(a) Purpose. The intent of this section is as follows.(1) This section provides for the specific licensing of radioactive material.(2) Unless otherwise exempted, no person may manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material except as authorized by:(A) a specific license issued under this section and any of the following sections:(i) §289.253 of this subchapter (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies);(ii) §289.255 of this subchapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography);(iii) §289.256 of this subchapter (relating to Medical and Veterinary Use of Radioactive Material);(iv) §289.258 of this subchapter (relating to Licensing and Radiation Safety Requirements for Irradiators); or(v) §289.259 of this subchapter (relating to Licensing of Naturally Occurring Radioactive Material (NORM)); or(B) a general license or general license acknowledgment issued under §289.251 of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements).(3) A person who manufactures, produces, receives, possesses, uses, transfers, owns, or acquires radioactive materials before receiving a license is subject to the requirements of this chapter.(b) Scope. In addition to the requirements of this section, the following requirements are applicable.(1) All licensees, unless otherwise specified, are subject to the requirements in:(A) §289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) §289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials);(C) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(E) §289.205 of this chapter (relating to Hearing and Enforcement Procedures); and(F) §289.257 of this subchapter (relating to Packaging and Transportation of Radioactive Material).(2) Licensees engaged in well logging service operations and tracer studies are subject to the requirements of §289.253 of this subchapter.(3) Licensees engaged in industrial radiographic operations are subject to the requirements of §289.255 of this subchapter.(4) Licensees using radioactive material for medical or veterinary use are subject to the requirements of §289.256 of this subchapter.(5) Licensees using sealed sources in irradiators are subject to the requirements of §289.258 of this subchapter.(6) Licensees possessing or using naturally occurring radioactive material are subject to the requirements of §289.259 of this subchapter.(c) Types of licenses. There are two types of licenses for radioactive materials: general and specific.(1) General licenses provided in §289.251 and §289.259 of this subchapter are effective without the filing of applications with the department or the issuance of licensing documents, although filing an application for acknowledgement with the department may be required for a particular general license. The general licensee is subject to any other applicable portions of this chapter and any conditions or limitations of the general license.(2) Specific licenses require the submission of an application to the department and the issuance of a licensing document by the department. The licensee is subject to all applicable portions of this chapter as well as any conditions or limitations specified in the licensing document.(d) Filing application for specific licenses. The department may request additional information at any time to determine if the application should be granted or denied or if an existing license should be modified or revoked.(1) Applications for specific licenses must be filed in a manner prescribed by the department.(2) Each application must be signed by the chief executive officer or other individual delegated the authority to manage, direct, or administer the licensee's activities.(3) An application for a license may include a request for a license authorizing one or more activities. The department may require the issuance of separate specific licenses for those activities.(4) An application for a license may include a request for more than one use location on the license. The department may require the issuance of a separate license for additional locations more than 30 miles from the main site specified on a license.(5) Each application for a specific license, other than a license exempted from §289.204 of this chapter, must be accompanied by the fee prescribed in §289.204 of this chapter.(6) Each application must be accompanied by a completed RC Form 252-1 (Business Information Form).(7) Each applicant must demonstrate to the department the applicant is financially qualified to conduct the activity requested for licensure, including any required decontamination, decommissioning, reclamation, and disposal before the department issues a license. Each licensee must demonstrate to the department it remains financially qualified to conduct the licensed activity before a license is renewed. Methods for demonstrating financial qualifications are specified in subsection (jj)(8) of this section. Demonstrating financial qualifications is separate from the requirement as specified in subsection (gg) of this section for certain applicants or licensees to provide financial assurance.(8) If facility drawings submitted in conjunction with the license application are prepared by a professional engineer or engineering firm, those drawings must be final and must be signed, sealed, and dated as specified in the requirements of the Texas Board of Professional Engineers and Land Surveyors, 22 Texas Administrative Code (TAC) Chapter 137 (relating to Compliance and Professionalism for Engineers).(9) Applications for licenses must be processed according to the following time periods.(A) The first period is the time from receipt of an application by the department 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 Texas Government Code, Chapter 2001.(10) Except as provided in this paragraph, an application for a specific license to use radioactive material in the form of a sealed source or in a device containing the sealed source must:(A) identify the source or device by manufacturer and model number as registered under subsection (v) of this section or with equivalent regulations of the United States Nuclear Regulatory Commission (NRC) or any agreement state, or for a source or a device containing radium-226 or accelerator-produced radioactive material registered under subsection (v) of this section; or(B) contain the information as specified in subsection (v)(3) - (4) of this section.(11) For sources or devices manufactured before October 23, 2012, that are not registered under subsection (v) of this section or with equivalent regulations of the NRC or any agreement state, and for which the applicant is unable to provide all categories of information as specified in subsection (v)(3) - (4) of this section, the application must include:(A) all available information identified in subsection (v)(3) - (4) of this section concerning the source, and, if applicable, the device; and(B) sufficient additional information to demonstrate there is reasonable assurance the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include:(i) a description of the source or device;(ii) a description of radiation safety features;(iii) the intended use and associated operating experience; and(iv) the results of a recent leak test.(12) For sealed sources and devices allowed to be distributed without registration of safety information as specified in subsection (v)(8)(A) of this section, the applicant must supply the manufacturer, model number, radionuclide, and quantity.(13) If it is not feasible to identify each sealed source and device individually, the applicant must propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, instead of identifying each sealed source and device.(14) Notwithstanding the provisions of §289.204(d)(1) of this chapter, reimbursement of application fees may be granted in the following manner.(A) If the application is not processed within the time periods stated in paragraph (9) of this subsection, the applicant may request a full reimbursement of all application fees paid in that application process from the director of the Radiation Control Program. 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 percent 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 according to 1 TAC Chapter 155 (relating to Rules of Procedure), and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title.(15) Applications for licenses may be denied for:(A) any materially false statement in the application or any statement of fact required under provisions of the Texas Radiation Control Act (Act);(B) conditions revealed by the application or statement of fact or any report, record, or inspection, or other means warranting department refusal to grant a license on an application; or(C) failure to clearly demonstrate how the requirements in this chapter are addressed.(16) Action on a specific license application is considered abandoned if the applicant does not respond within 30 days from the date of a request by the department for any information. Abandonment of these actions does not provide an opportunity for a hearing, but the applicant retains the right to resubmit the application as specified in paragraphs (1) - (8) of this subsection.(e) General requirements for the issuance of specific licenses. A license application will be approved if the department determines:(1) the applicant and all personnel who handle the radioactive material are qualified by training and experience to use the material for the purpose requested under this chapter in such a manner as to minimize danger to occupational and public health and safety, life, property, and the environment;(2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to occupational and public health and safety, life, property, and the environment;(3) the issuance of the license will not be harmful to the health and safety of the public;(4) the applicant satisfies any applicable special requirement in this section and other sections as specified in subsection (a)(2)(A) of this section;(5) the radiation safety information submitted for requested sealed sources or devices containing radioactive material complies with subsection (v) of this section;(6) qualifications of the designated radiation safety officer (RSO) as specified in subsection (f) of this section are adequate for the purpose requested in the application;(7) the applicant submitted adequate operating, safety, and emergency procedures;(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 (ee) of this section);(9) the owner of the property is aware radioactive material is stored or used on the property. If the proposed facility is not owned by the applicant, the applicant must provide a written statement from the owner, or from the owner's agent, indicating such. This paragraph does not apply to property owned or held by a government entity or to property on which radioactive material is used under an authorization for temporary job site use;(10) there is no reason to deny the license as specified in subsections (d)(13) or (x)(9) of this section; and(11) the applicant possesses a current registration with the Texas Secretary of State (SOS) to conduct business in the state unless the applicant is exempt. All applicants using an assumed name in their application must file an assumed name certificate as required under Texas Business and Commerce Code, Chapter 71.(f) RSO.(1) An RSO must be designated for every license issued by the department. A single individual may be designated as RSO for more than one license if authorized by the department.(2) The RSO's documented qualifications must include, at a minimum:(A) possession of a high school diploma or a certificate of high school equivalency based on the General Educational Development (GED) test;(B) completion of the training and testing requirements as 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) Every licensee must establish in writing the authority, duties, and responsibilities of the RSO and ensure the RSO is provided sufficient authority, organizational freedom, time, resources, and management prerogative to perform the specific duties of the RSO, including:(A) establishing and overseeing operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and reviewing them at least annually to ensure the procedures are current and conform with this chapter;(B) overseeing and approving all phases of the training program for operations and personnel so appropriate and effective radiation protection practices are taught;(C) ensuring required radiation surveys and leak tests are performed and documented as specified in this chapter, including any corrective measures when levels of radiation exceed established limits;(D) ensuring individual monitoring devices are used properly by occupationally exposed personnel, records are kept of the monitoring results, and timely notifications are made as specified in §289.203 of this chapter;(E) investigating and causing a report to be submitted to the department for each known or suspected case of radiation exposure to an individual or radiation level detected over the limits established by this chapter, determining the cause or causes, and taking steps to prevent recurrence;(F) investigating and causing a report to be submitted to the department for each theft or loss of radiation sources, determining the cause or causes, and taking steps to prevent recurrence;(G) investigating and causing a report to be submitted to the department for each known or suspected case of release of radioactive material to the environment over the limits established by this chapter;(H) having a thorough knowledge of management policies and administrative procedures of the licensee;(I) assuming control and having the authority to institute corrective actions, including shutdown of operations when necessary in emergency situations or unsafe conditions;(J) ensuring records are maintained as required by this chapter;(K) ensuring the proper storing, labeling, transport, use, and disposal of sources of radiation;(L) ensuring inventories are performed according to the activities for which the license application is submitted;(M) performing a physical inventory of the radioactive sealed sources authorized for use on the license every six months. Written records of the inventory must be made, maintained, and retained as specified in subsection (mm) of this section. Inventory records must include:(i) isotopes;(ii) quantities;(iii) activities;(iv) date inventory is performed;(v) location;(vi) unique identifying number or serial number; and(vii) signature of person performing the inventory;(N) ensuring personnel are complying with this chapter, the conditions of the license, and the operating, safety, and emergency procedures of the licensee;(O) serving as the primary contact with the department; and(P) having knowledge of and ensuring compliance with federal and state security measures for radioactive material.(4) The RSO must ensure the duties listed in paragraph (3)(A) - (P) of this subsection are performed.(5) The RSO must be on site periodically, appropriate to the scope of licensed activities, to satisfy the requirements of paragraphs (3) and (4) of this subsection.(6) The RSO, or a Site RSO designated on the license, must be capable of physically arriving at the licensee's authorized use site or sites within a reasonable time of being notified of an emergency or unsafe condition. A Site RSO must meet the qualifications in paragraph (2) of this subsection.(7) Requirements for an RSO for specific licenses for broad scope authorization for research and development. In addition to the requirements in paragraphs (1) and (3) - (6) of this subsection, the RSO's qualifications for specific licenses for broad scope authorization for research and development must include:(A) a bachelor's degree in health physics, radiological health, physical science, or a biological science with a physical science minor and four years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed; or(B) a master's degree in health physics or radiological health and three years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed; or(C) two years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed and one of the following:(i) doctorate degree in health physics or radiological health;(ii) comprehensive certification by the American Board of Health Physics;(iii) certification by the American Board of Radiology in Nuclear Medical Physics;(iv) certification by the American Board of Science in Nuclear Medicine in Radiation Protection; or(v) certification by the American Board of Medical Physics in Medical Health Physics; or(D) equivalent qualifications as approved by the department. (8) The qualifications in paragraph (7)(A) - (D) do not apply to individuals who have been adequately trained and designated as an RSO on licenses issued before October 1, 2000.(g) Duties and responsibilities of the Radiation Safety Committee (RSC). The duties and responsibilities of the RSC include:(1) meeting as often as necessary to conduct business but no less than three times a year;(2) reviewing summaries of the following information presented by the RSO:(A) over-exposures;(B) significant incidents, including spills, contamination, or medical events; and(C) items of non-compliance following an inspection;(3) reviewing the program for maintaining doses ALARA, and providing any necessary recommendations to ensure doses are ALARA;(4) reviewing the overall compliance status for authorized users;(5) sharing responsibility with the RSO to conduct periodic audits of the radiation safety program;(6) reviewing the audit of the radiation safety program and acting upon the findings;(7) developing criteria to evaluate training and experience of new authorized user applicants;(8) evaluating and approving authorized user applicants who request authorization to use radioactive material at the facility;(9) evaluating new uses of radioactive material;(10) reviewing and approving permitted program and procedural changes before implementation; and(11) having knowledge of and ensuring compliance with federal and state security measures for radioactive material.(h) Specific licenses of broad scope.(1) Types of specific licenses of broad scope.(A) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license. The quantities specified are usually in the multicurie range.(B) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material as specified in subsection (jj)(10) of this section.(i) The possession limit for a Type B specific license of broad scope, if only one radionuclide is possessed under such a license, is the quantity specified for that radionuclide in subsection (jj)(10) of this section.(ii) If two or more radionuclides are possessed under such a license, the possession limit for each is determined as follows:(I) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity as specified in subsection (jj)(10) of this section for that radionuclide.(II) The sum of the ratios for all radionuclides possessed under the license must not exceed unity.(C) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in subsection (jj)(10) of this section.(i) The possession limit for a Type C specific license of broad scope, if only one radionuclide is possessed under such a license, is the quantity specified for that radionuclide in subsection (jj)(10) of this section.(ii) If two or more radionuclides are possessed under such a license, the possession limit is determined for each as follows:(I) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity as specified in subsection (jj)(10) of this section for that radionuclide.(II) The sum of the ratios for all radionuclides possessed under the license must not exceed unity.(2) An application for a Type A specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section;(B) the applicant has engaged in a reasonable number of activities involving the use of radioactive material; and(C) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:(i) the establishment of an RSC composed of an RSO, a representative of management, and persons trained and experienced in the safe use of radioactive materials to fulfill the duties and responsibilities as specified in subsection (g) of this section;(ii) the appointment of a full-time RSO meeting the requirements of subsection (f)(7) or (8) of this section who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and(iii) the establishment of appropriate administrative procedures to ensure:(I) control of procurement and use of radioactive material; (II) completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and(III) review, approval, and recording by the RSC of safety evaluations of proposed uses prepared as specified in subclause (II) of this clause before use of the radioactive material.(3) An application for a Type B specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section; and(B) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:(i) the appointment of an RSO who is qualified by training and experience in radiation protection, and who is available for advice and assistance on safety matters; and(ii) the establishment of appropriate administrative procedures to ensure:(I) control of procurement and use of radioactive material; (II) completion of safety evaluations of proposed uses of radioactive material that take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and(III) review, approval, and recording by the RSO of safety evaluations of proposed uses prepared under subclause (II) of this clause before use of the radioactive material.(4) An application for a Type C specific license of broad scope will be approved if:(A) the applicant satisfies the general requirements as specified in subsection (e) of this section;(B) the applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:(i) a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and(ii) at least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and(C) the applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.(5) An application filed pursuant to subsection (e) of this section for a specific license other than one of broad scope is considered by the department as an application for a specific license of broad scope if the applicable requirements of this subsection are satisfied.(6) The following conditions apply to specific licenses of broad scope.(A) Unless specifically authorized by a separate license, a person licensed under this subsection must not:(i) conduct tracer studies in the environment involving direct release of radioactive material;(ii) receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;(iii) conduct activities for which a specific license issued by the department under subsections (i) - (u) of this section and §289.255, §289.256, and §289.259 of this subchapter is required;(iv) 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(v) commercially distribute radioactive materials.(B) Each Type A specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSC.(C) Each Type B specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSO.(D) Each Type C specific license of broad scope issued under this subsection is subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of paragraph (4) of this subsection.(i) Specific licenses for introduction of radioactive material into products in exempt concentrations. A person must not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to a person exempt under §289.251 of this subchapter except as specified with a license issued by the NRC.(j) Specific licenses for commercial distribution of radioactive material in exempt quantities.(1) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material, byproduct material, or naturally occurring and accelerator-produced radioactive material (NARM) 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 (NRC), Washington, DC 20555 under