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 16. ECONOMIC REGULATION PART I. Railroad Commission of Texas CHAPTER 11. Surface Mining and Reclamation Division SUBCHAPTER D. Coal Mining 16 TAC sec.11.221 The Railroad Commission of Texas adopts the repeal of 16 TAC sec.11.221, relating to state program regulations, without changes to the proposed text published in the January 10, 1997, issue of the Texas Register (22 TexReg 428). The Commission proposes the repeal for the sole purpose of renumbering the existing regulations (now adopted by reference) and incorporating the text into the Texas Administrative Code. No requirements are being added to or deleted from the existing coal mining and reclamation regulations. No comments were received on the proposed repeal. The repeal is adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703671 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 CHAPTER 12. Surface Mining and Reclamation Division The Railroad Commission of Texas adopts new sec.sec.12.1-12.7, 12.9, 12.10, 12.12-12.19, 12.21-12.23, 12.69, 12.71-12.73, 12.75-12.85, 12.100-12.163, 12.170-12.205, 12.207-12.223, 12.225-12.234, 12.236-12.243, 12.300-12.304, 12.306, 12.307, 12.312-12.314, 12.317, 12.325-12.328, 12.330-12.360, 12.362, 12.364-12.393, 12.395-12.403, 12.500-12.528, 12.530, 12.532-12.572, 12.600, 12.610-12.613, 12.620-12.622, 12.624, 12.625, 12.650, 12.651, 12.660, 12.661, 12.670-12.675, 12.677-12.684, 12.686-12.694, 12.696-12.699, 12.700, 12.702- 12.706, 12.708-12.710, and 12.800-12.817, and sec.sec.12.308-12.311, relating to regulation of coal mining and reclamation and the Texas Abandoned Mine Land Reclamation Program, without changes to the versions published in the January 10 and 21, 1997, issues of the Texas Register (22 TexReg 429 and 879, respectively). The text will not be republished. The Commission adopts new sec.sec.12.363, 12.531, 12.687 and 12.707, relating to regulation of coal mining and reclamation, with only format changes to the versions published in the January 10, 1997, issue of the Texas Register (22 TexReg 429). The Commission proposes the new sections for the sole purpose of renumbering the existing regulations (now adopted by reference) and incorporating the text into the Texas Administrative Code. No requirements are being added to or deleted from the existing coal mining and reclamation regulations. No comments were received within the 30-day comment period; however, after the comment period, one commenter indicated sec.12.350(b)(1)(B) made more sense in the original wording than the new wording and that the new wording is unclear. The commission does not concur. The amendments to sec.12.350(b)(1)(B) deleted a redundant "shall" that existed in the current text of the coal mining regulations because it made the sentence grammatically incorrect. The commenter also noted without comment that sec.12.3 replaces 700.003 and 701.008. The commenter also remarked about formatting of a version of the proposed rules mailed to interested persons by the Railroad Commission of Texas. These comments were outside the scope of the rules as proposed in the Texas Register, but may be considered in future rulemakings. The following individuals commented on these proposed rules and did not indicate either support or opposition: Northwestern Resources Co. SUBCHAPTER A. General 16 TAC sec.sec.12.1-12.7 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703674 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Permanent Regulatory Program 16 TAC sec.12.9 The new rule is adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703716 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Restriction of Financial Interests of State Employees 16 TAC sec.sec.12.10, 12.12-12.19 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703715 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Exemption for Coal Extraction Incident to Government-Financed Highway or Other Construction 16 TAC sec.12.21, sec.12.22 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703713 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Awards of Costs and Expenses 16 TAC sec.12.23 The new rule is adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703712 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER F. Lands Unsuitable for Mining General 16 TAC sec.12.69 The new rule is adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703711 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Areas Designed by Act of Congress 16 TAC sec.12.71, sec.12.72 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703710 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Criteria for Designating Areas as Unsuitable for Surface Coal Mining Operations 16 TAC sec.sec.12.73, 12.75-12.77 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703709 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Process for Designating Areas as Unsuitable for Surface Coal Mining Operations 16 TAC sec.sec.12.78-12.85 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703708 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER G. Surface Coal Mining and Reclamation Operations, Permits, and Coal Exploration Procedures Systems General Requirements for Permit and Exploration Procedure Systems Under Regulatory Programs 16 TAC sec.12.100, sec.12.102 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703707 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 General Requirements for Permits and Permit Applications 16 TAC sec.sec.12.103-12.108 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703706 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 General Requirements for Coal Exploration 16 TAC sec.sec.12.109-12.115 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703705 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Surface Mining Permit Applications--Minimum Requirements for Legal, Financial, Compliance, and Related Information 16 TAC sec.sec.12.116-12.123 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703704 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Surface Mining Permit Applications-Minimum Requirements for Information on Environmental Resources 16 TAC sec.sec.12.124-12.138 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703703 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Surface Mining Permit Applications-Minimum Requirements for Reclamation and Operation Plan 16 TAC sec.sec.12.139-12.154 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703702 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Surface, Mining Permit Applications-Minimum Requirements for Legal, Financial, Compliance, and Related Information 16 TAC sec.sec.12.155-12.163 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703701 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Underground Mining Permit Applications-Minimum Requirements for Information on Environmental Resources 16 TAC sec.sec.12.170-12.184 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703700 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Underground Mining Permit Applications-Minimum Requirements for Reclamation and Operation Plan 16 TAC sec.sec.12.185-12.199 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703699 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Requirements for Permits for Special Categories of Mining 16 TAC sec.sec.12.200-12.205 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703698 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Review, Public Participation, and Approval of Permit Applications and Permit Terms and Conditions 16 TAC sec.sec.12.207-12.221 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703697 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Administrative and Judicial Review of Decisions by the Commission on Permit Applications 16 TAC sec.12.222, sec.12.223 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703696 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Permit Reviews, Revisions, and Renewals, and Transfers, Sale, and Assignment of Rights Granted Under Permits 16 TAC sec.sec.12.225-12.233 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703695 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Small Operator Assistance 16 TAC sec.sec.12.234, 12.236-12.243 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703694 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER J. Bond and Insurance Requirements for Surface Coal Mining and Reclamation Operations General Requirements for Insurance and Bonding of Surface Coal Mining and Reclamation Operations Under Regulatory Program 16 TAC sec.sec.12.300-12.303 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703693 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Amount and Duration of Performance Bond 16 TAC sec.sec.12.304, 12.306, 12.307 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703692 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Form, Conditions, and Terms of Performance Bond and Liability Insurance 16 TAC sec.sec.12.308-12.311 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703691 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 21, 1997 For further information, please call: (512) 463-7008 Procedures, Criteria, and Schedule for Release of Performance Bond 16 TAC sec.12.312, sec.12.313 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703690 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Performance Bond Forfeitures Criteria and Procedures 16 TAC sec.12.314, sec.12.317 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703689 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER K. Permanent Program Performance Standards Permanent Program Performance Standards-Coal Exploration 16 TAC sec.sec.12.325-12.328 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703688 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Permanent Program Performance Standards - Surface Mining Activities 16 TAC sec.sec.12.330-12.360, 12.362-12.393, 12.395-12.403 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. sec.12.363. Disposal of Excess Spoil: General Requirements. (a) Spoil not required to achieve the approximate original contour within the area where overburden has been removed shall be hauled or conveyed to and placed in designated disposal areas within a permit area, if the disposal areas are authorized for such purposes in the approved permit application in accordance with this section and sec.sec.12.364 through 12.366 of this title (relating to Disposal of Excess Spoil: Valley Fills, Disposal of Excess Spoil: Head-of-Hollow Fills, and to Disposal of Excess Spoil: Durable Rock Fills). The spoil shall be placed in a controlled manner to ensure: (1) that leachate and surface runoff from the fill will not degrade surface or ground waters or exceed the effluent limitations referenced in sec.12.340 of this title (relating to Hydrologic Balance: Water-Quality Standards and Effluent Limitations); (2) stability of the fill; and (3) that the land mass designated as the disposal area is suitable for reclamation and revegetation compatible with the natural surroundings. (b) The fill shall be designed using recognized professional standards, certified by a registered professional engineer, and approved by the Commission. (c) All vegetative and organic materials shall be removed from the disposal area and the topsoil shall be removed, segregated, and stored or replaced under sec.sec.12.334 through 12.338 of this title (relating to Topsoil: General Requirements, to Topsoil: Removal, to Topsoil: Storage, to Topsoil: Redistribution, and to Topsoil: Nutrients and Soil Amendments). If approved by the Commission, organic material may be used as mulch or may be included in the topsoil to control erosion, promote growth of vegetation, or increase the moisture retention of the soil. (d) Slope protection shall be provided to minimize surface erosion at the site. Diversion design shall conform with the requirements of sec.12.341 of this title (relating to Hydrologic Balance: Diversions and Conveyance of Overland Flow and Shallow Ground-Water Flow, and Ephemeral Streams). All disturbed areas, including diversion ditches that are not riprapped, shall be vegetated upon completion of construction. (e) The disposal areas shall be located on the most moderately sloping and naturally stable areas available as approved by the Commission. If such placement provides additional stability and prevents mass movement, fill materials suitable for disposal shall be placed upon or above a natural terrace, bench, or berm. (f) The spoil shall be hauled or conveyed and placed in horizontal lifts in a controlled manner, concurrently compacted as necessary to ensure mass stability and prevent mass movement, covered, and graded to allow surface and subsurface drainage to be compatible with the natural surroundings and ensure a long-term static safety factor of 1.5. (g) The final configuration of the fill must be suitable for postmining land uses approved in accordance with sec.12.399 of this title (relating to Postmining Land Use), except that no depressions or impoundments shall be allowed on the completed fill. (h) Terraces may be utilized to control erosion and enhance stability if approved by the Commission and consistent with sec.12.385(b) of this title (relating to Backfilling and Grading: General Grading Requirements). (i) Where the slope in the disposal area exceeds 2.8h:1v (36%), or such lesser slope as may be designated by the Commission based on local conditions, keyway cuts (excavations to stable bedrock) or rock toe-buttresses shall be constructed to stabilize the fill. Where the toe of the spoil rests on a downslope, stability analyses shall be performed in accordance with sec.12.153(c) of this title (relating to Disposal of Excess Spoil) to determine the size of rock toe- buttresses and key-way cuts. (j) The fill shall be inspected for stability by a registered professional engineer, or other qualified professional specialist under the direction of the professional engineer, experienced in the construction of earth and rockfill embankments, at least quarterly throughout construction and during the following critical construction periods: (1) removal of all organic material and topsoil; (2) placement of underdrainage systems and protective filter systems; (3) installation of surface drainage systems; (4) placement and compaction of fill materials; and (5) revegetation. (k) The registered professional engineer shall provide to the Commission a certified report, within 2 weeks after each inspection, that the fill has been constructed as specified in the design approved by the Commission. The certified report on the drainage system and protective filters shall include color photographs taken during and after construction, but before underdrains are covered with excess spoil. If the underdrain system is constructed in phases, each phase shall be certified separately. A copy of the report shall be retained at the minesite. (l) Coal processing wastes shall not be disposed of in head-of-hollow or valley fills, and may only be disposed of in other excess spoil fills, if such waste is: (1) placed in accordance with sec.12.371 of this title (relating to Coal Processing Waste Banks: General Requirements); (2) demonstrated to be non-toxic and non-acid-forming; and (3) demonstrated to be consistent with the design stability of the fill. (m) If the disposal area contains springs, natural or manmade watercourses, or wet-weather seeps, an underdrain system consisting of durable rock shall be constructed from the wet areas in a manner that prevents infiltration of the water into the spoil material. The underdrain system shall be protected by an adequate filter and shall be designed and constructed using standard geotechnical engineering methods. Where excess durable rock spoil is placed in single or multiple lifts such that the underdrain system is constructed simultaneously with excess spoil placement by the natural segregation of dumped materials, color photographs shall be taken of the underdrain as the underdrain system is being formed. (n) The foundation and abutments of the fill shall be stable under all conditions of construction and operation. Sufficient foundation investigation and laboratory testing of foundation materials shall be performed in order to determine the design requirements for stability of the foundation. Analyses of foundation conditions shall include the effect of underground mine workings, if any, upon the stability of the structure. (o) Excess spoil may be returned to underground mine workings, but only in accordance with a disposal program approved by the Commission and MSHA upon the basis of a plan submitted under sec.12.193 of this title (relating to Underground Development Waste/Return of Coal Processing Waste to Abandoned Underground Workings). (p) Excess spoil that is acid-forming or toxic-forming or combustible shall be adequately covered with non-acid, non-toxic and noncombustible material, or treated, to control the impact on surface and ground water in accordance with this chapter (relating to Coal Mining Regulations), to prevent sustained combustion and to minimize adverse effects on plant growth and the approved postmining land use. (q) The photographs required by this section to accompany each certified report shall be taken in adequate size and number with enough terrain or other physical features of the site shown to provide a relative scale to the photographs and to specifically and clearly identify the site. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703687 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Permanent Program Performance Standards - Underground Mining Activities 16 TAC sec.sec.12.500-12.528, 12.530-12.572 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. sec.12.531. Disposal of Underground Development Waste and Excess Spoil: General Requirements. (a) Underground development waste and spoil not required to achieve the approximate original contour and which is not used as backfill shall be hauled or conveyed to and placed in designated disposal areas within a permit area if the disposal areas are authorized for such purposes in the approved permit application in accordance with this section and sec.sec.12.532 through 12.534 of this title (relating to Disposal of Underground Development Waste and Excess Spoil: Valley Fills, to Disposal of Underground Development Waste and Excess Spoil: Head-of-Hollow fills, and to Disposal of Underground Development Waste and Excess Spoil: Durable Rock Fills). The material shall be placed in a controlled manner to ensure: (1) that leachate and surface runoff from the fill will not degrade surface or ground waters or exceed the effluent limitations referenced in sec.12.510 of this title (relating to Hydrologic Balance: Water-Quality Standards and Effluent Limitations); (2) stability of the fill; and (3) that the land mass designated as the disposal area is suitable for reclamation and revegetation compatible with the natural surroundings. (b) The fill shall be designed using recognized professional standards, certified by a registered professional engineer, and approved by the Commission. (c) All vegetative and organic materials shall be removed from the disposal area and the topsoil shall be removed, segregated and stored or replaced in accordance with sec.sec.12.504 through 12.508 of this title (relating to Topsoil: General Requirements, to Topsoil: Removal, to Topsoil: Storage, to Topsoil: Redistribution, and to Topsoil: Nutrients and Soil Amendments). If approved by the Commission, organic material may be used as mulch or may be included in the topsoil to control erosion, promote growth of vegetation, or increase the moisture retention of the soil. (d) Slope protection shall be provided to minimize surface erosion at the site. Diversion design shall conform with the requirements of sec.12.511 of this title (relating to Hydrologic Balance: Diversions and Conveyance of Overland Flow, Shallow Ground-Water Flow, and Ephemeral Streams). All disturbed areas, including diversion ditches that are not riprapped, shall be vegetated upon completion of construction. (e) The disposal areas shall be located on the most moderately sloping and naturally stable areas available as approved by the Commission. If such placement provides additional stability and prevents mass movement, fill materials suitable for disposal shall be placed upon or above a natural terrace, bench, or berm. (f) The fill materials shall be hauled or conveyed and placed in horizontal lifts in a controlled manner, concurrently compacted as necessary to ensure mass stability and prevent mass movement, covered, and graded to allow surface and subsurface drainage to be compatible with the natural surroundings and ensure a long-term static safety factor of 1.5. (g) The final configuration of the fill must be suitable for postmining land uses approved in accordance with sec.12.568 of this title (relating to Postmining Land Use), except that no depressions or impoundments shall be allowed on the completed fill. (h) Terraces may be utilized to control erosion and enhance stability if approved by the Commission and consistent with sec.12.552(b) of this title (relating to Backfilling and Grading: General Grading Requirements). (i) Where the slope in the disposal area exceeds 2.8h:1v (36%), or such lesser slope as may be designated by the Commission based on local conditions, keyway cuts (excavations to stable bedrock) or rock toe-buttresses shall be constructed to stabilize the fill. Where the toe of the spoil rests on a downslope, stability analyses shall be performed in accordance with sec.12.183 of this title (relating to Cross Sections, Maps, and Plans) to determine the size of the rock toe-buttresses or keyway cuts. (j) The fill shall be inspected for stability by a registered professional engineer experienced in the construction of earth and rockfill embankments at least quarterly throughout construction, and during the following critical construction periods: (1) removal of all organic material and topsoil; (2) placement of underdrainage systems and protective filter systems; (3) installation of surface drainage systems; (4) placement and compaction of fill materials; and (5) revegetation. (k) The registered professional engineer shall provide to the Commission a certified report, within 2 weeks after each inspection that the fill has been constructed as specified in the design approved by the Commission. The certified report on the drainage system and protective filters shall include color photographs taken during and after construction, but before underdrains are covered with excess spoil. If the underdrain system is constructed in phases, each phase shall be certified separately. A copy of the report shall be retained at the minesite. (l) Coal processing waste shall not be disposed of in valley or head-of-hollow fills and may only be disposed of with underground development waste, or in other excess spoil fills, if such waste is: (1) placed in accordance with sec.12.538 of this title (relating to Coal Processing Waste Banks: Construction Requirements); (2) demonstrated to be non-toxic and non-acid forming; and (3) demonstrated to be consistent with the design stability of the fill. (m) If the disposal area contains springs, natural or manmade watercourses, or wet-weather seeps, an underdrain system consisting of durable rock shall be constructed from the wet areas in a manner that prevents infiltration of the water into the spoil material. The underdrain system shall be protected by an adequate filter and shall be designed and constructed using standard geotechnical engineering methods. Where excess durable rock spoil is placed in single or multiple lifts such that the underdrain system is constructed simultaneously with excess spoil placement by the natural segregation of dumped materials, color photographs shall be taken of the underdrain as the underdrain system is being formed. (n) The foundation and abutments of the fill shall be stable under all conditions of construction and operation. Sufficient foundation investigations and laboratory testing of foundation materials shall be performed in order to determine the design requirements for stability of the foundation. Analyses of foundation conditions shall include the effect of underground mine workings, if any, upon the stability of the structure. (o) Underground development waste and excess spoil may be returned to underground workings only in accordance with the disposal plans submitted under sec.12.193 of this title (relating to Underground Development Waste/Return of Coal Processing Waste to Abandoned Underground Workings) and approved by the Commission and MSHA. (p) Excess spoil that is acid-forming or toxic-forming or combustible shall be adequately covered with non-acid, non-toxic and noncombustible material, or treated, to control the impact on surface and ground water in accordance with this chapter (relating to Coal Mining Regulations), to prevent sustained combustion, and to minimize adverse effects on plant growth and the approved postmining land use. (q) The photographs required by this section to accompany each certified report shall be taken in adequate size and number, with enough terrain or other physical features of the site shown, to provide a relative scale to the photographs and to specifically and clearly identify the site. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703686 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Special Permanent Program Performance Standards - Auger Mining 16 TAC sec.12.600 The new rule is adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703685 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Special Permanent Program Performance Standards - Operations in Alluvial Valley Floors 16 TAC sec.sec.12.610-12.613 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703684 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Special Permanent Program Performance Standards - Operations on Prime Farmland 16 TAC sec.sec.12.620-12.622, 12.624, 12.625 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703683 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Special Permanent Program Performance Standards - Coal Processing Plants and Support Facilities not Located at or Near the Minesite or not Within the Permit Area for a Mine 16 TAC sec.12.650, sec.12.651 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703682 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Special Permanent Program Performance Standards - In Situ Processing 16 TAC sec.12.660, sec.12.661 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703681 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER L. Permanent Program Inspection and Enforcement Procedures Commission Inspection and Enforcement 16 TAC sec.sec.12.670-12.675 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703680 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Enforcement 16 TAC sec.sec.12.677-12.684 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703679 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Civil Penalties 16 TAC sec.sec.12.686-12.694 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. sec.12.687. Point System for Penalties. (a) The Commission shall use the point system described in this section to determine the amount of the penalty and, in the case of notices of violation, whether a mandatory penalty should be assessed as provided in sec.12.686(b) of this title (relating to When Penalty Will Be Assessed). (b) Points shall be assigned as follows: (1) History of previous violations. The commission shall assign up to 30 points based on the history of previous violations. One point shall be assigned for each past violation contained in a notice of violation. Five points shall be assigned for each violation (but not a condition or practice) contained in a cessation order. The history of previous violations, for the purpose of assigning points, shall be determined and the points assigned with respect to a particular coal exploration or surface coal mining operation. Points shall be assigned as follows: (A) a violation shall not be counted, if the notice or order is the subject of pending administrative or judicial review or if the time to request such review or to appeal any administrative or judicial decision has not expired, and thereafter it shall be counted for only one year; (B) no violation for which the notice or order has been vacated shall be counted; and (C) each violation shall be counted without regard to whether it led to a civil penalty assessment; (2) Seriousness. The Commission shall assign up to 30 points based on the seriousness of the violation, as follows: (A) Probability of occurrence. The Commission shall assign up to 15 points based on the probability of the occurrence of the event which a violated standard is designed to prevent. Points shall be assessed according to the following schedule: Figure: 16 TAC 12.687(b)(2)(A) (B) extent of potential or actual damage. The Commission shall assign up to 15 points, based on the extent of the potential or actual damage, in terms of area and impact on the public or environment, as follows: (i) if the damage or impact which the violated standard is designed to prevent would remain within the coal exploration or permit area, the Commission shall assign zero to seven points, depending on the duration and extent of the damage or impact; and (ii) if the damage or impact which the violated standard is designed to prevent would extend outside the coal exploration or permit area, the Commission shall assign eight to fifteen points, depending on the duration and extent of the damage or impact; and (C) Alternative. In the case of a violation of an administrative requirement, such as a requirement to keep records, the Commission shall, in lieu of subparagraphs (A) and (B) of this paragraph, assign up to 15 points for seriousness, based upon the extent to which enforcement is obstructed by the violation; (3) Negligence. (A) The Commission shall assign up to 25 points based on the degree of fault of the person to whom the notice or order was issued in causing or failing to correct the violation, condition, or practice which led to the notice or order, either through act or omission. Points shall be assessed as follows: (i) a violation which occurs through no negligence shall be assigned no penalty points for negligence; (ii) a violation which is caused by negligence shall be assigned 12 points or less, depending on the degree of negligence; (iii) a violation which occurs through a greater degree of fault than negligence shall be assigned 13 to 25 points, depending on the degree of fault; (B) In determining the degree of negligence involved in a violation and the number of points to be assigned, the following definitions apply: (i) No negligence-- An inadvertent violation which was unavoidable by the exercise of reasonable care; (ii) Negligence-- The failure of a permittee to prevent the occurrence of any violation of his or her permit or any requirement of the Act or this chapter (relating to Coal Mining Regulations) due to indifference, lack of diligence, or lack of reasonable care, or the failure to abate any violation of such permit or the Act due to indifference, lack of diligence, or lack of reasonable care; (iii) A greater degree of fault than negligence-- Reckless, knowing, or intentional conduct; and (C) In calculating points to be assigned for negligence, the acts of all persons working on the coal exploration or surface coal mining and reclamation site shall be attributed to the person to whom the notice or order was issued, unless that person establishes that they were acts of deliberate sabotage; and (4) Good faith in attempting to achieve compliance. (A) The Commission shall add points based on the degree of good faith of the person to whom the notice or order was issued in attempting to achieve rapid compliance after notification of the violation. Points shall be assigned as follows: Figure: 16 TAC 12.687(b)(4)(A) (B) The following definitions shall apply under subsection (b)(4)(A) of this section: (i) Rapid compliance-- That the person to whom the notice or order was issued took extraordinary measures to abate the violation in the shortest possible time and that abatement was achieved before the time set for abatement; (ii) Normal compliance-- The person to whom the notice or order was issued abated the violation within the time given for abatement; and (C) If the consideration of this criterion is impractical because of the length of the abatement period, the assessment may be made without considering this criterion and may be reassessed after the violation has been abated. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703678 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 Individual Civil Penalties 16 TAC sec.sec.12.696-12.699 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703677 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER M. Training Training, Examination, and Certification of Blasters 16 TAC sec.sec.12.700, 12.702-12.710 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. sec.12.707. Certification. (a) The Commission shall issue a Commission Blaster Certificate to those applicants examined and found to meet the requirements of sec.12.700, sec.sec.12.702 through 12.706, this section, and sec.sec.12.708 through 12.710 of this title (relating to Training, Examination, and Certification of Blasters) for accepting responsibility for blasting operations in mining operations regulated by the Commission. Blaster certifications shall expire as follows: (1) certificate issuance-- 3 years after issue date; (2) certificate renewal-- 3 years after the expiration date of the certificate being renewed; (3) certificate reissuance-- 3 years after issue date; (4) certificate replacement-- Same expiration date as certificate being replaced; and (5) certificate issued under reciprocity-- Same expiration date as that of the qualified jurisdiction certification for which reciprocity rights are granted by the Commission. (b) The conditions for maintaining blaster certification shall include: (1) certified blasters shall not assign or transfer certifications; (2) certified blasters shall immediately exhibit certifications to any authorized representative of the Commission upon request; (3) certified blasters shall protect certifications from loss, theft or unauthorized duplication, and immediately report any such occurrences to the Director of the Surface Mining and Reclamation Division; (4) certified blasters shall not delegate their responsibility for surface mining blasting operations to any individual who is not a certified blaster; (5) certified blasters shall complete a Commission-administered refresher course at least once every three years; (6) certified blasters shall notify the Commission in writing within 30 days of any change in address; and (7) certified blasters shall immediately surrender Commission Blaster Certificates to an authorized representative of the Commission upon notice of suspension or revocation or other good cause. (c) The Commission, when practicable, following written notice and opportunity for a hearing, may, and upon a finding of willful conduct, shall immediately suspend or revoke the certification of any blaster or take other necessary action for any of the following reasons: (1) noncompliance with any order of the Commission; (2) unlawful use in the work place of, or current addiction to, alcohol, narcotics, or other dangerous drugs; (3) violation of any provision of state, federal or local explosives statutes or regulations; or (4) providing false information or any misrepresentation of fact to obtain blaster certifications. (d) If advance notice and opportunity for hearing cannot be provided, an opportunity for hearing shall be provided as soon as practical following the suspension, revocation, or other adverse action. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703676 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 SUBCHAPTER R. Texas Abandoned Mine Land Reclamation Program 16 TAC sec.sec.12.800-12.817 The new rules are adopted pursuant to sec.134.013 of the Texas Natural Resources Code, which provides the commission the authority to promulgate rules pertaining to surface coal mining operations. 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. Issued in Austin, Texas, on March 17, 1997. TRD-9703675 Mary Ross McDonald Deputy General Counsel, Office of General Counsel Railroad Commission of Texas Effective date: April 7, 1997 Proposal publication date: January 10, 1997 For further information, please call: (512) 463-7008 TITLE 22. EXAMINING BOARDS PART XV. Texas State Board of Pharmacy CHAPTER 291. Pharmacies The Texas State Board of Pharmacy adopts amendments to sec.sec.291.31-291.34 and 291.36, concerning Definitions, Personnel, Operational Standards, Records in Community Pharmacy (Class C), and Class A Pharmacies Compounding Sterile Pharmaceuticals, and sec.291.72 and sec.291.73, concerning Definitions and Personnel in Institutional Pharmacy (Class C). Section 291.31 and sec.291.36 are adopted with changes to the proposed text as published in the October 1, 1996, and December 27, 1996, issues of the Texas Register (21 TexReg 12518 and 21 TexReg 12520). Sections 791.33, 791.34, 791.72, and 791.73 are adopted without changes to the proposed text as published in the December 27, 1996, issue of the Texas Register (21 TexReg 12522) and will not be republished. Section 291.32 is adopted without changes, however it will be republished for clarification. The Board adopts these amendments with changes to the definition of "dispensing pharmacist" as contained in sec.291.31 and sec.291.36. The adopted amendments redefine the definition of a new prescription to include any prescription transferred into a pharmacy and any drug a patient has not taken in the same strength and/or dosage form and specify that non-pharmacist personnel may not ask questions intended to limit a patient's access to a pharmacist. The amendments also specify procedures for transferring new prescriptions between pharmacies and allow pharmacists to delegate the affixing of a prescription label to a pharmacy technician or automated dispensing systems provided the pharmacist makes a final check of the prescription to verify the accuracy before delivery to the patients. The responsibility for the accuracy of the prescription remains with the pharmacist. The amendments also clearly specify that pharmacists-in-charge and dispensing or distributing pharmacists are responsible for accurate dispensing and distributing of drugs and devices, including right drug, right quantity, right strength, and right directions for use. Numerous written comments on the proposed rules were received and oral comments on the proposed rules were received at a public hearing on November 6, 1996. All of the oral and written comments concerned the proposed amendment to the duties of a pharmacists which would allow a pharmacist to delegate the task of affixing the label to the prescription container, provided a pharmacist performs a final check to ensure that the prescription has been dispensed accurately as prescribed. Four professional pharmacy associations (Texas Federation of Drug Stores, Texas Pharmacy Association, Texas Society of Health-System Pharmacists, and the West Texas Pharmaceutical Association) commented in favor of the amendment. In addition, the agency received comments from 162 individuals, of which 144 were against and 18 were in favor of the proposed change. Most of the persons against the proposed change stated that they believed that this change would endanger the public health because more errors could occur if pharmacists were allowed to delegate this task. The Board disagrees with these comments because of the following reasons: (1) the process of affixing a label is manipulative or mechanical and requires no judgmental skills; (2) pharmacists must be released from being required to perform nonjudgmental and manipulative duties so that they may have the time to perform more patient oriented duties such as drug use reviews, patient counseling, and medication therapy management; (3) all of the data currently available indicate that there is not a public health hazard attributable to pharmacy technicians performing technical or manipulative tasks associated with the dispensing of a prescription (including affixing the label to a prescription). In fact, all of the studies show that technicians are as accurate as pharmacists. One study (McGhan, 1983) concluded that: (a) technicians are as accurate as pharmacists in filling prescriptions (in fact the total error rate for technicians was slightly less than the error rate for pharmacists - 4.17% for technicians to 5.17% for pharmacists); and (b) pharmacists spend approximately one minute more per patient counseling when technicians performed the manipulative tasks of filling the prescription; (4) forty-four states currently allow technicians to affix the prescription label to the container if the pharmacist makes a final check before releasing the prescription. Community Pharmacy (Class A) 22 TAC sec.sec.291.31-291.34, 291.36 The amendments are adopted under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes): (1) Section 16(a) which specifies that the Board shall amend and adopt rules for the proper administration and enforcement of the Act; (2) Section 17(a)(4) which specifies that the Board is responsible for enforcement of the Act, including conduct and competence of pharmacists and pharmacies; (3) Section 17(b)(3) which specifies that the Board is responsible for the specification of standards for drug delivery, dispensing in a suitable container appropriately labeled, and providing of prescription drugs and devices; and gives the Board the authority to specify minimum standards for counseling of patients and maintenance of prescription drug records; and (4) Section 17(b)(4) which gives the Board the authority to adopt rules regarding the transmission of prescription drug orders by electronic means. The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1. sec.291.31. Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. Accurately as prescribed-- Dispensing, delivering, and/or distributing a prescription drug order: (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed; (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and (C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including sec.40 of the Texas Pharmacy Act. Automated drug dispensing system --An automated device that measures, counts, packages, and/or labels a specified quantity of dosage units for a designated drug product. Dispensing pharmacist --The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient. New prescription drug order - -A prescription drug order that: (A) has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year; (B) is transferred from another pharmacy; and/or (C) is a discharge prescription drug order. (Note: furlough prescription drug orders are not considered new prescription drug orders.) sec.291.32. Personnel. (a) Pharmacist-in-charge. (1) (No change.) (2) Responsibilities. The pharmacist-in-charge shall have responsibility for, at a minimum, the following: (A) dispensing of drugs, including: (i) packaging, preparation, compounding, and labeling; and (ii) ensuring that drugs are dispensed safely, and accurately as prescribed; (B) delivery of drugs to the patient or the patient's agent, including ensuring that drugs are delivered safely, and accurately as prescribed; (C)-(N) (No change) (b) Pharmacists. (1) General. (A)-(D) (No change) (E) A dispensing pharmacist shall ensure that the drug is dispensed and delivered safely, and accurately as prescribed. (2) Duties. Duties which may only be performed by a pharmacist are as follows: (A)-(C) (No change.) (D) performing the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed; (E)-(I) (No change.) (3) (No change.) (c) Supportive personnel/pharmacy technician. (1) (No change.) (2) Duties. (A)-(B) (No change.) (C) A pharmacist may not delegate the act of affixing a label to a prescription container unless the supportive person/pharmacy technician has completed the education and training requirements outlined in paragraphs (1) and (4) of this subsection. (3)-(4) (No change.) (5) Training program. Supportive personnel training shall be outlined in a training manual. Such training manual shall, at a minimum, contain the following: (A) (No change.) (B) instruction in the following areas and any additional areas appropriate to the duties of supportive personnel in the pharmacy: (i)-(vii) (No change.) (viii) Prescription drug order preparation: (I)-(V) (No change.) (VI) Affixing the prescription label; (VII) Affixing auxiliary labels, if indicated; and (VIII) Preparing the finished product for inspection and final check by pharmacists; (ix)-(xii) (No change.) (d) (No change.) sec.291.36. Class A Pharmacies Compounding Sterile Pharmaceuticals. (a) (No change.) (b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) ACPE--The American Council on Pharmaceutical Education. (2) Act--The Texas Pharmacy Act, Texas Civil Statutes, Article 4542a-1, as amended (3) Accurately as prescribed--Dispensing, delivering, and/or distributing a prescription drug order: (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed; (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and (C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including sec.40 of the Texas Pharmacy Act. (4) Advanced practice nurse--A registered nurse approved by the Texas State Board of Nurse Examiners to practice as an advanced practice nurse on the basis of completion of an advanced education program. The term includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a clinical nurse specialist. (5) Airborne particulate cleanliness class--The level of cleanliness specified by the maximum allowable number of particles per cubic foot of air as specified in Federal Standard 209E, et seq. For example: (A) Class 100 is an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air; (B) Class 10,000 is an atmospheric environment which contains less than 10,000 particles 0.5 microns in diameter per cubic foot of air; and (C) Class 100,000 is an atmospheric environment which contains less than 100,000 particles 0.5 microns in diameter per cubic foot of air. (6) Ancillary supplies--Supplies necessary for the administration of compounded sterile pharmaceuticals. (7) Aseptic preparation--The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing. (8) Automated compounding or drug dispensing system -- An automated device that compounds, measures, counts, packages, and/or labels a specified quantity of dosage units for a designated drug product. (9) Batch preparation compounding--Compounding of multiple sterile-product units, in a single discrete process, by the same individual(s), carried out during one limited time period. Batch preparation/compounding does not include the preparation of multiple sterile-product units pursuant to patient specific medication orders. (10) Biological Safety Cabinet--Containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49. (11) Board--The Texas State Board of Pharmacy. (12) Carrying out or signing--A prescription drug order, the completion of a prescription drug order presigned by the delegating physician, or the signing of a prescription by an advanced practice nurse or physician assistant after the person has been designated with the Texas State Board of Medical Examiners by the delegating physician as a person delegated to sign a prescription. The following information shall be provided on each prescription: (A) patient's name and address; (B) name, strength, and quantity of the drug to be dispensed; (C) directions for use; (D) the intended use of the drug, if appropriate; (E) the name, address, and telephone number of the physician; (F) the name, address, telephone number, and identification number of the advanced practice nurse or physician assistant completing the prescription drug order; (G) the date; and (H) the number of refills permitted. (13) Clean room--A room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E, et seq. (14) Clean zone--A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. (15) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device: (A) as the result of a practitioner's prescription drug or medication order or initiative based on the practitioner-patient pharmacist relationship in the course of professional practice; (B) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or (C) for the purpose of or as an incident to research, teaching, or chemical analysis and not for sale or dispensing. (16) Confidential record--Any health related record maintained by a pharmacy or pharmacist such as a patient medication record, prescription drug order, or medication drug order. (17) Controlled area--A controlled area is the area designated for preparing sterile pharmaceuticals. (18) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513). (19) Critical areas--Any area in the controlled area where products or containers are exposed to the environment. (20) Cytotoxic--A pharmaceutical that has the capability of killing living cells. (21) Dangerous drug--Any drug or device that is not included in Penalty Groups 1-4 of the Controlled Substances Act and that is unsafe for self-medication or any drug or device that bears or is required to bear the legend: (A) "Caution: federal law prohibits dispensing without prescription"; or (B) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian." (22) Data communication device--An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch or gateway). (23) Deliver or delivery--The actual, constructive, or attempted transfer of a prescription drug or device or controlled substance from one person to another, whether or not for a consideration. (24) Designated agent-- (A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner, and for whom the practitioner assumes legal responsibility, who communicates prescription drug orders to a pharmacist; (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a prescription drug order; or (C) an advanced practice nurse or physician assistant authorized by a practitioner to carry out or sign a prescription drug order for dangerous drugs under Medical Practice Act, Article 4495b, sec.3.06(d)(5) or (6). (25) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner. (26) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner. (27) Dispensing pharmacist -- the pharmacist responsible for the final check of the dispensed prescription before delivery to the patient. (28) Distribute--The delivery of a prescription drug or device other than by administering or dispensing. (29) Downtime--Period of time during which a data processing system is not operable. (30) Drug regimen review--An evaluation of prescription drug or medication orders and patient medication records for: (A) known allergies; (B) rational therapy--contraindications; (C) reasonable dose and route of administration; (D) reasonable directions for use; (E) duplication of therapy; (F) drug-drug interactions; (G) drug-food interactions; (H) drug-disease interactions; (I) adverse drug reactions; and (J) proper utilization, including overutilization or underutilization. (31) Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy). (32) Expiration date--The date (and time, when applicable) beyond which a product should not be used. (33) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open. (34) Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc.). (35) Medical Practice Act--The Texas Medical Practice Act, Texas Civil Statutes, Article 4495b, as amended. (36) New prescription drug order--A prescription drug order that: (A) has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year; (B) is transferred from another pharmacy; and/or (C) is a discharge prescription drug order. (Note: furlough prescription drug orders are not considered new prescription drug orders.) (37) Original prescription--The: (A) original written prescription drug orders; or (B) original verbal or electronic prescription drug orders reduced to writing either manually or electronically by the pharmacist. (38) Part-time pharmacist--A pharmacist who works less than full-time. (39) Patient counseling--Communication by the pharmacist of information to the patient or patient's agent, in order to improve therapy by ensuring proper use of drugs and devices. (40) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy. (41) Pharmaceutical care--The provision of drug therapy and other pharmaceutical services intended to assist in the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. (42) Physician assistant--A physician assistant recognized by the Texas State Board of Medical Examiners as having the specialized education and training required under the Medical Practice Act, sec.3.06(d), and issued an identification number by the Texas State Board of Medical Examiners. (43) Practitioner-- (A) a physician, dentist, podiatrist, veterinarian, or other person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state; (B) a person licensed by another state in a health field in which, under Texas law, licensees in this state may legally prescribe dangerous drugs or a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, having a current federal Drug Enforcement Administration registration number, and who may legally prescribe Schedule II, III, IV, or V controlled substances in such other state; or (C) a person licensed in the Dominion of Canada or the United Mexican States in a health field in which, under the laws of this state, a licensee may legally prescribe dangerous drugs; (D) does not include a person licensed under the Texas Pharmacy Act. (44) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container into a prescription container for dispensing by a pharmacist to the ultimate consumer. (45) Prescription drug-- (A) a substance for which federal or state law requires a prescription before it may be legally dispensed to the public; (B) a drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements: (i) "Caution: federal law prohibits dispensing without prescription"; or (ii) "Caution: federal law restricts this drug to use by or on order of a licensed veterinarian"; or (C) a drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only. (46) Prescription drug order-- (A) an order from a practitioner or a practitioner's designated agent to a pharmacist for a drug or device to be dispensed; or (B) an order pursuant to the Medical Practice Act, sec.3.06(d)(5) or (6). (47) Process validation--Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. (48) Quality assurance--The set of activities used to assure that the process used in the preparation of sterile drug products lead to products that meet predetermined standards of quality. (49) Quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final sterile pharmaceuticals prepared meet predetermined requirements with respect to identity, purity, non- pyrogenicity, and sterility. (50) Sample--A prescription drug which is not intended to be sold and is intended to promote the sale of the drug. (51) Sterile pharmaceutical--A dosage form free from living micro-organisms. (52) Supportive personnel/Pharmacy technician--Those individuals utilized in pharmacies whose responsibility it shall be to provide technical services that do not require professional judgment concerned with the preparation and distribution of drugs under the direct supervision of and responsible to a pharmacist. (53) Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended. (54) Unit-dose packaging--The ordered amount of drug in a dosage form ready for administration to a particular patient, by the prescribed route at the prescribed time, and properly labeled with name, strength, and expiration date of the drug. (55) Unusable drugs--Drugs or devices that are unusable for reasons such as they are adulterated, misbranded, expired, defective, or recalled. (56) Written protocol--A physicians order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas State Board of Medical Examiners under the Texas Medical Practice Act, (Texas Civil Statutes, Article 4495b) (c) Personnel. (1) Pharmacist-in-charge. (A) (No change) (B) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following: (i) ensuring that drugs and/or devices are dispensed and delivered safely and accurately as prescribed; (ii)-(xvi) (No change.) (2) Pharmacists. (A) General. (i)-(v) (No change.) (vi) A dispensing pharmacist shall ensure that the drug is dispensed and delivered safely, and accurately as prescribed. (B) Duties. Duties which may only be performed by a pharmacist are as follows: (i)-(iv) (No change.) (v) performing the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed; (vi)-(ix) (No change.) (3) Supportive personnel/pharmacy technicians. (A) (No change.) (B) Duties. (i)-(ii) (No change.) (iii) A pharmacist may not delegate the act of affixing a label to a prescription container unless the supportive person/pharmacy technician has completed the education and training requirements outlined in subparagraphs (A) and (D) of this paragraph. (C) -(D) (No change.) (E) Training program. Supportive personnel training shall be outlined in a training manual. Such training manual shall, at a minimum contain the following: (i) (No change.) (ii) instruction in the following areas and any additional areas appropriate to the duties of supportive personnel in the pharmacy: (I)-(VII) (No change.) (VIII) Prescription drug order preparation: (-a)-(-e-) (No change.) (-f-) Affixing the prescription label; (-g-) Affixing auxiliary labels, if indicated; and (-h-) Preparing the finished product for inspection and final check by pharmacists; (IX)-(XII) (No change.) (4)-(5) (No change.) (d) Operational standards. (1)-(2) (No change.) (3) Prescription dispensing and delivery. (A) Patient counseling and provision of drug information. (i) (No change.) (ii) Such communication: (I)-(III) (No change.) (IV) Beginning September 1, 1993, the communication shall be reinforced with written information. The following is applicable concerning this written information. (-a-)-(-c-) (No change.) (iii) Only a pharmacist may verbally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non- pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist. (iv) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation. (v) In addition to the requirements of clauses (i)-(iv) of this subparagraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable. (I) So that a patient will have access to information concerning his or her prescription, a prescription may not be delivered to a patient unless a pharmacist is in the pharmacy, except as provided in subclause (II) of this clause. (II) An agent of the pharmacist may deliver a prescription drug order to the patient or his or her agent during short periods of time when a pharmacist is absent from the pharmacy, provided the short periods of time do not exceed two hours, and provided a record of the delivery is maintained containing the following information: (-a-) date of the delivery; (-b-) unique identification number of the prescription drug order; (-c-) patient's name; (-d-) patient's phone number or the phone number of the person picking up the prescription; and (-e-) signature of the person picking up the prescription. (III) Any prescription delivered to a patient when a pharmacist is not in the pharmacy must meet the requirements described in clause (vi) of this subparagraph. (IV) A Class A pharmacy compounding sterile pharmaceuticals that delivers prescriptions to patients or their agents on-site shall make available for use by the public a current or updated edition of the United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient), or another source of such information, such as patient information leaflets. (vi) In addition to the requirements of clauses (i)-(iv) of this subparagraph, if a prescription drug order is delivered to the patient or his or her agent at the patient's residence or other designated location, the following is applicable. (I) The information specified in clause (i) of this subparagraph shall be delivered with the dispensed prescription in writing. (II) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist. (III) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions." (IV) The pharmacist-in-charge shall assure that: (-a-) adequate storage or shipment containers and shipping processes are used to ensure drug stability and potency; and (-b-) the pharmacy utilizes a delivery system which is designed to assure that the drugs are delivered to the appropriate patient. (vii) The provisions of this subparagraph do not apply to patients in facilities where drugs are administered to patients by a person authorized to do so by the laws of the state (i.e., nursing homes). (B)-(C) (No change.) (4)-(9) (No change.) (e) Records. (1)-(2) (No change.) (3) Prescription drug order records maintained in a manual system. (A)-(C) (No change.) (D) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements. (i)-(v) (No change.) (vi) The pharmacist or pharmacist intern receiving the transferred prescription drug order information shall: (I) (No change.) (II) record on the transferred prescription drug order the following information: (-a-) original date of issuance and date of dispensing or receipt, if different from date of issuance; (-b-) (No change.) (-c-) number of valid refills remaining and the date of last refill, if applicable; (-d-)-(-e-) (No change.) (E) (No change.) (4) Prescription drug order records maintained in a data processing system. (A) -(C) (No change.) (D) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements. (i)-(v) (No change.) (vi) The pharmacist or pharmacist intern receiving the transferred prescription drug order information shall: (I) (No change.) (II) record on the transferred prescription drug order the following information: (-a-) original date of issuance and date of dispensing or receipt, if different from date of issuance; (-b-) (No change.) (-c-) number of valid refills remaining and the date of last refill, if applicable; (-d-)-(-e-) (No change.) (vii)-(x) (No change.) (E)-(F) (No change.) (5)-(11) (No change.) (f) (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. Issued in Austin, Texas, on March 17, 1997. TRD-9703653 Fred S. Brinkley, Jr., R.Ph., M.B.A. Executive Director/Secretary Texas State Board of Pharmacy Effective date: April 7, 1997 Proposal publication date: October 1, and December 27, 1996 For further information, please call: (512) 305-8027 Institutional Pharmacy (Class C) 22 TAC sec.291.72, sec.291.73 The amendments are adopted under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes): (1) Section 16(a) which specifies that the Board shall amend and adopt rules for the proper administration and enforcement of the Act; (2) Section 17(a)(4) which specifies that the Board is responsible for enforcement of the Act, including conduct and competence of pharmacists and pharmacies; (3) Section 17(b)(3) which specifies that the Board is responsible for the specification of standards for drug delivery, dispensing in a suitable container appropriately labeled, and providing of prescription drugs and devices; and gives the Board the authority to specify minimum standards for counseling of patients and maintenance of prescription drug records; and (4) Section 17(b)(4) which gives the Board the authority to adopt rules regarding the transmission of prescription drug orders by electronic means. The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 17, 1997. TRD-9703654 Fred S. Brinkley, Jr., R.Ph., M.B.A. Executive Director/Secretary Texas State Board of Pharmacy Effective date: April 7, 1997 Proposal publication date: December 27, 1996 For further information, please call: (512) 305-8027 CHAPTER 295. Pharmacists 22 TAC sec.295.13 The Texas State Board of Pharmacy adopts new sec.295.13, concerning Drug Therapy Management by a Pharmacist under Written Protocol of a Physician, without changes to the proposed text as published in the December 27, 1996, of the Texas Register. The new rule specifies requirements for the maintenance of records of a pharmacist engaged in the provision of drug therapy management as authorized by the Medical Practices Act, sec.3.06. The agency received one comment from the Pharmaceutical Research and Manufacturers of America (PhRMA) which suggested that sec.295.13(d)(6) regarding physician supervision be amended by deleting the current language and adding "has determined that the pharmacist to whom the physician is delegating drug therapy management has established a relationship with the patient. The pharmacist shall notify the physician of any change in the maintenance of the pharmacist-patient relationship." The Board did not agree with this suggestion because the language in the proposed sec.295.13(d)(6) is almost identical to the suggested language in that it requires the pharmacist to establish and continue a relationship with the patient. In addition, the current paragraph (4) in this same subsection requires the pharmacist to make periodic status reports to the physician. These two paragraphs seem to address the concerns; therefore, no change was necessary in the rules. PhRMA also suggested that the Board add a new subparagraph (E) to sec.295.13(a)(4) that would read as follows: "generically equivalent drug selection if the physician's signature does not clearly indicate that the prescription must be dispensed as written with the exception of Narrow Therapeutic Index Drugs which shall require specific written authorization by the prescribing physician for interchange of this class of drugs. For purposes of this section, Narrow Therapeutic Index Drugs shall include digoxin, phenytoin, warfarin sodium, theophyllin, levothyroxine, carbamazine, valproic acid, and lithium; or" The Board did not include this suggested amendment because sec.40 of the Texas Pharmacy Act addresses the issue of pharmacist substitution of generically equivalent drug product selection. The suggested language (regarding Narrow Therapeutic Index Drugs) is arguably inconsistent with sec.40 of the Texas Pharmacy Act. The new rule is adopted under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes): Section 4, which specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; Section 16(a), which gives the Board the authority to adopt and amend rules for the proper administration and enforcement of the Act; and sec.17(x), which specifies the Board shall adopt rules regarding records to be maintained by a pharmacist performing a specific act under written protocol. The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 17, 1997. TRD-9703652 Fred S. Brinkley, Jr., R.Ph., M.B.A. Executive Director/Secretary Texas State Board of Pharmacy Effective date: April 7, 1997 Proposal publication date: December 27, 1996 For further information, please call: (512) 305-8027 TITLE 37. PUBLIC SAFETY AND CORRECTIONS PART I. Texas Department of Public Safety CHAPTER 18.Driver Education Parent or Legal Guardian Taught Driver Education 37 TAC sec.sec.18.21-18.24 The Texas Department of Public Safety adopts new sec.sec.18.21-18.24, concerning parent or legal guardian-taught driver education. Section 18.21 and sec.18.23 are adopted with changes to the proposed text as published in the September 27, 1996, issue of the Texas Register (21 TexReg 9229). Section 18.22 and sec.18.24 are adopted without changes and will not be republished. The justification for these sections is to implement Texas Civil Statutes, Article 6687b, sec.7A, which states that the department by rule shall provide for parent or legal guardian-taught driver education. The new sections set standards for parent or legal guardian-taught driver education, requests for information packets, classroom instruction, behind-the- wheel instruction, student requirements, and verification of course completion by minors. The changes to the proposed text are summarized as follows: Language in sec.18.21(b) was modified to correct a typographical error in the title of a form designated as DE-964. In sec.18.23(c) the requirement for persons having been taught driver education by a parent or legal guardian to take a driving test was deleted to be consistent with Texas Civil Statutes, Article 6687b, sec.7A(d), which provides that completion of a driver training course approved under this section has the same effect under that Act as completion of a driver training course approved by the Central Education Agency. The department received written comments generally in favor of the rules as proposed, with some of the comments suggesting changes from: Paula and Dan Darby, James B. Link, Brett I. Holcomb, Gary and Nadine Jackson, Karen Miller, Eric B. Neuman III, Ruth Pifer, and Lynn Tapp. Written comments in opposition to the rules were received from: Val David Eckles, Martha Gilley of AAA Security Driving Academy, Elizabeth Henrise of Quad-Cities Driver Training School, Verna Lee Kirchmeier, Marina T. Pothen of Quad-Cities Driver Training School, Benney Raley of Region VI Service Center, Carlos E. Reyna of Driving School Association of Texas, Carlos E. Reyna of Reyna Driving Systems, Marsha Rodsky of Spring Valley Driving School, and Charles Taylor of Advanced Traffic Technologies, Inc. A public hearing was requested on the proposed new rules and held November 1, 1996 to receive comments from interested persons. Testimony was presented by thirty-three persons. Comments generally in favor of the rules as proposed, with some of the comments suggesting changes were received from: Representative Jim Horn, James Link, Joshua Link, Patti Leestma, Paul Powell of the Office of Representative Charlie Howard, Donna Harp, Tim Lambert, Charles Taylor, Miriam Link, Gene Walker, John Davis, Jody Ripma, Sharon Wood, Dianne Hensley, and Amariah Harp. Persons who attended the public hearing and noted their position in favor of the proposed rules, but did not testify were: Sarah Link, Trey Blocker, DaTonya Vaughn, Sharon Aldridge, Deborah Stanton, Donna Kile, and Brannen Temple. Persons who testified in opposition to the proposed rules were: B. J. Amos, Pat Linthicum, Don Appelt, Martha Gilley, Don Archer, Don Ashley, David Eckles, Marina Pothen, Charles Green, Carolyn Campbell, Lucian Jalufka, Darrell Thorley, Marsha Rodsky, Carrol Fuller, Shelia Wagner, Glenn Field, Carey Willingham, and Cheryl Welsh. Persons who attended the public hearing and noted their opposition to the proposed rules, but did not testify, were: Michael Hamilton, JoLeen Eiklenberg, Suzanne Reyna, Larry Ormes, Allen and Verna Lee Kirchmeier, Bob Downing, Elizabeth Henrise, Carlos Reyna, Phil Ward, Norm Rodsky, T.D. Reed, Andrea Swann, Joe Gonzales, Mark Powhatan, Athe Swann, Clarence Francis, Franklin Huebner, and Scott Wilson. A summary of the written comments, comments made at the hearing, and the department response follow: COMMENT: Regarding sec.18.23(a), the rule should require liability insurance in the amount of $300,000 for vehicles used in behind-the-wheel instruction, and such vehicles should be required to have dual brakes and a second rear-view mirror for use of the instructor. RESPONSE: The department disagrees with the comment because the statute under which these rules are adopted (Texas Civil Statutes, Article 6687b, sec.7A) specifies that the department may not require that the vehicle used for the behind-the-wheel instruction have equipment other than the equipment otherwise required by law for operation of the vehicle on a highway while the vehicle is not being used for driver training. That statute does not provide for the department to set a requirement for an amount of liability insurance which is higher than the minimum amount already required for vehicles operated on the highways of this state. COMMENT: sec.18.23(b) should require the department to periodically monitor the parent or guardian classroom activity to make sure the classroom portion of the training is presented properly, as approved by the Texas Education Agency for driver education. RESPONSE: The department disagrees with the comment because the statute which requires the department to adopt the rules for parent and legal guardian-taught driver training does not authorize the department to conduct monitoring of such driver training. The department believes that its requirement to have the parent or legal guardian submit a sworn statement regarding the training meets the statutory requirement that the rules must provide a method by which approval of a course is obtained, and that an applicant submit proof of completion of the course. Since the statute does not provide for monitoring of the courses taught by parents or legal guardians, the department has concluded that the rules should not include that procedure. COMMENT: The department should charge a fee to the persons giving instruction under these sections that would cover the cost of monitoring or policing the at- home teaching of driver education. RESPONSE: There is no statutory authority for the department to charge any fee other than those specifically set out for application fees and costs of documents obtained from the department. COMMENT: Regarding sec.18.22(e)(7), the department should not require a social security number as a prerequisite for participating in the program. RESPONSE: The department is authorized by law, both state and federal, to obtain a social security number for use in the driver licensing process. COMMENT: The rules should require the vehicle to have a "student driver" sign and an additional brake. RESPONSE: For the reasons stated above, relating to a specific statutory prohibition, the rules may not require an additional brake on a vehicle used for driver training by parents or legal guardians. Likewise, the requirement of a sign designating the vehicle as a "student driver" vehicle is prohibited by the statute, as this would be an additional item of vehicle equipment not required by law for operation of a vehicle on a highway while the vehicle is not being used for driver training. COMMENT: The rules do not require the same standards for course materials as those required in a course approved by the Central Education Agency. Specifically, the rules should include a requirement that approval of a parent to teach driver education may be denied, suspended, or revoked for any one of the following: (1) signing the driver education certificate when the parent did not personally instruct the student during the course described on the certificate; (2) accumulating a personal driving record that does not meet the driver record evaluation standards established for Texas school bus drivers; (3) falsifying any records; or (4) permitting an unlicensed student to practice behind-the-wheel driving lessons on a public roadway, any other violation of a law, or the standards of the driver education program that, in the opinion of the director of the department, warrants suspension or revocation. The comment also proposes a period of suspension shall be at least 180 days. RESPONSE: The department disagrees with the comment because the statute does not require that all aspects of the parent or legal guardian-taught driver education program mirror those of the Texas Education Agency. The statute requires that course materials must be at least equal to those required in a course approved by the Central Education Agency but does not require that all other aspects of the program be the same. The proposal in the comment would require the department to go beyond the authority set out in the law (Texas Civil Statutes, Article 6687b, sec.7A) as to the eligibility for a parent or legal guardian to teach driver education. However, the rules do provide for denial of the student's driver's license application if all requirements set out in the rules are not met. Among the reasons for denial of an application is evidence of a false statement in the application. COMMENT: The rule does not address when a parent's driving record will be scrutinized. RESPONSE: The department agrees that the rule does not specify a particular time at which the parent or legal guardian's driving record will be reviewed. The department does not agree that this subject must be addressed in the rule. The department's operating procedures will contain provisions directing its personnel to review the driving record of the parent prior to any permit or license being issued to the student. Further, the materials provided by the department to parents and legal guardians will contain a notice of the statutory requirement that the parent or guardian must not have been convicted of criminally negligent homicide or driving while intoxicated. COMMENT: The rule does not address how the department will assess whether a parent or legal guardian is disabled because of mental illness. RESPONSE: The department disagrees with the comment since the rule requires a certification from the parent or legal guardian that the person meets all the requirements of the statute and rule, including a sworn statement that the person is not disabled because of mental illness. Further, since a parent or legal guardian who proposes to teach driver training must be a licensed driver, the statutory requirements for issuance and retention of that license must be met by the parent or legal guardian. The department believes that the existing statutory provisions relating to driver licenses and mental illness provide sufficient methods of dealing with persons who are disabled because of mental illness. Those provisions are contained in Texas Transportation Code, sec.sec.521.163, 521.201, 521.294, and 521.312. COMMENT: The rule does not address who will absorb the cost of a driving record review or background investigation. RESPONSE: The department agrees that the issue of the cost of a driving review is not addressed by the rule, but this is because the department intends to review the driving record of the individual and any other records which must be reviewed, at the department's cost. COMMENT: The rules should require proof of vehicle registration, proof of insurance, and vehicle inspection by department representatives prior to commencement of behind-the-wheel instruction, and in-car training should be restricted to approved vehicles only. RESPONSE: The department disagrees with the comment because the statute authorizing parent and legal guardian-taught driver education does not provide for the department to require, as a prerequisite to allowing a parent or legal guardian to teach driver education, that the parent or legal guardian submit proof of registration, proof of insurance, or have the vehicle inspected and approved by the department. The rule does require that proof of insurance be available in the vehicle while it is being operated, as is any other vehicle. Further, when the vehicle is being operated on the highway, it is subject to the statutes requiring proof of registration and vehicle inspections. COMMENT: The rules should require some form of parent refresher driver education prior to the training of the student. Many of the parents may not have adequate knowledge of current traffic laws, alcohol awareness, or safe driving procedures. The rules should require completion of a driving safety course within the last year; completion of an alcohol awareness program within the last year; and retaking and passing the Department of Public Safety's rules and signs exam. RESPONSE: The department disagrees with the comment because the statute authorizing parent and legal guardian-taught driver education does not provide for such additional requirements on the parent or legal guardian. The department interprets the statute as not authorizing the additional requirements. COMMENT: The rules should include a minimum qualifying standard for parents and legal guardians to the effect that they must have graduated from high school, have been a licensed driver for at least five (5) years, possess a Texas driver's license (valid for the type of vehicle used for the instruction), and meet the driving record evaluation standards established for Texas school bus drivers. RESPONSE: The department disagrees with the comment because the statute authorizing parent and legal guardian-taught driver education does not provide for such additional requirements on the parent or legal guardian. The department interprets the statute as not authorizing the additional requirements. COMMENT: There are no guidelines to enforce appropriate standards for parent and legal guardian-taught driver education. RESPONSE: The department disagrees with the comment. The rules, as adopted, do contain adequate procedures to follow the standards set out by the statute relating to qualifications of the instructors, the minimum standards for an approved course curriculum, and the completion of the training. COMMENT: The department should not require an applicant who has received driver education from a parent or legal guardian to take a driving test. The statute says that completion of a course taught by a parent or legal guardian has the same effect as a course taught by a commercial or training school. RESPONSE: The department agrees that the statute, Texas Civil Statutes, Article 6687(b), sec.7A, prohibits it from requiring a driving test for the person taught the driver training by a parent or legal guardian. The department has changed the rule, as originally proposed, to delete the driving test requirement for those persons. This provision will be consistent with 37 TAC, sec.15.55, (relating to Waiver of Knowledge and Skills Test). COMMENT: The department should check court documents to determine whether a person is the legal guardian of an individual. RESPONSE: An individual will be required to provide a sworn statement of status as a parent or legal guardian. Criminal penalties exist for persons proved to have made a false statement regarding the driver license application process. The department does not intend, at this time, to require other documentation of legal guardianship. COMMENT: The process should require the department to check the driving records of parents, require proof of automobile insurance, inspect for vehicle licensing, adequate brakes, document all course work, and document all in-car training. RESPONSE: For the reasons stated in response to previous comments, the department disagrees with the comment, except as to the documentation requirements relating to course work and in-car training, which are contained in the rules. COMMENT: A parent should be required to take a ticket dismissal course, an alcohol safety course, and the student should be required to take the driving test, and the department should charge a reasonable fee for students to take the course that would pay the salaries of employees to monitor and guarantee that the guidelines are followed. RESPONSE: For the reasons stated in response to previous comments, the department disagrees with this comment. COMMENT: The rules should require that the car have a "student driver" sign. RESPONSE: For the reasons stated in response to previous comments, the department disagrees with this comment. COMMENT: Every parent or legal guardian who would teach driver education should be required to have a refresher course. Further, the opportunity for fraud exists. RESPONSE: For the reasons stated in response to a previous comment, the department does not have the authority to require a refresher course. The requirement of certifying under oath that the requirements have been met, meets the statutory requirements. COMMENT: The department should require a driving test for all applicants for a driver license, not just those taught by a parent or legal guardian. RESPONSE: For the reasons stated in response to a previous comment, the department disagrees with this comment. Texas law, Transportation Code, sec.521.165, authorizes the department to waive the driving test in certain circumstances, which it has previously done by rule for persons who have completed a course of driver education. COMMENT: The rules should require proof of affiliation with a "home" school. RESPONSE: The statute does not require that the parent or legal guardian who teaches driver education be involved in the "home" school education of the student. COMMENT: The rule should require that a parent or guardian must present a current copy of that person's driving record, obtained within the previous thirty days. Approval to do at-home driver education will be denied if the parent has a record that demonstrates unsafe driving practices or recorded DWI convictions. RESPONSE: As stated in response to previously addressed comments, the department will review a parent's or legal guardian's driving record at the time the student appears for licensing. If the record of the parent or legal guardian shows that the person has been convicted of criminally negligent homicide or driving while intoxicated the application will be rejected. There is no statutory authority for a rule which would disqualify a parent or guardian whose record otherwise demonstrates unsafe driving practices. COMMENT: The rules should require proof of purchase or rental of state adopted textbook, student workbook, and teacher's edition. RESPONSE: The department disagrees with the comment. The parent or guardian will be required to certify that all requirements have been met, but those requirements do not include those suggested by the commenter. The rules merely require that a textbook approved by the Texas Education Agency for driver education is a required resource. This requirement meets the minimum standard set out in the Texas Education Agency curriculum, and is, therefore, consistent with the statutory requirement. Proof of purchase or rental of the textbook is not required, nor will there be a requirement relating to use of a workbook or teacher's edition, as those are not within the curriculum requirements. COMMENT: The parent instructor should be required to pass the written and driving portions of the Department of Public Safety's driving test. RESPONSE: The department disagrees with the comment because it would place additional requirements on the parent or legal guardian which are beyond those set out in the statute. One of the requirements for a parent or guardian to teach driver education is that the person be a licensed driver, which does establish that the person has met the requirements for obtaining a license. COMMENT: After proof of completion of six (6) classroom hours, by signed affidavit, the parent and student will return to the Department of Public Safety's office for the permit test. RESPONSE: The department agrees with the comment because this procedure is provided for when the concurrent program is used. COMMENT: After completion of the remaining twenty-six (26) hours of classroom instruction and fifty (50) hours of supervised driving, by signed affidavit, and having reached the age of 16, the student may return to the Department of Public Safety for a driving test to be administered by the Department of Public Safety's officer. RESPONSE: The department disagrees with the comment as to the proposal to require fifty (50) hours of supervised driving. The curriculum, as mentioned in response to previous comments, must contain a minimum of seven (7) hours of behind-the-wheel instruction and seven (7) hours of supervised instruction. The driving test will not be required, as previously discussed. COMMENT: The parent instructor should be responsible for all fees or costs that are applicable, including the cost of obtaining a driving record, the cost of the driving safety class, the packet cost, textbook costs, other materials, and testing fees for parent and student, both written and driving portions of the test. RESPONSE: The department agrees that the cost of the packet of materials provided by the department and textbooks and other materials, as well as all statutory fees for issuance of a permit or license, will be the responsibility of the parent, or of the student. As previously mentioned, the department will check the driving record of the parent or guardian at its expense. The department disagrees with the comment regarding costs associated with a driving safety class for the parent and testing fees for the parent. Since there will be no requirements for the parent, no fee would be applicable. Additional comments were received which duplicated the previous comments. Further, some comments merely stated the commenter's position of being against or in favor of the law or rule. The new sections are adopted under Texas Civil Statutes, Article 6687b, sec.7A, which provides the department with rule-making powers regarding this subject. sec.18.21.Obtaining Materials For Parent Taught Course. (a) Request for a Driver Education Packet. Prior to teaching a department approved course, a parent or legal guardian must send a completed Request for Driver Education Packet form with a non-refundable fee which is set by the department to satisfy the cost of preparing the materials, shipping, and applicable taxes. The request will be sent to the General Services Bureau of the Texas Department of Public Safety. Upon receipt of the request, a Driver Education Packet will be mailed to the address given on the request form. This packet will contain the following: (1) instructions and procedures; (2) a Texas Driver License application (DL-14A); (3) two Parental Driver Education Affidavits; (4) a Student Instruction Record; (5) a Texas Drivers Handbook; (6) a model curriculum guide; (7) a resource list; and (8) a list of department approved programs. (b) The applicant will be instructed to designate the local Driver License office where tests will be administered. A numbered Texas Driver Education Certificate, form DE-964, will be forwarded to that office and will be available for the parent/instructor to complete the required sections upon completion of each phase of the training. (c) THE PACKET SPECIFIED IN SUBSECTION (a) OF THIS SECTION DOES NOT CONTAIN ALL REQUIRED MATERIALS (i.e., TEXTBOOKS) NECESSARY TO PROVIDE THE DRIVER TRAINING COURSE. IT IS THE RESPONSIBILITY OF THE PARENT OR LEGAL GUARDIAN TO OBTAIN THESE ITEMS AS NECESSARY. POSSIBLE SOURCES WILL INCLUDE SOMEONE ON THE RESOURCE LIST, AN EDUCATION SERVICE CENTER, OR A PUBLIC LIBRARY. ANY COSTS FOR THESE ADDITIONAL MATERIALS ARE THE RESPONSIBILITY OF THE PARENT OR LEGAL GUARDIAN. sec.18.23.Behind-the-Wheel Instruction. (a) In-car instruction may be taught in any motor vehicle which may be legally operated with a Class C driver's license in Texas. The vehicle must have valid registration, have a currently valid motor vehicle inspection certificate, and be properly insured with proof of such liability insurance available in the vehicle. The vehicle is not required to have dual brakes but it is recommended that the vehicle have a second rear-view mirror for use of the instructor. (b) After a student has received an instruction permit, a parent may begin in- car instruction. The curriculum must be followed and all required instruction given. Upon completion of all course material, classroom and behind-the-wheel, the parent/instructor should apply to the same Driver License office where the DE-964 form is filed. To obtain an unrestricted driver's license the student must have reached his sixteenth birthday and must provide the following at a Driver License office: (1) instruction permit or learner's license; (2) parental driver education affidavit; (3) complete student instruction record; and (4) TEA certificate of enrollment or equivalent. (c) Upon acceptance of the above documentation, Driver License Service personnel will provide the form DE-964 for completion by the parent/instructor indicating successful completion of the course. The department copy and the TEA copy of the form will be surrendered to the department. The school copy and the insurance copy of the form will be given to the applicant. Once this is completed the "B" restriction will be removed. 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. Issued in Austin, Texas, on March 18, 1997. TRD-9703754 Dudley M. Thomas Director Texas Department of Public Safety Effective date: April 7, 1997 Proposal publication date: September 27, 1996 For further information, please call: (512) 424-2890 Department Approved Driver Education Courses 37 TAC sec.sec.18.31-18.33 The Texas Department of Public Safety adopts new sec.sec.18.31-18.33, concerning department-approved driver education courses, without changes to the proposed text as published in the September 27, 1996, issue of the Texas Register (21 TexReg 9232). Changes have been made to the DRIVER EDUCATION INSTRUCTION CURRICULUM MODEL FOR PARENTS AND LEGAL GUARDIANS which the department adopted by reference. Changes to page L and page 173 of the curriculum include changing the language to read "permitting two periods of 30 minutes of behind-the-wheel driving in one day, so long as the two periods are separated by at least 30 minutes of non driving time." Changes to the forms section include adding a second Parental Driver Education Affidavit which was inadvertently left out and adding a parental certification to the instruction record. The justification for these sections is to implement Texas Civil Statutes, Article 6687b, sec.7A, which states that the department by rule shall provide for approval of a driver training course given by the parent or legal guardian of a person who is required to successfully complete a driver training course to obtain a Class C license. The new sections promulgate the standards for course approval, course evaluation, and appeal procedures. The department received written comments generally in favor of the rules as proposed, with some of the comments suggesting changes, from: Paula and Dan Darby, James B. Link, Brett I. Holcomb, Gary and Nadine Jackson, Karen Miller, Eric B. Neuman III, Ruth Pifer, and Lynn Tapp. Written comments in opposition to the rules were received from: Val David Eckles, Martha Gilley of AAA Security Driving Academy, Elizabeth Henrise of Quad-Cities Driver Training School, Verna Lee Kirchmeier, Marina T. Pothen of Quad-Cities Driver Training School, Benney Raley of Region VI Service Center, Carlos E. Reyna of Driving School Association of Texas, Carlos E. Reyna of Reyna Driving Systems, Marsha Rodsky of Spring Valley Driving School, and Charles Taylor of Advanced Traffic Technologies Inc. A public hearing was requested on the proposed new rules and held November 1, 1996 to receive comments from interested persons. Testimony was presented by thirty-three persons. Comments generally in favor of the rules as proposed, with some of the comments suggesting changes, were received from: Representative Jim Horn, James Link, Joshua Link, Patti Leestma, Paul Powell of the Office of Representative Charlie Howard, Donna Harp, Tim Lambert, Charles Taylor, Miriam Link, Gene Walker, John Davis, Jody Ripma, Sharon Wood, Dianne Hensley, and Amariah Harp. Persons who attended the public hearing and noted their position in favor of the proposed rules, but did not testify, were: Sarah Link, Trey Blocker, DaTonya Vaughn, Sharon Aldridge, Deborah Stanton, Donna Kile, and Brannen Temple. Persons who testified in opposition to the proposed rules were: B. J. Amos, Pat Linthicum, Don Appelt, Martha Gilley, Don Archer, Don Ashley, David Eckles, Marina Pothen, Charles Green, Carolyn Campbell, Lucian Jalufka, Darrell Thorley, Marsha Rodsky, Carrol Fuller, Shelia Wagner, Glenn Field, Carey Willingham, and Cheryl Welsh. Persons who attended the public hearing and noted their opposition to the proposed rules, but did not testify, were: Michael Hamilton, JoLeen Eiklenberg, Suzanne Reyna, Larry Ormes, Allen and Verna Lee Kirchmeier, Bob Downing, Elizabeth Henrise, Carlos Reyna, Phil Ward, Norm Rodsky, T.D. Reed, Andrea Swann, Joe Gonzales, Mark Powhatan, Athe Swann, Clarence Francis, Franklin Huebner, and Scott Wilson. A summary of the written comments, comments made at the hearing, and the department response follow: COMMENT: The rules should contain a provision that the department may determine that evidence of a violation of the standards exists that may establish the course as inadequate or provide cause for suspension or revocation of the parent(s) approval. RESPONSE: The rules do provide for an evaluation of the proposed curriculum and a method for notification and appeal of disapprovals. Failure to meet the standards set out for the parent or legal guardian will result in denial of the driver license application. COMMENT: The commenter proposed that a specific rule be adopted which would state that the department will not accept a student for a driver license examination when there is conclusive evidence of any violation of standards that may establish the course in which the student was enrolled as inadequate, with examples of an inadequate course. The comment also proposes a rule which would allow the department to not issue a license if, after accepting an application, the department receives conclusive evidence the course was inadequate. The comment also proposes such a rule which would authorize revocation of a license. RESPONSE: Implicit within the rules adopted by the department is the requirement that all standards set forth in the rules be met prior to licensing. Existing law authorizes denial, suspension, revocation, and cancellation, in appropriate circumstances, for persons who are ineligible to be licensed. COMMENT: The rules do not address the issue of mastery of the essential elements for driver education. The mastery level currently set in the course approved by the Texas Education Agency (TEA) is a prerequisite to the award of a grade of 70 or above. The proposed rules or suggested forms (student records) do not allow or require scores to reflect mastery levels. The rules do not require or request any proof of mastery in the content of the course, except in the passing of the written exam over the rules of the road and a road test. The training process should be verified by department representatives. RESPONSE: The "Driver Education Instruction Curriculum Model For Parents and Legal Guardians," which was adopted by reference as the standard upon which each program will be evaluated, contains requirements relating to mastery of the curriculum. The adoption of that standard is contained in sec.18.31 (relating to Requirements for Approval of Course). That curriculum standard states that an instructor must establish a procedure to ensure that the student demonstrates an acceptable level of mastery of the essential elements of driver education and driver safety education. The standard also provides that mastery is a prerequisite to the award of a Texas Driver Education Certificate and a moral responsibility that the student is a competent driver. An acceptable level of mastery shall be set to ensure that the student is challenged for maximum performance. The curriculum standard also provides for performance outcomes in each topic to be taught which set out these student achievement standards. Therefore, appropriate mastery levels are set in the proposed rules. Inherent in the forms to be submitted by the parent or legal guardian is the requirement that the instructed student has met the mastery levels. There is no statutory authority, beyond those set out in the rules, for verification of the training process by department representatives. COMMENT: The model curriculum should be reviewed by the Texas Education Agency, Division of Curriculum Development, prior to final adoption. RESPONSE: Members of the department consulted with members of the Texas Education Agency during the development of the curriculum being adopted. COMMENT: There are no guidelines to enforce appropriate standards for parent and legal guardian-taught driver education. RESPONSE: The rules, as adopted, do contain adequate procedures for ensuring the qualifications of the instructors, as set out by law, the approval of the curriculum, and the minimum standards for an approved course curriculum. COMMENT: In summary, the comment is that the curriculum guide established by the department contained information which was useless and over-kill, and the method used in the curriculum guide is faulty. The comment also asserts that the commenter should have been consulted for assistance in creating the curriculum. RESPONSE: The curriculum standard adopted by the department was adapted from the curriculum guide prepared by the Texas Education Agency. The department believes that the course materials are at least equal to those required in a course approved by the Central Education Agency, as required by the statute. The department was not required to consult with third parties to comply with the statute which required it to develop its course materials using the Central Education Agency course as a baseline standard. The department did consult with that agency in developing the curriculum. COMMENT: The curriculum guide adopted by the department is unnecessarily technical and exhaustive. RESPONSE: The curriculum guide adopted by the department meets the statutory requirements, but is not mandated to be utilized verbatim. Any course which is approved by the department, having materials which are at least equal to those required in the curriculum guide, may be used. COMMENT: The curriculum guide adopted by the department provides little information to parents on how to instruct. RESPONSE: The curriculum standard adopted by the department meets the statutory requirements. COMMENT: Seven hours of behind-the-wheel instruction is insufficient. RESPONSE: The department has adopted a standard which is at least equal to that required by the Texas Education Agency. This follows the statutory requirement. COMMENT: The rules should not limit driving to 30 minutes per day. RESPONSE: The department agrees that the rule should not limit behind-the-wheel instruction to 30 minutes per day. The curriculum has been modified to make it clear that two periods of behind-the-wheel driving in one day are permitted, so long as the two periods are separated by at least 30 minutes of non driving time. COMMENT: The department should not require that a parent or legal guardian use a textbook approved by the Texas Education Agency. RESPONSE: A textbook approved by the Texas Education Agency is a requirement which meets the minimum standard set out in the Texas Education Agency curriculum, and is, therefore, consistent with the statutory requirement. COMMENT: The rules should not place a limit of two hours of videotaped instructional materials. RESPONSE: The two hour limitation is one which is contained in the Texas Education Agency curriculum. There is no prohibition on using additional videotapes, so long as they are not counted toward the minimum number of hours required to be taught. COMMENT: The rules should not require that all of the classroom instruction be conducted before the in-car training. RESPONSE: The department-approved curriculum does authorize a method of teaching classroom and in-car training concurrently. Six hours of driver education must be completed prior to beginning the behind-the-wheel instruction. A procedure for obtaining an instruction permit as a prerequisite of the behind-the-wheel driving is also included in the rules. COMMENT: The legislature did not intend for the department to develop a curriculum, only to approve a curriculum submitted to the department. RESPONSE: The department has set a standard upon which each proposed program will be evaluated. The standard, which is the Driver Education Instruction Curriculum Model For Parents and Legal Guardians, may be utilized as a curriculum. Since the standard contains sufficient information to be utilized as a curriculum, it is appropriate for parents and legal guardians to use it if they so desire. Parents and legal guardians are not prohibited from using another approved curriculum obtained from other sources. COMMENT: The limit on two hours of video materials in the 32 hour instruction period is too low. RESPONSE: For the reasons addressed above, the department disagrees with this comment. COMMENT: The rule should require more than seven hours of behind-the-wheel training. RESPONSE: For the reasons stated in response to previous comments, the department disagrees with this comment. Additional comments were received which duplicated the previous comments. Further, some comments merely stated the commenter's position of being against or in favor of the law or rule. The new sections are adopted under Texas Civil Statutes, Article 6687b, sec.7A, which provides the department with rule-making powers regarding this subject. 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. Issued in Austin, Texas, on March 18, 1997. TRD-9703753 Dudley M. Thomas Director Texas Department of Public Safety Effective date: April 7, 1997 Proposal publication date: September 27, 1996 For further information, please call: (512) 424-2890