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 10. COMMUNITY DEVELOPMENT Part I. Texas Department of Housing and Community Affairs Chapter 53. HOME Investment Partnerships Program 10 TAC sec.sec.53.50-53.62 The Texas Department of Housing and Community Affairs (Department) HOME Investment Partnerships (HOME) Program adopts Proposed Rules sec.sec.53.50- 53.62, concerning the requirements for application and distribution of funds available under federal and state laws and regulations for the HOME Program. Section 53.57 and sec.53.60 are adopted with changes to the proposed text as published in the January 26, 1996, issue of the Texas Register (21 TexReg 645). Sections 53.50-53.56, 53.58-53.59, and 53.61-53.62 are adopted without changes and will not be republished. The change to sec.53.57 was for clarification. The changes to sec.53.60(b) and (c) added a requirement of a notification period that was not in the original, for the benefit of applicants. The adoption of the rules will provide definitions of terms commonly used in the program, eligible applicants and activities, funding distributions and allocations, and scoring process and criteria. The sections will define the process the program will use to distribute HOME funds. The Department did not receive any public comment in opposition to the adoption of the HOME Program Rules during the 30-day comment period. However, the Department did receive one comment on a specific section of the Rules. The respondent requested that the Department increase the amount of funds available per person for the Homebuyer Assistance Program. The Department established the fund maximum in an effort to spread out limited resources. The Department believes that the Homebuyer Assistance Program is viable with the established per person maximum. The new sections are adopted under Title II of the Cranston-Gonzales National Affordable Housing Act of 1990, (42 United States Code sec.sec.12701-12839) and 24 Code of Federal Regulations, Part 92. The new sections are adopted pursuant to the authority at Texas Government Code, Chapter 2306; Acts of the 73rd Legislative Regular Session, SB 45, chapter 141, page 292, effective May 16, 1993; and Act of the 73rd Legislative Regular Session, Senate Bill 1356, Chapter 725, page 2838, effective September 1, 1993, which provides the Texas Department of Housing and Community Affairs with the authority to adopt rules governing the administration of the Department and its programs. sec. 53.57. Allocation Plan. The funding allocation plan will be based on the funding recommendations in the Consolidated Plan, ratified by the Board prior to submission to HUD. Upon notification of HOME Program funding authorization by HUD and the HUD final approval of the consolidated plan, the allocation plan for the HOME Program will be published in the Texas Register. sec.53.60. Process for Awards Made by Competition. (a) The Department will publish a NOFA in the Texas Register. The NOFA will establish a deadline for receiving applications and indicate the approximate amount of available funds. (b) Selection Procedures for Owner Occupied Housing Assistance, Homebuyer Assistance, and Tenant-Based Rental Assistance. (1) The proposed program design in the application must comply with all applicable HOME requirements or regulations established in 24 CFR Part 92, as may be amended, and in these rules. Applicants with program designs that do not comply with such requirements are disqualified. Disqualified applicants are notified in writing. (2) Applications are ranked from highest scores to lowest in their respective regions or activity according to the average of three HOME Program scores. CHDO Set-Aside scores are ranked from highest to lowest in each CHDO-eligible activity on a statewide basis. (3) Applications that meet or exceed a minimum score of 60% of the total HOME Program score established for the respective activities are considered for funding. (4) Applicants will be notified in writing at least seven days prior to the date of the Board meeting, including its committees, of the status of their application. (5) Applications receiving a favorable staff recommendation are then presented to the Board for approval, pending the availability of HOME funds for such activity. (6) In event of a tie between two or more applicants, the Department, with Board approval, reserves the right to determine which application will receive funding based on housing need factors and feasibility of the proposed project identified in the application. (c) Selection Procedures for Rental Project Assistance and Interim Construction Financing Assistance: (1) Applications are reviewed by the Department to ensure that the proposed rental housing project or the proposed interim construction program meets applicable HOME requirements. Applications with program designs that do not comply with HOME requirements are disqualified. Disqualified applicants are notified in writing. (2) Applications that meet or exceed a minimum score of 60% of the total HOME Program scoring points established for each Rental Assistance and Interim Construction Assistance program are considered for further processing. Applicants not meeting or exceeding the minimum score established in this section are disqualified and are notified in writing. (3) Applications meeting or exceeding the minimum HOME Program requirements established in sec. 53.60(c)(2) of this title (relating to Process for Awards made by Competition) must receive an underwriting analysis by the Department. A site visit may be conducted as part of the HOME Program feasibility and underwriting analysis. Applicants must receive recommendation for approval from the Department to be considered for HOME funding by the Board. (4) Applicants will be notified in writing at least 7 days prior to the date of the Board meeting of the status of their applications. (5) Applications receiving a favorable staff recommendation are then presented to the Board for approval, pending the availability of HOME funds for such activity. (6) In event of a tie between two or more applicants, the Department, with Board approval, reserves the right to determine which application will receive funding based on housing need factors identified in the application. (7) Board approval for the award of HOME Rental Project Assistance funds is conditional upon a completed loan closing. 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 May 1, 1996. TRD-9605996 Larry Paul Manley Executive Director Texas Department of Housing and Community Affairs Effective date: May 22, 1996 Proposal publication date: January 26, 1996 For further information, please call: (512) 475-2135 Title 16. ECONOMIC REGULATION Part I. Railroad Commission of Texas Chapter 9. Liquefied Petroleum Gas Division Subchapter A. General Applicability and Requirements 16 TAC sec.9.5, sec.9.6 The Railroad Commission of Texas adopts amendments to sec.9.5, relating to licensing requirements, and sec.9.6, relating to examination and course of instruction, with changes to the proposed text as published in the March 29, 1996, Texas Register (21 TexReg 2519). The commission adopts this action to increase the annual renewal fee from $10 to $25, to temporarily suspend the requalification seminars, and to clarify some licensing and course requirements for different types of licenses. The fee increase is necessary to fund the development of commission-approved hands-on training courses by the commission for both LP-gas licensees and applicants for license, which will be proposed in future rulemakings and which may also be proposed as mandatory training. Section 9.5 specifies the requirements and procedures for licensing, including staggered renewals. Adopted new language in subsection (i) specifies requirements for courses of instruction, which are being moved from sec.9.6 because they are licensing requirements, not examination requirements. Adopted new language in sec.9.5(i)(1)(A) and (B), and (i)(4) that is not currently in sec.9.6 is added for clarification. Section 9.6 describes requirements and procedures for examinations and courses. It also describes the general installers and repairmen exemption, discusses requirements for trainees, and specifies examination fees and renewal of certification procedures. The adopted substantive amendments, particularly in sec.9.6(e)(1), increase the annual renewal fee, which has not increased in over ten years, from $10 to $25 for LP-gas licensees and applicants. (Individuals holding general installers and repairmen exemptions explained in sec.9.6(b) will not have an increased fee.) As adopted, the $25 annual renewal fee will be due by June 30th for 1996 only, to allow time for the adopted amendments to become effective. Thereafter, the $25 annual renewal fee will be due by May 31st. This increase is necessary to fund an improved training program for licensees and applicants for license, which will include hands-on training and may be proposed in future rulemakings to be mandatory training. To offset the increased fee, the new training courses will be offered free of charge. During the time period of development and implementation of the new courses, the requalification seminar is temporarily suspended, as specified in subsection (f). The adopted amendment which is different from the published version is found in sec.9.6(a)(8). The adopted change is nonsubstantive, allows an examinee who fails an examination to retake the same examination one more time during that business day, and explains the procedure for subsequent examinations. Other adopted changes in sec.9.6 include subsection (b)(3), which clarify the requirements for general installers and repairmen exemption holders. The table in sec.9.6 has been modified; language formerly in the table concerning examination fees is added in subsection (d)(1) and (2). Also, as discussed in the explanation of amendments to sec.9.5, subsection (f) of sec.9.6 is being deleted from sec.9.6 and its contents moved to sec.9.5 as new subsection (i). Other adopted nonsubstantive amendments include some changes in wording, punctuation, or organization to provide clearer language. Only one comment was received; the commenter was in favor of the amendments and also suggested having the courses for two consecutive days, so that employers would not be burdened by having all their employees away from work during a day. The commission agrees with this comment and will make every attempt to offer the same class on consecutive days, especially when the courses are being scheduled outside the Austin area, where adequate enrollment can be ensured. The specifics regarding the training will be proposed in a future rulemaking. No groups or associations submitted comments. The amendments are adopted under the Texas Natural Resources Code, sec.113. 051, which authorizes the commission to adopt rules relating to any and all aspects or phases of the LP-gas industry that will protect or tend to protect the health, welfare, and safety of the general public. The following are the statutes, articles, or codes affected by the adopted amendments: Section 9.5 and sec.9.6-Texas Natural Resources Code, sec.113.051. sec.9.5. Licensing Requirements. (a)-(h) (No change.) (i) Course of instruction requirements are as follows: (1) Dates and locations of courses of instruction and seminars shall be listed in a schedule prepared by the commission which shall be published on a monthly basis, shall be posted in the Austin offices of the Gas Services and AFRED divisions, and shall be made available upon request and through electronic media. (A) The one-hour course of instruction for Category D, F, G, I, J, K, and L company representatives and operations supervisors shall be held in Austin and other selected sites around the state. (B) The 64-hour course of instruction for Category E shall be held in Austin or any other commission- approved facility at times to be determined by the commission, and shall include at least 64 hours of instruction. (2) Company representative and operations supervisor applicants for new Category D, E, F, G, I, J, K, and L licenses shall attend and complete an approved course of instruction and shall within one year take the LP-gas management examination. Such applicants shall be exempt from the course of instruction if they have been in a qualified status for at least three years with an active licensee immediately prior to taking the management examination. (3) Attendance at a course of instruction is not required for Category A, B, C, H, M, N, and O company representatives and operations supervisors. (4) The assistant director for the LP-Gas Section of the Gas Services Division may, for good cause shown, allow an individual to become conditionally qualified as a Category D, E, F, G, I, J, K, and L company representative or operations supervisor by taking the management examination if that individual attends and completes the appropriate course of instruction no more than 100 days after taking and passing the management examination. If such individual fails to complete the course of instruction within the time granted by the assistant director, the conditional qualification shall be voided. sec.9.6. Examination Requirements and Renewal of Certified Status. (a) Examination general provisions. (1) No individual may work or be employed in any capacity which requires contact with LP-gas or LP-gas systems until that individual has submitted to and passed a commission examination which measures the competency of that individual to perform the LP-gas related activities anticipated, and tests working knowledge of the Texas Natural Resources Code and the LP-gas safety rules related to the type of LP-gas work anticipated. Table 1 of this section sets forth specific requirements for employee level examinations for each category of license. This section applies to all licensees and their employees who perform LP-gas related activities, and also applies to any ultimate consumer who has purchased, leased, or obtained other rights in any vessel defined as an LP-gas transport by this chapter including any employee of such ultimate consumer if that employee drives or in any way operates such an LP-gas transport. Driving a motor vehicle powered by LP-gas or fueling of motor vehicles for an ultimate consumer by the ultimate consumer or its employees do not in themselves constitute LP-gas related work. Only paragraph (2) of this subsection applies to an employee of a state agency or institution, county, municipality, school district, or other governmental subdivision. Figure: 16 TAC 9.6(a)(1) (2) Any employee of an ultimate consumer or a state agency or institution, county, municipality, school district, or other governmental subdivision not required to submit to examination under this section shall be properly supervised and trained in the installation, maintenance, and storage of LP-gas, LP-gas systems, and vehicles fueled by LP-gas, and in the operation of equipment during the filling of and dispensing from storage containers. Such training shall also include the protection of containers and equipment against mechanical injury or tampering by unauthorized individuals. (3) Ultimate consumers who have purchased, leased, or obtained other rights in any vessel defined as an LP-gas transport, including any employee of an ultimate consumer that drives or in any way operates an LP-gas transport, shall pass one or more of the employee examinations listed in lines 1 and 2 of Table 1 of this section. (4) Each individual wishing to submit to examination by the commission shall file an LPG Form 16 with the commission prior to examination. (5) A licensee shall notify the commission when a previously certified individual is hired by immediately filing an LPG Form 16A with the commission. Notification shall include the employee's name as recorded on a current driver's license or Texas Department of Public Safety identification card, employee social security number, name of previous licensee-employer, and LP-gas related work to be performed. (6) All examinations shall be administered in Austin and at other selected sites, when appropriate, unless an applicant demonstrates good cause for administering the examination elsewhere. Good cause includes but is not limited to severe economic hardship. (7) Successful completion of any required examination shall be credited to and accrue to the individual. (8) Failure of any examination shall immediately disqualify the individual from performing any LP-gas related activities covered by the examination which is failed. Any individual who fails an examination administered by the commission may re-take the same examination one additional time during a business day. Any subsequent examination must be taken on another business day, unless approved by the assistant director for the LP-Gas Section, Gas Services Division, or another designated commission employee. (9) Dates and locations of examinations shall be listed in a schedule prepared annually by the commission by September 1st each year. The schedule shall be posted in the Austin offices of the Gas Services and AFRED divisions and made available upon request and through electronic media. (b) General Installers and Repairmen Exemption. (1) Any individual who is currently licensed as a master or journeyman plumber by the Texas State Board of Plumbing Examiners or who is currently licensed with a Class A or B Air Conditioning and Refrigeration Contractors License issued by the Department of Licensing and Regulation may apply for and be granted an exemption to the Category D management examination and any service and installation employee level examination for Categories D, E, K, or N, excluding an engine fuel examination, and applicable seminar or course of instruction requirements by submitting to the commission the following information: (A)-(C) (No change.) (2) (No change.) (3) An individual who holds a general installers and repairmen exemption shall not perform LP-gas related activities unless: (A) that individual works for a properly licensed Category D, E, K, or N licensee; (B) the individual successfully completes the applicable employee-level examinations required to work for a licensee in a category other than D, E, K, or N; or (C) the individual successfully completes all examination and licensing requirements for another category of license. (4) (No change.) (5) Any individual granted such exemption shall maintain certified status at all times. Upon failure to maintain certified status, all affected LP-gas operations shall cease immediately until proper status has been regained. (6) In order to maintain certified status, each individual issued an examination exemption card shall pay a $10 annual renewal fee to the commission on or before May 31st each year. Failure to pay the $10 annual renewal fee by the May 31st deadline shall result in a lapsed certification. If an individual's certification lapses, that individual shall cease all LP-gas activities until certified status has been renewed. To renew a lapsed certification, the applicant shall pay the $10 annual renewal fee plus a $10 late-filing fee and submit proof of successful completion of all examinations required for the certification to the commission. Failure to do so shall result in the expiration of the certification. If an individual's certification has been expired for more than two years, that individual shall comply with the requirements of subsection (b) of this section. (7) Each applicant for license who plans to substitute an individual as noted in sec.9.5(g)(2) of this title (relating to licensing requirements) for its company representative or operations supervisor may do so provided that individual complies with all of the other requirements. (8) Any individual who is issued this exemption agrees to comply with the current edition of the LP-gas safety rules. In the event the exempt individual surrenders, fails to renew, or has the license revoked either by the Texas State Board of Plumbing Examiners or Department of Licensing and Regulation, that individual shall immediately cease performing any LP-gas activity granted by this section. The examination exemption card shall be returned immediately to the commission and all rights and privileges surrendered. (9) Applicants for license or licensees who qualify for the general installers and repairmen exemption are not required to take the one-hour course of instruction specified in sec.9.5(i)(A) of this title (relating to licensing requirements). (c) Trainees. (1) Notwithstanding the examination requirements set forth in this section, a licensee or ultimate consumer may employ an individual as a trainee for a period not to exceed 45 days, without that individual having successfully completed the necessary examination, subject to the following conditions. (A) The trainee shall be directly and individually supervised at all times by an individual who has successfully completed the commission examination for the areas of work being performed by the trainee. (B) The licensee or ultimate consumer shall ensure that an LPG Form 16 is on file with the commission for each employee in training at the time that the trainee begins supervised LP-gas activities. (C) No trainee may perform any LP-gas work for which he or she is not currently certified while unsupervised. (2) A trainee who fails a commission examination shall cease to perform any LP-gas related activities covered by the examination failed. A trainee who has been in training for a total period of 45 days, in any combination and with any number of employers, shall cease to perform any LP-gas activities for which he or she is not currently certified. (3) A trainee who continues to work in violation of this subsection may be held responsible for the violation. An employer who employs an individual in violation of this subsection may be held responsible for the violation. Possible penalties for violation are set forth in the Texas Natural Resources Code, Chapter 113. The commission may call an administrative hearing to show cause why a license should not be subject to revocation, suspension or probation, or any combination of these penalties. (d) Examination fees. Each applicant shall pay to the commission the examination fee specified in this section in advance for each required examination. The fee is nonrefundable and shall be paid in full before each examination. An applicant who fails an examination shall pay the full examination fee for each subsequent examination. (1) The fee for a management level examination required for company representatives and operations supervisors for all license categories is $25. (2) The fee for all employee level examinations for all license categories is $10. (e) Renewal of certified status. (1) In order to maintain certified status, each individual who has been qualified by examination shall pay the $25 annual renewal fee to the commission on or before the specified deadline. For 1996 only, the $25 annual renewal fee shall be paid by June 30th. For each year thereafter, the $25 annual renewal fee shall be due by May 31st. (2) Failure to pay the $25 annual renewal fee by the deadline specified in subsection (e)(1) shall result in a lapsed certification. To renew a lapsed certification, the applicant shall pay the $25 annual renewal fee plus a $10 late-filing fee and submit proof of successful completion of all examinations required for the certification to the commission. Failure to do so shall result in the expiration of the certification. If an individual's certification has been expired for more than two years, that individual shall comply with the requirements of subsection (a) of this section. (3) Upon receipt of the annual renewal fee, late-filing penalty, and proof of successful completion of all examinations required, the commission shall verify that the individual's certification has not been suspended, revoked, or expired for more than two years. After verification, the commission shall renew the certification and the individual may resume LP-gas activities. (4) If an individual's certification lapses or expires, the individual shall immediately cease performance of all LP-gas activities which require certification. (f) Requalification seminars are temporarily suspended until February 28, 1998, or until further amendment of this subsection. 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 April 30, 1996. TRD-9605969 Mary Ross McDonald Assistant Director, Legal Division, Gas Utilities/LP Gas Railroad Commission of Texas Effective date: May 21, 1996 Proposal publication date: March 29, 1996 For further information, please call: (512) 463-7008 TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 241. Shellfish Sanitation Texas Crab Meat 25 TAC sec.sec.241.1, 241.2, 241.4-241.29 The Texas Department of Health (department) adopts amendments to sec.sec.241.1, 241.2 and 241.4-241.29, concerning Texas crab meat. Sections 241. 2, 241.4, 241.7, 241.8, 241.10, 241.12-241.17, 241.19, 241.20, 241.22, and 241. 23, are adopted with changes to the proposed text as published in the February 9, 1996 issue of the Texas Register (21 TexReg 934). Sections 241.1, 241.5, 241.6, 241.9, 241.11, 241.18, 241.21, and 241.24-241.29 are adopted without changes and will not be republished. The amendments update and clarify the existing rules and implement the statutory changes adopted by the 73rd Legislature. The amendments add new definitions and update existing definitions; establish new standards for the processing and distribution of crab meat; and establish new licensing and enforcement procedures. The amendments will better assure that crab meat processed in or imported into Texas will be free of disease or other health hazards transmissible by these products. A summary of comments and the department's responses to the comments follows. COMMENT: Concerning sec.241.2(a), one commenter stated that invalidating a license simply because there is a 5.0% or more change in shares of company stock owned by any one board member is not reasonable. The number of shares may vary and have nothing to do with how well the plant is operated. RESPONSE: The department agrees and has deleted the proposed wording. COMMENT: Concerning sec.241.2(c), during the review process, the department determined that a clarifying phrase was not necessary. RESPONSE: The department removed the phrase. COMMENT: Concerning sec.241.2(c) and (d), one commenter stated that these subsections were not necessary. RESPONSE: The department disagrees because our inspectors are not trained in these requirements, and the division which used to conduct such inspections has been transferred to another agency. COMMENT: Concerning sec.241.2(e) and sec.241.23(d), one commenter stated that these paragraphs should address a "CODE DATE" instead of a "SELL BY" date. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.2(f), during the review process, the department determined that additional wording was necessary for clarification. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.2(g), one commenter stated that this paragraph was too subjective and wanted it removed from the rules. RESPONSE: The department disagrees because past failure to comply with the rules should be reason for denial. COMMENT: Concerning sec.241.2(o), (p), (q), (r), and (s), one commenter stated that these monetary penalties were not necessary and were totally subjective, and the commenter was opposed to any penalties. RESPONSE: The department disagrees because monetary penalties provide an intermediate level of enforcement short of revocation and closing a business. COMMENT: Concerning sec.sec.241.4(d), 241.13(i), and 241.14(e), one commenter stated that since a study had been conducted showing that the rinsing of cooked crabs could be optional, these paragraphs needed to be changed to reflect that option. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.4(i), one commenter stated that this section needed clarification regarding the types of activities required to be under one roof. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.7(a), one commenter stated that a minimum of 50 foot candles was too restrictive and would be too costly to comply. RESPONSE: The department agrees and has changed the requirement to a minimum of 35 foot candles. COMMENT: Concerning sec.241.8(b), several commenters stated that requiring a maximum of 85 degrees in the backing room would be very costly for the industry to comply. RESPONSE: The department agrees and has deleted the proposed wording. COMMENT: Concerning sec.241.10(g), several commenters stated that requiring additional water closets is not reasonable and would be too costly for the current industry. RESPONSE: The department agrees and has deleted the proposed changes. COMMENT: Concerning sec.241.12(b), during the review process, the department determined that additional wording was necessary for clarification. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.13(f), one commenter stated that requiring racks to be a minimum of four inches off the floor was unreasonable and unduly costly when the floor of his cooler is all ready raised eight inches above the rest of the plant and is graded to drain properly. RESPONSE: The department agrees and has changed the requirement to a minimum of four inches unless the floor in the cooler is all ready a minimum of four inches above the rest of the plant. COMMENT: Concerning sec.241.15(i) and (j), one commenter stated that the requirement to pick into the final container is not reasonable. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.16(h), one commenter requested approval of repacking of crab meat by licensed dealers so that this section would not conflict with other proposed amendments and sections. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.16(j), during the review process, the department determined that additional wording was necessary for clarification. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.17(g), several commenters stated that this requirement was unreasonable. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.19(m) and (u), one commenter wanted clarification of the pasteurization requirements to allow pasteurization of one plant's crab meat in another plant. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.19(y), during the review process, the department determined that additional wording was necessary for clarification. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.20(d), one commenter stated that the department should clarify this subsection relating to premises. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.22(a), during the review process, the department determined that deleting the word "glass" was necessary because it is not "durable" by definition. RESPONSE: The department has made the deletion. COMMENT: Concerning sec.241.23(c) and (d), during the review process, the department determined that to be consistent with sec.241.2(e) these subsections must be changed. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.23(i), during the review process, the department determined that additional wording was necessary for clarification. RESPONSE: The department has made the appropriate changes. COMMENT: Concerning sec.241.29(c), one commenter stated he believed the Food Protection Management Program course should not be required since it did not deal with crab meat. RESPONSE: The department disagrees. This is the only course recognized by the department for food handlers. Until a more specific course for crab meat is developed, this course is the only sanitation training available. Editorial changes were made for clarification or consistency purposes. All of the commenters were individuals. The commenters were generally in favor of the rules; however, they expressed concerns and questions relating to the changes. The amendments are adopted under Texas Health and Safety Code, sec.436.12 and sec.12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.241.2. Licensing and Enforcement Procedures. (a) No crab meat shall be offered for sale for food in the State of Texas unless the crab meat has been processed and packaged in compliance with these sections or obtained from sources outside the state accepted by the Texas Department of Health (department). If obtained from sources outside of the state, the crab meat shall originate from a crab meat processor currently licensed by the appropriate state or other government authority. Crab meat obtained from sources other than those outlined in this section shall be considered unfit for human consumption. No one shall engage in the processing and packing of crab meat for sale without having complied with these sections. No one shall engage in any activity requiring a license under these sections without having applied for and obtained a numbered license from the commissioner. (b) Prior to beginning construction of a new crab meat plant, or major remodeling of an existing crab meat plant, (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure); complete, legible plans showing the floor plan of the building, with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to the Seafood Safety Division (SSD) for review and approval. Additional plans of the entire premises shall be required showing all structures, as well as, all water wells and septic systems with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any inside plant construction or any other construction which has the potential to contaminate the product is occurring. A legibly written or typed application on forms provided by the department must be filed with the SSD before any crab meat processing begins each license year. (c) The application for a license must be accompanied by a letter from the appropriate state agency, authorized agent, or designated representative, which states that the water supply is potable and the sewage disposal system is working properly. (1) For new construction, where the letter can not be submitted with the application, it must be submitted after the water supply connection is made and the sewage system is installed or the connection to an existing sewage system is made, the water supply and sewage system are inspected, and before the license will be issued. (2) For licensed locations where the crab meat activities are of a continuing nature, a letter concerning a public water supply and/or public sewage system shall be acceptable for a period not to exceed five years from the date of the letter. (3) For licensed locations where the crab meat activities are of a continuing nature, a letter concerning a private water supply and/or private sewage system shall be acceptable for a period not to exceed three years from the date of the letter. (4) A copy of the original letter may be submitted with the new application required each year. (5) If changes in activities increase the demand for water supply or the loading on the sewage system, if any construction or maintenance is required on the water supply or the sewage system or if any problems are observed or detected with the water supply or the sewage system, a new letter will be required. (d) The application for a license must be accompanied by acceptable sample results from at least one water sample from the water supply collected during the 30-day period immediately prior to the date on the application. (e) The application for a license must be accompanied by a written statement of the procedure the applicant will use to determine the code date for crab meat packed and shipped from the location listed in the application, if the applicant proposes to use a code date. (f) A license and unique number shall be issued by the commissioner only after an inspection of the plant by an authorized agent has revealed that past violative operational procedures have been corrected and the plant and procedures are currently in compliance with these sections. (g) The inspection of a previously licensed plant which has exhibited operational problems or violations of the operational requirements of these sections or had a license revoked shall not be conducted until written, complete operational procedures for all phases of the activity, including flow of the product, have been submitted to the SSD for review and approval. An application may be rejected and a license denied based on past failure to comply with the requirements of these sections. (h) Crab meat processing at the plant shall not begin until the commissioner has issued the Crab Meat Processing License for that location. Each license shall expire automatically at 11:59 p.m. the last day of February following the date of issue. Licenses shall not be transferable. (i) After a license is issued, unannounced inspections shall be conducted at any time the SSD has reason to believe the plant may be in operation or that crab meat may be stored on the premises and at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained. All crab meat at a licensed location shall be considered the responsibility of the licensed dealer at that location, for the purposes of this undesignated head. A copy of the completed inspection form listing written descriptions of the violations observed, along with any necessary explanation, shall be provided by an authorized agent of the department to the most responsible individual present at the firm at the conclusion of the inspection. Any violation of the same requirement found on a consecutive inspection may result in license suspension in accordance with subsection (j) of this section. (j) The SSD may initiate procedures to suspend or revoke a license as follows. (1) The procedures shall be in accordance with Texas Health and Safety Code, sec.436.114, and the provisions of the Administrative Procedure Act, the Government Code, Chapter 2001, and the department's formal hearing procedures in Chapter 1 of this title (relating to the Board of Health). (2) The grounds for suspension or revocation shall be either one of the following: (A) inspection results indicate unsatisfactory conditions in the plant or the existence of a public health hazard; or (B) the license holder or representative refuses to allow an inspection or otherwise interferes with an authorized agent of the department in the performance of his or her duties. (k) A licensee whose license has been suspended may not process any crab meat for a period determined by the commissioner, not to exceed 60 days after the date of signing of the final order of suspension. (l) A licensee whose license has been suspended shall not process any crab meat until the SSD is satisfied that all necessary corrections have been made. A suspension will not be rescinded until an inspection establishes that the firm has corrected all violations which resulted in the suspension and is in full compliance with all applicable criteria of these sections. (m) A license may be revoked for any of the reasons outlined in subsection (j) of this section or for either of the following: (1) the violations initiating a suspension fail to be corrected within the time frame established; or (2) the license has been suspended more than twice. (n) A licensee whose license has been revoked shall not apply for a new license for 180 days or before the next licensing period, whichever is longer, after the date of signing of the final order of revocation. When the department contemplates suspension or revocation, the license holder shall be afforded the opportunity for a hearing. Notice of the contemplated action shall be given to the license holder by personal service or certified mail, return receipt requested. If no request for a hearing is received by the director, within 14 days of personal service or the date of receipt, the department may proceed to take the action set out in the notice. (o) When the department determines that monetary penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with Texas Health and Safety Code, sec.436.114, the Administrative Procedures Act, the Government Code, Chapter 2001, and the department's formal hearing procedures in Chapter 1 of this title (relating to the Board of Health). (p) The seriousness of violations shall be categorized by one of the following severity levels. The examples following the severity levels are neither exhaustive nor controlling. They reflect only the seriousness of the violation and not the intent of the violator, the history of the violator, the amount necessary to deter future violations, or efforts to correct the violation. (1) Severity Level V-violations that are of minor public health significance. The following are examples of severity level V violations: (A) failure to keep premises clean and have adequate drainage; (B) failure to clean/maintain floors, walls, or ceilings; (C) failure to provide adequate & properly shielded lighting; (D) failure to post hand washing signs at hand washing stations; and (E) failure to restrict pickers from the packing room and all unauthorized persons from processing areas when operating. (2) Severity Level IV-Violations that are of more than minor significance, or if left uncorrected, could result in more serious violations. The following are examples of severity level IV violations: (A) failure to provide or use storage for employee clothing or personal articles; (B) failure to have clean, maintained, adequately drained floor; (C) failure to provide adequate heating/cooling/ventilation; (D) failure to provide adequate quantity of water to facility; (E) failure to provide hand washing stations with soap, sanitary towels, and/or waste receptacles with proper lids; (F) failure to properly construct, locate, maintain, and/or keep clean all non-food contact surfaces; (G) failure to provide detergents, approved sanitizers, brushes, and/or test kit to properly clean and sanitize the facility; (H) failure to properly store and/or keep single service containers clean; (I) failure to maintain frozen crab meat at 0 degrees Fahrenheit or less; (J) failure to require employees to wear clean outer garments, impermeable finger cots; to store properly; to wear proper hair restraints; (K) failure to promptly remove crab scrap or other accumulation; and (L) failure to meet code and/or install water disposal correctly or have adequate drainage where operations discharge water. (3) Severity Level III-Violations that are significant and which, if not corrected, could threaten public health. The following are examples of severity level III violations: (A) failure to exclude insects, rodents, vermin, or any other animals; (B) failure to provide hot and cold water at each sink/lavatory; (C) failure to protect plumbing from backflow, backsiphonage, and/or cross contamination; (D) failure to have toilets clean, repaired, or have self-closing doors; (E) failure to properly use, store, separate, and/or label poisonous/toxic materials; (F) failure to properly construct, locate, clean, and/or maintain food contact surfaces; (G) failure to provide a temperature measuring device in each refrigeration unit; (H) failure to wash/sanitize employees hands and/or exhibit good hygienic practice; (I) failure to restrict any personnel with infections from participating in crab meat processing operations; and (J) failure to maintain complete and accurate records. (4) Severity Level II-Violations that have a significant adverse impact on public health. The following are examples of severity level II violations: (A) failure to separate operations by partition, space, or time; (B) failure to provide adequate refrigeration units; (C) failure to clean and sanitize food contact surfaces effectively and within required time frame; (D) failure to label crab meat or properly complete label; (E) failure to protect crab meat from contamination; (F) failure to pack into containers with a valid license number for that location; comply with label requirements; to use proper date; (G) failure to promptly pick, pack, pasteurize, and/or protect the crab meat; and (H) failure to have responsible, effective, or designated person as supervisor. (5) Severity Level I-Violations that are most significant and create an imminent hazard to public health. The following are examples of severity level I violations: (A) failure to cease operations when location/plant is flooded; (B) failure to protect the water supply from contamination; (C) failure to install sewage disposal system properly; maintain or meet code; be adequate; (D) failure to maintain crab meat at the proper temperature; (E) failure to keep product from becoming contaminated; (F) failure to cool packed product to 45 degrees Fahrenheit within two hours of delivery to the packing room; (G) failure to maintain packed product at 40 degrees Fahrenheit or less during storage or to cover in ice; and (H) failure to provide sanitary ice and/or properly protect it. (q) The department may impose differing levels of penalties for different severity level violations and different persons. (1) Administrative penalties shall be imposed for Severity Level I, II and III violations. Administrative penalties shall be considered for Severity Level IV and V violations when they are combined with those of higher severity level(s) or for repeated violations which could have been prevented by corrective action and for which the license holder did not take effective corrective action. (2) Tables IA and IB show the base administrative penalties. FIGURE 1: TAC sec.241.2(q)(2) FIGURE 2: TAC sec.241.2(q)(2) (3) Adjustments to the values in Tables IA and IB in paragraph (2) of this subsection may be made for the presence or absence of the following factors: (A) prompt identification and reporting; (B) corrective action to prevent recurrence; (C) compliance history; (D) prior notice of similar event; and (E) multiple occurrences. (4) The penalty may be in an amount not to exceed $25,000 a day for each violation for a person who violates the Health and Safety Code, or this chapter, or an order. Each day a violation continues may be considered a separate violation for the purposes of penalty assessment. (r) The department may offer a license holder the opportunity to attend a settlement conference to discuss with the department, or a division thereof, methods and schedules for correcting the violation(s) or to show compliance with applicable provisions of the Health and Safety Code, this chapter, license conditions, and any orders of the department issued thereunder, or discuss both such topics. The department's Office of General Counsel may conduct settlement negotiations. (s) Notice of any settlement conference shall be sent by personal service or certified mail, return receipt requested. A settlement conference is not a prerequisite for the action to be taken under subsections (o), (p), or (q) of this section. (t) By acceptance of a license, the holder agrees to save, hold harmless, and indemnify the State of Texas, the department, and its employees against any and all liability, claims or losses for property damage or personal injury which result in whole or in part from the license holder's activities. The State of Texas shall not be held liable for financial losses incurred by the crab fishermen, plant supervisors, or plant owners due to failure of the crab industry, condemnation of crab meat, loss of crab meat, or other reasons. sec.241.4. Plant Location, Grounds, and Arrangements. (a)-(c) (No change.) (d) The backing room or area shall be adjacent to the cooking and cooling rooms and shall be physically separated from the live crab and cooking areas to prevent live crabs from entering the backing area. Entrance doors shall be provided to both the cooking and backing areas of the plant so that cooking and backing personnel can enter without passing through other processing areas of the plant. Cooking and backing personnel shall confine themselves to their particular area so as to retard cross-contamination of the cooked crab meat. (e)-(g) (No change.) (h) The waste product cool room shall be used to hold backing and picking room crab waste prior to disposal. This room shall be cleaned and disinfected each day of use. (i) All cooking, backing, picking, and packing of crab meat conducted in one plant shall be in processing areas directly connected and shall be under one roof to eliminate contamination potentials. (j) Crab bait shall not be allowed to create sanitation or nuisance problems in or near the crab meat plant at any time. (k) Processing and packing facilities shall be located so that they will not be subjected to flooding by ordinary high tides. If plant floors are flooded, all operations shall be discontinued and the SSD shall immediately be notified of the flooding. No operations may occur until waters have receded and the building is thoroughly cleaned and sanitized, and the facilities have been inspected by an authorized agent of the department. (l)-(p) (No change.) (q) Because picking and packing operations occur in separate areas, a delivery opening, shelf, or counter shall be provided so that pickers do not enter the packing area. The delivery opening area shall be equipped with a shelf or surface constructed of smooth, corrosion resistant, easily cleanable, durable materials which can be effectively sanitized. The shelf shall drain toward the picking room and, if necessary, be curbed on the packing room side. (r)-(s) (No change.) sec.241.7. Lighting. (a) Safe and adequate lighting shall be provided in all areas. A minimum of 35 foot candles, verified by an authorized agent, shall be required at product level in all processing areas. (b) (No change.) sec.241.8. Heating, Cooling, and Ventilation. (a) (No change.) (b) Processors shall have their picking and packing areas cooled with mechanical refrigeration adequate to maintain the internal air temperature at 72 degrees Fahrenheit or less. (c) Each processing room or area shall be equipped with an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location not to be more than six feet off the floor. sec.241.10. Plumbing, Sewage, and Related Facilities. (a) (No change.) (b) Drainage outlets shall be constructed and maintained to prevent the possible entrance of insects and rodents. Floor drainage shall not be allowed to drain from the plant on top of the ground. (c) There shall be no cross connections between the approved pressure water supply and water from an unapproved source, and there shall be no fixtures or connections through which the approved pressure water supply might be contaminated by backsiphonage. Adequate devices approved by a regulatory agency shall be installed to protect against backflow and backsiphonage at all fixtures and equipment where the air gap between the water supply inlet and the fixture's flood level rim is less than twice the diameter of the water system inlet. All submerged inlets including hoses attached to faucets shall be equipped with a backflow prevention device. If booster pumps are connected directly to the potable water supply, the pumps shall be equipped with a low pressure cutoff device or equivalent method to prevent backsiphonage. (d) Hand washing facilities shall be adequate in number and size for the number of employees, convenient to the work areas, and located so that the person responsible for supervision can readily observe that employees wash their hands before beginning work and after each interruption. There shall be at least one hand washing lavatory located in each of these areas: the backing area; the picking room; and the packing room. At least one hand washing lavatory shall be provided in each of these three areas for every 15 employees among the first 100 employees, and at least one hand washing lavatory for each 25 employees in excess of the first 100 employees. (Twenty-four lineal inches of wash sink or 18 inches of a circular basin, when provided with water outlets for such space, will be considered equivalent to one lavatory.) Three compartment sinks shall not be used for hand washing, but may be used to sanitize the hands after washing them in a lavatory. There shall be at least one three compartment sink located in the picking room, and one in the packing room. A three compartment sink shall be provided in the picking room for every 20 pickers. There shall be at least one large basin sink in the backing room. These sinks shall be of adequate size to completely immerse and properly clean and sanitize equipment and utensils. (e) Hand washing lavatories and three-compartment sinks shall be provided with hot water of at least 110 degrees Fahrenheit from either a controlled temperature source with a maximum temperature of 115 degrees Fahrenheit, or from a hot and cold mixing or combination faucet. Steam water mixing valves or steam water combination faucets shall not be acceptable. (f) A supply of hand cleaning soap or detergent shall be available at each hand washing lavatory. A container of bactericide for hand rinsing purposes shall be provided near each group of lavatories in the processing areas. A supply of disposable towels or a suitable hand drying device that provides heated air shall be conveniently located near each hand washing lavatory. Common towels shall be prohibited. Where disposable towels are used, easily cleanable waste receptacles, with covers, shall be conveniently located near the hand washing lavatories. Hand washing signs, in languages understood by the employees, shall be posted in toilet rooms and near hand washing lavatories. A hand washing lavatory shall be located immediately outside the toilet rooms so that hand washing can be readily observed. Hand washing lavatories, hand drying devices, and all related equipment shall be kept clean and in good repair. (g) Water closets, in toilet rooms separate for each sex, shall be provided in all places of employment in accordance with the following table. The number of water closets to be provided for each sex shall be based on the number of employees of that sex for whom the facilities are furnished. Where toilet rooms will be occupied by no more than one person at a time, can be locked from the inside, and contain at least one water closet, separate toilet rooms for each sex need not be provided. Where such single-occupancy rooms have more than one commode, only one such facility in each toilet room shall be counted for the purposes of the table due to the lack of partitions. The sewage disposal method shall not endanger the health of employees. Each water closet shall occupy a separate compartment with a door and walls or partitions between fixtures adequately high to assure privacy. Toilet room doors shall be tight fitting, self-closing, and not open directly into a processing area. Toilet rooms shall be kept clean and in good repair. A supply of toilet paper in a suitable holder shall be available in the toilet rooms. Air vents shall be screened or have self-closing louvers. A covered waste receptacle shall be provided in each toilet room. FIGURE 1: 25 TAC sec.241.10(g) (h) No drainpipes or wastepipes shall be located over food processing or storage areas, or over areas in which containers are stored or washed. (i) Sewage shall be discharged into an adequate sewerage system or shall be disposed of through other effective means. Where private sewerage systems are utilized, they shall be constructed and maintained according to state and local laws. Privies are not acceptable. The sewerage system shall be constructed and maintained in order that sewage will be inaccessible to flies or other insects, rodents, or other vermin, and the sewage shall not provide a source of contamination. All sewerage lines and floor drainage lines shall be separate and shall be trapped to prevent entrance of sewage into any portion of the plant. sec.241.12. Construction of Utensils and Equipment. (a) All plant equipment and utensils shall be suitable for their intended use, so designed and of such durable material and workmanship as to be readily cleanable and shall be kept in good repair. The design, construction, and use of such equipment and utensils shall preclude the contamination of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment shall be installed and maintained to facilitate the cleaning thereof and of all adjacent areas. (b) All utensils and equipment shall be designed and fabricated from smooth, corrosion resistant, safe, durable materials for conditions of normal use and resistant to denting, buckling, pitting, chipping, and crazing. Unfinished and unpainted wood shall not be approved for use in any processing area as food or non-food contact surfaces. (c) (No change.) (d) All utensils and equipment shall be subject to inspection for compliance by an agent of the SSD prior to licensing or initial use and shall be kept in good repair. (e) (No change.) (f) Equipment of new design necessitated by new processes shall be reviewed by an authorized agent of the SSD before it is put into operation. sec.241.13. Cooking, Cooling, and Storage Areas. (a)-(d) (No change.) (e) Crates and/or baskets used in cookers shall be of corrosion resistant metal or other durable material approved by the department and shall be durable under the conditions of normal use. They shall be resistant to denting, buckling, pitting, chipping, and crazing. They shall have air gaps close enough to prevent spillage of crabs, and yet with as much space as possible to facilitate cooking and air penetration when cooling. (f) Crates and/or baskets shall not be allowed to come in contact with the floor or other contaminated surfaces either while clean and empty and waiting to be used or while being used to hold cooked crabs. Raised racks or other devices shall be provided to permit free air circulation and shall elevate the crab bodies and/or claws a minimum of four inches off the floor unless the floor in the cooler is raised a minimum of four inches above the floor in the rest of the plant and is properly graded to drain. (g)-(h) (No change.) (i) Cooked crabs shall be backed immediately after cooking unless they are cooled to room temperature and placed under mechanical refrigeration at air temperatures of 45 degrees Fahrenheit or less within one hour of removal from the cooker. Refrigeration of unbacked cooked crabs shall not be allowed as a routine operation. Cooked, backed crabs shall be placed under mechanical refrigeration and shall be maintained at air temperatures of 45 degrees Fahrenheit or less until picked. Coolers for whole cooked or backed crabs shall be capable of maintaining air temperatures of 45 degrees Fahrenheit or less at any time crabs are held in the cooler. (j) (No change.) sec.241.14. Backing of Cooked Crabs. (a)-(c) (No change.) (d) Backing table tops shall be of corrosion resistant metal without butt joints or open seams. Backing table frames and legs shall be constructed of corrosion resistant, durable material. Spray nozzles used for rinsing the waste out of the backed crab shall be smooth and easily cleanable. (e) If rinsing of backed crabs is done, it shall be immediately after backing using sprayed water, and rinsed crabs shall be immediately placed in receptacles of approved design. Backed crabs and the containers shall not be exposed to the drainage or splash from the rinse. (f)-(h) (No change.) sec.241.15. Picking of Crab Meat. (a) (No change.) (b) Picking tables shall be made with frames and legs of corrosion resistant, durable material. Metal construction joints shall be made by welding and shall be ground to a smooth surface. Table top food contact surfaces shall be made without seams or butt joints. Table tops shall be made of type 302 and 304 stainless steel or its equivalent, number 4 finish or better on exposed surfaces, and 18 gauge or heavier. Construction and material may be of better quality than stated in this subsection. Construction shall be designed to avoid accumulation of organic material at the edge and underside of the table and all areas shall be easily cleanable. The tables shall be constructed to be graded to drain. (c) If wall tables are used, the backs of the tables shall extend at least 24 inches upward and be of durable material at least equal to the table top. (d)-(g) (No change.) (h) Only small quantities of cooked crabs shall be removed from the refrigeration room at any one time to be delivered to the pickers to prevent undue warming of the crabs before and during picking. Condensation drip shall not come in contact with the cooked crabs. (i) The crab meat shall be picked directly into one pound containers [the final container]. Each picker shall have no more than six containers at their work station at any time. (j) Upon filling not more than six containers of crab meat, each picker shall deliver the meat to the packing area to be weighed. (k) After each weighing, and before returning to work, the picker shall wash his/her hands and knife with hot water and detergent and then rinse them in a bactericide of approved strength. A bactericide solution of chlorine shall be kept between 50 and 100 parts per million (ppm) concentration, while an iodine solution shall be kept between 25 and 50 ppm concentration. (l)-(n) (No change.) sec.241.16. Packing of Crab Meat. (a) The packing area shall be equipped with a counter of rigid construction, surfaced with corrosion resistant metal or other impervious durable material with no open seams. (b)-(e) (No change.) (f) A record of the quantity of meat picked by individuals may be kept in a ledger at the delivery opening, or on a tally board, or by other sanitary methods. (g) (No change.) (h) Repacking of crab meat shall be allowed only at licensed crab meat picking plants. Repacked crab meat shall have on the principal display panel a lot or batch code. The records of a licensed crab meat picking plant which repacks crab meat shall include the quantity repacked, the original packer, the original pack date, and the lot or batch code for any repacked crab meat. (i) The packing operations shall be scheduled and conducted to pack and chill the crab meat to an internal temperature of 45 degrees Fahrenheit or less within two hours of delivery to the packing area and further chilled to an internal temperature of 40 degrees Fahrenheit or less within four hours after picking. This four hour time frame is the maximum time allowed and shall not be exceeded. (j) Storage air temperatures shall be maintained at 34 degrees Fahrenheit to 40 degrees Fahrenheit. (k) (No change.) (l) The packing process and equipment shall not transmit contaminants or objectionable substances to the products. Containers shall conform to applicable food additive regulations and provide adequate protection from contamination. Condensation drip shall not come in contact with the cooked crabs. (m)-(n) (No change.) sec.241.17. Refrigeration of Crab Meat. (a)-(b) (No change.) (c) Refrigeration rooms shall be large enough and constructed so that a full day's production, with ice, can be conveniently stored. Each room shall be equipped with an automatic temperature regulating control (thermostat) and an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location of the storage compartment. Condensation drip shall not come in contact with the cooked crabs. (d)-(f) (No change.) (g) Fresh crab meat shall be held and transported in such a manner that internal meat temperatures of 40 degrees Fahrenheit or less are maintained. Containers of fresh crab meat shall not be stored upside down. (h) (No change.) (i) Refrigeration and frozen storage compartments shall be equipped in compliance with this section. Mechanical refrigeration facilities shall be adequate in size and cooling capacity to properly refrigerate all crab meat on the premises to comply with the temperature requirements of this section. (j) (No change.) sec.241.19. Pasteurization of Crab Meat. (a) (No change.) (b) Recording and indicating thermometers shall be provided on all pasteurizing equipment, and shall serve as time and temperature controllers. The bulbs of both thermometers shall be located in such a place as to give a true representation of the operating temperature of the water bath. An authorized agent of the department shall check the accuracy of both thermometers as installed and thereafter at least once each operating season. The recording thermometer chart must be at least a 24-hour chart, and shall be at least 12 inches in diameter. (c)-(f) (No change.) (g) The pasteurization unit shall not be operated without a recording thermometer chart in place, the pen in contact with the chart and an inked record being made of the operating time-temperature cycle. Any indication of falsification of a thermometer chart shall constitute a failure to comply with this section. A new chart shall be used for each day's operations and the code number or date of each batch shall be affixed to the chart for each pasteurizing cycle. A permanent file of the used thermometer charts shall be maintained by the pasteurizer and kept available for inspection by the department for a period of one year. The following information shall be recorded within the confines of the pen markings after the pasteurization cycle has been completed: (1)-(3) (No change.) (4) if the pasteurizer processes meat for someone else, the packer's name, address and license number; (5)-(7) (No change.) (h)-(i) (No change.) (j) Crab meat for pasteurization shall meet all of the requirements for fresh crab meat. The pasteurization process shall be conducted under the same roof as where the crab meat is packed. (k) The containers of crab meat to be pasteurized shall be sealed as quickly as possible after the meat is picked. (l) The sealed containers of crab meat to be pasteurized shall be placed under mechanical refrigeration at air temperatures of 40 degrees Fahrenheit or less immediately after packing, unless they are to be pasteurized immediately after packing. (m) Crab meat may be packed by one processor for another in containers furnished for that purpose by the latter. In all instances the products processed under operations permitted by this paragraph shall meet the labeling requirements of this section. (n) Crab meat for pasteurization shall be pasteurized within 24 hours of the time it is picked. The minimum pasteurization specifications shall be the raising of the internal temperature of the container of crab meat to 185 degrees Fahrenheit and holding at that temperature for at least one minute at the geometric center of a container approved by the department. Each set of pasteurizing equipment shall be standardized so that the pasteurization treatment as described by this section can be obtained. The pasteurizer shall keep on file the standardization report, and his pasteurization procedure shall be performed in accordance with it. (o) The containers of pasteurized crab meat shall be chilled by cooling to 100 degrees Fahrenheit within 50 minutes to allow refrigerated storage within one hour after processing. The procedure for chilling shall be standardized. Pasteurized containers of crab meat shall be refrigerated immediately after reaching 100 degrees Fahrenheit. (p) Mechanically refrigerated storage shall be provided for the chilled pasteurized crab meat and shall maintain a storage temperature at or below 40 degrees Fahrenheit but above 32 degrees Fahrenheit. Pasteurized crab meat shall be transported under mechanical refrigeration between these same temperatures. (q) The label used shall clearly identify the contents of the container as pasteurized crab meat. Whenever the term CRAB MEAT (or its equivalent) appears on the label, the word PASTEURIZED shall be used in conjunction with it and in print of similar prominence. (r) Each container of pasteurized crab meat shall be permanently and legibly identified with a code indicating the batch and the day of processing. (s)-(t) (No change.) (u) When crab meat is packed by one licensed crab meat picking plant and pasteurized in another licensed crab meat pasteurization plant, the label shall clearly state the name and license number of both the packer and the pasteurizer. All containers of pasteurized crab meat shall have permanently recorded on the principal display panel, so as to be easily visible, the following information: (1) the packer's or distributor's name; (2) the packer's or distributor's address, including at least the city and state; and (3) the one to five digit license number preceded by the two letter state abbreviation and followed by the one or two letter abbreviation for the type of operation the dealer is qualified to perform. (v) Where the name and address of the distributor is used, it shall be preceded by the words PACKED FOR or DISTRIBUTED BY or followed by the word DISTRIBUTOR. (w) The presence of any chemical, if any is allowed, and the net weight of the contents shall be permanently recorded on the container. The proper designation of the content of the container shall be required, (lump, special, claw, fingers, etc.). (x) Such other matter pertinent to the public health as may be required by the department shall be recorded on the container. (y) All required information shall be provided in a legible and indelible form, and shall be either on the sidewall of the container or the cover or shall be sealed into an area where it remains legible and visible as the principal display panel until all product from the container has been used or disposed of. All information, except that which must be added by the licensed dealer, shall be impressed, embossed, lithographed, or otherwise permanently recorded on the container or the label by the container printing company. All labeling is subject to review and approval by the SSD. sec.241.20. General Maintenance and Cleanliness. (a)-(c) (No change.) (d) No wild or domestic animals other than crabs or other animals as allowed by this undesignated head to be processed shall be permitted in any crab meat processing area of the plant. Unauthorized persons shall be excluded from the processing areas of the plant. sec.241.22. Single Service Containers. (a) Containers for crab meat shall be clean; shall be constructed of non toxic metal, food grade plastic, or other impervious, durable material; and shall be designed and fabricated so that the contents shall be protected from contamination during shipping and storage. (b)-(d) (No change.) sec.241.23. Labeling Fresh or Fresh Frozen Crab Meat. (a)-(b) (No change.) (c) The principal display panel on each container of fresh or fresh frozen packed crab meat shall contain a calendar date. This date shall be the date of packing. The calendar date shall consist of and be in the following order: the abbreviation for the month, the numerical day of the month, and the year, unless a code date is established and used in accordance with subsection (d) of this section. (d) If the date is a code date, the method of determining that date shall be based on the date the crab meat is packed. The proposed method must be submitted in writing to the SSD and approved by the SSD before being used. (e) The presence of any chemical, if any is allowed, and the net weight of the contents shall be permanently recorded on the container. The proper designation of the content of the container shall be required, (lump, special, claw, fingers, etc.) and may be recorded on either the container sidewall or on the lid. (f) Frozen crab meat shall be labeled as FROZEN, Individually Quick Frozen, or IQF, in print of similar prominence adjacent to the words CRAB MEAT. The words FROZEN, Individually Quick Frozen, or IQF, shall be impressed, embossed, lithographed, or otherwise permanently recorded on the container. Stamping shall not be allowed. Containers shall be marked as frozen prior to freezing. (g) (No change.) (h) Such other matter pertinent to the public health as may be required by the department shall be recorded on the container. (i) All required information shall be provided in a legible and indelible form, and shall be on the sidewall of the container unless the cover becomes an integral part of the container during the sealing process. All information, except the date and the word FROZEN, if added by the dealer, shall be impressed, embossed, lithographed, or otherwise permanently recorded on the container by the container printing company, unless, an adhesive label which has been approved by the SSD is used. Adhesive labels shall be durable and waterproof and shall not be used unless prior approval from the SSD is obtained. The request must be submitted in writing. All labeling is subject to review and approval by the SSD. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 29, 1996. TRD-9605893 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1996 Proposal publication date: February 9, 1996 For further information, please call: (512) 458-7236 Molluscan Shellfish 25 TAC sec.241.51, sec.241.55 The Texas Department of Health (department) adopts amendments to sec.241. 51 and sec.241.55, concerning Texas molluscan shellfish. Section 241.55 is adopted with changes to the proposed text as published in the February 13, 1996 issue of the Texas Register (21 TexReg 1034). Section 241.51 is adopted without changes and, therefore, will not be republished. The amendments implement the requirements and guidelines established in the 1995 National Shellfish Sanitation Program Manual of Operations, Part I, dealing with a harvest control to reduce risk of illness attributable to a naturally occurring organism, Vibrio vulnificus. The amendments establish definitions and standards for a time-to-refrigeration matrix which will reduce the amount of time shellfish remain unrefrigerated after harvest and before the harvest boats are unloaded. A summary of comments and the department's responses to the comments follows. COMMENT: Concerning sec.241.55(a)(14), one comment was received that all harvest records should be available at the certified dealer's location. RESPONSE: The department agrees and has made the appropriate charges. COMMENT: Concerning sec.241.55(a)(14)(B)(i), one comment was received that overprinting a standard tag with neon-green print would be less expensive than using neon-green tags and would be just as effective. RESPONSE: The department agrees and has made the appropriate changes. COMMENT: Concerning sec.241.55(a)(14)(B)(iv), one comment was received that all certified dealer tags attached to shellfish harvested under exemption to the time requirements should have the same neon-green over stamping as harvester tags. RESPONSE: The department agrees and has made the appropriate changes. Editorial changes were made for clarification or consistency purposes. All of the commenters were individuals. The commenters were generally in favor of the rules; however, they expressed concerns and questions relating to the changes. The amendments are adopted under Texas Parks and Wildlife Code, sec.76.203, which authorizes the Texas Board of Health to adopt rules concerning the regulation of Texas molluscan shellfish; and the Health and Safety Code, sec.12. 001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the commissioner of health. sec.241.55. Harvesting and Handling Shellstock. (a) Boats and trucks. (1)-(11) (No change.) (12) Commercial harvesters shall be responsible for control of their shellstock until acceptance by a certified dealer. Commercial harvesters shall be required to deliver shellstock to a certified dealer within the day the shellstock is harvested. For this purpose a day shall be considered to be midnight to midnight. Delivery of the shellstock is considered to be the packing of the shellstock into an approved container, transfer of the shellstock from the boat to a certified location and acceptance of the shellstock by the certified dealer. Commercial harvesters shall sell their shellstock only to a currently certified shellfish dealer. It is illegal for commercial harvesters to sell shellstock directly to the public. (13) Mechanical refrigeration facilities shall be required for purposes of dealer certification at each certified location. Mechanical refrigeration which is mobile shall be immobilized or designated, in writing to the SSD, as the shellfish storage facility. Removal of immobilized or designated refrigeration shall constitute voluntary surrender of certification by the certified dealer for that certified location. Shellstock shall be placed under mechanical refrigeration at air temperatures between 45 degrees Fahrenheit and 35 degrees Fahrenheit within two hours of unloading from the boat. Shellstock shall not be allowed to remain on a dock unrefrigerated for more than two hours. During the period April 1 through April 30, shellstock shall not be harvested before 6:00 a.m. and shall be placed under mechanical refrigeration by 8:00 p.m. each day. Mechanical refrigeration facilities shall be adequate in size and cooling capacity to refrigerate all shellstock on the premises. Each facility shall be equipped with an automatic temperature regulating control (thermostat) and an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location in the storage compartment. (14) During the period May 1 through October 31, shellfish which may be intended for consumption raw, directly from the shell, shall be refrigerated as designated in paragraph (13) of this subsection, within the times established for each month by the bureau chief of the Bureau of Food and Drug Safety. Each harvester shall maintain records for each date shellfish are harvested that show the time the first shellfish are harvested; the time harvesting ends; and the time the shellfish are unloaded from the boat. These records shall be provided to the certified dealer with the shellstock and shall be maintained as part of the certified dealer's records. (A) The time from first harvest to refrigeration shall be established based on the average monthly maximum water temperature (AMMWT) and shall be in effect from 12:01 a.m. of the first day of the month until 11:59 p.m. of the last day of the month. The time shall be based on the following AMMWT ranges: (i) AMMWT 65 degrees Fahrenheit-74 degrees Fahrenheit, 14 hours; (ii) AMMWT 75 degrees Fahrenheit-84 degrees Fahrenheit, 12 hours; and (iii) AMMWT 524>84 degrees Fahrenheit, 6 hours. (B) Any shellfish which may be held without refrigeration for periods of time longer than those established in subparagraph (A) of this paragraph shall not be harvested before 6:00 a.m. and shall be placed under refrigeration as designated in paragraph (13) of this subsection by 8:00 p.m. each day and shall be identified, stored, and processed separately from shellfish that are refrigerated within the time periods. (i) Shellfish harvested and held exempt under this paragraph shall be tagged with a harvester tag meeting all requirements that shall be overstamped on both sides with the words "FOR SHUCKING BY A CERTIFIED DEALER" in ink that shall be neon green in color in letters at least one-half inch in height. This special harvester tag shall be placed on each container of shellfish at the conclusion of harvesting of these exempt shellfish and before harvesting of any other shellfish. This special harvester's tag shall remain attached to each container until the shellfish are shucked. (ii) If shellfish are harvested and held exempt under this paragraph, the harvester records required shall also include the time that harvesting of these exempt shellfish stops and the time that harvesting of other shellfish begins. (iii) Shellfish harvested, and held exempt under this paragraph, shall not be commingled with any other shellfish and shall be stored separately on harvest boats and at any certified location. (iv) Shellfish harvested, and held exempt under this paragraph, shall be shucked and placed in containers bearing the consumer information language adopted by the Interstate Shellfish Sanitation Conference, or an equivalent approved in writing by the SSD prior to use, unless the invoice and bill of lading for shipment of these exempt shellstock to another certified dealer both contain the following statement: "FOR SHUCKING BY A CERTIFIED DEALER. All certified dealer tags attached to shellfish harvested under the exemption in subparagraph (B) of this paragraph shall be overstamped identical to the harvester tag. (15) Refrigerated shellstock shall be maintained at internal temperatures between 45 degrees Fahrenheit and 35 degrees Fahrenheit. After initial refrigeration, shellstock removed from refrigeration shall not be permitted to remain in air temperatures above 45 degrees Fahrenheit for more than two hours. The internal air temperature in trailers shall be at or below 45 degrees Fahrenheit when shellstock loading begins. (16) Trucks used to transport shellstock shall have the storage area constructed of a nontoxic, smooth, impervious material so as to protect the shellfish from contamination and shall be kept clean. Shellstock shall be transported on land by harvesters, certified dealers, or any distributor in mechanically refrigerated trucks that can maintain an air temperature between 45 degrees Fahrenheit and 35 degrees Fahrenheit, shall be palletized, and shall be arranged to allow maximum air circulation. Shellstock storage areas shall be similarly constructed. (17) Dogs, cats, or other animals shall not be permitted on vessels, in vehicles, or in any other area where shellstock is held or transported. (b)-(c) (No change.) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 29, 1996. TRD-9605894 Susan K. Steeg General Counsel Texas Department of Health Effective date: June 1, 1996 Proposal publication date: February 13, 1996 For further information, please call: (512) 458-7236 Chapter 289. Radiation Control The Texas Department of Health (department) adopts the repeal of sec.289. 113; and adopts new sec.289.202, concerning standards for protection against radiation. New sec.289.202 is adopted with changes to the proposed text as published in the December 26, 1995, issue of the Texas Register (20 TexReg 11082). The repeal is adopted without changes and therefore the repeal will not be republished. The repealed sec.289.113 adopted by reference Part 21, titled "Standards For Protection Against Radiation" of the Texas Regulations for Control of Radiation (TRCR). The new section incorporates language from Part 21 that has been rewritten in Texas Register format and includes clarification of several subsections of the section. The clarified requirements concern definitions; determination of the effective dose equivalent when using fluoroscopic equipment; determination of occupational dose for the current year; planned special exposures; determination of dose to the embryo/fetus when multiple monitoring measurements are made; the location where individual monitoring devices are to be worn; posting; and recordkeeping. A memorandum of understanding between the department and the Texas Water Commission was deleted because it is outdated and inaccurate; and the limits for acceptable surface contamination were revised to clarify the appropriate limits for several isotopes of iodine. The repeal and new section are part of the first phase to convert existing sections that adopt by reference the various parts of the TRCR to Texas Register format. Following is a summary of changes that were made to the section as a result of comments received. In subsection (c)(6), the definition of "dosimetry processor" was changed to replace the word "individual" with "personnel" to more accurately reflect the type of monitoring devices evaluated. In subsection (n)(3)(B), the words "or registrant's" were deleted because a registrant does not have to apply for authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem. In subsection (o)(2)(B)(ii), the words "of radiation" were added for clarification so that the language now reads, "... the dose from external sources of radiation would not exceed...". In subsection (p)(2)(B), the words "more restrictive" were deleted and substituted with the word "different" to take into account different calibration intervals that may not be more restrictive. In subsection (p)(5), the words "for healing arts purposes" were added to the end of the sentence to clarify that the exemption does not apply to assemblers/consultants who may perform calibration or maintenance of the dental radiographic systems. In subsection (q)(2), a revision was made to reflect the fact that other healthcare personnel in addition to nurses may enter a high radiation area while providing patient care; the subsection now reads, "Notwithstanding paragraph (1)(C) of this subsection, a licensee is exempt from supplying individual monitoring devices to healthcare personnel who may enter a high radiation area while providing patient care if:". In subsection (q)(2)(A), the word "nursing" was deleted to be consistent with the change in subsection (q) (2). In subsection (q)(2)(B), the words "or registrant" were deleted to be consistent with the change in subsection (q)(2). In subsection (r)(1)(B), the sentence was revised to clarify confusion about possible contradiction with subsection (q)(1)(A); the subection now reads, "If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subsection (m)(1) of this section, it shall...". In subsection (r)(2), the specific timeframes and paperwork requirements were deleted because they caused an unnecessary burden to licensees/registrants; the subsection now reads, "Each licensee or registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing." In subsection (bb)(3), the terms "sealed source," "sealed source container," and "housing" were made plural to clarify that the exemption from posting applies if more than one source is stored in a room or area as long as the required radiation levels are met. In subsection (rr)(2), the words "and within 60 days of the end of the year" were added to the end of the sentence to clarify not only how often, but by when recordkeeping entries should be made. In subsection (zz), the words "or registrant" were deleted because planned special exposures do not apply to registrants. Subsection (ggg)(7) was clarified by deleting "I-125, I-126, I-131, and I-133" from the group of nuclides in which they were listed; these nuclides were included in the group of beta-gamma emitters. Other minor grammatical and reference changes were made to the section. The following are the public comments made concerning the proposed section and the department's responses to those comments. Comment: Concerning the section in general, two commenters emphasized support for the revisions/additions to subsections (f)(5); (j); (j)(5); and (m) (3). Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning the section in general, one commenter recommended recognizing the efforts of the National Council on Radiation Protection (NCRP) to become evermore precise in occupational dose identification. First, there was dose equivalent and then effective dose equivalent, and now effective dose as described in NCRP Report 116 published in 1993. The commenter suggested that the NCRP is correct and that the department should adopt the effective dose term. Response: In order to achieve and maintain nationwide consistency in many radiation protection standards, those standards must be essentially identical from state to state. Certain definitions and dose limits are examples of those standards and as such, the United States Nuclear Regulatory Commission (NRC) has designated them, including the term " effective dose equivalent," as strict items of compatibility. As an agreement state, Texas must adopt the term essentially verbatim to that of the NRC. The department made no change as a result of the comment. Comment: Concerning subsection (c)(6), a commenter asked if a licensee couldn't also process and evaluate individual monitoring devices under the definition of "dosimetry processor." Response: TRCR Part 42 as adopted by reference in 25 TAC sec.289.122 (relating to Registration of Radiation Machine Use and Services) provides for the registration of persons who are in the business of providing registration services. The provision of personnel dosimetry services is listed in 42.1(c)(8) of TRCR Part 42 as a radiation service. Therefore, by rule, a dosimetry processor is a registrant. The department made no change as a result of the comment. Comment: Concerning subsection (c)(6), a commenter suggested that the word "personnel" replace the word "individual" in order to very clearly set "dosimetry processors" apart from other radiation dose monitors such as area monitors and other types of chambers. Response: The department agreed with the comment and changed the definition of "dosimetry processor" to read, "...means a registrant that processes and evaluates personnel monitoring devices...". Comment: Concerning subsection (c)(6), a commenter stated that in the definition for "dosimetry processor," the term "registrant" is confusing. The commenter suggested that the definition read: "...an individual or organization that is registered with the Texas Department of Health, Bureau of Radiation Control, to provide dosimetry services in the State of Texas." Response: The term "registrant" is currently defined in 25 TAC sec.289.201 (relating to General Provisions) as "any person issued a certificate of registration by the department pursuant to this chapter and the Texas Radiation Control Act." The department made no change as a result of the comment. Comment: Concerning subsection (f)(5), four commenters stated that although this requirement is generally helpful to fluoroscopy users, the phrase "and the reported dose exceeds 25% of the limit specified in subsection (f)(1)" should be eliminated or modified to allow use of the 0.3 correction factor for any occupational exposure involving fluoroscopy. The commenters noted that it is appropriate, as proposed, that a registrant be able to not exercise this option, but if chosen, the commenter urged that the correction factor be utilized for any exposures received. The commenters' proposed modification would allow the badge vendor to apply the correction factor to each exposure for the applicably coded person. It also relieves institutions of an additional paperwork burden required to apply the correction factor only after a 25% limit has been exceeded. The commenters also requested that, if the language is retained in its proposed form, clarification of the rationale for using the 0.3 correction factor only when the recorded dose exceeds 25% of the limit specified in subsection (f)(1). The commenters asked for clarification as to whether this approach can be selectively used and if the commercial dosimetry services will be allowed to perform those calculations or if the licensee/registrant is required to perform the calculation subsequent to the dosimetry services report. Response: Personnel who perform or assist in fluoroscopic special procedures commonly have collar monitor deep dose equivalent values well in excess of those for routine fluoroscopy, and these annual dose equivalent values are likely to be in excess of 5 rem for full-time angiographers and interventionalists who wear their monitors properly. These values have historically caused frequent overexposure incidents, when in fact, the associated effective dose equivalent was much lower because of the use of protective aprons. The proposed changes define procedures by which the effective dose equivalent can be determined for special procedures fluoroscopists for whom the current method of overestimating effective dose equivalent is unacceptable, while excluding personnel who may be working in routine fluoroscopic or radiographic procedures. Wearing two individual monitoring devices has at least two drawbacks. The individual may confuse wearing the two monitors and inconsistently wear them in the same location, and the cost of monitors is doubled. Fluoroscopy personnel who perform or assist in routine fluoroscopic or radiographic procedures do not receive doses sufficiently high to warrant the expense and potential confusion of wearing two monitors in order to require a more accurate determination of effective dose equivalent. The criterion to allow calculation of effective dose equivalent based on the unshielded collar monitor by use of a 0.3 multiplication factor is set at 25% of the dose limit for the purpose of separating personnel who work in special procedures from personnel who work in routine fluoroscopic or radiographic procedures. Therefore, the number of individuals who may exceed the 25% limit and utilize two badges and the multiplication factors will be limited. The department made no change as a result of the comments. Comment: Concerning subsection (f)(5), a commenter questioned how previous exposure accumulation during the year is handled in conjunction with this subsection. The commenter also noted that he has taught many students that film badges or personnel monitors do not protect you and the proposed section seems intended to legislate physics to do just that. Response: Previous exposure accumulation during the year is to be considered when applying this subsection. The subsection is not intended to legislate physics. For regulatory purposes, it provides a method of more accurately calculating the effective dose equivalent. The department made no change as a result of the comment. Comment: Concerning subsection (j), a commenter noted that the revisions suggested in the proposed changes are a great improvement over the current regulation. The changes seem reasonable and easy to follow. Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning subsection (k), one commenter stated that the proposed revision represented excellent changes for the improvement of this burdensome section and noted that the elimination of the planned special exposures for registrants is also an important change for the better. Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning subsection (l), a commenter disagreed with the permissive nature of this subsection considering the lack of conclusive information of the effects of chronic low exposures to ionizing radiation. The commenter sees no reason for allowing minors to receive any exposure in excess of that permitted for the general public. This change is not consistent with keeping exposures as low as reasonably achievable and could unnecessarily expose the actively growing tissues of an immature biological organism to radiation. Response: The subsection applies to minors receiving an occupational dose, not minors as members of the public. This dose limit is also a matter of strict compatibility with the NRC. The department made no change as a result of the comment. Comment: Concerning subsection (m)(3), a commenter recommended an additional requirement be added to read: "As calculated by a qualified medical physicist so that the dose to an embryo/fetus shall be taken as the dose calculated by a qualified medical physicist." Response: The subsection applies to a dose to the embryo/fetus received while the declared pregnant woman is receiving an occupational dose, either in an industrial or medical setting. Determination of whether the calculation of a dose to an embryo/fetus is within the practice of medical physics must be made by the Texas Board of Licensed Medical Physicists. The department made no change as a result of the comment. Comment: Concerning subsection (m), a commenter noted that subsection (m)(1) references subsection (rr), but there is no direct mention made of records concerning embryo/fetus dose in that reference. Subsection (rr) should clearly indicate that embryo/fetus doses must be recorded. Additionally, the declaration of pregnancy should be required to be clearly documented by a letter of other written notice to the registrant or licensee. This would protect both the worker and the licensee or registrant. It would also make review by the department easier when there is no question of declaration. Response: Subsection (rr) requires records of doses to an embryo/fetus and requires that those records be kept with the dose records of the declared pregnant woman. The definition of "declared pregnant woman" requires that the declaration of pregnancy be in writing and subsection (rr)(4) requires the written declaration be maintained. The department made no change as a result of the comment. Comment: Concerning subsection (m)(3)(B), two commenters noted that this requirement is another case of overkill which is not supported by scientific investigation and is inconsistent with subsection (f). The response of a collar- positioned monitor does not represent the dose to the embryo/fetus and even the application of the 0.3 conversion factor would result in a considerable overestimation. The commenters noted that the truth lies somewhere below 0.1 according to all of the evaluations published on this subject. One of the commenters recommended the rule be changed to read: "...if multiple measurements have not been made, the reported deep dose equivalent value multiplied by 0.3 shall be the dose to the embryo/fetus; or...". Response: For regulatory purposes, the subsection provides reasonable methods for estimating a dose to the embryo/fetus. The department made no change as a result of the comment. Comment: Concerning subsection (n), three commenters stated that, notwithstanding the report of the NCRP, there is no reason for considering the exposure to registered devices less dangerous than exposure from gamma emitting nuclides. In essence this subsection says x-rays are less dangerous than gamma rays and sends the wrong message to the public. One of the commenters noted that considering the availability of commercially made lead shielding for radiation machine installations, the requirement for these devices to meet the same standards as any other facility is not unreasonable. Even after making prudent adjustments for the unreasonably high workload recommended in NCRP Report 49, for a small office diagnostic x-ray room the calculated lead shielding requirement may be in the order of five inches if gypsum board is not available as a stock item. It is economically impractical to have it made special because this would drive up the cost. Most facilities therefore opt for the 1/32 inch lead on gyp board at a cost of about $60 per 4 x 8 sheet from manufacturers. The idea that a couple of pieces of ordinary gyp board will stop x rays sufficiently is generally a myth. This is true even considering a small workload. One of the commenters stated that to be consistent with keeping exposures as low as reasonably achievable, there should be no difference in the allowable dose from x rays or radionuclides. Response: A study performed by a dosimetry processor showed that in a population of over 19,000 medical radiation workers from 50 typical medical installations and covering a 10 year period, 86.6% 4.4% of diagnostic x-ray workers had yearly doses below 100 millirem and 96.3% 2.0% had yearly doses below 250 millirem. This data represents a conservative estimate for possible doses to members of the public in surrounding unrestricted areas. The department realizes that existing radiation safety procedures and shielding have resulted in keeping these doses as low as reasonably achievable. Therefore, the department has retained the 0.5 rem total effective dose equivalent limit to members of the public from exposure to diagnostic and therapeutic radiation machines as a maximum limit and requires compliance with subsection (e)(2) to keep doses as low as reasonably achievable. The department made no change as a result of the comments. Comment: Concerning subsection (n)(1)(B), one commenter noted that "radiation machines" is not defined and suggested that subsection (n)(1)(B) should read "...radiation producing machines..." rather than "radiation machines." Response: The term "radiation machines" is defined in 25 TAC sec.289.201. The department made no change as a result of the comment. Comment: Concerning subsection (n)(3)(B), one commenter recommended that the word "registrant's" be deleted. Response: The department agreed with the comment and deleted the words, "or registrant's." Comment: Concerning subsection (o)(2)(B)(ii), a commenter suggested that if the term "external sources" means radioactive material, then the section should state that. Response: The department added the words, "of radiation" to clarify the language so that the sentence reads "...the dose from external sources of radiation would not exceed...". Comment: Concerning subsection (o)(3), a commenter noted that the exemption proposed is consistent with the concept that some machines are minimal threat devices. Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning subsection (p)(2)(E), a commenter questioned whether the requirement for 20% accuracy applies to all types of dosimeters as well as instruments. Response: The requirement for an accuracy within 20% of the true radiation level is intended for radiation measurement instruments, not dosimeters. The term "...operable and calibrated" implies a reference to instruments rather than dosimeters. The department made no change as a result of the comment. Comment: Concerning subsection (p)(3)(C), a commenter noted that the language appears to require an organization outside the state of Texas to become registered in order to supply Texas licensees and registrants with personnel monitoring devices. The commenter agreed with this concept since other jurisdictions may not exercise the control that a more industrialized state such as Texas may need for protection of the workers. Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning subsection (q)(2), a commenter recommended that this exception be widened for all healthcare personnel. Many occasions may arise in which specialized personnel (e.g., respiratory therapists) will need access to the patient and/or room. Assuming that all of the requirements of subsection (q) are met, any required personnel should be allowed. Response: The department agreed with the comment and changed the language to refer to healthcare personnel rather than nursing personnel. Comment: Concerning subsection (q)(3)(B), one commenter suggested that the term "ALARA" be used instead of referencing subsection (e)(2). Response: It is acceptable practice to reference subsections of the section. This practice provides an efficient method of relating various subsections of the rule instead of repeating verbiage throughout the section. The department made no change as a result of the comment. Comment: Concerning subsection (r), one commenter stated that there is nothing objectionable in this subsection, but it does seem excessively prescriptive considering that there are standards to be met before a person may act as Radiation Safety Officer (RSO) for a registrant or licensee. The commenter recommended that the instructions for wearing and using monitoring devices should be left to the judgement of the RSO if the RSO meets the education and experience requirements of 25 TAC sec.289.252 (relating to Licensing of Radioactive Material) and TRCR Part 42. The commenter also questioned if the proposed language means that requirements for an RSO in 25 TAC sec.289.252 and TRCR Part 42 have failed to provide adequate training and experience for persons who are appointed to be an RSO, or does it mean the requirements for RSOs should be more vigorously implemented by the department to avoid the necessity to develop such prescriptive regulations. Response: The department has historically and consistently received inquiries concerning the proper location for wearing individual monitoring devices and the proposed language is a response to those inquiries. The department made no change as a result of the comment. Comment: Concerning subsection (r)(1)(B), a commenter noted that there is one distinct contradiction between what is discussed in subsection (m)(3) and this requirement. Unless the department is requiring the use of two monitoring badges for pregnant women (which contradicts subsection (m)(3)(B)), a single badge must be located at two locations. Subsection (r)(1)(A) indicates that a badge worn for determining whole body exposure is to be worn outside a protective apron, typically at the neck. If only one badge is used, this prohibits meeting the requirement of subsection (m)(3) which requires placing the monitor at the waist in the case of a pregnant woman. If the department is requiring the use of two monitors, then it should be stated explicitly. The commenter suggested removing this requirement or making it a suggestion (may be located or typically located, rather than shall be located). In addition, the commenter noted that there is no indication how subsection (f)(5)(B) will apply in situations of pregnant women, or if it will apply. Response: For clarification, the department has reworded the requirement to read, "If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subsection (m)(1), it shall be...". Comment: Concerning subsection (r)(1)(C), a commenter noted that subsection (r)(1)(A) and (C) are not compatible. Dosimetry vendors provide a single whole body badge for each monitored individual which uses filters to determine all three dose equivalents at different depths-7mg/cm[sup]2 (SDE,wb), 300 mg/cm[sup]2 (LDE), and 1000 mg/cm[sup]2 (DDE). Subsection (r)(1)(A) requires that the badge be worn "at the unshielded location of the whole body likely to receive the highest exposure." If that location happens to be anywhere other than the collar (or higher), then that person cannot comply with subsection (r)(1)(C), which requires that it be worn at the collar or higher. The commenter recommended changing the "shall" in subsection (r)(1)(C) to "should" or deleting the entire subsection. Response: In comparison to the doses monitored, monitoring for eye dose equivalent is very infrequent. If a situation arises in which the monitor for the whole body is located other than at the neck and the eye dose must also be monitored, two badges may be required. The department made no change as a result of the comment. Comment: Concerning subsection (r)(1)(F), two commenters suggested eliminating the phrase "...whichever is more restrictive" or modifying it to exempt dosimeters used to measure only alpha, beta, gamma or x-ray radiation. The commenters are aware of no such National Voluntary Laboratory Accreditation Program accredited dosimeters that could not provide an adequate exposure if read within 3 months. Response: The dosimetry processor commits to a time interval as appropriate for accurate processing when applying for a certificate of registration. The certificate of registration then authorizes that interval. The department made no change as a result of the comments. Comment: Concerning subsection (r)(2), five commenters suggested deleting this requirement as it does not appear that imposing a 14-day timeframe for returning dosimeters and requiring additional paperwork for each wearer will effectively resolve problems such as lost badges or badges unreturned due to absences. Most licensees and registrants already have mechanisms for controlling and documenting such problems. The commenters stated that adding a 14-day limit will be an unnecessary added burden, particularly for institutions with large monitoring programs, such as the M.D. Anderson Cancer Center and The University of Texas Medical Branch which purchases and distributes approximately 10,000 badges on an annual basis. Personnel issues such as vacation, sickness, and varied work shifts in a hospital will make this recordkeeping exceedingly difficult. The commenters noted that if this provision is retained, the "or as soon as practical" requirement is too vague and suggested that the time limit be extended from 14 to at least 30 days. Response: The department deleted the timeframe and the language now reads "Each licensee or registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing." Comment: Concerning subsection (s)(2), a commenter recommended replacing the term "is capable of" with "will perform by." This causes the regulations to require an operating system because the term "is capable of" does not mean that a system is operational in a manner that will do a desired job. Response: The intent of the requirement is not for the surveillance system itself to prevent entry but to provide a means for achieving prevention. The department made no change as a result of the comment. Comment: Concerning subsection (y), one commenter stated that this is a very appropriate rule and it should not cause an inconvenience to registrants or licensees. Response: The department acknowledged the comment and made no change to the section as a result of the comment. Comment: Concerning subsection (y)(1), one commenter noted that in many hospitals, the night cleaning staff open all the doors in an area and then work on one room at a time. This leaves x-ray therapy rooms unsecured. Response: If radiation machines or radioactive material is available for unauthorized removal, the facility is in violation of the requirement. The department made no change as a result of the comment. Comment: Concerning subsection (aa)(3), two commenters noted that although the removal of the word "GRAVE" from this posting requirement is helpful, the commenters strongly recommended that this be further modified so that medical therapy treatment rooms are specifically exempted from using the posting "DANGER, VERY HIGH RADIATION AREA" and that such rooms continue to be posted with "CAUTION, HIGH RADIATION AREA" signs only. To the extent that patients under treatment notice the wording changes, the addition of the words, "DANGER" and "VERY" will only needlessly heighten anxiety for many such patients. The commenters also noted that since rooms with diagnostic and therapy x-ray systems and teletherapy units are exempted from provisions of subsection (t) and (u), it seems to serve no purpose to require posting of "DANGER", VERY HIGH RADIATION" on these type rooms. There appears to be no benefit that offsets the cost and potential confusion of this posting in a medical setting. Response: The terminology required on the posting is an item of compatibility with the NRC. While deleting the word "GRAVE" for postings in medical settings is appropriate, deleting "DANGER" and "VERY" threatens the compatibility of the rule to a greater degree. The posting is appropriate considering personnel other than patients may enter the area. The department made no change as a result of the comments. Comment: Concerning subsection (dd)(6), one commenter stated that this exemption from labeling for "...installed manufacturing or process equipment, such as piping and tanks" would not allow oil field workers or chemical plant workers to know whether or not they were dealing with radioactive scale or sludge when performing normal maintenance procedures on processing equipment, piping, or tanks. The commenter further stated that this is not fair to the worker and that all radioactive contaminated equipment should be surveyed and appropriately marked. Response: TRCR Part 46 as adopted by reference in 25 TAC sec.289.127 (relating to Licensing of Naturally Occurring Radioactive Material (NORM)) requires that any maintenance other than routine maintenance done on equipment, facilities, or land that is contaminated above the regulatory limits be done by a person specifically licensed to do so. The intent of that subsection is that any maintenance that alters the exposure pathways to workers is not routine. The exemption in this subsection is intended for installed manufacturing or process equipment, such as piping and tanks, during normal operating conditions. The department made no change as a result of the comment. Comment: Concerning subsection (ee)(3), one commenter suggested modifying the language to indicate that if a package received after normal working hours is severely damaged and/or possibly leaking, the package will either be surveyed immediately by designated radiation safety personnel or the package will be isolated and designated radiation safety personnel contacted. Such a package should be surveyed within 3 hours of receipt by designated radiation safety personnel and control measures implemented as needed. The commenter noted that most licensees do not have trained radiation safety personnel on site at all times after normal working hours. It is not practical or safe to rely on receiving, security, housekeeping, or other persons normally present after normal working hours, to perform more than simple emergency segregation and contact radiation safety personnel. Response: The licensee should have procedures for notifying radiation safety personnel who are available after hours to perform the survey. The department made no change as a result of the comment. Comment: Concerning subsection (ee)(4)(B)(i), one commenter recommended that the last line should read "The transport index shall not exceed 10 millirems/hr (0.1 mSv/hr) at 1 meter from the package." Response: The definition of "transport index" state in part "The transport index is determined by the number expressing the maximum radiation level in millirem per hour at 1 meter from the external surface of the package." The transport index is a dimensionless number, therefore the language is appropriately worded. The department made no change as a result of the comment. Comment: Concerning subsection (ff)(1)(B), one commenter recommended deleting the phrase "...with prior approval from the agency." The commenter stated that the wording does nothing but add another paperwork burden to licensees and department staff. Decaying in storage does not remove any of the licensee's responsibilities for meeting personnel exposure requirements or any other disposal requirements, so it seems unnecessary to obtain a prior review of such procedures by the department. It would seem more appropriate to describe actual decay in storage procedures in the licensee's Radiation Protection Program for review by department inspectors. Response: It is the responsibility of the department to ensure that a licensee has the appropriate procedures, equipment, and facilities to store licensed material in a manner that is protective of public health and safety and the environment. The department made no change as a result of the comment. Comment: Concerning subsection (jj)(5), one commenter stated that this requirement should be deleted since it places a totally unnecessary and probably unworkable requirement on both department personnel and licensees. There are probably more than one million packages containing radioactive material, including low-level radioactive waste, being transported each year on the nation's roads under the United States Department of Transportation regulations that require extensive packaging, manifest and labeling procedures, but do not require prior inspection by a regulatory agency. The extremely small number of accidents involving such shipments to date have not involved any harmful effects to members of the general public or the environment. There is nothing "broken" here, so why "fix" it, particularly in this burdensome way? The commenter asked to be informed of the source if this requirement results from a legislative or legal mandate. Response: The requirement results from a legislative mandate contained in the Health and Safety Code, Chapter 402. The department made no change as a result of the comment. Comment: Concerning subsection (ll)(4), two commenters stated that this requirement places a significant and unnecessary burden on licensees/registrants. Duplicate sets of records should be avoided whenever possible. Keeping one set of records in the Radiation Safety Office and another individualized set at seven satellite sites would require a significant investment in personnel time and paperwork. The commenters recommended that, if this requirement is retained, complete duplicate records of personnel exposure should not be required. For example, the copy of personnel exposure reports sent to Departments/Sections to be made available to monitored personnel does not contain each person's social security number or date of birth in order to prevent general public disclosure of what is considered strictly personal information. Also, for the purposes of routine inspection, it should be totally unnecessary to duplicate each person's complete monitoring file. If a satellite site is a significant distance from the main site and an department inspector feels a copy of a record is needed, the licensee/registrant should be allowed to fax a copy to the site if equipment is available. Response: The records to which the requirement is referring are listed; that is, those records required in accordance with 25 TAC sec.289.201(d) of this title, 25 TAC sec.sec.289.202(nn)-(uu), and by license of certificate of registration condition. The subsection only requires records relevant to operations at an additional authorized use/storage site to be maintained at that site. The licensee/registrant should determine what records are relevant based upon the activities conducted at the additional site(s). The department made no change as a result of the comments. Comment: Concerning subsection (xx)(1)(A)(iii), one commenter questioned why 250 rads (2.5 grays) is used instead of the unit "rems," since "rems" is the unit used in subsection (xx)(2)(A)(iii) and subsection (f)(1)(B)(ii). Response: With doses in this high range, it is more appropriate to use the unit "rad" instead of "rem." The department made no change as a result of the comment. Comment: Concerning subsection (zz), one commenter suggested deleting "registrant" from the requirement for submitting a planned special exposure report. Response: The department deleted the words "or registrant." Comment: Concerning subsection (ggg)(6), one commenter stated that this requirement is very useful and applauded the rulemaking effort. Response: The department acknowledged the comment and made no change as a result of the comment. Comment: Concerning subsection (ggg)(6), one commenter questioned if the records required by subsection (nn)(2) are to be transferred to the department after termination of the license/registration. Response: The records are not to be transferred to the department after termination of the license/registration. The department made no change as a result of the comment. Comment: Concerning subsection (ggg)(6), one commenter suggested simplifying the various recordkeeping time intervals, either to 3 or 5 years. The commenter further recommended that, since only one is 5 years, the interval be changed to 3 years. Alternately, if 5 years is that important for leakage/contamination of sealed sources, then it is probably also appropriate for each of the other sections. Response: The recordkeeping intervals are varied based upon the intended purpose of the record and on inspection intervals. The department made no change as a result of the comment. Comment: Concerning subsections (g)(1), (k)(1)(H), (r)(1), (kk), and (rr)(1) (G), a commenter noted that some cross-references appear to be incorrect. Response: The department acknowledged the comment and corrected the cross- references accordingly to clarify the section. Commenters included a representative from the University of Texas M.D. Anderson Cancer Center of Houston; Frank Malek and Associates of Montgomery; Richmond Imaging Associates of Houston; Texas A&M University of College Station; Baylor College of Medicine of Houston; the University of Texas System Office of Environmental Affairs of Austin; Shell Chemical Company of Houston; and one individual. The commenters were generally in favor of the proposal; however, they presented comments and suggestions for changes to the proposal as previously discussed. Texas Regulations for Control of Radiation 25 TAC sec.289.113 The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 29, 1996. TRD-9605921 Susan K. Steeg General Counsel Texas Department of Health Effective date: May 20, 1996 Proposal publication date: December 26, 1995 For further information, please call: (512) 458-7236 General 25 TAC sec.289.202 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.289.202. Standards for Protection Against Radiation. (a) Purpose. (1) This section establishes standards for protection against ionizing radiation resulting from activities conducted in accordance with licenses or certificates of registration issued by the agency. These rules are issued in accordance with the Texas Radiation Control Act. (2) The rules in this section are designed to control the receipt, possession, use, and transfer of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency. (b) Scope. Except as specifically provided in other sections of this chapter, this section applies to persons licensed or registered by the agency to receive, possess, use, or transfer sources of radiation. The limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs. (c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise. (1) Annual limit on intake (ALI)-The derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by Reference Man that would result in a committed effective dose equivalent of 5 rems (0.05 sievert) or a committed dose equivalent of 50 rems (0.5 sievert) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section. (2) Class-A classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which apply to a range of clearance half-times: for Class D, Days, of less than 10 days; for Class W, Weeks, from 10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of this section, lung class and inhalation class are equivalent terms. (3) Declared pregnant woman-A woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception. (4) Derived air concentration (DAC)-The concentration of a given radionuclide in air that, if breathed by Reference Man for a working year of 2, 000 hours under conditions of light work, results in an intake of 1 ALI. For purposes of this section, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Column 3 of Table I of subsection (ggg)(2) of this section. (5) Derived air concentration-hour (DAC-hour)-The product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 sievert). (6) Dosimetry processor-A registrant that processes and evaluates personnel monitoring devices in order to determine the radiation dose delivered to the monitoring devices. (7) Inhalation class (see definition for Class). (8) Lung class (see definition for Class). (9) Nonstochastic effect-A health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of this section, deterministic effect is an equivalent term. (10) Planned special exposure-An infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits. (11) Quarter-A period of time equal to one-fourth of the year observed by the licensee or registrant, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. (12) Reference man-A hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of Reference Man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man." (13) Respiratory protective equipment-An apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials. (14) Sanitary sewerage-A system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant. (15) Stochastic effect-A health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of this section probabilistic effect is an equivalent term. (16) Very high radiation area-An area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem. (17) Weighting factor w [sub]T for an organ or tissue (T) -The proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of w [sub]T are: Figure 1: 25 TAC sec.289.202(c)(17) (d) Implementation. (1) Any existing license or certificate of registration condition that is more restrictive than this section remains in force until there is an amendment or renewal of the license or registration. (2) If a license or certificate of registration condition exempts a licensee or registrant from a provision of this section in effect on or before January 1, 1994, it also exempts the licensee or registrant from the corresponding provision of this section. (3) If a license or registration condition cites provisions of this section in effect prior to January 1, 1994, that do not correspond to any provisions of this section, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition. (e) Radiation protection programs. (1) Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of this section. See subsection (mm) of this section for recordkeeping requirements relating to these programs. (2) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA). (3) The licensee or registrant shall, at intervals not to exceed 12 months, ensure the radiation protection program content and implementation is reviewed. (f) Occupational dose limits for adults. (1) The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures in accordance with subsection (k) of this section, to the following dose limits. (A) An annual limit shall be the more limiting of: (i) the total effective dose equivalent being equal to 5 rems (0.05 sievert); or (ii) the sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 sievert). (B) The annual limits to the lens of the eye, to the skin, and to the extremities shall be: (i) an eye dose equivalent of 15 rems (0.15 sievert); and (ii) a shallow dose equivalent of 50 rems (0.5 sievert) to the skin or to any extremity. (2) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See subsection (k)(1)(F)(i) and (ii) of this section. (3) The assigned deep dose equivalent and shallow dose equivalent shall be for the portion of the body receiving the highest exposure. (4) The deep dose equivalent, eye dose equivalent and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. (5) When a protective apron is worn while working with fluoroscopic equipment used for clinical diagnostic or research purposes, the effective dose equivalent for external radiation shall be determined as follows. (A) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation. (B) When only one individual monitoring device is used and it is located at the neck outside the protective apron, and the reported dose exceeds 25% of the limit specified in paragraph (1) of this subsection, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation. (C) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04. (6) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table I of subsection (ggg)(2) of this section and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See subsection (rr) of this section. (7) Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote 3 of subsection (ggg)(2) of this section. (8) The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person. See subsection (j)(4) of this section. (g) Compliance with requirements for summation of external and internal doses. (1) If the licensee is required to monitor in accordance with both subsection (q)(1) and (3) of this section, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only in accordance with subsection (q)(1) of this section or only in accordance with subsection (q)(3) of this section, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses in accordance with paragraphs (2), (3) and (4) of this subsection. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits. (2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity: (A) the sum of the fractions of the inhalation ALI for each radionuclide; or (B) the total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or (C) the sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, w [sub]T, and the committed dose equivalent, H [sub]T,50, per unit intake is greater than 10% of the maximum weighted value of H [sub]T,50, that is, w [sub]TH [sub]T,50, per unit intake for any organ or tissue. (3) If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits. (4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated or accounted for in accordance with this paragraph. (h) Determination of external dose from airborne radioactive material. (1) Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, eye dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See footnotes 1 and 2 of subsection (ggg)(2) of this section. (2) Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices. (i) Determination of internal exposure. (1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required in accordance with subsection (q) of this section, take suitable and timely measurements of: (A) concentrations of radioactive materials in air in work areas; (B) quantities of radionuclides in the body; (C) quantities of radionuclides excreted from the body; or (D) combinations of these measurements. (2) Unless respiratory protective equipment is used, as provided in subsection (x) of this section, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present. (3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may: (A) use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; (B) upon prior approval of the agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and (C) separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See subsection (ggg)(2) of this section. (4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (1)(A) or (B) of this subsection, the licensee may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by subsections (xx) or (yy) of this section. This delay permits the licensee to make additional measurements basic to the assessments. (5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either: (A) the sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from subsection (ggg)(2) of this section for each radionuclide in the mixture; or (B) the ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture. (6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture. (7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if: (A) the licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in subsection (f) of this section and in complying with the monitoring requirements in subsection (q)(3) of this section; (B) the concentration of any radionuclide disregarded is less than 10% of its DAC; and (C) the sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%. (8) When determining the committed effective dose equivalent, the following information may be considered. (A) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000 DAC- hours, results in a committed effective dose equivalent of 5 rems (0.05 sievert) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent. (B) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 50 rems (0.5 sievert), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 sievert), that is, the stochastic ALI, is listed in parentheses in Table I of subsection (ggg)(2) of this section. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in subsection (q)(1)(A) of this section is met. (j) Determination of occupational dose for the current year. (1) For each individual who may enter the licensee's or registrant's restricted area and is likely to receive, in a year, an occupational dose requiring monitoring in accordance with subsection (q) of this section, the licensee or registrant shall determine the occupational radiation dose received during the current year. (2) In complying with the requirements of paragraph (1) of this subsection, a licensee or registrant may: (A) accept, as a record of the occupational dose that the individual received during the current year, TRC Form 21-2 from prior employers, or other clear and legible record, of all information required on that form and indicating any periods of time for which data are not available; or (B) accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's prior employer(s) for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; or (C) obtain reports of the individual's dose equivalent from prior employer(s) for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established. (3) The licensee or registrant shall record the exposure data for the current year, as required by paragraph (1) of this subsection, on TRC Form 21-3, or other clear and legible record, of all the information required on that form. (4) If the licensee or registrant is unable to obtain a complete record of an individual's current occupational dose while employed by any other licensee or registrant, the licensee or registrant shall assume in establishing administrative controls in accordance with subsection (f)(8) of this section for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts) for each quarter; or 416 millirems (4.16 millisieverts) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure. (5) If an individual has incomplete (e.g., a lost or damaged personnel monitoring device) current occupational dose data for the current year and that individual is employed solely by the licensee or registrant during the current year, the licensee or registrant shall: (A) assume that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts) for each quarter; (B) assume that the allowable dose limit for the individual is reduced by 416 millirems (4.16 millisieverts) for each month; or (C) assess an occupational dose for the individual during the period of missing data using surveys, radiation measurements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits. (6) Administrative controls established in accordance with paragraph (4) of this subsection shall be documented and maintained for inspection by the agency. Occupational dose assessments made in accordance with paragraph (5) of this subsection and records of data used to make the assessment shall be maintained for inspection by the agency. The licensee or registrant shall retain the records in accordance with subsection (rr) of this section. (k) Planned special exposures. (1) A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in subsection (f) of this section provided that each of the following conditions is satisfied. (A) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical. (B) The licensee and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs. (C) Before a planned special exposure, the licensee ensures that each individual involved is: (i) informed of the purpose of the planned operation; (ii) informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and (iii) instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present. (D) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine: (i) the internal and external doses from all previous planned special exposures; (ii) all doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and (iii) all lifetime cumulative occupational radiation doses. (E) In complying with the requirements of subparagraph (D)(iii) of this paragraph, a licensee may: (i) accept, as the record of lifetime cumulative radiation dose, an up-to-date TRC Form 21-2 or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee; and (ii) obtain reports of the individual's dose equivalent from prior employer(s) for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee, by telephone, telegram, facsimile, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established. (F) Subject to subsection (f)(2) of this section, the licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed: (i) the numerical values of any of the dose limits in subsection (f) (1) of this section in any year; and (ii) five times the annual dose limits in subsection (f)(1) of this section during the individual's lifetime. (G) The licensee maintains records of the conduct of a planned special exposure in accordance with subsection (qq) of this section and submits a written report to the agency in accordance with subsection (zz) of this section. (H) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual in accordance with subsection (f)(1) but shall be included in evaluations required by subparagraphs (D) and (F) of this paragraph. (I) The licensee shall record the exposure history, as required by subparagraph (D) of this paragraph, on TRC Form 21-2, or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee obtains reports, the licensee shall use the dose shown in the report in preparing TRC Form 21-2 or equivalent. (2) Planned special exposures are not applicable to registrants. (l) Occupational dose limits for minors. The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in subsection (f) of this section. (m) Dose to an embryo/fetus. (1) If a woman declares her pregnancy, the licensee or registrant shall ensure that the dose to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 millisieverts). If a woman chooses not to declare pregnancy, the occupational dose limits specified in subsection (f)(1) of this section are applicable to the woman. See subsection (rr) of this section for recordkeeping requirements. (2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (1) of this subsection. The National Council on Radiation Protection and Measurements recommended in NCRP Report Number 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 millisievert) to the embryo/fetus be received in any 1 month. (3) The dose to an embryo/fetus shall be taken as: (A) the dose to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman; and (B) the dose that is most representative of the dose to the embryo/fetus from external radiation, that is, in the mother's lower torso region. (i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo/fetus. (ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device that is most representative of the dose to the embryo/fetus shall be the dose to the embryo/fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo/fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo/fetus. (4) If by the time the woman declares pregnancy to the licensee or registrant, the dose to the embryo/fetus has exceeded 0.45 rem (4.5 millisieverts), the licensee or registrant shall be deemed to be in compliance with paragraph (1) of this subsection, if the additional dose to the embryo/fetus does not exceed 0.05 rem (0.5 millisievert) during the remainder of the pregnancy. (n) Dose limits for individual members of the public. (1) Each licensee or registrant shall conduct operations so that: (A) except as provided in subparagraph (B) of this paragraph, the total effective dose equivalent to individual members of the public from the licensed and/or registered operation does not exceed 0.1 rem (1 millisievert) in a year, exclusive of the dose contribution from the licensee's disposal of radioactive material into sanitary sewerage in accordance with subsection (gg) of this section; (B) the total effective dose equivalent to individual members of the public from exposure to radiation from radiation machines does not exceed 0.5 rem (5 millisieverts) in a year; and (C) the dose in any unrestricted area from licensed and/or registered external sources does not exceed 0.002 rem (0.02 millisievert) in any 1 hour. (2) If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals. (3) A licensee or an applicant for a license may apply for prior agency authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 millisieverts). This application shall include the following information: (A) demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (1) of this subsection; (B) the licensee's program to assess and control dose within the 0.5 rem (5 millisieverts) annual limit; and (C) the procedures to be followed to maintain the dose ALARA. (4) In addition to the requirements of this section, a licensee subject to the provisions of the United States Environmental Protection Agency's (EPA) generally applicable environmental radiation standards in 40 Code of Federal Regulations (CFR), sec.190 shall comply with those requirements. (5) The agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose. (o) Compliance with dose limits for individual members of the public. (1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public as required in subsection (n) of this section. (2) A licensee or registrant shall show compliance with the annual dose limit in subsection (n) of this section by: (A) demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or (B) demonstrating that: (i) the annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of subsection (ggg)(2) of this section; and (ii) if an individual were continuously present in an unrestricted area, the dose from external sources of radiation would not exceed 0.002 rem (0.02 millisievert) in an hour and 0.05 rem (0.5 millisievert) in a year. (3) Registrants exempt from personnel monitoring requirements in accordance with subsection (p)(4)-(5) of this section are exempt from the requirements of paragraphs (1) and (2) of this subsection. (4) Upon approval from the agency, the licensee may adjust the effluent concentration values in Table II, of subsection (ggg)(2) of this section, for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as, aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form. (p) General surveys and monitoring. (1) Each licensee or registrant shall make, or cause to be made, surveys that: (A) are necessary for the licensee or registrant to comply with this section; and (B) are necessary under the circumstances to evaluate: (i) radiation levels; (ii) concentrations or quantities of radioactive material; and (iii) the potential radiological hazards that could be present. (2) The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are operable and calibrated: (A) by a person licensed or registered by the agency, another Agreement State, a Licensing State, or the United States Nuclear Regulatory Commission (NRC) to perform such service; (B) at intervals not to exceed 12 months unless a different time interval is specified in another section of this chapter; (C) after each instrument or equipment repair; (D) for the types of radiation used and at energies appropriate for use; and (E) at an accuracy within 20% of the true radiation level. (3) All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with subsection (f) of this section, with other applicable provisions of these rules, or with conditions specified in a license or certificate of registration, shall be processed and evaluated by a dosimetry processor: (A) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; (B) approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and (C) holding a current certificate of registration from the agency authorizing dosimetry processing. (4) Notwithstanding the requirements of subsection (q)(1) of this section, no personnel monitoring shall be required for personnel operating only minimal threat devices as specified in sec.289.201(q)(4) of this title (relating to General Provisions). (5) Notwithstanding the requirements of subsection (q)(1) of this section, no personnel monitoring shall be required for personnel operating only dental radiographic systems for healing arts purposes. (q) Conditions requiring individual monitoring of external and internal occupational dose. Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this section. As a minimum: (1) each licensee or registrant shall monitor occupational exposure to radiation and shall supply and require the use of individual monitoring devices by: (A) adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection (f)(1) of this section; (B) minors and declared pregnant women likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of any of the applicable limits in subsections (l) or (m) of this section; and (C) individuals entering a high or very high radiation area; (2) notwithstanding paragraph (1)(C) of this subsection, a licensee is exempt from supplying individual monitoring devices to healthcare personnel who may enter a high radiation area while providing patient care if: (A) the personnel are not likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection (f) (1) of this section; and (B) the licensee complies with the requirements of subsection (e)(2) of this section; and (3) each licensee shall monitor, to determine compliance with subsection (i) of this section, the occupational intake of radioactive material by and assess the committed effective dose equivalent to: (A) adults likely to receive, in 1 year, an intake in excess of 10% of the applicable ALI in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section; and (B) minors and declared pregnant women likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.05 rem (0.5 millisievert). (r) Location and use of individual monitoring devices. (1) Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subsection (q)(l) of this section wear and use individual monitoring devices as follows. (A) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar). (B) If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subsection (m)(1) of this section, it shall be located at the waist under any protective apron being worn by the woman. (C) An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with subsection (f)(1)(B)(i) of this section, shall be located at the neck (collar) or at a location closer to the eye, outside any protective apron being worn by the monitored individual. (D) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii) of this section, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device, to the extent practicable, shall be oriented to measure the highest dose to the extremity being monitored. (E) An individual monitoring device shall be assigned to and worn by only one individual. (F) An individual monitoring device shall be worn for the period of time authorized by the dosimetry processor's certificate of registration or for no longer than 3 months, whichever is more restrictive. (2) Each licensee or registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing. (3) Each licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device. (s) Control of access to high radiation areas. (1) The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features: (A) a control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 0.1 rem (1 millisievert) in 1 hour at 30 centimeters from the source of radiation from any surface that the radiation penetrates; (B) a control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or (C) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry. (2) In place of the controls required by paragraph (1) of this subsection for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry. (3) The licensee or registrant may apply to the agency for approval of alternative methods for controlling access to high radiation areas. (4) The licensee or registrant shall establish the controls required by paragraphs (1) and (3) of this subsection in a way that does not prevent individuals from leaving a high radiation area. (5) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the United States Department of Transportation (DOT) provided that: (A) the packages do not remain in the area longer than 3 days; and (B) the dose rate at 1 meter from the external surface of any package does not exceed 0.01 rem (0.1 millisievert) per hour. (6) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in this section and to operate within the ALARA provisions of the licensee's radiation protection program. (7) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in this subsection if the registrant has met all the specific requirements for access and control specified in other applicable sections of this chapter, such as, sec.289.115 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), sec.289.116 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine), and sec.289.119 of this title (relating to Radiation Safety Requirements for Particle Accelerators). (t) Control of access to very high radiation areas. (1) In addition to the requirements in subsection (s) of this section, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates at this level. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self- shielded irradiators. (2) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in paragraph (1) of this subsection if the registrant has met all the specific requirements for access and control specified in other applicable parts of this chapter, such as, sec.289.115 of this title, sec.289.116 of this title, and sec.289.119 of this title. (u) Control of access to very high radiation areas for irradiators. (1) This subsection applies to licensees with sources of radiation in non- self-shielded irradiators. This subsection does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual. (2) Each area in which there may exist radiation levels in excess of 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials shall meet the following requirements. (A) Each entrance or access point shall be equipped with entry control devices that: (i) function automatically to prevent any individual from inadvertently entering a very high radiation area; (ii) permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 millisievert) in 1 hour; and (iii) prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 0.1 rem (1 millisievert) in 1 hour. (B) Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subparagraph (A) of this paragraph: (i) the radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 millisievert) in 1 hour; and (ii) conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices. (C) The licensee shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container: (i) the radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 millisievert) in 1 hour; and (ii) conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier. (D) When the shield for stored sealed sources is a liquid, the licensee shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding. (E) Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances, need not meet the requirements of subparagraphs (C) and (D) of this paragraph. (F) Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation. (G) Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation. (H) Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 millisievert) in 1 hour. (I) The entry control devices required in subparagraph (A) of this paragraph shall be tested for proper functioning. See subsection (uu) of this section for recordkeeping requirements. (i) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day. (ii) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption. (iii) The licensee shall submit and adhere to a schedule for periodic tests of the entry control and warning systems. (J) The licensee shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly. (K) Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area. (3) Licensees or applicants for licenses for sources of radiation within the purview of paragraph (2) of this subsection that will be used in a variety of positions or in locations, such as open fields or forests, which make it impracticable to comply with certain requirements of paragraph (2) of this subsection, such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in paragraph (2) of this subsection. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used. (4) The entry control devices required by paragraphs (2) and (3) of this subsection shall be established in such a way that no individual will be prevented from leaving the area. (v) Use of process or other engineering controls. The licensee shall use, to the extent practicable, process or other engineering controls, such as containment or ventilation, to control the concentrations of radioactive material in air. (w) Use of other controls. When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means: (1) control of access; (2) limitation of exposure times; (3) use of respiratory protection equipment; or (4) other controls. (x) Use of individual respiratory protection equipment. (1) If the licensee uses respiratory protection equipment to limit intakes in accordance with subsection (w) of this section. (A) Except as provided in subparagraph (B) of this paragraph, the licensee shall use only respiratory protection equipment that is tested and certified or had certification extended by the National Institute for Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration (MSHA). (B) If the licensee wishes to use equipment that has not been tested or certified by the NIOSH and the MSHA, or has not had certification extended by the NIOSH and the MSHA, or for which there is no schedule for testing or certification, the licensee shall submit an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. (C) The licensee shall implement and maintain a respiratory protection program that includes: (i) air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; (ii) surveys and bioassays, as appropriate, to evaluate actual intakes; (iii) testing of respirators for operability immediately prior to each use; (iv) written procedures regarding selection, fitting, issuance, maintenance, and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bioassays; and recordkeeping; and (v) determination by a physician prior to initial fitting of respirators, and at least every 12 months thereafter, that the individual user is physically able to use the respiratory protection equipment. (D) The licensee shall issue a written policy statement on respirator usage covering: (i) the use of process or other engineering controls, instead of respirators; (ii) the routine, nonroutine, and emergency use of respirators; and (iii) the length of periods of respirator use and relief from respirator use. (E) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief. (F) The licensee shall use respiratory protection equipment within the equipment manufacturer's expressed limitations for type and mode of use and shall provide proper visual, communication, and other special capabilities, such as adequate skin protection, when needed. (2) When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes in accordance with subsection (w) of this section, provided that the following conditions, in addition to those in paragraph (1) of this subsection, are satisfied. (A) The licensee selects respiratory protection equipment that provides a protection factor, specified in subsection (ggg)(1) of this section, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Column 3 of Table I of subsection (ggg)(2) of this section. However, if the selection of respiratory protection equipment with a protection factor greater than the peak concentration is inconsistent with the goal specified in subsection (w) of this section of keeping the total effective dose equivalent ALARA, the licensee may select respiratory protection equipment with a lower protection factor provided that such a selection would result in a total effective dose equivalent that is ALARA. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the average concentration in air, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used; if the exposure is later found to be less than initially estimated, the corrected value may be used. (B) The licensee shall obtain authorization from the agency before assigning respiratory protection factors in excess of those specified in subsection (ggg)(1) of this section. The agency may authorize a licensee to use higher protection factors on receipt of an application that: (i) describes the situation for which a need exists for higher protection factors; and (ii) demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use. (3) In an emergency, the licensee shall use as emergency equipment only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by the NIOSH and the MSHA. (4) The licensee shall notify the agency in writing at least 30 days before the date that respiratory protection equipment is first used in accordance with either paragraphs (1) or (2) of this subsection. (y) Security and control of licensed or registered sources of radiation. (1) The licensee shall secure radioactive material from unauthorized removal or access. (2) The licensee shall maintain constant surveillance, using devices and/or administrative procedures to prevent unauthorized use of radioactive material that is in an unrestricted area and that is not in storage. (3) The registrant shall secure radiation machines from unauthorized removal. (4) The registrant shall use devices and/or administrative procedures to prevent unauthorized use of radiation machines. (z) Caution signs. (1) Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows: Figure 2: 25 TAC sec.289.202(z)(1) (A) the cross-hatched area of the symbol is to be magenta, or purple, or black; and (B) the background of the symbol is to be yellow. (2) Notwithstanding the requirements of paragraph (1) of this subsection, licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement. (aa) Posting requirements. (1) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." (2) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA." (3) The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA." If the very high radiation area involves medical treatment of patients, the licensee or registrant may omit the word "GRAVE" from the sign or signs. (4) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA." (5) The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in subsection (ggg)(3) of this section with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)." (bb) Exceptions to posting requirements. (1) A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met: (A) the sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in this section; and (B) the area or room is subject to the licensee's or registrant's control. (2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs in accordance with subsection (aa) of this section provided that the patient could be released from confinement in accordance with sec.289.252(f)(3) of this title (relating to Licensing of Radioactive Material). (3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source(s) provided the radiation level at 30 centimeters from the surface of the sealed source container(s) or housing(s) does not exceed 0.005 rem (0.05 millisievert) per hour. (cc) Labeling containers and radiation machines. (1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures. (2) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials. (3) Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit. (dd) Exemptions to labeling requirements. A licensee is not required to label: (1) containers holding licensed material in quantities less than the quantities listed in subsection (ggg)(3) of this section; (2) containers holding licensed material in concentrations less than those specified in Table III of subsection (ggg)(2) of this section; (3) containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this section; (4) containers when they are in transport and packaged and labeled in accordance with the rules of the DOT (labeling of packages containing radioactive materials is required by the DOT if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by DOT regulations 49 CFR 173.403(m) and (w) and 173.424); (5) containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or (6) installed manufacturing or process equipment, such as piping and tanks. (ee) Procedures for receiving and opening packages. (1) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in sec.289.201(b) and (q)(5) of this title, shall make arrangements to receive: (A) the package when the carrier offers it for delivery; or (B) the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously. (2) Each licensee shall: (A) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR 172.403 and 172.436-440, for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in sec.289.201(b) of this title; and (B) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR 172.403 and 172.436-440, for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in sec.289.201(b) and (q)(5) of this title; and (C) monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged. (3) The licensee shall perform the monitoring required by paragraph (2) of this subsection as soon as practicable after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than 3 hours from the beginning of the next working day. If the licensee discovers there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged, the package shall be surveyed immediately. (4) The licensee shall immediately notify the final delivery carrier and, by telephone and telegram, mailgram, or facsimile, the agency when removable radioactive surface contamination or external radiation levels exceed the limits established in subparagraphs (A) and (B) of this paragraph. (A) Limits for removable radioactive surface contamination levels. (i) The level of removable radioactive contamination on the external surfaces of each package offered for shipment shall be ALARA. The level of removable radioactive contamination may be determined by wiping an area of 300 square centimeters of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in clause (iii) of this subparagraph, the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in clause (ii) of this subparagraph at any time during transport. If other methods are used, the detection efficiency of the method used must be taken into account and in no case may the removable contamination on the external surfaces of the package exceed 10 times the limits listed in clause (ii) of this subparagraph. (ii) Removable external radioactive contamination wipe limits are as follows. Figure 3: 25 TAC sec.289.202(ee)(4)(ii) (iii) In the case of packages transported as exclusive use shipments by rail or highway only, the removable radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in clause (ii) of this subparagraph. The levels at the beginning of transport must not exceed the levels in clause (ii) of this subparagraph. (B) Limits for external radiation levels. (i) External radiation levels around the package and around the vehicle, if applicable, will not exceed 200 millirems/hr (2 mSv/hr) external surface of the package at any time during transportation. The transport index shall not exceed 10. (ii) For a package transported in exclusive use by rail, highway or water, radiation levels external to the package may exceed the limits specified in clause (i) of this subparagraph but shall not exceed any of the following: (I) 200 millirems/hr (2 mSv/hr) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 1,000 millirems/hr (10 mSv/hr): (-a-) the shipment is made in a closed transport vehicle; (-b-) provisions are made to secure the package so that its position within the vehicle remains fixed during transportation; and (-c-) there are no loading or unloading operations between the beginning and end of the transportation; (II) 200 millirems/hr (2 mSv/hr) at any point on the outer surface of the vehicle, including the upper and lower surfaces, or, in the case of a flat-bed style vehicle, with a personnel barrier, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load (or enclosure, if used), and on the lower external surface of the vehicle (a flat-bed style vehicle with a personnel barrier shall have radiation levels determined at vertical planes. If no personnel barrier, the package cannot exceed 200 millirems/hr (2 mSv/hr) at the surface.); (III) 10 millirems/hr (0.1 mSv/h) at any point 2 meters from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point 2 meters from the vertical planes projected from the outer edges of the vehicle; and (IV) 2 millirems/hr (0.02 mSv/hr) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training in accordance with 22.12 of Texas Regulations for Control of Radiation (TRCR) Part 22 as adopted by reference in sec.289.114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections). (5) Each licensee shall: (A) establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and (B) ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened. (6) Licensees transferring special form sources in vehicles owned or operated by the licensee to and from a work site are exempt from the contamination monitoring requirements of paragraph (2) of this subsection, but are not exempt from the monitoring requirement in paragraph (2) of this subsection for measuring radiation levels that ensures that the source is still properly lodged in its shield. (ff) General requirements for waste management. (1) Unless otherwise exempted, a licensee shall discharge, treat, or decay licensed material or transfer waste for disposal only: (A) by transfer to an authorized recipient as provided in subsection (jj) of this section or in sec.289.127 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), sec.289.252 of this title (relating to Licensing of Radioactive Material), or sec.289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities), or to the United States Department of Energy (DOE); (B) by decay in storage with prior approval from the agency; (C) by release in effluents within the limits in subsection (n) of this section; or (D) as authorized in accordance with subsections (gg) and (hh) of this section. (2) A person shall be specifically licensed to receive waste containing licensed material from other persons for: (A) treatment prior to disposal; (B) treatment by incineration; (C) decay in storage; (D) disposal at an authorized land disposal facility; or (E) storage until transferred to a storage or disposal facility authorized to receive the waste. (gg) Discharge by release into sanitary sewerage. (1) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied: (A) the material is readily soluble, or is readily dispersible biological material, in water; (B) the quantity of licensed radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table III of subsection (ggg)(2) of this section; and (C) if more than one radionuclide is released, the following additional conditions must also be satisfied: (i) the fraction of the limit in Table III of subsection (ggg)(2) of this section represented by discharges into sanitary sewerage determined by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table III of subsection (ggg)(2) of this section; and (ii) the sum of the fractions for each radionuclide required by clause (i) of this subparagraph does not exceed unity; and (D) the total quantity of licensed radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed 5 curies (185 gigabecquerels) of hydrogen-3, 1 curie (37 gigabecquerels) of carbon-14, and 1 curie (37 gigabecquerels) of all other radioactive materials combined. (2) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (1) of this subsection. (hh) Treatment by incineration. A licensee may treat licensed material by incineration only in the form and concentration specified in subsection (fff)(1) of this section or as authorized by the agency. (ii) Discharge by release into septic tanks. No licensee shall discharge radioactive material into a septic tank system except as specifically approved by the agency. (jj) Transfer for disposal and manifests. (1) The requirements of this subsection and subsection (ggg)(4) of this section are designed to control transfers of low-level radioactive waste intended for disposal at a licensed low-level radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. (2) Each shipment of radioactive waste designated for disposal at a licensed low-level radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in subsection (ggg)(4)(A) of this section. (3) Each shipment manifest shall include a certification by the waste generator as specified in subsection (ggg)(4)(B) of this section. (4) Each person involved in the transfer of waste for disposal including the waste generator, waste collector, and waste processor, shall comply with the requirements specified in subsection (ggg)(4)(C) of this section. (5) Each shipment of waste to a licensed land disposal facility in Texas shall be inspected by the agency prior to shipment. The waste shipper shall notify the agency no less than 72 hours prior to the scheduled shipment of the intent to transport waste to the licensed land disposal facility. (kk) Compliance with environmental and health protection regulations. Nothing in subsections (ff), (gg), (hh), or (jj) of this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of according to subsections (ff), (gg), (hh), or (jj) of this section. (ll) General provisions for records. (1) Each licensee or registrant shall use the SI units becquerel, gray, sievert, and coulomb per kilogram, or the special units curie, rad, rem, and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this section. Disintegrations per minute may be indicated on records of surveys performed to determine compliance with subsection (ggg)(7) of this section. (2) The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this section, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, eye dose equivalent, deep dose equivalent, or committed effective dose equivalent. (3) Records required in accordance with sec.289.201(d) of this title, and subsections (mm), (nn), (oo), (tt), and (uu) of this section shall include the date and the identification of individual(s) making the record, and, as applicable, a unique identification of survey instrument(s) used, and an exact description of the location of the survey. Records of receipt, transfer, and disposal of sources of radiation shall uniquely identify the source of radiation. (4) Copies of records required in accordance with sec.289.201(d) of this title, and subsections (mm) through (uu) of this section, and by license or certificate of registration condition that are relevant to operations at an additional authorized use/storage site shall be maintained at that site in addition to the main site specified on a license or certificate of registration. (mm) Records of radiation protection programs. (1) Each licensee or registrant shall maintain records of the radiation protection program, including: (A) the provisions of the program; and (B) audits and other reviews of program content and implementation. (2) The licensee or registrant shall retain the records required by paragraph (1)(A) of this subsection until the agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by paragraph (1)(B) of this subsection for 3 years after the record is made. (nn) Records of surveys. (1) Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by subsections (p) and (ee)(2) of this section. The licensee or registrant shall retain these records for 3 years after the record is made. (2) The licensee or registrant shall retain each of the following records until the agency terminates each pertinent license or registration requiring the record: (A) the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents; and (B) results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; and (C) results of air sampling, surveys, and bioassays required in accordance with subsection (x)(1)(C)(i) and (ii) of this section; and (D) results of measurements and calculations used to evaluate the release of radioactive effluents to the environment. (oo) Records of tests for leakage or contamination of sealed sources. Records of tests for leakage or contamination of sealed sources required by sec.289.201(g) of this title shall be kept in units of becquerel or microcurie and retained for inspection by the agency for 5 years after the records are made. (pp) Records of lifetime cumulative occupational radiation dose. The licensee shall retain the records of lifetime cumulative occupational radiation dose as specified in subsection (k) of this section on TRC Form 21-2 or equivalent until the agency terminates each pertinent license requiring this record. The licensee shall retain records used in preparing TRC Form 21-2 or equivalent for 3 years after the record is made. (qq) Records of planned special exposures. (1) For each use of the provisions of subsection (k) of this section for planned special exposures, the licensee shall maintain records that describe: (A) the exceptional circumstances requiring the use of a planned special exposure; (B) the name of the management official who authorized the planned special exposure and a copy of the signed authorization; (C) what actions were necessary; (D) why the actions were necessary; (E) what precautions were taken to assure that doses were maintained ALARA; (F) what individual and collective doses were expected to result; and (G) the doses actually received in the planned special exposure. (2) The licensee shall retain the records until the agency terminates each pertinent license requiring these records. (rr) Records of individual monitoring results. (1) Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required in accordance with subsection (q) of this section, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before January 1, 1994, need not be changed. These records shall include, when applicable: (A) the deep dose equivalent to the whole body, eye dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; (B) the estimated intake of radionuclides, see subsection (g) of this section; (C) the committed effective dose equivalent assigned to the intake of radionuclides; (D) the specific information used to calculate the committed effective dose equivalent in accordance with subsection (i)(3) of this section; (E) the total effective dose equivalent when required by subsection (g) of this section; (F) the total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose; and (G) the data used to make occupational dose assessments in accordance with subsection (j)(5) of this section. (2) The licensee or registrant shall make entries of the records specified in paragraph (1) of this subsection at intervals not to exceed 1 year and within 60 days of the end of the year. (3) The licensee or registrant shall maintain the records specified in paragraph (1) of this subsection on TRC Form 21-3, in accordance with the instructions for TRC Form 21-3, or in clear and legible records containing all the information required by TRC Form 21-3. (4) The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records. (5) The licensee or registrant shall retain each required form or record until the agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain records used in preparing TRC Form 21-3 or equivalent for 3 years after the record is made. (ss) Records of dose to individual members of the public. (1) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See subsection (n) of this section. (2) The licensee or registrant shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license or registration requiring the record. (tt) Records of discharge, treatment, or transfer for disposal. (1) Each licensee shall maintain records of the discharge or treatment of licensed materials made in accordance with subsection (gg) and (hh) of this section and of transfers for disposal made in accordance with subsection (jj) of this section. (2) The licensee shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license requiring the record. (uu) Records of testing entry control devices for very high radiation areas. (1) Each licensee or registrant shall maintain records of tests made in accordance with subsection (u)(2)(I) of this section on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function. (2) The licensee or registrant shall retain the records required by paragraph (1) of this subsection for 3 years after the record is made. (vv) Form of records. Each record required by this section shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records. (ww) Reports of stolen, lost, or missing licensed or registered sources of radiation. (1) Each licensee or registrant shall report to the agency by telephone as follows: (A) immediately after its occurrence becomes known to the licensee, stolen, lost, or missing licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in subsection (ggg)(3) of this section, under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas; or (B) within 30 days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than 10 times the quantity specified in subsection (ggg)(3) of this section that is still missing. (C) immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine. (2) Each licensee or registrant required to make a report in accordance with paragraph (1) of this subsection shall, within 30 days after making the telephone report, make a written report to the agency setting forth the following information: (A) a description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted; (B) a description of the circumstances under which the loss or theft occurred; (C) a statement of disposition, or probable disposition, of the licensed or registered source of radiation involved; (D) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; (E) actions that have been taken, or will be taken, to recover the source of radiation; and (F) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation. (3) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information. (4) The licensee or registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report. (xx) Notification of incidents. (1) Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause: (A) an individual to receive: (i) a total effective dose equivalent of 25 rems (0.25 sievert) or more; (ii) an eye dose equivalent of 75 rems (0.75 sievert) or more; or (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rads (2.5 grays) or more; or (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures. (2) Each licensee or registrant shall, within 24 hours of discovery of the event, report to the agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause: (A) an individual to receive, in a period of 24 hours: (i) a total effective dose equivalent exceeding 5 rems (0.05 sievert); (ii) an eye dose equivalent exceeding 15 rems (0.15 sievert); or (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rems (0.5 sievert); or (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures. (3) Licensees or registrants shall make the initial notification reports required by paragraphs (1) and (2) of this subsection by telephone to the agency and shall confirm the initial notification report within 24 hours by telegram, mailgram, or facsimile to the agency. (4) The licensee or registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report. (5) The provisions of this section do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with section (zz) of this section. (yy) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits. (1) In addition to the notification required by subsection (xx) of this section, each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences: (A) incidents for which notification is required by subsection (xx) of this section; (B) doses in excess of any of the following: (i) the occupational dose limits for adults in subsection (f) of this section; (ii) the occupational dose limits for a minor in subsection (l) of this section; (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m) of this section; (iv) the limits for an individual member of the public in subsection (n) of this section; or (v) any applicable limit in the license or registration; (C) levels of radiation or concentrations of radioactive material in: (i) a restricted area in excess of applicable limits in the license or registration; or (ii) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the license or registration, whether or not involving exposure of any individual in excess of the limits in subsection (n) of this section; or (D) for licensees subject to the provisions of the EPA's generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those requirements. (2) Each report required by paragraph (1) of this subsection shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate: (A) estimates of each individual's dose; (B) the levels of radiation and concentrations of radioactive material involved; (C) the cause of the elevated exposures, dose rates, or concentrations; and (D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, generally applicable environmental standards, and associated license or registration conditions. (3) Each report filed in accordance with paragraph (1) of this subsection shall include for each individual exposed: the name, social security number, and date of birth. With respect to the limit for the embryo/fetus in subsection (m) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report. (4) All licensees or registrants who make reports in accordance with paragraph (1) of this subsection shall submit the report in writing to the agency. (zz) Reports of planned special exposures. The licensee shall submit a written report to the agency within 30 days following any planned special exposure conducted in accordance with subsection (k) of this section, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by subsection (qq) of this section. (aaa) Notifications and reports to individuals. (1) Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in sec.289.114 of this title. (2) When a licensee or registrant is required in accordance with subsection (yy) of this section to report to the agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of 22.13(a) of TRCR Part 22 as adopted by reference in sec.289.114 of this title. (bbb) Reports of leaking or contaminated sealed sources. The licensee shall immediately notify the agency if the test for leakage or contamination required in accordance with sec.289.201(g) of this title indicates a sealed source is leaking or contaminated. A written report of a leaking or contaminated source shall be submitted to the agency within 5 days. The report shall include the equipment involved, the test results and the corrective action taken. (ccc) Vacating premises. Each licensee, registrant, or person possessing non- exempt sources of radiation shall, no less than 30 days before vacating or relinquishing possession or control of premises, notify the agency, in writing, of the intent to vacate. The licensee or person possessing non-exempt radioactive material shall decommission the premises to a degree consistent with subsequent use as an unrestricted area and in accordance with the requirements of subsections (ddd) and (eee) of this section. (ddd) Soil contamination limits. (1) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contamination of soil in unrestricted areas, to the extent that the contamination exceeds, on a dry weight basis, the concentration limits specified in: (A) subsection (ggg)(9) of this section; or (B) the effluent concentrations in Table III of subsection (ggg)(2) of this section, with the units changed from microcuries per milliliter to microcuries per gram, for radionuclides not specified in subsection (ggg)(9) of this section or paragraph (3) of this subsection. (2) Where combinations of radionuclides are involved, the sum of the ratios between the concentrations present and the limits specified in paragraph (1) of this subsection shall not exceed one. (3) Except for the requirements in sec.289.127 of this title and notwithstanding the limits imposed by paragraph (1) of this subsection, the concentration of radium-226 or radium-228 in soil averaged over any 100 square meters shall not exceed the background level by more than: (A) 5 pCi/gm, averaged over the first 15 centimeters of soil below the surface; and (B) 15 pCi/gm, averaged over 15 centimeter thick layers of soil more than 15 centimeters below the surface. (eee) Surface contamination limits for facilities and equipment. Prior to vacating any facility or releasing areas or equipment for unrestricted use, each licensee shall ensure that radioactive contamination has been removed to levels as low as reasonably achievable. In no case shall the licensee vacate a facility or release areas or equipment for unrestricted use until radioactive surface contamination levels are below the limits specified in subsection (ggg) (7) of this section. (fff) Exemption of specific wastes. (1) A licensee may discard the following licensed material without regard to its radioactivity: (A) 0.05 microcurie (1.85 kilobecquerels), or less, of hydrogen-3, carbon-14, or iodine-125 per gram of medium used for liquid scintillation counting or in vitro clinical or in vitro laboratory testing; and (B) 0.05 microcurie (1.85 kilobecquerels), or less, of hydrogen-3, carbon-14, or iodine-125, per gram of animal tissue, averaged over the weight of the entire animal. (2) A licensee shall not discard tissue in accordance with paragraph (1) (B) of this subsection in a manner that would permit its use either as food for humans or as animal feed. (3) The licensee shall maintain records in accordance with subsection (tt) of this section. (4) Any licensee may, upon agency approval of procedures required in paragraph (6) of this subsection, discard licensed material included in subsection (ggg)(8) of this section, provided that it does not exceed the concentration and total curie limits contained therein, in a Type I municipal solid waste site as defined in the Municipal Solid Waste Regulations of the authorized regulatory agency (31 TAC Chapter 330), unless such licensed material also contains hazardous waste, as defined in Section 3(15) of the Solid Waste Disposal Act, Health and Safety Code, Chapter 361. Any licensed material included in subsection (ggg)(8) of this section and which is a hazardous waste as defined in the Solid Waste Disposal Act may be discarded at a facility authorized to manage hazardous waste by the authorized regulatory agency. (5) Each licensee who discards material described in paragraphs (1) or (4) of this subsection shall: (A) make surveys adequate to assure that the limits of paragraphs (1) or (4) of this subsection are not exceeded; and (B) remove or otherwise obliterate or obscure all labels, tags, or other markings that would indicate that the material or its contents is radioactive. (6) Prior to authorizations in accordance with paragraph (4) of this subsection, a licensee shall submit procedures to the agency for: (A) the physical delivery of the material to the disposal site; (B) surveys to be performed for compliance with paragraph (5)(A) of this subsection; (C) maintaining secure packaging during transportation to the site; and (D) maintaining records of any discards made under paragraph (4) of this subsection. (7) Nothing in this section relieves the licensee of maintaining records showing the receipt, transfer, and discard of such radioactive material as specified in sec.289.201(d) of this title. (8) Nothing in this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous property of these materials. (9) Licensed material discarded under this section is exempt from the requirements of sec.289.252(t) of this title. (ggg) Appendices. (1) Protection factors for respirators. The following table contains protection factors for respirators: Figure 4: 25 TAC sec.289.202(ggg)(1) (2) Annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage. (A) Introduction. (i) For each radionuclide, Table I of subparagraph (F) of this paragraph indicates the chemical form that is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 micron, and for three classes (D,W,Y) of radioactive material, which refer to their retention (approximately days, weeks, or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. Table II of subparagraph (F) of this paragraph provides concentration limits for airborne and liquid effluents released to the general environment. Table III of subparagraph (F) of this paragraph provides concentration limits for discharges to sanitary sewerage. (ii) The values in Tables I, II, and III of subparagraph (F) of this paragraph are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6 x 10 point=5.02p [sup]-2 or 0.06, 6E represents 6 x 10[sup]2 or 600, and 6E represents 6 x 10[sup]0 or 6. (B) Occupational values. (i) Note that the columns in Table I of subparagraph (F) of this paragraph captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive material. (ii) The ALIs in subparagraph (F) of this paragraph are the annual intakes of given radionuclide by "Reference Man" that would result in either a committed effective dose equivalent of 5 rems (0.05 sievert), stochastic ALI, or a committed dose equivalent of 50 rems (0.5 sievert) to an organ or tissue, non- stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 5 rems (0.05 sievert). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, w [sub]T. This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of w [sub]T are listed under the definition of "weighting factor" in subsection (c) of this section. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function. (iii) A value of w [sub]T = 0.06 is applicable to each of the five organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the GI tract; stomach, small intestine, upper large intestine, and lower large intestine, are to be treated as four separate organs. (iv) The dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. (v) When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used as follows: (I) LLI wall = lower large intestine wall; (II) St. wall = stomach wall; (III) Blad wall = bladder wall; and (IV) Bone surf= bone surface. (vi) Figure 5: 25 TAC sec.289.202(ggg)(2)(B)(vi) (vii) The dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. (viii) The DAC values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by: Figure 6: 25 TAC sec.289.202(ggg)(2)(B)(viii) (ix) The DAC values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately. (x) The ALI and DAC values include contributions to exposure by the single radionuclide named and any in-growth of daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures. (xi) The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See subsection (g) of this section. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as, Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different radionuclides. (xii) It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides. (C) Effluent concentrations. (i) The columns in Table II of subparagraph (F) of this paragraph captioned "Effluents," "Air," and "Water" are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of subsection (o) of this section. The concentration values given in Columns 1 and 2 of Table II of subparagraph (F) of this paragraph are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.05 rem (0.5 millisievert). (ii) Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table II of subparagraph (F) of this paragraph. For this reason, the DAC and airborne effluent limits are not always proportional as they were in the previous radiation protection standards. (iii) The air concentration values listed in Column I of Table II of subparagraph (F) of this paragraph were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 10 [sup]9, relating the inhalation ALI to the DAC, as explained in subparagraph (B)(viii) of this paragraph, and then divided by a factor of 300. The factor of 300 includes the following components: (I) a factor of 50 to relate the 5 rems (0.05 sievert) annual occupational dose limit to the 0.1 rem limit for members of the public; (II) a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and (III) a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups. (iv) For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Column 3 of Table I of subparagraph (F) of this paragraph was divided by 219. The factor of 219 is composed of a factor of 50, as described in clause (iii) of this subparagraph, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case. (v) The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 10[sup]7. The factor of 7.3 x 10[sup]7 (ml) includes the following components: (I) the factors of 50 and 2 described in clause (iii) of this subparagraph; and (II) a factor of 7.3 x 10[sup]5 (ml) which is the annual water intake of "Reference Man." (vi) Note 2 of subparagraph (F) of this paragraph provides groupings of radionuclides that are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations, and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements. (D) Releases to sewers. The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in subsection (gg) of this section. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 10 [sup]6 (ml). The factor of 7.3 x 10 [sup]6 (ml) is composed of a factor of 7.3 x 10[sup]5 (ml), the annual water intake by "Reference Man," and a factor of 10, such that the concentrations, if the sewage released by the licensee were the only source of water ingested by a "Reference Man" during a year, would result in a committed effective dose equivalent of 0.5 rem. (E) List of elements. Figure 7: 25 TAC sec.289.202(ggg)(2)(E) (F) Tables-Values for annual limits. The following tables contain values for annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage: Figure 8: 25 TAC sec.289.202(ggg)(2)(F) (3) Quantities of licensed material requiring labeling. The following tables contain quantities of licensed material requiring labeling: Figure 9: 25 TAC sec.289.202(ggg)(3) (4) Requirements for transfer of low-level radioactive waste for disposal at land disposal facilities and manifests. (A) Manifest. The shipment manifest shall contain the name, address, and telephone number of the person generating the waste. The manifest shall also include the name, address, and telephone number or the name and U.S. Environmental Protection Agency hazardous waste identification number of the person transporting the waste to the land disposal facility. The manifest shall also indicate: a physical description of the waste, the volume, radionuclide identity and quantity, the total radioactivity, and the principal chemical form. The solidification agent shall be specified. Waste containing more than 0.1% chelating agents by weight shall be identified and the weight percentage of the chelating agent estimated. Wastes classified as Class A, Class B, or Class C in paragraph (5)(A) of this subsection shall be clearly identified as such in the manifest. The total quantity of the radionuclides hydrogen-3, carbon-14, technetium-99, and iodine-129 shall be shown. The manifest required by this subparagraph may be shipping papers used to meet DOT or EPA regulations or requirements of the receiver, provided all the required information is included. Copies of manifests required by this paragraph may be legible carbon copies or legible photocopies. (B) Certification. The waste generator shall include in the shipment manifest a certification that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the DOT and the agency. An authorized representative of the waste generator shall sign and date the manifest. (C) Control and tracking. (i) Any radioactive waste generator who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in subclauses (I)-(IX) of this clause. Any radioactive waste generator who transfers waste to a licensed waste processor who treats or repackages waste shall comply with the requirements of subclauses (IV)-(IX) of this clause. A licensee shall: (I) prepare all wastes so that the waste is classified according to paragraph (5)(A) of this subsection and meets the waste characteristics requirements in paragraph (5)(B) of this subsection; (II) label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with paragraph (5)(A) of this subsection; (III) conduct a quality control program to ensure compliance with paragraph (5)(A) and (B) of this subsection; the program shall include manage- ment evaluation of audits; (IV) prepare shipping manifests to meet the requirements of subparagraphs (A) and (B) of this paragraph; (V) forward a copy of the manifest to the intended recipient, at the time of shipment, or deliver to a collector at the time the waste is collected, obtaining acknowledgment of receipt in the form of a signed copy of the manifest or equivalent documentation from the collector; (VI) include one copy of the manifest with the shipment; (VII) retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by sec.289.252(p) of this title; (VIII) for any shipments or any portion of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation in clause (v) of this subparagraph; and (IX) forward a legible copy of the manifest to the agency at the time of transfer or shipment. (ii) Any waste collector licensee who handles only prepackaged waste shall: (I) acknowledge receipt of the waste from the generator within one week of receipt by returning a signed copy of the manifest or equivalent documentation; (II) prepare a new manifest to reflect consolidated shipments; the new manifest shall serve as a listing or index for the detailed generator manifests. Copies of the generator manifests shall be a part of the new manifest. The waste collector may prepare a new manifest without attaching the generator manifests, provided the new manifest contains for each package the information specified in subparagraph (A) of this paragraph. The collector licensee shall certify that nothing has been done to the waste that would invalidate the generator's certification; (III) forward a copy of the new manifest to the land disposal facility operator at the time of shipment; (IV) include the new manifest with the shipment to the disposal site; (V) retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by sec.289.252(p) of this title, and retain information from generator manifest until disposition is authorized by the agency; (VI) for any shipments or any portion of a shipment for which acknowledgment of receipt is not received within the times set forth in this paragraph, conduct an investigation in accordance with clause (v) of this subparagraph; and (VII) forward a legible copy of the manifest to the agency no later than the date of shipment of the waste to the land disposal facility. (iii) Any licensed waste processor who treats or repackages wastes shall: (I) acknowledge receipt of the waste from the generator within one week of receipt by returning a signed copy of the manifest or equivalent documenta- tion; (II) prepare a new manifest that meets the requirements of subparagraphs (A) and (B) of this paragraph. Preparation of the new manifest reflects that the processor is responsible for the waste; (III) prepare all wastes so that the waste is classified according to paragraph (5)(A) of this subsection and meets the waste characteristics requirements in paragraph (5)(B) of this subsection; (IV) label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with paragraph (5)(A) and (C) of this subsection; (V) conduct a quality control program to ensure compliance with paragraph (5)(A) and (B) of this subsection. The program shall include manage- ment evaluation of audits; (VI) forward a copy of the new manifest to the disposal site operator or waste collector at the time of shipment, or deliver to a collector at the time the waste is collected, obtaining acknowledgment of receipt in the form of a signed copy of the manifest or equivalent documentation by the collector; (VII) include the new manifest with the shipment; (VIII) retain copies of original manifests and new manifests and documentation of acknowledgment of receipt as the record of transfer of licensed material required by sec.289.252(p) of this title; (IX) for any shipment or portion of a shipment for which acknowledgment is not received within the times set forth in this section, conduct an investigation in accordance with clause (v) of this subparagraph; and (X) forward a legible copy of the manifest to the agency no later than the date of the shipment to the land disposal facility. (iv) The land disposal facility operator shall: (I) acknowledge receipt of the waste within one week of receipt by returning a signed copy of the manifest or equivalent documentation to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. The returned copy of the manifest or equivalent documentation shall indicate any discrepancies between materials listed on the manifest and materials received; (II) maintain copies of all completed manifests or equivalent documentation until the agency authorizes their disposition; and (III) notify the shipper, that is, the generator, the collector, or processor, and the agency when any shipment or portion of a shipment has not arrived within 60 days after the advance manifest was received. (v) Any shipment or portion of a shipment for which acknowledgment is not received within the times set forth in this section shall: (I) be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and (II) be traced and reported. The investigation shall include tracing the shipment and filing a report with the agency. Each licensee who conducts a trace investigation shall file a written report with the agency within 2 weeks of completion of the investigation. (5) Classification and characteristics of low-level radioactive waste. (A) Classification of radioactive waste for land disposal. (i) Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concen- tration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionucli- des could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective. (ii) Classes of waste. (I) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in subparagraph (B)(i) of this paragraph. If Class A waste also meets the stability requirements set forth in subparagraph (B)(ii) of this paragraph, it is not necessary to segregate the waste for disposal. (II) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph. (III) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph. (iii) Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in subclause (V) of this clause, classification shall be determined as follows. (I) If the concentration does not exceed 0.1 times the value in subclause (V) of this clause, the waste is Class A. (II) If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value in subclause (V) of this clause, the waste is Class C. (III) If the concentration exceeds the value in subclause (V) of this clause, the waste is not generally acceptable for land disposal. (IV) For wastes containing mixtures of radionuclides listed in subclause (V) of this clause, the total concentration shall be determined by the sum of fractions rule described in clause (vii) of this subparagraph. (V) Classification table for long-lived radionuclides. Figure 10: 25 TAC sec.289.202(ggg)(5)(A)(iii)(V) (iv) Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in clause (iii)(V) of this subparagraph, classification shall be determined based on the concentrations shown in subclause (VI) of this clause. However, as specified in clause (vi) of this subparagraph, if radioactive waste does not contain any nuclides listed in either clause (iii)(V) of this subparagraph or subclause (VI) of this clause, it is Class A. (I) If the concentration does not exceed the value in Column 1 of subclause (VI) of this clause, the waste is Class A. (II) If the concentration exceeds the value in Column 1 of subclause (VI) of this clause but does not exceed the value in Column 2 of subclause (VI) of this clause, the waste is Class B. (III) If the concentration exceeds the value in Column 2 of subclause (VI) of this clause but does not exceed the value in Column 3 of subclause (VI) of this clause, the waste is Class C. (IV) If the concentration exceeds the value in Column 3 of subclause (VI) of this clause, the waste is not generally acceptable for near-surface disposal. (V) For wastes containing mixtures of the radionuclides listed in subclause (VI) of this clause, the total concentration shall be determined by the sum of fractions rule described in clause (vii) of this subparagraph. (VI) Classification table for short-lived radionuclides. Figure 11: 25 TAC sec.289.202(ggg)(5)(A)(iv)(VI) (v) Classification determined by both long- and short-lived radionuclides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in clause (iii)(V) of this subparagraph and some of which are listed in clause (iv)(VI) of this subparagraph, classification shall be determined as follows: (I) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph is less than 0.1 times the value listed in clause (iii)(V) of this subparagraph, the class shall be that determined by the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph. (II) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph exceeds 0.1 times the value listed in clause (iii)(V) of this subparagraph, but does not exceed the value listed in clause (iii)(V) of this subparagraph, the waste shall be Class C, provided the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph does not exceed the value shown in Column 3 of clause (iv)(VI) of this subparagraph. (vi) Classification of wastes with radionuclides other than those listed in clauses (iii)(V) and (iv)(VI) of this subparagraph. If the waste does not contain any radionuclides listed in either clauses (iii)(V) and (iv) (VI) of this subparagraph, it is Class A. (vii) The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 Ci/m [sup]3 (1.85 TBq/m[sup]3) and Cs-137 in a concentration of 22 Ci/m [sup]3 (814 Gbq/m[sup]3). Since the concentrations both exceed the values in Column 1 of clause (iv)(VI) of this subparagraph, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B. (viii) Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors, which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocurie (becquerel) per gram. (B) Radioactive waste characteristics. (i) The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site. (I) Wastes shall be packaged in conformance with the conditions of the license issued to the site operator to which the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of this section, the site license conditions shall govern. (II) Wastes shall not be packaged for disposal in cardboard or fiberboard boxes. (III) Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid. (IV) Solid waste containing liquid shall contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume. (V) Waste shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water. (VI) Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with subclause (VIII) of this clause. (VII) Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable. (VIII) Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total activity shall not exceed 100 curies (3.7 terabecquerels) per container. (IX) Wastes containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials. (ii) The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste. (I) Waste shall have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal. (II) Notwithstanding the provisions in clause (i)(III) and (IV) of this subparagraph, liquid wastes, or wastes containing liquid, shall be converted into a form that contains as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form. (III) Void spaces within the waste and between the waste and its package shall be reduced to the extent practicable. (C) Labeling. Each package of waste shall be clearly labeled to identify whether it is Class A, Class B, or Class C waste, in accordance with subparagraph (A) of this paragraph. (6) Time requirements for record keeping. Figure 12: 25 TAC sec.289.202(ggg)(6) (7) Acceptable surface contamination levels. Figure 13: 25 TAC sec.289.202(ggg)(7) (8) Concentration and activity limits of nuclides for disposal in a Type I municipal solid waste site or a hazardous waste facility (for use in subsection (fff) of this section). Figure 14: 25 TAC sec.289.202(ggg)(8) (9) Soil contamination limits for selected radionuclides (for use in subsection (ddd) of this section). Figure 15: 25 TAC sec.289.202(ggg)(9) (10) The following, TRC Form 21-2, is to be used to document cumulative occupational exposure history: Figure 16: 25 TAC sec.289.202(ggg)(10) (11) The following, TRC Form 21-3, is to be used to document occupational exposure record for a monitoring period: Figure 17: 25 TAC sec.289.202(ggg)(11) This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 29, 1996. TRD-9605923 Susan K. Steeg General Counsel Texas Department of Health Effective date: May 20, 1996 Proposal publication date: December 26, 1995 For further information, please call: (512) 458-7236 25 TAC sec.289.201 The Texas Department of Health (department) adopts an amendment to sec.289. 201, concerning general provisions of radiation control, with changes to the proposed text as published in the February 16, 1996, issue of the Texas Register (21 TexReg 1238). The amendment specifies the criteria the department will consider in determining exemptions to the section and increases the inspection intervals for dental and veterinary facilities and assemblers/consultants of x-ray machines. The amendment also deletes the requirements for routine inspection of mammography systems because these requirements are now included in 25 TAC sec.289.230 (relating to Certification of Mammography Systems). References to the Texas Open Records Act have been revised to reflect the correct title of that statute. Following is a summary of changes that were made to the section as a result of comments received. In subsection (c)(1), the words, "or exceptions" were deleted because they were redundant of the word "exemption". Concerning subsection (c)(1), to clarify the intent of the section, subparagraph (B) was deleted; subparagraph (C) was renumbered and reworded to read, "economic considerations in relation to benefits to the public health and safety, and ..."; subparagraph (D) was renumbered and the words, "or public health and safety" were added. Concerning subsection (q)(3), the grouping of categories listed as "Industrial" was renamed "Other" because assembler/consultants and other services could be other than industrial. In addition to these changes, other minor grammatical changes were made throughout the section. The following are the public comments made concerning the proposed section and the department's responses to those comments. Comment: Concerning subsection (q)(3), one commenter stated that increasing the inspection interval for dental facilities does not seem prudent in conjunction with the changes being drafted in Texas Regulations for Control of Radiation (TRCR) Part 32 as adopted by reference in 25 TAC sec.289.116 (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine). A physicist is explicitly not required to evaluate dental facilities according to the latest draft of 32.22 of TRCR Part 32. The commenter expressed that relaxation of inspection intervals would further dilute the remaining professional oversight of equipment viability. Response: The proposed changes in the inspection intervals are based upon department inspection data concerning the average number of health-related violations per inspection per category. Recent data has shown a decrease in health-related violations, thereby justifying an extended interval. Should the average number of health-related violations increase in the future, the inspection intervals will be adjusted to reflect that fluctuation. The department made no change as a result of the comment. Comment: Concerning subsection (q)(3), a commenter noted that facilities are separated between medical/educational and industrial, and that consultants are listed under industrial facilities. The commenter questioned whether consultants working in the medical area only should be registered. Response: The section is intended to apply to all consultants, whether working exclusively in industrial or medical/educational settings. The department changed the section heading from "Industrial" to "Other" in order to clarify the section. Comment: Concerning subsection (q)(3), a commenter stated that the proposed change that increases the inspection intervals for dental facilities is a positive step to reflect the improvements in technology and training in the last several years. Response: The department acknowledged the comment and made no change as a result of the comment. Commenters included a representative from Scott and White Clinic of Temple; Frank Malek and Associates of Montgomery; Texas Dental Association of Austin; Fuji Medical Systems U.S.A., Inc. of Stamford, Connecticut; and two individuals. The commenters were generally in favor of the proposal; however, they presented comments and suggestions for changes to the proposal as previously discussed. The amendment is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.289.201. General Provisions. (a)-(b) (No change.) (c) Exemptions. (1) General provision. The agency may, upon application therefor or upon its own initiative, grant exemptions from the requirements of this chapter as it determines will not result in undue hazard to public health and safety or property. In determining such exemptions, the agency will consider: (A) state of technology; (B) economic considerations in relation to benefits to the public health and safety; and (C) other societal, socioeconomic, or public health and safety considerations. (2)-(3) (No change.) (d) (No change.) (e) Inspections. (1)-(3) (No change.) (4) Training for agency inspectors of electronic products. (A) The agency will conduct inspections of medical, podiatric medical, dental, veterinary, and chiropractic electronic products in a manner designed to cause as little disruption of a medical, podiatric medical, dental, veterinary, or chiropractic practice as is practicable. (B) A person who inspects medical, podiatric medical, dental, veterinary, or chiropractic electronic products will have training in the design and uses of the products. (C) A person performing inspections of electronic products for the uses described in subparagraph (A) of this paragraph will receive training specified in subsection (q)(6) of this section. (f)-(m) (No change.) (n) Open records. (1) Subject to the limitations provided in the Texas Public Information Act, Government Code, Chapter 552, all information and data collected, assembled, or maintained by the agency are public records open to inspection and copying during regular office hours. (2) Any person who submits written information or data to the agency and requests that the information be considered confidential, privileged, or otherwise not available to the public under the Texas Public Information Act, shall justify such request in writing, including statutes and cases where applicable, addressed to the agency. (A) Documents containing information that is claimed to be an exception to the Texas Public Information Act shall be marked to indicate that fact. Markings shall be placed on the document on origination or submission. (i) (No change.) (ii) The following wording shall be placed at the bottom of the front cover and title page, or first page of text if there is no front cover or title page: FIGURE 1: 25 TAC sec.289.201(n)(A)(ii) (B) The agency requests, whenever possible, that all information submitted under the claim of an exception to the Texas Public Information Act be extracted from the main body of the application and submitted as a separate annex or appendix to the application. (C) (No change.) (3) Whether information falls within one of the exceptions to the Texas Public Information Act shall be determined by the agency. The Office of General Counsel will be queried as to whether or not there has been a previous determination that the information falls within one of the exceptions to the Texas Public Information Act. If there has been no previous determination and the agency believes that the information falls within one of the exceptions, an opinion of the Attorney General will be requested. If the agency agrees in writing to the request, the information shall not be open for public inspection unless the Attorney General's office subsequently determines that it is not an exception. (4) Requests for information. (A) (No change.) (B) The agency will ascertain whether the information may be released or whether it falls within an exception to the Texas Public Information Act. (i) The agency may take a reasonable period of time to determine whether information falls within one of the exceptions to the Texas Public Information Act. (ii) (No change.) (C) (No change.) (o)-(p) (No change.) (q) Appendices. (1)-(2) (No change.) (3) Routine inspection intervals for registrants. FIGURE 2: 25 TAC sec.289.201(q)(3) (4)-(6) (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 authority. Issued in Austin, Texas, on April 29, 1996. TRD-9605922 Susan K. Steeg General Counsel Texas Department of Health Effective date: May 20, 1996 Proposal publication date: February 16, 1996 For further information, please call: (512) 458-7236 Part II. Texas Department of Mental Health and Mental Retardation Chapter 409. Medicaid Programs Subchapter J. Reimbursement for Services in Institutions for Mental Diseases (IMD) 25 TAC sec.409.374, sec.409.375 The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts amendments to sec.409.374 and sec.409.375, concerning reimbursement for services in institutions for mental diseases (IMD). Section 409.374 is adopted with changes to the proposed text as published in the February 2, 1996, issue of the Texas Register (21 TexReg 749). Section 409.375 is adopted without changes and will not be republished. The adopted amendments to Chapter 409, Subchapter J, incorporate prior and continued stay authorization procedures with the department's Office of Medicaid Administration for the delivery of IMD services and the quantifying of the provider eligibility requirement of a consistent historical pattern of accepting persons involuntarily committed for inpatient mental health services. Language in sec.409.374 is changed to explicitly state that prior authorizations will occur within seven calendar days of the individual's receipt of IMD services for which a claim is submitted. Language is also changed to reflect the credentials of the authorizing reviewer as being a registered nurse or a licensed physician. Additional language is changed regarding the date the amendments become effective. Language also clarifies when requests for reauthorization must be submitted and the length of time an authorization is valid. A public hearing was held on February 16, 1996, with no oral or written testimony presented. Written comment was received from the Superintendent of Kerrville State Hospital and one private citizen. Written comment was received from one individual who supported the addition of the requirement for services to meet the patient's mental and psychosocial well- being. The commenter also indicated that it was very important that services be monitored by a medical review team outside TDMHMR. The department responds that recent initiatives have established a clear separation of service authority and service provider responsibilities within TDMHMR. Medical review inspections are an authority responsibility. While inspections are accomplished internally by TDMHMR, the department maintains an arms'-length approach in its relationship with TDMHMR providers. It should also be noted that providers of IMD services are subject to several external reviews that include Medicare certification by the Texas Department of Health, certification by the Joint Commission of Accreditation of Healthcare Organizations, as well as federal audit by the Health Care Financing Administration. The commenter characterized inspections conducted on an annual basis as inadequate. The department responds that sec.409.375(c) provides that inspection frequency will occur at an interval decided upon by the department but will occur no less frequently than annually. The department reserves the authority to conduct inspections at a frequency it determines necessary to fulfill its responsibilities. Other reviews such as Medicare certification by the Texas Department of Health, certification by the Joint Commission of Accreditation of Healthcare Organizations, and federal audits by the Health Care Financing Administration occur at intervals established by their respective agency policies. Another commenter stated that the department was incorrect in its determination that there will be no economic cost to persons who are required to comply with the amended sections. The commenter expressed concern that there will be an increased workload and a corresponding need to increase the number of staff in the provider's utilization review and reimbursement departments. The department responds that because only data required for Medicare certification are being requested, the department anticipates that the impact on the facilities' workload would be minimal and the economic cost negligible. The commenter requested clarification regarding the requirement that the request for initial authorization be submitted to the department within seven calendar days of the determination of need for IMD services. The department responds that the language regarding initial authorization for IMD services, as described in sec.409.374(8), does require clarification. The department will amend the proposal to indicate that prior authorization will be obtained within seven days of the individual's receipt of IMD services for which a claim is to be submitted. The commenter inquired as to the maximum number of days which will be authorized for both the initial and continued stay authorization. The department responds that the maximum length of time for the initial and subsequent continued stay authorizations will be based on the needs of the individual, but in no case will the period exceed 30 days as described in sec.409.375(8). The commenter asserted that the rule should state the qualifications/credentials of the authorizing reviewer. The department agrees that the qualifications and credentials of the authorizing reviewer should be specified in the rule and sec.409.374(8) has been revised to reflect that either a registered nurse or a physician will conduct the prior and continued stay authorizations. The amendments are adopted under the Texas Health and Safety Code, sec.532. 015, which provides the Texas Department of Mental Health and Mental Retardation Board with broad rule rulemaking authority, and under the provisions of the Texas Civil Statutes, Article 4413(502), sec.16, which provide the Texas Health and Human Services Commission with the authority to administer federal medical assistance funds. sec.409.374. Eligible Population. Reimbursement for IMD services is limited to individuals: (1) who are age 65 years or older; (2) who have one or more mental diseases; (3) who have no acceptable alternate placement as determined by the individual's treatment team; (4) who are eligible for participation in the Texas Medicaid program; (5) who are not eligible for medical compensation from other payment sources; (6) who have been certified by a licensed physician to need inpatient hospitalization for the care and treatment of a mental disease; (7) who meet all other federal, state and local regulations applicable to admission to a mental hospital; and (8) for whom the department has authorized IMD services based on medical necessity. Effective June 1, 1996, request for initial authorization must be submitted to the department's Office of Medicaid Administration within seven calendar days of the first day a claim is submitted for reimbursement of IMD services. Authorization for continued stay is valid for up to 30 calendar days. Request for reauthorization of continued stay must be submitted seven calendar days prior to the end date of the initial and all subsequent authorizations. For persons currently receiving IMD services, admitted prior to June 1, 1996, authorization will be granted until July 1, 1996. Requests for reauthorization of continued stay for these persons must also be submitted seven calendar days prior to the end date of the authorization. Authorizations will be determined by a registered nurse or a licensed physician. 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 May 1, 1996. TRD-9605988 Ann Utley Chairman, Texas MHMR Board Texas Department of Mental Health and Mental Retardation Effective date: June 1, 1996 Proposal publication date: February 2, 1996 For further information, please call: (512) 206-4516 TITLE 28. INSURANCE Part I. Texas Department of Insurance Chapter 3. Life, Accident and Health Insurance and Annuities The Commissioner of Insurance adopts an amendment to sec.3.5302 and new sec.3.5502, concerning joint credit accident and health insurance. Section 3. 5502 is adopted with changes to the proposed text as published in the October 31, 1995 issue of the Texas Register (20 TexReg 8965). Section 3.5302 is adopted without changes and will not be republished. The adopted sections will result in the additional availability of credit disability coverage which can be written on two individuals who are jointly responsible for the repayment of a debt. Today's families increasingly rely on two incomes to provide for basic needs and most married adults are jointly liable for repayment of the indebtedness they incur. Under such coverage, if either or both of the joint debtors are disabled, the periodic indemnity payment due will be paid during the period of disability. Amended sec.3.5302 is necessary to delete the provision which currently prohibits the writing of joint credit accident and health insurance. New sec.3. 5502 defines and describes joint credit accident and health insurance, including limitations on the amounts of each periodic indemnity payment and on the total amount of indemnity payable on a single transaction, and the required adjustments due to certain terminations of the joint disability coverage. The agency has changed subsection (g) by changing the word "percentage" to "amount" for clarification. The agency has changed subsection (h) based on comments that it is important to have historical experience on which to set rates for the new policy forms. The agency will collect joint disability data separate from single life data and will collect data separately for the two joint disability options. General A commenter recommends adoption and believes that carriers can elect to submit forms and a schedule of rates to be used immediately in lieu of waiting until a rate hearing is held to determine the prima facie rate for such coverage. This commenter also believes the forms should be approved immediately if the insurer has submitted justification for its rate schedule. Another commenter believes that the agency should not approve any filings because the value to the consumer of the product is a function of the rates and a premium rate needs to be set at the next credit insurance rate hearing before filings should be approved. A commenter believes that this type of coverage is sought by many consumers and should be authorized so that it may be offered where appropriate. A few commenters support adoption of the joint partial coverage plan only. These commenters believe that the consumer should be able to choose among plans and decide whether each person should be insured for the full debt or part of the debt rather than the lender determining the type of joint coverage to be offered to borrowers. The commenters believe that lenders will only offer full coverage on each joint debtor, since such coverage generates higher premiums and commission income. One commenter recommends that if both plans are approved then it should be required that both plans (full coverage and partial coverage) are offered to every applicant so that the joint debtors can decide which plan they prefer. One commenter argues that the joint credit disability product with 100% coverage for each debtor is of limited value to consumers, but will be the joint credit disability option offered because of higher premiums and commissions relative to the other joint credit disability option. The commenter believes that only one option -- coverage for both debtors equal to a total of 100% -- should be offered and the other option should be eliminated. Agency Response: The agency disagrees that carriers can use a schedule of rates immediately upon filing. All parties must be given the opportunity to present evidence at a contested rate hearing to assure that a reasonable relation of benefits to premium is provided for this new coverage. The purpose of the adoption is to permit the issuance of joint credit disability coverage. After the effective date of the amendment, forms may be filed for approval which address joint disability coverage under either one or both types of coverages, as set forth in sec.3.5502(b). However, until presumptive rates are established for joint disability coverage when both debtors are insured for 100% of the monthly payment, as set forth in sec.3.5502(b)(2), the coverage may not be issued. This coverage in most situations is optional coverage obtained by the consumer at the time of incurring a debt. The creditor negotiates with an insurer the various plans of coverage that it intends to make available to its debtors. The debtor can elect the plan offered by the creditor, not elect the plan offered by the creditor or choose to provide the coverage by some other method. The agency can not require the creditor to select specific plans to offer to its debtors. The agency disagrees with the proposal to eliminate the joint credit disability option for 100% coverage to each debtor. There is no evidence to suggest that either product is of limited value to consumers and the market will decide if the products are valued and subsequently offered. The two joint disability policies represent two different products and both should be available to the public. The fairness of each product is a function of the benefits offered relative to the rate charged and the commissioner sets the rates in a manner to ensure that the rates are fair relative to the benefits. Section 3.5302. A commenter supports the repeal of subsection (c) in this section as staying current with the extension of credit and the ability of borrowers to repay loans is dependent on continued employment and the income of joint debtors. The commenter believes this will permit insuring the full potential risk of loss of income due to disability when joint borrowers are involved. Agency Response: The agency agrees. With the change in borrowing patterns, the agency believes it is necessary to permit coverage for joint debtors. Section 3.5502(b). A commenter suggests that insurers should be permitted to provide in the joint disability forms that, if coverage on one joint insured is voided ab initio or terminated during the coverage term, the portion of the disability benefit for which the other joint debtor is insured will become 100% of the total disability benefit from the date of voiding or termination of coverage. The commenter believes that inclusion of this suggestion in the form would not require payment of a premium refund since the premium charged for the joint coverage is identical to the premium for single coverage providing for the same total benefit payment. Agency response: The agency agrees that the issue of premium refund with regard to this product might appropriately be revisited, and may consider this issue in a future proposal. Section 3.5502(d). A commenter suggests modifications to subsections (d) and (e) and a new subsection (f) to clarify provisions relating to termination of coverage on one joint debtor and the amount of refund. This commenter recommends including the phrases "voided ab initio" and "during the coverage term" in subsection (d), including the word "successfully" in (d)(1) for clarification and to enhance readability, and applying (d)(4) to death from any cause, not just suicide. The commenter believes that death of a joint insured should result only in termination of coverage on that joint insured as of the date of death, not retroactive to the effective date of coverage. The commenter believes that only the remaining (unearned) premium should be refunded in such an instance. Agency Response: The agency agrees with the inclusion of the word "successfully" and has made the change. The agency disagrees with the other suggested modifications. The term "termination" is appropriate for terminations either at the start of coverage or after the coverage commences. In addition, the reference to "termination" is consistent with other similar references in other adopted sections of Subchapter FF. Also, the addition of Latin terminology into the language might not be readily understood by the average insured debtor. The agency does not agree with substituting the more general term "death" in lieu of the current reference to "suicide." When a full death benefit is paid, the underlying indebtedness of the insured is repaid; therefore, the insurance coverage is required to be terminated (sec.3. 5103(9) requires that all insurance coverage shall terminate upon the discharge of the indebtedness). However, if one of the insureds commits suicide, no death benefit will be paid. The total indebtedness will only be partially repaid to the extent of the required refund of premium, as set forth in sec.3.5104 and subsection (e) of the proposed section. The agency believes that "other life exclusions" which require the same refund of premium yet pay no death benefit, as does suicide, should be included in the language and has made the change. The refund for joint credit life insurance, for other than open-end coverages, is to be computed as the gross premium charged for joint life coverage minus the gross premium that would have been charged if only single life coverage (on a single insured) had been provided at the time coverage was originally issued. For open-end coverage, the life refund is the total amount of joint credit life premium charged or collected since the date of death minus the single life rate that would have been charged if only single life coverage (on a single insured) had been provided. The agency disagrees that an alternative to providing a refund if the joint disability coverage was provided under the option where each debtor is insured for a portion of the total monthly benefit should be provided. The agency believes that adding such a provision at this time would require republication of the sections and will consider the issue for possible future rulemaking. A commenter suggests revision of the amount of premium refund in the event that termination of coverage occurs on a joint debtor due to suicide or other life exclusions would be appropriate. Agency Response: The agency agrees and has changed the section to reflect that the insurer is entitled to a portion of the joint disability premium for the period prior to the date of death due to suicide or other life exclusion and has included language to reflect the appropriate refund. The disability refund to be paid is in addition to any required life refund on the joint insured. For: Consumer Credit Insurance Association. For with changes: Consumers Union, CUNA Mutual Group, and Office of Public Insurance Counsel. Subchapter FF. Joint Credit Disability Coverage Presumptively Acceptable Relation of Credit Life Insurance Benefits t Premiums 28 TAC sec.3.5302 The amendment adopted under the authority of the Insurance Code, Articles 3.53, sec.12 and 1.03A. Article 3.53, sec.12 authorizes the Commissioner of Insurance to issue such rules and regulations as he deems appropriate for the supervision of The Model Act for the Regulation of Credit Life Insurance and Credit Accident and Health Insurance. Article 1.03A provides that the commissioner may adopt rules and regulations to execute the duties and functions of the department. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 20, 1996. TRD-9605917 Alicia M. Fechtel General Counsel and Chief Clerk Texas Department of Insurance Effective date: May 20, 1996 Proposal publication date: October 31, 1996 For further information, please call: (512) 463-6327 28 TAC sec.3.5502 The amendment adopted under the authority of the Insurance Code, Articles 3.53, sec.12 and 1.03A. Article 3.53, sec.12 authorizes the Commissioner of Insurance to issue such rules and regulations as he deems appropriate for the supervision of The Model Act for the Regulation of Credit Life Insurance and Credit Accident and Health Insurance. Article 1.03A provides that the commissioner may adopt rules and regulations to execute the duties and functions of the department. sec.3.5502. Joint Credit Accident and Health Insurance. (a) Joint debtors, for purposes of credit accident and health insurance written under Article 3.53, Texas Insurance Code, means only spouses or business partners, and such persons must be jointly and severally liable for repayment of the single indebtedness and be joint signers of the instrument of indebtedness. Endorsers and guarantors are not eligible for credit insurance coverage. Joint accident and health coverage shall not be written covering more than two debtors. (b) Coverage may be provided by either of the methods set forth in paragraphs (1) and (2) of this subsection: (1) each debtor is insured for 100% of the disability payment; (2) each debtor is insured for a portion of the disability payment. The total of the portions shall equal 100% of the disability payment. The joint disability insurance benefit cannot exceed the amount of insurance that would have been provided if coverage had been issued on a single debtor. (c) Joint disability coverage shall be evidenced by an individual policy or, in the case of group insurance, by a certificate of insurance. The form shall specify the amount of disability benefit to be provided on each debtor. The coverage shall not be provided by two single individual disability policies or by two single group disability certificates of insurance. Jointly indebted persons shall not both be covered separately at single accident and health rates. (d) Joint disability forms shall provide that if coverage on one of the joint debtors is terminated, the coverage on the other debtor shall be continued under a single individual disability policy or a single group disability certificate. Coverage may be terminated for any of the reasons stated in paragraphs (1) through (4) of this subsection: (1) the coverage is successfully contested; (2) the coverage was issued in error to a joint insured who exceeded the eligibility age limits and who correctly stated his age. Under these circumstances, the insurer has the right to terminate the portion of coverage provided on such insured as long as the adjustment is handled as set forth in subsection (b) of sec.3.5106 of this title (relating to Prohibited Provisions and Practices) addressing excess coverage; (3) coverage was issued in error to a joint insured who did not meet the eligibility employment requirements, if required, and who correctly stated his employment status in writing. Under these circumstances, the insurer has the right to terminate the portion of coverage provided on such insured as long as the adjustment is made as set forth in subsection (b) of sec.3.5106 of this title (relating to Prohibited Provisions and Practices) addressing excess coverage; (4) suicide or any other life exclusions, as set forth in the policy and/or certificate of insurance. (e) If termination occurs for any of the reasons set forth in subsection (d) (1)-(3) of this section, the amount of premium refund required will be equal to the difference between the premium charged for joint disability coverage and the premium that would have been charged if only single disability coverage (on a single insured) had been provided at the time the coverage was originally issued. If termination occurs for the reason set forth in subsection (d)(4) of this section, the amount of premium refund required will be equal to the unearned portion, at the date of death, of the premium charged for joint disability coverage minus the unearned portion, at the date of death, of the premium that would have been charged if only single disability coverage (on the single "surviving" insured) had been provided at the time the coverage was originally issued. The refund for joint disability coverage is to be paid in addition to the refund for joint life insurance coverage, in accordance with sec.3.5104(a)(2) of this title (relating to Benefits and Refunds), if joint life coverage was issued. (f) If a separate identifiable premium is charged for the joint disability coverage, and if joint coverage is desired by the debtors, each debtor must elect and sign for the joint coverage. (g) The maximum premiums to be charged for joint disability coverage when each debtor is insured for 100% of the disability payment must be equal to the amount set forth in the latest adopted presumptive premium rates for joint credit disability coverage. The maximum premiums to be charged for joint disability coverage when each debtor is insured for a portion of the disability payment, with the total of the portions equal to 100% of the disability payment, must be equal to the premium that would have been charged if 100% of the disability insurance amount was provided on a single life, as set forth in the latest adopted presumptive premium rates for single life credit disability coverage. (h) The annual experience data reports required under sec.3.5701 of this title (relating to Statistical Data and Annual Experience Calls) shall be submitted as follows: (1) if joint disability coverage is provided on each debtor for 100% of the disability payment, the experience data will be reported as joint disability coverage 1; (2) if joint disability coverage is provided on each debtor for a portion of the disability payment, with the total of the portions equal to 100%, the experience data will be reported as joint disability coverage 2. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 20, 1996. TRD-9605918 Alicia M. Fechtel General Counsel and Chief Clerk Texas Department of Insurance Effective date: May 20, 1996 Proposal publication date: October 31, 1996 For further information, please call: (512) 463-6327 TITLE 40. SOCIAL SERVICES AND ASSISTANCE Part I. Texas Department of Human Services Chapter 4. Medicaid Programs-Children and Pregnant Women Eligibility Requirements 40 TAC sec.4.1010 The Texas Department of Human Services (DHS) adopts an amendment to sec.4. 1010, without changes to the proposed text as published in the March 19, 1996, issue of the Texas Register (21 TexReg 2211). The justification for the amendment is to exercise an option under the Social Security Act that allows states the choice to use less restrictive income and resource methods than those used under the most closely related cash assistance programs. DHS proposes to exercise the option to allow a less restrictive income method of determining Medicaid eligibility for children and is amending rules and the Medicaid State Plan to reflect this change. The amendment will function by ensuring that the eligibility determination process will be streamlined, which will improve staff productivity. No comments were received regarding adoption of the amendment. The amendment is adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Government Code sec.531. 021, which provides the Health and Human Service Commission with the authority to administer federal medical assistance funds. The amendment implements the Human Resources Code sec. sec.22.001-22.030 and sec.sec.32.001-32.042. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 20, 1996. TRD-9605953 Glenn Scott General Counsel, Legal Services Texas Department of Human Services Effective date: May 21, 1996 Proposal publication date: March 19, 1996 For further information, please call: (512) 438-3765 Chapter 15. Medicaid Eligibility The Texas Department of Human Services (DHS) adopts the repeal of sec.15. 453; new sec.15.453 and sec.15.454; and an amendment to sec.15.475 without changes to the proposed text as published in the March 19, 1996, issue of the Texas Register (21 TexReg 2212). The justification for the repeal, amendment, and new sections is to include in the rules that DHS does not deem income or resources from an alien's sponsor in its long term care Medicaid programs. The amendment will function by ensuring that DHS will be in compliance with federal regulations. No comments were received by the department regarding adoption of the repeal, amendment, and new sections. Subchapter E. Income 40 TAC sec.15.453 The repeal is adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Government Code, sec.531. 021, which provides the Health and Human Services Commission with the authority to administer federal medical assistance funds. The repeal implements the Human Resources Code, sec.sec.22.001-22.030 and sec.sec.32.001-32.042. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 20, 1996. TRD-9605954 Glenn Scott General Counsel, Legal Services Texas Department of Human Services Effective date: June 1, 1996 Proposal publication date: March 19, 1996 For further information, please call: (512) 438-3765 40 TAC sec.sec.15.453, 15.454, 15.475 The new sections and amendment are adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Government Code, sec.531.021, which provides the Health and Human Services Commission with the authority to administer federal medical assistance funds. The new sections and amendment implement the Human Resources Code, sec.sec.22. 001-22.030 and sec.sec.32.001-32.042. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on April 20, 1996. TRD-9606109 Glenn Scott General Counsel, Legal Services Texas Department of Human Services Effective date: June 1, 1996 Proposal publication date: March 19, 1996 For further information, please call: (512) 438-3765