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 V. Texas Department of Commerce Chapter 186. Smart Jobs Fund Program Subchapter A. General Provisions 10 TAC sec.sec.186.101-186.104, 186.106 The Texas Department of Commerce adopts amendments to sec. sec.186.101-186.104 and new sec.186.106 of the Smart Jobs Fund Program rules, without changes to the proposed text as published in the June 23, 1995, issue of the Texas Register (20 TexReg 4525). Section 186.101, concerning Authority, adds a reference to the Texas Government Code, Chapter 2001, Subchapter B, Rulemaking. Section 186.102, concerning Purpose, clarifies that the Smart Jobs Fund was established as a business incentive program. Section 186.103, concerning Policy Board Monitoring, changes the monitoring of the program from a regular basis to a quarterly basis in order to be more specific about how often the Policy Board will monitor the program. Section 186.104, concerning Definitions, adds definitions for "emerging occupation" and "manufacturing occupation" since the new sec.186.106 and sec.186. 302 references these occupations. It also adds definitions for "skills" and "Smart Job" which were previously not defined and deletes the definitions for "labor market information" because it is not required in administering the program and "literacy skills" or "basic skills" because the definition is incorporated into the definition for "job-related basic skills." Changes to the definitions for "benefits", "competencies", "completed application", "contract", "existing job", "job-related basic skills", job-related occupational skills", "matching costs", "new job", "reimbursable costs", "subcontract", and "total project cost" clarifies those definitions. Section 186.106, concerning Modifications, specifies that a wage modification may be made by the executive director for small businesses and businesses with manufacturing and emerging occupations to reduce the 10% wage increase requirement for existing jobs to 5.0% within the limitations specified in the Smart Jobs Fund Act, sec.481.155(c). This change clarifies which businesses are eligible for a wage modification and what the modification is. No comments opposing the rule changes were received. Comments generally supportive of the rule changes in Subchapter A of the rules were received from the Bill J. Priest Institute for Economic Development. The amendments and new section are adopted under the authority of Texas Government Code, Subchapter J, sec.481.153, which requires the Texas Department of Commerce Policy Board to adopt rules to implement the Smart Jobs Fund Program; and the Administrative Procedure Act, Chapter 2001, Subchapter B, Rulemaking, Texas Government Code, which prescribes the standards for agency rulemaking. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 16, 1995. TRD-9510353 Michael Regan Chief Administrative Officer Texas Department of Commerce Effective date: September 6, 1995 Proposal publication date: June 23, 1995 For further information, please call: (512) 936-0178 Subchapter B. Methodologies for Determining Certain Variables 10 TAC sec.186.201 The Texas Department of Commerce adopts an amendment to sec.186.201 of the Smart Jobs Fund Program rules, without changes to the proposed text as published in the June 23, 1995, issue of the Texas Register (20 TexReg 4527). Section 186.201, concerning State Average Weekly Wage; Regional Variances, deletes the references to the Texas Employment Commission and refers instead to the Texas Workforce Commission as a result of the legislation passed in the 74th Legislative Session which abolishes the Texas Employment Commission and establishes the Texas Workforce Commission. A nonsubstantive grammatical change was also made. No comments were received in opposition to the adoption of the rule. Comments generally supportive of Subchapter B of the rules were received from the Bill J. Priest Institute for Economic Development. The amendment is adopted under the authority of Texas Government Code, Subchapter J, sec.481.153, which requires the Texas Department of Commerce Policy Board to adopt rules to implement the Smart Jobs Fund Program; and the Administrative Procedure Act, Chapter 2001, Subchapter B, Rulemaking, Texas Government Code, which prescribes the standards for agency rulemaking. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 16, 1995. TRD-9510354 Michael Regan Chief Administrative Officer Texas Department of Commerce Effective date: September 6, 1995 Proposal publication date: June 23, 1995 For further information, please call: (512) 936-0178 Subchapter C. Application for Grants 10 TAC sec.sec.186.301, 186.302, 186.304-186.308 The Texas Department of Commerce adopts amendments to sec. sec.186.301, 186. 302, and 186.304-186.308 of the Smart Jobs Fund Program rules, without changes to the proposed text as published in the June 23, 1995, issue of the Texas Register (20 TexReg 4527). Section 186.301, concerning Eligibility, provides that only businesses that have been in operation for at least one year, are financially sound and have fulfilled state tax obligations are eligible. The Smart Jobs Fund Act states that this program is job-driven and this will help ensure that businesses which are awarded a grant will be able to provide full-time employment to the trainees at the end of the training project. This section also limits the amount that large businesses may receive per trainee and limits the grant amount that a business may receive during a biennium in order to ensure statewide distribution of businesses receiving grants and availability of funds throughout the fiscal year. Section 186.302, concerning Application Requirements, clarifies sec.481.155 of the Smart Jobs Fund Act which enables businesses to secure training for emerging occupations and other occupations, especially manufacturing, within the limitations specified in this section. This section also clarifies that employee leasing firms are eligible to participate in an application, but are not eligible for a grant; clarifies that line item breakdown of costs needs to be included in the project budget, and that the number of hours each participant spends in training needs to be included in the business and training plan in order to ensure accountability of expenditures; enables businesses to specify up to four project periods for trainee and wage verification purposes related to the 90-day retention period; includes the geographic location of jobs in the business and training plan to ensure statewide distribution of grant awards; includes job descriptions in the business and training plan in order to assist in the classification of the occupation; clarifies the wage information that is needed for existing jobs; and clarifies that the line item breakdown of costs will become part of the contract if a grant is awarded. Section 481.155 also limits the grant amount for instructor and trainee travel and per diem in order to promote the prudent use of training resources; clarifies that administrative costs are limited to 10% of the costs related to direct training as stated in the Smart Jobs Fund Act; deletes the references to job analysis, task analysis, job development, childcare and public transportation under costs related to direct training since the majority of businesses are not requesting grant monies for these items and there is already a category for other such reasonable costs related to direct training; includes emerging and manufacturing occupations in the economic data that a business might provide since the new sec.186.106 references these occupations; clarifies how the matching cost is determined; clarifies that the executive director has 30 business days to act on the application after an application is complete; and makes other nonsubstantive grammatical changes. Section 186.304, concerning Application Packet; Review, deletes reference to proprietary information since it is already stated that the application will not contain unreasonable demands for information and deletes that the application and packet will be readable and understandable since this is assured through the annual review by the executive director and customer input. Section 186.305, concerning Funding; Contracts, now renamed "Funding; Grants" enables the executive director to award grants based on quarterly allocations of funds in order to ensure the availability of funds throughout the fiscal year. Section 186.306, concerning Funding Priorities, includes a scoring mechanism to ensure consistent evaluation of applications for funding based only on program objectives and priorities outlined in the Smart Jobs Fund Act and General Provisions and incorporates language required by Senate Bill 1180 passed by the 74th Legislative Session. Section 186.307, concerning Provider Eligibility, deletes the word "program" after Smart Jobs Fund as it is not necessary. Section 186.308, concerning Contracts, now renamed "Contracts and Contract Amendments", outlines an amendment process, simplifies the contract process and attrition rate, and clarifies the retention and verification of trainees and the reimbursement of the 25% of the grant amount that is withheld by the department for 90 days after the training is complete. Written comments were received from the Bill J. Priest Institute for Economic Development, Dallas County Community College District. Although generally supportive of the changes to the rules, they requested that the Texas Department of Commerce leave "job and task analysis" in the Smart Jobs Fund application budget page. No changes are being made to the rules as a result of this comment. Section 186.302 deletes the reference to job and task analysis since there is already a category for other such reasonable costs related to direct training to the extent that if the Department determines that job and task analysis are reasonable training costs in an application, such costs may be allowed under sec.186.302. "Job and task analysis" will still be included in the Smart Jobs Fund application budget page as requested by the Bill J. Priest Institute for Economic Development. The amendments are adopted under the authority of Texas Government Code, Subchapter J, sec.481.153, which requires the Texas Department of Commerce Policy Board to adopt rules to implement the Smart Jobs Fund Program; and the Administrative Procedure Act, Chapter 2001, Subchapter B, Rulemaking, Texas Government Code, which prescribes the standards for agency rulemaking. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 16, 1995. TRD-9510355 Michael Regan Chief Administrative Officer Texas Department of Commerce Effective date: September 6, 1995 Proposal publication date: June 23, 1995 For further information, please call: (512) 936-0178 TITLE 22. EXAMINING BOARDS Part XXIV. Texas Board of Veterinary Medical Examiners Chapter 573. Rules of Professional Conduct Responsibilities to Clients 22 TAC sec.573.67 The Texas Board of Veterinary Medical Examiners adopts the repeal of sec.573.67, concerning Temporary Suspensions, and simultaneously adopting a new rule with the same number entitled Temporary License Suspensions. The proposed text is published in the June 27, 1995, issue of the Texas Register (20 TexReg 4620). The new rule provides the Board with detailed guidelines to be followed when temporarily suspending a licensee. The repeal is necessary because the current rule does not provide the public with adequate notice of the Board's procedures when placing a licensee on temporary suspension. No comments were received regarding adoption of the repeal. The repeal is adopted under the authority of the Veterinary Licensing Act, sec.7(a), Texas Civil Statutes, Article 8890, which state "The Board may make, alter, or amend such rules and regulations as may be necessary or desirable to carry into effect the provisions of this Act." The repeal relates to the Veterinary Licensing Act, sec.14C, Texas Civil Statutes, Article 8890, which provide the Board with the authority to temporarily suspend a license if continued practice by a licensee constitutes a continuing or imminent threat to the public welfare. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 14, 1995. TRD-9510357 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: September 6, 1995 Proposal publication date: June 27, 1995 For further information, please call: (512) 447-1183 The Texas Board of Veterinary Medical Examiners adopts new sec.573.67, concerning Temporary Suspensions, with changes to the proposed text as published in the June 27, 1995, issue of the Texas Register (20 TexReg 4620). Changes made to the previously published version are limited to correction of statutory cites, including reference to an amendment to the Open Meetings Act. The new rule replaces the current rule and provides for a more detailed explanation of the process to be followed by the Board when ordering a temporary suspension of a license. The adopted amendments are necessary because the Board believes the previous rule did not provide the public with adequate notice of the procedures to be followed by the Board. It is in the public interest to establish adequate procedures to allow the Board to immediately suspend a veterinary licensee when a continuing or imminent threat to the public welfare exists. Ellis Gilleland commented that he supports the concept of this rule but feels it will be ineffectual since it does not prohibit attorneys asking for continuances, thereby nullifying the purpose of the rule. The Board has no authority to prevent counsel from requesting continuances. The new section is adopted under the authority of the Veterinary Licensing Act, sec.7(a), Texas Civil Statutes, Article 8890, which state "The Board may make, alter, or amend such rules and regulations as may be necessary or desirable to carry into effect the provisions of this Act." The new section relates to the Veterinary Licensing Act, sec.14C, Texas Civil Statutes, Article 8890, which provide the Board with the authority to temporarily suspend a license if continued practice by a licensee constitutes a continuing or imminent threat to the public welfare. sec.573.67. Temporary License Suspensions. (a) In accordance with the Act, sec.14C, the president of the board shall appoint a three-member executive disciplinary committee consisting of the president, the Board secretary and one public member, for the purpose of determining whether a person's license to practice veterinary medicine in this state should be temporarily suspended under this section. (b) If the executive disciplinary committee determines from the evidence or information presented to it that a person licensed to practice veterinary medicine in this state would constitute a continuing or imminent threat to the public welfare by his/her continuation in practice, the executive disciplinary committee shall temporarily suspend the license of that person. (c) A license may be suspended under this section without notice or a hearing on the complaint, provided the Board's enforcement committee (established pursuant to the Act, sec.18F and sec.575.27(c)) shall meet within 14 days of the date of suspension to determine if formal disciplinary proceedings should be initiated against the licensee. The licensee must be notified of this meeting pursuant to Administrative Procedures Act (APA), sec.2001.051. Determination by the enforcement committee that a violation of the Act or Board rules has occurred and a complaint should be formally docketed will result in a hearing pursuant to subsection (d) of this section. A determination by the enforcement committee that no violation of the Act or Board rules occurred will result in the suspended license being reinstated. A proposed licensee will result in the suspended license being reinstated subject to the terms of the proposed settlement. (d) Docketing of a formal complaint by the enforcement committee will result in an administrative hearing pursuant to the APA within 60 days of the date the suspension was ordered. If this hearing is not held within the 60-day period for any reason other than the licensee's delay, the suspended license is automatically reinstated. (e) Pursuant to the Open Meetings Act, Government Code, sec.551.125, the executive disciplinary committee may hold a meeting by telephone conference call if immediate action is required and the convening at one location of the executive disciplinary committee is inconvenient for any member of the executive disciplinary committee. (f) In the event of the recusal of a executive disciplinary committee member, or the inability of a panel member to attend a temporary suspension proceeding, an alternate executive disciplinary committee member may serve on the panel if previously appointed by the president, acting president, or presiding officer of the board, and approved by the board. (g) To the extent practicable, in the discretion of the chairman or acting chairman of the executive disciplinary committee, the sequence of events will be as follows: (1) Call to order; (2) Roll call; (3) Calling of the case; (4) Recusal statement; (5) Introductions/appearances on the record; (6) Presentation of the case; (7) Deliberations; (8) Announcement of decision; and (9) Adjournment. (h) Witnesses may provide sworn statements in writing or verbally or choose to provide statements which are not sworn for consideration by the executive disciplinary committee or the enforcement committee under this rule. However, whether or not a statement is sworn may be a factor to be considered by the executive disciplinary committee or the enforcement committee in evaluating the weight to be given to the statement. Questioning of witnesses by the parties or panel members shall be at the discretion of the chairman or acting chairman of the executive disciplinary committee, or the Board secretary at a meeting of the enforcement committee, with due consideration being given to the need to obtain accurate information and prevent the harassment or undue embarrassment of witnesses. (i) Presentations by the parties may be based on evidence or information and shall not be excluded on objection of a party unless determined by the chairman or acting chairman of the executive disciplinary committee, or the Board secretary at a meeting of the enforcement committee, that the evidence or information is clearly irrelevant or unduly inflammatory in nature; however, objections by a party may be noted for the record. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 14, 1995. TRD-9510358 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: September 6, 1995 Proposal publication date: June 27, 1995 For further information, please call: (512) 447-1183 Chapter 577. General Administration and Duties Staff and Miscellaneous 22 TAC sec.577.15 The Texas Board of Veterinary Medical Examiners adopts an amendment to sec.575.15, concerning Fee Schedule, without changes to the proposed text as published in the June 27, 1995, issue of the Texas Register (20 TexReg 4622). The section sets out the fees charged for examinations, license renewals, open records, and mailing lists and labels. The adopted amendment is necessary because: legislation passed during the 74th legislative session exempts examinations administered by the Board from the $200 professional fee previously charged, which lowers the cost for the State Board Examination and an increase in fees charged to the Board for the National Examinations requires increases in the fees charged for these examinations. No comments were received regarding adoption of the amendment. The amendment is adopted under the authority of the Veterinary Licensing Act, sec.7(a), Texas Civil Statutes, Article 8890, which state "The Board may make, alter, or amend such rules and regulations as may be necessary or desirable to carry into effect the provisions of this Act." The amendment relates to the Veterinary Licensing Act, sec.19(a), Texas Civil Statutes, Article 8890, which mandate that the Board, by rule, establish reasonable and necessary fees to produce sufficient revenue to cover the costs of administering the Act. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 14, 1995. TRD-9510359 Ron Allen Executive Director Texas Board of Veterinary Medical Examiners Effective date: September 6, 1995 Proposal publication date: June 27, 1995 For further information, please call: (512) 447-1183 TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 289. Radiation Control Texas Regulations for the Control of Radiation The Texas Department of Health (department) adopts the repeal of existing sec.289.121 and new sec.289.252, concerning licensing of radioactive material. New sec.289.252 is adopted with changes to the proposed text as published in the April 18, 1995, issue of the Texas Register (20 TexReg 2785). The repeal is adopted as proposed. The new section incorporates language from Part 41 titled "Licensing of Radioactive Material" of the Texas Regulations for the Control of Radiation (TRCR), which was adopted by reference in sec.289.121 which is now being repealed. In addition to incorporating existing language into the new section, requirements were included for licensees to report to the department incidents involving events that prevent immediate protective actions necessary to avoid exposures to or releases of radioactive materials that could exceed regulatory limits and to clarify the requirements for the amounts of financial assurance needed for decommissioning based upon the quantity of radioactive material possessed. An option was added for required supervised clinical experience for certain medical uses of radioactive material to be obtained under an authorized physician in a medical teaching institution that also provides appropriate training programs that have been accredited by the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. The section was clarified to specify the classroom and laboratory training initiated before the effective date of the section and completed two years from the effective date of the section will be accepted if obtained in an accredited medical school, a federal teaching hospital, or a training program for medical use of radioactive material that has been accepted by the department, NRC, or another agreement state. A provision was added to allow the department to accept alternative training if it provides an equal or greater level of training than that specified and clarifies the types of supervised clinical experience required for unspecified radiopharmaceuticals for therapeutic treatment. These additional requirements are items of compatibility with the United States Nuclear Regulatory Commission (NRC) and as an agreement state, Texas must adopt them. The following paragraph is a summary of all changes made to the proposed new section. The language in subsection (d)(7) was deleted and replaced with the words "Each application shall be accompanied by TRC Form 12-2." to more accurately reflect the intent of the section and the contents of TRC Form 12-2. In subsections (h)(4)(A)(ii)(II) and (h)(12)(A)(ii), the words "calendar quarter" were deleted and replaced with "year" to reflect the current radiation protection standards. In subsection (h)(4)(C), the words "calendar quarter" were replaced with "annual" for the same reason. The wording in subsection (u) (1), (2), and (3) was changed from "Each applicant for a specific license..." to "The applicant for each specific license..." to clarify that financial assurance is required for each licensed facility rather for each licensee. The wording in subsection (v)(1) was changed to "An application for each specific license..." for the same reason. Certification by the American Osteopathic Board of Nuclear Medicine was added to subsection (w)(5)(A)(i)(I)(-e-), (w)(5) (B)(i)(I)(-e), (w)(5)(C)(i)(I)(-e-), and (w)(5)(F)(i)(I)(-e-) because this board requires essentially the same qualifications as the American Board of Nuclear Medicine. Radiology was added to subsection (w)(5)(C)(i)(I)(-c-) to more accurately reflect the intent of the section. In subsection (w)(5)(B)(ii), the acronym ACCME was replaced by ACGME to correct an error. Diagnostic radiology was deleted from subsection (w)(5)(C)(i)(I)(-c-) to more accurately reflect the intent of the section. The term "radiation oncology" was added to subsection (w)(5)(F)(i)(I)(-a-) and (w)(5)(G)(i)(I)(-a-) to more accurately reflect the intent of the rule. The terms "Therapeutic radiology" and "radiology" were added to subsection (w)(5)(G)(i)(I)(-b-) to more accurately reflect the intent of the section. In subsection (w)(5)(H), the date of September 1, 1993 was returned to the section and the words "...and those issued by the agency before (the effective date of this section)..." were added to more accurately reflect the intent of this "grandfather" clause in the section. Throughout subsection (w)(5), the references to the Committee on Postdoctoral Training of the American Osteopathic Association (CPTAOA) were changed to the Council on Postdoctoral Training of the American Osteopathic Association (COPT-AOA). This was done because the Texas Osteopathic Medical Association clarified that the COPT-AOA approves residency programs. In subsection (w)(5)(A)(iii) and (w)(5)(B)(iv), the wording "...after providing the Medical Committee of the Texas Radiation Advisory Board with the opportunity to review and comment..." was added. The following are the comments made concerning the proposed section and the department's responses to those comments. Comment. The commenter stated that the requirements of subsection (r) concerning notification of incidents and the requirements in 21.1202 of Texas Regulations for Control of Radiation Part 21 as adopted by reference in sec.289. 113 concerning notification of incidents are different. The commenter stated that to have two reporting procedures in the same chapter that are stated differently could cause confusion as to what is required and suggested that the two requirements read the same or only be referenced once (see subsection (r)). Response. Subsection (r) and 21.1202 of TRCR Part 21 as adopted by reference in sec.289.113 of this title refer to different types of incidents, and therefore different reporting requirements. TRCR 21.1202 refers to incidents in which an individual receives a dose in excess of the stated limits or a release of radioactive material such that, if an individual were present, that individual could receive a dose in excess of the stated limits. The incidents referred to in subsection (r) are unplanned contamination events, equipment failures, fire, explosion, etc. and these are required to be reported under certain stated conditions. The department made no change to the section as a result of the comment. Comment. A commenter stated that the proposed wording in subsection (w)(5) (A)(ii) opens the possibility for any physician to train on the medical uses of radioactive material. The commenter noted that most university programs are ACGME-accredited and therefore the section is not clear. For example, an ophthalmologist who is an authorized user and is working in a university in an ACGME-accredited program could train on the use of radioactive material. The commenter recommends rewording the subsection to read, "...or by an authorized nuclear physician in an ACGME-accredited medical teaching institution (see subsection (w)(5)(A)(ii))." Response. The intent of the section is to ensure an adequate level of training in radiation safety practices by those individuals authorized to use radioactive materials. Upon recommendation of the Texas Radiation Advisory Board in 1993, the language in the section was clarified to reflect this intent. The language in the section has been further revised to provide a clearer description of this intent. The section contains language agreed upon by members of the Texas Radiation Advisory Board, the American College of Cardiology, and the Texas Radiological Society. In addition, when a user is authorized by the department on a radioactive materials license, it is for a specific use and therefore, those individuals can preceptor only for the specific use for which they are authorized. The department made no change to the section as a result of the comment. Comment. Six commenters expressed opposition to the proposed subsection (w) (5)(B). One of the commenters stated that limiting preceptors to associations with residency programs is paramount to placing the preceptor under the control of the academic radiologist who is neither qualified or experienced in cardiology, and in fact, cannot even perform the cardiac portion of the procedure. This commenter recommends that all physicians, regardless of their board standing, be required to document their actual training and the validity of their preceptor. Another commenter stated that any cardiologist who has completed the 200 hours of didactic work currently required for radioactive licensing, and who has a preceptorship letter documenting 500 hours of clinical experience and 500 hours of work experience should be allowed to interpret their own nuclear scans. Another commenter noted that the subject matter specified for the required 200 hours of classroom and laboratory training has not changed, but the requirements in subsection (w)(5)(B)(iii) would make a program that had been previously accepted by the department not acceptable after two years from the effective date of the rule, unless approved under the provisions of subsection (w)(5)(B)(iv). This commenter suggested deleting the timeframe encompassing training that was initiated before the effective date of the section and completed by two years from the effective date of the section, so that a training program that had been previously accepted by the department will still be accepted automatically without having to be approved under the provisions of subsection (w)(5)(B)(iv). This commenter also suggested that programs accredited by the American Council of Education be accepted because this would still allow the department the assurance that training has been approved by an independent organization. One commenter recommended deleting any reference to the Accreditation Council for Continuing Medical Education (ACCME) as it approves only providers of the programs and not the continuing education programs themselves, that the Accreditation Council for Graduate Medical (ACGME) be deleted, and that the American Board of Nuclear Cardiology be added to the list of acceptable certifications. This commenter also requested that the department postpone any changes to the section until the magnitude of safety problems is evaluated by an independent investigator, and minimum training standards for all physicians can be established based upon objective criteria and established need for change based upon safety issues. In addition, this commenter requested that an investigation be conducted by the department and the NRC into the adequacy of residency training programs in radiology and provide the commenter with actual physician names for investigation. Two of the commenters in opposition to the section requested that the comment period be extended to allow additional comments, including those from physicians outside of Texas (see subsection (w) (5)(B)). Response. The intent of the section is to ensure an adequate level of training in radiation safety practices by those individuals authorized to use radioactive materials. Upon recommendation of the Texas Radiation Advisory Board in 1993, the language in the section was clarified to reflect this intent. The language in the section has been further revised to provide a clear description of this intent. The section contains language agreed upon by members of the Texas Radiation Advisory Board, the American College of Cardiology, and the Texas Radiological Society, and allows for cardiologists who are authorized users to preceptor other cardiologists for clinical training in an ACGME-accredited facility. The proposed section was appropriately noticed in the Texas Register as required by the Administrative Procedures Act and the department believes that adequate time has been provided for comment on the proposed section as well as during the draft rulemaking stage, and therefore is not extending the comment period. The reference to the ACCME was a typographical error. The correct reference should be to the ACGME and the final section will reflect that correction. The Texas Radiation Advisory Board has advised the department that ACGME-accredited residency programs in radiology do provide the training outlined in the proposed section. The department made no change to the section as a result of the comments. Comment. The commenter requested that in the subparagraphs relating to physician certification in nuclear medicine, the American Osteopathic Board of Nuclear Medicine (AOBNM) also be included as a certifying body. The AOBNM requires specific residency training in nuclear medicine or a residency in radiology, pathology, or internal medicine with a fellowship in nuclear medicine and includes an examination that consists of both a written and oral test of the candidate's nuclear medicine imaging skills. These training and examination requirements are very similar to those of the American Board of Nuclear Medicine (see subsection (w)(5)). Response. The department agrees and has added the reference to the AOBNM to the appropriate subparagraphs of the section. Comment. Eight commenters expressed support of the proposed subsection (w) (5)(B). One of the commenters stated that this section modification will ensure that qualified cardiologists will not be wrongly prevented from certifying trainees in nuclear cardiology and that it is in the best interest of the public and cardiac patients that qualified cardiologists be allowed to continue to be authorized single-organ users and also be allowed to certify the clinical training of trainees in nuclear cardiology (see subsection (w)(5) (B)). Response. The department acknowledged the commenters' remarks. Comment. A commenter suggested that the wording in subsection (w)(5)(B)(i) (II)(-d-) be changed to read, "...training in all topics identified in (w)(5) (B)(i)(II)(-a-), which is not a part of a residency program as in subsection (w)(5)(B)(i)(II)(-d-), shall be obtained in a teaching program that provides appropriate training that has been accredited by ACGME or CPTOA." The commenter believes that this change would allow physicians in-training the option to obtain classroom training in an ACGME or CPTOA accredited program other than at medical teaching institutions. This provides an option for physicians training in cardiovascular medicine who may be unable to attend classroom training in the medical teaching institution where they are receiving other components of their training due to the inability to accommodate them in residency training programs that are run by the radiology department (see subsection (w)(5)(B)(i)(II)(-d-)). Response. The intent of the section is to ensure an adequate level and appropriateness of training in radiation safety practices by those individuals authorized to use radioactive materials. The department made no change to the section as a result of the comment. Comment. A commenter requested that the words "NRC, or another agreement state..." be deleted from subsection (w)(5)(B)(iii). The commenter also recommended adding the words "...after providing the Texas Radiation Advisory Board with the opportunity to review and comment..." to subsection (w)(5)(A) (iii) and (w)(5)(B)(iv) (see subsection (w)(5)(B)(iii) and (iv)). Response. The provisions in subsection (w)(5)(B)(iii) provide for a "grandfathering" of certain classroom and laboratory training within a specified timeframe. The department believes this should include training approved by the NRC or another agreement state. The department added the wording "...after providing the Medical Committee of the Texas Radiation Advisory Board with the opportunity to review and comment..." to subsections (w)(5)(A)(iii) and (w)(5)(B)(iv). Representative from Ludlum Measurements, Inc. in Sweetwater; the University of Texas Medical Branch at Galveston in Galveston; the American College of Cardiology in Bethesda, Maryland; the University of Texas Houston Health Science Center in Houston; the American College of Radiology in Reston, Virginia; the American Society of Nuclear Cardiology in Bethesda, Maryland; the Texas Radiological Society in Austin; Baylor College of Medicine in Houston; Austin Cardiovascular Association in Austin; and an individual were in favor of the new section, however, they presented comments and suggestions for changes to the proposed new section as discussed in the summary of comments. Representatives from Cardiovascular Consultants of Vincennes, P.C. in Vincennes, Indiana; Pasadena Internal Medicine and Cardiology in Pasadena; the American Association of Nuclear Cardiology, Inc. in Boulder, Colorado; the Institute for Nuclear Medicine Education in Boulder, Colorado; and an individual were opposed to the new section and presented comments and suggestions for changes to the proposed new section as previously discussed. 25 TAC sec.289.121 The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the 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 rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510251 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 458-7236 License Regulations 25 TAC sec.289.252 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the 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.289.252. Licensing of Radioactive Material. (a) Purpose. This section and sec.289.115 of this title (relating to Radiation Safety, Requirements and Licensing and Registration Procedures for Industrial Radiography), sec.289.127 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), sec.289.251 of this title (relating to Exemptions, General Licenses, and General License Acknowledgements), and sec.289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities) provide for the licensing of radioactive material. Unless otherwise exempted, no person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a specific license issued in accordance with this section, or as otherwise provided in this section, in a specific license issued in accordance with sec. sec.289.115, 289.127, or 289.254 of this title, or in a general license or general license acknowledgement issued in accordance with sec.289.251 of this title. (b) Scope. In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of sec.289.112 of this title (relating to Hearing and Enforcement Procedures), sec.289.113 of this title (relating to Standards for Protection Against Radiation), and sec.289.114 of this title (relating to Notices, Instructions, and Reports to Workers), sec.289.126 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), and sec.289.201 of this title (relating to General Provisions). Licensees engaged in industrial radiographic operations are subject to the requirements of sec.289.115 of this title; licensees using sealed sources in the healing arts are subject to the requirements of sec.289.117 of this title (relating to Use of Sealed Radioactive Sources in the Healing Arts); and licensees engaged in well logging service operations and tracer studies are subject to the requirements of sec.289.120 of this title (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies). (c) Types of licenses. Licenses for radioactive materials are of two types: general and specific. (1) General licenses provided in sec.289.251 of this title are effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons, although the filing of an application for acknowledgement with the agency may be required by the particular general license. The general licensee is subject to any other applicable portions of this chapter and any limitations of the general license. (2) Specific licenses require the submission of an application to the agency and the issuance of a licensing document by the agency. The licensee is subject to all applicable portions of this chapter as well as any limitations specified in the licensing document. (d) Filing application for specific licenses. (1) Applications for specific licenses shall be filed in duplicate on a form prescribed by the agency. (2) The agency may, at any time after the filing of the original application and before issuance of the license, require further statements in order to enable the agency to determine whether the application should be granted or denied. (3) Each application shall be signed by the applicant or licensee, or a person duly authorized to act for and on the applicant's or licensee's behalf. (4) An application for a license may include a request for a license authorizing one or more activities. The agency may require the issuance of separate specific licenses for those activities. (5) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with sec.289. 201(n) of this title. The agency may also request additional information after the license has been issued to enable the agency to determine whether the license should be modified or revoked. (6) Each application for a specific license, other than a license exempted from sec.289.126 of this title, shall be accompanied by the fee prescribed in 12.21 of Texas Regulations for Control of Radiation (TRCR) Part 12 as adopted by reference in sec.289.126 of this title. (7) Each application shall be accompanied by TRC Form 12-2. (8) Applications for licenses shall be processed in accordance with the following time periods. (A) The first period is the time from receipt of an application by the Division of Licensing, Registration and Standards to the date of issuance or denial of the license or a written notice outlining why the application is incomplete or unacceptable. This time period is 60 days. (B) The second period is the time from receipt of the last item necessary to complete the application to the date of issuance or denial of the license. This time period is 30 days. (C) These time periods are exclusive of any time period incident to hearings and post-hearing activities required by the Government Code, Chapters 2001 and 2002. (9) Notwithstanding the provisions of 12.11(a) of TRCR Part 12 as adopted by reference in sec.289.126 of this title, reimbursement of application fees may be granted in the following manner. (A) In the event the application is not processed in the time periods as stated in paragraph (8) of this subsection, the applicant has the right to request of the director of the Radiation Control Program full reimbursement of all application fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied. (B) Good cause for exceeding the period established is considered to exist if: (i) the number of applications for licenses to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year; (ii) another public or private entity utilized in the application process caused the delay; or (iii) other conditions existed giving good cause for exceeding the established periods. (C) If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed in accordance with the formal hearing procedures of the Texas Department of Health, sec.sec.1.21-1.34 of this title (relating to Formal Hearing Procedures). (e) General requirements for the issuance of specific licenses. A license application will be approved if the agency determines that: (1) the applicant and all personnel who will be handling the radioactive material are qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this chapter in such a manner as to minimize danger to public health and safety or the environment; (2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or the environment; (3) the issuance of the license will not be inimical to the health and safety of the public; (4) the applicant satisfies any applicable special requirement in this section; (5) the radiation safety information submitted for requested sealed source(s) or device(s) containing radioactive material is in accordance with subsection (i) of this section; (6) qualifications of the designated radiation safety officer (RSO) as specified in subsection (g) of this section are adequate for the purpose requested in the application; (7) the applicant submits an adequate operating, safety, and emergency procedures manual; (8) the applicant's permanent facility is located in Texas (if the applicant's permanent facility is not located in Texas, reciprocal recognition must be sought as required by subsection (s) of this section); and (9) all personnel who will be handling radioactive material have adequate training and experience in the handling of radioactive material. (f) Special requirements for issuance of certain specific licenses for radioactive material by specific groups. (1) Human use of radioactive material. In addition to the requirements set forth in subsection (e) of this section, a specific license for human use of radioactive material will be issued if: (A) the applicant possesses adequate facilities for the clinical care of patients; (B) the physician designated on the application as the individual user has completed the training and experience requirements in subsection (w)(5) of this section as applicable; (C) the application is for a license authorizing unspecified forms and/or multiple types of radioactive material for medical research, diagnosis and therapy, (i.e., a broad medical license); and (D) the agency determines that: (i) the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses; (ii) the applicant has committee that includes adequate professional and technical representation from multiple applicable medical specialties. Representatives on this committee should include authorized users from each specialty using radioactive material (including research, diagnostic, and therapeutic uses), technical staff from each specialty, a senior administrative representative, representation from affected nursing staff, and other special services that may be affected (E.R., O.R., I.C.U., etc.) and the RSO; and (iii) a full-time RSO and/or staff has been appointed. (2) Specific licenses for medical uses of radioactive material. (A) Subject to the provisions of subparagraphs (B), (C), and (D) of this paragraph, an application for a specific license in accordance with paragraph (1) of this subsection for any medical use or uses of radioactive material specified in one or more of Groups I, II, and III, defined in subsection (w)(2) of this section, will be approved for all of the medical uses within the group or groups, that include the use or uses as specified in the application, if: (i) the applicant satisfies the requirements of paragraph (1) of this subsection and the requirements of this paragraph; (ii) the applicant, or the physician designated in the application as the individual user, has completed the training and experience requirements in subsection (w)(5) of this section as applicable; (iii) the applicant or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups; (iv) the applicant's radiation detection and measuring instrumentation is appropriate for conducting the procedures involved in the uses included in the group or groups; and (v) the applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups. (B) Any licensee who is authorized to use one or more of the medical use groups of radioactive material in accordance with subparagraph (A) of this paragraph and subsection (w)(2) of this section is subject to the following conditions. (i) For Groups I and II of subsection (w)(2) of this section, no licensee shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged, and distributed in accordance with a specific license issued by the agency in accordance with subsection (h)(10) of this section or by the commission, another agreement state, or a licensing state. (ii) For Group III of subsection (w)(2) of this section, no licensee shall receive, possess, or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except: (I) reagent kits not containing radioactive material that are approved by the agency, the commission, an agreement state, or a licensing state for use by persons licensed in accordance with this paragraph and subsection (w)(2) of this section or equivalent regulations; and (II) generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the agency in accordance with subsection (h)(11) of this section or a specific license issued by the commission, an agreement state, or a licensing state in accordance with equivalent regulations. (iii) For Group III of subsection (w)(2) of this section, any licensee who uses generators or reagent kits shall: (I) elute the generator or process radioactive material with the reagent kit in accordance with instructions that are approved by the agency, the commission, an agreement state, or a licensing state, and furnished by the manufacturer on the label attached to or in the leaflet or brochure that accompanies the generator or reagent kit; (II) before administration to patients, cause each elution or extraction of technetium-99m from a molybdenum-99/technetium-99m generator to be tested to determine either the total molybdenum-99 activity or the concentration of molybdenum-99. This testing shall be conducted according to written procedures and by personnel who have been specifically trained to perform the test; (III) prohibit the administration to patients of technetium-99m containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m; and (IV) maintain for three years for agency inspection records of the molybdenum- 99 test conducted on each elution from the generator. (iv) Except as specified in subparagraph (G) of this paragraph, for uses of radioactive material within Groups I, II, and III of subsection (w)(2) of this section, the licensee shall comply with the product labeling (package insert) specifications and recommendations. (v) For Groups I, II, and III of subsection (w)(2) of this section, any licensee using radioactive material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding: (I) chemical and physical form; (II) route of administration; and (III) dosage range. (C) Any licensee who is licensed in accordance with subparagraph (A) of this paragraph for one or more of the medical use groups in subsection (w)(2) of this section is also authorized to use radioactive material in accordance with the general license in sec.289.251(j)(2) of this title for the specified in vitro uses without filing an application for acknowledgement with the agency as required by sec.289.251(j)(2)(B) of this title; provided the licensee is subject to the other provisions of sec.289.251(j)(2) of this title. (D) Any licensee who is licensed in accordance with subparagraph (A) of this paragraph for one or more of the medical use groups in subsection (w)(2) of this section is also authorized, subject to the provisions of this subparagraph and subparagraph (E) of this paragraph, to receive, possess, and use for calibration and reference standards: (i) any radioactive material listed in Group I, II, or III of subsection (w)(2) of this section with a half-life not longer than 100 days, in amounts not to exceed 15 millicuries total; (ii) any radioactive material listed in Group I, II, or III of subsection (w)(2) of this section with half-life greater than 100 days in amounts not to exceed 200 microcuries total; (iii) technetium-99m in amounts not to exceed 30 millicuries; and (iv) any radioactive material, in amounts not to exceed 6 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the agency in accordance with subsection (h)(7) of this section, a specific license issued by the commission in accordance with 10 Code of Federal Regulations (CFR) 32.74, or a specific license issued to the manufacturer by an agreement state or a licensing state in accordance with equivalent regulations. (E) Any licensee or registrant who possesses and uses calibration and reference sources in accordance with subparagraph (D)(iv) of this paragraph shall: (i) follow the radiation safety and handling instructions approved by the agency, the commission, an agreement state, or a licensing state, and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and (ii) conduct a physical inventory at intervals not to exceed six months to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the agency and shall include the quantities and kinds of radioactive material, source identification numbers, location of sources, and the date of the inventory. (F) The use of gases, gas solutions, and aerosols shall be specifically requested in a license application. (G) In addition to the requirements set forth in subsection (e) of this section, an application for a specific license to prepare and dispense radiopharmaceuticals for human use will be approved if the nuclear pharmacist designated in the application as the individual user has completed the training and experience requirements specified in the rules of the Texas State Board of Pharmacy, contained in Title 22, Texas Administrative Code sec.291.52. Nuclear pharmacists identified as authorized users on a nuclear pharmacy license issued by the agency in accordance with paragraph (2) of this subsection before September 1, 1994, need not comply with the training and experience requirements specified in this section. (H) Any licensee who processes and prepares radiopharmaceuticals for human use shall do so according to: (i) instructions that are approved by the agency, the commission, an agreement state, or a licensing state that are furnished by the manufacturer on the label attached to a generator or reagent kit, or contained in the accompanying leaflet or brochure; (ii) procedures approved by the agency; or (iii) the provisions of the practice of pharmacy, as recognized by the Texas State Board of Pharmacy, by an authorized nuclear pharmacist. (I) If the authorized nuclear pharmacist elutes generators or processes radioactive material with the reagent kit in a manner that deviates from instructions furnished by the manufacturer on the label attached to the generator or reagent kit or in the accompanying leaflet or brochure, a complete description of the deviation shall be made and maintained for inspection by the agency for a period of three years. (3) Release of patients containing radiopharmaceuticals, temporary implants, or permanent implants. (A) Any individual to whom more than 30 millicuries of a radiopharmaceutical is administered shall be confined to an agency-approved inpatient facility and shall not be released from confinement until the activity of the administered radiopharmaceutical in the patient is less than 30 millicuries, or until the measured dose rate from the patient is less than 5 millirems per hour at a distance of 1 meter. (B) Immediately after removing the last temporary implant source or retraction of a source(s) from a remote control brachytherapy device at the conclusion of treatment, and before the patient is released from the therapy room, the licensee shall perform a radiation survey of the patient with an appropriate survey instrument. The licensee shall not release from confinement for medical care a patient treated by temporary implant or remote control brachytherapy device until all sources have been removed. (C) Any individual containing permanent implant sources shall remain hospitalized and shall not be released from confinement until the exposure rate from the patient is less than 6 milliroengtens per hour at a distance of 1 meter from the implant location. (4) Records and reports of misadministrations. (A) When a misadministration involves any therapy procedure, the licensee shall notify the agency. The licensee shall also notify the referring physician of the affected patient and the patient or a responsible relative or guardian, unless the referring physician agrees to inform the patient or believes, based on medical judgment, that telling the patient or the patient's responsible relative or guardian would be harmful to one or the other, respectively. These notifications must be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this. (B) Within 15 days after an initial therapy misadministration report to the agency, the licensee shall report, in writing, to the agency and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative or guardian if either was previously notified by the licensee as required by subparagraph (A) of this paragraph. The written report must include the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative or guardian, and if not, why not. The report to the agency must not include the patient's name or other information that could lead to identification of the patient. (C) When a misadministration involves a diagnostic procedure, the RSO shall promptly investigate its cause, make a record for agency review, and retain the record in accordance with subparagraph (D) of this paragraph. The licensee shall also notify the referring physician and the agency in writing within 15 days if the misadministration involved the use of radioactive material not intended for medical use, administration of dosage five-fold different from the intended dosage, or misadministration of radioactive material such that the patient is likely to receive an individual organ dose greater than 50 rems dose equivalent or a whole body dose greater than 5 rems effective dose equivalent. Licensees may use dosimetry tables in package inserts, corrected only for amount of radioactivity administered, to determine whether a report is required. (D) Each licensee shall retain a record of each misadministration for 10 years. The record must contain the name of all individuals involved in the event, including the physician, allied health personnel, the patient, and the patient's referring physician; the patient's social security number or identification number if one has been assigned; a brief description of the event; the effect on the patient; and the action taken, if any, to prevent recurrence. (E) Aside from the notification requirement, nothing in subparagraphs (A)-(D) of this paragraph shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives, or guardians. (5) Use of sealed sources in industrial radiography. In addition to the requirements set forth in subsection (e) of this section, a specific license for use of sealed sources in industrial radiography will be issued if the applicant submits to the agency the items in accordance with sec.289.115 of this title. (6) Multiple quantities or types of radioactive material for use in research and development. (A) In addition to the requirements set forth in subsection (e) of this section, a specific license for multiple quantities or types of radioactive material for use in research and development (i.e., a broad license), not to include the internal or external administration of radiation or radioactive material to humans, will be issued only if each item below is adequately addressed: (i) the applicant's staff has substantial experience in the use of a variety of radioisotopes for a variety of research and development uses; (ii) the applicant has established a radiation safety committee (composed of such persons as an RSO, a representative of senior management, and one or more persons trained or experienced in the safe use of radioactive materials) that will review and approve proposals for such uses in advance of purchase of radioisotopes; (iii) the applicant has with subsection (g) of this section; (iv) the applicant has a full-time RSO and/or staff; and (v) the applicant submits the names and qualifications of the committee and designated RSO. (B) Unless specifically authorized, persons licensed according to subparagraph (A) of this paragraph shall not conduct tracer studies involving direct release of radioactive material to the environment. (C) Unless specifically authorized, in accordance with a separate license, persons licensed according to subparagraph (A) of this paragraph shall not: (i) receive, acquire, own, possess, use, or transfer devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials; (ii) conduct activities for which a specific license issued by the agency in accordance with subsection (h) of this section and sec.289.115, sec.289.127, and sec.289.254 of this title is required; (iii) add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being; or (iv) commercially distribute radioactive material. (g) Radiation safety officer. (1) An RSO shall be designated for every license issued by the agency. (2) The RSO's documented qualifications shall include as a minimum: (A) possession of a high school diploma or a certificate of high school equivalency based on the GED test; (B) completion of the training and testing requirements specified in this chapter for the activities for which the license application is submitted; and (C) training and experience necessary to supervise the radiation safety aspects of the licensed activity. (3) The specific duties of the RSO include, but are not limited to, the following: (A) to establish and oversee operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and to review them at least annually to ensure that the procedures are current and conform with this chapter; (B) to oversee and approve all phases of the training program for operations and/or personnel so that appropriate and effective radiation protection practices are taught; (C) to ensure that required radiation surveys and leak tests are performed and documented in accordance with this chapter, including any corrective measures when levels of radiation exceed established limits; (D) to ensure that personnel monitoring is used properly by occupationally- exposed personnel, that records are kept of the monitoring results, and that timely notifications are made in accordance with sec.289.114 of this title; (E) to investigate and cause a report to be submitted to the agency for each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this chapter and each theft or loss of source(s) of radiation, to determine the cause(s), and to take steps to prevent a recurrence; (F) to investigate and cause a report to be submitted to the agency for each known or suspected case of release of radioactive material(s) to the environment in excess of limits established by this chapter; (G) to have a thorough knowledge of management policies and administrative procedures of the licensee; (H) to assume control and have the authority to institute corrective actions, including shutdown of operations when necessary in emergency situations or unsafe conditions; (I) to ensure that records are maintained as required by this chapter; (J) to ensure the proper storing, labeling, transport, and use of sources of radiation, storage, and/or transport containers; (K) to ensure that inventories are performed in accordance with the activities for which the license application is submitted; and (L) to ensure that personnel are complying with this chapter, the conditions of the license, and the operating, safety, and emergency procedures of the licensee. (h) Special requirements for a specific license to manufacture, assemble, repair, or commercially distribute commodities, products, or devices that contain radioactive material. (1) Introduction of radioactive material into products in exempt concentrations. (A) In addition to the requirements set forth in subsection (e) of this section, a specific license authorizing the introduction of radioactive material into a product or material in the possession of the licensee or another to be transferred to persons exempt from this chapter in accordance with sec.289.251(d)(1)(A) of this title will be issued if: (i) the applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and (ii) the applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in sec.289.251(q)(1) of this title, that reconcentration of the radioactive material in concentrations exceeding those in sec.289.251(q)(1) of this title is not likely, that the use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human. (B) Each person licensed in accordance with this paragraph shall file with the agency an annual report that identifies the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material when the radioactive material was introduced; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made in accordance with this paragraph during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter. (2) Commercial distribution of radioactive material in exempt quantities. (A) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555. (B) In addition to the requirements set forth in subsection (e) of this section, an application for a specific license to distribute naturally occurring or accelerator-produced radioactive material (NARM) to persons exempt from this chapter in accordance with sec.289.251(d)(2) of this title will be approved if: (i) the radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human; (ii) the radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and (iii) the applicant submits copies of prototype labels and brochures and the agency approves such labels and brochures. (C) The license issued in accordance with subparagraph (B) of this paragraph is subject to the following conditions. (i) No more than 10 exempt quantities shall be sold or commercially distributed in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity. (ii) Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any other package for commercial distribution to persons exempt from this chapter in accordance with sec.289.251(d)(2) of this title. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour. (iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that: (I) identifies the radionuclide and the quantity of radioactivity; and (II) bears the words "Radioactive Material." (iv) In addition to the labeling information required by clause (iii) of this subparagraph, the label affixed to the immediate container, or an accompanying brochure, shall: (I) state that the contents are exempt from the commission, agreement state, or licensing state requirements; (II) bear the words "Radioactive Material-Not for Human Use- Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited-Exempt Quantities Should Not Be Combined"; and (III) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material. (D) Each person licensed in accordance with this paragraph shall maintain records identifying, by name and address, each person to whom radioactive material is commercially distributed for use in accordance with sec.289.251(d)(2) of this title or the equivalent regulations of an agreement state or a licensing state, and stating the kinds and quantities of radioactive material commercially distributed. An annual summary report stating the total quantity of each radionuclide commercially distributed in accordance with the specific license shall be filed with the agency. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no commercial distributions of radioactive material have been made in accordance with this paragraph during the reporting period, the report shall so indicate. (3) Incorporation of NARM into gas and aerosol detectors. In addition to the requirements set forth in subsection (e) of this section, an application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt from this chapter in accordance with sec.289.251(d)(3)(C) of this title will be approved if the application satisfies requirements equivalent to those contained in 10 CFR 32.26. The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie. (4) Licensing the manufacture and commercial distribution of devices to persons generally licensed in accordance with sec.289.251(j)(1) of this title. (A) An application for a specific license to manufacture or commercially distribute devices containing radioactive material to persons generally licensed in accordance with sec.289.251(g)(1)(C) and (j)(1) of this title or equivalent regulations of the commission, an agreement state, or a licensing state will be approved if: (i) the applicant satisfies the general requirements of subsection (e) of this section; (ii) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: (I) the device can be safely operated by persons not having training in radiological protection; (II) under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one year a dose in excess of 10% of the limits specified in 21.201 of TRCR Part 21 as adopted by reference in sec.289.113 of this title; and (III) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses: (-a-) 15 rems to the whole body; head and trunk; active blood-forming organs; gonads; or lens of eye; (-b-) 200 rems to the hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter; or (-c-) 50 rems to other organs; (iii) each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement: (I) instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information); (II) the requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and (III) the information called for in one of the following statements, as appropriate, in the same or substantially similar form: (-a-) For radioactive materials other than NARM, the following statement is appropriate: Figure 1: 25 TAC sec.289.252(h)(4)(A)(iii)(III)(-a-) (-b-) For NARM, the following statement is appropriate: Figure 2: 25 TAC sec.289.252(h)(4)(A)(iii)(III)(-b-) (-c-) The model, serial number, and name of manufacturer or distributor may be omitted from this label provided they are elsewhere stated in labeling affixed to the device. (B) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that have a significant bearing on the probability or consequences of radioactive material leakage from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for radioactive material leakage, the agency will consider information that includes, but is not limited to: (i) primary containment (source capsule); (ii) protection of primary containment; (iii) method of sealing containment; (iv) containment construction materials; (v) form of contained radioactive material; (vi) maximum temperature withstood during prototype tests; (vii) maximum pressure withstood during prototype tests; (viii) maximum quantity of contained radioactive material; (ix) radiotoxicity of contained radioactive material; and (x) operating experience with identical devices or similarly designed and constructed devices. (C) In the event the applicant desires that the general licensee in accordance with sec.289.251(g)(1)(C) and (j)(1) of this title or in accordance with equivalent regulations of the commission, an agreement state, or a licensing state be authorized to mount the device, collect the sample to be analyzed by a specific licensee for radioactive material leakage, perform maintenance of the device consisting of replacement of labels, rust and corrosion prevention, and for fixed gauges, repair and maintenance of source holder mounting brackets, test the "on-off" mechanism and indicator, device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated annual doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices in accordance with the general license, is unlikely to cause that individual to receive an annual dose in excess of 10% of the limits specified in 21.201 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. (D) Each person licensed in accordance with this subparagraph to commercially distribute devices to generally licensed persons shall: (i) furnish a copy of the general license in sec.289.251(g)(1)(C) and (j)(1) of this title to each person to whom the licensee directly or through an intermediate person commercially distributes radioactive material in a device for use in accordance with the general license in sec.289.251(g)(1) (C) and (j)(1) of this title; (ii) furnish a copy of the general license in the commission's, agreement state's, or licensing state's regulation equivalent to sec.289.251(g) (1)(C) and (j)(1) of this title, or alternatively, furnish a copy of the general license in sec.289.251 (g)(1)(C) and (j)(1) of this title to each person to whom the licensee directly or through an intermediate person commercially distributes radioactive material in a device for use in accordance with the general license of the commission, the agreement state, or the licensing state. If a copy of the general license in sec.289.251(g)(1)(C) and (j)(1) of this title is furnished to such a person, it shall be accompanied by an explanation that the use of the device is regulated by the commission, agreement state, or licensing state in accordance with requirements substantially the same as those in sec.289.251(g)(1)(C) and (j)(1) of this title; (iii) report to the agency all commercial distributions of such devices to persons for use in accordance with the general license in sec.289. 251(g)(1)(C) and (j)(1) of this title, or equivalent regulations of another agreement state or licensing state. Such report shall identify each general licensee by name and address, an individual by name and/or position who of contact between the agency and the general licensee, the type, model, serial number of device and serial number of source commercially distributed, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall also include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no commercial distributions have been made to persons generally licensed in accordance with sec.289.251(g)(1)(C) and (j)(1) of this title during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter; (iv) report to the commission all commercial distributions of such devices to persons for use in accordance with the commission general license in 10 CFR 31.5; (v) report to the appropriate agreement state or licensing state all transfers of devices manufactured and commercially distributed in accordance with this paragraph for use in accordance with a general license in that state's regulations equivalent to sec.289.251(g)(1)(C) and (j)(1) of this title; (vi) identify in such reports each general licensee by name and address, an individual by name and/or position who may contact between the agency and the general licensee, the type, model, serial number of the device and serial number of source commercially distributed, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall also include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is commercially distributed to the generally licensed person; (vii) report to the commission information indicating no commercial distributions have been made to the commission licensees during the reporting period if no such commercial distributions have been made; and (viii) keep records showing the name, address, and for each general licensee to whom the licensee directly or through an intermediate person commercially distributes radioactive material in devices for use in accordance with the general license provided in sec.289.251(g)(1)(C) and (j)(1) of this title, or equivalent regulations of the commission, an agreement state, or a licensing state. The records should show the date of each commercial distribution, the isotope and the quantity of radioactivity in each device commercially distributed, the identity of any intermediate person, and compliance with the reporting requirements of this subparagraph. (5) Special requirements for the manufacture, assembly, or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for commercial distribution to persons generally licensed in accordance with sec.289.251(g)(4) of this title, will be approved subject to the following conditions: (A) the applicant satisfies the general requirements specified in subsection (e) of this section; and (B) the applicant satisfies the requirements of 10 CFR 32.53, 32.54, 32. 55, 32.56, and 32.101 or their equivalent. (6) Special requirements for license to manufacture calibration sources containing americium-241, plutonium, or radium-226 for commercial distribution to persons generally licensed in accordance with sec.289.251(g)(6) of this title. An application for a specific license to manufacture calibration sources containing americium-241, plutonium, or radium-226 to persons generally licensed in accordance with sec.289.251(g)(6) of this title will be approved subject to the following conditions: (A) the applicant satisfies the general requirement of subsection (e) of this section; and (B) the applicant satisfies the requirements of 10 CFR 32.57, 32.58, 32. 59, and 32.102 and 10 CFR 70.39 or their equivalent. (7) Manufacture and commercial distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and commercially distribute sources and devices containing radioactive material to persons licensed for use of sealed sources in the healing arts or in accordance with subsection (f)(2) of this section for use as a calibration or reference source will be approved if: (A) the applicant satisfies the general requirements in subsection (e) of this section; (B) the applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: (i) the radioactive material contained, its chemical and physical form, and amount; (ii) details of design and construction of the source or device; (iii) procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents; (iv) for devices containing radioactive material, the radiation profile of a prototype device; (v) details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (vi) procedures and standards for calibrating sources and devices; and (vii) instructions for handling and storing the source or device from the radiation are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device, provided that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label; (C) the label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the name of the source or device is licensed by the agency for commercial distribution to persons licensed for use of sealed sources in the healing arts or in accordance with subsection (f)(2) of this section or equivalent licenses of the commission, an agreement state, or a licensing state, provided that such labeling for sources that do not require long-term storage may be on a leaflet or brochure that accompanies the source; (D) in the event the applicant desires that the source or device be required to be tested for radioactive material leakage at intervals longer than six months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of radioactive material leakage from the source; and (E) in determining the acceptable interval for testing radioactive material leakage, the agency will consider information that includes, but is not limited to: (i) primary containment or source capsule; (ii) protection of primary containment; (iii) method of sealing containment; (iv) containment construction materials; (v) form of contained radioactive material; (vi) maximum temperature withstood during prototype tests; (vii) maximum pressure withstood during prototype tests; (viii) maximum quantity of contained radioactive material; (ix) radiotoxicity of contained radioactive material; and (x) operating experience with identical sources or devices or similarly designed and constructed sources or devices. (8) Manufacture and commercial distribution of radioactive material for certain in vitro clinical or laboratory testing in accordance with the general license. An application for a specific license to manufacture or commercially distribute radioactive material for use in accordance with the general license in sec.289.251(j)(2) of this title will be approved if: (A) the applicant satisfies the general requirements specified in subsection (e) of this section; (B) the radioactive material is to be prepared for distribution in prepackaged units of: (i) iodine-125 in units not exceeding 10 microcuries each; (ii) iodine-131 in units not exceeding 10 microcuries each; (iii) carbon-14 in units not exceeding 10 microcuries each; (iv) hydrogen-3 (tritium) in units not exceeding 50 microcuries each; (v) iron-59 in units not exceeding 20 microcuries each; (vi) cobalt-57 in units not exceeding 10 microcuries each; (vii) selenium-75 in units not exceeding 10 microcuries each; or (viii) mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; (C) each prepackaged unit bears a durable, clearly visible label: (i) identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3 (tritium); 20 microcuries of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium- 241; and (ii) displaying the radiation caution symbol in accordance with 21. 901(a) and (b) of TRCR Part 21 as adopted by reference in sec.289.113 of this title and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals"; (D) one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package: (i) option 1: Figure 3: 25 TAC sec.289.252(h)(8)(D)(i) (ii) option 2: Figure 4: 25 TAC sec.289.252(h)(8)(D)(ii) (E) the label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of a mock iodine- 125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements of 21.1001 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. (9) Licensing the manufacture and commercial distribution of ice detection devices. An application for a specific license to manufacture and commercially distribute ice detection devices to persons generally licensed in accordance with sec.289.251(g)(8) of this title will be approved subject to the following conditions: (A) the applicant satisfies the general requirements of subsection (e) of this section; and (B) the criteria of 10 CFR 32.61, 32.62, and 32.103 are met. (10) Manufacture and commercial distribution of radiopharmaceuticals containing radioactive material for medical use in accordance with group licenses. (A) An application for a specific license to manufacture and commercially distribute radiopharmaceuticals containing radioactive material for use by persons licensed in accordance with subsection (f)(2) of this section for the medical uses listed in Groups I and II defined in subsection (w)(2) of this section will be approved if: (i) the applicant satisfies the general requirements specified in subsection (e) of this section; (ii) the applicant submits evidence that: (I) the radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) or a product license application (PLA) approved by the United States Food and Drug Administration (FDA), or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA; or (II) the manufacture and commercial distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; (iii) the applicant submits information on: (I) the radionuclide, chemical and physical form; (II) packaging including maximum activity per package; and (III) shielding provided by the packaging of the radioactive material that is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and (iv) the label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay; and (v) the label affixed to each package, or the leaflet or brochure that accompanies each package, contains a statement that the radiopharmaceutical is licensed by the agency for commercial distribution to persons licensed in accordance with subsection (f)(2) of this section and for medical uses listed in Groups I and II defined in subsection (w)(2) of this section, as appropriate, or in accordance with equivalent licenses of the commission, an agreement state, or a licensing state. (B) The labels, leaflets, or brochures required by this paragraph are in addition to the labeling required by the FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. (11) Manufacture and commercial distribution of generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material. (A) An application for a specific license to manufacture and commercially distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed in accordance with subsection (f)(2) of this section for the medical uses listed in Group III defined in subsection (w)(2) of this section will be approved if: (i) the applicant satisfies the general requirements specified in subsection (e) of this section; (ii) the applicant submits evidence that: (I) the generator or reagent kit is to be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a NDA or a PLA approved by the FDA, or a IND that has been accepted by the FDA; or (II) the manufacture and commercial distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; (iii) the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit; (iv) the label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of the assay; and (v) the label affixed to the generator or reagent kit, or the leaflet or brochure that accompanies the generator or reagent kit contains: (I) adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit; and (II) a statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the agency in accordance with subsection (f)(2) of this section and for the medical uses listed in Group III defined in subsection (w)(2) of this section or in accordance with equivalent licenses of the commission, an agreement state, or a licensing state. (B) The labels, leaflets, or brochures required by this paragraph are in addition to the labeling required by FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. (C) Although the agency does not regulate the manufacture and commercial distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have the reagent kits approved by the agency for use by persons licensed in accordance with subsection (f)(2) of this section and for the medical uses in Group III defined in subsection (w)(2) of this section should submit the pertinent information specified in this paragraph. (12) Manufacture and commercial distribution of products containing depleted uranium for mass-volume applications. (A) An application for a specific license to manufacture products and devices containing depleted uranium for use in accordance with sec.289.251(f)(5) of this title or equivalent regulations of the commission or an agreement state, will be approved if: (i) the applicant satisfies the general requirements specified in subsection (e) of this section; (ii) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the product or device to provide reasonable assurance that possession, use, or commercial distribution of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one year a radiation dose in excess of 10% of the limits specified in 21.201 of TRCR Part 21 as adopted by reference in sec.289.113 of this title; and (iii) the applicant submits sufficient information regarding the product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device. (B) In the case of a product or device whose unique benefits are questionable, the agency will approve an application for a specific license in accordance with this paragraph only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment. (C) The agency may deny any application for a specific license in accordance with this paragraph if the end use(s) of the product or device cannot be reasonably foreseen. (D) Each person licensed in accordance with subparagraph (A) of this paragraph shall: (i) maintain the level of quality control required by the license in the manufacture of the product or device, and in the installation of the depleted uranium into the product or device; (ii) label or mark each unit to: (I) identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device, and (II) state that the receipt, possession, use, and commercial distribution of the product or device are subject to a general license or the equivalent and the regulations of the commission or of an agreement state; (iii) assure that before being installed in each product or device, the depleted uranium has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium"; (iv) furnish a copy of the general license in: (I) sec.289.251(f)(5) of this title to each person to whom the licensee commercially distributes depleted uranium in a product or device for use in accordance with the general license in sec.289.251(f)(5) of this title, or (II) the commission's or agreement state's regulation equivalent to the general license in sec.289.251(f)(5) of this title and a copy of the commission's or agreement state's certificate, or alternatively, furnish a copy of the general license in sec.289.251(f)(5) of this title to each person to whom the licensee commercially distributes depleted uranium in a product or device for use in accordance with the general license of the commission or an agreement state; (v) report to the agency all commercial distributions of products or devices to persons for use in accordance with the general license in sec.289. 251(f)(5) of this title. Such report shall identify each general licensee by name and address, an individual by name and/or position who of contact between the agency and the general licensee, the type and model number of device commercially distributed, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is commercially distributed to the generally licensed person. If no commercial distributions have been made to persons generally licensed in accordance with sec.289.251(f)(5) of this title during the reporting period, the report shall so indicate; (vi) report to the commission and each responsible agreement state agency all commercial distributions of industrial products or devices to persons for use in accordance with the general license in the commission's or agreement state's equivalent rule to sec.289.251(f)(5) of this title. Such report shall meet the provisions of clause (v) of this subparagraph; and (vii) keep records showing the name, address, and each general licensee to whom the licensee commercially distributes depleted uranium in products or devices for use in accordance with the general license provided in sec.289.251(f)(5) of this title or equivalent regulations of the commission or of an agreement state. The records shall be maintained for a period of two years and shall show the date of each commercial distribution, the quantity of depleted uranium in each product or device commercially distributed, and compliance with the report requirements of this section. (13) Processing of loose radioactive material for manufacture and commercial distribution. An application to process loose radioactive material for manufacture and commercial distribution of radioactive material to persons authorized to possess such radioactive material in accordance with this chapter will be approved if: (A) the applicant satisfies the general requirements specified in subsection (e) of this section; (B) the applicant submits sufficient information relating to the radionuclides to be used, including the chemical and/or physical form and the maximum activity of each radionuclide; (C) the applicant submits sufficient information relating to the intended use of each radionuclide and the sealed sources and/or other products to be manufactured that includes: (i) receipt of radioactive material; (ii) chemical or physical preparations; (iii) sealed source construction; (iv) final assembly or processing; (v) quality assurance testing; (vi) quality control program; (vii) leak testing; (viii) American National Standard (ANSI) testing procedures; (ix) transportation containers; and (x) shipping procedures; (D) the applicant submits information related to the facility(ies) scaled drawings to include, but not limited to: (i) air filtration; (ii) ventilation system; (iii) plumbing; and (iv) radioactive material handling systems and, when applicable, remote handling hot cells; (E) the applicant submits details of the environmental monitoring program; (F) the applicant submits documentation of training as specified in subsection (w)(1) of this section for all personnel who will be handling radioactive materials; and (G) the applicant submits the name and qualifications of the full-time RSO as specified in subsection (g) of this section. (14) Other manufacture and commercial distribution of radioactive material. An application to manufacture and commercially distribute radioactive material to persons authorized to possess such radioactive material in accordance with this chapter will be approved if: (A) the applicant satisfies the general requirements specified in subsection (e) of this section; (B) the applicant submits sufficient information relating to the radionuclides to be used, including the chemical and/or physical form and the maximum activity of each radionuclide; (C) the applicant submits sufficient information relating to the intended use of each radionuclide and the sealed sources and/or other products to be manufactured that includes: (i) receipt of radioactive material; (ii) chemical or physical preparations; (iii) sealed source construction; (iv) final assembly or processing; (v) quality assurance testing; (vi) quality control program; (vii) leak testing; (viii) ANSI testing procedures; (ix) transportation containers; and (x) shipping procedures; (D) the applicant submits scaled drawings of radioactive material handling systems; (E) the applicant submits documentation of training as specified in subsection (w)(1) of this section for all personnel who will be handling radioactive material; and (F) the applicant submits the name and qualifications of the full-time RSO as specified in subsection (g) of this section. (i) Sealed source or device evaluation. No sealed source or device containing radioactive material shall be authorized on a specific license or general license until radiation safety information for that sealed source or device has been evaluated by the agency, the commission, another agreement state, or a licensing state. (1) Any manufacturer or initial distributor of a sealed source or device containing a sealed source licensed by the agency shall submit a request to the agency for evaluation of radiation safety information about the sealed source or device containing a sealed source. (2) The request for review shall be submitted in duplicate. (3) The request for review shall contain sufficient information about the sealed source or device to include: (A) the radioactive material contained, its chemical and physical form, and amount; (B) details of design and construction; (C) procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents; (D) details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (E) labeling; (F) proposed uses; and (G) procedures for leak testing. (4) For a device containing radioactive material, the request shall also contain sufficient information about the device to include: (A) the radiation profile of a prototype device; (B) method of installation; (C) service and maintenance requirements; and (D) operating and safety instructions. (5) After review of the request, the agency may issue an evaluation documenting the information in paragraph (3) of this subsection for sealed sources and paragraph (4) of this subsection for devices containing radioactive material. (6) The manufacturer/distributor submitting the request for evaluation of the safety information about the product shall manufacture and distribute the product in accordance with: (A) the statements and representations contained in the request; (B) documentation required to support the request; and (C) the provisions of the evaluation. (j) Issuance of specific licenses. (1) Upon a determination that an application meets the requirements of the Act and the rules of the agency, the agency will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. (2) The agency may incorporate in any license at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this section as it deems appropriate or necessary in order to: (A) minimize danger to public health and safety or the environment; (B) require such reports and the keeping of such records, and to provide for such inspections of activities in accordance with the license as may be appropriate or necessary; and (C) prevent loss or theft of material subject to this section. (k) Specific terms and conditions of licenses. (1) Each license issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to applicable rules and orders of the agency. (2) No license issued or granted in accordance with this section and no right to possess or utilize radioactive material granted by any license issued in accordance with this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency shall, after securing full information, find that the transfer is in accordance with the provisions of the Act, now or hereafter in effect, and to applicable rules and orders of the agency, and shall give its consent in writing. (3) Each person licensed by the agency in accordance with this section shall confine use and possession of the material licensed to the locations and purposes authorized in the license. (4) Each licensee shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy in accordance with any Chapters of Title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against: (A) a licensee; (B) an entity, as that term is defined in 11 U.S.C. 101(14), controlling a licensee or listing the license or licensee as property of the estate; or (C) an affiliate, as that term is defined in 11 U.S.C. 101(2), of the licensee. (5) The notification in paragraph (4) of this subsection must indicate: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the date of the filing of the petition. (l) Expiration and termination of licenses. (1) Except as provided in paragraph (6) of this subsection and subsection (m)(2) of this section, each specific license expires at the end of the day, in the month and year stated in the license. (2) Each licensee shall notify the agency within 30 days, in writing, and request termination of the license when the licensee decides to terminate all activities involving materials authorized in accordance with the license. This notification and request for termination of the license must include a written commitment to submit reports and information specified in paragraph (4) (C) of this subsection and a plan for completion of decommissioning if required by paragraph (7)(A) of this subsection or by license condition no less than 60 days after date of decision to terminate. The licensee is subject to the provisions of paragraphs (4) and (7) of this subsection, as applicable. (3) No less than 30 days before the expiration date indicated in a specific license, the licensee shall either: (A) submit an application for license renewal in accordance with subsection (m) of this section; or (B) notify the agency in writing, in accordance with paragraph (2) of this subsection, if the licensee decides to discontinue all activities involving radioactive material. (4) If a licensee does not submit an application for license renewal in accordance with subsection (m) of this section, the licensee shall on or before the expiration date specified in the license: (A) terminate use of radioactive material; (B) properly dispose of radioactive material; (C) submit a record of disposal of radioactive material and radiation survey(s) of the licensee's permanent location(s) of use and/or storage. Levels of radiation shall be reported in units as required by 21.1302 and 21. 1303 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. The survey or measurement instrument(s) used for conducting the survey shall be specified; and (D) pay any outstanding fees in accordance with sec.289.126 of this title and resolve any outstanding notices of violations of this chapter or of license conditions. (5) If no radiation attributable to activities conducted in accordance with the license is detected, the licensee shall submit a certification that no detectable radioactive contamination of the location(s) was found. If the information submitted in accordance with this paragraph and paragraph (4)(C) of this subsection is adequate, the agency will notify the licensee in writing that the license is terminated. (6) If radiation levels or radioactive material in excess of the limits of 21.1302 or 21.1303 of TRCR Part 21 as adopted by reference in sec.289.113 of this title are found, the license continues in effect beyond the expiration date, if necessary, with respect to possession of residual radioactive material until the agency notifies the licensee in writing that the license is terminated. During this time, the licensee is subject to the provisions of paragraph (13) of this subsection. In addition to the information submitted in accordance with paragraph (4)(C) of this subsection, the licensee shall submit a plan, if appropriate, for decontaminating the location(s). (7) If the licensee does not submit an application for license renewal in accordance with subsection (m) of this section, in addition to the information required in accordance with paragraph (4)(C) of this subsection, the licensee shall submit a plan for completion of decommissioning if the procedures necessary to carry out decommissioning have not been previously approved by the agency and could increase potential health and safety impacts to workers or to the public such as in any of the following cases: (A) procedures would involve techniques not applied routinely during cleanup or maintenance operations; (B) workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; (C) procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or (D) procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation. (8) Procedures with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan by the agency. (9) The proposed decommissioning plan, if required by paragraph (7) of this subsection or by license condition, must include: (A) a description of planned decommissioning activities; (B) a description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning; (C) a description of the planned final radiation survey; and (D) an updated, detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning. (10) The proposed decommissioning plan will be approved by the agency if the information therein demonstrates that the decommissioning will be completed as soon as is reasonable and that the health and safety of workers and the public will be adequately protected. (11) Upon approval of the decommissioning plan by the agency, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall again submit the information required in paragraph (4)(C) of this subsection. (12) If the information submitted in accordance with paragraphs (4)(C) or (11) of this subsection does not adequately demonstrate that the premises are suitable for release for unrestricted use, the agency will inform the license of the appropriate further actions required for termination of license. (13) Each licensee who possesses residual radioactive material in accordance with paragraph (6) of this subsection, following the expiration date specified in the license, shall: (A) be limited to actions, involving radioactive material, related to preparing the location(s) for release for unrestricted use; and (B) continue to control entry to restricted areas until the location(s) are suitable for release for unrestricted use and the agency notifies the licensee in writing that the license is terminated. (14) Each licensee shall submit to the agency all records required by 21.1103(b) of TRCR Part 21 as adopted by reference in sec.289.113 of this title before the license is terminated. (m) Renewal of license. (1) Requests for renewal of specific licenses shall be filed in accordance with subsection (d) of this section. (2) In any case in which a licensee, not less than 30 days prior to expiration of an existing license, has filed a request in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the request has been finally determined by the agency. (n) Amendment of licenses at request of licensee. (1) Requests for amendment of a license shall be filed in accordance with subsection (d) of this section and shall specify the respects in which the licensee desires a license to be amended and the grounds for such amendment. (2) Requests for amendments to delete a subsite from a license shall be filed in accordance with subsections (d), (l)(4) and (l)(7) of this section. (o) Agency action on requests to renew or amend. In considering a request by a licensee to renew or amend a license, the agency will apply the criteria set forth in subsections (e) and (f). (p) Transfer of material. (1) No licensee shall transfer radioactive material except as authorized in accordance with this chapter. (2) Except as otherwise provided in a license and subject to the provisions of paragraphs (3) and (4) of this subsection, any licensee may transfer radioactive material: (A) to the agency (A licensee may transfer material to the agency only after receiving prior approval from the agency.); (B) to the United States Department of Energy (DOE); (C) to any person exempt from this section to the extent permitted in accordance with such exemption; (D) to any person authorized to receive such material in accordance with the terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the agency, the commission, any agreement state, or any licensing state, or to any person otherwise authorized to receive such material by the Federal government or any agency thereof, the agency, any agreement state, or any licensing state; or (E) as otherwise authorized by the agency in writing. (3) Before transferring radioactive material to a specific licensee of the agency, the commission, an agreement state, or a licensing state, or to a general licensee who is required to register with the agency, the commission, an agreement state, or a licensing state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. (4) The following methods for the verification required by paragraph (3) of this subsection are acceptable. (A) The transferor may possess and have read a current copy of the transferee's specific license or certificate of registration. (B) The transferor may possess a written certification by the transferee that the transferee is authorized by the license or certificate of registration to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or certificate of registration number, issuing agency, and expiration date. (C) For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or certificate of registration to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or certificate of registration number, issuing agency, and expiration date, provided that the oral certification is confirmed in writing within 10 days. (D) The transferor may obtain other sources of information compiled by a reporting service from official records of the agency, the commission, or the licensing agency of an agreement state or a licensing state as to the identity of licensees and the scope and expiration dates of licenses and registrations. (E) When none of the methods of verification described in subparagraphs (A)- (D) of this paragraph are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to- date, the transferor may obtain and record confirmation from the agency, the commission, or the licensing agency of an agreement state or a licensing state that the transferee is licensed to receive the radioactive material. (5) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of subsection (t) of this section. (q) Modification and revocation of licenses. (1) The terms and conditions of all licenses shall be subject to amendment, revision, or modification. A license may be suspended or revoked by reason of amendments to the Act, or by reason of rules and orders issued by the agency. (2) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required in accordance with provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a license on an original application, or for violation of, or failure to observe applicable terms and conditions of the Act, or of the license, or of any rule or order of the agency. (3) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements. (r) Notification of incidents. (1) Immediate report. Each licensee shall notify the agency as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radioactive materials that could exceed regulatory limits or releases of radioactive materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). (2) Twenty-four hour report. Each licensee shall notify the agency within 24 hours after the discovery of any of the following events involving radioactive material: (A) an unplanned contamination event that: (i) requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (ii) involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix 21-B of TRCR Part 21 as adopted by reference in sec.289.113 of this title for the material; and (iii) has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination. (B) an event in which equipment is disabled or fails to function as designed when: (i) the equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (ii) the equipment is required to be available and operable when it is disabled or fails to function; and (iii) no redundant equipment is available and operable to perform the required safety function. (C) an event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; or (D) an unplanned fire or explosion damaging any radioactive material or any device, container, or equipment containing radioactive material when: (i) the quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix 21-B of TRCR Part 21 as adopted by reference in sec.289.113 of this title for the material; and (ii) the damage affects the integrity of the radioactive material or its container. (3) Preparation and submission of reports. Reports made by licensees in response to the requirements of paragraphs (1) and (2) of this subsection shall be made as follows. (A) Licensees shall make reports required by paragraphs (1) and (2) of this subsection by telephone to the agency. To the extent that the information is available at the time of notification, the information provided in these reports shall include: (i) the caller's name and call back telephone number; (ii) a description of the event, including date and time; (iii) the exact location of the event; (iv) the isotopes, quantities, and chemical and physical form of the radioactive material involved; and (v) any personnel radiation exposure data available. (B) Each licensee who makes a report required by paragraphs (1) and (2) of this subsection shall submit to the agency a written follow-up report within 30 days of the initial report. Written reports prepared in accordance with other requirements of this chapter submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. The reports must include the following: (i) a description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (ii) the exact location of the event; (iii) the isotopes, quantities, and chemical and physical form of the radioactive material involved; (iv) date and time of the event; (v) corrective actions taken or planned and the results of any evaluations or assessments; and (vi) the extent of exposure of individuals to radioactive materials without identification of individuals by name. (s) Reciprocal recognition of licenses. (1) Subject to this section, any person who holds a specific license from the commission, any agreement state, or any licensing state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within the state of Texas provided that: (A) the licensing document does not limit the activity authorized by such document to specified installations or locations; (B) the out-of-state licensee notifies the agency in writing at least three working days prior to engaging in such activity. If, for a specific case, the three working-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities in accordance with the general license provided in this subsection. Such notification shall include: (i) the exact location, start date, duration, and type activity to be conducted; (ii) the identification of the sources of radiation to be used; (iii) the name(s) and in-state address(es) of the individual(s) performing the activity; (iv) a copy of the pertinent license; (v) a copy of the licensee's operating, safety, and emergency procedures; and (vi) an annual fee as specified in 12.11(c) of TRCR Part 12 as adopted by reference in sec.289.126 of this title. (C) the out-of-state licensee complies with all applicable rules of the agency and with all the terms and conditions of the licensee's licensing document, except any such terms and conditions that may be inconsistent with applicable rules of the agency; (D) the out-of-state licensee supplies such other information as the agency may request; and (E) the out-of-state licensee shall not transfer or dispose of radioactive material possessed or used in accordance with the general license provided in this section except by transfer to a person: (i) specifically licensed by the agency, the commission, another agreement state, or another licensing state to receive such material, or (ii) exempt from the requirements for a license for such material in accordance with sec.289.251(d)(1) of this title. (2) In addition to the provisions of paragraph (1) of this subsection, any person who holds a specific license issued by the commission, an agreement state, or a licensing state authorizing the holder to manufacture, transfer, install, or service a device described in sec.289.251(g)(1)(C) and (j)(1) of this title, within areas subject to the jurisdiction of the licensing body, is hereby granted a general license to install, transfer, demonstrate, or service such a device in the state of Texas provided that: (A) such person shall file a report with the agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in the state of Texas. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred by manufacture's name, model number, serial number of the device and serial number of the sealed source, and the quantity and type of radioactive material contained in the device; (B) the device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the commission, an agreement state, or a licensing state; (C) such person shall assure that any labels required to be affixed to the device in accordance with regulations of the authority that licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and (D) the holder of the specific license shall furnish to each general licensee to whom the holder of the specific license transfers such device or on whose premises the holder of the specific license installs such device a copy of the general license contained in sec.289.251(g)(1)(C) and (j)(1) of this title. (3) The agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed in accordance with such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or the environment. (t) Preparation of radioactive material for transport. (1) No licensee shall deliver any radioactive material to a carrier for transport, unless: (A) the licensee complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the United States Department of Transportation (DOT) insofar as such regulations relate to the packing of radioactive material, and to the monitoring, marking, and labeling of those packages; (B) the licensee has established procedures for opening and closing packages in which radioactive material is transported to provide safety and to assure that, prior to the delivery to a carrier for transport, each package is properly closed for transport; and (C) prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to, or have been made available to, the consignee. (2) For the purpose of this subsection, licensees who transport their own licensed material as private carriers are considered to have delivered such material to a carrier for transport. (u) Financial assurance and record keeping for decommissioning. (1) The applicant for each specific license authorizing the possession and use of unsealed radioactive material with a half-life greater than 120 days and in quantities exceeding 10[sup]5 times the applicable quantities set forth in subsection (w)(6) of this section shall submit a decommissioning funding plan as described in paragraph (5) of this subsection. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 10 point=5.02p [sup]5 is greater than 1 (unity rule), where R is defined as the sum of the ratios of the quantity of each isotope to the applicable value in subsection (w)(6) of this section. (2) The applicant for each specific license authorizing possession and use of radioactive material of half-life greater than 120 days and in quantities specified in paragraph (4) of this subsection shall either: (A) submit a decommissioning funding plan as described in paragraph (5) of this subsection; or (B) submit a certification that financial assurance for decommissioning has been provided in the amount in accordance with paragraph (4) of this subsection using one of the methods described in paragraph (6) of this subsection. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued, but prior to the receipt of licensed material. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection is to be submitted to the agency. (3) The holder of each specific license issued: (A) on or after January 1, 1995, which is of a type described in paragraph (2) of this subsection, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section; (B) before January 1, 1995, and of a type described in paragraph (1) of this subsection shall submit, on or before January 1, 1995, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount at least equal to $750,000, in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal; (C) before January 1, 1995, and of a type described in paragraph (2) of this subsection shall submit, on or before January 1, 1995, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this section. (4) The required amounts of financial assurance for decommissioning are determined by quantity of material and are as follows: (A) $750,000 for quantities of material greater than 10[sup]4 but less than or equal to 10[sup]5 times the applicable quantities in subsection (w)(6) of this section in unsealed form. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10[sup]4 is greater than 1 but R divided by 10 point=5.02p [sup]5 is less than or equal to 1.); (B) $150,000 for quantities of material greater than 10[sup]3 but less than or equal to 10[sup]4 times the applicable quantities in subsection (w)(6) of this section in unsealed form. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10[sup]3 is greater than 1 but R divided by 10 point=5.02p [sup]4 if less than or equal to 1.); or (C) $75,000 for quantities of material greater than 10 point=5.02p [sup]10 times the applicable quantities in subsection (w)(6) of this section in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10 point=5.02p [sup]10 is greater than 1.) (5) Each decommissioning funding plan must contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from paragraph (6) of this subsection, including means of adjusting cost estimates and associated funding levels periodically over the life of the facility. (6) Financial assurance for decommissioning must be provided by one or more of the following methods. (A) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. (B) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid should the licensee default. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in subsection (w)(3) of this section. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions. (i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the agency, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the agency within 30 days after receipt of notification of cancellation. (ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the agency. An acceptable trustee includes an appropriate state or federal government agency or an entity that has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency. (iii) The surety method or insurance must remain in effect until the agency has terminated the license. (C) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be in accordance with subparagraph (B) of this paragraph. (D) In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount in accordance with paragraph (4) of this subsection, and indicating that funds for decommissioning will be obtained when necessary. (7) Each person licensed in accordance with this section shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the license is terminated by the agency. If records of relevant information are kept for other purposes, reference to these records and their locations may be used. Information the agency considers important to decommissioning consists of: (A) records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas, as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations; (B) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes that may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations; and (C) records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used. (v) Emergency plan for responding to a release. (1) An application for each specific license to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in subsection (w)(4) of this section must contain either: (A) an evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or (B) an emergency plan for responding to a release of radioactive material. (2) One or more of the following factors may be used to support an evaluation submitted in accordance with paragraph (1)(A) of this subsection: (A) the radioactive material is physically separated so that only a portion could be involved in an accident; (B) all or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged; (C) the release fraction in the respirable size range would be lower than the release fraction in subsection (w)(4) of this section due to the chemical or physical form of the material; (D) the solubility of the radioactive material would reduce the dose received; (E) facility design or engineered safety features in the facility would cause the release fraction to be lower than that in subsection (w)(4) of this section; (F) operating restrictions or procedures would prevent a release fraction as large as that in subsection (w)(4) of this section; or (G) other factors appropriate for the specific facility. (3) An emergency plan for responding to a release of radioactive material submitted in accordance with paragraph (1)(B) of this subsection must include the following information. (A) Facility description. A brief description of the licensee's facility and area near the site. (B) Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed. (C) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies. (D) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner. (E) Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment. (F) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials. (G) Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the agency; also, responsibilities for developing, maintaining, and updating the plan. (H) Notification and coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees of complying with the requirements in accordance with the Emergency Planning and Community Right-to-Know-Act of 1986, Title III, Publication L. 99-499 or other state or federal reporting requirements. (I) Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the agency. (J) Training. A brief description of the frequency, performance objectives, and plans for the training that the licensee will provide workers on how to respond to an emergency, including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios. (K) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident. (L) Exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected. (M) Hazardous chemicals. A certification that the applicant has met its responsibilities in accordance with the Emergency Planning and Community Right- to-Know Act of 1986, Title III, Publication L. 99-499, if applicable to the applicant's activities at the proposed place of use of the byproduct material. (4) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the agency. The licensee shall provide any comments received within the 60 days to the agency with the emergency plan. (w) Appendices. (1) Subjects to be included in training courses: (A) fundamentals of radiation safety: (i) characteristics of radiation; (ii) units of radiation dose (rem) and activity of radioactivity (curie); (iii) significance of radiation dose; (I) radiation protection standards; and (II) biological effects of radiation; (iv) levels of radiation from sources of radiation; (v) methods of controlling radiation dose; (I) time; (II) distance; and (III) shielding; (vi) radiation safety practices, including prevention of contamination and methods of decontamination; and (vii) discussion of internal exposure pathways; (B) radiation detection instrumentation to be used: (i) radiation survey instruments: (I) operation; (II) calibration; and (III) limitations; (ii) survey techniques; (iii) personnel monitoring equipment: (I) film badges; (II) thermoluminescent dosimeters (TLDs); and (III) pocket dosimeters; (C) equipment to be used: (i) handling equipment and remote handling tools; (ii) sources of radiation; (iii) storage, control, disposal, and transport of equipment and sources of radiation; (iv) operation and control of equipment; and (v) maintenance of equipment; (D) the requirements of pertinent federal and state regulations; (E) the licensee's written operating, safety, and emergency procedures; and (F) the licensee's record keeping procedures. (2) Groups of medical uses of radioactive material. (A) Group I. (i) Medical uses under Group I include the use of prepared radiopharmaceuticals for certain diagnostic studies involving measurements of uptake, dilution, and excretion as follows: (I) iodine-123, iodine-125, and iodine-131, as sodium iodide (NaI) for measurement of thyroid uptake; (II) iodine-125 and iodine-131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume and for studies of cardiovascular function and protein turnover; (III) iodine-131 as labeled rose bengal for liver function studies; (IV) iodine-125 and iodine-131 as labeled fats or fatty acids for fat absorption studies; (V) iodine-125 as labeled sodium iothalamate for kidney function studies; (VI) iodine-123 and iodine-131 as labeled sodium iodohippurate for kidney function studies; (VII) cobalt-57, cobalt-58, and cobalt-60 as labeled cyanocobalamin for intestinal absorption studies; (VIII) chromium-51 as sodium chromate for determination of red blood cell volume and studies of red blood cell survival time and gastrointestinal blood loss; (IX) chromium-51 as labeled human serum albumin for gastrointestinal protein loss studies; (X) iron-59 as citrate for iron turnover studies; (XI) potassium-42 as chloride for potassium space determinations; (XII) sodium-24 as chloride for sodium space determinations; (XIII) technetium-99m as pertechnetate for blood flow studies; or (XIV) any radioactive material contained in a pharmaceutical used for diagnostic purpose involving the measurement of uptake, dilution, or excretion for which a NDA or PLA has been approved by the FDA when the product is used in accordance with the manufacturer's product package insert for the purposes specified therein. (ii) This group does not include uses involving imaging and tumor localizations. (B) Group II. Medical uses under Group II include the use of prepared radiopharmaceuticals for diagnostic studies involving imaging and tumor localizations as follows: (i) fluorine-18 in solution for bone imaging; (ii) indium-111 as disodium pentetate for cisternography; (iii) indium-111 as oxyquinoline (oxine) for preparation of labeled autologous leukocytes for focal inflammatory lesion imaging; (iv) indium-113m as indium chloride for placenta localization and blood pool imaging; (v) iodine-123, I-125, and I-131 as sodium iodide (NaI) for thyroid imaging; (vi) iodine-125 as labeled fibrinogen (human) for use as an aid in the diagnosis of deep-vein thrombosis of the legs; (vii) iodine-131 as iodinated human serum albumin (IHSA) for brain tumor localizations, cardiac imaging, and placenta localization; (viii) iodine-131 as macroaggregated IHSA for lung imaging; (ix) iodine-131 as colloidal (microaggregated) IHSA for liver imaging; (x) iodine-131 as labeled rose bengal for liver imaging; (xi) iodine-131 as sodium iodohippurate for kidney imaging; (xii) chromium-51 as labeled human serum albumin for placenta localization; (xiii) gallium-67 as citrate for tumor imaging and diagnosis of acute inflammatory lesions; (xiv) gold-198 in colloidial form for liver imaging; (xv) mercury-197 as labeled chlormerodrin for kidney and brain imaging; (xvi) selenium-75 as labeled selenomethionine for pancreas imaging; (xvii) strontium-85 as nitrate for bone imaging; (xviii) technetium-99m as pertechnetate for brain, thyroid, salivary gland, blood pool, placenta localization, cystography, and dacryocystography; (xix) technetium-99m as labeled sulfur colloid for liver, spleen, esophageal, and bone marrow imaging; (xx) technetium-99m as labeled macroaggregated human serum albumin for lung imaging; (xxi) ytterbium-169 as pentetate calcium trisodium for cisternography; (xxii) thallium-201 as chloride for myocardial and myocardial perfusion imaging; (xxiii) any radioactive material in a radiopharmaceutical prepared from a reagent kit listed in subparagraph (C)(iii) of this paragraph; or (xxiv) any radioactive material contained in a pharmaceutical for diagnostic purposes involving imaging for which a NDA or PLA has been approved by the FDA when the product is used in accordance with the manufacturer's product package insert for the purposes specified therein. (C) Group III. Medical uses under Group III include the use of generators and reagent kits for the preparation and use of radiopharmaceuticals containing radioactive material for certain diagnostic uses as follows: (i) molybdenum-99/technetium-99m generators for the elution of technetium-99m as pertechnetate for: (I) brain imaging; (II) thyroid imaging; (III) salivary gland imaging; (IV) blood pool imaging including placenta localization; (V) blood flow studies; (VI) cystography; (VII) dacryocystography; or (VIII) use with reagent kits for preparation and use of radiopharmaceuticals containing technetium-99m as provided in clauses (iii) and (iv) of this subparagraph; (ii) tin-113/indium-113m generators for the elution of indium-113m as chloride for: (I) blood pool imaging; (II) placenta localization; or (III) use with reagent kits for preparation and use of radiopharmaceuticals containing indium-113m as provided in clause (iv) of this subparagraph; (iii) reagent kits for preparation of technetium-99m labeled: (I) sulfur colloid for liver, spleen, gastroesophageal, and bone marrow imaging; (II) pentetate sodium for brain and kidney imaging and kidney function studies; (III) human serum albumin microspheres for lung imaging and diagnosis of deep vein thrombosis of the legs; (IV) polyphosphates for bone imaging; (V) macroaggregated human serum albumin for lung imaging; (VI) etidronate sodium for bone imaging; (VII) stannous pyrophosphate for bone and cardiac imaging; (VIII) human serum albumin for heart blood pool and pericardial imaging; (IX) medronate sodium for bone imaging; (X) gluceptate sodium for brain and renal perfusion imaging; (XI) oxidronate sodium for bone imaging; (XII) disofenin for hepatobiliary imaging; (XIII) succimer for renal imaging; or (XIV) albumin colloid for liver, spleen, and bone marrow imaging; or (iv) any generator or reagent kit used for the preparation of radiopharmaceuticals for which the FDA has approved a NDA or PLA when used in accordance with the manufacturer's product package insert for the purposes specified therein. (3) Criteria relating to use of financial tests and parent company guarantees for providing reasonable assurance of funds for decommissioning. (A) Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This paragraph establishes criteria for passing the financial test and for obtaining the parent company guarantee. (B) Financial test. (i) To pass the financial test, the parent company must meet the criteria of either subclause (I) or (II) of this clause. (I) The parent company must have: (-a-) two of the following three ratios: (-1-) a ratio of total liabilities to net worth less than 2.0; (-2-) a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and (-3-) a ratio of current assets to current liabilities greater than 1.5; (-b-) net working capital and tangible net worth each at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used); (-c-) tangible net worth of at least $10 million; and (-d-) assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used.) (II) The parent company must have: (-a-) a current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as issued by Moody's; (-b-) tangible net worth at least six times the current decommissioning cost estimate (or prescribed amount if a certification is used); (-c-) tangible net worth of at least $10 million; and (-d-) assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates (or prescribed amount if certification is used). (ii) The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the agency within 90 days of any matters coming to the auditor's attention that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. (iii) After the initial financial test, the parent company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year. (iv) If the parent company no longer meets the requirements of clause (i) of this subparagraph, the licensee must send notice to the agency of intent to establish alternate financial assurance as specified in the commission's regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year end financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year. (C) Parent company guarantee. The terms of a parent company guarantee that an applicant or licensee obtains must provide that: (i) the parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the agency. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the agency, as evidenced by the return receipts; (ii) if the licensee fails to provide alternate financial assurance as specified in the agency's regulations within 90 days after receipt by the licensee and the agency of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee; (iii) the parent company guarantee and financial test provisions must remain in effect until the agency has terminated the license; and (iv) if a trust is established for decommissioning costs, the trustee and trust must be acceptable to the agency. An acceptable trustee includes an appropriate state or federal government agency or an entity that has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency. (4) Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release. Figure 5: 25 TAC sec.289.252(w)(4) (5) Acceptable training and experience for medical uses of radioactive material. (A) Training for uptake, dilution, and excretion studies. (i) The licensee shall require the authorized user of a radiopharmaceutical listed in Group I of subsection (w)(2) of this section, to be a physician who: (I) is certified in: (-a-) nuclear medicine by the American Board of Nuclear Medicine (ABNM); (-b-) diagnostic radiology or radiology by the American Board of Radiology (ABR); (-c-) diagnostic radiology or radiology by the American Osteopathic Board of Radiology (AOBR); (-d-) nuclear medicine by the Royal College of Physicians and Surgeons of Canada (RCPSC); or (-e) nuclear medicine by the American Osteopathic Board of Nuclear Medicine (AOBNM); or (II) has successfully completed classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals and supervised clinical experience as follows: (-a-) 40 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3-) mathematics pertaining to the use and measurement of radioactivity; (-4-) radiation biology; and (-5-) radiopharmaceutical chemistry; and (-b-) 20 hours of supervised clinical experience under the supervision of an authorized user and that includes: (-1-) examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (-2-) selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (-3-) administering dosages to patients and using syringe radiation shields; (-4-) collaborating with the authorized user in the interpretation of radioisotope test results; and (-5-) patient follow-up; or (-c-) has successfully completed a six-month training program in nuclear medicine as part of a residency program that has been accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the Council on Postdoctoral Training of the American Osteopathic Association (COPT-AOA) and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in this subclause. (ii) Training in all the topics identified in clause (i)(II)(-a-) of this subparagraph, which is not a part of a residency program as in clause (i)(II)(- c-) of this subparagraph, shall be obtained in an ACGME- or COPT-AOA-accredited medical teaching institution. The clinical experience described in clause (i)(II)(-b-) of this subparagraph shall be supervised by a physician licensed for the full scope of diagnostic nuclear medicine procedures or by an authorized physician in an ACGME-accredited medical teaching institution. (iii) Notwithstanding the requirements of clauses (i) and (ii) of this subparagraph, proof of alternative training that includes the topics and hours listed in subparagraph (B)(i)(II) of this paragraph may be accepted on a case- by-case basis if the agency, after providing the Medical Committee of the Texas Radiation Advisory Board with the opportunity to review and comment, determines that the alternative training would give an equal or greater level of training to the standards in clauses (i) and (ii) of this subparagraph. (B) Training for imaging and localization studies. (i) The licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit listed in Groups II and III of paragraph (2)(B) and (C) of this subsection, to be a physician who: (I) is certified in: (-a-) nuclear medicine by the ABNM; (-b-) diagnostic radiology or radiology by the ABR; (-c-) diagnostic radiology or radiology by the AOBR; (-d-) nuclear medicine by the RCPSC; or (-e-) nuclear medicine by the AOBNM; or (II) has successfully completed classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows: (-a-) 200 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3-) mathematics pertaining to the use and measurement of radioactivity; (-4-) radiopharmaceutical chemistry; and (-5-) radiation biology; and (-b-) 500 hours of supervised work experience under the supervision of an authorized user that includes: (-1-) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (-2-) calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (-3-) calculating and safely preparing patient dosages; (-4-) using administrative controls to prevent the misadministration of byproduct material; (-5-) using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (-6-) eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and (-c-) 500 hours of supervised clinical experience under the supervision of an authorized user that includes: (-1-) examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (-2-) selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (-3-) administering dosages to patients and using syringe radiation shields; (-4-) collaborating with the authorized user in the interpretation of radioisotope test results; and (-5-) patient follow-up; or (-d-) has successfully completed a six-month training program in nuclear medicine as part of a residency program that has been accredited by the ACGME or the COPT-AOA and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in this subclause. (ii) Training in all the topics identified in clause (i)(II)(-a-) of this subparagraph, which is not a part of a residency program as in clause (i)(II)(- d-) of this subparagraph, shall be obtained in a medical teaching institution that provides appropriate training programs that have been accredited by the ACGME or the COPT-AOA. The work and clinical experience described in clause (i)(II)(-b-) and (-c-) of this subparagraph shall be supervised by a physician licensed for the full scope of diagnostic nuclear medicine procedures or by a licensed authorized physician in a medical institution that also provides appropriate training programs that have been accredited by the ACGME or the COPT-AOA. The experience in clause (i)(II)(-b-) and (-c-) of this subparagraph may be obtained concurrently. (iii) Classroom and laboratory training identified in clause (i)(II) (-a-) of this subparagraph that was initiated before (the effective date of this rule) and completed by (two years from the effective date of the rule) will be accepted if it is obtained in an accredited medical school, a federal teaching hospital, or a training program for medical use of radioactive material that has been accepted by the agency, the commission, or another agreement state. (iv) Notwithstanding the requirements of clauses (i) and (ii) of this subparagraph, proof of alternative training that includes the topics and hours listed in clause (i)(II) of this subparagraph may be accepted on a case-by-case basis if the agency, after providing the Medical Committee of the Texas Radiation Advisory Board with the opportunity to review and comment, determines that the alternative training would give an equal or greater level of training to the standards in clauses (i) and (ii) of this subparagraph. (C) Training for the therapeutic use of radiopharmaceuticals. (i) The licensee shall require the authorized user of radiopharmaceuticals for therapeutic use to be a physician who: (I) is certified in: (-a-) nuclear medicine by the ABNM; (-b-) radiology or therapeutic radiology by the ABR; (-c-) therapeutic radiology or radiology by the AOBR; (-d-) nuclear medicine by the RCPSC; or (-e-) nuclear medicine by the AOBNM; or (II) has classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals and supervised clinical experience as follows: (-a-) 80 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3-) mathematics pertaining to the use and measurement of radioactivity; and (-4-) radiation biology; and (-b-) supervised clinical experience under the supervision of an authorized physician user for the type of therapy authorization requested from the following list: (-1-) use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism in 10 individuals; (-2-) use of iodine-131 for treatment of thyroid carcinoma in three individuals; (-3-) use of colloidal phosphorus-32 for intracavitary treatment in three patients; (-4-) use of phosphorus-32 for treatment of polycythemia vera, leukemia and/or bone metastasis in three patients; (-5-) use of colloidal gold-198 for intracavitary treatment in three patients; or (-6-) use of radiopharmaceuticals not listed in subitems (-1-) through (-5-) of this item for therapeutic treatment in three patients; or (-7-) has successfully completed a six-month training program in nuclear medicine as part of a residency program that has been accredited by the ACGME or the COPT-AOA and that included classroom and laboratory training, work experience and supervised clinical experience in all the topics identified in this subclause. (ii) Training in all the topics identified in clause (i)(II) of this subparagraph, which is not a part of a residency program as in clause (i) (II)(- b-) of this subparagraph, shall be obtained in a medical teaching institution accredited by the ACCME or the COPT-AOA. (D) Training for use of brachytherapy sources (except for beta applicators-See subparagraph (E) of this paragraph). (i) The licensee shall require the authorized user of a brachytherapy source to be a physician who: (I) is certified in: (-a-) therapeutic radiology, radiation oncology, or radiology by the ABR; or (-b-) therapeutic radiology, radiation oncology, or radiology by the AOBR; or (-c-) radiology with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (-d-) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (II) is in the active practice of therapeutic radiology, has had classroom training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, and supervised clinical experience as follows: (-a-) 200 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3-) mathematics pertaining to the use and measurement of radioactivity; and (-4-) radiation biology; and (-b-) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes: (-1-) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (-2-) checking survey meters for proper operation; (-3-) preparing, implanting, and removing sealed sources; (-4) maintaining running inventories of material on hand; (-5-) using administrative controls to prevent the misadministration of byproduct material; and (-6-) using emergency procedures to control byproduct material; and (-c-) three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the ACGME or the COPT-AOA, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes: (-1-) examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications; (-2-) selecting the proper brachytherapy sources and dose and method of administration; (-3-) calculating the dose; and (-4-) post-administration follow-up and review of case histories in collaboration with the authorized user. (ii) Training in all the topics identified in clause (i)(II)(-a-) this subparagraph shall be accredited by the ACGME or the COPT-AOA. The clinical experience described in clause (i)(II)(-b-) and (-c-) of this subparagraph should be supervised by a physician licensed to use brachytherapy sources. The experience in clause (i)(II)(-b-) and (-c-) of this subparagraph may be obtained concurrently. (E) Training for ophthalmic use of strontium-90. (i) The licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who: (I) is certified in: (-a-) therapeutic radiology, radiation oncology, or radiology by the ABR; (-b-) therapeutic radiology, radiation oncology, or radiology by the AOBR; (-c-) radiology with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (-d-) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (II) is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows: (-a-) 24 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3) mathematics pertaining to the use and measurement of radioactivity; and (-4-) radiation biology; and (-b-) supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes: (-1) examination of each individual to be treated; (-2-) calculation of the dose to be administered; (-3) administration of the dose; and (-4-) follow-up and review of each individual's case history. (ii) Training in all the topics identified in clause (i)(II)(-a-) of this subparagraph shall be obtained in a medical teaching institution or shall be accredited by the ACGME or the COPT-AOA. The clinical experience described in clause (i)(II)(-b-) of this subparagraph shall be supervised by a physician licensed for the use of sealed sources in therapy. (F) Training for use of sealed sources for diagnosis. (i) The licensee shall require the authorized user of a sealed source in the devices listed in clause (ii) of this subparagraph, to be a physician, dentist, or podiatrist who: (I) is certified in: (-a-) therapeutic radiology, diagnostic radiology, radiation oncology, or radiology by the ABR; (-b-) nuclear medicine by the ABNM; (-c-) diagnostic radiology or radiology by the AOBR; (-d-) nuclear medicine by the RCPSC; or (-e-) nuclear medicine by the AOBNM; or (II) has had eight hours of classroom and laboratory training in radioisotope handling techniques specifically applicable to the use of the device that includes: (-a-) radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation; (-b-) radiation biology; (-c-) radiation protection; and (-d-) training in the use of the device for the uses requested. (ii) The following sealed sources shall be used in accordance with the manufacturer's radiation safety and handling instructions: (I) iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis; and (II) iodine-125 as a sealed source in a portable imaging device. (iii) Training in all the topics identified in clause (i)(II) of this subparagraph shall be obtained in a medical teaching institution or shall be accredited by the ACGME or the COPT-AOA. The clinical experience shall be supervised by a physician, dentist, or podiatrist licensed to use the devices. (G) Training for teletherapy. (i) The licensee shall require the authorized user of a sealed source in a teletherapy unit to be a physician who: (I) is certified in: (-a-) therapeutic radiology, radiation oncology, or radiology by the ABR; (-b-) therapeutic radiology, radiation oncology, or radiology by the AOBR; (-c-) radiology with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (-d-) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (II) is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, supervised work experience, and supervised clinical experience as follows: (-a-) 200 hours of classroom and laboratory training that includes: (-1-) radiation physics and instrumentation; (-2-) radiation protection; (-3-) mathematics pertaining to the use and measurement of radioactivity; and (-4-) radiation biology; and (-b-) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes: (-1-) review of the full calibration measurements and periodic spot checks; (-2-) preparing treatment plans and calculating treatment times; (-3-) using administrative controls to prevent misadministration; (-4-) implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and (-5-) checking and using survey meters; and (-c-) three years of supervised clinical experience that includes one year in a formal training program accredited by the ACGME or the COPT-AOA and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes: (-1-) examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment; and any limitations or contraindications; (-2-) selecting the proper dose and how it is to be administered; (-3-) calculating the therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and (-4-) post-administration follow-up and review of case histories. (ii) Training in all the topics identified in clause (i)(II)(-a-) of this subparagraph shall be accredited by the ACGME or the COPT-AOA. The clinical experience described in clause (i)(II)(-b-) and (-c-) of this subparagraph shall be supervised by a physician licensed for teletherapy procedures. The experience in clause (i)(II)(-b-) and (-c-) of this subparagraph may be obtained concurrently. (H) Training for experienced authorized users. Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or podiatric use of radioactive material on a commission or agreement state license issued before September 1, 1993 and those issued by the agency before (the effective date of this section) who perform only those methods of use for which they were authorized on that date need not comply with the training requirements in this paragraph. (I) Recentness of training. (i) The training and experience specified in this paragraph must have been obtained within the five years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. (ii) If active board certification required by this paragraph does not include continuing education and experience, the individual must have had related continuing education and experience since the board certification was obtained. (6) Isotope quantities (For use in subsection (u) of this section). Figure 6: 25 TAC sec.289.252(w)(6) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510250 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 458-7236 The Texas Department of Health (department) adopts the repeal of existing sec.289.128 and the new sec.289.251, concerning exemptions, general licenses, and general license acknowledgements. New sec.289.251 is adopted with changes to the proposed text as published in the April 21, 1995, issue of the Texas Register (20 TexReg 2983). The repeal is adopted as proposed. The new section incorporates language from Part 40 titled "Exemptions, General Licenses, and General License Acknowledgements," of the Texas Regulations of Radiation Control (TRCR) which was adopted by reference in sec.189.128 and which is now being repealed. In addition to incorporating existing language into the new section, requirements were added to include requirements for general licensees and general license acknowledgement holders to report to the department incidents involving events that prevent immediate protective actions necessary to avoid exposures to or releases of radioactive materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). The section was clarified to indicate which manufacturers of generally-licensed devices must be specifically licensed by the United States Nuclear Regulatory Commission (NRC) and which may be specifically licensed by the NRC, an agreement state, or a licensing state; and it also specifies the type of licensee to which a generally-licensed device may be transferred. Also, the section was further clarified to require that tests for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator must be performed in accordance with instructions provided by the labels or by a person specifically licensed to perform such test. These additional requirements are items of compatibility with the NRC, and as an agreement state, Texas must adopt them. The following is a summary of all changes made tothe proposed rules. In subsection (e), a reference to "21.1201(d) of Texas Regulations for Control of Radiation (TRCR) as adopted by reference in sec.289.113 of this title (relating to Standards for Protection Against Radiation)" was added because this requirement is also applicable to general licenses. The references to "21.902 through 21.906 of TRCR Part 21 as adopted by reference in sec.289.113 of this title" and "subsection (j)" were deleted in subsection (i). In subsection (g)(1)(C)(iii), wording was added to clarify that the tests required by subsection (g)(1)(C)(ii) may also be performed "in accordance with written instructions provided by the manufacturer as specified in new sec.289. 252(h)(4)(C)." A new clause was added to subsection (g)(1)(C) to ensure that the written instructions provided for in the new subsection (g)(1)(C)(iii)(II) are to be followed and maintained for inspection by the department. The footnote to Figure 1 in subsection (g)(4)(C)(ii)(I) was inadvertently omitted from the published version of the proposed section and is included in the final section with no changes. The word "specific" was deleted from subsection (g)(4)(C)(iii) as it was used to describe "person" because it was inaccurate. In subsection (i), references to "21.1201(d) and 21.1202(c) and (d) of TRCR Part 21 as adopted by reference in sec.289.113 of this title" were added because these requirements are also applicable to general license acknowledgement holders. Wording was parenthetically added to subsection (j)(1) (E)(iii) to clarify that installation means the removal of the manufacturer's lock and initial alignment of the radiation beam. Language in subsection (j)(1) (D) was deleted and replaced with the words, "Each application shall be accompanied by TRC Form 12-2." to more accurately reflect the intent of the section and the contents of TRC Form 12-2. In subsection (j)(1)(E)(iii), wording was added to clarify that the tests required by subsection (j)(1)(E) (ii) may also be performed in accordance with written instructions provided by the manufacturer as specified in new sec.289.252(h)(4)(C). Wording was added to subsection (j)(1)(E)(x) to clarify that devices containing radioactive material are to be transferred or disposed of by transfer to a person holding a specific license issued by the commission, an agreement state, or a licensing state that is equivalent to the specific license issued by the department pursuant to new sec.289.252(h)(4)(C). Wording was also added to subsection (j)(1)(E)(x) to clarify that when the device is temporarily transferred to the specific licensee for repair, the referenced report is not required. A new subsection (j)(1)(G) was added to ensure that the written instructions provided for in the new subsection (j)(1)(E)(iii) are to be followed and maintained for inspection by the department. Language in subsection (j)(2)(B)(v) was deleted and replaced with "...TRC Form 12-2." to more accurately reflect the intent of the section and the contents of the TRC Form 12-2. In subsection (m)(2), the wording was changed from "...authorized under the general license acknowledgement." to "...specified in the general license acknowledgement." to more accurately reflect the intent of the rule. In subsection (o)(2), the wording "...and the grounds for such amendment." was deleted because it was redundant. The following is a comment made concerning the proposed section and the department's response to that comment. Comment. A commenter stated that subsections (e) and (i) state that general licensees and general license acknowledgement holders are subject to the requirements of new sec.289.252(r) concerning notification of incidents and noted that these requirements are different than what is required in 21.1202 of TRCR Part 21 as adopted by reference in sec.289.113 concerning notification of incidents. The commenter stated that to have two reporting procedures in the same chapter that are stated differently could cause confusion as to what is required and suggested that the two requirements read the same or only be referenced once (see subsections (e) and (i)). Response. New sec.289.252(r) and sec.21.1202 of TRCR Part 21 as adopted by reference in sec.289.113 refer to different types of incidents, and therefore have different reporting requirements. TRCR 21.1202 refers to incidents in which an individual receives a dose in excess of the stated limits or a release of radioactive material such that, if an individual were present, that individual could receive a dose in excess of the stated limits. The incidents referred to in new sec.289.252(r) are unplanned contamination events, equipment failures, fire, explosion, etc. and these are required to be reported under certain stated conditions. The department made no change to the section as a result of the comment. The commenter was a representative from Ludlum Measurements, Inc. in Sweetwater. The commenter was in favor of the amendments, however, he presented a comment and suggestion for changes to the proposed amendments as discussed in the summary of comments. 25 TAC sec.289.128 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 rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510249 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 21, 1995 For further information, please call: (512) 458-7236 25 TAC sec.289.251 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.289.251. Exemptions, General Licenses, and General License Acknowledgements. (a) Scope and purpose. This section provides for exemptions to licensing requirements, general licensing of radioactive material, and acknowledgement of general licenses. Except as otherwise authorized, no person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a general license or general license acknowledgement issued in accordance with this section, or in a specific license issued in accordance with sec.289.115 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), 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). (b) Definitions. The following terms when used in this chapter shall have the following meanings, unless the text clearly indicates otherwise. (1) General license-An authorization granted in accordance with this section. General licenses provided in this section are effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons. The general licensee is subject to all other applicable portions of this chapter and any limitations of the general license. (2) General license acknowledgement-A written recognition of a general license issued in accordance with this section. General license acknowledgements require the submission of an application to the agency and the issuance of a written acknowledgement of a general license granted in accordance with this section. The holder of a general license acknowledgement is subject to all other applicable portions of this chapter as well as any limitations specified in the acknowledgement document. (c) Exemptions for source material. (1) Any person is exempt from this section and sec.289.252 of this title if that person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture, compound, solution, or alloy. (2) Any person is exempt from this section and sec.289.252 of this title if that person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. This exemption does not apply to the mining of ore containing source material. (3) Any person is exempt from this section and sec.289.252 of this title if that person receives, possesses, uses, or transfers: (A) any quantities of thorium contained in: (i) incandescent gas mantles; (ii) vacuum tubes; (iii) welding rods; (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium; (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium; (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or (vii) personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium; (B) source material contained in the following products: (i) glazed ceramic tableware, provided that the glaze contains not more than 20% by weight source material; (ii) glassware containing not more than 10% by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; (iii) glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983; or (iv) piezoelectric ceramic containing not more than 2.0% by weight source material; (C) photographic film, negatives, and prints containing uranium or thorium; (D) any finished product or part fabricated of, or containing, metal-thorium alloys, provided that the thorium content of the alloy does not exceed 4.0% by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part; (E) depleted uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that: (i) the counterweights are manufactured in accordance with a specific license issued by the commission authorizing distribution by the licensee in accordance with 10 Code of Federal Regulations (CFR) Part 40; (ii) each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM," (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend, "CAUTION-RADIOACTIVE MATERIAL-URANIUM," as previously required by this chapter); (iii) each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED," (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend, "CAUTION-RADIOACTIVE MATERIAL- URANIUM," as previously required by this chapter); and (iv) the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating, covering, or labeling; (F) depleted uranium used as shielding constituting part of any shipping container, provided that: (i) the shipping container is conspicuously and legibly impressed with the legend "CAUTION-RADIOACTIVE SHIELDING-URANIUM;" and (ii) the uranium metal is encased in a one-eighth inch minimum wall thickness of mild steel or equally fire resistant material; (G) thorium contained in finished optical lenses, provided that each lens does not contain more than 30% by weight of thorium, and that the exemption contained in this subparagraph shall not be deemed to authorize either: (i) the shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens; or (ii) the receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or in other optical instruments; (H) uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium; or (I) thorium contained in any finished aircraft engine part containing nickel- thoria alloy, provided that: (i) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and (ii) the thorium content in the nickel-thoria alloy does not exceed 4.0% by weight. (4) The exemptions in paragraph (3) of this subsection do not authorize the manufacture of any of the products described. (d) Exemptions for radioactive material other than source material. (1) Exempt concentrations. (A) Except as provided in subparagraph (B) of this paragraph, any person is exempt from this section and sec.289.252 of this title if that person receives, possesses, uses, transfers, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in subsection (q)(1) of this section. (B) No person may introduce radioactive material into a product or material, including waste, knowing or having reason to believe that it will be transferred to persons exempt in accordance with subparagraph (A) of this paragraph or equivalent regulations of the commission, any agreement state, or any licensing state, except in accordance with a specific license issued in accordance with sec.289.252(h)(1) of this title or the general license provided in sec.289.252(s) of this title. (2) Exempt quantities. (A) Except as provided in subparagraph (C) of this paragraph, any person is exempt from these rules if that person receives, possesses, uses, transfers, or acquires radioactive material in individual quantities, each of which does not exceed the applicable quantity set forth in subsection (q)(2) of this section. (B) Any person who possesses radioactive material received or acquired in accordance with the general license provided in subsection (g)(1)(B) of this section is exempt from the requirements for a license set forth in sec.289. 252 of this title if that person possesses, uses, or transfers such radioactive material. (C) This paragraph does not authorize the production, packaging, or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution. (D) No person may, for purposes of commercial distribution, transfer radioactive material in quantities greater than the individual quantities set forth in subsection (q)(2) of this section, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt in accordance with this paragraph or equivalent regulations of the commission, any agreement state, or any licensing state, except in accordance with a specific license issued by the commission in accordance with 10 CFR 32.18 or by the agency in accordance with sec.289.252(h)(2) of this title, which states that the radioactive material may be transferred by the licensee to persons exempt in accordance with this paragraph or the equivalent regulations of the commission, any agreement state, or any licensing state. (E) The schedule of quantities set forth in subsection (q)(2) of this section applies only to radioactive materials distributed as exempt quantities in accordance with a specific license issued by the agency, another licensing state, or the commission. Subsection (q)(2) of this section does not apply to radioactive materials that have decayed from quantities not originally exempt and does not make such material, or the sources or devices in which the material is contained, exempt from the licensing requirements in this section or sec.289.252 of this title. (3) Exempt items. (A) Certain items containing radioactive material. (i) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from this chapter if that person receives, possesses, uses, transfers, or acquires the following products: (I) timepieces, hands, or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation: (-a-) 25 millicuries of tritium per timepiece; (-b-) five millicuries of tritium per hand; (-c-) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial); (-d-) 100 microcuries of promethium-147 per watch or 200 microcuries of promethium-147 per any other timepiece; (-e-) 20 microcuries of promethium-147 per watch hand or 40 microcuries of promethium-147 per other timepiece hand; (-f-) 60 microcuries of promethium-147 per watch dial or 120 microcuries of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial); (-g-) the levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber: (-1-) for wrist watches, 0.1 millirad per hour at ten centimeters from any surface; (-2-) for pocket watches, 0.1 millirad per hour at one centimeter from any surface; and (-3-) for any other timepiece, 0.2 millirad per hour at ten centimeters from any surface; or (-h-) one microcurie of radium-226 per timepiece in timepieces, hands, or dials manufactured or initially distributed prior to January 1, 1986; (II) lock illuminators containing not more than 15 millicuries of tritium or not more than 2 millicuries of promethium-147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium-147 will not exceed one millirad per hour at one centimeter from any surface when measured through 50 milligrams per square centimeter of absorber; (III) balances of precision containing not more than one millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part; (IV) automobile shift quadrants containing not more than 25 millicuries of tritium; (V) marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas; (VI) thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat; (VII) electron tubes; provided that each tube does not contain more than one of the following specified quantities of radioactive material and that the levels of radiation from each electron tube containing byproduct material do not exceed one millirad per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber: (For purposes of this clause, "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube designed to control electrical currents): (-a-) 150 millicuries of tritium per microwave receiver protector tube or ten millicuries of tritium per any other electron tube; (-b-) one microcurie of cobalt-60; (-c-) five microcuries of nickel-63; (-d-) 30 microcuries of krypton-85; (-e-) five microcuries of cesium-137; or (-f-) 30 microcuries of promethium-147; (VIII) ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material not exceeding the applicable quantity set forth in subsection (q)(2) of this section or 0.05 microcurie of americium-241; or (IX) spark gap irradiators containing not more than one microcurie of cobalt- 60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three gallons per hour. (ii) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555.) (B) Self-luminous products containing tritium, krypton-85, promethium-147, or radium-226. (i) Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from this chapter if that person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the commission in accordance with 10 CFR 32.22, which authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this subparagraph does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments. (ii) Any person is exempt from this chapter if that person receives, possesses, uses, transfers, or owns articles acquired prior to January 1, 1986, each of which contains less than 0.1 microcurie of radium-226. (C) Gas and aerosol detectors containing radioactive material. (i) Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from this chapter if that person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that: (I) detectors containing radioactive material shall have been manufactured, imported, or transferred in accordance with a specific license issued by the commission in accordance with 10 CFR 32.26, or an agreement state or a licensing state in accordance with sec.289.252(h)(3) of this title; and (II) the specific license issued in accordance with sec.289.252 of this title authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. (ii) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555. (iii) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state or a licensing state shall be considered exempt in accordance with clause (i) of this subparagraph, provided that the devices are labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of sec.289.252 of this title. (D) Resins containing scandium-46 and designed for sand consolidation in oil wells. Any person is exempt from this chapter if that person receives, possesses, uses, transfers, or acquires synthetic plastic resins containing scandium-46, which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the agency or any agreement state to the manufacturer of such resins in accordance with licensing requirements equivalent to those in 10 CFR 32.16 and 32.17. This exemption does not authorize the manufacture of any resins containing scandium-46. (e) General licenses. In addition to the requirements of this section, all general licenses, unless otherwise specified, are subject to the requirements of sec.289.112 of this title (relating to Hearing and Enforcement Procedures), sec.289.126 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), and sec.289.201 of this title (relating to General Provisions), 21.1201(a), (b), (c), and (d) of Texas Regulations for Control of Radiation (TRCR) as adopted by reference in sec.289. 113 of this title (relating to Standards for Protection Against Radiation), and sec.289.252(r) of this title. (f) General licenses for source material. (1) A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and state and local government agencies to use and transfer not more than 15 pounds of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, in accordance with this general license, may not possess more than a total of 150 pounds of source material in any one calendar year. (2) Persons who receive, possess, use, or transfer source material in accordance with the general license in paragraph (1) of this subsection are prohibited from administering source material, or the radiation therefrom, either externally or internally, to humans except as may be authorized by the agency in a specific license. (3) A general license is hereby issued to own source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material. (4) A general license is hereby issued to mine, transport, and transfer ores containing source material without regard to quantity. Notwithstanding the provisions of subsection (e) of this section, persons who mine, transport, and transfer ores containing source material in accordance with this part shall also comply with the provisions of 21.301, 12.1001, and 21.1003 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. (5) A general license is hereby issued to receive, acquire, possess, use, or transfer depleted uranium contained in products or devices for the purpose of providing shielding, including beam shaping and collimation, in accordance with the provisions of subparagraphs (A), (B), (C), and (D) of this paragraph. (A) The general license in this paragraph applies only to products or devices that have been manufactured either in accordance with a specific license issued by the agency to the manufacturer of the products or devices in accordance with sec.289.252(h)(12) of this title or in accordance with a specific license issued to the manufacturer by another agreement state or the commission that authorizes manufacture of the products or devices for distribution to persons generally licensed by another agreement state or the commission. (B) Persons who receive, acquire, possess, or use depleted uranium in accordance with the general license in this paragraph shall notify the agency within 30 days after the first receipt of acquisition of such depleted uranium. The general licensee shall furnish the following information and such other information as may be required by the agency: (i) name and address of the general licensee; (ii) a statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium in accordance with this paragraph and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and (iii) name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in clause (ii) of this subparagraph. (C) The general licensee possessing or using depleted uranium in accordance with the general license in this paragraph shall report in writing to the agency any changes in information furnished by the general licensee. The report shall be submitted within 30 days after the effective date of such change. (D) A person who receives, acquires, possesses, or uses depleted uranium in accordance with the general license in this paragraph: (i) shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium; (ii) shall not abandon such depleted uranium; (iii) shall transfer or dispose of such depleted uranium only in accordance with the provisions of sec.289.252(p) of this title. In the case where the transferee receives the depleted uranium in accordance with the general license in this paragraph or equivalent rule of the commission or an agreement state, the transferor shall furnish the transferee a copy of this paragraph; (iv) in each calendar quarter, shall report in writing to the agency the name and address of the person receiving the depleted uranium in accordance with such transfer; and (v) shall not export such depleted uranium except in accordance with a license issued by the commission in accordance with 10 CFR Part 110. (E) Any person receiving, acquiring, possessing, using, or transferring depleted uranium in accordance with the general license in this paragraph is exempt from the requirements of sec.289.113 of this title (relating to Standards for Protection Against Radiation) and sec.289.114 of this title with respect to the depleted uranium covered by that general license. (g) General licenses for radioactive material other than source material. (1) Certain devices and equipment. A general license is hereby issued to transfer, receive, acquire, possess, and use radioactive material incorporated in the devices or equipment specified in subparagraphs (A) and (B) of this paragraph that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the commission authorizing distribution in accordance with this general license or its equivalent. A general license is hereby issued to transfer, receive, acquire, possess, and use radioactive material incorporated in the devices or equipment specified in subparagraph (C) of this paragraph that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the commission, an agreement state, or a licensing state authorizing distribution in accordance with this general license or its equivalent. Notwithstanding the provisions of subsection (e) of this section, this general license is subject to the provisions of subsection (d)(1)(B) of this section, and sec.289.252(p) and (t) of this title. (A) Static elimination devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material totaling not more than 500 microcuries of polonium-210 per device. The general license in this subparagraph (A) of this paragraph does not authorize the manufacture of devices containing radioactive material. (B) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material totaling not more than 500 microcuries of polonium-210 per device or a total of not more than 50 millicuries of tritium per device. (C) Other devices designed and manufactured for the purpose of producing light or an ionized atmosphere. Any person who receives, possesses, uses, or transfers radioactive material in a device in accordance with the general license in this subparagraph: (i) shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon, are clearly visible and legible, and shall comply with all instructions and precautions provided by such labels; (ii) shall assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as specified in the label; however: (I) devices containing only krypton need not be tested for leakage of radioactive material; and (II) devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or ten microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose; provided that each source is tested for leakage within six months prior to being used or transferred; (iii) shall assure that the tests required by clause (ii) of this subparagraph and other testing, installation, servicing, and removal from location of installation involving the radioactive materials, shielding or containment, are performed: (I) in accordance with the instructions provided by the labels; (II) in accordance with written instructions provided by the manufacturer as specified in sec.289.252(h)(4)(C) of this title; or (III) by a person holding a specific license from the agency, the commission, an agreement state, or a licensing state to perform such activities; (iv) shall maintain records showing compliance with the requirements of clauses (ii) and (iii) of this subparagraph. The records shall show the test results. The records also shall identify the device tested by manufacturer, model number, serial number of the device and serial number of the sealed source, show the dates of performance and the names of persons performing testing, installation, servicing, and removal from location of installation, of the radioactive material, its shielding or containment; (v) upon the occurrence of failure or damage to, or any indication of a possible failure or damage to, the radioactive material shielding or the "on- off" mechanism, or upon the detection of 0.005 microcuries or more of removable radioactive contamination, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license from the agency, the commission, an agreement state, or a licensing state to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the radioactive material contained in the device and, within 30 days, furnish the agency with a report containing a brief description of the event and the remedial action taken; (vi) shall not abandon the device containing radioactive material; (vii) except as provided in clause (viii) of this subparagraph, shall transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the agency, the commission, an agreement state, or a licensing state, whose specific license authorizes the receipt of the device, and within 30 days after transfer of a device to a specific licensee, shall furnish the agency with a report containing identification of the device by manufacturer's name, model number, serial number of the device and serial number of the sealed source, and address of the person receiving the device; (viii) shall transfer the device to another general license(e) only: (I) where the device remains in use at a particular location. In such case, the transferor shall give the transferee a copy of this rule and any safety documents identified in the label on the device and, within 30 days of the transfer, report to the agency the manufacturer's name and model number of device transferred, the serial number of the sealed source transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the agency and the transferee; or (II) where the device is stored in the original shipping container at its intended location of use prior to initial use by the holder of a general license acknowledgement; and (ix) shall submit the written instructions specified in subparagraph (C)(iii)(II) of this paragraph which shall be followed while performing the testing and shall be maintained for inspection by the agency. (2) Luminous safety devices for aircraft. (A) A general license is hereby issued to receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided: (i) each device contains not more than ten curies of tritium or 300 millicuries of promethium-147; and (ii) each device has been manufactured, assembled, or imported in accordance with a specific license issued by the commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the agency or any agreement state to the manufacturer or assembler of such device in accordance with licensing requirements equivalent to those in 10 CFR 32.53. (B) The general license in subparagraph (A) of this paragraph does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147. (C) The general license in subparagraph (A) of this paragraph does not authorize the receipt, acquisition, possession, or use of tritium or promethium- 147 contained in instrument dials. (D) Notwithstanding the provisions of subsection (e) of this section, the general license in subparagraph (A) of this paragraph is subject to the provisions of sec.289.252(t) of this title. (3) Ownership of radioactive material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this section, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material. (4) Calibration, stabilization, and reference sources. (A) A general license is hereby issued to those persons listed below to receive, acquire, possess, use, and transfer, in accordance with the provisions of subparagraphs (B) and (C) of this paragraph, americium-241, plutonium, and/or radium-226, in the form of calibration, stabilization, or reference sources: (i) any person who holds a specific license issued by the agency that authorizes that person to receive, possess, use, and transfer radioactive material; and (ii) any person who holds a specific license issued by the Commission that authorizes that person to receive, possess, use, and transfer radioactive material. (B) The general license in subparagraph (A) of this paragraph applies only to calibration, stabilization, or reference sources that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the commission in accordance with 10 CFR 32.57 or 10 CFR 70.39 or that have been manufactured in accordance with the authorizations contained in a specific license issued to the manufacturer by the agency, any agreement state, or any licensing state, in accordance with licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR 70.39. (C) Notwithstanding the provisions of subsection (e) of this section, the general license provided in subparagraph (A) of this paragraph is subject to the provisions of sec.289.252(t) of this title. In addition, persons who receive, acquire, possess, use, or transfer one or more calibration or reference sources in accordance with these general licenses: (i) shall not possess at any one time, at any one location of storage or use, more than 5 microcuries each of americium-241, plutonium-238, plutonium-239, and radium-226 in such sources; (ii) shall not receive, possess, use, or transfer such source unless the source or the storage container bears a label that includes the following statements, or a substantially similar statement that contains the information in the following statements: (I) option 1, as appropriate: Figure 1: 25 TAC sec.289.251(g)(4)(C)(ii)(I) (II) option 2, as appropriate: Figure 2: 25 TAC sec.289.251(g)(4)(C)(ii)(II) (iii) shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a specific license from the agency, the commission, an agreement state, or a licensing state to receive the source; (iv) shall store such source, except when the source is being used, in a closed container designed and constructed to contain americium-241, plutonium- 238, plutonium-239, or radium-226; and (v) shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources. (D) The general license in subparagraph (A) of this paragraph does not authorize the manufacture of calibration or reference sources containing americium-241, plutonium-238, plutonium-239, or radium-226. (5) Ice detection devices. (A) A general license is hereby issued to receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 microcuries of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the commission or each device has been manufactured in accordance with the authorizations contained in a specific license issued by the agency or any agreement state to the manufacturer of such device in accordance with licensing requirements equivalent to those in 10 CFR 32.61. (B) Persons who receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices in accordance with the general license in subparagraph (A) of this paragraph: (i) shall, upon occurrence of visually observable damage, such as bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license from the commission or an agreement state to manufacture or service such devices; or shall dispose of the device by transfer to a person authorized by a specific license from the agency, the commission, or an agreement state; and (ii) shall assure that all labels affixed to the device at the time of receipt, and which bear a statement prohibiting removal of the labels, are maintained thereon. (C) The general license in subparagraph (A) of this paragraph does not authorize the manufacture, assembly, disassembly, or repair of strontium-90 in ice detection devices. (D) Notwithstanding the provisions of subsection (e) of this section, the general license in subparagraph (A) of this paragraph is subject to the provisions of sec.289.252(t) of this title. (h) Intrastate transportation of radioactive material. (1) A general license is hereby issued to any common or contract carrier to transport and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the United States Department of Transportation (DOT) insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with the agency and the DOT. Persons who transport and store radioactive material in accordance with the general license in this paragraph are exempt from the requirements of sec.289.113 of this title and 289. 114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections). (2) A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the DOT insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with the agency and the DOT. (i) General license acknowledgements. In addition to the requirements of this section, all general license acknowledgement holders, unless otherwise specified, are subject to the requirements of sec.sec.289.112, 289.126, and 289. 201 of this title, and 21.1201(a), (b), (c), and (d), 21.1202(a), (b), (c), and (d) of TRCR Part 21 as adopted by reference in sec.289.113 of this title, and sec.289.252(r) of this title. (j) General license acknowledgements for radioactive material other than source material. (1) Certain measuring, gauging, and controlling devices. (A) A general license is hereby issued to commercial and industrial firms and to research, educational, and medical institutions, individuals in the conduct of their business, and state or local government agencies to receive, acquire, possess, use, or transfer in accordance with the provisions of subparagraphs (B), (C), (D), and (E) of this paragraph, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition. (B) The general license in subparagraph (A) of this paragraph applies only to radioactive material contained in devices that have been manufactured and labeled in accordance with the authorizations contained in a specific license issued by the agency in accordance with sec.289.252(h)(4) of this title or in accordance with the authorizations contained in a specific license issued by the commission, an agreement state, or a licensing state, which authorizes distribution of devices to persons generally licensed by the commission, an agreement state, or a licensing state. (C) Within 30 days following the receipt, acquisition, or possession of radioactive material in a device, except for calibration, stabilization, and reference sources, issued in accordance with the general license in subparagraph (A) of this paragraph, the general licensee shall file an application for an acknowledgement on a form prescribed by the agency. The application shall be signed by the individual duly authorized to act for or on behalf of the general licensee. (D) Each application shall be accompanied by TRC Form 12-2. (E) Any person who receives, acquires, possesses, uses, or transfers radioactive material in a device in accordance with the general license in subparagraph (A) of this paragraph: (i) shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon, are clearly visible and legible, and shall comply with all instructions and precautions provided by such labels; (ii) shall assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as specified in the label; however: (I) devices containing only krypton need not be tested for leakage of radioactive material; and (II) devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or ten microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose, provided that each source is tested for leakage within six months prior to being used or transferred; (iii) shall assure that the tests required by clause (ii) of this subparagraph and other testing, installation (removal of the manufacturer's lock and initial alignment of the radiation beam), servicing, and removal from location of installation involving the radioactive materials, shielding or containment, are performed: (I) in accordance with the instructions provided by the labels; (II) in accordance with written instructions provided by the manufacturer as specified in sec.289.252(h)(4)(C) of this title; or (III) by a person holding a specific license from the agency, the commission, an agreement state, or a licensing state to perform such activities; (iv) shall maintain records showing compliance with the requirements of clauses (ii) and (iii) of this subparagraph. The records shall show the test results. The records also shall identify the device tested by manufacturer, model number, serial number of the device and serial number of the sealed source, and show the dates of performance of and the names of persons performing testing, installation, servicing, and removal from location of installation, of the radioactive material, its shielding or containment; (v) shall maintain assignment records for portable or mobile devices for inspection by the agency at the location listed in the general license acknowledgement. These records shall include: (I) a unique identification (e.g. serial number) of each portable or mobile device; (II) the location(s) where each portable or mobile device is assigned; and (III) the date(s) each portable or mobile device is assigned to the location(s) in accordance with subclause (II) of this clause. (vi) shall maintain utilization records for each portable or mobile device used at the location(s) in accordance with clause (v)(II) of this subparagraph for inspection by the agency at that location(s); (vii) shall have a copy of the appropriate operating and instruction manual at each temporary site for agency inspection; (viii) upon the occurrence of failure or damage to, or any indication of a possible failure or damage to, the radioactive material shielding or the "on- off" mechanism, or upon the detection of 0.005 microcuries or more of removable radioactive contamination, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license from the agency, the commission, an agreement state, or a licensing state to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the radioactive material contained in the device and, within 30 days, furnish the agency with a report containing a brief description of the event and the remedial action taken; (ix) shall not abandon the device containing radioactive material; (x) except as provided in clause (xi) of this subparagraph, shall transfer or dispose of the device containing radioactive material only by transfer to a person holding a specific license issued by the agency in accordance with sec.289.252(h)(4) of this title, or an equivalent specific license issued by the commission, an agreement state, or a licensing state, whose specific license authorizes the receipt of the device, or as otherwise authorized by the agency in writing, and within 30 days after transfer of a device to a specific licensee, shall furnish the agency with a report containing identification of the device by manufacturer's name, model number, serial number of the device and serial number of the sealed source, and address of the person receiving the device (except when the device is temporarily transferred to the specific licensee for repair of the device); and (xi) shall transfer the device to another general license(e) only: (I) where the device remains in use at a particular location. In such case, the transferor shall give the transferee a copy of this rule and any safety documents identified in the label on the device and, within 30 days of the transfer, report to the agency the manufacturer's name and model number of device transferred, the serial number of the sealed source transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the agency and the transferee, or (II) where the device is stored in the original shipping container at its intended location of use prior to initial use by the holder of a general license acknowledgement. (F) The general license in subparagraph (A) of this paragraph does not authorize the manufacture of devices containing radioactive material. (G) The written instructions specified in subparagraph (E)(iii)(II) of this paragraph shall be followed while performing the testing and shall be maintained for inspection by the agency. (2) General license acknowledgements for use of radioactive material for certain in vitro clinical or laboratory testing. (The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.) (A) A general license is hereby issued to any physician, veterinarian, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of subparagraphs (B), (C), and (D) of this paragraph, the following radioactive materials in prepackaged units: (i) iodine-125, in units not exceeding ten microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (ii) iodine-131, in units not exceeding ten microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (iii) carbon-14, in units not exceeding ten microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (iv) hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (v) iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (vi) selenium-75, in units not to exceed ten microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; (vii) mock iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals; or (viii) cobalt-57, in units not exceeding ten microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to humans or animals. (B) No person shall receive, acquire, possess, use, or transfer radioactive material in accordance with the general license in subparagraph (A) of this paragraph until that person has filed an application for an acknowledgement on a form prescribed by the agency and has received from the agency an acknowledgement with an assigned number. The applicant shall furnish the following information and such other information as may be required by the agency: (i) name and address of the physician, veterinarian, clinical laboratory, or hospital; (ii) the location of use; (iii) a statement that the physician, veterinarian, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized in accordance with the general license in subparagraph (A) of this paragraph, and that such tests will be performed only by personnel trained specifically in the use of such instruments and in the handling of the radioactive material; (iv) name, title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee supervising the use of radioactive material authorized by subparagraph (A) of this paragraph; and (v) TRC Form 12-2. (C) A person who receives, acquires, possesses, or uses radioactive material in accordance with the general license in subparagraph (A) of this paragraph shall comply with the following. (i) The holder of the general license acknowledgement shall not possess at any one time, at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 microcuries. (ii) The holder of the general license acknowledgement shall store the radioactive material in the original shipping container or in a container providing equivalent radiation protection and meeting the requirements of 21. 904 of TRCR Part 21 as adopted by reference in sec.289.113 of this title until used. (iii) The holder of the general license acknowledgement shall use the radioactive material only for the uses authorized by subparagraph (A) of this paragraph. (iv) The holder of the general license acknowledgement shall not transfer the radioactive material to a person who is not authorized to receive it in accordance with a specific license issued by the agency, the commission, any agreement state, or any licensing state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier. (v) The holder of the general license acknowledgement shall dispose of the mock iodine-125 reference or calibration sources described in subparagraph (A)(vii) of this paragraph as required by 21.1001 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. (D) The holder of the general license acknowledgement in accordance with the general license in subparagraph (A) of this paragraph shall not receive, acquire, possess, or use radioactive material: (i) except as prepackaged units that are labeled in accordance with the provisions of an applicable specific license issued in accordance with sec.289.252(h)(8) of this title or in accordance with the provisions of a specific license issued by the commission, any agreement state, or any licensing state that authorizes the manufacture and distribution of iodine-125, iodine- 131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or mock iodine-125 to persons holding general license acknowledgements in accordance with this paragraph or its equivalent; and (ii) unless one of the statements in the following figures, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package: (I) option 1, as appropriate: Figure 3: 25 TAC sec.289.251(j)(2)(D)(ii)(I) (II) option 2, as appropriate: Figure 4: 25 TAC sec.289.251(j)(2)(D)(ii)(II) (k) Issuance of general license acknowledgements. (1) Upon a determination that the information submitted by the applicant meets the requirements of the Texas Radiation Control Act (Act) and the rules of the agency, the agency will issue a general license acknowledgement recognizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. (2) The agency may incorporate in any general license acknowledgement at the time of issuance, or thereafter by amendment, additional requirements and conditions governing the receipt, possession, use, transfer, and disposal of radioactive material subject to this section as it deems appropriate or necessary in order to: (A) minimize danger to public health and safety or the environment; (B) require such reports and the keeping of such records, and to provide for such inspections of activities in accordance with the license as may be appropriate or necessary; and (C) prevent loss or theft of material subject to this section. (l) Specific terms and conditions. (1) Each general license acknowledgement issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable rules and orders of the agency. (2) Each person holding a general license acknowledgement issued by the agency in accordance with this section shall confine use and possession of the material licensed to the locations and purpose authorized in the general license acknowledgement. (3) Each holder of a general license acknowledgement shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy in accordance with any Chapters of Title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against: (A) a holder of a general license acknowledgement; (B) an entity, (as that term is defined in 11 U.S.C. 101(14)) controlling the holder of a general license acknowledgement or listing the general license acknowledgement or the holder of the general license acknowledgement as property of the estate; or (C) an affiliate, (as that term is defined in 11 U.S.C. 101(2)) of the holder of a general license acknowledgement. (4) The notification in paragraph (3) of this subsection must indicate: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the date of the filing of the petition. (5) A copy of the "Petition for Bankruptcy" shall be submitted to the agency with the written notification. (m) Expiration and termination of general license acknowledgements. (1) Each general license acknowledgement expires at the end of the day, in the month and year stated in the general license acknowledgement. (2) Each holder of a general license acknowledgement shall notify the agency immediately, in writing, and request termination of the general license acknowledgement when the holder of the general license acknowledgement decides to terminate all activities involving materials specified in the general license acknowledgement. (3) No less than 30 days before the expiration date specified in a general license acknowledgement, the holder of the general license acknowledgement shall submit an application for general license acknowledgement renewal in accordance with subsection (n) of this section. (4) Each holder of a general license acknowledgement shall, no less than 30 days before vacating or relinquishing possession of control of premises that have been used as a place of storage or use of radioactive material as a result of general licensed activities, notify the agency in writing of intent to vacate. (5) If a holder of a general license acknowledgement does not submit an application for renewal in accordance with subsection (n) of this section, such person shall on or before the expiration date specified in the general license acknowledgement: (A) terminate use of radioactive material; and (B) dispose of radioactive material in accordance with this section and/or 21.1001 of TRCR Part 21 as adopted by reference in sec.289.113 of this title. (n) Renewal of general license acknowledgements. (1) Applications for renewal of general license acknowledgements shall be filed in accordance with subsection (j)(1)(C) or (2)(B) of this section, as applicable. (2) If a holder of a general license acknowledgement has properly filed a renewal application for the same activities at least 30 days before the expiration of the existing general license acknowledgement in accordance with this section, such existing general license acknowledgement shall not expire until the application has been finally determined by the agency. (o) Amendment of general license acknowledgements. (1) The holder of the general license acknowledgement in accordance with the general license in subsections (j)(1)(A) and (2)(A) of this section shall report in writing to the agency any changes in information furnished by the holder of the general license acknowledgement. The report shall be submitted within 30 days after the effective date of such change. (2) Applications for amendments of a general license acknowledgement shall be filed in accordance with subsection (j)(1)(C) or (2)(B) of this section, as applicable, and shall specify the respects in which the holder of a general license acknowledgement desires a general license acknowledgement to be amended. (p) Modification and revocation of general licenses and general license acknowledgements. (1) The terms and conditions of all general license acknowledgements shall be subject to amendment, revision, or modification. (2) A general license acknowledgement may be suspended or revoked by reason of amendments to the Act, or by reason of rules and orders issued by the agency. The agency may incorporate in the general license acknowledgement at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the general license acknowledgement holder's possession, use, and transfer of radioactive material as it deems appropriate or necessary. (3) Any general license acknowledgement may be revoked, suspended, or modified, in whole or in part: (A) for any material false statement in the application or any statement of fact required in accordance with provisions of the Act; (B) because of the Act; (C) because of conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a general license acknowledgement on an original application; (D) for violation of, or failure to observe, any of the terms and conditions of the Act or of the general license acknowledgement; or (E) of any rule or order of the agency. (4) Except in cases of willfulness or those in which the public health, interest, or safety requires otherwise, no general license acknowledgement shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the holder of the general license acknowledgement in accordance with sec.289.112 of this title and the holder of the general license acknowledgement has an opportunity to demonstrate or achieve compliance with all lawful requirements. (q) Appendices. (1) Exempt concentrations. Figure 5: 25 TAC sec.289.251(q)(1) (2) Exempt quantities. Figure 6: 25 TAC sec.289.251(q)(2) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510248 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 21, 1995 For further information, please call: (512) 458-7236 The Texas Department of Health (department) adopts the repeal of existing sec.289.124 and new sec.289.254, concerning the licensing requirements of radioactive waste processing and storage facilities; requirements for emergency plans, financial assurance and recordkeeping for decommissioning, and criteria for determining acceptable financial security for radioactive waste and processing facilities. The new sec.289.254 is adopted with changes to the proposed text as published in the March 28, 1995, issue of the Texas Register (20 TexReg 2268). The repeal is adopted as proposed. The section incorporates language from Part 44, titled "Licensing Requirements of Radioactive Waste Processing and Storage Facilities" of the Texas Regulation for Control of Radiation (TRCR), which was adopted by reference in sec.289.124 which is now being repealed. In addition to incorporating existing language into the new section, definitions were added and existing definitions were clarified; and new requirements concerning a decommissioning were included. These requirements are designated items of compatibility by the United States Nuclear Regulatory Commission (NCR), and in accordance with the agreement between Texas and the NRC, the department must adopt a similar rule. The repeal and new section are part of the first phase to convert existing section that adopt by reference the various parts of the TRCR to Texas Register format. The following changes were made in response to staff comments. Definitions of "commission" and "person" were deleted because these definitions are already defined in sec.289.201 of this title (relating to General Provisions). In subsection (d)(1) the word "four" was deleted to more accurately reflect the definition of "transport group." In subsections (h) and (i), language was added to clarify that, when required, financial assurance is to be provided for each specific license held by a licensee. In addition, references to repealed sec.289.111 have been changed to reflect the new sec.289. 201. The following is a comment made on the proposed section and the department's response to that comment. Comment. A commenter expressed concern that when the department refers to "persons who receive, possess, or process sealed sources of radioactive materials...," this reference does not refer to scrap recyclers who may accidentally receive radioactive materials. The commenter suggested that the section be changed to read "persons who intentionally receive, possess or process sealed sources" (See subsection (e) paragraphs (1), (2)(A) and (B), and (3).) Response. A scrap dealer who unintentionally receives improperly discarded radioactive material does not fall under the purpose and scope of the section as stated under subsection (a). The department made no change to the section as a result of the comment. The commenter was a representative from the Institute of Scrap Recycling Industries, Inc. in Washington, D.C.. The commenter was generally in favor of the rule, but presented comments and suggestions for changes to the proposed section as previously discussed. 25 TAC sec.289.124 The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the 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 rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510247 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: March 28, 1995 For further information, please call: (512) 458-7236 25 TAC sec.289.254 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the 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.289.254. Licensing of Radioactive Waste Processing and Storage Facilities. (a) Purpose and scope. (1) This section establishes the requirements for management of commercial radioactive waste processing and storage facilities, the procedures and criteria for the issuance of licenses to receive, possess, transport, store, and process radioactive waste from other persons, and the terms and conditions upon which the agency will issue such licenses. (2) Except as otherwise provided, this section applies to all persons who transport, receive, possess, store, or process radioactive waste from other persons. In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of sec.289.112 of this title (relating to Hearing and Enforcement Procedures), sec.289.113 of this title (relating to Standards for Protection Against Radiation), sec.289. 114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), sec.289.126 of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), sec.289.201 of this title (relating to General Provisions), and sec.289.252 of this title (relating to Licensing of Radioactive Material). (b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the text clearly indicates otherwise. (1) Commencement of major construction-Any major structural erection or major alterations to existing structures, or other substantial action that would change the facility design or site for the purpose of establishing a radioactive waste processing or storage facility. The term does not mean the acquisition of existing structures or minor changes thereto. (2) Decommissioning-The final activities carried out at a radioactive waste processing or storage site after completion of processing operations to remove safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and/or termination of the license. Such activities shall include: (A) disposing of all radioactive waste at a licensed radioactive waste disposal site; (B) dismantling or decontaminating site structures; (C) decontaminating site surfaces and remaining equipment; and (D) conducting final closure surveys, decontamination, and reclamation of the site. (3) Disposal-Isolation or removal of radioactive wastes from mankind and his environment. The term does not include emissions and discharges under rules of the agency. (4) Engineered barriers-Man-made devices to contain or limit the potential movement of radioactive material, which might result from spills or other accidents. (5) Floodplain-The lowland and relatively flat areas adjoining inland and coastal waters, including flood prone areas of off-shore islands. (6) Local government-A county, an incorporated city or town, a special district, or other political subdivision of the state. (7) Major aquifer-An aquifer which yields large quantities of water in a comparatively large area of the state. Major aquifers are located in the following formations: Ogallala, Alluvium and Bolsom Deposits, Edwards-Trinity (Plateau), Edwards (Balcones Fault Zone-San Antonio Region), Edwards (Balcones Fault Zone-Austin Region), Trinity Group, Carrizo-Wilcox, and Gulf Coast. (8) Natural barriers-The natural characteristics of a site or surface and subsurface composition that serves to impede the movement of radioactive material. Natural barriers may include, for example, the location of a facility remote from an aquifer, or the sorptive capability of the soil surrounding a facility. (9) Person affected-A person: (A) who is a resident of a county, or a county adjacent to the county, in which radioactive materials subject to the Texas Radiation Control Act (Act) are/or will be located, including any person who is doing business or who has a legal interest in land in the county or adjacent county, and any local government in the county; and (B) who shall demonstrate that he has suffered or will suffer actual injury or economic damage. (10) Processing-The storage, extraction of materials, transfer, volume reduction, compaction, incineration, solidification, or other separation and preparation of radioactive waste from other persons for reuse or disposal, including any treatment or activity that renders the waste less hazardous, safer for transport, or amenable to recovery, storage, or disposal. (11) Radioactive waste-Any discarded or unwanted radioactive material unless exempted by agency section or any radioactive material that would require processing before it could be put to a beneficial reuse. The term does not include byproduct material as defined in sec.289.201(b) of this title, uranium ore, naturally occurring radioactive material (NORM) waste, or oil and gas NORM waste. (12) Radioactive waste processing facility-A facility where radioactive waste received from other persons is processed and repackaged according to United States Department of Transportation (DOT) regulations. (13) Radioactive waste storage facility-A facility where radioactive waste received from other persons and packaged according to DOT regulations is stored while awaiting shipment to a licensed radioactive waste processing or disposal facility. (14) Reconnaissance level information-Any information or analysis that can be retrieved or generated without the performance of new comprehensive site- specific investigations. Reconnaissance level information includes, but is not limited to, relevant published scientific literature; drilling records required by state agencies, such as the Railroad Commission of Texas, the Texas Department of Water Resources, and the Texas Natural Resources Information System; and reports of governmental agencies. (15) Site-The real property, including the buffer zone, on which a radioactive waste processing or storage facility may be located. (16) Site monitoring-The procedures for the monitoring of the site and environment to assess quality of site operations and performance and to detect and quantify levels and types of radioactivity and chemicals in the environment. It includes preoperational, operational, and license termination phases. (17) Site operations-The routine day-to-day activities carried out at the site for the receipt, processing, and storage of radioactive waste. (18) Site suitability-The capability of the various characteristics of a processing or storage facility or site to safely contain the radioactive waste expected to be present at the site. (19) Sole source aquifer-The aquifer which is the sole or principal source of drinking water for an area designated under the Safe Drinking Water Act of 1974, 42 United States Codes Annotated 300f, et seq. (20) Transport group-Transport group is defined as: (A) Any one of seven groups into which radionuclides in normal form are classified, according to their toxicity and their relative potential hazard in transport, in sec.289.201(q)(1) of this title. (B) Any radionuclide not specifically listed in one of the groups in sec.289.201(q)(1) this title shall be assigned to one of the groups in accordance with the following table: Figure 1: 25 TAC sec.289.254(b)(20)(B) (21) Wetlands-Areas that are inundated or saturated by surface or groundwater at a frequency and duration sufficient to support and that, under normal circumstances, do support a prevalence of vegetation typically adapted for life in saturated soil conditions. Wetlands generally include playa lakes, swamps, marshes, bogs, and similar areas. (c) Activities requiring license. Except for persons exempted by this section, no person shall receive, possess, and store or process radioactive waste from another person except as authorized in a specific license issued pursuant to this section. (d) Radioactive waste processing and storage facility classification. (1) Classification of radioactive waste processing and storage facilities. Radioactive waste processing and storage facilities are classified according to the radionuclides, other than sealed sources, received, possessed, or processed in each of the transport groups, as defined in sec.289.201(b) of this title with all applicable provisions, except that, for the purposes of this section which apply to processing and storage of radioactive waste, Group IV shall include total possession limit of each group of unsealed (dispersible) radionuclides for each category of facility is as follows: Figure 2: 25 TAC sec.289.254(d)(1) (A) Class C storage facilities are those in which the applicable possession limit of radioactive waste exceeds any limit of class B storage facilities. (B) Class C processing facilities are those in which the applicable possession limit of radioactive waste exceeds any limit of class B processing facilities. (2) For mixtures of radionuclides, the following shall apply: (A) If the identity and respective activity of each radionuclide are known, the permissible activity of each radionuclide shall be such that the sum, for all groups present, of the ratio between the total activity for each group to the permissible activity for each group will not be greater than unity. (B) If the groups of the radionuclides are known but the amount in each group cannot be reasonably determined, the mixture shall be assigned to the most restrictive group present. (C) If the identity of all or some of the radionuclides cannot be reasonably determined, each of those unidentified radionuclides shall be considered as belonging to the most restrictive group which cannot be positively excluded. (D) Mixtures consisting of a single radioactive decay chain where the radionuclides are in the naturally occurring proportions shall be considered as consisting of a single radionuclide. The group and activity shall be that of the first member present in the chain, except that if a radionuclide "X" has a half- life longer than that of that first member and an activity greater than that of any other member, including the first, at any time during processing, the transport group shall be that of the nuclide "X" and the activity of the mixture shall be the maximum activity of that nuclide "X" during processing. (e) Exemptions. (1) Sealed sources. Persons who receive, possess, or process sealed sources of radioactive material as radioactive waste from other persons are exempt from this section, provided that: (A) encapsulated sources are tested upon receipt and determined to have less than 0.005 microcurie of removable contamination; and (B) sealed sources of radioactive material remain in sealed form after receipt. (2) Unsealed sources. (A) Persons who receive, possess, or process sources of radioactive material in unsealed form as radioactive waste from other persons are exempt from this section, provided that: (i) the total radioactivity of all radioactive waste possessed at any one time does not exceed the applicable limits for class A processing or storage facilities as described in subsection (d) of this section; and (ii) the total volume of radioactive waste processed in any one year does not exceed 50 cubic feet. (B) Persons who receive, possess, and store radioactive material in unsealed form as radioactive waste from other persons are exempt from this section provided that: (i) the radioactive waste consists only of radiopharmaceutical residues resulting from radiopharmaceuticals manufactured, compounded, and supplied by those persons receiving the radiopharmaceutical residues as radioactive waste; (ii) the radioactive waste is held in storage for decay to background radiation levels; and (iii) the radioactive waste is not shipped to a radioactive waste processing or disposal facility. (3) Radioactive material. A person who receives, possesses, and stores radioactive material as radioactive waste from sites owned and controlled by that same person is not considered to have received waste from other persons. (f) Filing application for specific license. (1) The applicant for a license to receive, possess, or process radioactive waste from other persons shall submit, on a form supplied by the agency, 10 copies of each license application or application for amendment and any supporting documents. Applications for issuance of licenses shall include all general and specific technical requirements, financial information, and environmental requirements, if applicable, described in this section. (2) The agency may at any time after the submission of the original application, and before the expiration of the license, require further statements or data to enable the agency to determine whether the application should be denied or whether a license should be granted, modified, or revoked. (3) The applicant or licensee or a person legally authorized to act for and on his behalf shall sign each application. (4) An application for a license may include a request for one or more of the activities specified in paragraph (1) of this subsection. (5) The applicant shall submit any applicable fees prescribed in this chapter. (6) In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the agency provided such references are clear and specific. (7) Applications or documents submitted to the agency in connection with licensing actions shall be made available for public inspection in accordance with provisions of the Texas Open Records Act, Government Code, Chapter 552. If the application contains information of the type described in the Texas Open Records Act which, the applicant wishes withheld from public disclosure, such information shall be submitted with the application under separate cover, along with a justification for withholding the information. (8) Each application must clearly demonstrate how the requirements of this subsection and subsections (g), (h), (i), (j), (t), and (u) of this section have been addressed. (9) If the applicant is a corporation under the Texas Business Corporation Act, written verification (either affidavit or tax receipt) shall be submitted with application to confirm that no tax owed the state is delinquent under Tax Code, Chapter 171. (10) Applications for licenses shall be processed in accordance with the following time periods. (A) The first period is a time from receipt of an application by the Division of Licensing, Registration and Standards to the date of issuance or denial of the license or a written notice outlining why the application is incomplete or unacceptable. This time period is 90 days. (B) The second period is a time from receipt of the last item necessary to complete the application to the date of issuance or denial of the license. This time period is 90 days. (C) These time periods are exclusive of any time period incident to hearings and post-hearing activities required by Government Code, Chapters 2001 and 2002. (11) Notwithstanding the provisions of 12.11(a) of TRCR Part 12 as adopted by reference in sec.289.126 of this title, reimbursement of application fees may be granted in the following manner. (A) In the event the application is not processed in the time periods as stated in paragraph (10) of this subsection, the applicant has the right to request of the director of the Radiation Control Program full reimbursement of all application fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied. (B) Good cause for exceeding the period established is considered to exist if: (i) the number of applications for licenses to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year; (ii) another public or private entity utilized in the application process caused the delay; or (iii) other conditions existed giving good cause for exceeding the established periods. (C) If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed in accordance with the formal hearing procedures of the Texas Department of Health, sec.sec.1.21-1.34 of this title (relating to Formal Hearing Procedures). (g) Application requirements. An applicant for a license under this section shall include the following information in the application to the agency: (1) identity of the applicant including the full name, address, telephone number, and description of the business(es) or occupation(s) of the applicant; (2) the organizational structure of the applicant, both off-site and on-site, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise; (3) a description of past operations that the applicant has been involved in including any license limitations, suspensions or revocations of such licenses, and any other information that will allow the agency to assess the applicant's past operating history; (4) the technical qualifications, including training and experience, of the applicant and members of the applicant's staff to engage in the proposed activities; and minimum training and experience requirements for personnel; (5) a description of the personnel training and retraining program; (6) a statement of need and a description of the proposed activities identifying: (A) the location of the proposed site; (B) the character of the proposed activities; (C) the types, chemical and/or physical forms and quantities of radioactive waste to be received, possessed, and processed; and (D) the plans for use of the facility for purposes other than processing of radioactive waste; (7) proposed time schedules for construction and receipt and processing of radioactive waste at the proposed facility; (8) description of the site and accurate drawings of the facility including, but not limited to: (A) construction; (B) foundation details; (C) ventilation; (D) plumbing and fire suppression systems; (E) physical security system; (F) storage areas; (G) radioactive waste handling or processing areas; (H) proximity to creeks or culverts; and (I) soil types under facility with respect to compatibility with foundation and structural design; (9) a flow diagram of radioactive waste processing operations; (10) a description and accurate drawings of processing equipment and any required special handling techniques to be employed; (11) a description of personnel monitoring methods, training, and procedures to be followed to keep employees from ingesting and inhaling radioactive materials, including a description of methods to keep the radiation exposure to levels as low as reasonably achievable; (12) a description of the site monitoring program to include prelicense data and proposed operational and postlicense monitoring programs for direct gamma radiation measurements and radioactive and chemical characteristics of the soils, groundwater, surface waters, and vegetation, as applicable; (A) for radioactive waste storage facilities, the applicant shall address on- site air quality; and (B) for radioactive waste processing facilities, the applicant shall address on-site and off-site air quality; (13) spill detection and cleanup plans for the licensed site and for associated transportation of radioactive material; (14) an Operating, Safety, and Emergency procedures manual that shall provide detailed procedures for receiving, handling, storing, processing, and shipping radioactive waste; (15) for radioactive waste processing facilities, a description of the equipment to be installed to maintain control over maximum concentrations of radioactive materials in gaseous and liquid effluents produced during normal operations and the means to be employed for keeping levels of radioactive material in effluents to unrestricted areas as low as reasonably achievable and within the limits listed in sec.289.113 of this title; and (16) methods of ultimate disposal and decommissioning, and the system for maintaining inventory of receipt, storage, and transfer of radioactive waste. (h) Financial assurance and record keeping for decommissioning. (1) The applicant for each specific license authorizing the receipt, possession, transport, storage, and processing of radioactive waste from other persons with a half-life greater than 120 days and in quantities exceeding 10 [sup]5 times the applicable quantities set forth in sec.289.252(w) (6) of this title shall submit a decommissioning funding plan as described in paragraph (5) of this subsection. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 10 [sup]5 is greater than 1 (unity rule), where R is defined as the sum of the ratios of the quantity of each isotope to the applicable value in sec.289.252(w)(6) of this title. (2) The applicant for each specific license authorizing receipt, possession, transport, storage, and processing of radioactive waste from other persons with a half-life greater than 120 days and in quantities specified in paragraph (4) of this subsection shall either: (A) submit a decommissioning funding plan as described in paragraph (5) of this subsection; or (B) submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (4) of this subsection using one of the methods described in paragraph (6) of this subsection. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued, but prior to the receipt of radioactive waste. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection is to be submitted to the agency. (3) The holder of each specific license issued: (A) on or after March 1, 1995, which is of a type described in paragraph (1) or (2) of this subsection, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section; (B) before March 1, 1995, and of a type described in paragraph (1) of this subsection shall submit, on or before March 1, 1996, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount at least equal to $750,000, in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal; or (C) before March 1, 1995, and of a type described in paragraph (2) of this subsection shall submit, on or before March 1, 1996, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this section. (4) The required amounts of financial assurance for decommissioning are determined by quantity of material and are as follows: (A) $750,000 for quantities of material greater than 10[sup]4 but less than or equal to 10[sup]5 times the applicable quantities in sec.289.252(w)(6) of this title in unsealed form. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10[sup]4 is greater than 1 but R divided by 10 point=5.02p [sup]5 is less than or equal to 1.); (B) $150,000 for quantities of material greater than 10[sup]3 but less than or equal to 10[sup]4 times the applicable quantities in sec.289.252(w)(6) of this title in unsealed form. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10[sup]3 is greater than 1 but R divided by 10 point=5.02p [sup]4 is less than or equal to 1.); or (C) $75,000 for quantities of material greater than 10 point=5.02p [sup]10 times the applicable quantities in sec.289.252(w)(6) of this title in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in paragraph (1) of this subsection, divided by 10 point=5.02p [sup]10 is greater than 1.) (5) Each decommissioning funding plan must contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from paragraph (6) of this subsection, including means of adjusting cost estimates and associated funding levels periodically over the life of the facility. (6) Financial assurance for decommissioning must be provided by one or more of the following methods. (A) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. (B) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid should the licensee default. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in sec.289.252(w)(3) of this title. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions. (i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the agency, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the agency within 30 days after receipt of notification of cancellation. (ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the agency. An acceptable trustee includes an appropriate state or federal government agency or an entity that has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency. (iii) The surety method or insurance must remain in effect until the agency has terminated the license. (C) External sinking fund. An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in subparagraph (B) of this paragraph. (D) Statement of intent. In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount pursuant to paragraph (4) of this subsection, and indicating that funds for decommissioning will be obtained when necessary. (7) Each person licensed under this part shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the license is terminated by the agency. If records of relevant information are kept for other purposes, reference to these records and their locations may be used. Information the agency considers important to decommissioning consists of: (A) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas, as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations. (B) As-built drawings and modifications of structures and equipment in restricted areas where radioactive waste is processed and/or stored, and of locations of possible inaccessible contamination such as buried pipes that may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations. (C) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used. (i) Emergency plan for responding to a release. (1) An application for each specific license authorizing the receipt, possession, transport, storage, and processing of radioactive waste from other persons in excess of the quantities in sec.289.252(w)(4) of this title must contain either: (A) an evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or (B) an emergency plan for responding to a release of radioactive waste. (2) One or more of the following factors may be used to support an evaluation submitted pursuant to paragraph (1)(A) of this subsection: (A) the radioactive waste is physically separated so that only a portion could be involved in an accident; (B) all or part of the radioactive waste is not subject to release during an accident because of the way it is stored or packaged; (C) the release fraction in the respirable size range would be lower than the release fraction shown in sec.289.252(w)(4) of this title due to the chemical or physical form of the waste; (D) the solubility of the radioactive waste would reduce the dose received; (E) facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in sec.289.252(w)(4) of this title; (F) operating restrictions or procedures would prevent a release fraction as large as that shown in sec.289.252(w)(4) of this title; or (G) other factors appropriate for the specific facility. (3) An emergency plan for responding to a release of radioactive waste submitted pursuant to paragraph (1)(B) of this subsection must include the following information: (A) a brief description of the licensee's facility and area near the site; (B) an identification of each type of radioactive waste accident for which protective actions may be needed; (C) a classification system for classifying accidents as alerts or site area emergencies; (D) identification of the means of detecting each type of accident in a timely manner; (E) a brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment; (F) a brief description of the methods and equipment to assess releases of radioactive waste; (G) a brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the agency; also, responsibilities for developing, maintaining, and updating the plan; (H) a commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Publication L. 99-499 or other state or federal reporting requirements; (I) a brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the agency; (J) a brief description of the frequency, performance objectives, and plans for the training that the licensee will provide workers on how to respond to an emergency, including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios; (K) a brief description of the means of restoring the facility to a safe condition after an accident; (L) provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected; and (M) a certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Publication L. 99-499, if applicable to the applicant's activities at the proposed place of processing and/or storage of radioactive waste. (4) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the agency. The licensee shall provide any comments received within the 60 days to the agency with the emergency plan. (j) Additional environmental requirements for class C facilities. An application for a license for a class C processing or storage facility shall include environmental information which may be based on reconnaissance level information when appropriate and addresses the following: (1) description of present land uses and population distribution in the vicinity of the site: (A) for radioactive waste storage facilities, the description shall address properties adjacent to the site; and (B) for radioactive waste processing facilities, the description shall address properties adjacent to the site and shall include population distribution within a one-mile radius of the site; (2) area/site suitability including geology, hydrology, and natural hazards. For radioactive waste processing facilities, area meteorology also shall be addressed; (3) site and project alternatives including alternative siting analysis; (4) socioeconomic effects on surrounding communities of operation of the licensed activity and of associated transportation of radioactive material; and (5) environmental effects of postulated accidents. (k) Issuance of license. A license for a radioactive waste processing or storage facility will be issued if the agency finds reasonable assurance that: (1) the proposed radioactive waste facility will be sited, designed, operated, decommissioned, and closed in accordance with this section; and (2) the issuance of the license will not be inimical to the health and safety of the public or the environment. (l) Commencement of major construction. Commencement of major construction is prohibited until 30 days after the agency has given notice that a license is to be granted or renewed, and the environmental analysis is available. If a hearing is requested, the commencement of major construction is prohibited until notice of the contested case hearing is noticed in accordance with the Act. Commencement of major construction subsequent to issuance of the notices is at the economic risk of the applicant. (m) Commencement of operations. No licensee issued a license under this section may commence operations until the licensee has obtained licenses or permits from other agencies as required by law. (n) Specific terms and conditions to license. (1) Each license issued pursuant to this section shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the agency. (2) No license issued or granted under this section and no right to possess or utilize radioactive material granted by any license issued pursuant to this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency shall, after securing full information, find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing. (3) Each person licensed by the agency pursuant to this section shall confine his use and possession of the material licensed to the locations and purposes authorized in the license. (4) A license issued under this section shall include license conditions derived from the evaluations of the application and analyses performed by the agency, including amendments and changes made before a license is issued. License conditions may include but are not limited to items in the following categories: (A) restrictions as to the total radioactive inventory of radioactive waste to be received; (B) restrictions as to size, shape, and materials and methods of construction of radioactive waste packaging and maximum number of package units stored, at any one time; (C) restrictions as to the physical and chemical form and radioisotopic content and concentration of radioactive waste; (D) controls to be applied to restrict access to the site; (E) controls to be applied to maintain and protect the health and safety of the public and site employees and the environment; (F) administrative controls, which are the provisions relating to organization, management, and operating procedures; record-keeping, review and audit; and reporting necessary to assure that activities at the facility are conducted in a safe manner and in conformity with agency rules and license conditions; and (G) maximum retention time for radioactive waste received at the facility. (5) Each licensee shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapters of Title 11 (Bankruptcy) of the United States Code (11 U.S. C.) by or against: (A) a licensee; (B) an entity (as that term is defined in 11 U.S.C. 101(14)) controlling a licensee or listing the license or licensee as property of the estate; or (C) an affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee. (6) The notification required in paragraph (5) of this subsection must indicate: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the date of the filing of the petition. (o) Expiration of license. Except as provided in subsection (p)(2) of this section, each specific license shall expire at the end of the day, in the month and year stated on the license. (p) Renewal of license. (1) Application for renewal of specific licenses shall be filed in accordance with subsection (f) of this section. (2) In any case in which a licensee, not less than 90 days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the agency has made a final determination on the application. (3) The licensee is responsible for decommissioning the facility and continued safe storage of any radioactive waste whether an application for continued receipt of wastes is filed or not. (q) Amendment of license at request of licensee. Applications for amendment of a license shall be filed in accordance with subsection (f) of this section, except that the requirements of subsection (f)(5) of this section may be waived at the discretion of the agency. Such applications shall also specify how the licensee desires his license to be amended and the basis for such amendment. (r) Agency action on application to renew or amend. In considering an application by a licensee to renew or amend his license, the agency will apply the criteria set forth in subsection (k) of this section. (s) Modification, revocation, and termination of licenses. (1) The terms and conditions of all licenses shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the agency. (2) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection, or other means which would warrant the agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or the license, or of any rule, regulation, or order of the agency. (3) Except in cases of willfulness or an agency determination that an emergency exists in which the public health, interest, or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been afforded an opportunity to demonstrate or achieve compliance with all lawful requirements. (4) The agency may terminate a specific license upon request submitted by the licensee to the agency in writing. (t) Site suitability criteria. The following requirements specify the characteristics which a new site must have to be acceptable for licensure. (1) The overall hydrogeologic environment of the site, in combination with engineering design, shall act to minimize and control potential radioactive waste migration into surface water and groundwaters. (2) No new site shall be located in a 100-year floodplain as designated by the Texas Natural Resource Conservation Commission or wetland. (3) No new site shall be located in the recharge area of a sole source aquifer or a major aquifer unless it can be demonstrated with reasonable assurance that the new site will be designed, constructed, operated, and closed without an unreasonable risk to the aquifer. (u) Minimum criteria for facility design and operation. (1) The building used for processing radioactive wastes shall have a minimum classification of Type II (111) in accordance with National Fire Protection Association 220 titled Standards Types of Building Construction. (A) Buildings used for processing or storage of radioactive wastes shall have ventilation and fire protection systems to minimize the release of radioactive materials into the soils, waters, and the atmosphere. (B) Facilities and equipment for repackaging leaking and/or damaged containers shall be provided. (2) The design and operation of the radioactive waste processing or storage facility shall be such that: (A) releases of non-radiological noxious materials from the facility are minimized; and (B) radiation levels, concentrations, and potential exposures off-site due to airborne releases during operations are within the limits established in sec.289.113 of this title and are maintained as low as reasonably achievable. (3) The design and operation of the radioactive waste processing or storage facility shall be compatible with the objectives of the site closure and decommissioning funding plan. (4) The facility shall be designed to confine spills. Independent and diverse engineered barriers shall be provided, as necessary, to complement natural barriers in minimizing potential releases from the facility and in complying with this section. (5) The location and construction of any new radioactive waste processing facility shall have a buffer zone adequate to permit emergency measures to be implemented following accidents and to address airborne plume dispersions and, as a minimum, shall be such that: (A) the active components of a class B facility are located at least 30 meters from the nearest residence as of the date of the license application; and (B) the active components of a class C facility are located at least 30 meters from the nearest property not owned or occupied by the licensee. (v) Waste processing and packaging requirements. All processed radioactive waste offered for transport or disposal must meet: (1) all applicable transportation requirements of the agency, the Commission and of the DOT; and (2) all applicable disposal facility license conditions. (w) Environmental assessment. A written analysis of the impact on the human environment will be prepared or secured by the agency for any license for a class C processing or storage facility and shall be available to the public for written comment at least 30 days prior to the beginning of a hearing, if any, on the issuance or renewal of the license. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510246 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: March 28, 1995 For further information, please call: (512) 458-7236 The Texas Department of Health (department) adopts the repeal of sec.289.111 and new sec.289.201, concerning general provisions and requirements for persons who inspect medical, podiatric medical, dental, veterinary, and chiropractic electronic products to have specialized training in the design and use of the product, without changes to the proposed text as published in the April 18, 1995, issue of the Texas Register (20 TexReg 2775). However, the proposed text contained two errors in subsection (b)(22) and (b) (31) for which a correction of error was published in the May 9, 1995, issue of the Texas Register (20 TexReg 3495). Unfortunately the correction of error notice contained errors as well and had to be republished in the July 11, 1995, issue of the Texas Register (20 TexReg 5082). The repealed section adopted by reference Part 11, titled "General Provisions" of the Texas Regulations for Control of Radiation (TRCR). The adopted new section incorporates language from Part 11 that has been rewritten in Texas Register format and covers general provisions and adds requirements for persons who inspect medical, podiatric medical, dental, veterinary, and chiropractic electronic products to have specialized training in the design and use of the products. The Burea of Radiation Control (BRC) has developed a training curriculum education/training curriculum for current x-ray inspectors. Also, a paragraph was added to specify the subjects covered in the curriculum. These requirements are added in order to implement House Bill 781, which states that the Board of Health, by regulation, shall require this training for inspectors of electronic devices. The repeal and new section are part of the first phase in the process for converting existing sections that adopt by reference the various parts of the TRCR to Texas Register format. The following is a comment made on the proposed section and the department's response to that comment. Comment. A commenter expressed concerns in the training of inspectors for electronic devices by department personnel. The commenter believes that House Bill 781 was necessary to correct a problem it observed in the training of inspectors and that resulted in an apparent technical weakness of the inspectors after being trained by department personnel. The commenter suggested that the department contract with one of the state universities for conducting the training courses (see subsection (e)(6)). Response. The department believes the current department training program for x-ray inspectors meets the intent of House Bill 781. The current training is a revision of previous training provided and represents a formalization of the curriculum, the process, the evaluation tools, and the continuing training component. No additional funding was provided to the department to cover the cost of training specified in House Bill 781. Therefore, obtaining this type of training outside of the department is not economically feasible. The department made no change to the section as a result of the comment. The commenter was a representative from Richmond Imaging Associates in Houston. The commenter expressed opposition to a provisions in the section and presented suggestions for changes to the proposed amendment as previously discussed. 25 TAC sec.289.111 The repeal is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510245 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 458-7236 25 TAC sec.289.201 The new section is adopted under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health with the 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 rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on August 9, 1995. TRD-9510244 Susan K. Steeg General Counsel Texas Department of Health Effective date: October 1, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 458-7236 TITLE 34. PUBLIC FINANCE Part I. Comptroller of Public Accounts Chapter 3. Tax Administration Subchapter GG. Insurance Tax 34 TAC sec.3.809 The Comptroller of Public Accounts adopts an amendment to sec.3.809, concerning the overpayment of premium tax liability, without changes to the proposed text as published in the April 18, 1995, issue of the Texas Register (20 TexReg 2811). The amendment revises the method the taxpayer uses to have an overpayment applied to future prepayments. The amendment also eliminates the requirement that the taxpayer indicate that either all or a portion of a particular prepayment premium tax liability will be exhausted or reduced by the existing overpayment carried forward from the previous tax year. No comments were received regarding adoption of the amendment. The amendment is adopted under the Tax Code, sec.111.002, which provides the comptroller with the authority to prescribe, adopt, and enforce rules relating to the administration and enforcement of the provisions of the Tax Code, Title 2. The amendment implements the Insurance Code, Article 4.10, sec.6(b); Article 4.11, sec.13; and Article 9.59, sec.3(b). This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 15, 1995. TRD-9510368 Martin Cherry Chief, General Law Comptroller of Public Accounts Effective date: September 6, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 463-4028 34 TAC sec.3.810 The Comptroller of Public Accounts adopts the repeal of sec.3.810, concerning use of reproduction or facsimile copies of tax forms, without changes to the proposed text as published in the April 18, 1995, issue of the Texas Register (20 TexReg 2811). House Bill 1461, 73rd Legislature, 1993, transferred tax collection to the Comptroller of Public Accounts and created the Insurance Code, Article 1.04D, which gives the comptroller the authority to prescribe appropriate report forms. This section is obsolete and is not consistent with policies of the comptroller that allow taxpayers to file using copies of report forms. There are no restrictions regarding color, size, weight, or margins in order to file tax reports. No comments were received regarding adoption of the repeal. The repeal is adopted under the Tax Code, sec.111.002, which provides the comptroller with the authority to prescribe, adopt, and enforce rules relating to the administration and enforcement of the provisions of the Tax Code, Title 2. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 15, 1995. TRD-9510367 Martin Cherry Chief, General Law Comptroller of Public Accounts Effective date: September 6, 1995 Proposal publication date: April 18, 1995 For further information, please call: (512) 463-4028 TITLE 40. SOCIAL SERVICES AND ASSISTANCE Part I. Texas Department of Human Services Chapter 72. Memoranda of Understanding with Other State Agencies Memorandum of Understanding with the Texas Department of Criminal Justice 40 TAC sec.72.4001 The Texas Department of Human Services (DHS) adopts new sec.72.4001, without changes to the proposed text as published in the July 11, 1995, issue of the Texas Register (20 TexReg 5051). The new sec.72.4001 adopts by reference Texas Administrative Code Title 37, Public Safety and Corrections, Part VI, Texas Department of Criminal Justice, Chapter 15, Special Programs; sec.159.5 and sec.159.7 which was proposed in the April 4, 1995, issue of the Texas Register (20 TexReg 2523) and was adopted without changes in the May 16, 1995, issue of the Texas Register (20 TexReg 3673). The justification for the new section is to implement the requirement in Senate Bill 252, enacted by the 73rd Legislature, that DHS enter into two memoranda of understanding with the Texas Department of Criminal Justice (TDCJ) and other health and human service agencies in order to develop and implement a continuity of care system for offenders with physical disabilities and elderly offenders. The new section will function by ensuring that communication and coordination between the various health and human services agencies and the TDCJ system will be improved. The department received no comments regarding adoption of this new section. The new section is adopted under the Human Resources Code, Title 2, Chapter 22, which provides the department with the authority to administer public assistance programs. The new section implements the Human Resources Code sec. sec.22.001-22.024. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on August 15, 1995. TRD-9510296 Nancy Murphy Section, Manager Media and Policy Services Texas Department of Human Services Effective date: September 5, 1995 Proposal publication date: July 11, 1995 For further information, please call: (512) 450-3765