation. (a) The HCSS agency must orally notify the case manager by the next Texas Department of Human Services (DHS) work day if services cannot be initiated: (1) within seven calendar days of the effective date entered on DHS's Notification of CBA Services form, for cases in which a service initiation date was not negotiated; or (2) by the negotiated service initiation date documented on DHS's Case Information form sent to the HCSS agency by the case manager as part of the written authorization. (b) The HCSS agency must submit DHS's Case Information form to the case manager confirming verbal agreements by the next DHS work day of having negotiated a new service initiation date with the case manager. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 23, 1998. TRD-9804127 Glenn Scott General Counsel, Legal Services Texas Department of Human Services Effective date: May 1, 1998 Proposal publication date: January 23, 1998 For further information, please call: (512) 438-3765 PART III. Texas Commission on Alcohol and Drug Abuse CHAPTER 142.Investigations and Hearings 40 TAC sec.142.31, sec.142.32 The Texas Commission on Alcohol and Drug Abuse adopts amendments to sec.142.31 and sec.142.32, concerning disciplinary actions. These sections are adopted with changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 718). The amendments are adopted to clarify decision-making authority in contested cases, implement the administrative penalty provisions of Sunset legislation for counselor licensure, and further implement the administrative penalty provisions for facility licensure. Section 142.31 was revised to specify that imposition of administrative penalties may result from a licensure inspection. A number of changes were made to the proposed text of sec.142.32. In subsection (d), language was revised to clarify that the provisions regarding self-reported violations only apply to situations where licensure rules require a facility to report alleged violations. Subsections (e) and (f) were revised to establish a minimum threshold for administrative penalties when all violations fall into Categories C or D (less serious violations). The matrix referenced in subsection (e) has been changed to reflect the correct number of base points for Category C violations in all areas of the matrix. The matrices referenced in subsections (e) and (f) have also been revised to reflect a change in the evaluation of past disciplinary action for both facilities and counselors. These rules, which apply to licensed facilities and counselors, describe procedures for contested case hearings and for the application of administrative penalties. The commission received comments from the Texas Association of Substance Abuse Programs, which are summarized below. Comment: The item-by-item approach proposed has great potential for every facility to face penalties regardless of the overall quality of the program. We recommend building in a threshold that serves to capture the existence of global failure and/or triggers the assessment and application of penalties. Or, build in a positive point system for balance. Response: It is not the commission's intent to impose administrative penalties for minor infractions if a program is in substantial compliance with licensure rules. Subsections (e) and (f) of sec.142.32 have been revised to establish a minimum threshold for administrative penalties when all violations fall into Categories C or D (less serious violations). The commission will waive collection of administrative penalties if the assessed penalty is less than $1,000 (for facilities) or less than $500 (for counselors). Comment: How TCADA implements this system is one of our foremost concerns. The system has the potential for penalties to be applied for minor infractions and deficiencies. The classification of violations and the implementation are critical. We have two recommendations. First, after an initial field test period (6-8 visits), convene a provider panel to provide input on the application of the guidelines and penalty system. Secondly, organize a team that includes peer representation to review licensure reports and to assure the fair and consistent application of findings and the penalty process. This team can help to arbitrate and substantiate findings before a final determination is made. Response: The commission will convene a provider panel to review initial field testing. We believe this dialogue will be extremely helpful in assuring appropriate categorization and application of the guidelines. Our goal is to achieve substantial compliance with licensure rules, not to punish licensees for occasional minor infractions. To ensure the guidelines are applied fairly and consistently, the commission will implement an internal quality review process. We decline the suggestion to include providers who would have a role in substantiation and arbitration. The system for administrative penalties already has due process provisions that include an administrative hearing before an administrative law judge, which ensures objective external review of contested cases. Comment: It is unclear how/when the counselor licensure sanctions process will be initiated in relation to a facility investigation. It appears that a licensure investigation could result in administrative penalties against not only the facility, but the counseling staff as well. A distinction needs to be drawn between the facility and counselor review/sanctions process. Response: A facility inspection or investigation could lead to action against a counselor if the commission finds that the counselor committed a serious violation of professional standards of conduct. In such cases, however, the commission initiates a separate investigation on the counselor to clearly identify responsibility and ensure due process. Comment: We support the provision delaying collection of administrative penalties against facilities until January 1, 1999. Allowing time to field test this system and make modifications will be instrumental in the development of an effective use of penalties. Response: The commission concurs. Comment: When assessing penalties, the commission proposes considering facility history of disciplinary action during the past ten years. We believe ten years is too long. An organization may have made substantial changes such as removing staff and re-organizing. To be additionally punished for actions caused by previous management for course of ten years seems excessive. Response: The rule has been revised to reduce the period to five years. Comment: When assessing penalties, a greater penalty is attached to disciplinary action that resulted in a contested case hearing at the State Office of Administrative Hearings (SOAH) than a disciplinary action that resulted in an agreed order or voluntary surrender. This seems to represent a penalty for exercising your rights to due process and additionally does not take into consideration the outcome of the SOAH hearing. Response: The commission's intent is not to penalize licensees for exercising their rights to due process. We have revised this rule to base the number of points on the severity of the final action. Comment: We are opposed to any enforcement fee. We believe enforcement costs are incorporated in the initial licensure fee. Response: Statute requires the commission to consider enforcement costs in determining the amount of an administrative penalty. The commission does not anticipate routine follow-up visits that would result in additional cost to providers. The amendments are adopted under the Texas Health and Safety Code, Chapter 464, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to adopt rules and standards for licensure of chemical dependency treatment facilities; and under Texas Civil Statutes, Article 4510o, which provides the commission with the authority to establish procedures for the licensure of chemical dependency treatment counselors. The code affected by the new rules is the Texas Health and Safety Code, Chapter 464, and Texas Civil Statutes, Article 4512o. sec.142.31. Procedure for Facility and Chemical Dependency Counselor Disciplinary Hearings. (a) The executive director, upon investigation/inspection and development of information indicating that grounds may exist to take disciplinary action, may issue a notice of intent notifying the respondent of the proposed action to be taken. (b)-(c) (No change.) (d) At the conclusion of the informal conference, or in lieu of an informal conference, the executive director or the director's designee may offer the respondent an agreed final order. If the respondent accepts the proposed order, the matter is concluded upon concurrence of the board. If the respondent does not accept the agreed final order, the case will be scheduled for administrative hearing. (e)-(g) (No change.) (h) The board will consider the proposal for decision in all matters other than an administrative penalty for a chemical dependency counselor at a public meeting and issue an order. (i) The executive director will consider the proposal for decision regarding an administrative penalty for a chemical dependency counselor. (j)-(l) (No change.) sec.42.32. Administrative Penalties. (a) Violations are categorized according to the seriousness of the violation and the actual or potential harm to the health, safety, and welfare of the public. The commission has established specific guidelines for assigning categories. These guidelines are available for review at the commission's administrative offices at 9001 North IH 35, Suite 105, Austin, Texas, 78753. (b) Administrative penalties are not assessed for the most serious violations, which are assigned to Category A. Instead, the commission will seek to revoke or suspend the license. (c) Administrative penalties are not an option if the licensee has failed to pay administrative penalties assessed in the past. (d) Self-reported facility violations are not subject to administrative penalties provided: (1) the facility is required to report the violation; (2) the facility achieves compliance by the established deadline; and (3) the commission does not initiate a field investigation. (e) Administrative penalties for facilities are assessed using the following point system. (1) Points are assigned to each violation using the matrix shown in Figure 1: 40 TAC sec.142.32(e). (2) The point value of all violations is added and the total is multiplied by $10 per point. (3) If the total dollar value is over $5,000, the commission will seek to revoke or suspend the facility's license instead of imposing an administrative penalty. (4) The commission will waive collection of the administrative penalties if: (A) all violations fall into Category C or Category D; and (B) the total assessed dollar value is less than $1,000. (f) Administrative penalties for counselors are assessed using the following point system. (1) Points are assigned to each violation using the matrix shown in Figure 2: 40 TAC sec.142.32(f). (2) The point value of all violations is added and the total is multiplied by $12 per point. (3) If the total dollar value is over $2,000, the commission will seek to revoke or suspend the counselor's license instead of imposing an administrative penalty. (4) The commission will waive collection of the administrative penalties if: (A) all violations fall into Category C or Category D; and (B) the total assessed dollar value is less than $500. (g) When administrative penalties are recommended, the executive director shall report staff findings and recommendations to the board, including the amount of the recommended penalty. (h) The executive director shall give written notice to the licensee adversely affected within 14 days of the date the report is issued. The notice will be by certified mail. The notice shall include: (1) a brief summary of the alleged violations; (2) a statement of the amount of the recommended penalty; and (3) a notification that the licensee has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both. (i) The licensee shall accept the determination and recommended penalty or request an administrative hearing in writing within 20 days of the mailing of the notice. If the licensee accepts the determination and recommended penalty, the board shall issue an order approving both. (j) If the licensee requests an administrative hearing or fails to respond within 20 days, the executive director or the director's designee shall set a hearing before the State Office of Administrative Hearings. (k) Section 142.31 (e)-(k) of this title (relating to Procedure for Facility and Chemical Dependency Counselor Disciplinary Hearings) apply to notice of the hearing, the hearing, hearings procedures, the proposal for decision, exceptions, replies to exceptions, the commission's decision, and motions for rehearing. (l) A licensee who has not paid final administrative penalties is not eligible for licensure renewal. (m) Facilities shall not be required to pay administrative penalties under these rules until January 1, 1999. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803949 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: June 1, 1998 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 147.Approved Drug Offender Education Program General Provisions 40 TAC sec.sec.147.1-147.9 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.147.1-147.9, concerning general provisions for approved drug offender education programs, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 Tex Reg 720). The repeals are being adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections define terms used in this chapter and describe the objectives of the chapter; scope of the rules, regulations and standards; fees; program approval; program approval expiration; uniform certificates of course completion; denial, revocation, or nonrenewal of approval; and invalidity of provisions. No comments were received regarding the adoption of the repeals. The repeals are adopted under the Texas Transportation Code,sec.sec.521.374- 521.376, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved drug offender education programs. The code affected by the repealed sections is the Texas Transportation Code, sec.sec.521.374-521.376. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803906 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1998 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 Drug Offender Education Program Standards 40 TAC sec.sec.147.31-147.44 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.147.31-147.44, concerning program standards and procedures for drug offender education program standards, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 720). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections describe the program purpose, content, admission criteria, confidentiality, operational requirements, discrimination prohibitions, provisions for participants complaints, and requirements for program administrators, instructors, classroom facilities, recordkeeping and reporting. These sections also state that the commission will maintain a listing of programs and has the right to monitor programs for compliance. No comments were received regarding adoption of the repeals. The repeals are adopted under the Texas Transportation Code, sec.sec.521.374- 521.376, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved drug offender education programs. The code affected by the repealed sections is the Texas Transportation Code, sec.sec.521.374-521.376. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803910 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1998 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 149.Court Commitments SUBCHAPTER A.Civil Court Commitments 40 TAC sec.sec.149.1, 149.13, 149.15, 149.16 The Texas Commission on Alcohol and Drug Abuse adopts amendments to sec.sec.149.1, 149.13, 149.15, and 149.16, concerning civil court commitments without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 721). These amendments are being adopted to eliminate provisions repetitious of state law and to add certain programmatic elements. These sections define the terms used in this chapter, licensure and general procedures of the facilities, and the documentation requirements. No comments were received regarding adoption of these amendments. The amendments are adopted under the Texas Health and Safety Code, Chapter 461 and 462, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to adopt rules and standards for approval of chemical dependency treatment facilities to accept court commitments. The code affected by the amendments is the Texas Health and Safety Code, Chapter 461 and 462. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803950 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1998 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 40 TAC sec.sec.149.21, 149.22, 149.31, 149.32, 149.33, 149.54 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.149.21, 149.22, 149.31, 149.32, 149.33, and 149.54, concerning civil court commitments, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 723). These sections are being repealed as they are repetitious of state law. These sections describe admissions for chemical dependency emergency detention, persons court-ordered to inpatient and outpatient chemical dependency services, rights of persons apprehended for emergency detention, special rights for clients under order of protective custody, passes and furloughs. No comments were received regarding adoption of the repeals. The repeals are adopted under the Texas Health and Safety Code, Chapter 461 and 462, which provide the Texas Commission on Alcohol and Drug Abuse with the authority to adopt rules and standards for approval of chemical dependency treatment facilities to accept court commitments. The code affected by the repealed sections is the Texas Health and Safety Code, Chapter 461. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803911 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: Arpil 7, 1998 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 152.Approved Alcohol Awareness Program General Provisions 40 TAC sec.sec.152.1-152.8 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.152.1-152.8, concerning general provisions for approved alcohol awareness programs, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 Tex Reg 723). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections define terms used in this chapter and describe the objectives of the chapter; scope of the rules, regulations, and standards; program approval; approved program renewal; denial, revocation, or nonrenewal of approval; invalidity of provisions; and fees. No comments were received regarding the adoption of the repeals. The repeals are adopted under the Texas Alcoholic Beverage Code, sec.106.115, and Texas Health and Safety Code, sec.461.012(18) which provide the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved alcohol awareness programs. The codes affected by the repealed sections are the Texas Alcoholic Beverage Code, sec.106.115, and Texas Health and Safety Code, sec.461.012(18). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803916 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 Alcohol Awareness Program Standards 40 TAC sec.sec.152.20-152.33 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.152.20-152.33, concerning program standards for alcohol awareness programs, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 724). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections describe the purpose of approved program, program content, curriculum criteria, program admission, confidentiality, program operation requirements, discrimination prohibitions, provisions for participant complaints, and requirements for program administrators, instructors, classroom facilities, recordkeeping and reporting. These sections also state that the commission will maintain a listing of programs and has the right to monitor programs for compliance. No comments were received regarding adoption of the repeals. The repeals are adopted under the Texas Alcoholic Beverage Code, sec.106.115, and Texas Health and Safety Code, sec.461.012(18) which provide the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved alcohol awareness programs. The codes affected by the repealed sections are the Texas Alcoholic Beverage Code, sec.106.115, and Texas Health and Safety Code, sec.461.012(18). This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803914 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 153.DWI Education Program Standards and Procedures General Provisions 40 TAC sec.sec.153.1-153.19 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.153.1-153.19, concerning general provisions for approved drug offender education programs, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 724). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections define terms used in this chapter and describe the objective of the chapter; scope of the rules, regulations, and standards; program certification; certification renewal; denial or revocation of certification; exceptions from the provisions of the standards; invalidity of provisions; opinions and advice; precedent; initiation, notice; hearings; petitions of interested persons; validity; terminology; complaint procedures; discrimination prohibited; and fees. The repeals are adopted under the Texas Code of Criminal Procedure, Article 42.12, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved driving while intoxicated education programs. The code affected by the repealed sections is the Texas Code of Criminal Procedure, Article 42.12. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803913 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 General Provisions and Procedures 40 TAC sec.sec.153.1, 153.2, 153.4-153.8 The Texas Commission on Alcohol and Drug Abuse adopts new sec.sec.153.1, 153.2, and 153.4-153.8, concerning offender education programs. Sections 153.1, 153.4, 153.5, 153.7, and 153.8 are adopted with changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 726). Section 153.2 and sec.153.6 are adopted without changes to the proposed text and will not be republished. Proposed sec.153.3 (relating to fees) has been withdrawn. These rules are being adopted to establish definitions; confirm the scope of the rules; set requirements for the application and approval/certification process, expiration and renewal of certification; establish stipulations for exceptions to the standards; institute sanctions; and describe the process for disciplinary hearings. Some changes have been to improve clarity and readability. A summary of the changes to the rules follows. Throughout these rules, the term Alcohol Awareness Program has been changed to Alcohol Education Program for Minors. This change was made to reflect the current, official title of this program. The definition of Alcohol Education Program for Minors was modified to include education of participants on laws relating to minors driving under the influence of alcohol. The definition of class roster was changed to more correctly reflect the purpose of this form. Section 153.7 was modified to affirm the commission's authority to monitor programs and to clarify that sanctions include denial of program renewal. The new sections are adopted to consolidate into one chapter the requirements for programs to become an approved or certified offender education program. The new sections establish the requirements for programs to become an offender education program approved or certified by the Texas Commission on Alcohol and Drug Abuse. No comments were received regarding the adoption of the new sections. These rules are adopted under the Texas Transportation Code, sec.sec.521.374- 521.376, the Texas Alcoholic Beverage Code, sec.106.115, the Texas Health and Safety Code, sec.461.012(18), and the Texas Code of Criminal Procedure, Article 42.12, which provide the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules setting forth minimum standards for the approval or certification of offender education programs. The codes affected by the new rules are the Texas Transportation Code sec.sec.521.374-521.376, the Texas Alcoholic Beverage Code, sec.106.115, the Texas Health Safety Code, sec.461.012(18), and the Texas Code of Criminal Procedure, Article 42.12. sec.153.1. Definitions. The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly states otherwise. Alcohol education program for minors - The educational program for minors approved by the commission as set forth under this chapter, and authorized by Texas Alcoholic Beverage Code, sec.106.115. The program is designed to: (A) present information to participants on the effects of alcohol upon behavior and upon the lives of persons who use alcohol; (B) help participants identify their own drinking patterns or problems; (C) educate participants about the laws relating to possession, consumption, and purchase of alcoholic beverages and laws relating to minors driving under the influence of alcohol; and (D) assist participants in developing a plan to reduce the probability of involvement in future alcohol-related illegal behavior or detrimental activity. Approval period - That period of time beginning with the date approval (of a Drug Offender Education Program, Alcohol Education Program for Minors, or DWI Intervention Program) was granted and ending August 31 of every odd-numbered year. Branch office/site - An additional site which is located in the same county as the program headquarters or in an adjacent county where the approved Offender Education Program operates a program in compliance with this chapter. Certificates of course completion - Uniform certificates of completion issued by the Texas Commission on Alcohol and Drug Abuse which are serially numbered and provided to approved/certified programs for dissemination to program participants. Certification period - That period of time beginning with the date certification (of a DWI Education Program) was granted and ending August 31 of every even- numbered year. Class records - Personal data forms, pre- and post-tests, self-assessments, screening instrument(s), homework assignments, action plans, and any other written material required or used in the class instruction. Class roster - A form used to record data on all participants enrolled and in attendance at the first class session and to record data on those participants throughout the course. Class size - The number of participants officially enrolled and in attendance at each class session. Commission - The Texas Commission on Alcohol and Drug Abuse. Continuing education hour - At least 50 minutes of participation in an organized, systematic learning experience which deals with and is designed for the acquisition of knowledge, skills, and information on drug-related topics. Drug offender - A person convicted of: (A) a misdemeanor or felony offense under the Controlled Substances Act (United States Code, Title 21, sec.321 et seq.); (B) a drug offense as assigned by United States Code, Title 23, sec.159(c); (C) an offense under the Texas Penal Code, sec.sec. 49.04 - 49.09, committed as a result of the introduction into the body of any substance the possession of which is prohibited under the Controlled Substances Act; or (D) a felony under the Texas Health and Safety Code, Chapter 481, that is not a drug offense. Drug offender education program - The educational program for convicted drug offenders approved by the commission as set forth in this chapter, and authorized under Texas Transportation Code, sec.512.374. The program is designed to: (A) educate participants on the dangers of drug use/abuse and associated illegal activities; (B) provide information on the effects of drug use/abuse and related illegal activities on personal, family, social, economic and community life; (C) assist participants in evaluating their own abusive patterns connected with their use of drugs or associated illegal activities; and (D) assist participants in developing a plan for positive lifestyle changes to reduce chances of being involved in future drug use/abuse and related illegal behaviors. DWI - The offense of driving while intoxicated as defined in the Texas Penal Code, Chapter 49. DWI certification committee - A standing committee comprised of at least one representative of each of the four approving agencies: the Texas Commission on Alcohol and Drug Abuse (TCADA); the Department of Public Safety (DPS); the Texas Department of Transportation (TxDOT); and the Texas Department of Criminal Justice, Community Justice Assistance Division (CJAD). The committee's purposes are to approve or disapprove applications for program certification/recertification and waiver requests promulgated by Code of Criminal Procedure, Article 42.12, sec.13(h), and to serve as a resource for recommendations on rule changes to the governing board of the Texas Commission on Alcohol and Drug Abuse. DWI education program - The educational program for individuals convicted of DWI approved by the commission as set forth in this chapter, and authorized under Texas Code of Criminal Procedure, Article 42.12, sec.13(h). The program is designed to: (A) present information on the effects of alcohol and other drugs on driving skills; (B) help participants identify their own individual drinking or drugged driving patterns; and (C) assist participants in developing a plan to reduce the probability that they will be involved in future DWI behavior. DWI intervention program - The educational program for DWI repeat offenders which has been approved by the commission as set forth in this chapter, and authorized under Texas Code of Criminal Procedures, Article 42.12, sec.13(j). The program is designed to: (A) educate participants about chemical dependency and the problems associated with chemical dependency; (B) provide intensive instruction about specific actions participants can take to prevent future DWI offenses; and (C) instruct participants about methods and ways to make necessary lifestyle changes in order to prevent alcohol/drug-related problems in other areas of the participants' lives. Minor - A person under the age of 21 years. Program headquarters - The primary administrative center of the approved program identified as the business address in the application. Offender education program - The Alcohol Education Program for Minors, Drug Offender Education Program, DWI Education Program, or DWI Intervention Program approved under this chapter. Reporting period - That period of time beginning with the date program approval was granted and ending August 31 of each year. Screening instrument - A written device approved by the commission and administered to each program participant for the purpose of: (A) identifying indicators of a potential substance abuse problem; and (B) making recommendations for further evaluation, where indicated. sec.153.4. Application and Approval/Certification. (a) The program seeking approval (applicable to Drug Offender Education Programs, Alcohol Education Program for Minors, and DWI Intervention Programs) or certification (applicable to DWI Education Programs) shall submit the application fee and the application form prescribed by the commission. (b) When the program has met all requirements set forth in this chapter, the commission will issue a certificate. A certificate for a DWI Education Program will not be issued until the DWI Certification Committee approves the application. (c) A certificate of approval becomes effective on the first day of the following month after approval and expires on August 31 of every odd-numbered year. A DWI Education certificate becomes effective on the first day of the following month after certification and expires on August 31 of every even- numbered year. (d) A certificate shall be prominently displayed at each location where services are provided. (e) The program shall obtain a duplicate certificate from the commission for each branch site. Branch sites shall be located in the same county as the program headquarters or in an adjacent county. Each branch office or program site must have a local address and telephone number for participants to register and obtain information. (f) The organization must submit a separate application and application fee to operate the program at a site that is not located in the same county as the program headquarters or in an adjacent county. The new application shall designate a program headquarters and may establish branch sites. sec.153.5. Expiration and Renewal. (a) At least 30 days before the certificate's expiration date, a program seeking renewal shall submit the application fee and the application form prescribed by the commission. (b) Applicants for renewal must demonstrate continued compliance with applicable requirements. (c) When the program has met all renewal requirements, the commission will issue a certificate. A certificate for a DWI Education Program will not be issued until the DWI Certification Committee approves the renewal application. (d) Renewal of a Drug Offender Education Program, Alcohol Education Program for Minors, or DWI Intervention Program becomes effective on September 1st of the year of renewal, and expires on the 31st day of August of every odd numbered year. Renewal of a DWI Education Program becomes effective on September 1st of the year of renewal and expires on the 31st day of August of every even-numbered year. (e) Programs which fail to obtain renewal before the expiration date must submit a new application as required in sec.153.4 of this title (relating to Application and Approval/Certification). sec.153.7. Sanctions. The commission may monitor a program at anytime. Any violation of the requirements of this chapter shall be considered sufficient cause for revocation or denial of program approval, certification, or renewal. sec.153.8. Procedure for Disciplinary Hearings. (a) When the commission has substantiated information indicating that a violation has been committed, the commission may issue a notice of intent to take disciplinary action. The notice shall state the alleged violation(s) and the action to be taken. (b) The respondent may request an informal conference no later than 20 days following the day the notice of intent was mailed. (c) If the commission receives a timely request for an informal conference, the conference will be scheduled before the executive director or the director's designee. At the conference the respondent will be given the opportunity to show compliance with all requirements of law and why the proposed action should not be taken. (d) At the conclusion of the informal conference, or in lieu of an informal conference, the executive director or the director's designee may offer the respondent an agreed final order. If the respondent accepts the proposed order, the matter is concluded upon concurrence of the board. If the respondent does not accept the agreed final order, the executive director or the director's designee shall prepare a proposed order. (e) The board will consider the proposed order regarding a program and issue a final order. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803951 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 153.DWI Education Program Standards and Procedures DWI Education Program Standards 40 TAC sec.sec.153.31-153.42 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.153.31-153.42, concerning program standards and procedures for drug offender education program standards, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 725). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections describe the program purpose, content, admission and readmission criteria, confidentiality, operational requirements, and requirements for program administrators, staff, facilities, fiscal, and recordkeeping and reporting. These sections also state that the commission has the right to monitor programs for compliance. The repeals are adopted under the Texas Transportation Code, sec.sec.521.374- 521.376, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved drug offender education programs. The code affected by the repealed sections is the Texas Transportation Code, sec.sec.521.374-521.376. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803959 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 153.Offender Education Programs Program Standards 40 TAC sec.sec.153.32-153.36, 153.41-153.44, 153.51-153.55 The Texas Commission on Alcohol and Drug Abuse adopts new sec.sec.153.32-153.36, 153.41-153.44, and 153.51-153.55, concerning program standards for offender education programs. Sections 153.43, 153.44, 153.53 and 153.54 are adopted with changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 728). Sections 153.32-153.36, 153.41, 153.42, 153.51, 153.52, and 153.55 are adopted without changes and will not be republished. These rules are being adopted to describe the program content and materials, uniform certificates of completion, confidentiality, discrimination prohibited, procedures to resolve participant complaints, classroom facilities and equipment, program administration, recordkeeping and reporting, program instructors, general program operation requirements, and additional requirements for Drug Offender Education Programs, Alcohol Education Program for Minors, DWI Education Programs, and DWI Intervention Programs. Some changes have been to improve clarity and readability. A summary of the changes to the rules follows. Throughout these rules, the term Alcohol Awareness Program has been changed to Alcohol Education Program for Minors. This change was made to reflect the current, official title of this program. Changes were made to sec.153.43(a) to clarify the minimum data collection requirements for each of the offender education programs. The proposed sec.153.54(e) was deleted as it described a requirement of probationers rather than a program requirement. The new sections are adopted to consolidate into one chapter the requirements for programs to become an approved or certified offender education program. The new sections establish the program standards for offender education programs approved or certified by the Texas Commission on Alcohol and Drug Abuse. No comments were received regarding the adoption of the proposed sections. The new sections are proposed under the Texas Transportation Code, sec.sec.521.374-521.376, the Texas Alcoholic Beverage Code, sec.106.115, the Texas Health and Safety Code, sec.461.012(18), and the Texas Code of Criminal Procedure, Article 42.12, which provide the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules setting forth minimum standards for the approval or certification of offender education programs. The codes affected by the proposed rules are Texas Transportation Code, sec.sec.521.374-521.376, the Texas Alcoholic Beverage Code, sec.106.115, the Texas Health and Safety Code, sec.461.012(18), and the Texas Code of Criminal Procedure, Article 42.12. sec.153.43. Recordkeeping and Reporting. (a) The program administrator shall be responsible for collecting and maintaining all required data on each class participant. (1) All programs shall collect the following information: (A) name; (B) street address, city, and zip code; (C) date of birth; (D) sex; (E) driver's license number (if any); (F) grade in school or educational level achieved; (G) present employment; (H) date of enrollment; (I) date of course completion; (J) attendance record; and (K) certificate of completion number. (2) Drug Offender Education Programs and DWI Education Programs shall also collect the following information: (A) individual pre-and post-test scores ; (B) pre- and post-test class averages; (C) percent of knowledge increase; (D) screening instrument utilized; (E) screening instrument indicator codes/scores; and (F) referral recommendations. (3) DWI Intervention Programs shall also collect: (A) blood alcohol level at time of arrest (if known); (B) number of prior alcohol/drug-related arrests; (C) documentation that the agreement form, AA attendance, family/significant other attendance, individual sessions, and exit interview requirements were completed as outlined in the Texas DWI Intervention Program Manual; (D) screening instrument utilized; (E) screening instrument indicator codes/scores; and (F) referral recommendations. (4) Alcohol Education Program for Minors shall also collect: (A) the name of the referring judge; (B) individual pre- and post-test scores; (C) pre- and post-test class averages; and (D) percent of knowledge increase. (b) Class rosters and copies of the issued certificates of completion shall be retained by the program administrator for at least three years from the date of course completion. All other records shall be retained for a period of one year from the date of course completion. (c) The following items shall be submitted to the commission by September 15 of each year: (1) total number of participants entering the course; (2) total number of participants successfully completing the course; (3) total number of courses held annually; (4) names of all certified instructors employed by the program and number of courses each conducted during the annual reporting period; (5) driver's license numbers of all participants, or, in the absence of a driver's license number, the date of birth of each participant completing the course; (6) average percent of knowledge increase from pre-test to post-test for all courses conducted during the reporting period (not required for DWI Intervention Programs); (7) percent of total participants indicating significant substance abuse problem as defined in the required screening procedure (not required for Alcohol Education Program for Minors); and (8) the number of participants who entered treatment as a result of participation (required for DWI Intervention Programs only). (d) The program administrator shall notify the commission within 30 days of any change in address, telephone number, or change of program administrator or instructors. sec.153.44.Program Instructors. (a) All program instructors must: (1) be certified instructors who have successfully completed the applicable administrator/instructor offender education training program approved by the commission; (2) possess good communication skills and have demonstrated instructional ability; (3) have the ability to use a variety of teaching strategies; (4) serve as a resource manager by referring participants to a full range of community services as needed; and (5) keep the commission informed of their current mailing address at all times. (b) Instructors in Alcohol Education Program for Minors and DWI Intervention Programs must teach at least one complete course during the annual reporting period to retain certification. (c) If an instructor's certification lapses due to failure to comply with applicable requirements, the instructor must repeat and successfully complete the applicable initial administrator/instructor training program.. sec.153.53. Additional Requirements for Alcohol Education Program for Minors. (a) Instructors shall conduct a minimum of one complete course during the annual reporting period. (b) The program shall: (1) conduct the course a minimum of two times during each reporting period; (2) provide a minimum of six hours of class instruction per course; (3) conduct class sessions which are not longer than three hours in length; (4) conduct no more than one class session per day; and (5) conduct classes no larger than 25 participants (not including parents and guardians) (c) The program shall administer and evaluate pre-and post-test instruments for each participant. sec.153.54. Additional Requirements for DWI Education Programs. (a) Each instructor must teach a minimum of two complete courses (24 hours) and successfully complete the Texas DWI Education Inservice Training Program approved by the commission during the instructor's certification period. (b) The program shall: (1) conduct the program a minimum of two times during each reporting period; (2) provide a minimum of 12 hours of instruction per course. (3) provide no more than four hours of instruction in any one day; and (4) conduct classes no larger than 30 participants. (c) The program shall administer and evaluate pre-and post-test instruments for each participant. (d) Within ten working days after completion of the course and/or exit interview, the program shall forward the following information to the appropriate community supervision and corrections department and/or other referral resources(s): (1) recommendation resulting from administration of the screening instrument; and (2) notice of completion of the program. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803952 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 CHAPTER 154.DWI Repeat Offender Program Standards and Procedures General Provisions 40 TAC sec.sec.154.1-154.8 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.154.1-154.8, concerning general provisions for DWI repeat offender education programs, without changes to the proposed text as published in the January 30, 1998, issue of the Texas Register (23 TexReg 731). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections define terms used in this chapter and describe the objective of the chapter; scope of the rules, regulations, and standards; program approval and renewal; denial, revocation, or nonrenewal of approval; invalidity of provisions; and fees. No comments were received regarding adoption of the repeals. The repeals are adopted under the Texas Code of Criminal Procedure, Article 42.12, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved driving while intoxicated education programs. The code affected by the repealed sections is the Texas Code of Criminal Procedure, Article 42.12. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803947 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794 DWI Repeat Offender Program Standards and Procedures 40 TAC sec.sec.154.20-154.32 The Texas Commission on Alcohol and Drug Abuse adopts the repeal of sec.sec.154.20-154.32 concerning program standards and procedures for DWI repeat offender education programs, without changes to the proposed text as published in the January 30, 1998 issue of the Texas Register (23 TexReg 732). The repeals are adopted because the rules for the various offender education programs are being updated and consolidated into one chapter. These sections describe the program purpose, content, admission criteria, confidentiality, operational requirements, discrimination prohibitions, provisions for participant complaints, and requirements for program administrators, instructors, classroom facilities, recordkeeping and reporting. These sections also state that the commission will maintain a listing of programs and has the right to monitor programs for compliance. No comments were received regarding adoption of the repeals. The repeals are adopted under the Texas Code of Criminal Procedure, Article 42.12, which provides the Texas Commission on Alcohol and Drug Abuse with the authority to promulgate written rules and regulations setting forth minimum standards for the operation of approved driving while intoxicated education programs. The code affected by the repealed sections is the Texas Code of Criminal Procedure, Article 42.12. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Filed with the Office of the Secretary of State on March 18, 1998. TRD-9803948 Mark S. Smock Deputy for Finance and Administration Texas Commission on Alcohol and Drug Abuse Effective date: April 7, 1997 Proposal publication date: January 30, 1998 For further information, please call: (512) 349-6794